WorldWideScience

Sample records for cell research oversight

  1. Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies

    International Nuclear Information System (INIS)

    Wolf, Susan M.; Jones, Cortney M.

    2011-01-01

    The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health and Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research—nanomedicine—is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.

  2. Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies

    Science.gov (United States)

    Wolf, Susan M.; Jones, Cortney M.

    2011-04-01

    The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research—nanomedicine—is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.

  3. Oversight framework over oocyte procurement for somatic cell nuclear transfer: comparative analysis of the Hwang Woo Suk case under South Korean bioethics law and U.S. guidelines for human embryonic stem cell research.

    Science.gov (United States)

    Kim, Mi-Kyung

    2009-01-01

    We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang's potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight framework of the Bioethics and Biosafety Act in South Korea and the US National Academies' Guidelines for Human Embryonic Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act would institute centralized oversight under governmental auspices while the Guidelines recommend politically-independent, decentralized oversight bodies including a special review body for human embryonic stem cell research at an institutional level and that the Guidelines would have provided more vigorous protection for the women who had undergone oocyte procurement for Hwang's research than the Act. We also suggest additional regulations to protect those who provide oocytes for research in South Korea.

  4. Oversight and management of a cell therapy clinical trial network: experience and lessons learned.

    Science.gov (United States)

    Moyé, Lemuel A; Sayre, Shelly L; Westbrook, Lynette; Jorgenson, Beth C; Handberg, Eileen; Anwaruddin, Saif; Wagner, Kristi A; Skarlatos, Sonia I

    2011-09-01

    The Cardiovascular Cell Therapy Research Network (CCTRN), sponsored by the National Heart, Lung, and Blood Institute (NHLBI), was established to develop, coordinate, and conduct multiple collaborative protocols testing the effects of cell therapy on cardiovascular diseases. The Network was born into a difficult political and ethical climate created by the recent removal of a dozen drugs from the US formulary and the temporary halting of 27 gene therapy trials due to safety concerns. This article describes the Network's challenges as it initiated three protocols in a polarized cultural atmosphere at a time when oversight bodies were positioning themselves for the tightest vigilance of promising new therapies. Effective strategies involving ongoing education, open communication, and relationship building with the oversight community are discussed. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. Institutional Oversight of Occupational Health and Safety for Research Programs Involving Biohazards.

    Science.gov (United States)

    Dyson, Melissa C; Carpenter, Calvin B; Colby, Lesley A

    2017-06-01

    Research with hazardous biologic materials (biohazards) is essential to the progress of medicine and science. The field of microbiology has rapidly advanced over the years, partially due to the development of new scientific methods such as recombinant DNA technology, synthetic biology, viral vectors, and the use of genetically modified animals. This research poses a potential risk to personnel as well as the public and the environment. Institutions must have appropriate oversight and take appropriate steps to mitigate the risks of working with these biologic hazards. This article will review responsibilities for institutional oversight of occupational health and safety for research involving biologic hazards.

  6. Real-time Responsiveness for Ethics Oversight During Disaster Research.

    Science.gov (United States)

    Eckenwiler, Lisa; Pringle, John; Boulanger, Renaud; Hunt, Matthew

    2015-11-01

    Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. © 2015 John Wiley & Sons Ltd.

  7. Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field

    Science.gov (United States)

    Fatehi, Leili; Wolf, Susan M.; McCullough, Jeffrey; Hall, Ralph; Lawrenz, Frances; Kahn, Jeffrey P.; Jones, Cortney; Campbell, Stephen A.; Dresser, Rebecca S.; Erdman, Arthur G.; Haynes, Christy L.; Hoerr, Robert A.; Hogle, Linda F.; Keane, Moira A.; Khushf, George; King, Nancy M.P.; Kokkoli, Efrosini; Marchant, Gary; Maynard, Andrew D.; Philbert, Martin; Ramachandran, Gurumurthy; Siegel, Ronald A.; Wickline, Samuel

    2015-01-01

    The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary’s Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern. PMID:23289677

  8. 78 FR 12369 - United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of...

    Science.gov (United States)

    2013-02-22

    ... Oversight of Life Sciences Dual Use Research of Concern AGENCY: Office of Science and Technology Policy... comments on the proposed United States Government Policy for Institutional Oversight of Life Sciences Dual... requirements for certain categories of life sciences research at institutions that accept Federal funding for...

  9. Institutional Oversight of Occupational Health and Safety for Research Programs Involving Biohazards

    OpenAIRE

    Dyson, Melissa C; Carpenter, Calvin B; Colby, Lesley A

    2017-01-01

    Research with hazardous biologic materials (biohazards) is essential to the progress of medicine and science. The field of microbiology has rapidly advanced over the years, partially due to the development of new scientific methods such as recombinant DNA technology, synthetic biology, viral vectors, and the use of genetically modified animals. This research poses a potential risk to personnel as well as the public and the environment. Institutions must have appropriate oversight and take app...

  10. Post-approval monitoring and oversight of U.S.-initiated human subjects research in resource-constrained countries.

    Science.gov (United States)

    Brown, Brandon; Kinsler, Janni; Folayan, Morenike O; Allen, Karen; Cáceres, Carlos F

    2014-06-01

    The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study's investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide.

  11. Policy, Practice, and Research Agenda for Emergency Medical Services Oversight: A Systematic Review and Environmental Scan.

    Science.gov (United States)

    Taymour, Rekar K; Abir, Mahshid; Chamberlin, Margaret; Dunne, Robert B; Lowell, Mark; Wahl, Kathy; Scott, Jacqueline

    2018-02-01

    Introduction In a 2015 report, the Institute of Medicine (IOM; Washington, DC USA), now the National Academy of Medicine (NAM; Washington, DC USA), stated that the field of Emergency Medical Services (EMS) exhibits signs of fragmentation; an absence of system-wide coordination and planning; and a lack of federal, state, and local accountability. The NAM recommended clarifying what roles the federal government, state governments, and local communities play in the oversight and evaluation of EMS system performance, and how they may better work together to improve care. This systematic literature review and environmental scan addresses NAM's recommendations by answering two research questions: (1) what aspects of EMS systems are most measured in the peer-reviewed and grey literatures, and (2) what do these measures and studies suggest for high-quality EMS oversight? To answer these questions, a systematic literature review was conducted in the PubMed (National Center for Biotechnology Information, National Institutes of Health; Bethesda, Maryland USA), Web of Science (Thomson Reuters; New York, New York USA), SCOPUS (Elsevier; Amsterdam, Netherlands), and EMBASE (Elsevier; Amsterdam, Netherlands) databases for peer-reviewed literature and for grey literature; targeted web searches of 10 EMS-related government agencies and professional organizations were performed. Inclusion criteria required peer-reviewed literature to be published between 1966-2016 and grey literature to be published between 1996-2016. A total of 1,476 peer-reviewed titles were reviewed, 76 were retrieved for full-text review, and 58 were retained and coded in the qualitative software Dedoose (Manhattan Beach, California USA) using a codebook of themes. Categorizations of measure type and level of application were assigned to the extracted data. Targeted websites were systematically reviewed and 115 relevant grey literature documents were retrieved. A total of 58 peer-reviewed articles met inclusion

  12. Recommendations for oversight of nanobiotechnology: dynamic oversight for complex and convergent technology

    International Nuclear Information System (INIS)

    Ramachandran, Gurumurthy; Wolf, Susan M.; Paradise, Jordan; Kuzma, Jennifer; Hall, Ralph; Kokkoli, Efrosini; Fatehi, Leili

    2011-01-01

    Federal oversight of nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between “soft” and “hard” approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government.

  13. Oversight and enforcement at DOE

    International Nuclear Information System (INIS)

    Fergus, I.E., Christopher, R.K.

    1996-01-01

    This paper addresses recent changes to the independent oversight and enforcement programs within the U.S. Department of Energy (DOE) and applications to criticality safety. DOE's Office of Oversight (Oversight hereafter), in the Office of Environment, Safety, and Health (EH), independently evaluates whether management systems ensure adequate protection of the worker, public, and environment. Oversight has adopted a new approach to performing evaluations based on the guiding principles for safety management identified by the Secretary of Energy. The principles Oversight evaluates are line management responsibility for safety and health, comprehensive requirements, and competence commensurate with responsibilities. Recently, the DOE codified the implementation of integrated safety management, further expounding on these basic guiding principles and Oversight's role. The Office of Enforcement and Investigations in EH (Enforcement hereafter) is responsible for enforcement, and relevant documents describe its role. This paper briefly discusses criticality safety aspects of the twin initiatives of Oversight and Enforcement

  14. Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

    Science.gov (United States)

    Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten

    2017-01-01

    In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight's evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.

  15. 12 CFR 985.4 - Finance Board oversight.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board oversight. 985.4 Section 985.4 Banks and Banking FEDERAL HOUSING FINANCE BOARD OFFICE OF FINANCE THE OFFICE OF FINANCE § 985.4 Finance Board oversight. (a) Oversight and enforcement actions. The Finance Board shall have the same regulatory oversight authority and enforcement powers...

  16. 13 CFR 120.1005 - Bureau of PCLP Oversight.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Bureau of PCLP Oversight. 120.1005 Section 120.1005 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Risk-Based Lender Oversight Supervision § 120.1005 Bureau of PCLP Oversight. SBA's Bureau of PCLP Oversight within...

  17. Nuclear Oversight Function at Krsko NPP

    International Nuclear Information System (INIS)

    Bozin, B.; Kavsek, D.

    2010-01-01

    The nuclear oversight function is used at the Krsko NPP constructively to strengthen safety and improve performance. Nuclear safety is kept under constant examination through a variety of monitoring techniques and activities, some of which provide an independent review. The nuclear oversight function at the Krsko NPP is accomplished by Quality and Nuclear Oversight Division (SKV). SKV has completed its mission through a combination of compliance, performance and effectiveness-based assessments. The performance-based assessment is an assessment using various techniques (observations, interviews, walk-downs, document reviews) to assure compliance with standards and regulations, obtain insight into performance, performance trends and also to identify opportunities to improve effectiveness of implementation. Generally, the performance-based approach to oversight function is based on some essential elements. The most important one which is developed and implemented is an oversight program (procedure). The program focuses on techniques, activities and objectives commensurate with their significance to plant operational safety. These techniques and activities are: self-assessments, assessments, audits, performance indicators, monitoring of corrective action program (CAP), industry independent reviews (such as IAEA's OSART and WANO Peer Review), industry benchmarking etc. Graded approach is an inherent product of a performance based program and ranking process. It is important not only to focus on the highest ranked performance based attributes but to lead to effective utilization of an oversight program. The attributes selected for oversight need to be based on plant specific experience, current industry operating experience, supplier's performance and quality issues. Collaboration within the industry and effective utility oversight of processes and design activities are essential for achieving good plant performance. So the oversight program must integrate relevant

  18. Tennessee Oversight Agreement combined annual reports, May 13, 1991--May 12, 1993

    International Nuclear Information System (INIS)

    1993-01-01

    The Tennessee Oversight Agreement provides independent oversight and monitoring of the Department of Energy's activities on the Oak Ridge Reservation by the State. The agreement obligates the state to provide an annual report to DOE and for public distribution of the results of the DOE Oversight Division's monitoring and analysis activities and its findings of the quality and effectiveness of the Department of Energy's environmental monitoring and surveillance programs. The DOE Oversight Division's first report will discuss the status of the entire oversight agreement for the first two years of its existence. The 1991--1993 combined annual reports include a short history of the Division, a list of the Tennessee Oversight Agreement commitments and a status report on each of DOE Oversight Division's programs. Each Division program includes a descriptive status of its findings and recommendations. These findings and recommendations were also consolidated into a separate segment of the report (Chapter 7). Findings indicate there have been genuine successes in the areas of site access and data availability. More effort, however, is required in both of these areas before the state can verify that DOE and its contractors are meeting its obligations. Ambient surveillance monitoring by DOE is extensive. The DOE Oversight Division reviews this data to assure the state and its citizens that all areas of the environment are adequately protected by DOE operations. There is a noticeable lack of research and development in the technology for environmental remediation and radiological and mixed waste treatment, storage and disposal. The DOE Oversight Division's recommendations for improvement are provided with each of the findings listed in this report

  19. 5 CFR 330.611 - Oversight.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Oversight. 330.611 Section 330.611 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS RECRUITMENT, SELECTION, AND... Employees § 330.611 Oversight. OPM provides advice and assistance to agencies in implementing their Career...

  20. 12 CFR 370.10 - Oversight.

    Science.gov (United States)

    2010-01-01

    ... LIQUIDITY GUARANTEE PROGRAM § 370.10 Oversight. (a) Participating entities are subject to the FDIC's oversight regarding compliance with the terms of the temporary liquidity guarantee program. (b) A..., for the duration of the temporary liquidity guarantee program, to be subject to the FDIC's authority...

  1. Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa

    Directory of Open Access Journals (Sweden)

    Hennig, Michael

    2017-01-01

    Full Text Available In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA when performing outsourced clinical studies.This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s.Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight’s evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.

  2. 32 CFR 2700.51 - Information Security Oversight Committee.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Information Security Oversight Committee. 2700... MICRONESIAN STATUS NEGOTIATIONS SECURITY INFORMATION REGULATIONS Implementation and Review § 2700.51 Information Security Oversight Committee. The OMSN Information Security Oversight Committee shall be chaired...

  3. Methods of cell purification: a critical juncture for laboratory research and translational science.

    Science.gov (United States)

    Amos, Peter J; Cagavi Bozkulak, Esra; Qyang, Yibing

    2012-01-01

    Research in cell biology and the development of translational technologies are driven by competition, public expectations, and regulatory oversight, putting these fields at a critical juncture. Success in these fields is quickly becoming dependent on the ability of researchers to identify and isolate specific cell populations from heterogeneous mixtures accurately and efficiently. Many methods for cell purification have been developed, and each has advantages and disadvantages that must be considered in light of the intended application. Current cell separation strategies make use of surface proteins, genetic expression, and physics to isolate specific cells by phenotypic traits. Cell purification is also dependent on the cellular reagents available for use and the intended application, as these factors may preclude certain mechanisms used in the processes of labeling and sorting cells. Copyright © 2011 S. Karger AG, Basel.

  4. 32 CFR 2103.51 - Information Security Oversight Committee.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Information Security Oversight Committee. 2103... BE DECLASSIFIED Implementation and Review § 2103.51 Information Security Oversight Committee. The NCS Information Security Oversight Committee shall be chaired by the Staff Counsel of the National Security...

  5. 76 FR 71081 - Public Aircraft Oversight Safety Forum

    Science.gov (United States)

    2011-11-16

    ... NATIONAL TRANSPORTATION SAFETY BOARD Public Aircraft Oversight Safety Forum The National Transportation Safety Board (NTSB) will convene a Public Aircraft Oversight Safety Forum which will begin at 9 a... ``Public Aircraft Oversight Forum: Ensuring Safety for Critical Missions'', are to (1) raise awareness of...

  6. 13 CFR 120.1000 - Risk-Based Lender Oversight.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Risk-Based Lender Oversight. 120.1000 Section 120.1000 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Risk-Based Lender Oversight Supervision § 120.1000 Risk-Based Lender Oversight. (a) Risk-Based Lender...

  7. Oversight Institutions Within the United Nations

    DEFF Research Database (Denmark)

    Pontoppidan, Caroline Aggestam

    2015-01-01

    This article will give a description of the role of internal audit and governance functions within the United Nations system. The United Nations has, during the last 10 years, worked to establish effective oversight services. Oversight, governance and hereunder the internal audit function has been...

  8. A qualitative phenomenological study: Enhanced, risk-based FAA oversight on part 145 maintenance practices

    Science.gov (United States)

    Sheehan, Bryan G.

    The purpose of this qualitative phenomenological study was to examine the phenomenon of enhanced, risk-based Federal Aviation Administration (FAA) oversight of Part 145 repair stations that performed aircraft maintenance for Part 121 air carriers between 2007 and 2014 in Oklahoma. Specifically, this research was utilized to explore what operational changes have occurred in the domestic Part 145 repair station industry such as variations in management or hiring practices, training, recordkeeping and technical data, inventory and aircraft parts supply-chain logistics, equipment, and facilities. After interviewing 12 managers from Part 145 repair stations in Oklahoma, six major theme codes emerged from the data: quality of oversight before 2007, quality of oversight after 2007, advantages of oversight, disadvantages of oversight, status quo of oversight, and process improvement . Of those six major theme codes, 17 subthemes appeared from the data that were used to explain the phenomenon of enhanced oversight in the Part 145 repair station industry. Forty-two percent of the participants indicated a weak FAA oversight system that has hindered the continuous process improvement program in their repair stations. Some of them were financially burdened after hiring additional full-time quality assurance inspectors to specifically manage enhanced FAA oversight. Notwithstanding, the participants of the study indicated that the FAA must apply its surveillance on a more standardized and consistent basis. They want to see this standardization in how FAA inspectors interpret regulations and practice the same quality of oversight for all repair stations, particularly those that are repeat violators and fail to comply with federal aviation regulations. They believed that when the FAA enforces standardization on a consistent basis, repair stations can become more efficient and safer in the performance of their scope of work for the U.S. commercial air transportation industry.

  9. Notification: Oversight of Clean Water State Revolving Loan Funds

    Science.gov (United States)

    Project #OA-FY15-0153, April 6, 2015. The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) is beginning preliminary research on the EPA oversight of the Clean Water State Revolving Fund (CWSRF).

  10. Which bank? A guardian model for regulation of embryonic stem cell research in Australia.

    Science.gov (United States)

    McLennan, A

    2007-08-01

    In late 2005 the Legislation Review: Prohibition of Human Cloning Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth) recommended the establishment of an Australian stem cell bank. This article aims to address a lack of discussion of issues surrounding stem cell banking by suggesting possible answers to the questions of whether Australia should establish a stem cell bank and what its underlying philosophy and functions should be. Answers are developed through an analysis of regulatory, scientific and intellectual property issues relating to embryonic stem cell research in the United Kingdom, United States and Australia. This includes a detailed analysis of the United Kingdom Stem Cell Bank. It is argued that a "guardian" model stem cell bank should be established in Australia. This bank would aim to promote the maximum public benefit from human embryonic stem cell research by providing careful regulatory oversight and addressing ethical issues, while also facilitating research by addressing practical scientific concerns and intellectual property issues.

  11. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

    Directory of Open Access Journals (Sweden)

    George Q. Daley

    2016-06-01

    Full Text Available The International Society for Stem Cell Research (ISSCR presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016. The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008 to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.

  12. Surrogate receptivity to participation in critical illness genetic research: aligning research oversight and stakeholder concerns.

    Science.gov (United States)

    Freeman, Bradley D; Butler, Kevin; Bolcic-Jankovic, Dragana; Clarridge, Brian R; Kennedy, Carie R; LeBlanc, Jessica; Chandros Hull, Sara

    2015-04-01

    Collection of genetic biospecimens as part of critical illness investigations is increasingly commonplace. Oversight bodies vary in restrictions imposed on genetic research, introducing inconsistencies in study design, potential for sampling bias, and the possibility of being overly prohibitive of this type of research altogether. We undertook this study to better understand whether restrictions on genetic data collection beyond those governing research on cognitively intact subjects reflect the concerns of surrogates for critically ill patients. We analyzed survey data collected from 1,176 patients in nonurgent settings and 437 surrogates representing critically ill adults. Attitudes pertaining to genetic data (familiarity, perceptions, interest in participation, concerns) and demographic information were examined using univariate and multivariate techniques. We explored differences among respondents who were receptive (1,333) and nonreceptive (280) to genetic sample collection. Whereas factors positively associated with receptivity to research participation were "complete trust" in health-care providers (OR, 2.091; 95% CI, 1.544-2.833), upper income strata (OR, 2.319; 95% CI, 1.308-4.114), viewing genetic research "very positively" (OR, 3.524; 95% CI, 2.122-5.852), and expressing "no worry at all" regarding disclosure of results (OR, 2.505; 95% CI, 1.436-4.369), black race was negatively associated with research participation (OR, 0.410; 95% CI, 0.288-0.585). We could detect no difference in receptivity to genetic sample collection comparing ambulatory patients and surrogates (OR, 0.738; 95% CI, 0.511-1.066). Expressing trust in health-care providers and viewing genetic research favorably were associated with increased willingness for study enrollment, while concern regarding breach of confidentiality and black race had the opposite effect. Study setting had no bearing on willingness to participate.

  13. Information exchange - DOE oversight programs

    International Nuclear Information System (INIS)

    Tubbs, D.C.; Field, H.C.

    1988-01-01

    Oversight programs are conducted by the U.S. Department of Energy to review activities carried out by field and contractor organizations. Two of these oversight programs focus on safeguards and security and on safety and health activities. These two programs are independent, but share many common objectives and review techniques. The mutual potential benefit was recognized from an exchange of information on review techniques. The first step in this exchange was the participation by an Office of Security Evaluations (OSE) staff member with the Office of Nuclear Safety (ONS) during their planning, conduct and reporting of a Technical Safety Appraisal (TSA). This paper briefly describes the OSE and ONS programs. It also identifies and analyzes the similarities and differences of the two programs. The purpose of this paper is to provide perspectives on the approach taken, the techniques used and the differences between two oversight programs conducted by the Department of Energy

  14. Institutional Oversight of Faculty-Industry Consulting Relationships in U.S. Medical Schools: A Delphi Study.

    Science.gov (United States)

    Morain, Stephanie R; Joffe, Steven; Campbell, Eric G; Mello, Michelle M

    2015-01-01

    The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful. © 2015 American Society of Law, Medicine & Ethics, Inc.

  15. Regulatory oversight of safety culture in nuclear installations - New IAEA developments

    International Nuclear Information System (INIS)

    Kerhoas, Anne; )

    2012-01-01

    Ms. Anne Kerhoas described the IAEA work on guidance for regulatory oversight of safety culture. She summarised the various IAEA, OECD/NEA and ANS meetings that have been held on the topic between 1995 and 2011. The IAEA has carried out two recent projects with the Bulgarian and Romanian regulatory bodies to develop a safety culture oversight program. The work was funded by the Norwegian government and has involved 30 experts from 17 different countries. Draft guidance for regulators on how to monitor licensee safety culture has also been produced (IAEA-TECDOC-DD1070). The document is intended to provide practical guidance on oversight strategies and is applicable to a wide range of nuclear installations, including nuclear power plants, fuel cycle facilities, research reactors and waste management facilities. A number of principles for regulatory oversight of safety culture were summarised. For example, the primary responsibility for safety remains with the licensee, safety culture oversight should be performed at all stages of the life cycle of the nuclear installation, and multiple data collection methods should be used. The overall approach to safety culture described in the draft IAEA Tech doc includes a range of approaches to build up a meaningful picture of the licensee's safety culture. These include interviews, observations, review of documents, review of events, discussions and surveys. The importance of ongoing discussion with the licensee throughout the process to develop a deeper shared understanding of issues was emphasised. The results of the Chester 2 workshop will be used as an input to finalization of the draft Tech Doc

  16. 12 CFR 4.66 - Oversight and monitoring.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Oversight and monitoring. 4.66 Section 4.66 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY ORGANIZATION AND FUNCTIONS...; Contracting for Goods and Services § 4.66 Oversight and monitoring. The Deputy Comptroller for Resource...

  17. Review of the OSHA framework for oversight of occupational environments.

    Science.gov (United States)

    Choi, Jae-Young; Ramachandran, Gurumurthy

    2009-01-01

    The OSHA system for oversight of chemicals in the workplace was evaluated to derive lessons for oversight of nanotechnology. Criteria relating to the development, attributes, evolution, and outcomes of the system were used for evaluation that was based upon quantitative expert elicitation and historical literature analysis. The oversight system had inadequate resources in terms of finances, expertise, and personnel, and insufficient incentive for compliance. The system showed a lack of flexibility in novel situations. There were minimal requirements on companies for data on health and safety of their products. These factors have a strong influence on public confidence and health and safety. The oversight system also scored low on attributes such as public input, transparency, empirical basis, conflict of interest, and informed consent. The experts in our sample tend to believe that the current oversight system for chemicals in the workplace is neither adequate nor effective. It is very likely that the performance of the OSHA oversight system for nanomaterials will be equally inadequate.

  18. The role of Quality Oversight in nuclear and hazardous waste management and environmental restoration at Westinghouse Hanford Company

    International Nuclear Information System (INIS)

    Fouad, H.Y.

    1994-05-01

    The historical factors that led to the waste at Hanford are outlined. Westinghouse Hanford Company mission and organization are described. The role of the Quality Oversight organization in nuclear hazardous waste management and environmental restoration at Westinghouse Hanford Company is delineated. Tank Waste Remediation Systems activities and the role of the Quality Oversight organization are described as they apply to typical projects. Quality Oversight's role as the foundation for implementation of systems engineering and operation research principles is pointed out

  19. 12 CFR 1700.1 - Office of Federal Housing Enterprise Oversight.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Office of Federal Housing Enterprise Oversight. 1700.1 Section 1700.1 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE OVERSIGHT, DEPARTMENT OF... of Federal Housing Enterprise Oversight. (a) Scope and authority. The Office of Federal Housing...

  20. A Study on the Construct Validity of Safety Culture Oversight Model for Nuclear Power Operating Organization

    International Nuclear Information System (INIS)

    Jung, Su Jin; Choi, Young Sung; Oh, Jang Jin

    2015-01-01

    In Korea, the safety policy statement declared in 1994 by government stressed the importance of safety culture and licensees were encouraged to manage and conduct their self-assessments. A change in regulatory position about safety culture oversight was made after the event of SBO cover-up in Kori unit 1 and several subsequent falsification events. Since then KINS has been developing licensee's safety culture oversight system including conceptual framework of oversight, prime focus area for oversight, and specific details on regulatory expectations, all of which are based on defence-in-depth (DiD) safety enhancement approach. Development and gathering of performance data which is related to actual 'safety' of nuclear power plant are needed to identify the relationship between safety culture and safety performance. Authors consider this study as pilot which has a contribution on verifying the construct validity of the model and the effectiveness of survey based research. This is the first attempt that the validity of safety culture oversight model has been investigated with empirical data obtained from Korean nuclear power operating organization

  1. A Study on the Construct Validity of Safety Culture Oversight Model for Nuclear Power Operating Organization

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Su Jin; Choi, Young Sung; Oh, Jang Jin [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2015-05-15

    In Korea, the safety policy statement declared in 1994 by government stressed the importance of safety culture and licensees were encouraged to manage and conduct their self-assessments. A change in regulatory position about safety culture oversight was made after the event of SBO cover-up in Kori unit 1 and several subsequent falsification events. Since then KINS has been developing licensee's safety culture oversight system including conceptual framework of oversight, prime focus area for oversight, and specific details on regulatory expectations, all of which are based on defence-in-depth (DiD) safety enhancement approach. Development and gathering of performance data which is related to actual 'safety' of nuclear power plant are needed to identify the relationship between safety culture and safety performance. Authors consider this study as pilot which has a contribution on verifying the construct validity of the model and the effectiveness of survey based research. This is the first attempt that the validity of safety culture oversight model has been investigated with empirical data obtained from Korean nuclear power operating organization.

  2. 49 CFR 659.29 - Oversight agency safety and security reviews.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Oversight agency safety and security reviews. 659... Role of the State Oversight Agency § 659.29 Oversight agency safety and security reviews. At least... safety program plan and system security plan. Alternatively, the on-site review may be conducted in an on...

  3. 27 | Page OVERSIGHT FUNCTIONS OF THE LEGISLATURE: AN ...

    African Journals Online (AJOL)

    Fr. Ikenga

    2004-09-06

    Sep 6, 2004 ... its oversight functions remains weak because legislative role and ... ministers of his government and other officers in the public service of the Federation9, while .... 22 “Parliamentary Oversight of Finance and the Budgetary Process” - The ... Association of First Nations National, Chief Matthew Coon29 ...

  4. Governance and oversight of researcher access to electronic health data: the role of the Independent Scientific Advisory Committee for MHRA database research, 2006-2015.

    Science.gov (United States)

    Waller, P; Cassell, J A; Saunders, M H; Stevens, R

    2017-03-01

    In order to promote understanding of UK governance and assurance relating to electronic health records research, we present and discuss the role of the Independent Scientific Advisory Committee (ISAC) for MHRA database research in evaluating protocols proposing the use of the Clinical Practice Research Datalink. We describe the development of the Committee's activities between 2006 and 2015, alongside growth in data linkage and wider national electronic health records programmes, including the application and assessment processes, and our approach to undertaking this work. Our model can provide independence, challenge and support to data providers such as the Clinical Practice Research Datalink database which has been used for well over 1,000 medical research projects. ISAC's role in scientific oversight ensures feasible and scientifically acceptable plans are in place, while having both lay and professional membership addresses governance issues in order to protect the integrity of the database and ensure that public confidence is maintained.

  5. 78 FR 49257 - Proposed Information Collection; Comment Request; Management and Oversight of the National...

    Science.gov (United States)

    2013-08-13

    ... award. Each reserve compiles an ecological characterization or site profile to describe the biological... Collection; Comment Request; Management and Oversight of the National Estuarine Research Reserve System... estuarine research reserves representative of various regions and estuarine types in the United States to...

  6. 41 CFR 105-53.133 - Information Security Oversight Office.

    Science.gov (United States)

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Information Security... FUNCTIONS Central Offices § 105-53.133 Information Security Oversight Office. (a) Creation and authority. The Information Security Oversight Office (ISOO), headed by the Director of ISOO, who is appointed by...

  7. 10 CFR 440.23 - Oversight, training, and technical assistance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 3 2010-01-01 2010-01-01 false Oversight, training, and technical assistance. 440.23... PERSONS § 440.23 Oversight, training, and technical assistance. (a) The Secretary and the appropriate..., directly or indirectly, training and technical assistance to any grantee or subgrantee. Such training and...

  8. Evaluating oversight systems for emerging technologies: a case study of genetically engineered organisms.

    Science.gov (United States)

    Kuzma, Jennifer; Najmaie, Pouya; Larson, Joel

    2009-01-01

    The U.S. oversight system for genetically engineered organisms (GEOs) was evaluated to develop hypotheses and derive lessons for oversight of other emerging technologies, such as nanotechnology. Evaluation was based upon quantitative expert elicitation, semi-standardized interviews, and historical literature analysis. Through an interdisciplinary policy analysis approach, blending legal, ethical, risk analysis, and policy sciences viewpoints, criteria were used to identify strengths and weaknesses of GEOs oversight and explore correlations among its attributes and outcomes. From the three sources of data, hypotheses and broader conclusions for oversight were developed. Our analysis suggests several lessons for oversight of emerging technologies: the importance of reducing complexity and uncertainty in oversight for minimizing financial burdens on small product developers; consolidating multi-agency jurisdictions to avoid gaps and redundancies in safety reviews; consumer benefits for advancing acceptance of GEO products; rigorous and independent pre- and post-market assessment for environmental safety; early public input and transparency for ensuring public confidence; and the positive role of public input in system development, informed consent, capacity, compliance, incentives, and data requirements and stringency in promoting health and environmental safety outcomes, as well as the equitable distribution of health impacts. Our integrated approach is instructive for more comprehensive analyses of oversight systems, developing hypotheses for how features of oversight systems affect outcomes, and formulating policy options for oversight of future technological products, especially nanotechnology products.

  9. New York State's landmark policies on oversight and compensation for egg donation to stem cell research.

    Science.gov (United States)

    Roxland, Beth E

    2012-05-01

    In 2009, New York became the first US state to implement a policy permitting researchers to use public funds to reimburse women who donate oocytes directly and solely to stem cell research, not only for the woman's out-of-pocket expenses, but also for the time, burden and discomfort associated with the donation process. The debate about the propriety of such compensation was recently renewed with the publication of a stem cell study in which women were provided with compensation for donating their eggs. This article explores the scientific and ethical rationales that led to New York's decision to allow donor compensation. The multifaceted deliberation process and comprehensive policies may serve as a model for other states and countries considering the issue of oocyte donor compensation.

  10. Regulatory Oversight of Safety Culture — Korea’s Experience

    International Nuclear Information System (INIS)

    Jung, S.J.; Choi, Y.S.; Kim, J.T.

    2016-01-01

    In Korea, a regulatory oversight program of safety culture was launched in 2012 to establish regulatory measures against several events caused by weak safety culture in the nuclear industry. This paper is intended to introduce the preliminary regulatory oversight framework, development and validation of safety culture components, pilot safety culture inspection results and lessons learned. The safety culture model should be based on a sound understanding of the national culture and industry characteristics where the model will be applied. The nuclear safety culture oversight model is being developed and built on the Korean regulatory system to independently assess the nuclear power operating organizations’ safety culture.

  11. Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 2: Appendices

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-31

    On July, 1993, a Regulatory Oversight (RO) organization was established within the US DOE, Oak Ridge Operations to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the OR program was to ensure continued plant safety, safeguards and security while the plants were transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). Volume 2 contains copies of the documents which established the relationship between NRC, DOE, USEC, and DOL (Dept of Labor) required to facilitate regulatory oversight transition.

  12. Regulatory Oversight Program, July 1, 1993 - March 3, 1997. Volume 2: Appendices

    International Nuclear Information System (INIS)

    1997-01-01

    On July, 1993, a Regulatory Oversight (RO) organization was established within the US DOE, Oak Ridge Operations to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the OR program was to ensure continued plant safety, safeguards and security while the plants were transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). Volume 2 contains copies of the documents which established the relationship between NRC, DOE, USEC, and DOL (Dept of Labor) required to facilitate regulatory oversight transition

  13. Improving Defense Health Program Medical Research Processes

    Science.gov (United States)

    2017-08-08

    research , including a Business Cell; 87 Research Development, 88 Research Oversight, 89 and Research Compliance offices;90 and the Center...needed for DHP medical research , such as the Army’s Clinical and Translational Research Program Office, 38 the Navy’s Research Methods Training Program... research stated, “key infrastructure for a learning health system will encompass three core elements: data networks, methods , and workforce.” 221

  14. Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-31

    On July, 1993, a Regulatory Oversight (RO) organization was established within the US DOE, Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the OR program was to ensure continued plant safety, safeguards and security while the plants were transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). Volume 3 contains copies of two reports that document the DOE/ORO regulatory oversight inspection and enforcement history for each gaseous diffusion plant site. Each report provides a formal mechanism by which DOE/ORO could communicate the inspection and enforcement history to NRC. The reports encompass the inspection activities that occurred during July 1, 1993 through March 2, 1997.

  15. Beyond Measure: New Approaches to Analyzing Congressional Oversight of Homeland Security

    Science.gov (United States)

    2015-03-01

    published books and peer reviewed journal articles. The Congressional Research Service being the key source on congressional procedure and theory ...Transportation Committee 1 Senate Homeland Security & Governmental Affairs Committee 15 Senate Small Business & Entrepreneurship 1 Senate Special...military contracting procedures in a war zone are not necessarily oversight of national security functions, reviews of FEMA contracting practices

  16. The impact of masculinity on safety oversights, safety priority and safety violations in two male-dominated occupations

    DEFF Research Database (Denmark)

    Nielsen, Kent; Hansen, Claus D.; Bloksgaard, Lotte

    2015-01-01

    Background Although men have a higher risk of occupational injuries than women the role of masculinity for organizational safety outcomes has only rarely been the object of research. Aim The current study investigated the association between masculinity and safety oversights, safety priority......-related context factors (safety leadership, commitment of the safety representative, and safety involvement) and three safety-related outcome factors (safety violations, safety oversights and safety priority) were administered twice 12 months apart to Danish ambulance workers (n = 1157) and slaughterhouse workers...

  17. 10 Standards for Oversight and Transparency of National Intelligence Services

    NARCIS (Netherlands)

    Eskens, S.; van Daalen, O.; van Eijk, N.

    2016-01-01

    This report aims to enhance the policy debate on surveillance by intelligence services by focusing on two key components: oversight and transparency. Both oversight and transparency are essential to devising checks and balances in a way that respects human rights. By offering this concise list of

  18. Hospital board oversight of quality and safety: a stakeholder analysis exploring the role of trust and intelligence.

    Science.gov (United States)

    Millar, Ross; Freeman, Tim; Mannion, Russell

    2015-06-16

    Hospital boards, those executive members charged with developing appropriate organisational strategies and cultures, have an important role to play in safeguarding the care provided by their organisation. However, recent concerns have been raised over boards' ability to enact their duty to ensure the quality and safety of care. This paper offers critical reflection on the relationship between hospital board oversight and patient safety. In doing so it highlights new perspectives and suggestions for developing this area of study. The article draws on 10 interviews with key informants and policy actors who form part of the 'issue network' interested in the promotion of patient safety in the English National Health Service. The interviews surfaced a series of narratives regarding hospital board oversight of patient safety. These elaborated on the role of trust and intelligence in highlighting the potential dangers and limitations of approaches to hospital board oversight which have been narrowly focused on a risk-based view of organisational performance. In response, a need to engage with the development of trust based organisational relationships is identified, in which effective board oversight is built on 'trust' characterised by styles of leadership and behaviours that are attentive to the needs and concerns of both staff and patients. Effective board oversight also requires the gathering and triangulating of 'intelligence' generated from both national and local information sources. We call for a re-imagination of hospital board oversight in the light of these different perspectives and articulate an emerging research agenda in this area.

  19. 76 FR 31416 - Federal Acquisition Regulation; Oversight of Contractor Ethics Programs

    Science.gov (United States)

    2011-05-31

    ...-AL92 Federal Acquisition Regulation; Oversight of Contractor Ethics Programs AGENCY: Department of... that contractors have implemented the mandatory contractor business ethics program requirements. DATES... to Improve DoD's Oversight of Contractor Ethics Programs. The ethics program requirement flows from...

  20. ENSI Approach to Oversight of Safety Culture

    International Nuclear Information System (INIS)

    Humbel Haag, Claudia

    2012-01-01

    Claudia Humbel Haag presented developments in ENSI approach to safety culture oversight. ENSI has developed a definition/understanding of Safety Culture and a concept of how to perform oversight of Safety Culture. ENSI defines safety culture in the following way: Safety Culture comprises the behaviour, world views (in the sense of conceptualisations of reality and explanation models), values (in the sense of aims and evaluation scales), and features of the physical environment (specifically, the nuclear power plant and the documents used) which are shared by many members of an organization, in as much as these are of significance to nuclear safety. A model of the accessibility of safety culture was presented ranging from the observable (external aspects of safety culture), to aspects that are accessible by asking questions, through to aspects that are not accessible (internal part of safety culture). ENSI considers observable aspects through the existing systematic safety assessment compliance program. Aspects that are observable by asking questions will be addressed by additional oversight activities outside the systematic assessment program. Aspects that are not accessible are addressed by helping the licensee to re-think its safety culture through proactive discussions on safety culture. Reports are issued to the licensee on assumptions and observations identified through the discussions. The conclusions of the presentation emphasised the importance of basing any interventions in this area on a solid understanding of the concept of safety culture. ENSI safety culture oversight principles were also described. These include licensee responsibility for safety, and the need for the regulator to critically review their own activities to ensure a positive influence on the licensee

  1. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

    Science.gov (United States)

    Farajkhoda, Tahmineh

    2017-01-01

    Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems

  2. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review.

    Science.gov (United States)

    Farajkhoda, Tahmineh

    2017-02-01

    Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems

  3. 48 CFR 52.236-24 - Work Oversight in Architect-Engineer Contracts.

    Science.gov (United States)

    2010-10-01

    ... Architect-Engineer Contracts. 52.236-24 Section 52.236-24 Federal Acquisition Regulations System FEDERAL... Provisions and Clauses 52.236-24 Work Oversight in Architect-Engineer Contracts. As prescribed in 36.609-3, insert the following clause: Work Oversight in Architect-Engineer Contracts (APR 1984) The extent and...

  4. Corporate social responsibility for nanotechnology oversight.

    Science.gov (United States)

    Kuzma, Jennifer; Kuzhabekova, Aliya

    2011-11-01

    Growing public concern and uncertainties surrounding emerging technologies suggest the need for socially-responsible behavior of companies in the development and implementation of oversight systems for them. In this paper, we argue that corporate social responsibility (CSR) is an important aspect of nanotechnology oversight given the role of trust in shaping public attitudes about nanotechnology and the lack of data about the health and environmental risks of nanoproducts. We argue that CSR is strengthened by the adoption of stakeholder-driven models and attention to moral principles in policies and programs. In this context, we examine drivers of CSR, contextual and leadership factors that influence CSR, and strategies for CSR. To illustrate these concepts, we discuss existing cases of CSR-like behavior in nanotechnology companies, and then provide examples of how companies producing nanomedicines can exhibit morally-driven CSR behavior.

  5. Navy Acquisition Executive's Management Oversight and Procurement Authority Category I and II Programs

    National Research Council Canada - National Science Library

    2007-01-01

    .... This report discusses the management oversight and procurement authority within the Navy. Two other reports discussed the management oversight and procurement authority within the Army and Air Force...

  6. Animal Research, the 3Rs, and the "Internet of Things": Opportunities and Oversight in International Pharmaceutical Development.

    Science.gov (United States)

    Niemi, Steven M; Davies, Gail F

    2016-12-01

    Stages of drug (and vaccine) discovery and evaluation that involve laboratory animals increasingly occur via scientific collaborations across national borders and continents. Many of these research collaborations are between asset-rich institutions and others in less wealthy parts of the world. The care and use of laboratory animals in geographically disparate locations introduces new complexities, such as different oversight requirements and available resources, as well as diverse organizational and cultural milieus. These complexities can hamper the effectiveness of local animal welfare committees and regulatory compliance, as well as compromise good science and animal welfare. At the same time, new technologies are becoming available that offer greater transparency in how these collaborations and their animal subjects are faring in real time that, in turn, can enable progress towards the 3 Rs. The focus of this essay is to identify potential rewards and risks stemming from new techniques for producing and connecting data in preclinical pharmaceutical development and consider how further social scientific investigations have the potential to enhance the benefits of international research collaborations for both human health and animal welfare. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. Notification: Audit of EPA's Adherence to Policies, Procedures and Oversight Controls Pertaining to the Administrator’s Travel

    Science.gov (United States)

    Project #OA-FY17-0382, August 28, 2017. The EPA OIG plans to begin preliminary research on the EPA’s adherence to policies, procedures and oversight controls pertaining to the Administrator’s travel to Oklahoma.

  8. 17 CFR 202.11 - Public Company Accounting Oversight Board budget approval process.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Public Company Accounting Oversight Board budget approval process. 202.11 Section 202.11 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION INFORMAL AND OTHER PROCEDURES § 202.11 Public Company Accounting Oversight...

  9. Strategic planning of an integrated program for state oversight agreements

    International Nuclear Information System (INIS)

    Walzer, A.E.; Cothron, T.K.

    1991-01-01

    Among the barrage of agreements faced by federal facilities are the State Oversight Agreements (known as Agreements in Principle in many states). These agreements between the Department of Energy (DOE) and the states fund the states to conduct independent environmental monitoring and oversight which requires plans, studies, inventories, models, and reports from DOE and its management and operating contractors. Many states have signed such agreements, including Tennessee, Kentucky, Washington, Idaho, Colorado, California, and Florida. This type of oversight agreement originated in Colorado as a result of environmental concerns at the Rocky Flats Plant. The 5-year State Oversight Agreements for Tennessee and Kentucky became effective on May 13, 1991, and fund these states nearly $21 million and $7 million, respectively. Implementation of these open-quotes comprehensive and integratedclose quotes agreements is particularly complex in Tennessee where the DOE Oak Ridge Reservation houses three installations with distinctly different missions. The program development and strategic planning required for coordinating and integrating a program of this magnitude is discussed. Included are the organizational structure and interfaces required to define and coordinate program elements across plants and to also effectively negotiate scope and schedules with the state. The planned Program Management Plan, which will contain implementation and procedural guidelines, and the management control system for detailed tracking of activities and costs are outlined. Additionally, issues inherent in the nature of the agreements and implementation of a program of this magnitude are discussed. Finally, a comparison of the agreements for Tennessee, Kentucky, Colorado, and Idaho is made to gain a better understanding of the similarities and differences in State Oversight Agreements to aid in implementation of these agreements

  10. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

    Directory of Open Access Journals (Sweden)

    Tahmineh Farajkhoda

    2017-08-01

    Full Text Available Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies, appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening

  11. Biological Select Agents and Toxins: Risk-Based Assessment Management and Oversight.

    Energy Technology Data Exchange (ETDEWEB)

    Burnett, LouAnn Crawford; Brodsky, Benjamin H.

    2016-12-01

    Sandia National Laboratories' International Biological and Chemical Threat Reduction (SNL/IBCTR) conducted, on behalf of the Federal Select Agent Program (FSAP), a review of risk assessment in modern select agent laboratories. This review and analysis consisted of literature review, interviews of FSAP staff, entities regulated by FSAP, and deliberations of an expert panel. Additionally, SNL/IBCTR reviewed oversight mechanisms used by industries, US agencies, and other countries for high-consequence risks (e.g, nuclear, chemical, or biological materials, aviation, off-shore drilling, etc.) to determine if alternate oversight mechanisms existed that might be applicable to FSAP oversight of biological select agents and toxins. This report contains five findings, based on these reviews and analyses, with recommendations and suggested actions for FSAP to consider.

  12. 75 FR 10507 - Information Security Oversight Office; National Industrial Security Program Policy Advisory...

    Science.gov (United States)

    2010-03-08

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office; National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and Records... individuals planning to attend must be submitted to the Information Security Oversight Office (ISOO) no later...

  13. Improving regulatory oversight of maintenance programs

    International Nuclear Information System (INIS)

    Cook, S.

    2008-01-01

    Safe nuclear power plant operation requires that risks due to failure or unavailability of Structures, Systems and Components (SSCs) be minimized. Implementation of an effective maintenance program is a key means for achieving this goal. In its regulatory framework, the important relationship between maintenance and safety is acknowledged by the CNSC. A high level maintenance program requirement is included in the Class I Facilities Regulations. In addition, the operating licence contains a condition based on the principle that the design function and performance of SSCs needs to remain consistent with the plant's design and analysis documents. Nuclear power plant licensees have the primary responsibility for safe operation of their facilities and consequently for implementation of a successful maintenance program. The oversight role of the Canadian Nuclear Safety Commission (CNSC) is to ensure that the licensee carries out that responsibility. The challenge for the CNSC is how to do this consistently and efficiently. Three opportunities for improvement to regulatory maintenance oversight are being pursued. These are related to the regulatory framework, compliance verification inspection activities and monitoring of self-reporting. The regulatory framework has been improved by clarifying expectations through the issuance of S-210 'Maintenance Programs for Nuclear Power Plants'. Inspection activities have been improved by introducing new maintenance inspections into the baseline program. Monitoring is being improved by making better use of self-reported and industry produced maintenance related performance indicators. As with any type of program change, the challenge is to ensure the consistent and optimal application of regulatory activities and resources. This paper is a summary of the CNSC's approach to improving its maintenance oversight strategy. (author)

  14. Whistleblower Protection: DOD Needs to Enhance Oversight of Military Whistleblower Reprisal Investigations

    Science.gov (United States)

    2015-05-01

    WHISTLEBLOWER PROTECTION DOD Needs to Enhance Oversight of Military Whistleblower Reprisal Investigations Report...00-2015 to 00-00-2015 4. TITLE AND SUBTITLE Whistleblower Protection: DOD Needs to Enhance Oversight of Military Whistleblower Reprisal...Government Accountability Office Highlights of GAO-15-477, a report to congressional requesters May 2015 WHISTLEBLOWER PROTECTION DOD

  15. Improving MC and A Oversight in Russia by Implementing Measurement and Training Programs

    International Nuclear Information System (INIS)

    Bokov, Dmitry; Byers, Kenneth R.

    2004-01-01

    As the Russian State regulatory agency responsible for oversight of nuclear material control and accounting (MC and A), Gosatomnadzor of Russia (GAN) determines the status of the MC and A programs at Russian facilities. Last year, GAN developed and implemented their Nuclear Material Measurement Program Plan which documents current non-destructive assay (NDA) measurement capability in all regions of GAN; provides justification for upgrades to equipment, procedures and training; and defines the inspector-facility operator interface as it relates to NDA measurement equipment use. This Program Plan has helped to give the GAN inspection measurements more legal and official status as an oversight tool, and has also helped to improve other GAN MC and A oversight activities. These improvements include developing a tamper-indicating device program, conducting NDA workshops at specific Russian nuclear facilities to better train MC and A inspectors, and developing training evaluation programs. The Program is an important tool to address the GAN role in oversight of the Russian Federal Information System nuclear material database. This paper describes the feedback received from the GAN regional offices on the implementation of the Program Plan during its first year in operation and how the Program Plan has affected other GAN inspection activities to improve MC and A oversight.

  16. Ethics in action: Approving and improving medical research with human subjects

    NARCIS (Netherlands)

    de Jong, J.P.

    2013-01-01

    In this thesis, Jean Philippe de Jong presents a new understanding of ethical oversight on medical research with human subjects and proposes that two philosophies for ethical oversight exist: '(dis)approving' and 'improving'. Systems for ethical oversight on medical research have been in place for

  17. Regulatory Oversight of Safety Culture in Finland: A Systemic Approach to Safety

    International Nuclear Information System (INIS)

    Oedewald, P.; Väisäsvaara, J.

    2016-01-01

    In Finland the Radiation and Nuclear Safety Authority STUK specifies detailed regulatory requirements for good safety culture. Both the requirements and the practical safety culture oversight activities reflect a systemic approach to safety: the interconnections between the technical, human and organizational factors receive special attention. The conference paper aims to show how the oversight of safety culture can be integrated into everyday oversight activities. The paper also emphasises that the scope of the safety culture oversight is not specific safety culture activities of the licencees, but rather the overall functioning of the licence holder or the new build project organization from safety point of view. The regulatory approach towards human and organizational factors and safety culture has evolved throughout the years of nuclear energy production in Finland. Especially the recent new build projects have highlighted the need to systematically pay attention to the non-technical aspects of safety as it has become obvious how the HOF issues can affect the design processes and quality of construction work. Current regulatory guides include a set of safety culture related requirements. The requirements are binding to the licence holders and they set both generic and specific demands on the licencee to understand, monitor and to develop safety culture of their own organization but also that of their supplier network. The requirements set for the licence holders has facilitated the need to develop the regulator’s safety culture oversight practices towards a proactive and systemic approach.

  18. Does nanobiotechnology oversight present a uniquely complex challenge to interagency cooperation?

    International Nuclear Information System (INIS)

    Karkkainen, Bradley C.

    2011-01-01

    Numerous regulatory and oversight challenges exist in the field of nanobiotechnology. Although these challenges may appear novel and complex, similar issues have plagued environmental regulation since the 1970 s. This article argues that complexity, uncertainty, and regulatory gaps are common problems in environmental regulation, and that the lessons learned and progress made during more than 40 years of environmental regulation can serve as a guidepost for addressing nanobiotechnology regulation and oversight issues.

  19. Parliamentary Oversight of European Security and Defence Policy: A Matter of Formal Competences or the Will of Parliamentarians?

    OpenAIRE

    Maatsch, A.; Galella, P.

    2016-01-01

    Are parliaments with strong formal powers for the deployment of troops likely to conduct more intensive oversight than their counterparts with weak or no powers? The literature suggests that strong formal powers delineate boundaries of parliamentary oversight. However, this article demonstrates that strong formal powers are not necessary for parliaments in order to conduct oversight. If parliaments with weak formal powers had strong incentives to carry out oversight of the EU NAVFOR Operation...

  20. Reinventing oversight in the twenty-first century: the question of capacity

    International Nuclear Information System (INIS)

    Bosso, Christopher; DeLeo, Rob A.; Kay, W. D.

    2011-01-01

    This article addresses a key question emerging from this project based at the University of Minnesota: the fundamental capacity of government to engage in “dynamic oversight” of emergent technologies. This conception of oversight requires additional or new types of capacity for government agencies that must arbitrate conflicts and endow any outcomes with necessary democratic legitimacy. Rethinking oversight thus also requires consideration of the fundamental design and organizational capacity of the regulatory regime in the democratic state.

  1. Creating a Learning Organization in Law Enforcement: Maturity Levels for Police Oversight Agencies

    Science.gov (United States)

    Filstad, Cathrine; Gottschalk, Petter

    2010-01-01

    Purpose: The purpose of this paper is to conceptualize a stage model for maturity levels for police oversight agencies. Design/methodology/approach: The paper is based on a literature review covering police oversight organizations and stages of growth models. Findings: As a conceptual paper, the main findings are related to the appropriateness of…

  2. Regulatory Oversight Program, July 1, 1993 - March 3, 1997. Volume 1

    International Nuclear Information System (INIS)

    1997-09-01

    On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation

  3. Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-09-01

    On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation.

  4. 22 CFR 96.32 - Internal structure and oversight.

    Science.gov (United States)

    2010-04-01

    ... Accreditation and Approval Licensing and Corporate Governance § 96.32 Internal structure and oversight. (a) The... number of such other provider; and (3) The name, address, and phone number of any entity it uses or...

  5. Transparency and Oversight in Local Wellness Policies

    Science.gov (United States)

    Chriqui, Jamie F.; Chaloupka, Frank J.

    2011-01-01

    Background: Advocates have called for increased wellness policy transparency and oversight through the use of health advisory councils. This study examines (1) wellness policy transparency, (2) advisory council requirements, (3) factors associated with each, and (4) whether transparency or advisory council requirements are indicative of a stronger…

  6. 1992 Annual performance report for Environmental Monitoring and Oversight at Department of Energy facilities in New Mexico

    Energy Technology Data Exchange (ETDEWEB)

    1992-12-31

    In October 1990 an Agreement-in-Principle (AIP) was entered into between the US Department of Energy (DOE) and the State of New Mexico for the purpose of supporting State oversight activities at DOE facilities in New Mexico. The State`s lead agency for the Agreement is the New Mexico Environment Department (NMED). DOE has agreed to provide the State with resources over a five year period to support State activities in environmental oversight, monitoring, access and emergency response to ensure compliance with applicable federal, state, and local laws at Los Alamos National Laboratory (LANL), Sandia National Laboratories (SNL), the Waste Isolation Pilot Plant (WIPP), and the Inhalation Toxicology Research Institute (ITRI). The Agreement is designed to assure the citizens of New Mexico that public health, safety and the environment are being protected through existing programs; DOE is in compliance with applicable laws and regulations; DOE has made substantial new commitments; cleanup and compliance activities have been prioritized; and a vigorous program of independent monitoring and oversight by the State is underway. This report relates the quality and effectiveness of the facilities` environmental monitoring and surveillance programs. This report satisfies that requirement for the January--December 1992 time frame.

  7. 1992 Annual performance report for Environmental Monitoring and Oversight at Department of Energy facilities in New Mexico

    International Nuclear Information System (INIS)

    1992-01-01

    In October 1990 an Agreement-in-Principle (AIP) was entered into between the US Department of Energy (DOE) and the State of New Mexico for the purpose of supporting State oversight activities at DOE facilities in New Mexico. The State's lead agency for the Agreement is the New Mexico Environment Department (NMED). DOE has agreed to provide the State with resources over a five year period to support State activities in environmental oversight, monitoring, access and emergency response to ensure compliance with applicable federal, state, and local laws at Los Alamos National Laboratory (LANL), Sandia National Laboratories (SNL), the Waste Isolation Pilot Plant (WIPP), and the Inhalation Toxicology Research Institute (ITRI). The Agreement is designed to assure the citizens of New Mexico that public health, safety and the environment are being protected through existing programs; DOE is in compliance with applicable laws and regulations; DOE has made substantial new commitments; cleanup and compliance activities have been prioritized; and a vigorous program of independent monitoring and oversight by the State is underway. This report relates the quality and effectiveness of the facilities' environmental monitoring and surveillance programs. This report satisfies that requirement for the January--December 1992 time frame

  8. 17 CFR 201.440 - Appeal of determinations by the Public Company Accounting Oversight Board.

    Science.gov (United States)

    2010-04-01

    ... and Commission Review § 201.440 Appeal of determinations by the Public Company Accounting Oversight... for registration of a public accounting firm, may file an application for review. (b) Procedure. An... the Public Company Accounting Oversight Board. 201.440 Section 201.440 Commodity and Securities...

  9. 32 CFR 2400.19 - Declassification by the Director of the Information Security Oversight Office.

    Science.gov (United States)

    2010-07-01

    ... Information Security Oversight Office. 2400.19 Section 2400.19 National Defense Other Regulations Relating to... SCIENCE AND TECHNOLOGY POLICY INFORMATION SECURITY PROGRAM Declassification and Downgrading § 2400.19 Declassification by the Director of the Information Security Oversight Office. If the Director of the Information...

  10. 13 CFR 120.1070 - Lender oversight fees.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Lender oversight fees. 120.1070 Section 120.1070 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Risk-Based... Lender” means a Small Business Lending Company or a Non-Federally Regulated Lender. (2) On-site reviews...

  11. 75 FR 39954 - Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location

    Science.gov (United States)

    2010-07-13

    ...] Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location AGENCY: Food and Drug... location for the upcoming public meeting entitled ``Oversight of Laboratory Developed Tests.'' A new... the public meeting, FDA is announcing in this notice a new location for the public meeting. II. New...

  12. Independent oversight review of the Department of Energy Quality Assurance Program for suspect/counterfeit parts. Revision 1

    International Nuclear Information System (INIS)

    1996-05-01

    To address the potential threat that suspect/counterfeit parts could pose to DOE workers and the public, the Office of the Deputy Assistant Secretary for Oversight initiated a number of activities beginning in mid-1995. Oversight placed increased emphasis on the field's quality assurance-suspect/counterfeit parts programs during safety management evaluations, in keeping with the Office of Environment, Safety and Health (EH) oversight responsibilities, which include oversight of the Department's quality assurance (QA) programs. In addition, Oversight reviewed relevant policy documents and occurrence reports to determine the nature and magnitude of the problem within the Department. The results of that review, contained in an Office of Oversight report, Independent Oversight Analysis of Suspect/Counterfeit Parts Within the Department of Energy (November 1995), indicate a lack of consistency and comprehensiveness in the Department's QA-suspect/counterfeit parts program. A detailed analysis of the causes and impacts of the problem was recommended. In response, this review was initiated to determine the effectiveness of the Department's QA program for suspect/counterfeit parts. This study goes beyond merely assessing and reporting the status of the program, however. It is the authors intention to highlight the complex issues associated with suspect/counterfeit parts in the Department today and to present approaches that DOE managers might consider to address these issues

  13. Independent oversight review of the Department of Energy Quality Assurance Program for suspect/counterfeit parts. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-05-01

    To address the potential threat that suspect/counterfeit parts could pose to DOE workers and the public, the Office of the Deputy Assistant Secretary for Oversight initiated a number of activities beginning in mid-1995. Oversight placed increased emphasis on the field`s quality assurance-suspect/counterfeit parts programs during safety management evaluations, in keeping with the Office of Environment, Safety and Health (EH) oversight responsibilities, which include oversight of the Department`s quality assurance (QA) programs. In addition, Oversight reviewed relevant policy documents and occurrence reports to determine the nature and magnitude of the problem within the Department. The results of that review, contained in an Office of Oversight report, Independent Oversight Analysis of Suspect/Counterfeit Parts Within the Department of Energy (November 1995), indicate a lack of consistency and comprehensiveness in the Department`s QA-suspect/counterfeit parts program. A detailed analysis of the causes and impacts of the problem was recommended. In response, this review was initiated to determine the effectiveness of the Department`s QA program for suspect/counterfeit parts. This study goes beyond merely assessing and reporting the status of the program, however. It is the authors intention to highlight the complex issues associated with suspect/counterfeit parts in the Department today and to present approaches that DOE managers might consider to address these issues.

  14. Ideal Police Oversight and Review: The Next Piece of the Community Policing Puzzle

    Science.gov (United States)

    2015-12-01

    oversight. Included in that malpractice are instances of perceived physical and verbal abuse , perceived harassment, failure to take appropriate action...a kid from south Stockton. 1 I. INTRODUCTION A. PROBLEM STATEMENT—BACKGROUND Independent oversight boards are asked to make the complaint...communities with inclusion and investigative transparency when filing complaints of police misconduct and abuse of police powers. In his article “Race

  15. Oil and gas site contamination risks : improved oversight needed

    International Nuclear Information System (INIS)

    2010-02-01

    British Columbia has seen record levels of activities in the oil and gas sector. Upstream petroleum processes include exploration, well completion and production. Site contamination can occur during all of these activities, resulting in potential environmental and human health impacts. Although well operators are responsible by law for site restoration, there is a potential risk that some operators will not fulfill their responsibilities, thereby leaving the province liable for the site restoration costs. In British Columbia, the BC Oil and Gas Commission (OGC) is responsible for managing these risks through oversight activities designed to ensure that industry meets its obligations. The OGC also manages the orphan sites reclamation fund. This report presented an audit of the OGC in order to determine if it is providing adequate oversight of upstream oil and gas site contamination risks. The audit examined whether the agency responsibilities are clear and whether the OGC is fully aware of the environmental and financial risks associated with upstream oil and gas site contamination. The audit also examined if the OGC has established appropriate procedures to oversee the risks and to inform the public of how effectively site contamination risks are being managed. The report presented the audit background, audit expectations, findings, conclusions and recommendations. It was concluded that the OGC's oversight of the environmental and financial risks associated with oil and gas site contamination needs improving. tabs., figs.

  16. Integrating GIS and GPS in environmental remediation oversight

    International Nuclear Information System (INIS)

    Kaletsky, K.; Earle, J.R.; Schneider, T.A.

    1996-01-01

    This paper presents findings on Ohio EPA Office of Federal Facilities Oversight's (OFFO) use of GIS and GPS for environmental remediation oversight at the U.S. Department of Energy's (DOE) Fernald Site. The Fernald site is a former uranium metal production facility within DOE's nuclear weapons complex. Significant uranium contamination of soil and groundwater is being remediated under state and federal regulations. OFFO uses GIS/GPS to enhance environmental monitoring and remediation oversight. These technologies are utilized within OFFO's environmental monitoring program for sample location and parameter selection, data interpretation and presentation. GPS is used to integrate sample data into OFFO's GIS and for permanently linking precise and accurate geographic data to samples and waste units. It is important to identify contamination geographically as all visual references (e.g., buildings, infrastructure) will be removed during remediation. Availability of the GIS allows OFFO to perform independent analysis and review of DOE contractor generated data, models, maps, and designs. This ability helps alleviate concerns associated with open-quotes black boxclose quotes models and data interpretation. OFFO's independent analysis has increased regulatory confidence and the efficiency of design reviews. GIS/GPS technology allows OFFO to record and present complex data in a visual format aiding in stakeholder education and awareness. Presented are OFFO's achievements within the aforementioned activities and some reasons learned in implementing the GIS/GPS program. OFFO's two years of GIS/GPS development have resulted in numerous lessons learned and ideas for increasing effectiveness through the use of GIS/GPS

  17. Notification: Audit of EPA’s Adherence to Policies, Procedures and Oversight Controls Pertaining to the Administrator’s Travel (2nd notification)

    Science.gov (United States)

    Project #OA-FY17-0382, October 6, 2017 - The EPA OIG plans to expand the scope of preliminary research on the EPA’s adherence to policies, procedures and oversight controls pertaining to the Administrator’s travel.

  18. Defense Forensics: Additional Planning and Oversight Needed to Establish an Enduring Expeditionary Forensic Capability

    Science.gov (United States)

    2013-06-01

    forensic pathology, forensic anthropology, and forensic toxicology . 13DOD’s forensic directive defines DOD components as the Office of the...DEFENSE FORENSICS Additional Planning and Oversight Needed to Establish an Enduring Expeditionary Forensic ...COVERED 00-00-2013 to 00-00-2013 4. TITLE AND SUBTITLE Defense Forensics : Additional Planning and Oversight Needed to Establish an Enduring

  19. A survey of front-line paramedics examining the professional relationship between paramedics and physician medical oversight.

    Science.gov (United States)

    Foerster, Christopher R; Tavares, Walter; Virkkunen, Ilkka; Kämäräinen, Antti

    2018-03-01

    Paramedicine is often dependent on physician medical directors and their associated programs for direction and oversight. A positive relationship between paramedics and their oversight physicians promotes safety and quality care while a strained or ineffective one may threaten these goals. The objective of this study was to explore and understand the professional relationship between paramedics and physician medical oversight as viewed by front-line paramedics. All active front-line paramedics from four municipal paramedic services involving three medical oversight groups in Ontario were invited to complete an online survey. Five hundred and four paramedics were invited to participate in the study, with 242 completing the survey (48% response rate); 66% male, 76% primary care paramedics with an average of 13 (SD=9) years of experience. Paramedics had neutral or positive perceptions regarding their autonomy, opportunities to interact with their medical director, and medical director understanding of the prehospital setting. Paramedics perceived medical directives as rigid and ambiguous. A significant amount of respondents reported a perception of having provided suboptimal patient care due to fear of legal or disciplinary consequences. Issues of a lack of support for critical thinking and a lack of trust between paramedics and medical oversight groups were often raised. Paramedic perceptions of physician medical oversight were mixed. Concerning areas identified were perceptions of ambiguous written directives and concerns related to the level of trust and support for critical thinking. These perceptions may have implications for the system of care and should be explored further.

  20. Aviation Safety: FAA Oversight of Repair Stations Needs Improvement

    Science.gov (United States)

    1997-10-24

    This report by the General Accounting Office examines the Federal Aviation : Administration's (FAA) oversight of the aviation repair station industry. : Specifically, this report addresses the following questions: (1) What is the : nature and scope o...

  1. Tangible and intangible costs of "protecting human subjects": The impact of the National Research Act of 1974 onuniversity research activities

    Directory of Open Access Journals (Sweden)

    Frederic Jacobs

    2004-11-01

    Full Text Available This article (1 examines the overall structure of regulatory research oversight in the United States; (2 details the origins and evolution of federal legislation pertaining to the protection of human subjects in biomedical and behavioral treatment and research; and (3 describes the expansion of oversight regulation from biomedical and behavioral treatment areas to the social sciences. In addition, the paper describes three areas identified by compliance administrators as susceptible to abuse: (1 informed consent, (2 assessment of risks and benefits, and (3 equitable selection of human subjects. There is a discussion of existing tensions in the implementation of oversight policies and procedures. Finally, the paper identifies four issues for future consideration: (1 scope of the mandate regarding protection of human subjects, (2 impact on the nature of research being undertaken, (3 financial burden of compliance and oversight activities, and (4 ethical standards, constraints, and potential.

  2. 15 CFR 2008.18 - Information Security Oversight Committee.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Information Security Oversight Committee. 2008.18 Section 2008.18 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE REGULATIONS TO IMPLEMENT E.O. 12065; OFFICE OF...

  3. 1993 Annual performance report for Environmental Oversight and Monitoring at Department of Energy facilities in New Mexico

    International Nuclear Information System (INIS)

    1993-01-01

    In October of 1990, the New Mexico Environment Department entered into an agreement with the US Department of Energy (DOE) to create the Department of Energy Oversight and Monitoring Program. This program is designed to create an avenue for the State to ensure DOE facilities are in compliance with applicable environmental regulations, to allow the State oversight and monitoring independent of the DOE, to allow the State valuable input into remediation decision making, and to protect the environment and the public health and safety of New Mexicans concerning DOE facility activities. This agreement, called the Agreement in Principle (AIP), includes all four of New Mexico's DOE facilities: Los Alamos National Laboratory in Los Alamos; Sandia National Laboratories and the Inhalation Toxicology Research Institute on Kirtland Air Force Base in Albuquerque; and the Waste Isolation Pilot Plant near Carlsbad

  4. Comparison of the Canadian and US Laws, Regulations, Policies, and Systems of Oversight for Animals in Research.

    Science.gov (United States)

    Griffin, Gilly; Locke, Paul

    2016-05-01

    The Canadian and United States' approaches to oversight of animals in research are both based on the "3Rs" principles outlined in Russell and Burch's classic text, The Principles of Humane Experimental Technique. Each country seeks to protect the welfare of animals, while permitting the legitimate goals of scientific research to be attained according to the legal principles, cultures, and strengths and constraints of their jurisprudential and societal traditions. Canada is one of the most decentralized federations in the world, and regulation of activities is based to a great extent on custom and practice. The United States is more hierarchical and, at least with respect to laws governing animal research, more centralized. Accordingly, the Canadian approach is rooted in the concepts of social contracts, with a greater emphasis on guidance and policy and less reliance on legislation. No federal (national) direct legislation of laboratory animal welfare exists, although the federal government uses its criminal and spending authorities to shape behavior. The central feature of the Canadian system is the Canadian Council on Animal Care, which was formed to support universities and government departments involved in animal-based science. Animal care committees play a central role in implementing the guidelines and policies in facilities that carry out animal research. The United States has enacted two federal (national) laws applicable to animals in research. The Animal Welfare Act is a more traditional, command-and-control law that gives authority to the US Department of Agriculture to promulgate regulations, inspect facilities, and enforce violations. The Health Research Extension Act, which amended the US Public Health Services (PHS) Act, applies to any activity conducted or supported by the PHS, including research efforts supported by the US National Institutes of Health. It is largely nonregulatory and establishes a system of assurances and policies that covered

  5. Moving forward responsibly: Oversight for the nanotechnology-biology interface

    International Nuclear Information System (INIS)

    Kuzma, Jennifer

    2007-01-01

    Challenges and opportunities for appropriate oversight of nanotechnology applied to or derived from biological systems (nano-bio interface) were discussed in a public workshop and dialog hosted by the Center for Science, Technology, and Public Policy of the University of Minnesota on September 15, 2005. This paper discusses the themes that emerged from the workshop, including the importance of analyzing potential gaps in current regulatory systems; deciding upon the general approach taken toward regulation; employing non-regulatory mechanisms for governance; making risk and other studies transparent and available to the public; bolstering mechanisms for public participation in risk analysis; creating more opportunities for meaningful discussion of the social and ethical dimensions of the nano-bio interface; increasing funds for implications and problem-solving research in this area; and having independent and reliable sources for communication. The workshop was successful in identifying ways of moving forward responsibly so that ultimately nanotechnology and its products can succeed in developers', researchers', regulators', and the public's eyes

  6. 'We all want to succeed, but we've also got to be realistic about what is happening': an ethnographic study of relationships in trial oversight and their impact.

    Science.gov (United States)

    Daykin, Anne; Selman, Lucy E; Cramer, Helen; McCann, Sharon; Shorter, Gillian W; Sydes, Matthew R; Gamble, Carrol; Macefield, Rhiannon; Lane, J Athene; Shaw, Alison

    2017-12-22

    developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines.

  7. 76 FR 52997 - Public Company Accounting Oversight Board; Order Approving Proposed Board Funding Final Rules for...

    Science.gov (United States)

    2011-08-24

    ... Accounting Oversight Board; Order Approving Proposed Board Funding Final Rules for Allocation of the Board's... August 18, 2011. I. Introduction On June 21, 2011, the Public Company Accounting Oversight Board (the... public accounting firm, in amounts that are sufficient to cover the costs of processing and reviewing...

  8. 1991 Annual performance report for environmental oversight and monitoring at Department of Energy Facilities in New Mexico

    International Nuclear Information System (INIS)

    1994-01-01

    On October 22, 1990 an agreement was entered into between the US DOE and the State of New Mexico. The agreement was designed to assure the citizens of New Mexico that the environment is protected and that public health, as related to the environment is also protected. The Agreement reflects the understanding and commitments between the parties regarding environmental oversight, monitoring, remediation and emergency response at the following DOE facilities: the Inhalation Toxicology Research Institute (ITRI); Los Alamos National Laboratory (LANL); Sandia National Laboratory (SNL); and the Waste Isolation Pilot Plant (WIPP). These provision are ongoing through a vigorous program of independent monitoring and oversight; prioritization of clean-up and compliance activities; and new commitments by DOE. While the initial assessment of the quality and effectiveness of the facilities' environmental monitoring and surveillance programs is not yet complete, preliminary findings are presented regarding air quality monitoring, environmental monitoring, and groundwater monitoring

  9. Auditing the Auditors: Has the Establishment of the Audit Oversight Board Affected Audit Quality?

    OpenAIRE

    Ismail, Hashanah; Theng, Ung Chui

    2015-01-01

    This paper reports on the results of a research into the relationship between audit quality during the years before and after the incorporation of the Audit Oversight Board (AOB) in Malaysia in 2010. As the AOB only audits auditors of listed companies this study is based on 50 companies’ audited financial statements 2 years before and after AOB was established. A total of 200 firm years were observed. Using reported companies’ earnings to proxy for earnings and audit quality the data collecte...

  10. Brief introduction of USA new reactor oversight process and suggestions for our country

    International Nuclear Information System (INIS)

    Hao Xiaofeng; Chen Rui; Zhou Limin; Wang Xiuqing

    2002-01-01

    The NRC New Reactor Oversight Process focuses the nuclear safety supervision on the 3 areas: Reactor Safety, Radiation safety and Plant Security. Within the 3 areas, 7 cornerstones are detailed for the purpose. They are Initiating Events, Mitigating Systems, Barrier Integrity, Emergency Preparedness, Occupational Radiation Protection, Public Radiation Safety and Physical Protection. On cooperating with the inspections, the new process ensures a more effective, objective and timely evaluation of the safety level of the operating nuclear power plants. On considering the practices and the status in China nuclear safety supervision, the authors have to learn something from the NRC New Reactor Oversight Process. The authors must make an optimization on Chinese limited resources and put the emphasis on the issues with high risk in order to prevent the occurrence of the accidents. Properly inducing some ideas and methodology from the NRC New Reactor Oversight Process will benefit the development and perfection of the supervision mode of the NNSA

  11. 40 CFR 51.362 - Motorist compliance enforcement program oversight.

    Science.gov (United States)

    2010-07-01

    ... deviate from established requirements, or in the case of non-government entities that process... registrations; and (10) The prevention of fraudulent procurement or use of inspection documents by controlling... measurements. (c) SIP requirements. The SIP shall include a description of enforcement program oversight and...

  12. State safety oversight program : audit of the tri-state oversight committee and the Washington metropolitan area transit authority, final audit report, March 4, 2010.

    Science.gov (United States)

    2010-03-04

    The Federal Transit Administration (FTA) conducted an on-site audit of the safety program implemented by the Washington Metropolitan Area Transit Authority (WMATA) and overseen by the Tri-State Oversight Committee (TOC) between December 14 and 17, 20...

  13. Poor Government Oversight of Anham and Its Subcontracting Procedures Allowed Questionable Costs To Go Undetected

    Science.gov (United States)

    2011-07-30

    contractor purchasing system review of Anham. Management Comments and Audit Response The Defense Contract Mangement Agency and the U.S. Central... Introduction 1  Background 1  Government Agency Roles and Oversight Responsibilities 4  Objectives 7  Weak Government Oversight Resulted in Significant...Subcontracting Procedures Allowed Questionable Costs To Go Undetected SIGIR 11-022 July 30, 2011 Introduction Since 2003, the United States Government

  14. Dynamic oversight: implementation gaps and challenges

    Science.gov (United States)

    Howard, John

    2011-04-01

    Nanotechnology is touted as a transformative technology in that it is predicted to improve many aspects of human life. There are hundreds of products in the market that utilize nanostructures in their design, such as composite materials made out of carbon or metal oxides. Potential risks to consumers, to the environment, and to workers from the most common passive nanomaterial—carbon nanotubes—are emerging through scientific research. Newer more active nanostructures—such as cancer therapies and targeted drug systems—are also increasing in use and are raising similar risk concerns. Governing the risks to workers is the subject of this commentary. The Occupational Safety and Health Act of 1970 grants the Occupational Safety and Health Administration the legal authority to set occupational health standards to insure that no worker suffers material impairment of health from work. However, setting a standard to protect workers from nanotechnology risks may occur some time in the future because the risks to workers have not been well characterized scientifically. Alternative risk governances—such as dynamic oversight through stakeholder partnerships, "soft law" approaches, and national adoption of international consensus standards—are evaluated in this article.

  15. Dynamic oversight: implementation gaps and challenges

    International Nuclear Information System (INIS)

    Howard, John

    2011-01-01

    Nanotechnology is touted as a transformative technology in that it is predicted to improve many aspects of human life. There are hundreds of products in the market that utilize nanostructures in their design, such as composite materials made out of carbon or metal oxides. Potential risks to consumers, to the environment, and to workers from the most common passive nanomaterial—carbon nanotubes—are emerging through scientific research. Newer more active nanostructures—such as cancer therapies and targeted drug systems—are also increasing in use and are raising similar risk concerns. Governing the risks to workers is the subject of this commentary. The Occupational Safety and Health Act of 1970 grants the Occupational Safety and Health Administration the legal authority to set occupational health standards to insure that no worker suffers material impairment of health from work. However, setting a standard to protect workers from nanotechnology risks may occur some time in the future because the risks to workers have not been well characterized scientifically. Alternative risk governances—such as dynamic oversight through stakeholder partnerships, “soft law” approaches, and national adoption of international consensus standards—are evaluated in this article.

  16. Regulatory oversight of nuclear safety in Finland. Annual report 2011

    Energy Technology Data Exchange (ETDEWEB)

    Kainulainen, E. (ed.)

    2012-07-01

    The report constitutes the report on regulatory control in the field of nuclear energy which the Radiation and Nuclear Safety Authority (STUK) is required to submit once a year to the Ministry of Employment and the Economy pursuant to Section 121 of the Nuclear Energy Decree. The report is also delivered to the Ministry of Environment, the Finnish Environment Institute, and the regional environmental authorities of the localities in which a nuclear facility is located. The regulatory control of nuclear safety in 2011 included the design, construction and operation of nuclear facilities, as well as nuclear waste management and nuclear materials. The first parts of the report explain the basics of nuclear safety regulation included as part of STUK's responsibilities, as well as the objectives of the operations, and briefly introduce the objects of regulation. The chapter concerning the development and implementation of legislation and regulations describes changes in nuclear legislation, as well as the progress of STUK's YVL Guide revision work. The section concerning the regulation of nuclear facilities contains an overall safety assessment of the nuclear facilities currently in operation or under construction. The chapter concerning the regulation of the final disposal project for spent nuclear fuel de-scribes the preparations for the final disposal project and the related regulatory activities. The section concerning nuclear non-proliferation describes the nuclear non-proliferation control for Finnish nuclear facilities and final disposal of spent nuclear fuel, as well as measures required by the Additional Protocol of the Safeguards Agreement. The chapter describing the oversight of security arrangements in the use of nuclear energy discusses oversight of the security arrangements in nuclear power plants and other plants, institutions and functions included within the scope of STUK's regulatory oversight. The chapter also discusses the national and

  17. Oversight of Department of Defense Reconstruction Projects in Afghanistan

    Science.gov (United States)

    2016-03-16

    had to reschedule some of our site visits multiple times due to security conditions. As an alternative means for conducting oversight, due to a limited...employed less than 20 percent of the staff it was expected to employ. According to the doctors and nurses on site during our inspection, the limited

  18. U.S. Nuclear Regulatory Commission Safety Culture Oversight

    International Nuclear Information System (INIS)

    Sieracki, D. J.

    2016-01-01

    The NRC recognises that it is important for all organizations performing or overseeing regulated activities to establish and maintain a positive safety culture commensurate with the safety and security significance of their activities and the nature and complexity of their organizations and functions. The NRC’s approach to safety culture is based on the premise that licencees bear the primary responsibility for safety. The NRC provides oversight of safety culture through expectations detailed in policy statements, safety culture assessor training for NRC inspectors, the oversight process, and the Allegations and Enforcement Programs. The NRC’s Safety Culture Policy Statement (SCPS) sets forth the Commission’s expectation that individuals and organizations establish and maintain a positive safety culture commensurate with the safety and security significance of their activities and the nature and complexity of their organizations and functions. The SCPS is not a regulation. It applies to all licencees, certificate holders, permit holders, authorisation holders, holders of quality assurance program approvals, vendors and suppliers of safety-related components, and applicants for a licence, certificate, permit, authorisation, or quality assurance program approval, subject to NRC authority.

  19. The concept of oversight, its connection to memory keeping and its relevance for the medium term: The findings of the RK and M initiative

    International Nuclear Information System (INIS)

    Hotzel, Stephan

    2015-01-01

    The medium term was introduced as the period of indirect oversight after repository closure, with timescales in the order of a few hundred years. While the importance of intrinsic control or 'passive' safety features in the post-closure phase of a geological repository has been recognised and stressed before, the role of oversight, by providing the capability to reduce or avoid some exposures, has come to the fore only recently. Oversight for the time being generally refers to 'watchful care' and society 'keeping an eye' on the technical system and the actual implementation of plans and decisions. In some regulatory frameworks oversight is indirectly required, for instance when mandating the creation of a land exclusion zone. In other frameworks, oversight is directly required, as illustrated, for instance, by the long-term stewardship concept of the US Environmental Protection Agency. Although sheer memory of the presence of the facility cannot be enough to constitute oversight, oversight and RK and M preservation do go hand in hand. For example, monitoring after repository closure fosters RK and M preservation, and vice versa. The presenter focused on terminology, potential oversight measures, and on roles and responsibilities of different stakeholders

  20. Safety Oversight of Decommissioning Activities at DOE Nuclear Sites

    International Nuclear Information System (INIS)

    Zull, Lawrence M.; Yeniscavich, William

    2008-01-01

    The Defense Nuclear Facilities Safety Board (Board) is an independent federal agency established by Congress in 1988 to provide nuclear safety oversight of activities at U.S. Department of Energy (DOE) defense nuclear facilities. The activities under the Board's jurisdiction include the design, construction, startup, operation, and decommissioning of defense nuclear facilities at DOE sites. This paper reviews the Board's safety oversight of decommissioning activities at DOE sites, identifies the safety problems observed, and discusses Board initiatives to improve the safety of decommissioning activities at DOE sites. The decommissioning of former defense nuclear facilities has reduced the risk of radioactive material contamination and exposure to the public and site workers. In general, efforts to perform decommissioning work at DOE defense nuclear sites have been successful, and contractors performing decommissioning work have a good safety record. Decommissioning activities have recently been completed at sites identified for closure, including the Rocky Flats Environmental Technology Site, the Fernald Closure Project, and the Miamisburg Closure Project (the Mound site). The Rocky Flats and Fernald sites, which produced plutonium parts and uranium materials for defense needs (respectively), have been turned into wildlife refuges. The Mound site, which performed R and D activities on nuclear materials, has been converted into an industrial and technology park called the Mound Advanced Technology Center. The DOE Office of Legacy Management is responsible for the long term stewardship of these former EM sites. The Board has reviewed many decommissioning activities, and noted that there are valuable lessons learned that can benefit both DOE and the contractor. As part of its ongoing safety oversight responsibilities, the Board and its staff will continue to review the safety of DOE and contractor decommissioning activities at DOE defense nuclear sites

  1. A Grey Area: Congressional Oversight of the Middle Ground Between Title 10 and Title 50

    Science.gov (United States)

    2012-06-01

    1950’s, just a few short years after the Agency’s creation.1 With Watergate fresh on the country’s mind having just witnessed President Nixon’s...3 Congressional Oversight Legislative Overview Congressional oversight is not a result of modern scandals as one might think; it is as old as the...President Reagan’s tenure, however, members of Congress believed that he had overstepped his authority in the so-called “Iran-Contra affair.” The scandal

  2. MEDICAID FINANCIAL MANAGEMENT: Better Oversight of State Claims for Federal Reimbursement Needed

    National Research Council Canada - National Science Library

    Calbom, Linda

    2002-01-01

    .... Developing baseline information on Medicaid issues at greatest risk for improper payments and measuring improvements in program management against that baseline is key to achieving effective financial oversight...

  3. Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.

    Science.gov (United States)

    Lee, Sandra Soo-Jin; Kelley, Maureen; Cho, Mildred K; Kraft, Stephanie Alessi; James, Cyan; Constantine, Melissa; Meyer, Adrienne N; Diekema, Douglas; Capron, Alexander M; Wilfond, Benjamin S; Magnus, David

    2016-01-01

    Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship. Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.

  4. Enhancing board oversight on quality of hospital care: an agency theory perspective.

    Science.gov (United States)

    Jiang, H Joanna; Lockee, Carlin; Fraser, Irene

    2012-01-01

    Community hospitals in the United States are almost all governed by a governing board that is legally accountable for the quality of care provided. Increasing pressures for better quality and safety are prompting boards to strengthen their oversight function on quality. In this study, we aimed to provide an update to prior research by exploring the role and practices of governing boards in quality oversight through the lens of agency theory and comparing hospital quality performance in relation to the adoption of those practices. Data on board practices from a survey conducted by The Governance Institute in 2007 were merged with data on hospital quality drawn from two federal sources that measured processes of care and mortality. The study sample includes 445 public and private not-for-profit hospitals. We used factor analysis to explore the underlying dimensions of board practices. We further compared hospital quality performance by the adoption of each individual board practice. Consistent with the agency theory, the 13 board practices included in the survey appear to center around enhancing accountability of the board, management, and the medical staff. Reviewing the hospital's quality performance on a regular basis was the most common practice. A number of board practices, not examined in prior research, showed significant association with better performance on process of care and/or risk-adjusted mortality: requiring major new clinical programs to meet quality-related criteria, setting some quality goals at the "theoretical ideal" level, requiring both the board and the medical staff to be as involved as management in setting the agenda for discussion on quality, and requiring the hospital to report its quality/safety performance to the general public. Hospital governing boards should examine their current practices and consider adopting those that would enhance the accountability of the board itself, management, and the medical staff.

  5. PARTICULARITIES OF PARLIAMENTARY OVERSIGHT IN DIFFERENT POLITICAL REGIMES

    Directory of Open Access Journals (Sweden)

    Silvia-Claudia CĂLIN-MIHALCEA

    2015-07-01

    Full Text Available The quality and intensity of the parliamentary oversight performed over the Government are shaped by several major criteria: political regime, electoral system, structure of the Parliament (unicameral/bicameral, parliamentary culture and tradition. This paper emphasizes some distinctive elements and particular mechanisms of the control exercised over the activities of the executive power, from the point of view of the political regime established in states with modern democracies.

  6. 48 CFR 36.609-3 - Work oversight in architect-engineer contracts.

    Science.gov (United States)

    2010-10-01

    ... architect-engineer contracts. 36.609-3 Section 36.609-3 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 36.609-3 Work oversight in architect-engineer contracts. The contracting officer...

  7. Still Human: A Call for Increased Focus on Ethical Standards in Cadaver Research.

    Science.gov (United States)

    Bach, Michelle C

    2016-12-01

    Research on human cadavers is an important mechanism of scientific progress and comprises a large industry in the United States. However, despite its importance and influence, there is little ethical or regulatory oversight of cadaver-based research. This lack of transparency raises important ethical questions. Thus, this paper serves as a call for ethicists and regulators to pay increased attention to cadaver research. I argue that cadaver research ought to be considered a subset of human subjects research and held accountable to higher ethical standards. After describing current practices, I argue that oversight of cadaver research as a form of human subjects research is appropriate because cadaver research is similar to other types of human research, participants in cadaver research incur risks of harm, and a current lack of oversight has allowed the cadaver industry to entice research participation through ethically questionable practices. This paper urges greater dialogue among human subjects research ethicists and regulators about what constitutes appropriate protections for participants in cadaver research.

  8. Nuclear safety and security culture - an integrated approach to regulatory oversight

    International Nuclear Information System (INIS)

    Tronea, M.; Ciurea Ercau, C.

    2013-01-01

    The paper presents the development and implementation of regulatory guidelines for the oversight of safety and security culture within licensees organizations. CNCAN (the National Commission for Nuclear Activities of Romania) has used the International Atomic Energy Agency (IAEA) attributes for a strong safety culture as the basis for its regulatory guidelines providing support to the reviewers and inspectors for recognizing and gathering information relevant to safety culture. These guidelines are in process of being extended to address also security culture, based on the IAEA Nuclear Security Series No. 7 document Nuclear Security Culture: Implementing Guide. Recognizing that safety and security cultures coexist and need to reinforce each other because they share the common objective of limiting risk and that similar regulatory review and inspection processes are in place for nuclear security oversight, an integrated approach is considered justified, moreover since the common elements of these cultures outweigh the differences. (authors)

  9. Oversight of the Air Force - What is the Audit Component and How Can Air Force Managers Deal with It Effectively?

    Science.gov (United States)

    1988-05-01

    This report discusses authority, mission, and responsibilities of the audit organizations that perform oversight of Air Force operations. A...the discussion of the major audit organizations. The audit oversight function is here to stay. Auditors and audit organizations can be beneficial to Air

  10. 17 CFR 240.19d-4 - Notice by the Public Company Accounting Oversight Board of disapproval of registration or of...

    Science.gov (United States)

    2010-04-01

    ... Accounting Oversight Board of disapproval of registration or of disciplinary action. (a) Definitions—(1... Accounting Oversight Board of disapproval of registration or of disciplinary action. 240.19d-4 Section 240.19d-4 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) GENERAL RULES...

  11. 48 CFR 936.609-3 - Work oversight in architect-engineer contracts.

    Science.gov (United States)

    2010-10-01

    ... architect-engineer contracts. 936.609-3 Section 936.609-3 Federal Acquisition Regulations System DEPARTMENT OF ENERGY SPECIAL CATEGORIES OF CONTRACTING CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Architect-Engineer Services 936.609-3 Work oversight in architect-engineer contracts. In addition to the clause at 48...

  12. Technical oversight for installation of TNX piezometers, Final Report

    Energy Technology Data Exchange (ETDEWEB)

    Pidcoe, W.W. Jr. [Westinghouse Savannah River Company, Aiken, SC (United States)

    1997-06-05

    Science Applications International Corporation was tasked under subcontract C002025P to provide technical oversight for the drilling of one pilot borehole, and the drilling and installation of five piezometers in the TNX Area Swamp. The work was performed in accordance with the Statement of Work in Task Order Proposal No. ER39-129 dated August 6, 1996. This report describes the activities associated with the performance of the task.

  13. AGB Statement on Board Responsibility for the Oversight of Educational Quality

    Science.gov (United States)

    Association of Governing Boards of Universities and Colleges, 2011

    2011-01-01

    This "Statement on Board Responsibility for the Oversight of Educational Quality," approved by the Board of Directors of the Association of Governing Boards (AGB) in March 2011, urges institutional administrators and governing boards to engage fully in this area of board responsibility. The seven principles in this statement offer suggestions to…

  14. 77 FR 6411 - Training, Qualification, and Oversight for Safety-Related Railroad Employees

    Science.gov (United States)

    2012-02-07

    ... Oversight for Safety-Related Railroad Employees AGENCY: Federal Railroad Administration (FRA), Department of... establishing minimum training standards for each category and subcategory of safety-related railroad employee... or contractor that employs one or more safety-related railroad employee to develop and submit a...

  15. Stem cell therapy clinical research: A regulatory conundrum for academia.

    Science.gov (United States)

    Nagpal, Anjali; Juttner, Chris; Hamilton-Bruce, Monica Anne; Rolan, Paul; Koblar, Simon A

    2017-12-01

    The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety. Copyright © 2016 Elsevier B.V. All rights reserved.

  16. Research Ethics: Institutional Review Board Oversight of Art Therapy Research

    Science.gov (United States)

    Deaver, Sarah P.

    2011-01-01

    By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…

  17. Ethics committees and the changed clinical research environment in India in 2016: A perspective!

    Science.gov (United States)

    Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi

    2017-01-01

    Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

  18. 48 CFR 207.172 - Human research.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Human research. 207.172... OF DEFENSE ACQUISITION PLANNING ACQUISITION PLANNING Acquisition Plans 207.172 Human research. Any DoD component sponsoring research involving human subjects— (a) Is responsible for oversight of...

  19. Political and Budgetary Oversight of the Ukrainian Intelligence Community: Processes, Problems and Prospects for Reform

    National Research Council Canada - National Science Library

    Petrov, Oleksii

    2007-01-01

    This thesis addresses the problem of providing policy and budget oversight of Ukrainian intelligence organizations in accordance with norms and practices developed in contemporary Western democracies...

  20. Maintaining Oversight of Licensee Safety Culture. CSNI/WGHOF Survey Results

    International Nuclear Information System (INIS)

    2008-01-01

    In preparation for this workshop, a survey was sent to members of the WGHOF in Autumn 2006. Purpose of the Survey was to explore and share the methods and approaches used to maintain oversight of licensee safety culture. 13 countries responded to the survey. The responses were used in the development of discussion topics and themes for this workshop. This presentation (slides) summarizes the results of the survey

  1. Political and Budgetary Oversight of the Ukrainian Intelligence Community: Processes, Problems and Prospects for Reform

    National Research Council Canada - National Science Library

    Petrov, Oleksii

    2007-01-01

    .... Official government documents, news reports and other literature on the intelligence system in Ukraine, as well as studies of intelligence oversight within democracies are the primary sources of data...

  2. Oversight and Management of a Cell Therapy Clinical Trial Network: Experience and Lessons Learned

    OpenAIRE

    Moyé, Lemuel A.; Sayre, Shelly L.; Westbrook, Lynette; Jorgenson, Beth C.; Handberg, Eileen; Anwaruddin, Saif; Wagner, Kristi A.; Skarlatos, Sonia I.

    2011-01-01

    The Cardiovascular Cell Therapy Research Network (CCTRN), sponsored by the National Heart, Lung, and Blood Institute (NHLBI), was established to develop, coordinate, and conduct multiple collaborative protocols testing the effects of cell therapy on cardiovascular diseases. The Network was born into a difficult political and ethical climate created by the recent removal of a dozen drugs from the US formulary and the temporary halting of 27 gene therapy trials due to safety concerns. This arti...

  3. Information on Stem Cell Research

    Science.gov (United States)

    ... Home » Current Research » Focus on Research Focus on Stem Cell Research Stem cells possess the unique ability to differentiate into ... virus infection. To search the complete list of stem cell research projects funded by NIH please go to NIH ...

  4. The Global Fund's paradigm of oversight, monitoring, and results in Mozambique.

    Science.gov (United States)

    Warren, Ashley; Cordon, Roberto; Told, Michaela; de Savigny, Don; Kickbusch, Ilona; Tanner, Marcel

    2017-12-12

    The Global Fund is one of the largest actors in global health. In 2015 the Global Fund was credited with disbursing close to 10 % of all development assistance for health. In 2011 it began a reform process in response to internal reviews following allegations of recipients' misuse of funds. Reforms have focused on grant application processes thus far while the core structures and paradigm have remained intact. We report results of discussions with key stakeholders on the Global Fund, its paradigm of oversight, monitoring, and results in Mozambique. We conducted 38 semi-structured in-depth interviews in Maputo, Mozambique and members of the Global Fund Board and Secretariat in Switzerland. In-country stakeholders were representatives from Global Fund country structures (eg. Principle Recipient), the Ministry of Health, health or development attachés bilateral and multilateral agencies, consultants, and the NGO coordinating body. Thematic coding revealed concerns about the combination of weak country oversight with stringent and cumbersome requirements for monitoring and evaluation linked to performance-based financing. Analysis revealed that despite the changes associated with the New Funding Model, respondents in both Maputo and Geneva firmly believe challenges remain in Global Fund's structure and paradigm. The lack of a country office has many negative downstream effects including reliance on in-country partners and ineffective coordination. Due to weak managerial and absorptive capacity, more oversight is required than is afforded by country team visits. In-country partners provide much needed support for Global Fund recipients, but roles, responsibilities, and accountability must be clearly defined for a successful long-term partnership. Furthermore, decision-makers in Geneva recognize in-country coordination as vital to successful implementation, and partners welcome increased Global Fund engagement. To date, there are no institutional requirements for

  5. Approaches to the mathematical description of NPP operational safety management and oversight

    International Nuclear Information System (INIS)

    Bilej, D.V.; Berzhanskij, S.V.

    2014-01-01

    The paper presents analysis of features related to NPP operational safety management and oversight. According to analysis results, approaches are proposed to perform mathematical description of specific processes and to develop a scale for management to the current safety level as regards NPP power generation. Proposed approaches are making experimental equations and process approach of ISO-9001 quality system

  6. Los Alamos National Laboratory Facilities, Security and Safeguards Division, Safeguards and Security Program Office, Protective Force Oversight Program

    International Nuclear Information System (INIS)

    1995-01-01

    The purpose of this document is to identify and describe the duties and responsibilities of Facility Security and Safeguards (FSS) Safeguards and Security (SS) organizations (groups/offices) with oversight functions over the Protection Force (PF) subcontractor. Responsible organizations will continue their present PF oversight functions under the Cost Plus Award Fee (CPAF) assessment, but now will be required to also coordinate, integrate, and interface with other FSS S and S organizations and with the PF subcontractor to measure performance, assess Department of Energy (DOE) compliance, reduce costs, and minimize duplication of effort. The role of the PF subcontractor is to provide the Laboratory with effective and efficient protective force services. PF services include providing protection for the special nuclear material, government property and classified or sensitive information developed and/or consigned to the Laboratory, as well as protection for personnel who work or participate in laboratory activities. FSS S and S oversight of both performance and compliance standards/metrics is essential for these PF objectives to be met

  7. More DoD Oversight Needed for Purchases Made Through the Department of Energy

    Science.gov (United States)

    2010-12-03

    obligations or to liquidate prior valid obligations. However, expired funds are not available for new obligations nor can they be used for new requirements...Oversight Would Enable The Department of Homeland Security To Address Risks,” September 2006 GAO Report No. GAO-05-456, “Interagency Contracting Franchise

  8. A Voice Crying in the Wilderness: Legislative Oversight Agencies' Efforts to Achieve Utilization

    Science.gov (United States)

    VanLandingham, Gary R.

    2006-01-01

    While legislative oversight offices, like many evaluation and policy analysis units, face substantial challenges in promoting use of their work by policymakers, they often have not taken steps to overcome these challenges by adopting the strategies suggested by the evaluation literature. Although the offices seek utilization, they have not fully…

  9. Nanotechnology, voluntary oversight, and corporate social performance: does company size matter?

    International Nuclear Information System (INIS)

    Kuzma, Jennifer; Kuzhabekova, Aliya

    2011-01-01

    In this article, we examine voluntary oversight programs for nanotechnology in the context of corporate social performance (CSP) in order to better understand the drivers, barriers, and forms of company participation in such programs. At the theoretical level, we use the management framework of CSP to understand the voluntary behavior of companies. At the empirical level, we investigate nanotech industry participation in the Environmental Protection Agency’s Nanoscale Materials Stewardship Program (NMSP) as an example of CSP, in order to examine the effects of company characteristics on CSP outcomes. The analysis demonstrates that, on the average, older and larger companies for which nanotech is one of the many business activities demonstrate greater CSP as judged by company actions, declarations, and self-evaluations. Such companies tended to submit more of the requested information to the NMSP, including specific information about health and safety, and to claim fewer of the submitted items as confidential business information. They were also more likely to have on-line statements of generic and nano-specific corporate social responsibility principles, policies, and achievements. The article suggests a need to encourage smaller and younger companies to participate in voluntary oversight programs for nanotechnology and presents options for better design of these programs.

  10. Nanotechnology, voluntary oversight, and corporate social performance: does company size matter?

    Science.gov (United States)

    Kuzma, Jennifer; Kuzhabekova, Aliya

    2011-04-01

    In this article, we examine voluntary oversight programs for nanotechnology in the context of corporate social performance (CSP) in order to better understand the drivers, barriers, and forms of company participation in such programs. At the theoretical level, we use the management framework of CSP to understand the voluntary behavior of companies. At the empirical level, we investigate nanotech industry participation in the Environmental Protection Agency's Nanoscale Materials Stewardship Program (NMSP) as an example of CSP, in order to examine the effects of company characteristics on CSP outcomes. The analysis demonstrates that, on the average, older and larger companies for which nanotech is one of the many business activities demonstrate greater CSP as judged by company actions, declarations, and self-evaluations. Such companies tended to submit more of the requested information to the NMSP, including specific information about health and safety, and to claim fewer of the submitted items as confidential business information. They were also more likely to have on-line statements of generic and nano-specific corporate social responsibility principles, policies, and achievements. The article suggests a need to encourage smaller and younger companies to participate in voluntary oversight programs for nanotechnology and presents options for better design of these programs.

  11. 75 FR 78779 - Order Approving Public Company Accounting Oversight Board Supplemental Budget Request To...

    Science.gov (United States)

    2010-12-16

    ...; Securities Exchange Act of 1934 Release No. 63526/December 10, 2010] Order Approving Public Company... Company Accounting Oversight Board (the ``PCAOB'') to oversee the audits of companies and related matters..., subject to approval by the Commission, auditing and related attestation, quality control, ethics, and...

  12. 20 CFR 411.595 - What oversight procedures are planned for the EN payment systems?

    Science.gov (United States)

    2010-04-01

    ... EN payment systems? 411.595 Section 411.595 Employees' Benefits SOCIAL SECURITY ADMINISTRATION THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM Employment Network Payment Systems § 411.595 What oversight procedures are planned for the EN payment systems? We use audits, reviews, studies and observation of daily...

  13. Human factors in nuclear safety oversight

    International Nuclear Information System (INIS)

    Taylor, K.

    1989-01-01

    The mission of the nuclear safety oversight function at the Savannah River Plant is to enhance the process and nuclear safety of site facilities. One of the major goals surrounding this mission is the reduction of human error. It is for this reason that several human factors engineers are assigned to the Operations assessment Group of the Facility Safety Evaluation Section (FSES). The initial task of the human factors contingent was the design and implementation of a site wide root cause analysis program. The intent of this system is to determine the most prevalent sources of human error in facility operations and to assist in determining where the limited human factors resources should be focused. In this paper the strategy used to educate the organization about the field of human factors is described. Creating an awareness of the importance of human factors engineering in all facets of design, operation, and maintenance is considered to be an important step in reducing the rate of human error

  14. The Nuclear Regulator's Role in Assessing Licensee. Oversight of Vendor and Other Contracted Services

    International Nuclear Information System (INIS)

    2011-01-01

    Contracted services are an integral part of the design, construction and operation of a nuclear facility. Changes in the nuclear industry sector, including varied availability of nuclear expertise, the expansion of the international supply market and the introduction of new technologies, have tended to increase licensees' use of contracted services. These changes have created challenges for licensees and regulators related to the retention of nuclear expertise, the effective management of the interfaces between the licensees and contractors, and the oversight of contractor manufacturing quality in the context of greater multinational diversity. The regulatory body must address these challenges to provide assurance that the licensees maintain their responsibility for the safety of the facilities, regardless of who provides goods and services or where the activities involved in the supply chain take place. This report is intended to assist regulatory bodies in assessing their current practices for the regulatory oversight of licensees' use of contractors, and adapting them where necessary to meet the evolving situation

  15. Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative 'Pre-Review' Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis.

    Science.gov (United States)

    Coleman, Carl H; Ardiot, Chantal; Blesson, Séverine; Bonnin, Yves; Bompart, Francois; Colonna, Pierre; Dhai, Ames; Ecuru, Julius; Edielu, Andrew; Hervé, Christian; Hirsch, François; Kouyaté, Bocar; Mamzer-Bruneel, Marie-France; Maoundé, Dionko; Martinent, Eric; Ntsiba, Honoré; Pelé, Gérard; Quéva, Gilles; Reinmund, Marie-Christine; Sarr, Samba Cor; Sepou, Abdoulaye; Tarral, Antoine; Tetimian, Djetodjide; Valverde, Olaf; Van Nieuwenhove, Simon; Strub-Wourgaft, Nathalie

    2015-12-01

    Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel 'pre-review' process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. © 2014 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.

  16. 76 FR 10135 - Public Housing Evaluation and Oversight: Changes to the Public Housing Assessment System (PHAS...

    Science.gov (United States)

    2011-02-23

    ... Vol. 76 Wednesday, No. 36 February 23, 2011 Part III Department of Housing and Urban Development 24 CFR Parts 901, 902, and 907 Public Housing Evaluation and Oversight: Changes to the Public Housing...

  17. Fuel Cell Manufacturing Research and Development | Hydrogen and Fuel Cells

    Science.gov (United States)

    | NREL Fuel Cell Manufacturing Research and Development Fuel Cell Manufacturing Research and Development NREL's fuel cell manufacturing R&D focuses on improving quality-inspection practices for high costs. A researcher monitoring web-line equipment in the Manufacturing Laboratory Many fuel cell

  18. Tennessee Oversight Agreement annual report, May 31, 1994--June 30, 1995

    International Nuclear Information System (INIS)

    1995-01-01

    The Tennessee Department of Environment and Conservation's DOE Oversight Division (TDEC/DOE-O) is responsible for assuring the citizens of Tennessee that their health, safety and environment on the Oak Ridge Reservation are protected and that appropriate remedial action is taken to provide this protection. TDEC/DOE-O has five program sections that reflect the organizational structure of the TDEC Bureau of Environment Divisions, as well as DOE's Environmental Safety and Health, Waste Management, and Environmental Restoration Programs

  19. Control, oversight and related terms in the international guidance on geological disposal of radioactive waste - Review of definitions and use

    International Nuclear Information System (INIS)

    2014-01-01

    This document presents the most complete analysis of the use of the words control, oversight, etc. as used in NEA, IAEA and ICRP literature connected to radioactive waste disposal. It reveals the many different ways the same word, 'control', has been used in international guidance and ambiguities than can arise, especially so for the post-closure phase of the repository. The newly introduced ICRP terminology, namely the use of the words 'oversight' and 'built-in controls', represents a step forward in terminology and resolves the ambiguity

  20. 75 FR 81684 - Order Approving Public Company Accounting Oversight Board Budget and Annual Accounting Support...

    Science.gov (United States)

    2010-12-28

    ... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2011 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''), established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...

  1. 78 FR 11915 - Order Approving Public Company Accounting Oversight Board Budget and Annual Accounting Support...

    Science.gov (United States)

    2013-02-20

    ... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2013 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''),\\1\\ established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...

  2. 77 FR 2576 - Order Approving Public Company Accounting Oversight Board Budget and Annual Accounting Support...

    Science.gov (United States)

    2012-01-18

    ... Accounting Oversight Board Budget and Annual Accounting Support Fee for Calendar Year 2012 The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley Act''),\\1\\ established the Public Company Accounting... through registration of public accounting firms and standard setting, inspection, and disciplinary...

  3. Contract Audits: Role in Helping Ensure Effective Oversight and Reducing Improper Payments

    Science.gov (United States)

    2011-02-01

    the risk of improper paymen Department of Energy (DOE). DOE’s internal controls over payments to its Waste Treatment Plant ( WTP ) contractor did not...provide reasonab assurance against the risk of improper payments, particularly given the WTP project’s substantial inherent risks. 18 Several factors...DCAA and the contractor, with little oversight of its own, exposed the hundreds of millions of dolla spent annually on the WTP project to an

  4. Regulatory oversight strategy for chemistry program at Canadian nuclear power plants

    International Nuclear Information System (INIS)

    Kameswaran; Ram

    2012-09-01

    Chemistry program is one of the essential programs for the safe operation of a nuclear power plant. It helps to ensure the necessary integrity, reliability and availability of plant structures, systems and components important to safety. Additionally, the program plays an important role in asset preservation, limiting radiation exposure and environmental protection. A good chemistry program will minimize corrosion of materials, reduce activation products, minimize of the buildup of radioactive material leading to occupational radiation exposure and it helps limit the release of chemicals and radioactive materials to the environment. The legal basis for the chemistry oversight at Canadian NPPs is established by the Nuclear Safety and Control Act and its associated regulations. It draws on the Canadian Nuclear Safety Commission's regulatory framework and NPP operating license conditions that include applicable standards such as CAN/CSA N286-05 Management System Requirements for Nuclear Power Plants. This paper focuses on the regulatory oversight strategy used in Canada to assess the performance of chemistry program at the nuclear power plants (NPPs) licensed by CNSC. The strategy consists of a combination of inspection and performance monitoring activities. The activities are further supported from information gathered through staff inspections of cross-cutting areas such as maintenance, corrective-action follow-ups, event reviews and safety related performance indicators. (authors)

  5. 75 FR 82417 - Public Company Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standards...

    Science.gov (United States)

    2010-12-30

    ... Standards Board (``ASB'') of the American Institute of Certified Public Accountants); and observations from... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63606; File No. PCAOB 2010-01] Public Company.... Introduction On September 15, 2010, the Public Company Accounting Oversight Board (the ``Board'' or the ``PCAOB...

  6. International Society for Stem Cell Research

    Science.gov (United States)

    ... renowned stem cell and regenerative medicine community. More stem cell research Take a closer look Recent Blogs View ... story independent nonprofit organization & the voice of the stem cell research community The International Society for Stem Cell ...

  7. Inspector General, DOD, Oversight of the Audit of the FY 2000 Military Retirement Fund Financial Statements

    Science.gov (United States)

    2001-02-28

    statements and to report on the adequacy of internal controls and compliance with laws and regulations. We contracted the audit of the FY 2000 Military...performed on the oversight of the audit of the FY 2000 Military Retirement Fund Financial Statements.

  8. 76 FR 33763 - Findings of Misconduct in Science/Research Misconduct

    Science.gov (United States)

    2011-06-09

    ..., Ph.D., St. Jude Children's Research Hospital: Based on the findings of an investigation report by St... oversight review, ORI found that Philippe Bois, Ph.D., former postdoctoral fellow, Department of Biochemistry, St. Jude, engaged in misconduct in science and research misconduct in research funded by National...

  9. Regulatory Oversight of Safety Culture in Nuclear Installations

    International Nuclear Information System (INIS)

    2013-03-01

    Experience across the international nuclear industry and in other technical fields over the past few decades has demonstrated the importance of a healthy safety culture in maintaining the safety of workers, the public and the environment. Both regulators and the nuclear industry recognize the need for licensees to develop a strong safety culture in order to support successful and sustainable nuclear safety performance. Progress over recent years can be observed in the rapid development of approaches to overseeing licensees' safety culture. This publication follows on and complements earlier publications on safety culture, from the publication Safety Culture (Safety Series No. 75-INSAG-4 (1991)), published after the Chernobyl accident, to the more recently published Safety Requirements on The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3 (2006)), which states that the management system is to be used to promote and support a strong safety culture. A number of attempts have been made at both the international and national levels to establish practical approaches to regulatory oversight of safety culture. During 2010 and 2011, two projects were conducted by the IAEA under the scope of the Safe Nuclear Energy - Regional Excellence Programme within the Norwegian Cooperation Programme with Bulgaria and Romania. These projects were implemented at the Bulgarian and Romanian regulatory bodies. They encompassed the development of a specific process to oversee licensees' safety culture, and involved 30 experts from 17 countries and 22 organizations. The IAEA continues to support Member States in the area of safety culture through its projects on safety management and capacity building. This publication addresses the basics of regulatory oversight of safety culture, describes the approaches currently implemented at several regulatory bodies around the world and, based on these examples, proposes a path to developing such a process

  10. Self-audit as part of a research governance framework for health research.

    Science.gov (United States)

    Crammond, Bradley R; Parker, Anna V; Brooks, Megan; Skiba, Marina; McNeil, John J

    2011-03-21

    Clinical research is an area of increasing activity for hospitals, universities and research institutions, which requires formal governance and oversight to manage risks. Monitoring research practice should be a part of research governance activities. However, formal audits have proved time consuming for researchers and auditors. To increase attention to good research practice and screen for poor practice, the Department of Epidemiology and Preventive Medicine at Monash University and the Alfred Research and Ethics Unit in Melbourne have developed a brief self-audit tool for researchers. We evaluated the self-audit using a questionnaire for researchers. The results were positive, with most respondents believing that it promoted good research practice.

  11. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Science.gov (United States)

    2012-02-27

    ... Oversight of PET Drug Products--Questions and Answers.'' The draft guidance provides questions and answers... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic... PET Drug Products--Questions and Answers.'' In 1997, Congress passed the Food and Drug Administration...

  12. 75 FR 3509 - Public Company Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standard No...

    Science.gov (United States)

    2010-01-21

    ... Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standard No. 7, Engagement Quality... (the ``Commission'') a notice (the ``Notice'') of proposed rules (File No. PCAOB-2009-02) on Auditing... identify any significant engagement deficiencies before it issues its audit report. Auditing Standard No. 7...

  13. STEM CELL RESEARCH-CONCEPT AND CONTROVERSIES

    African Journals Online (AJOL)

    Dr. E. P. Gharoro

    cells, heart cells, brain cells, etc.). Some researchers regard them as offering the greatest potential for the .... anaemia, heart damage, corneal damage, etc. To be useful for transplant purposes, stem cells must ... activity in the brain was demonstrated contradicting caja's “no new neurons” dogma. However, research into.

  14. Counterfeit Parts: DOD Needs to Improve Reporting and Oversight to Reduce Supply Chain Risk

    Science.gov (United States)

    2016-02-01

    agencies and contractors we met with stated that they have encountered counterfeit parts less frequently in the DOD supply chain , in part, because...the DOD supply chain as a method to prevent further counterfeiting.22 DOD and industry officials noted that timely reporting of...COUNTERFEIT PARTS DOD Needs to Improve Reporting and Oversight to Reduce Supply Chain Risk Report to Congressional Committees

  15. College Students' Conceptions of Stem Cells, Stem Cell Research, and Cloning

    Science.gov (United States)

    Concannon, James P.; Siegel, Marcelle A.; Halverson, Kristy; Freyermuth, Sharyn

    2010-01-01

    In this study, we examined 96 undergraduate non-science majors' conceptions of stem cells, stem cell research, and cloning. This study was performed at a large, Midwest, research extensive university. Participants in the study were asked to answer 23 questions relating to stem cells, stem cell research, and cloning in an on-line assessment before…

  16. 77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

    Science.gov (United States)

    2012-12-04

    ... PET Drug Products--Questions and Answers.'' This guidance provides questions and answers that address.... 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in... availability of a guidance entitled ``FDA Oversight of PET Drug Products--Questions and Answers.'' In 1997...

  17. 76 FR 52996 - Public Company Accounting Oversight Board; Order Approving Proposed Temporary Rule for an Interim...

    Science.gov (United States)

    2011-08-24

    ... Accounting Oversight Board; Order Approving Proposed Temporary Rule for an Interim Program of Inspection Related to Audits of Brokers and Dealers August 18, 2011. I. Introduction On June 21, 2011, the Public... that would be imposed on different categories of registered public accounting firms and classes of...

  18. Bioprinting for stem cell research

    Science.gov (United States)

    Tasoglu, Savas; Demirci, Utkan

    2012-01-01

    Recently, there has been a growing interest to apply bioprinting techniques to stem cell research. Several bioprinting methods have been developed utilizing acoustics, piezoelectricity, and lasers to deposit living cells onto receiving substrates. Using these technologies, spatially defined gradients of immobilized proteins can be engineered to direct stem cell differentiation into multiple subpopulations of different lineages. Stem cells can also be patterned in a high-throughput manner onto flexible implementation patches for tissue regeneration or onto substrates with the goal of accessing encapsulated stem cell of interest for genomic analysis. Here, we review recent achievements with bioprinting technologies in stem cell research, and identify future challenges and potential applications including tissue engineering and regenerative medicine, wound healing, and genomics. PMID:23260439

  19. Torture, Impunity, and the Need for Independent Prosecutorial Oversight of the Executive Branch

    OpenAIRE

    Quigley, Fran

    2017-01-01

    Fran Quigley, Torture, Impunity, and the Need for Independent Prosecutorial Oversight of the Executive Branch, 20 Cornell J. L. & Pub. Pol'y 271 (2010) Allegations of Executive Branch misconduct present an inherent conflict of interest because prosecutorial discretion is invested in a U.S. Attorney General appointed by – and serving at the pleasure of – the President. Various commentators, including Justice Antonin Scalia, Professor Stephen Carter, and the many critics of the former indep...

  20. South African surgical registrar perceptions of the research project ...

    African Journals Online (AJOL)

    organisation and strict oversight that are well developed in clinical training.[2]. In order to improve the research capability of registrars, we suggest mandating the completion of a validated formal research methodology course for all surgical registrars within the first year of their registrar training, or as a requirement for.

  1. 12 CFR 361.5 - What are the FDIC's oversight and monitoring responsibilities in administering this program?

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false What are the FDIC's oversight and monitoring responsibilities in administering this program? 361.5 Section 361.5 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND STATEMENTS OF GENERAL POLICY MINORITY AND WOMEN OUTREACH PROGRAM CONTRACTING § 361...

  2. 76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

    Science.gov (United States)

    2011-08-29

    ... 200N, Rockville, MD 20852-1448; or the Office of Communication, Education and Radiation Programs... describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies... appropriate, and other forms of information technology. Title: Draft Guidance for Industry: Oversight of...

  3. Fuel cells: Trends in research and applications

    Science.gov (United States)

    Appleby, A. J.

    Various aspects of fuel cells are discussed. The subjects addressed include: fuel cells for electric power production; phosphoric acid fuel cells; long-term testing of an air-cooled 2.5 kW PAFC stack in Italy; status of fuel cell research and technology in the Netherlands, Bulgaria, PRC, UK, Sweden, India, Japan, and Brazil; fuel cells from the manufacturer's viewpoint; and fuel cells using biomass-derived fuels. Also examined are: solid oxide electrolye fuel cells; aluminum-air batteries with neutral chloride electrolyte; materials research for advanced solid-state fuel cells at the Energy Research Laboratory in Denmark; molten carbonate fuel cells; the impact of the Siemens program; fuel cells at Sorapec; impact of fuel cells on the electric power generation systems in industrial and developing countries; and application of fuel cells to large vehicles.

  4. 78 FR 67363 - Findings of Research Misconduct

    Science.gov (United States)

    2013-11-12

    ... University--Canada (formerly University of Western Ontario): Based on the report of an investigation conducted by Western University--Canada (WU) and ORI's subsequent oversight analysis, ORI found that Dr. Hao...-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI...

  5. Regulatory Oversight of Cell and Gene Therapy Products in Canada.

    Science.gov (United States)

    Ridgway, Anthony; Agbanyo, Francisca; Wang, Jian; Rosu-Myles, Michael

    2015-01-01

    Health Canada regulates gene therapy products and many cell therapy products as biological drugs under the Canadian Food and Drugs Act and its attendant regulations. Cellular products that meet certain criteria, including minimal manipulation and homologous use, may be subjected to a standards-based approach under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. The manufacture and clinical testing of cell and gene therapy products (CGTPs) presents many challenges beyond those for protein biologics. Cells cannot be subjected to pathogen removal or inactivation procedures and must frequently be administered shortly after final formulation. Viral vector design and manufacturing control are critically important to overall product quality and linked to safety and efficacy in patients through concerns such as replication competence, vector integration, and vector shedding. In addition, for many CGTPs, the value of nonclinical studies is largely limited to providing proof of concept, and the first meaningful data relating to appropriate dosing, safety parameters, and validity of surrogate or true determinants of efficacy must come from carefully designed clinical trials in patients. Addressing these numerous challenges requires application of various risk mitigation strategies and meeting regulatory expectations specifically adapted to the product types. Regulatory cooperation and harmonisation at an international level are essential for progress in the development and commercialisation of these products. However, particularly in the area of cell therapy, new regulatory paradigms may be needed to harness the benefits of clinical progress in situations where the resources and motivation to pursue a typical drug product approval pathway may be lacking.

  6. Setting FIRES to Stem Cell Research

    Science.gov (United States)

    Miller, Roxanne Grietz

    2005-01-01

    The goal of this lesson is to present the basic scientific knowledge about stem cells, the promise of stem cell research to medicine, and the ethical considerations and arguments involved. One of the challenges of discussing stem cell research is that the field is constantly evolving and the most current information changes almost daily. Few…

  7. 76 FR 40950 - Public Company Accounting Oversight Board; Notice of Filing of Proposed Board Funding Final Rules...

    Science.gov (United States)

    2011-07-12

    ... available, the issuer's net asset value. (i)(v) Issuer Accounting Support Fee The term ``issuer accounting... Accounting Oversight Board; Notice of Filing of Proposed Board Funding Final Rules for Allocation of the Board's Accounting Support Fee Among Issuers, Brokers, and Dealers, and Other Amendments to the Board's...

  8. Report: Enhanced EPA Oversight and Action Can Further Protect Water Resources From the Potential Impacts of Hydraulic Fracturing

    Science.gov (United States)

    Report #15-P-0204, July 16, 2015. Enhanced EPA oversight of the permitting process for diesel fuel use during hydraulic fracturing can further EPA efforts to protect water resources, and establishment of a plan for determining whether to propose a chemical

  9. 3 CFR - Guidelines for Human Stem Cell Research

    Science.gov (United States)

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Guidelines for Human Stem Cell Research Presidential Documents Other Presidential Documents Memorandum of July 30, 2009 Guidelines for Human Stem Cell Research..., scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent...

  10. Attitude of A Sample of Iranian Researchers toward The Future of Stem Cell Research.

    Science.gov (United States)

    Lotfipanah, Mahdi; Azadeh, Fereydoon; Totonchi, Mehdi; Omani-Samani, Reza

    2018-10-01

    Stem cells that have unlimited proliferation potential as well as differentiation potency are considered to be a promising future treatment method for incurable diseases. The aim of the present study is to evaluate the future trend of stem cell researches from researchers' viewpoints. This was a cross-sectional descriptive study on researchers involved in stem cell research at Royan Institute. We designed a questionnaire using a qualitative study based on expert opinion and a literature review. Content validity was performed using three rounds of the Delphi method with experts. Face validity was undertaken by a Persian literature expert and a graphics designer. The questionnaire was distributed among 150 researchers involved in stem cell studies in Royan Institute biology laboratories. We collected 138 completed questionnaires. The mean age of participants was 31.13 ± 5.8 years; most (60.9%) were females. Participants (76.1%) considered the budget to be the most important issue in stem cell research, 79.7% needed financial support from the government, and 77.5% felt that charities could contribute substantially to stem cell research. A total of 90.6% of participants stated that stem cells should lead to commercial usage which could support future researches (86.2%). The aim of stem cell research was stipulated as increasing health status of the society according to 92.8% of the participants. At present, among cell types, importance was attached to cord blood and adult stem cells. Researchers emphasized the importance of mesenchymal stem cells (MSCs) rather than hematopoietic stem cells (HSCs, 57.73%). The prime priorities were given to cancer so that stem cell research could be directed to sphere stem cell research whereas the least preference was given to skin research. Regenerative medicine is considered the future of stem cell research with emphasis on application of these cells, especially in cancer treatment. Copyright© by Royan Institute. All rights

  11. Teamwork for Oversight of Processes and Systems (TOPS). Implementation guide for TOPS version 2.0, 10 August 1992

    Science.gov (United States)

    Strand, Albert A.; Jackson, Darryl J.

    As the nation redefines priorities to deal with a rapidly changing world order, both government and industry require new approaches for oversight of management systems, particularly for high technology products. Declining defense budgets will lead to significant reductions in government contract management personnel. Concurrently, defense contractors are reducing administrative and overhead staffing to control costs. These combined pressures require bold approaches for the oversight of management systems. In the Spring of 1991, the DPRO and TRW created a Process Action Team (PAT) to jointly prepare a Performance Based Management (PBM) system titled Teamwork for Oversight of Processes and Systems (TOPS). The primary goal is implementation of a performance based management system based on objective data to review critical TRW processes with an emphasis on continuous improvement. The processes are: Finance and Business Systems, Engineering and Manufacturing Systems, Quality Assurance, and Software Systems. The team established a number of goals: delivery of quality products to contractual terms and conditions; ensure that TRW management systems meet government guidance and good business practices; use of objective data to measure critical processes; elimination of wasteful/duplicative reviews and audits; emphasis on teamwork--all efforts must be perceived to add value by both sides and decisions are made by consensus; and synergy and the creation of a strong working trust between TRW and the DPRO. TOPS permits the adjustment of oversight resources when conditions change or when TRW systems performance indicate either an increase or decrease in surveillance is appropriate. Monthly Contractor Performance Assessments (CPA) are derived from a summary of supporting system level and process-level ratings obtained from objective process-level data. Tiered, objective, data-driven metrics are highly successful in achieving a cooperative and effective method of measuring

  12. Teamwork for Oversight of Processes and Systems (TOPS). Implementation guide for TOPS version 2.0, 10 August 1992

    Science.gov (United States)

    Strand, Albert A.; Jackson, Darryl J.

    1992-01-01

    As the nation redefines priorities to deal with a rapidly changing world order, both government and industry require new approaches for oversight of management systems, particularly for high technology products. Declining defense budgets will lead to significant reductions in government contract management personnel. Concurrently, defense contractors are reducing administrative and overhead staffing to control costs. These combined pressures require bold approaches for the oversight of management systems. In the Spring of 1991, the DPRO and TRW created a Process Action Team (PAT) to jointly prepare a Performance Based Management (PBM) system titled Teamwork for Oversight of Processes and Systems (TOPS). The primary goal is implementation of a performance based management system based on objective data to review critical TRW processes with an emphasis on continuous improvement. The processes are: Finance and Business Systems, Engineering and Manufacturing Systems, Quality Assurance, and Software Systems. The team established a number of goals: delivery of quality products to contractual terms and conditions; ensure that TRW management systems meet government guidance and good business practices; use of objective data to measure critical processes; elimination of wasteful/duplicative reviews and audits; emphasis on teamwork--all efforts must be perceived to add value by both sides and decisions are made by consensus; and synergy and the creation of a strong working trust between TRW and the DPRO. TOPS permits the adjustment of oversight resources when conditions change or when TRW systems performance indicate either an increase or decrease in surveillance is appropriate. Monthly Contractor Performance Assessments (CPA) are derived from a summary of supporting system level and process-level ratings obtained from objective process-level data. Tiered, objective, data-driven metrics are highly successful in achieving a cooperative and effective method of measuring

  13. 76 FR 40961 - Public Company Accounting Oversight Board; Notice of Filing of Proposed Temporary Rule for an...

    Science.gov (United States)

    2011-07-12

    ... of the Board Section 1. General Provisions * * * Rule 1001. Definitions of Terms Employed in Rules... Accounting Oversight Board; Notice of Filing of Proposed Temporary Rule for an Interim Program of Inspection... Act of 2002 (the ``Act''), notice is hereby given that on June 21, 2011, the Public Company Accounting...

  14. Environment, safety, and health. Status of DOE's reorganization of its safety oversight function

    International Nuclear Information System (INIS)

    Bannerman, Carl J.; Cannon, Doris E.; Jones, Gary L.; Ulrich, Timothy W.

    1990-01-01

    Several major events that preceded the Secretary's decision to restructure DOE's management of its nuclear facilities were identified. The proposed restructuring plan, in concept, is designed to set in place an oversight framework, which will provide confidence in DOE's ability to operate its nuclear facilities in a safe manner. Further, on the basis of the previous work in this area as well as other independent studies, several issues were identified that may affect the success of the proposed restructuring plan

  15. Cell-based interventions for neurologic conditions: ethical challenges for early human trials.

    Science.gov (United States)

    Mathews, D J H; Sugarman, J; Bok, H; Blass, D M; Coyle, J T; Duggan, P; Finkel, J; Greely, H T; Hillis, A; Hoke, A; Johnson, R; Johnston, M; Kahn, J; Kerr, D; Kurtzberg, J; Liao, S M; McDonald, J W; McKhann, G; Nelson, K B; Rao, M; Regenberg, A; Siegel, A W; Smith, K; Solter, D; Song, H; Vescovi, A; Young, W; Gearhart, J D; Faden, R

    2008-07-22

    Attempts to translate basic stem cell research into treatments for neurologic diseases and injury are well under way. With a clinical trial for one such treatment approved and in progress in the United States, and additional proposals under review, we must begin to address the ethical issues raised by such early forays into human clinical trials for cell-based interventions for neurologic conditions. An interdisciplinary working group composed of experts in neuroscience, cell biology, bioethics, law, and transplantation, along with leading disease researchers, was convened twice over 2 years to identify and deliberate on the scientific and ethical issues raised by the transition from preclinical to clinical research of cell-based interventions for neurologic conditions. While the relevant ethical issues are in many respects standard challenges of human subjects research, they are heightened in complexity by the novelty of the science, the focus on the CNS, and the political climate in which the science is proceeding. Distinctive challenges confronting US scientists, administrators, institutional review boards, stem cell research oversight committees, and others who will need to make decisions about work involving stem cells and their derivatives and evaluate the ethics of early human trials include evaluating the risks, safety, and benefits of these trials, determining and evaluating cell line provenance, and determining inclusion criteria, informed consent, and the ethics of conducting early human trials in the public spotlight. Further study and deliberation by stakeholders is required to move toward professional and institutional policies and practices governing this research.

  16. Management process invaded Ames as the Center shifted from NACA to NASA oversight. Ames constructed

    Science.gov (United States)

    1968-01-01

    Management process invaded Ames as the Center shifted from NACA to NASA oversight. Ames constructed a review room in its headquarters building where, in the graphical style that prevailed in the 1960's, Ames leadership could review progress against schedule, budget and performance measures. Shown, in October 1965 is Merrill Mead chief of Ames' program and resources office. (for H Julian Allen Retirement album)

  17. 42 CFR 137.368 - Is the Secretary responsible for oversight and compliance of health and safety codes during...

    Science.gov (United States)

    2010-10-01

    ... compliance of health and safety codes during construction projects being performed by a Self-Governance Tribe... SERVICES TRIBAL SELF-GOVERNANCE Construction Roles of the Secretary in Establishing and Implementing Construction Project Agreements § 137.368 Is the Secretary responsible for oversight and compliance of health...

  18. Clinical oversight and the avoidance of repeat induced abortion.

    Science.gov (United States)

    Jacovetty, Erica L; Clare, Camille A; Squire, Mary-Beatrice; Kubal, Keshar P; Liou, Sherry; Inchiosa, Mario A

    2018-06-03

    To evaluate the impact of patient counseling, demographics, and contraceptive methods on repeat induced abortion in women attending family planning clinics. A retrospective chart review of repeat induced abortions was performed. The analysis included patients with an initial induced abortion obtained between January 1, 2001, and March 31, 2014, at New York City Health + Hospitals/Metropolitan. The duration of involvement in the family planning program, the use of contraceptive interventions, and 18 patient factors were analyzed for their correlation with the incidence of repeat induced abortions per year of follow-up. A decreased rate of repeat induced abortions was associated with a longer duration of clinical oversight (r 2 =0.449, Pabortions. By determining the patient characteristics that most influence repeat induced abortion rates, providers can best choose the most efficacious method of contraception available. © 2018 International Federation of Gynecology and Obstetrics.

  19. Stem Cell Research: Unlocking the Mystery of Disease

    Science.gov (United States)

    ... Home Current Issue Past Issues From the Director: Stem Cell Research: Unlocking the Mystery of Disease Past Issues / ... Zerhouni, NIH Director, described the need for expanding stem cell research. Recently, he spoke about stem cell research ...

  20. WTO oversight over bilateral agreements: from a notification to an examination process?

    DEFF Research Database (Denmark)

    Mortensen, Jens Ladefoged

    2014-01-01

    The TTIP will – like other free trade agreements (FTAs) – violate one of the cornerstones of the WTO, i.e. the Most-Favoured-Nation (MFN) principle. However, the multilateral trading system has since 1947 permitted the formation of trading blocks and preferential bilateral trading partnerships....... This contribution asks how the WTO can fulfill its task of ensuring that FTAs do not systematically undermine the multilateral trading order. It focuses on the issue of transparency in the current oversight process and discusses whether the WTO secretariat should be granted a stronger mandate to proactively...... investigate the economic effects of the notified FTAs....

  1. Ethical Issues in Stem Cell Research

    OpenAIRE

    Lo, Bernard; Parham, Lindsay

    2009-01-01

    Stem cell research offers great promise for understanding basic mechanisms of human development and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord injury, Parkinson’s disease, and myocardial infarction. However, human stem cell (hSC) research also raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes about the onset of human personhood. The reprogramm...

  2. A Comparison of the Audit and Accreditation Tools Used By The Health Care Financing Administration, The Texas Department of Insurance, and The National Committee on Quality Assurance: The Cost of Multi-Agency Oversight on Medicare+Choice Plans in Texas

    Science.gov (United States)

    2001-04-12

    Comparison of Oversight Models in Managed Care 1 Running Head: Comparison of Oversight Models in Managed Care A Comparison of the Audit and...TITLE AND SUBTITLE A Comparison of the Audit and Accreditation Tools Used By The Health Care Financing Administration, The Texas Department of...Comparison of Oversight Models in Managed Care 5 A Comparison of the Audit and Accreditation Tools Used By The Health Care Financing

  3. Improvements Needed in Managing Scope Changes and Oversight of Construction Projects at Camp Lemonnier, Djibouti

    Science.gov (United States)

    2016-09-30

    efficiency; advises the Secretary of Defense and Congress; and informs the public. Vision Our vision is to be a model oversight organization in the...Bachelor Enlisted Quarters and P220, Ammunition Supply Point, with combined estimated costs of $65.2 million, for audit . This is one in a series of...The Director stated that maintaining contract files was secondary to construction completion. As a result, there is an increased risk that

  4. Microfluidic cell culture systems for drug research.

    Science.gov (United States)

    Wu, Min-Hsien; Huang, Song-Bin; Lee, Gwo-Bin

    2010-04-21

    In pharmaceutical research, an adequate cell-based assay scheme to efficiently screen and to validate potential drug candidates in the initial stage of drug discovery is crucial. In order to better predict the clinical response to drug compounds, a cell culture model that is faithful to in vivo behavior is required. With the recent advances in microfluidic technology, the utilization of a microfluidic-based cell culture has several advantages, making it a promising alternative to the conventional cell culture methods. This review starts with a comprehensive discussion on the general process for drug discovery and development, the role of cell culture in drug research, and the characteristics of the cell culture formats commonly used in current microfluidic-based, cell-culture practices. Due to the significant differences in several physical phenomena between microscale and macroscale devices, microfluidic technology provides unique functionality, which is not previously possible by using traditional techniques. In a subsequent section, the niches for using microfluidic-based cell culture systems for drug research are discussed. Moreover, some critical issues such as cell immobilization, medium pumping or gradient generation in microfluidic-based, cell-culture systems are also reviewed. Finally, some practical applications of microfluidic-based, cell-culture systems in drug research particularly those pertaining to drug toxicity testing and those with a high-throughput capability are highlighted.

  5. Tennessee Oversight Agreement annual report, May 13, 1993 - May 12, 1994

    International Nuclear Information System (INIS)

    1994-01-01

    This report discusses the activities of the Division of DOE Oversight in the areas of coordination with other State Agencies with regard to environmental restoration, corrective action, and waste management activities on the Oak Ridge Reservation; and the Division's efforts to keep the public informed of those DOE activities that may impact their health and the environment. This report includes the status of the Division's efforts in implementing the Tennessee Oversight Agreement (TOA). Each Program Section provides information concerning the status of its activities. The Administrative Section has been instrumental in achieving access to the ORR without prior notification to DOE and in obtaining documents and environmental, waste management, safety, and health information in a timely manner. The Environmental Restoration Program has provided in-depth document reviews and on-site coordination and monitoring of field activities required under the Federal Facility Agreement. Most notable of the activities are the investigations and planned remediation of the Lower East Fork Poplar Creek and the Watts Bar Reservoir. The Waste Management Program has audited DOE's compliance with air, water, solid, hazardous, and mixed waste storage, treatment, and disposal regulations. Effort was focused on all three DOE Facilities on the ORR. The final portion of this report discusses the Division's findings and recommendations. Most significant of these issues is the Division's request to be an active participant in DOE's prioritization of its TOA commitments. Other issues discussed include long term storage of radioactive waste and the use of environmental restoration funds. A discussion of those findings and recommendations provided in last year's annual report and addressed by DOE are included in this report as well. All documents, logs, files, etc. supporting this report are available for review during routine business hours at the Division's office

  6. Cell Science and Cell Biology Research at MSFC: Summary

    Science.gov (United States)

    2003-01-01

    The common theme of these research programs is that they investigate regulation of gene expression in cells, and ultimately gene expression is controlled by the macromolecular interactions between regulatory proteins and DNA. The NASA Critical Path Roadmap identifies Muscle Alterations and Atrophy and Radiation Effects as Very Serious Risks and Severe Risks, respectively, in long term space flights. The specific problem addressed by Dr. Young's research ("Skeletal Muscle Atrophy and Muscle Cell Signaling") is that skeletal muscle loss in space cannot be prevented by vigorous exercise. Aerobic skeletal muscles (i.e., red muscles) undergo the most extensive atrophy during long-term space flight. Of the many different potential avenues for preventing muscle atrophy, Dr. Young has chosen to study the beta-adrenergic receptor (betaAR) pathway. The reason for this choice is that a family of compounds called betaAR agonists will preferentially cause an increase in muscle mass of aerobic muscles (i.e., red muscle) in animals, potentially providing a specific pharmacological solution to muscle loss in microgravity. In addition, muscle atrophy is a widespread medical problem in neuromuscular diseases, spinal cord injury, lack of exercise, aging, and any disease requiring prolonged bedridden status. Skeletal muscle cells in cell culture are utilized as a model system to study this problem. Dr. Richmond's research ("Radiation & Cancer Biology of Mammary Cells in Culture") is directed toward developing a laboratory model for use in risk assessment of cancer caused by space radiation. This research is unique because a human model will be developed utilizing human mammary cells that are highly susceptible to tumor development. This approach is preferential over using animal cells because of problems in comparing radiation-induced cancers between humans and animals.

  7. A Critical Review of the Oversight Role of the Office of the Auditor-General in Financial Accountability

    Directory of Open Access Journals (Sweden)

    Ogochukwu Nzewi

    2014-03-01

    Full Text Available Accountability is the very essence of the Constitution of the Republic of South Africa (Act No. 108 of 1996. In this regard, the Auditor-General of South Africa (AGSA as the supreme audit institution of the Republic of South Africa plays an important oversight role of promoting financial accountability in government. The purpose of this article is to examine the challenges facing the office of the Auditor-General in executing its oversight role of promoting financial accountability in the sphere of provincial government. Information and sources for this article was gathered through literature review. The article gives some background on the establishment and rationale of Supreme Audit Institutions (SAI. It explores some policy framework that informs public finance management in the Republic of South Africa, establishing the role of the AGSA within this purview. Based on the data gathered through literature review, the key challenges facing the office of the Auditor-General are discussed. Finally, possible solutions are recommended to the challenges that were identified.

  8. Lessons Learned from a Five-year Evaluation of the Belgian Safety Culture Oversight Process

    International Nuclear Information System (INIS)

    Bernard, B.

    2016-01-01

    The Belgian Regulatory Body has implemented a Safety Culture oversight process since 2010. In a nutshell, this process is based on field observations provided by inspectors or safety analysts during any contact with a licencee (inspections, meetings, phone calls, etc). These observations are recorded within an observation (excel) sheet—aiming at describing factual and contextual issues — and are linked to IAEA Safety Culture attributes. It should be stressed that the purpose of the process is not to give a comprehensive view of a licencee safety culture but to address findings that require attention or action on the part of a licencee. In other words, gathering safety culture observations aims at identifying cultural, organizational or behavioural issues in order to feed a regulatory response to potential problems. Safety Culture Observations (SCO) are then fully integrated in routine inspection activities and must be seen as an input of the overall oversight process. As a result, the assessment of the SCO is inserted within the yearly safety evaluation report performed by Bel V and transmitted to the licencee. However, observing safety culture is not a natural approach for engineers. Guidance, training and coaching must be provided in order to open up safety dimensions to be captured. In other words, a SCO process requires a continuous support in order to promote a holistic and systemic view of safety.

  9. Regulatory Oversight of the Legacy Gunner Uranium Mine and Mill Site in Northern Saskatchewan, Canada - 13434

    Energy Technology Data Exchange (ETDEWEB)

    Stenson, Ron; Howard, Don [Canadian Nuclear Safety Commission, P.O. Box 1046, Station B, 280 Slater Street, Ottawa ON K1P 5S9 (Canada)

    2013-07-01

    As Canada's nuclear regulator, the Canadian Nuclear Safety Commission (CNSC) is responsible for licensing all aspects of uranium mining, including remediation activities at legacy sites. Since these sites already existed when the current legislation came into force in 2000, and the previous legislation did not apply, they present a special case. The Nuclear Safety and Control Act (NSCA), was written with cradle-to- grave oversight in mind. Applying the NSCA at the end of a 'facilities' life-cycle poses some challenges to both the regulator and the proponent. When the proponent is the public sector, even more challenges can present themselves. Although the licensing process for legacy sites is no different than for any other CNSC license, assuring regulatory compliance can be more complicated. To demonstrate how the CNSC has approached the oversight of legacy sites the history of the Commission's involvement with the Gunnar uranium mine and mill site provides a good case study. The lessons learned from the CNSC's experience regulating the Gunnar site will benefit those in the future who will need to regulate legacy sites under existing or new legislation. (authors)

  10. Health physics self-assessment and the nuclear regulatory oversight process at a nuclear power plant

    International Nuclear Information System (INIS)

    Schofield, R.S.

    2003-01-01

    The U.S. Nuclear Regulatory Commission has developed improvements in their Nuclear Power Plant inspection, assessment and enforcement practices. The objective of these changes was to link regulatory action with power plant performance through a risk- informed process which is intended to enhance objectivity. One of the Strategic Performance Areas of focus by the U.S. NRC is radiation safety. Two cornerstones, Occupational Radiation Safety and Public Radiation Safety, make up this area. These cornerstones are being evaluated through U.S. NRC Performance Indicators (PI) and baseline site inspections. Key to the U.S. NRC's oversight program is the ability of the licensee to implement a self-assessment program which pro-actively identifies potential problems and develops improvements to enhance management's effectiveness. The Health Physics Self-Assessment Program at San Onofre Nuclear Generating Station (SONGS) identifies radiation protection-related weakness or negative trends. The intended end result is improved performance through rapid problem identification, timely evaluation, corrective action and follow-up effectiveness reviews. A review of the radiation protection oversight process and the SONGS Health Physics Self-Assessment Program will be presented. Lessons learned and management tools, which evaluate workforce and Health Physics (HP) staff performance to improve radiological practices, are discussed. (author)

  11. 78 FR 19713 - Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research...

    Science.gov (United States)

    2013-04-02

    ... tobacco product research could be subject to third-party governance? For example, could it be applied to... governance? For example, should both the design and conduct of research studies be subject to third-party... more key functions, including the design and conduct of research, the oversight of specific studies...

  12. The World Bank Inspection Panel and Quasi-Judicial Oversight: In Search of the 'Judicial Spirit' in Public International Law

    NARCIS (Netherlands)

    A. Naudé Fourie (Andria)

    2009-01-01

    textabstractThis PhD dissertation conceptualizes the World Bank Inspection Panel as a mechanism of quasi-judicial review or oversight, aimed at enhancing the accountability and legitimacy of the World Bank – which is conceived as an international institution exercising public power. The author

  13. Research ethics consultation: ethical and professional practice challenges and recommendations.

    Science.gov (United States)

    Sharp, Richard R; Taylor, Holly A; Brinich, Margaret A; Boyle, Mary M; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

    2015-05-01

    The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.

  14. US system of oversight for genetic testing: a report from the Secretary's Advisory Committee on Genetics, Health and Society.

    Science.gov (United States)

    Ferreira-Gonzalez, Andrea; Teutsch, Steven; Williams, Marc S; Au, Sylvia M; Fitzgerald, Kevin T; Miller, Paul Steven; Fomous, Cathy

    2008-09-01

    As genetic testing technology is integrated into healthcare, increasingly detailed information about individual and population genetic variation is available to patients and providers. Health professionals use genetic testing to diagnose or assess the risk of disease in individuals, families and populations and to guide healthcare decisions. Consumers are beginning to explore personalized genomic services in an effort to learn more about their risk for common diseases. Scientific and technological advances in genetic testing, as with any newly introduced medical technology, present certain challenges to existing frameworks of oversight. In addition, the growing use of genetic testing will require a significant investment in evidence-based assessments to understand the validity and utility of these tests in clinical and personal decisionmaking. To optimize the use of genetic testing in healthcare, all sectors of the oversight system need to be strengthened and yet remain flexible in order to adapt to advances that will inevitably increase the range of genetic tests and methodologies.

  15. Preventing biological weapon development through the governance of life science research.

    Science.gov (United States)

    Epstein, Gerald L

    2012-03-01

    The dual-use dilemma in the life sciences-that illicit applications draw on the same science and technology base as legitimate applications-makes it inherently difficult to control one without inhibiting the other. Since before the September 11 attacks, the science and security communities in the United States have struggled to develop governance processes that can simultaneously minimize the risk of misuse of the life sciences, promote their beneficial applications, and protect the public trust. What has become clear over that time is that while procedural steps can be specified for assessing and managing dual-use risks in the review of research proposals, oversight of ongoing research, and communication of research results, the actions or decisions to be taken at each of these steps to mitigate dual-use risk defy codification. Yet the stakes are too high to do nothing, or to be seen as doing nothing. The U.S. government should therefore adopt an oversight framework largely along the lines recommended by the National Science Advisory Board for Biosecurity almost 5 years ago-one that builds on existing processes, can gain buy-in from the scientific community, and can be implemented at modest cost (both direct and opportunity), while providing assurance that a considered and independent examination of dual-use risks is being applied. Without extraordinary visibility into the actions of those who would misuse biology, it may be impossible to know how well such an oversight system will actually succeed at mitigating misuse. But maintaining the public trust will require a system to be established in which reasonably foreseeable dual-use consequences of life science research are anticipated, evaluated, and addressed.

  16. Ethical and regulatory aspects of embryonic stem cell research.

    Science.gov (United States)

    Jain, Kewal K

    2002-12-01

    Ethical and regulatory issues concerning embryonic stem (ES) cell research are reviewed here a year after the controversy became a public and political issue in the US. The background of various issues are examined and the current regulations in various countries are reviewed. In the US, the debate is linked with abortion, as well as the status of a fetus as a human being, and is politically driven. Obtaining stem cells from embryonic tissues involves destruction of the embryo, to which objections are raised. Religious beliefs are examined and no serious impediments to ES cell research could be identified. Regulations vary from one country to another and it is unlikely that there will ever be any universally uniform ethical and regulatory standards for ES cell research. Currently, the most liberal and favourable environments for ES cell research are in the UK, Singapore, Sweden, India, Israel and China. Unless the US liberalises ES cell research, it may lose its lead in ES cell research and investments in this area may drift to countries with better environments for research. Suggestions are offered in this review to improve the ethical environment for ES cell research.

  17. Financial Management: DOD Needs to Clarify Its General Gift Fund Policies to Provide for Effective Oversight

    Science.gov (United States)

    2009-05-27

    Representatives Subject: Financial Management: DOD Needs to Clarify Its General Gift Fund Policies to Provide for Effective Oversight From fiscal...year 2005 through fiscal year 2008, the military services received about $295 million in monetary and nonmonetary gifts from individuals and...organizations wishing to donate gifts to the Department of Defense (DOD).1 Section 2601(a) of Title 10, U.S. Code is a long-standing authority under which

  18. Pluripotent stem cell-derived neural stem cells: From basic research to applications

    OpenAIRE

    Otsu, Masahiro; Nakayama, Takashi; Inoue, Nobuo

    2014-01-01

    Basic research on pluripotent stem cells is designed to enhance understanding of embryogenesis, whereas applied research is designed to develop novel therapies and prevent diseases. Attainment of these goals has been enhanced by the establishment of embryonic stem cell lines, the technological development of genomic reprogramming to generate induced-pluripotent stem cells, and improvements in vitro techniques to manipulate stem cells. This review summarizes the techniques required to generate...

  19. 75 FR 46904 - Request for Proposals: Fiscal Year 2010 Funding Opportunity for Research on the Economic Impact...

    Science.gov (United States)

    2010-08-04

    ... supporting documentation for completed tasks include, but are not limited to, questionnaire or interview... 2009 research. 6. The performance of subcontracting services, oversight, and financial controls for the... United States Government and the eligible recipient during the performance of the research in the...

  20. Fuel Cell Research

    Energy Technology Data Exchange (ETDEWEB)

    Weber, Peter M. [Brown University

    2014-03-30

    Executive Summary In conjunction with the Brown Energy Initiative, research Projects selected for the fuel cell research grant were selected on the following criteria: They should be fundamental research that has the potential to significantly impact the nation’s energy infrastructure. They should be scientifically exciting and sound. They should synthesize new materials, lead to greater insights, explore new phenomena, or design new devices or processes that are of relevance to solving the energy problems. They involve top-caliper senior scientists with a record of accomplishment, or junior faculty with outstanding promise of achievement. They should promise to yield at least preliminary results within the given funding period, which would warrant further research development. They should fit into the overall mission of the Brown Energy Initiative, and the investigators should contribute as partners to an intellectually stimulating environment focused on energy science. Based on these criteria, fourteen faculty across three disciplines (Chemistry, Physics and Engineering) and the Charles Stark Draper Laboratory were selected to participate in this effort.1 In total, there were 30 people supported, at some level, on these projects. This report highlights the findings and research outcomes of the participating researchers.

  1. Scientist, Single Cell Analysis Facility | Center for Cancer Research

    Science.gov (United States)

    The Cancer Research Technology Program (CRTP) develops and implements emerging technology, cancer biology expertise and research capabilities to accomplish NCI research objectives.  The CRTP is an outward-facing, multi-disciplinary hub purposed to enable the external cancer research community and provides dedicated support to NCI’s intramural Center for Cancer Research (CCR).  The dedicated units provide electron microscopy, protein characterization, protein expression, optical microscopy and nextGen sequencing. These research efforts are an integral part of CCR at the Frederick National Laboratory for Cancer Research (FNLCR).  CRTP scientists also work collaboratively with intramural NCI investigators to provide research technologies and expertise. KEY ROLES AND RESPONSIBILITIES We are seeking a highly motivated Scientist II to join the newly established Single Cell Analysis Facility (SCAF) of the Center for Cancer Research (CCR) at NCI. The SCAF will house state of the art single cell sequencing technologies including 10xGenomics Chromium, BD Genomics Rhapsody, DEPPArray, and other emerging single cell technologies. The Scientist: Will interact with close to 200 laboratories within the CCR to design and carry out single cell experiments for cancer research Will work on single cell isolation/preparation from various tissues and cells and related NexGen sequencing library preparation Is expected to author publications in peer reviewed scientific journals

  2. Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations

    Science.gov (United States)

    Sharp, Richard R.; Taylor, Holly A.; Brinich, Margaret A.; Boyle, Mary M.; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

    2015-01-01

    The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include: assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical Translational Science Award (CTSA) Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: 1) managing multiple institutional roles and responsibilities, 2) managing sensitive information, and 3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services. PMID:25607942

  3. External Police Oversight in Mexico: Experiences, Challenges, and Lessons Learned

    Directory of Open Access Journals (Sweden)

    Rubén Guzmán Sánchez

    2014-11-01

    Full Text Available After nearly 20 years of ‘reformist’ measures, the police in Mexico continues to be an ineffective, unreliable, and ‘far from citizen’ institution. The efforts made so far have faded amongst political interests and agendas; multidimensional frameworks out-dated at both conceptual and interagency levels; short-sighted competition for resources; evaluation and performance monitors that are handicapped by bureaucratic inaction; and weak transparency and accountability that perpetuate the opacity in which the police operate. In this context, the agenda of external police oversight is still at a rudimentary stage. However, there are several initiatives that have managed to push the issue to the frontier of new knowledge and promising practices. This paper outlines the experiences and challenges of—as well as the lessons learned by—the Institute for Security and Democracy (Insyde A.C., one of the most recognised think tanks in Mexico.

  4. Stem cell research in pakistan; past, present and future.

    Science.gov (United States)

    Zahra, Sayeda Anum; Muzavir, Sayed Raheel; Ashraf, Sadia; Ahmad, Aftab

    2015-05-01

    Stem cells have proved to have great therapeutic potential as stem cell treatment is replacing traditional ways of treatment in different disorders like cancer, aplastic anemia, stroke, heart disorders. The developed and developing countries are investing differently in this area of research so research output and clinical translation of research greatly vary among developed and developing countries. Present study was done to investigate the current status of stem cells research in Pakistan and ways to improve it. Many advanced countries (USA, UK and Canada etc.) are investing heavily in stem cell research and treatment. Different developing countries like Iran, Turkey and India are also following the developed countries and investing a lot in stem cells research. Pakistan is also making efforts in establishing this field to get desired benefits but unfortunately the progress is at very low pace. If Government plays an active role along with private sector, stem cell research in Pakistan can be boosted up. The numbers of publications from Pakistan are very less compared to developed and neighboring countries and Pakistan also has very less number of institutes working in this area of research. Stem cells research is at its initial stages in Pakistan and there is great need to bring Government, academia and industry together so they could make serious efforts to promote research in this very important field. This will help millions of patients suffering from incurable disorders and will also reduce economic loss.

  5. Copyright Law in Australia--Fair Dealing for Research or Study Purposes.

    Science.gov (United States)

    Khan, Anwar (Andy); Hancock, Philip

    2001-01-01

    Explores several issues involving provisions of the Australian copyright law that allow for "fair dealing for the purpose of research and study" in the use of copyrighted materials. Discusses liability of libraries for improper oversight of illegal photocopying of books and other copyrighted materials. Reviews recent efforts to improve…

  6. Assessment of Research Needs for Advanced Fuel Cells

    Energy Technology Data Exchange (ETDEWEB)

    Penner, S.S.

    1985-11-01

    The DOE Advanced Fuel Cell Working Group (AFCWG) was formed and asked to perform a scientific evaluation of the current status of fuel cells, with emphasis on identification of long-range research that may have a significant impact on the practical utilization of fuel cells in a variety of applications. The AFCWG held six meetings at locations throughout the country where fuel cell research and development are in progress, for presentations by experts on the status of fuel cell research and development efforts, as well as for inputs on research needs. Subsequent discussions by the AFCWG have resulted in the identification of priority research areas that should be explored over the long term in order to advance the design and performance of fuel cells of all types. Surveys describing the salient features of individual fuel cell types are presented in Chapters 2 to 6 and include elaborations of long-term research needs relating to the expeditious introduction of improved fuel cells. The Introduction and the Summary (Chapter 1) were prepared by AFCWG. They were repeatedly revised in response to comments and criticism. The present version represents the closest approach to a consensus that we were able to reach, which should not be interpreted to mean that each member of AFCWG endorses every statement and every unexpressed deletion. The Introduction and Summary always represent a majority view and, occasionally, a unanimous judgment. Chapters 2 to 6 provide background information and carry the names of identified authors. The identified authors of Chapters 2 to 6, rather than AFCWG as a whole, bear full responsibility for the scientific and technical contents of these chapters.

  7. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    International Nuclear Information System (INIS)

    Elliott, Kevin C.; Volz, David C.

    2012-01-01

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345–1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  8. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    Energy Technology Data Exchange (ETDEWEB)

    Elliott, Kevin C., E-mail: ke@sc.edu [University of South Carolina, Department of Philosophy, USC NanoCenter (United States); Volz, David C. [University of South Carolina, Department of Environmental Health Sciences, Arnold School of Public Health (United States)

    2012-01-15

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  9. Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

    Science.gov (United States)

    Elliott, Kevin C.; Volz, David C.

    2012-01-01

    Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

  10. Genetics researchers’ and iRB professionals’ attitudes toward genetic research review: a comparative analysis

    Science.gov (United States)

    Edwards, Karen L.; Lemke, Amy A.; Trinidad, Susan B.; Lewis, Susan M.; Starks, Helene; Snapinn, Katherine W.; Griffin, Mary Quinn; Wiesner, Georgia L.; Burke, Wylie

    2012-01-01

    Purpose Genetic research involving human participants can pose challenging questions related to ethical and regulatory standards for research oversight. However, few empirical studies describe how genetic researchers and institutional review board (IRB) professionals conceptualize ethical issues in genetic research or where common ground might exist. Methods Parallel online surveys collected information from human genetic researchers (n = 351) and IRB professionals (n = 208) regarding their views about human participant oversight for genetic protocols. Results A range of opinions were observed within groups on most issues. In both groups, a minority thought it likely that people would be harmed by participation in genetic research or identified from coded genetic data. A majority of both groups agreed that reconsent should be required for four of the six scenarios presented. Statistically significant differences were observed between groups on some issues, with more genetic researcher respondents trusting the confidentiality of coded data, fewer expecting harms from reidentification, and fewer considering reconsent necessary in certain scenarios. Conclusions The range of views observed within and between IRB and genetic researcher groups highlights the complexity and unsettled nature of many ethical issues in genome research. Our findings also identify areas where researcher and IRB views diverge and areas of common ground. PMID:22241102

  11. Supplemental investigations in support of environmental assessments by the Idaho INEL Oversight Program at the Idaho National Engineering Laboratory

    International Nuclear Information System (INIS)

    1992-01-01

    This document reports on the status of supplemental investigations in support of environmental assessments by the Idaho INEL Oversight Program at the Idaho National Engineering Laboratory. Included is information on hydrology studies in wells open through large intervals, unsaturated zone contamination and transport processes, surface water-groundwater interactions, regional groundwater flow, and independent testing of air quality data

  12. Ground Zero in the Debate over Stem-Cell Research.

    Science.gov (United States)

    Southwick, Ron

    2001-01-01

    Describes how political, legal, and ethical battles over embryonic stem-cell research are focused on the University of Wisconsin at Madison, where the cells were first isolated. Addresses the issue of access to the university's stem cells and a recent presidential decision regarding funding for stem-cell research.(EV)

  13. State performance in pluripotent and adult stem cell research, 2009-2016.

    Science.gov (United States)

    Surani, Sana H; Levine, Aaron D

    2018-04-01

    To examine how the geographic distribution of pluripotent and adult stem cell research publications within the USA differs from other areas of biomedical research. Publication count data for pluripotent stem cell research, adult stem cell research and a comparison group representative of biomedical research more broadly were collected and analyzed for each US state from 2009 to 2016. The distribution of pluripotent stem cell research differed from the other fields with overperformance in pluripotent stem cell research observed in California, as well as Wisconsin, Massachusetts, Maryland and Connecticut. Our analysis suggests that permissive state stem cell policy may be one of the several factors contributing to strong state performance in pluripotent stem cell research.

  14. Contemporary Approaches to Safety Culture: Lessons from Developing a Regulatory Oversight Approach

    International Nuclear Information System (INIS)

    Goebel, V.; Heppell-Masys, K.

    2016-01-01

    The Canadian Nuclear Safety Commission (CNSC) regulates the use of nuclear energy and materials to protect health, safety, security and the environment, and to implement Canada’s international commitments on the peaceful use of nuclear energy; and to disseminate objective scientific, technical and regulatory information to the public. In the late 1990s, the CNSC conducted research into an Organization and Management (O&M) assessment method. Based on this research the CNSC conducted O&M assessments at all Canadian nuclear power plants and conducted additional assessments of nuclear research and uranium mine and mill operations. The results of these assessments were presented to licencees and used to inform their ongoing actions related to safety culture. Additional safety culture outreach and oversight activities provided licencees with opportunities to develop effective safety culture assessment methods, to share best practices across industry, and to strive for continual improvement of their organizations. Recent changes to the Canadian Standards Association (CSA) management system standard have resulted in the inclusion of requirements associated to safety culture and human performance. Representatives from several sectors of Canada’s nuclear industry, as well as participation from regulators such as the CNSC took part to the development of this consensus standard. Specifically, these requirements focus on monitoring and understanding safety culture, integrating safety into all of the requirements of the management system, committing workers to adhere to the management system and supporting excellence in workers’ performance. The CNSC is currently developing a regulatory document on safety culture which includes key concepts applicable to all licencees and specific requirements related to self-assessment, and additional guidance for nuclear power plants. Developing a regulatory document on safety culture requires consultation and fact finding initiatives at

  15. Ethical review of research on human subjects at Unilever: reflections on governance.

    Science.gov (United States)

    Sheehan, Mark; Marti, Vernon; Roberts, Tony

    2014-07-01

    This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research. © 2013 John Wiley & Sons Ltd.

  16. "Something of an adventure": postwar NIH research ethos and the Guatemala STD experiments.

    Science.gov (United States)

    Spector-Bagdady, Kayte; Lombardo, Paul A

    2013-01-01

    The STD experiments in Guatemala from 1946-1948 have earned a place of infamy in the history of medical ethics. But if the Guatemala STD experiments were so "ethically impossible," how did the U.S. government approve their funding? Although much of the literature has targeted the failings of Dr. John Cutler, we focus on the institutional context and research ethos that shaped the outcome of the research. After the end of WWII, Dr. Cassius Van Slyke reconstructed the federal research contracts process into a grant program. The inaugural NIH study section recommended approval of the Guatemala STD experiments at its first meeting. The funding and oversight process of the Guatemala research was marked with serious conflicts of interest and a lack of oversight, and it was this structure, as opposed to merely a maleficent individual, that allowed the Guatemala STD experiments to proceed. We conclude that while current research regulations are designed to prevent the abuses perpetrated on the subjects of the Guatemala STD experiments, it takes a comprehensive understanding of research ethics through professional education to achieve the longstanding ideal of the responsible investigator, and ensure ethical research under any regulatory scheme. © 2013 American Society of Law, Medicine & Ethics, Inc.

  17. Dye solar cell research

    CSIR Research Space (South Africa)

    Cummings, F

    2009-11-01

    Full Text Available Cummings Energy and Processes Materials Science and Manufacturing Council for Scientific and Industrial Research P.O. Box 395 Pretoria 0001, South Africa 27 November 2009 CONTENT head2rightBackground head2rightCSIR Dye Solar Cell Research head2... rightCollaborations and Links © CSIR 2007 www.csir.co.za head2rightAcknowledgements BACKGROUND head2rightSA is dry: Annual rainfall average of 450 mm compared with a world average of 860 mm head2rightOn upside, we have some...

  18. Trust in regulatory relations: how new insights from trust research improve regulation theory

    NARCIS (Netherlands)

    Six, F.E.

    2013-01-01

    Regulatory oversight is a key feature of public governance. This study argues - based on recent trust research - that the way in which the relation between trust and control is conceptualized in the dominant responsive regulation theory (RRT) may be improved using self determination theory (SDT).

  19. Fake news portrayals of stem cells and stem cell research.

    Science.gov (United States)

    Marcon, Alessandro R; Murdoch, Blake; Caulfield, Timothy

    2017-10-01

    This study examines how stem cells and stem cell research are portrayed on websites deemed to be purveyors of distorted and dubious information. Content analysis was conducted on 224 articles from 2015 to 2016, compiled by searching with the keywords 'stem cell(s)' on a list of websites flagged for containing either 'fake' or 'junk science' news. Articles contained various exaggerated positive and negative claims about stem cells and stem cell science, health and science related conspiracy theories, and statements promoting fear and mistrust of conventional medicine. Findings demonstrate the existence of organized misinformation networks, which may lead the public away from accurate information and facilitate a polarization of public discourse.

  20. Research ethics across the 49th parallel: the potential value of pilot testing "equivalent protections" in Canadian research institutions.

    Science.gov (United States)

    Lavery, James V; McDonald, Michael; Meslin, Eric M

    2005-01-01

    Canada and the United States share the world's largest trade partnership and an increasing concern about divergent regulatory approaches to common industries. Canadian research institutes receive more research funding from the U.S. National Institutes of Health than any other country, much of it to fund multi-centre and collaborative research between the two countries. Because of these close economic and research ties, and the extensive similarities between the two countries in the review and oversight of ethics in human subjects research, we propose that Canada would be an ideal country for a pilot-test of the feasibility of "equivalent protections," a U.S. regulation that permits comparison of protections for human subjects between institutions in the two countries. The "equivalent protections" has been advocated by various bodies in the United States as a potentially beneficial mechanism for improving oversight of foreign trials. As well, we argue that "equivalent protections" could prove to be valuable for Canada in five specific ways: (1) by potentially reducing administrative burden on Canadian research institutions administering U.S. federal research funding; (2) by creating symbolic value of an explicit recognition by the United States that procedures normally followed for the protection of human subjects in Canadian research institutions are at least equivalent to those provided by the U.S. regulations; (3) by lowering the opportunity cost of investing in research in Canada; (4) by affording Canada an opportunity to enhance its leadership role in international research by offering an alternative to the U.S. regulatory model for the protection of human subjects; and (5) by providing a model for how the idea of equivalent protections might be addressed for research funded by Canadian agencies but conducted in other countries.

  1. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

    Science.gov (United States)

    Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

    2014-07-01

    The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

  2. The ethical dilemma of embryonic stem cell research.

    Science.gov (United States)

    Manzar, Nabeel; Manzar, Bushra; Hussain, Nuzhat; Hussain, M Fawwad Ahmed; Raza, Sajjad

    2013-03-01

    To determine the knowledge, attitude, and ethical concerns of medical students and graduates with regard to Embryonic Stem Cell (ESC) research. This questionnaire based descriptive study was conducted at the Civil Hospital Karachi (CHK), Pakistan from February to July 2008. A well structured questionnaire was administered to medical students and graduate doctors, which included their demographic profile as well as questions in line with the study objective. Informed consent was taken and full confidentiality was assured to the participants. Data were entered in a Statistical Package for Social Sciences (SPSS version.12) and analyzed. A total of 204 male and 216 female medical students and doctors were administered questionnaires out of which 105 males (51.4%) and 108 females (50%) were aware of the embryonic stem cell research and its ethical implications. Forty percent males and 47% of females were of the opinion that life begins at conception. Forty-six percent males and 39% females were in favor of stem cell research while only 31% males and 28% females supported the ESC research. Less than 1/3 of students supported using frozen embryos for research purposes while more than 2/3 indicated that they were unlikely to support abortion for stem cell research purposes. The majority of the students were in favor of stem cell research with some reservations regarding ESC research. A sizeable number of students withheld their views, reflecting their poor understanding of medical ethics. The result of the study indicates a need for incorporating bioethics into the medical curriculum.

  3. What's missing? Discussing stem cell translational research in educational information on stem cell "tourism".

    Science.gov (United States)

    Master, Zubin; Zarzeczny, Amy; Rachul, Christen; Caulfield, Timothy

    2013-01-01

    Stem cell tourism is a growing industry in which patients pursue unproven stem cell therapies for a wide variety of illnesses and conditions. It is a challenging market to regulate due to a number of factors including its international, online, direct-to-consumer approach. Calls to provide education and information to patients, their families, physicians, and the general public about the risks associated with stem cell tourism are mounting. Initial studies examining the perceptions of patients who have pursued stem cell tourism indicate many are highly critical of the research and regulatory systems in their home countries and believe them to be stagnant and unresponsive to patient needs. We suggest that educational material should include an explanation of the translational research process, in addition to other aspects of stem cell tourism, as one means to help promote greater understanding and, ideally, curb patient demand for unproven stem cell interventions. The material provided must stress that strong scientific research is required in order for therapies to be safe and have a greater chance at being effective. Through an analysis of educational material on stem cell tourism and translational stem cell research from patient groups and scientific societies, we describe essential elements that should be conveyed in educational material provided to patients. Although we support the broad dissemination of educational material on stem cell translational research, we also acknowledge that education may simply not be enough to engender patient and public trust in domestic research and regulatory systems. However, promoting patient autonomy by providing good quality information to patients so they can make better informed decisions is valuable in itself, irrespective of whether it serves as an effective deterrent of stem cell tourism. © 2013 American Society of Law, Medicine & Ethics, Inc.

  4. Cell culture techniques in honey bee research

    Science.gov (United States)

    Cell culture techniques are indispensable in most if not all life science disciplines to date. Wherever cell culture models are lacking scientific development is hampered. Unfortunately this has been and still is the case in honey bee research because permanent honey bee cell lines have not yet been...

  5. Scientists' perspectives on the ethical issues of stem cell research.

    Science.gov (United States)

    Longstaff, Holly; Schuppli, Catherine A; Preto, Nina; Lafrenière, Darquise; McDonald, Michael

    2009-06-01

    This paper describes findings from an ethics education project funded by the Canadian Stem Cell Network (SCN). The project is part of a larger research initiative entitled "The Stem Cell Research Environment: Drawing the Evidence and Experience Together". The ethics education study began with a series of focus groups with SCN researchers and trainees as part of a "needs assessment" effort. The purpose of these discussions was to identify the main ethical issues associated with stem cell (SC) research from the perspective of the stem cell community. This paper will focus on five prominent themes that emerged from the focus group data including: (1) the source of stem cells; (2) the power of stem cells; (3) working within a charged research environment; (4) the regulatory context; and (5) ethics training for scientists. Additional discussions are planned with others involved in Canadian stem cell research (e.g., research ethics board members, policy makers) to supplement initial findings. These assessment results combined with existing bioethics literature will ultimately inform a web-based ethics education module for the SCN. We believe that our efforts are important for those analyzing the ethical, legal, and social issues (ELSI) in this area because our in depth understanding of stem cell researcher perspectives will enable us to develop more relevant and effective education material, which in turn should help SC researchers address the important ethical challenges in their area.

  6. The Gulf of Mexico Research Initiative: A Funding Model for Science, Engineering, and Technology

    Science.gov (United States)

    Colwell, R. R.

    2016-12-01

    The Deepwater Horizon oil spill, a massive ecological event, resulted in the tragic loss of 11 lives, and an environmental release of more than 130 million gallons of crude oil. Approximately 1.8 million gallons of dispersants were used in remediation efforts. An immediate response by BP was to establish a ten-year research program, with funding of 500 million. The funding was to determine the impact and long-term ecological and public health effects of oil spills and to develop improved preparation in the event of future oil or gas release into the environment. This Gulf of Mexico Research Initiative (GoMRI), established by BP, provided independent leadership for both the program and administration of the 500 million funding, and the Research Board provides oversight, assisted by excellent staff. The Research Board of the GoMRI comprises twenty scientists, many of whom have prior scientific research administrative expertise. The Research Board, in accordance with its charge, develops research programs and carries out their evaluation and oversight, employing the peer review and operational principles of the National Science Foundation and the National Academies of Science. With these guiding principles, the Research Board established procedures for conflict of interest oversight and requesting and evaluating research programs. It has also focused on communicating the research findings accurately and responsibly. The GoMRI Research Board operates with transparency and ensures availability of all scientific results and data. GoMRI, currently midway through its 10-year mandate, has funded more than 3,000 scientists, representing 278 institutions in 42 states and 17 countries, who have produced more than 1,000 peer-reviewed publications to date. The Research Board is exploring mechanisms by which the GoMRI science findings can be communicated to the broader community and the public and to continue availability of data when the program has ended. A major contribution

  7. Advanced research on separating prostate cancer stem cells

    International Nuclear Information System (INIS)

    Hao Yumei; He Xin; Song Naling

    2013-01-01

    Prostate cancer is a common malignant tumor in male urinary system,and may easily develop into the hormone refractory prostate cancer which can hardly be cured. Recent studies had found that the prostate cancer stem cells may be the source of the prostate cancer's occurrence,development, metastasis and recurrence. The therapy targeting the prostate cancer stem cells may be the effective way to cure prostate cancer. But these cells is too low to be detected. The difficulty lies in the low separation efficiency of prostate cancer stem cell, so the effectively separating prostate cancer stem cells occupied the main position for the more in-depth research of prostate cancer stem cells. This paper reviews the research progress and existing problems on the several main separating methods of prostate cancer stem cells, includes the fluorescence activated cells sorting and magnetic activated cells sorting based on prostate cancer stem cell surface markers, the side-population sorting and serum-free medium sphere forming sorting based on prostate cancer stem cell's biology. (authors)

  8. Hydrogen and fuel cell research networking in Ontario

    Energy Technology Data Exchange (ETDEWEB)

    Peppley, B.A. [Queen' s-RMC Fuel Cell Research Centre, Kingston, ON (Canada)

    2009-07-01

    This presentation reviewed the activities of the Ontario Fuel Cell Research and Innovation Network since its launch in 2006. Funded by the Ontario Ministry of Research and Innovation, the project involves 17 academic researchers from 8 universities and is supported by 8 industrial partners. The group of researchers has made progress in supporting the developing fuel cell industry in Ontario and in Canada. Their work has the potential to help deploy the province's automotive-oriented manufacturing sector in directions that address the issues of clean air and climate change. New initiatives in the development of hydrogen and fuel cell technologies are instrumental in expanding this network to leverage new business activities in the post financial crisis period. These activities are expected to result in economic benefits for job and economic growth.

  9. Fuel cell research: Towards efficient energy

    CSIR Research Space (South Africa)

    Rohwer, MB

    2008-11-01

    Full Text Available fuel cells by optimising the loading of catalyst (being expensive noble metals) and ionomer; 2) Improving conventional acidic direct alcohol fuel cells by developing more efficient catalysts and by investigating other fuels than methanol; 3... these components add significantly to the overall cost of a PEMFC. 1 We focused our research activities on: 1) The effect of the loading of catalytic ink on cell performance; 2) The effect of the ionomer content in the catalytic ink; 3) Testing...

  10. Further Improvements Needed in Navy’s Oversight and Management of Contracting for Facilities Construction on Diego Garcia.

    Science.gov (United States)

    1984-05-23

    1981, the Navy awarded a cost reimbursable contract to a joint venture to construct facility projects for fiscal years 1981 and 1982 with an estimated...through fiscal year 1986. In July 1981, the Navy awarded a cost reimburs - able contract (cost plus award fee) to Raymond, Brown & Root, Molem, a joint...Navy’s oversight and management of the acquisition of these facilities. A COST REIMBURSABLE CONTRACT MAKES STRONG CONTRACT ADMINISTRATION VITAL Under

  11. Fraudsters operate and officialdom turns a blind eye: a proposal for controlling stem cell therapy in China.

    Science.gov (United States)

    Jiang, Li; Dong, Bing He

    2016-09-01

    Stem cell tourism-the flow of patients from home countries to destination countries to obtain stem cell treatment-is a growing business in China. Many concerns have been raised regarding fraudsters that operate unsafe stem cell therapies and an officialdom that turns a blind eye to the questionable technology. The Chinese regulatory approach to stem cell research is based on Guidelines and Administrative Measures, rather than legislation, and may have no binding force on certain institutions, such as military hospitals. There is no liability and traceability system and no visible set of penalties for non-compliance in the stem cell legal framework. In addition to the lack of safety and efficacy systems in the regulations, no specific expert authority has been established to monitor stem cell therapy to date. Recognizing the global nature of stem cell tourism, this article argues that resolving stem cell tourism issues may require not only the Chinese government but also an international mechanism for transparency and ethical oversight. A stringent set of international regulations that govern stem cell therapies can encourage China to improve stem cell regulation and enforcement to fulfill its obligations. Through an international consensus, a minimum standard for clinical stem cell research and a central enforcement system will be provided. As a result, rogue clinics that conduct unauthorized stem cell therapies can be penalized, and countries that are reluctant to implement the reconciled regulations should be sanctioned.

  12. Development of New Technologies for Stem Cell Research

    Directory of Open Access Journals (Sweden)

    Xibo Ma

    2012-01-01

    Full Text Available Since the 1960s, the stem cells have been extensively studied including embryonic stem cells, neural stem cells, bone marrow hematopoietic stem cells, and mesenchymal stem cells. In the recent years, several stem cells have been initially used in the treatment of diseases, such as in bone marrow transplant. At the same time, isolation and culture experimental technologies for stem cell research have been widely developed in recent years. In addition, molecular imaging technologies including optical molecular imaging, positron emission tomography, single-photon emission computed tomography, and computed tomography have been developed rapidly in recent the 10 years and have also been used in the research on disease mechanism and evaluation of treatment of disease related with stem cells. This paper will focus on recent typical isolation, culture, and observation techniques of stem cells followed by a concise introduction. Finally, the current challenges and the future applications of the new technologies in stem cells are given according to the understanding of the authors, and the paper is then concluded.

  13. Support of Activities of the NAS in Relation to the Radiation Effects Research Foundation

    International Nuclear Information System (INIS)

    Douple, Evan B.

    2006-01-01

    The National Academies (NA) provides support for the activities related to the long-term follow up of the health of the survivors of the atomic bombings of Hiroshima and Nagasaki being conducted by the Radiation Effects Research Foundation (RERF) laboratories in Hiroshima and Nagasaki, Japan. The NA serves as scientific and administrative liaison between the U.S. Department of Energy (DOE) and RERF, and performs tasks in the areas of scientific oversight, information/public interface, fiscal oversight, and personnel management. The project includes recruitment and support of approximately 10 NA employees who work at RERF in Japan. Specific activities are performed consistent with the cooperative agreement's Statement of Work between DOE and NA and consistent with an Annual Work Plan developed by DOE and NA

  14. Regulatory Oversight of Radioactive Sources through the Integrated Management of Safety and Security

    International Nuclear Information System (INIS)

    Horvath, K.

    2016-01-01

    The Hungarian Atomic Energy Authority (HAEA) has full regulatory competence; its mission is to oversee the safety and security of all the peaceful applications of atomic energy. All the radioactive sources having activity above the exemption level is registered and licensed both from safety and security points of view. The Hungarian central register of radioactive sources contains about 7,000 radioactive sources and 450 license holders. In order to use its limited resources the HAEA has decided to introduce an integrated regulatory oversight programme. Accordingly, during the licensing process and inspection activities the HAEA intends to assess both safety and security aspects at the same time. The article describes the Hungarian the various applications of radioactive materials, and summarizes the preparation activities of the HAEA. (author)

  15. Deceased Donor Intervention Research: A Survey of Transplant Surgeons, Organ Procurement Professionals, and Institutional Review Board Members.

    Science.gov (United States)

    Rodrigue, J R; Feng, S; Johansson, A C; Glazier, A K; Abt, P L

    2016-01-01

    Innovative deceased donor intervention strategies have the potential to increase the number and quality of transplantable organs. Yet there is confusion over regulatory and legal requirements, as well as ethical considerations. We surveyed transplant surgeons (n = 294), organ procurement organization (OPO) professionals (n = 83), and institutional review board (IRB) members (n = 317) and found wide variations in their perceptions about research classification, risk assessment for donors and organ transplant recipients, regulatory oversight requirements, and informed consent in the context of deceased donor intervention research. For instance, when presented with different research scenarios, IRB members were more likely than transplant surgeons and OPO professionals to feel that study review and oversight were necessary by the IRBs at the investigator, donor, and transplant center hospitals. Survey findings underscore the need to clarify ethical, legal, and regulatory requirements and their application to deceased donor intervention research to accelerate the pace of scientific discovery and facilitate more transplants. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

  16. Guidelines for human embryonic stem cell research

    National Research Council Canada - National Science Library

    Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council

    2005-01-01

    Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research...

  17. Guidelines for human embryonic stem cell research

    National Research Council Canada - National Science Library

    Committee on Guidelines for Human Embryonic Stem Cell Research; National Research Council; Board on Health Sciences Policy; Institute of Medicine; Division on Earth and Life Studies; National Research Council

    2005-01-01

    .... Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind...

  18. Stem Cell Research and Health Education

    Science.gov (United States)

    Eve, David J.; Marty, Phillip J.; McDermott, Robert J.; Klasko, Stephen K.; Sanberg, Paul R.

    2008-01-01

    Stem cells are being touted as the greatest discovery for the potential treatment of a myriad of diseases in the new millennium, but there is still much research to be done before it will be known whether they can live up to this description. There is also an ethical debate over the production of one of the most valuable types of stem cell: the…

  19. Basic Science Research and the Protection of Human Research Participants

    Science.gov (United States)

    Eiseman, Elisa

    2001-03-01

    Technological advances in basic biological research have been instrumental in recent biomedical discoveries, such as in the understanding and treatment of cancer, HIV/AIDS, and heart disease. However, many of these advances also raise several new ethical challenges. For example, genetic research may pose no physical risk beyond that of obtaining the initial blood sample, yet it can pose significant psychological and economic risks to research participants, such as stigmatization, discrimination in insurance and employment, invasion of privacy, or breach of confidentiality. These harms may occur even when investigators do not directly interact with the person whose DNA they are studying. Moreover, this type of basic research also raises broader questions, such as what is the definition of a human subject, and what kinds of expertise do Institutional Review Boards (IRBs) need to review the increasingly diverse types of research made possible by these advances in technology. The National Bioethics Advisory Commission (NBAC), a presidentially appointed federal advisory committee, has addressed these and other ethical, scientific and policy issues that arise in basic science research involving human participants. Two of its six reports, in particular, have proposed recommendations in this regard. "Research Involving Human Biological Materials: Ethical and Policy Guidance" addresses the basic research use of human tissues, cells and DNA and the protection of human participants in this type of research. In "Ethical and Policy Issues in the Oversight of Human Research" NBAC proposes a definition of research involving human participants that would apply to all scientific disciplines, including physical, biological, and social sciences, as well as the humanities and related professions, such as business and law. Both of these reports make it clear that the protection of research participants is key to conducting ethically sound research. By ensuring that all participants in

  20. Discovery of HeLa Cell Contamination in HES Cells: Call for Cell Line Authentication in Reproductive Biology Research.

    Science.gov (United States)

    Kniss, Douglas A; Summerfield, Taryn L

    2014-08-01

    Continuous cell lines are used frequently in reproductive biology research to study problems in early pregnancy events and parturition. It has been recognized for 50 years that many mammalian cell lines contain inter- or intraspecies contaminations with other cells. However, most investigators do not routinely test their culture systems for cross-contamination. The most frequent contributor to cross-contamination of cell lines is the HeLa cell isolated from an aggressive cervical adenocarcinoma. We report on the discovery of HeLa cell contamination of the human endometrial epithelial cell line HES isolated in our laboratory. Short tandem repeat analysis of 9 unique genetic loci demonstrated molecular identity between HES and HeLa cells. In addition, we verified that WISH cells, isolated originally from human amnion epithelium, were also contaminated with HeLa cells. Inasmuch as our laboratory did not culture HeLa cells at the time of HES cell derivations, the source of contamination was the WISH cell line. These data highlight the need for continued diligence in authenticating cell lines used in reproductive biology research. © The Author(s) 2014.

  1. Experts, meta-expertise and mediators. Ethical oversight of research in multidisciplinary scenarios

    Directory of Open Access Journals (Sweden)

    Wilfredo Betancourt Mosquera

    2016-07-01

    Full Text Available Based on a case study drawn from the written records of a Colombian Research Ethics Committee (rec, this article discusses the impact that its multidisciplinary nature has on its decision-making processes. recs are analyzed as “boundary organizations” in which experts from different disciplines can meet. Additionally, recs are viewed as contemporary socio-epistemic arenas in which research ethics are produced. It was found that multiple expertise is often seen by some of its members as an «anomaly» which impedes ordinary work and ideally should be avoided. During the assessment of research projects the rec sought to manage this task through homogenizing decision-making processes in accordance with the expertise of some of its members, avoiding the convergence of «communities of practice.» Furthermore, the members of the rec frequently base their decisions either on their own ethical judgments, or by mirroring those of more qualified reviewers. This dynamic is largely a consequence of «meta-expertise,» that is to say, rec members’ ability or legitimacy to judge expert knowledge which they do not possess. It is concluded that researchers have wide possibilities to interpret and define the ethical dimension of their work. Within local practices of ethical reviews, researchers act as «interactional» actors able to assess and communicate recs about their own ethics. Paradoxically, despite their character as a public setting for multidisciplinary dialogue, recs end up being spaces in which the professional esotericism of disciplinary communities is reaffirmed and the socio-epistemic authority of experts reinforced.

  2. Why budget accountability fails? The elusive links between parliaments and audit agencies in the oversight of the budget

    Directory of Open Access Journals (Sweden)

    CARLOS SANTISO

    2015-09-01

    Full Text Available ABSTRACTParliaments and audit agencies have critical and complementary roles in the oversight of the budget and the enforcement of government accountability. Yet, the nexus between parliaments and audit agencies is one of the weakest links in the accountability chain, generating an accountability gap in the budget process. This articles analyses the interactions between parliaments and audit agencies in the oversight of government finances during the latter stages of the budget process. Using proxies to evaluate the quality of those linkages, such as the follow-up to audit findings and the discharge of government, it shows important dysfunctions in the interactions between parliaments and audit agencies due to a combination of technical capacity constraints and political economy disincentives. It suggests that the effective functioning of the system of checks and balances in public budgeting critically hinges on the agility of the linkages between accountability institutions. As such, the failure of budget accountability is due to systemic dysfunctions in the systems of accountability, rather than the failure of an individual accountability institution acting in isolation. In addition, the effectiveness of the horizontal accountability architecture depends on the political economy incentives shaping the budget process, which are generated by the interactions between the choice of institutional design and budget rules, with the degree of political competition and electoral rules.

  3. Potential high efficiency solar cells: Applications from space photovoltaic research

    Science.gov (United States)

    Flood, D. J.

    1986-01-01

    NASA involvement in photovoltaic energy conversion research development and applications spans over two decades of continuous progress. Solar cell research and development programs conducted by the Lewis Research Center's Photovoltaic Branch have produced a sound technology base not only for the space program, but for terrestrial applications as well. The fundamental goals which have guided the NASA photovoltaic program are to improve the efficiency and lifetime, and to reduce the mass and cost of photovoltaic energy conversion devices and arrays for use in space. The major efforts in the current Lewis program are on high efficiency, single crystal GaAs planar and concentrator cells, radiation hard InP cells, and superlattice solar cells. A brief historical perspective of accomplishments in high efficiency space solar cells will be given, and current work in all of the above categories will be described. The applicability of space cell research and technology to terrestrial photovoltaics will be discussed.

  4. Translational research: cells, tissues and organisms

    International Nuclear Information System (INIS)

    Chang, P.Y.

    2003-01-01

    Exposure to the complex space radiation environment poses an important health hazard for astronauts in long-term space missions. The central theme of NASA's space radiation health research effort is to acquire scientific knowledge to understand the mechanisms of particle radiation effects in biological systems and to use this knowledge to set exposure limits and to design countermeasures that will protect the astronauts. During the past few decades, a rich body of data has been developed to characterize HZE-induced biological responses both in vitro and in vivo using ground-based accelerator facilities available in a number of facilities around the world. Although much is known about particle-radiation-induced DNA damage and cell killing in cultured cell lines, recent evidence suggest that numerous other factors, such as membrane effects, altered gene expression, bystander effects and specific cell-type dependent features also play critical roles in cellular responses. Dose- and particle-dependent studies are also available for multicellular tissues and animal model systems where emerging information demonstrates complex interactions between cells including intercellular communications, activation of proteins, alterations in the microenvironment, tissue-specificity, and genetic status and these contribute in determining the consequences of HZE radiation. Due to the lack of human data, risk estimates depend on the extrapolation of experimental results in animals and cultured cell systems to man. In this presentation, selected topics reviewing particle radiation effects in cells, tissues and animal will be used to illustrate the importance of translational research and some of the limitations of such approaches

  5. The New Federalism: State Policies Regarding Embryonic Stem Cell Research.

    Science.gov (United States)

    Acosta, Nefi D; Golub, Sidney H

    2016-09-01

    Stem cell policy in the United States is an amalgam of federal and state policies. The scientific development of human pluripotent embryonic stem cells (ESCs) triggered a contentious national stem cell policy debate during the administration of President George W. Bush. The Bush "compromise" that allowed federal funding to study only a very limited number of ESC derived cell lines did not satisfy either the researchers or the patient advocates who saw great medical potential being stifled. Neither more restrictive legislation nor expansion of federal funding proved politically possible and the federal impasse opened the door for a variety of state-based experiments. In 2004, California became the largest and most influential state venture into stem cell research by passing "Prop 71," a voter initiative that created a new stem cell agency and funded it with $3 billion. Several states followed suit with similar programs to protect the right of investigators to do stem cell research and in some cases to invest state funding in such projects. Other states devised legislation to restrict stem cell research and in five states, criminal penalties were included. Thus, the US stem cell policy is a patchwork of multiple, often conflicting, state and federal policies. © 2016 American Society of Law, Medicine & Ethics.

  6. A Study of Construction Reactor Oversight Process in US

    International Nuclear Information System (INIS)

    Yun, I.; Kim, S. Y.; Jeong, G. Y.; Kim, S. P.

    2015-01-01

    This process provides a risk-informed approach such as construction significance determination process (SDP) and construction program performance index analogous to those used in the Reactor Oversight Process (ROP). The cROP has been applied to Vogtle units 3, 4 and V.C. Summer units 2, 3 under construction for the regulatory inspection. In this paper, the cROP is dissected to present its major contents and characteristics. The main features of the cROP can be summarized as followings: 1) The cROP which adopts the concept of the ROP used for operating NPPs assesses NPP under construction periodically to determine the appropriate level of regulatory response. 2) The cROP consists of three parts: the CIP, the CAP and the CEP. 3) The inspections for NPPs under construction can be categorized into three parts: vendor inspection, baseline inspection and supplemental and plant specific inspections. USNRC's regulatory resources can be used effectively based on baseline inspection, which is using ITAAC inspections. The construction SDP is used to assign the color scheme to categorize the significance of inspection findings. Regulatory actions are taken from CAM to which the significance of inspection findings input. In this paper, major contents and characteristics of USNRC's cROP have been presented

  7. Sino-Canadian collaborations in stem cell research: a scientometric analysis.

    Directory of Open Access Journals (Sweden)

    Sarah E Ali-Khan

    Full Text Available International collaboration (IC is essential for the advance of stem cell research, a field characterized by marked asymmetries in knowledge and capacity between nations. China is emerging as a global leader in the stem cell field. However, knowledge on the extent and characteristics of IC in stem cell science, particularly China's collaboration with developed economies, is lacking.We provide a scientometric analysis of the China-Canada collaboration in stem cell research, placing this in the context of other leading producers in the field. We analyze stem cell research published from 2006 to 2010 from the Scopus database, using co-authored papers as a proxy for collaboration. We examine IC levels, collaboration preferences, scientific impact, the collaborating institutions in China and Canada, areas of mutual interest, and funding sources. Our analysis shows rapid global expansion of the field with 48% increase in papers from 2006 to 2010. China now ranks second globally after the United States. China has the lowest IC rate of countries examined, while Canada has one of the highest. China-Canada collaboration is rising steadily, more than doubling during 2006-2010. China-Canada collaboration enhances impact compared to papers authored solely by China-based researchers This difference remained significant even when comparing only papers published in English.While China is increasingly courted in IC by developed countries as a partner in stem cell research, it is clear that it has reached its status in the field largely through domestic publications. Nevertheless, IC enhances the impact of stem cell research in China, and in the field in general. This study establishes an objective baseline for comparison with future studies, setting the stage for in-depth exploration of the dynamics and genesis of IC in stem cell research.

  8. Sino-Canadian collaborations in stem cell research: a scientometric analysis.

    Science.gov (United States)

    Ali-Khan, Sarah E; Ray, Monali; McMahon, Dominique S; Thorsteinsdóttir, Halla

    2013-01-01

    International collaboration (IC) is essential for the advance of stem cell research, a field characterized by marked asymmetries in knowledge and capacity between nations. China is emerging as a global leader in the stem cell field. However, knowledge on the extent and characteristics of IC in stem cell science, particularly China's collaboration with developed economies, is lacking. We provide a scientometric analysis of the China-Canada collaboration in stem cell research, placing this in the context of other leading producers in the field. We analyze stem cell research published from 2006 to 2010 from the Scopus database, using co-authored papers as a proxy for collaboration. We examine IC levels, collaboration preferences, scientific impact, the collaborating institutions in China and Canada, areas of mutual interest, and funding sources. Our analysis shows rapid global expansion of the field with 48% increase in papers from 2006 to 2010. China now ranks second globally after the United States. China has the lowest IC rate of countries examined, while Canada has one of the highest. China-Canada collaboration is rising steadily, more than doubling during 2006-2010. China-Canada collaboration enhances impact compared to papers authored solely by China-based researchers This difference remained significant even when comparing only papers published in English. While China is increasingly courted in IC by developed countries as a partner in stem cell research, it is clear that it has reached its status in the field largely through domestic publications. Nevertheless, IC enhances the impact of stem cell research in China, and in the field in general. This study establishes an objective baseline for comparison with future studies, setting the stage for in-depth exploration of the dynamics and genesis of IC in stem cell research.

  9. Stem cell research ethics: consensus statement on emerging issues.

    Science.gov (United States)

    Caulfield, Timothy; Ogbogu, Ubaka; Nelson, Erin; Einsiedel, Edna; Knoppers, Bartha; McDonald, Michael; Brunger, Fern; Downey, Robin; Fernando, Kanchana; Galipeau, Jacques; Geransar, Rose; Griener, Glenn; Grenier, Glenn; Hyun, Insoo; Isasi, Rosario; Kardel, Melanie; Knowles, Lori; Kucic, Terrence; Lotjonen, Salla; Lyall, Drew; Magnus, David; Mathews, Debra J H; Nisbet, Matthew; Nisker, Jeffrey; Pare, Guillaume; Pattinson, Shaun; Pullman, Daryl; Rudnicki, Michael; Williams-Jones, Bryn; Zimmerman, Susan

    2007-10-01

    This article is a consensus statement by an international interdisciplinary group of academic experts and Canadian policy-makers on emerging ethical, legal and social issues in human embryonic stem cells (hESC) research in Canada. The process of researching consensus included consultations with key stakeholders in hESC research (regulations, stem cell researchers, and research ethics experts), preparation and distribution of background papers, and an international workshop held in Montreal in February 2007 to discuss the papers and debate recommendations. The recommendations provided in the consensus statement focus on issues of immediate relevance to Canadian policy-makers, including informed consent to hESC research, the use of fresh embryos in research, management of conflicts of interest, and the relevance of public opinion research to policy-making.

  10. Drosophila's contribution to stem cell research [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Gyanesh Singh

    2016-08-01

    Full Text Available The discovery of Drosophila stem cells with striking similarities to mammalian stem cells has brought new hope for stem cell research. Recent developments in Drosophila stem cell research is bringing wider opportunities for contemporary stem cell biologists. In this regard, Drosophila germ cells are becoming a popular model of stem cell research. In several cases, genes that controlled Drosophila stem cells were later discovered to have functional homologs in mammalian stem cells. Like mammals, Drosophila germline stem cells (GSCs are controlled by both intrinsic as well as external signals. Inside the Drosophila testes, germline and somatic stem cells form a cluster of cells (the hub. Hub cells depend on JAK-STAT signaling, and, in absence of this signal, they do not self-renew. In Drosophila, significant changes occur within the stem cell niche that contributes to a decline in stem cell number over time. In case of aging Drosophila, somatic niche cells show reduced DE-cadherin and unpaired (Upd proteins. Unpaired proteins are known to directly decrease stem cell number within the niches, and, overexpression of upd within niche cells restored GSCs in older males also . Stem cells in the midgut of Drosophila are also very promising. Reduced Notch signaling was found to increase the number of midgut progenitor cells. On the other hand, activation of the Notch pathway decreased proliferation of these cells. Further research in this area should lead to the discovery of additional factors that regulate stem and progenitor cells in Drosophila.

  11. Medical Oversight, Educational Core Content, and Proposed Scopes of Practice of Wilderness EMS Providers: A Joint Project Developed by Wilderness EMS Educators, Medical Directors, and Regulators Using a Delphi Approach.

    Science.gov (United States)

    Millin, Michael G; Johnson, David E; Schimelpfenig, Tod; Conover, Keith; Sholl, Matthew; Busko, Jonnathan; Alter, Rachael; Smith, Will; Symonds, Jennifer; Taillac, Peter; Hawkins, Seth C

    2017-01-01

    A disparity exists between the skills needed to manage patients in wilderness EMS environments and the scopes of practice that are traditionally approved by state EMS regulators. In response, the National Association of EMS Physicians Wilderness EMS Committee led a project to define the educational core content supporting scopes of practice of wilderness EMS providers and the conditions when wilderness EMS providers should be required to have medical oversight. Using a Delphi process, a group of experts in wilderness EMS, representing educators, medical directors, and regulators, developed model educational core content. This core content is a foundation for wilderness EMS provider scopes of practice and builds on both the National EMS Education Standards and the National EMS Scope of Practice Model. These experts also identified the conditions when oversight is needed for wilderness EMS providers. By consensus, this group of experts identified the educational core content for four unique levels of wilderness EMS providers: Wilderness Emergency Medical Responder (WEMR), Wilderness Emergency Medical Technician (WEMT), Wilderness Advanced Emergency Medical Technician (WAEMT), and Wilderness Paramedic (WParamedic). These levels include specialized skills and techniques pertinent to the operational environment. The skills and techniques increase in complexity with more advanced certification levels, and address the unique circumstances of providing care to patients in the wilderness environment. Furthermore, this group identified that providers having a defined duty to act should be functioning with medical oversight. This group of experts defined the educational core content supporting the specific scopes of practice that each certification level of wilderness EMS provider should have when providing patient care in the wilderness setting. Wilderness EMS providers are, indeed, providing health care and should thus function within defined scopes of practice and with

  12. A Brief History of Biomedical Research Ethics in Iran: Conflict of Paradigms.

    Science.gov (United States)

    Aramesh, Kiarash

    2015-08-01

    During the past two decades, Iran has experienced a noteworthy growth in its biomedical research sector. At the same time, ethical concerns and debates resulting from this burgeoning enterprise has led to increasing attention paid to biomedical ethics. In Iran, Biomedical research ethics and research oversight passed through major periods during the past decades, separated by a paradigm shift. Period 1, starting from the early 1970s, is characterized by research paternalism and complete reliance on researchers as virtuous and caring physicians. This approach was in concordance with the paternalistic clinical practice of physicians outside of research settings during the same period. Period 2, starting from the late 1990s, was partly due to revealing of ethical flaws that occurred in biomedical research in Iran. The regulatory and funding bodies concluded that it was not sufficient to rely solely on the personal and professional virtues of researchers to safeguard human subjects' rights and welfare. The necessity for independent oversight, emphasized by international declarations, became obvious and undeniable. This paradigm shift led to the establishment of research ethics committees throughout the country, the establishment of academic research centers focusing on medical ethics (MEHR) and the compilation of the first set of national ethical guidelines on biomedical research-one of the first and most important projects conducted by and in the MEHR. Although not yet arrived, 'period 3' is on its way. It is predictable from the obvious trends toward performance of high-quality clinical research and the appearance of a highly educated new generation, especially among women. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

  13. Comparison of Management Oversight and Risk Tree and Tripod-Beta in Excavation Accident Analysis

    Directory of Open Access Journals (Sweden)

    Mohamadfam

    2015-01-01

    Full Text Available Background Accident investigation programs are a necessary part in identification of risks and management of the business process. Objectives One of the most important features of such programs is the analysis technique for identifying the root causes of accidents in order to prevent their recurrences. Analytical Hierarchy Process (AHP was used to compare management oversight and risk tree (MORT with Tripod-Beta in order to determine the superior technique for analysis of fatal excavation accidents in construction industries. Materials and Methods MORT and Tripod-Beta techniques were used for analyzing two major accidents with three main steps. First, these techniques were applied to find out the causal factors of the accidents. Second, a number of criteria were developed for the comparison of the techniques and third, using AHP, the techniques were prioritized in terms of the criteria for choosing the superior one. Results The Tripod-Beta investigation showed 41 preconditions and 81 latent causes involved in the accidents. Additionally, 27 root causes of accidents were identified by the MORT analysis. Analytical hierarchy process (AHP investigation revealed that MORT had higher priorities only in two criteria than Tripod-Beta. Conclusions Our findings indicate that Tripod-Beta with a total priority of 0.664 is superior to MORT with the total priority of 0.33. It is recommended for future research to compare the available accident analysis techniques based on proper criteria to select the best for accident analysis.

  14. Research on ZnO/Si heterojunction solar cells

    Science.gov (United States)

    Chen, Li; Chen, Xinliang; Liu, Yiming; Zhao, Ying; Zhang, Xiaodan

    2017-06-01

    We put forward an n-ZnO/p-Si heterojunction solar cell model based on AFORS-HET simulations and provide experimental support in this article. ZnO:B (B-doped ZnO) thin films deposited by metal-organic chemical vapor deposition (MOCVD) are planned to act as electrical emitter layer on p-type c-Si substrate for photovoltaic applications. We investigate the effects of thickness, buffer layer, ZnO:B affinity and work function of electrodes on performances of solar cells through computer simulations using AFORS-HET software package. The energy conversion efficiency of the ZnO:B(n)/ZnO/c-Si(p) solar cell can achieve 17.16% ({V}{oc}: 675.8 mV, {J}{sc}: 30.24 mA/cm2, FF: 83.96%) via simulation. On a basis of optimized conditions in simulation, we carry out some experiments, which testify that the ZnO buffer layer of 20 nm contributes to improving performances of solar cells. The influences of growth temperature, thickness and diborane (B2H6) flow rates are also discussed. We achieve an appropriate condition for the fabrication of the solar cells using the MOCVD technique. The obtained conversion efficiency reaches 2.82% ({V}{oc}: 294.4 mV, {J}{sc}: 26.108 mA/cm2, FF: 36.66%). Project supported by the State Key Development Program for Basic Research of China (Nos. 2011CBA00706, 2011CBA00707), the Tianjin Applied Basic Research Project and Cutting-Edge Technology Research Plan (No. 13JCZDJC26900), the Tianjin Major Science and Technology Support Project (No. 11TXSYGX22100), the National High Technology Research and Development Program of China (No. 2013AA050302), and the Fundamental Research Funds for the Central Universities (No. 65010341).

  15. Human rhabdomyosarcoma cell lines for rhabdomyosarcoma research: Utility and pitfalls

    Directory of Open Access Journals (Sweden)

    Ashley R.P. Hinson

    2013-07-01

    Full Text Available Rhabdomyosarcoma (RMS is the most common soft tissue sarcoma of childhood and adolescence. Despite intergroup clinical trials conducted in Europe and North America, outcomes for high risk patients with this disease have not significantly improved in the last several decades, and survival of metastatic or relapsed disease remains extremely poor. Accrual into new clinical trials is slow and difficult, so in vitro cell line research and in vivo xenograft models present an attractive alternative for preclinical research for this cancer type. Currently, 30 commonly used human RMS cell lines exist, with differing origins, karyotypes, histologies, and methods of validation. Selecting an appropriate cell line for RMS research has important implications for outcomes. There are also potential pitfalls in using certain cell lines including contamination with murine stromal cells, cross-contamination between cell lines, discordance between the cell line and its associated original tumor, imposter cell lines, and nomenclature errors that result in the circulation of two or more presumed unique cell lines that are actually from the same origin. These pitfalls can be avoided by testing for species-specific isoenzymes, microarray analysis, assays for subtype-specific fusion products, and short tandem repeat analysis.

  16. Human Rhabdomyosarcoma Cell Lines for Rhabdomyosarcoma Research: Utility and Pitfalls

    Science.gov (United States)

    Hinson, Ashley R. P.; Jones, Rosanne; Crose, Lisa E. S.; Belyea, Brian C.; Barr, Frederic G.; Linardic, Corinne M.

    2013-01-01

    Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma of childhood and adolescence. Despite intergroup clinical trials conducted in Europe and North America, outcomes for high risk patients with this disease have not significantly improved in the last several decades, and survival of metastatic or relapsed disease remains extremely poor. Accrual into new clinical trials is slow and difficult, so in vitro cell-line research and in vivo xenograft models present an attractive alternative for preclinical research for this cancer type. Currently, 30 commonly used human RMS cell lines exist, with differing origins, karyotypes, histologies, and methods of validation. Selecting an appropriate cell line for RMS research has important implications for outcomes. There are also potential pitfalls in using certain cell lines including contamination with murine stromal cells, cross-contamination between cell lines, discordance between the cell line and its associated original tumor, imposter cell lines, and nomenclature errors that result in the circulation of two or more presumed unique cell lines that are actually from the same origin. These pitfalls can be avoided by testing for species-specific isoenzymes, microarray analysis, assays for subtype-specific fusion products, and short tandem repeat analysis. PMID:23882450

  17. Experience with Regulatory Strategies in Nuclear Power Oversight. Part 1: An International Exploratory Study. Part 2: Workshop Discussions and Conclusions

    International Nuclear Information System (INIS)

    Melber, Barbara; Durbin, Nancy E.; Tael, Irene

    2005-03-01

    This report presents the results of a study which explored the use of six different regulatory strategies for oversight of commercial nuclear power facilities: prescriptive, case-based, outcome-based, risk-based, process-based, and self-assessment strategies. Information was collected on experiences with the use of these different regulatory strategies from experts from nuclear regulatory agencies in Canada, Finland, Spain, Sweden, the United Kingdom and the United States. Systematic, structured open-ended interviews with expert regulators with extensive experience were used in order to understand how regulatory strategies are applied in practice. Common patterns were identified regarding: Experts' perspectives on the major benefits and difficulties of using specific regulatory strategies; Experts' experiences with using regulatory strategies for three areas of oversight-design and modifications, quality systems, and training and qualifications; Expert views of the consequences of different regulatory strategies; Issues that emerged in the interviews regarding regulatory strategies. The major benefit of a prescriptive strategy was that it is clear about requirements and expectations. The major difficulties were that it takes responsibility away from the licensee, it requires a high use of regulator resources and is rigid and difficult to change. A case-based strategy had the key benefit of flexibility for adapting regulatory responses to unique situations, but the difficulties of being considered arbitrary, inconsistent, and unfair and requiring heavy resource use. An outcome-based strategy had the main benefit of allowing licensees to decide the best way to operate m order to meet safety goals, but the major difficulty of identifying appropriate ways to measure safety performance. The major benefit of a risk strategy was its use co prioritize safety issues and allocate resources. However, it was considered inappropriate to use as a stand alone strategy and a

  18. Experience with Regulatory Strategies in Nuclear Power Oversight. Part 1: An International Exploratory Study. Part 2: Workshop Discussions and Conclusions

    Energy Technology Data Exchange (ETDEWEB)

    Melber, Barbara [Melber Consulting, Seattle, WA (United States); Durbin, Nancy E. [Nancy E. Durbin Consulting, Kirkland, WA (United States); Tael, Irene (ed.) [Swedish Nuclear Power Inspectorate, Stockholm (Sweden)

    2005-03-01

    This report presents the results of a study which explored the use of six different regulatory strategies for oversight of commercial nuclear power facilities: prescriptive, case-based, outcome-based, risk-based, process-based, and self-assessment strategies. Information was collected on experiences with the use of these different regulatory strategies from experts from nuclear regulatory agencies in Canada, Finland, Spain, Sweden, the United Kingdom and the United States. Systematic, structured open-ended interviews with expert regulators with extensive experience were used in order to understand how regulatory strategies are applied in practice. Common patterns were identified regarding: Experts' perspectives on the major benefits and difficulties of using specific regulatory strategies; Experts' experiences with using regulatory strategies for three areas of oversight-design and modifications, quality systems, and training and qualifications; Expert views of the consequences of different regulatory strategies; Issues that emerged in the interviews regarding regulatory strategies. The major benefit of a prescriptive strategy was that it is clear about requirements and expectations. The major difficulties were that it takes responsibility away from the licensee, it requires a high use of regulator resources and is rigid and difficult to change. A case-based strategy had the key benefit of flexibility for adapting regulatory responses to unique situations, but the difficulties of being considered arbitrary, inconsistent, and unfair and requiring heavy resource use. An outcome-based strategy had the main benefit of allowing licensees to decide the best way to operate m order to meet safety goals, but the major difficulty of identifying appropriate ways to measure safety performance. The major benefit of a risk strategy was its use co prioritize safety issues and allocate resources. However, it was considered inappropriate to use as a stand alone strategy

  19. Progress in InP solar cell research

    International Nuclear Information System (INIS)

    Weinberg, I.; Brinker, D.J.

    1988-01-01

    Progress, in the past year, in InP solar cell research is reviewed. Small area cells with AMO, total area efficiencies of 18.8 percent were produced by OMCVD and Ion Implantation. Larger area cells (2 and 4 sq cm) were processed on a production basis. One thousand of the 2 sq cm cells will be used to supply power to a small piggyback lunar orbiter scheduled for launch in February 1990. Laboratory tests of ITO/InP cells, under 10 MeV proton irradiation, indicate radiation resistance comparable to InP n/p homojunction cells. Computer modeling studies indicate that, for identical geometries and dopant concentrations, InP solar cells are significantly more radiation resistant than GaAs under 1 MeV electron irradiation. Additional computer modeling calculations were used to produce rectangular and circular InP concentrator cell designs for both the low concentration SLATS and higher concentration Cassegrainian Concentrators

  20. Derivation of porcine pluripotent stem cells for biomedical research.

    Science.gov (United States)

    Shiue, Yow-Ling; Yang, Jenn-Rong; Liao, Yu-Jing; Kuo, Ting-Yung; Liao, Chia-Hsin; Kang, Ching-Hsun; Tai, Chein; Anderson, Gary B; Chen, Lih-Ren

    2016-07-01

    Pluripotent stem cells including embryonic stem cells (ESCs), embryonic germ cells (EGCs), and induced pluripotent stem cells (iPSCs) are capable of self-renew and limitlessly proliferating in vitro with undifferentiated characteristics. They are able to differentiate in vitro, spontaneously or responding to suitable signals, into cells of all three primary germ layers. Consequently, these pluripotent stem cells will be valuable sources for cell replacement therapy in numerous disorders. However, the promise of human ESCs and EGCs is cramped by the ethical argument about destroying embryos and fetuses for cell line creation. Moreover, there are still carcinogenic risks existing toward the goal of clinical application for human ESCs, EGCs, and iPSCs. Therefore, a suitable animal model for stem cell research will benefit the further development of human stem cell technology. The pigs, on the basis of their similarity in anatomy, immunology, physiology, and biochemical properties, have been wide used as model animals in the study of various human diseases. The development of porcine pluripotent stem cell lines will hold the opportunity to provide an excellent material for human counterpart to the transplantation in biomedical research and further development of cell-based therapeutic strategy. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Program for fundamental and applied research of fuel cells in VNIIEF

    Energy Technology Data Exchange (ETDEWEB)

    Anisin, A.V.; Borisseonock, V.A.; Novitskii, Y.Z.; Potyomckin, G.A.

    1996-04-01

    According to VNIIEF the integral part of development of fuel cell power plants is fundamental and applied research. This paper describes areas of research on molten carbonate fuel cells. Topics include the development of mathematical models for porous electrodes, thin film electrolytes, the possibility of solid nickel anodes, model of activation polarization of anode, electrolyte with high solubility of oxygen. Other areas include research on a stationary mode of stack operation, anticorrosion coatings, impedance diagnostic methods, ultrasound diagnostics, radiation treatments, an air aluminium cell, and alternative catalysts for low temperature fuel cells.

  2. Resolving ethical issues in stem cell clinical trials: the example of Parkinson disease.

    Science.gov (United States)

    Lo, Bernard; Parham, Lindsay

    2010-01-01

    Clinical trials of stem cell transplantation raise ethical issues that are intertwined with scientific and design issues, including choice of control group and intervention, background interventions, endpoints, and selection of subjects. We recommend that the review and IRB oversight of stem cell clinical trials should be strengthened. Scientific and ethics review should be integrated in order to better assess risks and potential benefits. Informed consent should be enhanced by assuring that participants comprehend key aspects of the trial. For the trial to yield generalizable knowledge, negative findings and serious adverse events must be reported.

  3. Application of single-cell technology in cancer research.

    Science.gov (United States)

    Liang, Shao-Bo; Fu, Li-Wu

    2017-07-01

    In this review, we have outlined the application of single-cell technology in cancer research. Single-cell technology has made encouraging progress in recent years and now provides the means to detect rare cancer cells such as circulating tumor cells and cancer stem cells. We reveal how this technology has advanced the analysis of intratumor heterogeneity and tumor epigenetics, and guided individualized treatment strategies. The future prospects now are to bring single-cell technology into the clinical arena. We believe that the clinical application of single-cell technology will be beneficial in cancer diagnostics and treatment, and ultimately improve survival in cancer patients. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  4. Building research infrastructure in community health centers: a Community Health Applied Research Network (CHARN) report.

    Science.gov (United States)

    Likumahuwa, Sonja; Song, Hui; Singal, Robbie; Weir, Rosy Chang; Crane, Heidi; Muench, John; Sim, Shao-Chee; DeVoe, Jennifer E

    2013-01-01

    This article introduces the Community Health Applied Research Network (CHARN), a practice-based research network of community health centers (CHCs). Established by the Health Resources and Services Administration in 2010, CHARN is a network of 4 community research nodes, each with multiple affiliated CHCs and an academic center. The four nodes (18 individual CHCs and 4 academic partners in 9 states) are supported by a data coordinating center. Here we provide case studies detailing how CHARN is building research infrastructure and capacity in CHCs, with a particular focus on how community practice-academic partnerships were facilitated by the CHARN structure. The examples provided by the CHARN nodes include many of the building blocks of research capacity: communication capacity and "matchmaking" between providers and researchers; technology transfer; research methods tailored to community practice settings; and community institutional review board infrastructure to enable community oversight. We draw lessons learned from these case studies that we hope will serve as examples for other networks, with special relevance for community-based networks seeking to build research infrastructure in primary care settings.

  5. Electrocatalysis research for fuel cells and hydrogen production

    CSIR Research Space (South Africa)

    Mathe, MK

    2012-01-01

    Full Text Available The CSIR undertakes research in the Electrocatalysis of fuel cells and for hydrogen production. The Hydrogen South Africa (HySA) strategy supports research on electrocatalysts due to their importance to the national beneficiation strategy. The work...

  6. TRANSPARENT COATINGS FOR SOLAR CELLS RESEARCH

    Energy Technology Data Exchange (ETDEWEB)

    Glatkowski, P. J.; Landis, D. A.

    2013-04-16

    Todays solar cells are fabricated using metal oxide based transparent conductive coatings (TCC) or metal wires with optoelectronic performance exceeding that currently possible with Carbon Nanotube (CNT) based TCCs. The motivation for replacing current TCC is their inherent brittleness, high deposition cost, and high deposition temperatures; leading to reduced performance on thin substrates. With improved processing, application and characterization techniques Nanofiber and/or CNT based TCCs can overcome these shortcomings while offering the ability to be applied in atmospheric conditions using low cost coating processes At todays level of development, CNT based TCC are nearing commercial use in touch screens, some types of information displays (i.e. electronic paper), and certain military applications. However, the resistivity and transparency requirements for use in current commercial solar cells are more stringent than in many of these applications. Therefore, significant research on fundamental nanotube composition, dispersion and deposition are required to reach the required performance commanded by photovoltaic devices. The objective of this project was to research and develop transparent conductive coatings based on novel nanomaterial composite coatings, which comprise nanotubes, nanofibers, and other nanostructured materials along with binder materials. One objective was to show that these new nanomaterials perform at an electrical resistivity and optical transparency suitable for use in solar cells and other energy-related applications. A second objective was to generate new structures and chemistries with improved resistivity and transparency performance. The materials also included the binders and surface treatments that facilitate the utility of the electrically conductive portion of these composites in solar photovoltaic devices. Performance enhancement venues included: CNT purification and metallic tube separation techniques, chemical doping, CNT

  7. Stem cells: basic research on health, from ethics to panacea

    Directory of Open Access Journals (Sweden)

    Naara Luna

    2007-01-01

    Full Text Available Even though stem cell therapies are still under experimentation, the media has represented them as a panacea that would cure all diseases. This fact secured the authorization for using human embryos as research material. Therapies include manipulation of human material in tissue bioengineering, suggesting a representation of the body as a factory. This article describes stem cell research projects being carried out in the health sciences center of a higher education institution, focusing on field organization and on the system of values underlying scientific activity. Researchers at different levels were interviewed about perspectives on, and implications of, their research in order to analyze the discourse of the projects' participants. Experiments with adult stem cells enjoyed wide support, while the use of human embryos was disputed. The foundations of those arguments were sought in their relation both to the structure of the scientific field and to the researchers' religious background.

  8. Self-Determination in Health Research: An Alaska Native Example of Tribal Ownership and Research Regulation

    Directory of Open Access Journals (Sweden)

    Vanessa Y. Hiratsuka

    2017-10-01

    Full Text Available Alaska Native (AN and American Indian (AI people are underrepresented in health research, yet many decline to participate in studies due to past researcher misconduct. Southcentral Foundation (SCF, an Alaska Native-owned and operated health care organization, is transforming the relationship between researchers and the tribal community by making trust and accountability required features of health research in AN/AI communities. In 1998, SCF assumed ownership from the federal government of health services for AN/AI people in south central Alaska and transformed the health system into a relationship-based model of care. This change reimagines how researchers interact with tribal communities and established community oversight of all health research conducted with AN/AI people in the region. We describe the SCF research review process, which requires tribal approval of the research concept, full proposal, and dissemination products, as well as local institutional review board approval, and a researcher-signed contract. This review evaluates research through the lens of tribal principles, practices, and priorities. The SCF example provides a framework for other tribes and organizations seeking to reshape the future of health research in AN/AI communities.

  9. Promises and challenges of stem cell research for regenerative medicine.

    Science.gov (United States)

    Power, Carl; Rasko, John E J

    2011-11-15

    In recent years, stem cells have generated increasing excitement, with frequent claims that they are revolutionizing medicine. For those not directly involved in stem cell research, however, it can be difficult to separate fact from fiction or realistic expectation from wishful thinking. This article aims to provide internists with a clear and concise introduction to the field. While recounting some scientific and medical milestones, the authors discuss the 3 main varieties of stem cells-adult, embryonic, and induced pluripotent-comparing their advantages and disadvantages for clinical medicine. The authors have sought to avoid the moral and political debates surrounding stem cell research, focusing instead on scientific and medical issues.

  10. Federal Research: Opportunities Exist to Improve the Management and Oversight of Federally Funded Research and Development Centers

    National Research Council Canada - National Science Library

    Woods, William; Mittal, Anu; Neumann, John; Williams, Cheryl; Candon, Sharron; Sterling, Suzanne; Wade, Jacqueline; Zwanzig, Peter

    2008-01-01

    .... FFRDCs -- including laboratories, studies and analyses centers, and systems engineering centers -- conduct research in military space programs, nanotechnology, microelectronics, nuclear warfare...

  11. THE EFFECT OF THE INTERNAL AUDIT AND FIRM PERFORMANCE: A PROPOSED RESEARCH FRAMEWORK

    Directory of Open Access Journals (Sweden)

    Ebrahim Mohammed Al-Matari

    2014-01-01

    Full Text Available This study attempts to propose a structure of the relationships between the internal audits characteristics (IAC; such as professional qualifications of the chief audit executive of the Internal Audit (IA, size, experience, and qualification; and firm performance. The presence of an internal audit department is significant as it is considered as the main element in employing accounting systems and this, in turn, assists in evaluating the department’s work. The internal audit is deemed as the core of business accounting as it is the section that keeps track of all businesses associated with the sector. The internal audit efficiency assists in developing the company’s work because the financial reports present the internal audit department’s quality. In addition, an internal audit is a crucial part of corporate governance structure in an organization and corporate governance (CG covers the activities of oversight conducted by the board of directors and audit committees to ensure credible financial reporting process (Public Oversight Board, 1994. Consistent with previous studies of the importance of internal audit, this study provides comprehensive oversights on the relationship between internal audit and firm performance. The past literature reveals there is a paucity of studies exploring the association between internal audit characteristics (IAC and firm performance whether conceptual or empirical. The main objective of this study is to fill up the gap in the literature and provide an opportunity for future research to deeply to investigate this relationship.

  12. Stem cell research: applicability in dentistry.

    Science.gov (United States)

    Mathur, Shivani; Chopra, Rahul; Pandit, I K; Srivastava, Nikhil; Gugnani, Neeraj

    2014-01-01

    In the face of extraordinary advances in the prevention, diagnosis, and treatment of human diseases, the inability of most tissues and organs to repair and regenerate after damage is a problem that needs to be solved. Stem cell research is being pursued in the hope of achieving major medical breakthroughs. Scientists are striving to create therapies that rebuild or replace damaged cells with tissues grown from stem cells that will offer hope to people suffering from various ailments. Regeneration of damaged periodontal tissue, bone, pulp, and dentin is a problem that dentists face today. Stem cells present in dental pulp, periodontal ligament, and alveolar bone marrow have the potential to repair and regenerate teeth and periodontal structures. These stem cells can be harvested from dental pulp, periodontal ligament, and/or alveolar bone marrow; expanded; embedded in an appropriate scaffold; and transplanted back into a defect to regenerate bone and tooth structures. These cells have the potential to regenerate dentin, periodontal ligament, and cementum and can also be used to restore bone defects. The kind of scaffold, the source of cells, the type of in vitro culturing, and the type of surgical procedure to be used all require careful consideration. The endeavor is clearly multidisciplinary in nature, and the practicing dental surgeon has a critical role in it. Playing this role in the most effective way requires awareness of the huge potential associated with the use of stem cells in a clinical setting, as well as a proper understanding of the related problems.

  13. FTA fuel cell bus program : research accomplishments through 2011.

    Science.gov (United States)

    2012-03-01

    Prepared by the Federal Transit Administration (FTA) Office of Research, Demonstration, and Innovation (TRI), this report summarizes the accomplishments of fuel-cell-transit-bus-related research and demonstrations projects supported by FTA through 20...

  14. Translational findings from cardiovascular stem cell research.

    Science.gov (United States)

    Mazhari, Ramesh; Hare, Joshua M

    2012-01-01

    The possibility of using stem cells to regenerate damaged myocardium has been actively investigated since the late 1990s. Consistent with the traditional view that the heart is a "postmitotic" organ that possesses minimal capacity for self-repair, much of the preclinical and clinical work has focused exclusively on introducing stem cells into the heart, with the hope of differentiation of these cells into functioning cardiomyocytes. This approach is ongoing and retains promise but to date has yielded inconsistent successes. More recently, it has become widely appreciated that the heart possesses endogenous repair mechanisms that, if adequately stimulated, might regenerate damaged cardiac tissue from in situ cardiac stem cells. Accordingly, much recent work has focused on engaging and enhancing endogenous cardiac repair mechanisms. This article reviews the literature on stem cell-based myocardial regeneration, placing emphasis on the mutually enriching interaction between basic and clinical research. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. Stem cell research as innovation: expanding the ethical and policy conversation.

    Science.gov (United States)

    Dresser, Rebecca

    2010-01-01

    Research using human embryonic stem cells raises an array of complex ethical issues, including, but by no means limited to, the moral status of developing human life. Unfortunately much of the public discussion fails to take into account this complexity. Advocacy for liberal and conservative positions on human embryonic stem cell research can be simplistic and misleading. Ethical concepts such as truth-telling, scientific integrity, and social justice should be part of the debate over federal support for human embryonic stem cell research. Moreover, the debate should be conducted in accord with principles of deliberative democracy, including respect for people holding competing views.

  16. Recent developments in blood cell labeling research

    Energy Technology Data Exchange (ETDEWEB)

    Srivastava, S.C.; Straub, R.F.; Meinken, G.E.

    1988-09-07

    A number of recent developments in research on blood cell labeling techniques are presented. The discussion relates to three specific areas: (1) a new in vitro method for red blood cell labeling with /sup 99m/Tc; (2) a method for labeling leukocytes and platelets with /sup 99m/Tc; and (3) the use of monoclonal antibody technique for platelet labeling. The advantages and the pitfalls of these techniques are examined in the light of available mechanistic information. Problems that remain to be resolved are reviewed. An assessment is made of the progress as well as prospects in blood cell labeling methodology including that using the monoclonal antibody approach. 37 refs., 4 figs.

  17. Recent developments in blood cell labeling research

    International Nuclear Information System (INIS)

    Srivastava, S.C.; Straub, R.F.; Meinken, G.E.

    1988-01-01

    A number of recent developments in research on blood cell labeling techniques are presented. The discussion relates to three specific areas: (1) a new in vitro method for red blood cell labeling with /sup 99m/Tc; (2) a method for labeling leukocytes and platelets with /sup 99m/Tc; and (3) the use of monoclonal antibody technique for platelet labeling. The advantages and the pitfalls of these techniques are examined in the light of available mechanistic information. Problems that remain to be resolved are reviewed. An assessment is made of the progress as well as prospects in blood cell labeling methodology including that using the monoclonal antibody approach. 37 refs., 4 figs

  18. Nanotechnology in stem cells research: advances and applications.

    Science.gov (United States)

    Deb, Kaushik Dilip; Griffith, May; Muinck, Ebo De; Rafat, Mehrdad

    2012-01-01

    Human beings suffer from a myriad of disorders caused by biochemical or biophysical alteration of physiological systems leading to organ failure. For a number of these conditions, stem cells and their enormous reparative potential may be the last hope for restoring function to these failing organ or tissue systems. To harness the potential of stem cells for biotherapeutic applications, we need to work at the size scale of molecules and processes that govern stem cells fate. Nanotechnology provides us with such capacity. Therefore, effective amalgamation of nanotechnology and stem cells - medical nanoscience or nanomedicine - offers immense benefits to the human race. The aim of this paper is to discuss the role and importance of nanotechnology in stem cell research by focusing on several important areas such as stem cell visualization and imaging, genetic modifications and reprogramming by gene delivery systems, creating stem cell niche, and similar therapeutic applications.

  19. The use of human cells in biomedical research and testing.

    Science.gov (United States)

    Combes, Robert D

    2004-06-01

    The ability to use human cells in biomedical research and testing has the obvious advantage over the use of laboratory animals that the need for species extrapolation is obviated, due to the presence of more-relevant morphological, physiological and biochemical properties, including receptors. Moreover, human cells exhibit the same advantages as animal cells in culture in that different cell types can be used, from different tissues, with a wide range of techniques, to investigate a wide variety of biological phenomena in tissue culture. Human cells can also be grown as organotypic cultures to facilitate the extrapolation from cells to whole organisms. Human cell lines have been available for many years on an ad hoc basis from individual researchers, and also from recognised sources, such as the European Collection of Animal Cell Cultures (ECACC) and, in the USA, the Human Cell Culture Centre (HCCC). Such cells have usually been derived from tumours and this has restricted the variety of types of cells available. This problem has been addressed by using primary human cells that can be obtained from a variety of sources, such as cadavers, diseased tissue, skin strips, peripheral blood, buccal cavity smears, hair follicles and surgical waste from biopsy material that is unsuitable for transplantation purposes. However, primary human cells need to be obtained, processed, distributed and handled in a safe and ethical manner. They also have to be made available at the correct time to researchers very shortly after they become available. It is only comparatively recently that the safe and controlled acquisition of surgical waste and non-transplantable human tissues has become feasible with the establishment of several human tissue banks. Recently, the formation of a UK and European centralised network for human tissue supply has been initiated. The problems of short longevity and loss of specialisation in culture are being approached by: a) cell immortalisation to

  20. Restart oversight assessment of Hanford 242-A evaporator: Summary report

    International Nuclear Information System (INIS)

    1994-08-01

    This report summarizes a January 17--28, 1994, oversight assessment of restart activities for the 242-A Evaporator at the US Department of Energy's (DOE's) Hanford Site about 25 miles northeast of Hanford, Washington. The assessment was conducted by qualified staff and consultants from the DOE Office of Environment, Safety and Health (EH). Its focus was the readiness of the facility for the resumption of safe operations, in particular those operations involved in the treatment and disposal of condensate from the evaporation of liquid radioactive waste, a key element of the tank waste remediation project administered by the DOE Richland Operations Office (DOE-RL). Overall, the assessment yielded eight programmatic concerns, supported by 38 individual findings. Of the concerns, four have already been closed, and the other four have been resolved. Results pointed up strengths in management and engineering design, as well as effective support of facility training programs by the management and operating contractor, Westinghouse Hanford Company (WHC). Weaknesses were evident, however, in conduct of operations, maintenance, and radiological practices. Furthermore, problems in the submittal and approval of Compliance Schedule Approvals--that is, WHC documentation of the status of compliance with DOE orders--were indicative of a programmatic breakdown in the DOE Order compliance process. According to the results of this assessment, there are no safety and health issues that would preclude or delay restart of the evaporator

  1. Single cell analysis contemporary research and clinical applications

    CERN Document Server

    Cossarizza, Andrea

    2017-01-01

    This book highlights the current state of the art in single cell analysis, an area that involves many fields of science – from clinical hematology, functional analysis and drug screening, to platelet and microparticle analysis, marine biology and fundamental cancer research. This book brings together an eclectic group of current applications, all of which have a significant impact on our current state of knowledge. The authors of these chapters are all pioneering researchers in the field of single cell analysis. The book will not only appeal to those readers more focused on clinical applications, but also those interested in highly technical aspects of the technologies. All of the technologies identified utilize unique applications of photon detection systems.

  2. Lenses for Framing Decisions: Undergraduates' Decision Making about Stem Cell Research

    Science.gov (United States)

    Halverson, Kristy Lynn; Siegel, Marcelle A.; Freyermuth, Sharyn K.

    2009-01-01

    Decision making is influenced by multiple factors, especially when approaching controversial socio-scientific issues, such as stem cell research. In the present study, we used qualitative data from 132 college student papers in a biotechnology course to investigate how students made decisions about stem cell research issues. Students indicated…

  3. Public Attitudes toward Animal Research: A Review

    Directory of Open Access Journals (Sweden)

    Elisabeth H. Ormandy

    2014-06-01

    Full Text Available The exploration of public attitudes toward animal research is important given recent developments in animal research (e.g., increasing creation and use of genetically modified animals, and plans for progress in areas such as personalized medicine, and the shifting relationship between science and society (i.e., a move toward the democratization of science. As such, public engagement on issues related to animal research, including exploration of public attitudes, provides a means of achieving socially acceptable scientific practice and oversight through an understanding of societal values and concerns. Numerous studies have been conducted to explore public attitudes toward animal use, and more specifically the use of animals in research. This paper reviews relevant literature using three categories of influential factors: personal and cultural characteristics, animal characteristics, and research characteristics. A critique is given of survey style methods used to collect data on public attitudes, and recommendations are given on how best to address current gaps in public attitudes literature.

  4. Joint Professional Military Education: Opportunities Exist for Greater Oversight and Coordination of Associated Research Institutions

    Science.gov (United States)

    2014-03-01

    research requests across the department exposes DOD to the risk of potential overlap of studies and analysis research. View GAO-14-216. For more...National Defense University GPRA Government Performance and Results Act CCO Center for Complex Operations CSR Center for Strategic...their future leadership positions. To provide broad educational experiences, students can conduct research at the JPME research institutions as part

  5. Some applications of nanotechnologies in stem cells research

    International Nuclear Information System (INIS)

    Belicchi, M.; Cancedda, R.; Cedola, A.; Fiori, F.; Gavina, M.; Giuliani, A.; Komlev, V.S.; Lagomarsino, S.; Mastrogiacomo, M.; Renghini, C.; Rustichelli, F.

    2009-01-01

    Stem cell based tissue engineering therapies involve the administration of ex vivo manipulated stem cell populations with the purpose of repairing and regenerating damaged or diseased tissue. Currently available methods of monitoring transplanted cells are quite limited. To monitor the outcomes of stem cell therapy longitudinally requires the development of non-destructive strategies that are capable of identifying the location, magnitude, and duration of cellular survival and fate. The recent development of imaging techniques offers great potential to address these critical issues by non-invasively tracking the fate of the transplanted cells. This review offers a focused presentation of some examples of the use of imaging techniques connected to the nanotechnological world in research areas related to stem cells. In particular investigations will be considered concerning tissue-engineered bone, treatment of intervertebral disc degeneration, treatment by human stem cells of muscular dystrophy of Duchenne in small animal models and the repair of spinal cord injuries.

  6. Some applications of nanotechnologies in stem cells research

    Energy Technology Data Exchange (ETDEWEB)

    Belicchi, M. [Fondazione IRCCS Ospedale Policlinico di Milano, Via Francesco Sforza, Milano 20122 (Italy); Cancedda, R. [Istituto Nazionale per la Ricerca sul Cancro and Dipartimento di Oncologia Biologia e Genetica - Universita di Genova, Largo R. Benzi 10, Genova 16132 (Italy); Cedola, A. [Istituto di Fotonica e Nanotecnologie - CNR, Via Cinto Romano 42, Roma 00156 (Italy); Fiori, F. [Dipartimento S.A.I.F.E.T. Sezione di Scienze Fisiche - Universita' Politecnica delle Marche, Via Brecce Bianche, Ancona 60131 (Italy); INBB - Istituto Nazionale Biostrutture e Biosistemi (Italy); CNISM - Matec (Ancona) (Italy); Gavina, M. [Fondazione IRCCS Ospedale Policlinico di Milano, Via Francesco Sforza, Milano 20122 (Italy); Giuliani, A. [Dipartimento S.A.I.F.E.T. Sezione di Scienze Fisiche - Universita' Politecnica delle Marche, Via Brecce Bianche, Ancona 60131 (Italy); CNISM - Matec (Ancona) (Italy); Komlev, V.S. [Dipartimento S.A.I.F.E.T. Sezione di Scienze Fisiche - Universita' Politecnica delle Marche, Via Brecce Bianche, Ancona 60131 (Italy); Institute for Physical Chemistry of Ceramics, Russian Academy of Sciences, Ozernaya 48, 119361 Moscow (Russian Federation); Lagomarsino, S. [Istituto di Fotonica e Nanotecnologie - CNR, Via Cinto Romano 42, Roma 00156 (Italy); Mastrogiacomo, M. [Istituto Nazionale per la Ricerca sul Cancro and Dipartimento di Oncologia Biologia e Genetica - Universita di Genova, Largo R. Benzi 10, Genova 16132 (Italy); Renghini, C. [Dipartimento S.A.I.F.E.T. Sezione di Scienze Fisiche - Universita' Politecnica delle Marche, Via Brecce Bianche, Ancona 60131 (Italy); INBB - Istituto Nazionale Biostrutture e Biosistemi (Italy); CNISM - Matec (Ancona) (Italy); Rustichelli, F., E-mail: f.rustichelli@univpm.i [Dipartimento S.A.I.F.E.T. Sezione di Scienze Fisiche - Universita' Politecnica delle Marche, Via Brecce Bianche, Ancona 60131 (Italy); INBB - Istituto Nazionale Biostrutture e Biosistemi (Italy); CNISM - Matec (Ancona) (Italy)

    2009-12-15

    Stem cell based tissue engineering therapies involve the administration of ex vivo manipulated stem cell populations with the purpose of repairing and regenerating damaged or diseased tissue. Currently available methods of monitoring transplanted cells are quite limited. To monitor the outcomes of stem cell therapy longitudinally requires the development of non-destructive strategies that are capable of identifying the location, magnitude, and duration of cellular survival and fate. The recent development of imaging techniques offers great potential to address these critical issues by non-invasively tracking the fate of the transplanted cells. This review offers a focused presentation of some examples of the use of imaging techniques connected to the nanotechnological world in research areas related to stem cells. In particular investigations will be considered concerning tissue-engineered bone, treatment of intervertebral disc degeneration, treatment by human stem cells of muscular dystrophy of Duchenne in small animal models and the repair of spinal cord injuries.

  7. Hydrogen Research for Spaceport and Space-Based Applications: Fuel Cell Projects

    Science.gov (United States)

    Anderson, Tim; Balaban, Canan

    2008-01-01

    The activities presented are a broad based approach to advancing key hydrogen related technologies in areas such as fuel cells, hydrogen production, and distributed sensors for hydrogen-leak detection, laser instrumentation for hydrogen-leak detection, and cryogenic transport and storage. Presented are the results from research projects, education and outreach activities, system and trade studies. The work will aid in advancing the state-of-the-art for several critical technologies related to the implementation of a hydrogen infrastructure. Activities conducted are relevant to a number of propulsion and power systems for terrestrial, aeronautics and aerospace applications. Fuel cell research focused on proton exchange membranes (PEM), solid oxide fuel cells (SOFC). Specific technologies included aircraft fuel cell reformers, new and improved electrodes, electrolytes, interconnect, and seals, modeling of fuel cells including CFD coupled with impedance spectroscopy. Research was conducted on new materials and designs for fuel cells, along with using embedded sensors with power management electronics to improve the power density delivered by fuel cells. Fuel cell applications considered were in-space operations, aviation, and ground-based fuel cells such as; powering auxiliary power units (APUs) in aircraft; high power density, long duration power supplies for interplanetary missions (space science probes and planetary rovers); regenerative capabilities for high altitude aircraft; and power supplies for reusable launch vehicles.

  8. Somatic Cells Become Cancer’s “Starter Dough” | Center for Cancer Research

    Science.gov (United States)

    Cancer stem cells (CSCs) is a term that sparks animated differences of opinions among researchers in the oncology community.  Much of the disagreement comes from the difficulty involved in isolating these cells and manipulating them ex vivo. When putative CSCs are isolated from clinical samples, researchers are unable to retrospectively identify the cell type that suffered the

  9. Introduction of hot cell facility in research center Rez - Poster

    International Nuclear Information System (INIS)

    Petrickova, A.; Srba, O.; Miklos, M.; Svoboda, P.

    2015-01-01

    This poster presents the hot cell facility which is being constructed as part of the SUSEN project at the Rez research center (Czech Republic). Within this project a new complex of 10 hot cells and one semi-hot cell will be built. There will be 8 gamma hot cells and 2 alpha hot cells. In each hot cell a hermetic, removable box made of stainless steel will home different type of devices. The hot cells and semi hot cell will be equipped with devices for processing samples (cutting, welding, drilling, machining) as well as equipment for testing (sample preparation area, stress testing machine, fatigue machine, electromechanical creep machine, high frequency resonance pulsator...) and equipment for studying material microstructure (nano-indenter with nano-scratch tester and scanning electron microscope). An autoclave with water loop, installed in a cell will allow mechanical testing in control environment of water, pressure and temperature. A scheme shows the equipment of each cell. This hot laboratory will be able to cover all the process to study radioactive materials: receiving the material, the preparation of the samples, mechanical testing and microstructure observation. Our hot cells will be close to the research nuclear reactor LVR-15 and new irradiation facility (high irradiation by cobalt source) is planned to be built within the SUSEN project

  10. How can nanobiotechnology oversight advance science and industry: examples from environmental, health, and safety studies of nanoparticles (nano-EHS)

    International Nuclear Information System (INIS)

    Wang Jing; Asbach, Christof; Fissan, Heinz; Hülser, Tim; Kuhlbusch, Thomas A. J.; Thompson, Drew; Pui, David Y. H.

    2011-01-01

    Nanotechnology has great potential to transform science and industry in the fields of energy, material, environment, and medicine. At the same time, more concerns are being raised about the occupational health and safety of nanomaterials in the workplace and the implications of nanotechnology on the environment and living systems. Studies on environmental, health, and safety (EHS) issues of nanomaterials have a strong influence on public acceptance of nanotechnology and, eventually, affect its sustainability. Oversight and regulation by government agencies and non-governmental organizations (NGOs) play significant roles in ensuring responsible and environmentally friendly development of nanotechnology. The EHS studies of nanomaterials can provide data and information to help the development of regulations and guidelines. We present research results on three aspects of EHS studies: physico-chemical characterization and measurement of nanomaterials; emission, exposure, and toxicity of nanomaterials; and control and abatement of nanomaterial releases using filtration technology. Measurement of nanoparticle agglomerates using a newly developed instrument, the Universal NanoParticle Analyzer (UNPA), is discussed. Exposure measurement results for silicon nanoparticles in a pilot scale production plant are presented, as well as exposure measurement and toxicity study of carbon nanotubes (CNTs). Filtration studies of nanoparticle agglomerates are also presented as an example of emission control methods.

  11. Developments in stem cell research and therapeutic cloning: Islamic ethical positions, a review.

    Science.gov (United States)

    Fadel, Hossam E

    2012-03-01

    Stem cell research is very promising. The use of human embryos has been confronted with objections based on ethical and religious positions. The recent production of reprogrammed adult (induced pluripotent) cells does not - in the opinion of scientists - reduce the need to continue human embryonic stem cell research. So the debate continues. Islam always encouraged scientific research, particularly research directed toward finding cures for human disease. Based on the expectation of potential benefits, Islamic teachings permit and support human embryonic stem cell research. The majority of Muslim scholars also support therapeutic cloning. This permissibility is conditional on the use of supernumerary early pre-embryos which are obtained during infertility treatment in vitro fertilization (IVF) clinics. The early pre-embryos are considered in Islamic jurisprudence as worthy of respect but do not have the full sanctity offered to the embryo after implantation in the uterus and especially after ensoulment. In this paper the Islamic positions regarding human embryonic stem cell research and therapeutic cloning are reviewed in some detail, whereas positions in other religious traditions are mentioned only briefly. The status of human embryonic stem cell research and therapeutic cloning in different countries, including the USA and especially in Muslim countries, is discussed. © 2010 Blackwell Publishing Ltd.

  12. Research Insights About Risk Governance

    Directory of Open Access Journals (Sweden)

    Therese R. Viscelli

    2016-11-01

    Full Text Available In recent years, expectations for increased risk governance have been placed explicitly on boards of directors. In response, boards are being held responsible for not only understanding and approving management’s risk management processes, but they are also being held responsible for assessing the risks identified by those processes as part of overseeing management’s pursuit of value. These increasing responsibilities have led a number of organizations to adopt enterprise risk management (ERM as a holistic approach to risk management that extends beyond traditional silo-based risk management techniques. As boards, often through their audit committee, consider management’s implementation of ERM as part of the board’s risk oversight, a number of questions emerge that can be informed by academic research related to ERM. This article summarizes findings from ERM research to provide insights related to the board’s risk governance responsibilities. We also identify a number of research questions that warrant further analysis by governance scholars. It is our hope that this article will spawn varying types of research about ERM and corporate governance.

  13. Ethical considerations in stem cell research on neurologic and orthopedic conditions.

    Science.gov (United States)

    Banja, John Dennis

    2015-04-01

    The range and gravity of ethical considerations in stem cell research are remarkable and, quite possibly, unprecedented. From the point of securing stem cells for implantation, through the translational and first-in-humans process, and then proceeding through clinical trials culminating in product or service line launch, the entire research trajectory is replete with risk, uncertainty, and problems overweighing foreseeable harms against hoped-for benefits. This article offers an overview of some of the most salient ethical challenges of stem cell research, including ones involving moral status, the intersection of research risks and informed consent processes, methodologic considerations in early phase 1 trials, the temptation to exaggerate the benefits of research discoveries, managing conflicts of interest, and the ethical obligation to conduct various monitoring practices throughout a trial, which could last years. The article will conclude with a glimpse into the future of these technologies wherein the need for ethical scrutiny will likely not diminish. Copyright © 2015. Published by Elsevier Inc.

  14. The establishment of research ethics consultation services (RECS): an emerging research resource.

    Science.gov (United States)

    McCormick, Jennifer B; Sharp, Richard R; Ottenberg, Abigale L; Reider, Carson R; Taylor, Holly A; Wilfond, Benjamin S

    2013-02-01

    Emphasis on translational research to facilitate progression from the laboratory into the community also creates a dynamic in which ethics and social policy questions and solutions are ever pressing. In response, academic institutions are creating Research Ethics Consultation Services (RECS). All Clinical Translational Science Award institutions were surveyed in early 2010 to determine which institutions have a RECS in operation and what is their composition and function. Of the 46 institutions surveyed, 33 (70%) have a RECS. Only 15 RECS have received any consult requests in the last year. Issues that are common among these relatively nascent services include relationships with institutional oversight committees, balancing requestor concerns about confidentiality with research integrity and human subjects protection priorities, tracking consult data and outcomes, and developing systems for internal evaluation. There is variability in how these issues are approached. It will be important to be attentive to the institutional context to develop an appropriate approach. Further data about the issues raised by requestors and the recommendations provided are necessary to build a community of scholars who can navigate and resolve ethical issues encountered along the translational research pathway. © 2012 Wiley Periodicals, Inc.

  15. The roles of antitrust law and regulatory oversight in the restructured electricity industry

    Energy Technology Data Exchange (ETDEWEB)

    Glazer, C.A.; Little, M.B.

    1999-05-01

    The introduction of retail wheeling is changing the roles of regulators and the courts. When states unbundle the vertically integrated investor-owned utility (IOU) into generation companies, transmission companies, and distribution companies, antitrust enforcement and policy setting by the state public utility/service commissions (PUCs) will be paramount. As was seen in the deregulation of the airline industry, vigorous enforcement of antitrust laws by the courts and proper policy setting by the regulators are the keys to a successful competitive market. Many of the problems raised in the airline deregulation movement came about due to laxity in correcting clear antitrust violations and anti-competitive conditions before they caused damage to the market. As retail wheeling rolls out, it is critical for state PUCs to become attuned to these issues and, most of all, to have staff trained in these disciplines. The advent of retail wheeling changes the application of the State Action Doctrine and, in turn, may dramatically alter the role of the state PUC--meaning antitrust law and regulatory oversight must step in to protect competitors and consumers from monopolistic abuse.

  16. What Undergraduates Misunderstand about Stem Cell Research

    Science.gov (United States)

    Halverson, Kristy Lynn; Freyermuth, Sharyn K.; Siegel, Marcelle A.; Clark, Catharine G.

    2010-01-01

    As biotechnology-related scientific advances, such as stem cell research (SCR), are increasingly permeating the popular media, it has become ever more important to understand students' ideas about this issue. Very few studies have investigated learners' ideas about biotechnology. Our study was designed to understand the types of alternative…

  17. Mort User's Manual: For use with the Management Oversight and Risk Tree analytical logic diagram

    Energy Technology Data Exchange (ETDEWEB)

    Knox, N.W.; Eicher, R.W.

    1992-02-01

    This report contains the User's Manual for MORT (Management Oversight and Risk Tree), a logic diagram in the form of a work sheet'' that illustrates a long series of interrelated questions. MORT is a comprehensive analytical procedure that provides a disciplined method for determining the causes and contributing factors of major accidents. Alternatively, it serves as a tool to evaluate the quality of an existing system. While similar in many respects to fault tree analysis, MORT is more generalized and presents over 1500 specific elements of an ideal universal'' management program for optimizing environment, safety and health, and other programs. This User's Manual is intended to be used with the MORT diagram dated February 1992.

  18. 75 FR 8085 - National Institutes of Health Guidelines for Human Stem Cell Research

    Science.gov (United States)

    2010-02-23

    ... Health Guidelines for Human Stem Cell Research SUMMARY: The National Institutes of Health (NIH) is requesting public comment on a revision to the definition of human embryonic stem cells (hESCs) in the ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines). On July 7, 2009, NIH...

  19. 75 FR 13137 - National Institutes of Health Guidelines for Human Stem Cell Research

    Science.gov (United States)

    2010-03-18

    ... Health Guidelines for Human Stem Cell Research SUMMARY: The National Institutes of Health (NIH) is extending the public comment period on a revision to the definition of human embryonic stem cells (hESCs) in the ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines). Due to a...

  20. Examples of NRC research products used in regulation

    International Nuclear Information System (INIS)

    Anderson, N.R.

    1987-01-01

    The key to effective research is a close relationship between information needs and research results. This can only be achieved by close cooperation between the researchers and the regulators. At the NRC, this relationship has matured over the years until now the researchers participate in definition of the information needs and the regulators help define the research programs. The more formal means of ensuring a close match between needs and results include joint research groups, oversight working groups, and a system of Research Information Letters (RILs). On an informal basis there are many day to day discussions and meetings on the various programs which ensure effective program guidance and early identification of significant findings. This paper describes both the formal and informal researcher/regulation interface and discusses some examples of how specific research programs are utilized in the regulatory process. Specific programs described are the pressurized thermal shock program, the seismic margins program and the Category 1 structures program. Other examples cited are the aging and life extension programs

  1. Use of the Management Oversight and Risk Tree (MORT) methodology in health-physics program appraisals

    International Nuclear Information System (INIS)

    Essig, T.H.; Gilchrist, R.L.

    1981-06-01

    In January 1980, Pacific Northwest Laboratory (PNL) assumed a major role in helping the Nuclear Regulatory Commission (NRC) conduct comprehensive health physics appraisals at 47 operating nuclear power plants. These appraisals required the development of an analytical technique that permitted a deductive analysis of a health-physics program on an element-by-element basis. The technique employed was a modification of the Management Oversight and risk Tree (MORT) analytical logic methodology used in probabilistic assessments. This paper includes the method used in establishing the appraisal guidelines and assigning the proper level of importance within the analytical tree structure. The system for ensuring the proper subdivision necessary for an adequate assessment of each area (e.g., exposure controls and radioactive waste management) will also be discussed. In addition to these major subjects, the generation of specific review questions that correspond to the analytical trees is addressed

  2. Research on human placenta-derived mesenchymal stem cells ...

    African Journals Online (AJOL)

    Research on human placenta-derived mesenchymal stem cells transfected with pIRES2-EGFP-VEGF165 using liposome. ... African Journal of Biotechnology. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue ...

  3. Research progress on organic-inorganic halide perovskite materials and solar cells

    Science.gov (United States)

    Ono, Luis K.; Qi, Yabing

    2018-03-01

    Owing to the intensive research efforts across the world since 2009, perovskite solar cell power conversion efficiencies (PCEs) are now comparable or even better than several other photovoltaic (PV) technologies. In this topical review article, we review recent progress in the field of organic-inorganic halide perovskite materials and solar cells. We associate these achievements with the fundamental knowledge gained in the perovskite research. The major recent advances in the fundamental perovskite material and solar cell research are highlighted, including the current efforts in visualizing the dynamical processes (in operando) taking place within a perovskite solar cell under operating conditions. We also discuss the existing technological challenges. Based on a survey of recently published works, we point out that to move the perovskite PV technology forward towards the next step of commercialization, what perovskite PV technology need the most in the coming next few years is not only further PCE enhancements, but also up-scaling, stability, and lead-toxicity.

  4. Methods in Molecular Biology: Germline Stem Cells | Center for Cancer Research

    Science.gov (United States)

    The protocols in Germline Stem Cells are intended to present selected genetic, molecular, and cellular techniques used in germline stem cell research. The book is divided into two parts. Part I covers germline stem cell identification and regulation in model organisms. Part II covers current techniques used in in vitro culture and applications of germline stem cells.

  5. Cell biology and biotechnology research for exploration of the Moon and Mars

    Science.gov (United States)

    Pellis, N.; North, R.

    Health risks generated by human long exposure to radiation, microgravity, and unknown factors in the planetary environment are the major unresolved issues for human space exploration. A complete characterization of human and other biological systems adaptation processes to long-duration space missions is necessary for the development of countermeasures. The utilization of cell and engineered tissue cultures in space research and exploration complements research in human, animal, and plant subjects. We can bring a small number of humans, animals, or plants to the ISS, Moon, and Mars. However, we can investigate millions of their cells during these missions. Furthermore, many experiments can not be performed on humans, e.g. radiation exposure, cardiac muscle. Cells from critical tissues and tissue constructs per se are excellent subjects for experiments that address underlying mechanisms important to countermeasures. The development of cell tissue engineered for replacement, implantation of biomaterial to induce tissue regeneration (e.g. absorbable collagen matrix for guiding tissue regeneration in periodontal surgery), and immunoisolation (e.g. biopolymer coating on transplanted tissues to ward off immunological rejection) are good examples of cell research and biotechnology applications. NASA Cell Biology and Biotechnology research include Bone/Muscle and Cardiovascular cell culture and tissue engineering; Environmental Health and Life Support Systems; Immune System; Radiation; Gravity Thresholds ; and Advanced Biotechnology Development to increase the understanding of animal and plant cell adaptive behavior when exposed to space, and to advance technologies that facilitates exploration. Cell systems can be used to investigate processes related to food, microbial proliferation, waste management, biofilms and biomaterials. The NASA Cell Science Program has the advantage of conducting research in microgravity based on significantly small resources, and the ability to

  6. Some applications of nanotechnologies in stem cells research

    Czech Academy of Sciences Publication Activity Database

    Belicchi, M.; Cancedda, R.; Cedola, A.; Fiori, F.; Gavina, M.; Giuliani, A.; Komlev, V. S.; Lagomarsino, S.; Mastrogiacomo, M.; Renghini, C.; Rustichelli, F.; Syková, Eva; Torrente, Y.

    2009-01-01

    Roč. 165, č. 3 (2009), s. 139-147 ISSN 0921-5107 Institutional research plan: CEZ:AV0Z50390512 Keywords : imaging techniques * stem cells * nanoparticles Subject RIV: FH - Neurology Impact factor: 1.715, year: 2009

  7. Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.

    Science.gov (United States)

    Ogbogu, Ubaka; Burningham, Sarah; Ollenberger, Adam; Calder, Kathryn; Du, Li; El Emam, Khaled; Hyde-Lay, Robyn; Isasi, Rosario; Joly, Yann; Kerr, Ian; Malin, Bradley; McDonald, Michael; Penney, Steven; Piat, Gayle; Roy, Denis-Claude; Sugarman, Jeremy; Vercauteren, Suzanne; Verhenneman, Griet; West, Lori; Caulfield, Timothy

    2014-02-03

    The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors' clinical information for research and regulatory purposes, and existing practices that limit research participants' ability to control what is done with their genetic data, amplify the privacy concerns. To date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public. This paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that privacy risks associated with cell

  8. Fiscal 1999 leading research report. Research on 3-D cell tissue module technology; 1999 nendo sanjigen saibo soshiki module kogaku chosa kenkyu hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-03-01

    For forming cell tissues alternative to bio-tissues, this research targets the technology for forming bio-tissue modules by cultivating 3-D cell tissues from various kinds of cells. In fiscal 1999, research was made on various issues of element technologies necessary for forming module structure of bio-tissues, and study was also made on the application of 3-D cell tissue module engineering to industrial fields. Survey was made on element technologies and solutions supporting such engineering, and in addition, on progressive conditions of cell cultivation techniques, and concrete techniques for expressing cell functions. Research was made on a cell behavior under physicochemical stimulus environment to study the optimum environment for cell multiplication and function expression. Further research was made on state analysis of cells, in particular, fast precise measurement techniques of activation or malignant of cells and secretion of toxic substances by physical/optical analytical evaluation techniques such as photo-CT and spectroscopic analysis, and biochemical analysis techniques using bio-sensors. Study was also made on successful development and application cases of practical bio-artificial organs in western countries. (NEDO)

  9. Research on imaging, sensing, and characterization of cells at Research Center for Applied Sciences (RCAS), Academia Sinica

    Science.gov (United States)

    Tsai, Hui-Chen; Chang, Chun-Fang; Chen, Bi-Chang; Cheng, Ji-Yen; Chu, Chih-Wei; Han, Hsieh-Cheng; Hatanaka, Koji; Hsieh, Tung-Han; Lee, Chau-Hwang; Lin, Jung-Hsin; Tung, Yi-Chung; Wei, Pei-Kuen; Yang, Fu-Liang; Tsai, Din Ping

    2015-12-01

    Development of imaging, sensing, and characterization of cells at Research Center for Applied Sciences (RCAS) of Academia Sinica in Taiwan is progressing rapidly. The research on advanced lattice light sheet microscopy for temporal visualization of cells in three dimensions at sub-cellular resolution shows novel imaging results. Label-free observation on filopodial dynamics provides a convenient assay on cancer cell motility. The newly-developed software enables us to track the movement of two types of particles through different channels and reconstruct the co-localized tracks. Surface plasmon resonance (SPR) for detecting urinary microRNA for diagnosis of acute kidney injury demonstrates excellent sensitivity. A fully automated and integrated portable reader was constructed as a home-based surveillance system for post-operation hepatocellular carcinoma. New microfluidic cell culture devices for fast and accurate characterizations prove various diagnosis capabilities.

  10. Governmental oversight of prescribing medications: history of the US Food and Drug Administration and prescriptive authority.

    Science.gov (United States)

    Plank, Linda S

    2011-01-01

    The evolution of drug regulation and awarding of prescriptive authority is a complex and sometimes convoluted process that can be confusing for health care providers. A review of the history of how drugs have been manufactured and dispensed helps explain why this process has been so laborious and complicated. Because the federal and state governments have the responsibility for protecting the public, most regulations have been passed with the intentions of ensuring consumer safety. The current system of laws and regulations is the result of many years of using the legal system to correct drug marketing that had adverse health consequences. Government oversight will continue as prescribing medications transitions to an electronic form and as health care professionals in addition to physicians seek to gain prescriptive authority. © 2011 by the American College of Nurse-Midwives.

  11. HANARO Neutron Radiography Facility and Fuel Cell Research

    International Nuclear Information System (INIS)

    Kim, Taejoo

    2013-01-01

    Fuel cell which generates electric energy from hydrogen and oxygen is one of noticed renewable energy system because this has high efficiency and free from CO 2 . Especially, PEMFC (Polymer Electrolyte Membrane Fuel Cell) is focused by automotive companies because PEMFC, which has high power rate per volume and low operating temperature (60∼80), is suited due to the compact design and short start-up time. The water management is one of the most critical issues for fuel cell commercialization. In order to make a proper scheme for water management, thein formation of water distribution and behavior is very important. Neutron imaging is the best method to visualize the water at fuel cell and has been applied worldwide with qualitative and quantitative results. Because the NRF has large beam size (350Χ450mm 2 ) and relatively high neutron flux (2Χ107 n/cm 2 sec), it is suitable for large scale fuel cell research. Neutron imaging technique was used to investigate the water distribution and behavior in PEMFC under different operating conditions. The NRF has contributed the improvement of fuel cell performance and is one of the best choices for fuel cell study

  12. Hydrogen and fuel cell research: Institute for Integrated Energy Systems (IESVic)

    International Nuclear Information System (INIS)

    Pitt, L.

    2006-01-01

    Vision: IESVic's mission is to chart feasible paths to sustainable energy. Current research areas of investigation: 1. Energy system analysis 2. Computational fuel cell engineering; Fuel cell parameter measurement; Microscale fuel cells 3. Hydrogen dispersion studies for safety codes 4. Active magnetic refrigeration for hydrogen liquifaction and heat transfer in metal hydrides 5. Hydrogen and fuel cell system integration (author)

  13. Cost reduction has priority in solar cell research

    International Nuclear Information System (INIS)

    Van Zolingen, R.J.C.; Sinke, W.C.

    1993-01-01

    The main topic in the research and development of photovoltaic cells is cost reduction. Although new materials, improved techniques and increasing efficiency are promising aspects of the clean and sustainable option of a photovoltaic conversion of sunlight to produce electricity at a large scale, the high prices form an obstacle. Photovoltaic conversion is at least a factor three too expensive compared to the conventional power generation techniques by means of fossil fuels. Attention is paid to the theoretical maximum efficiency of photovoltaic conversion, the efficiencies realized sofar, the importance of thin film solar cells, the payback period of photovoltaic modules, the environmental impacts of using photovoltaic cells, and finally the costs. 2 figs., 1 ill., 2 tabs., 6 refs

  14. Applications of Mesenchymal Stem Cells and Neural Crest Cells in Craniofacial Skeletal Research

    Directory of Open Access Journals (Sweden)

    Satoru Morikawa

    2016-01-01

    Full Text Available Craniofacial skeletal tissues are composed of tooth and bone, together with nerves and blood vessels. This composite material is mainly derived from neural crest cells (NCCs. The neural crest is transient embryonic tissue present during neural tube formation whose cells have high potential for migration and differentiation. Thus, NCCs are promising candidates for craniofacial tissue regeneration; however, the clinical application of NCCs is hindered by their limited accessibility. In contrast, mesenchymal stem cells (MSCs are easily accessible in adults, have similar potential for self-renewal, and can differentiate into skeletal tissues, including bones and cartilage. Therefore, MSCs may represent good sources of stem cells for clinical use. MSCs are classically identified under adherent culture conditions, leading to contamination with other cell lineages. Previous studies have identified mouse- and human-specific MSC subsets using cell surface markers. Additionally, some studies have shown that a subset of MSCs is closely related to neural crest derivatives and endothelial cells. These MSCs may be promising candidates for regeneration of craniofacial tissues from the perspective of developmental fate. Here, we review the fundamental biology of MSCs in craniofacial research.

  15. Culture in embryonic kidney serum and xeno-free media as renal cell carcinoma and renal cell carcinoma cancer stem cells research model.

    Science.gov (United States)

    Krawczyk, Krzysztof M; Matak, Damian; Szymanski, Lukasz; Szczylik, Cezary; Porta, Camillo; Czarnecka, Anna M

    2018-04-01

    The use of fetal bovine serum hinders obtaining reproducible experimental results and should also be removed in hormone and growth factor studies. In particular hormones found in FBS act globally on cancer cell physiology and influence transcriptome and metabolome. The aim of our study was to develop a renal carcinoma serum free culture model optimized for (embryonal) renal cells in order to select the best study model for downstream auto-, para- or endocrine research. Secondary aim was to verify renal carcinoma stem cell culture for this application. In the study, we have cultured renal cell carcinoma primary tumour cell line (786-0) as well as human kidney cancer stem cells in standard 2D monolayer cultures in Roswell Park Memorial Institute Medium or Dulbecco's Modified Eagle's Medium and Complete Human Kidney Cancer Stem Cell Medium, respectively. Serum-free, animal-component free Human Embryonic Kidney 293 media were tested. Our results revealed that xeno-free embryonal renal cells optimized culture media provide a useful tool in RCC cancer biology research and at the same time enable effective growth of RCC. We propose bio-mimic RCC cell culture model with specific serum-free and xeno-free medium that promote RCC cell viability.

  16. Each cell counts: Hematopoiesis and immunity research in the era of single cell genomics.

    Science.gov (United States)

    Jaitin, Diego Adhemar; Keren-Shaul, Hadas; Elefant, Naama; Amit, Ido

    2015-02-01

    Hematopoiesis and immunity are mediated through complex interactions between multiple cell types and states. This complexity is currently addressed following a reductionist approach of characterizing cell types by a small number of cell surface molecular features and gross functions. While the introduction of global transcriptional profiling technologies enabled a more comprehensive view, heterogeneity within sampled populations remained unaddressed, obscuring the true picture of hematopoiesis and immune system function. A critical mass of technological advances in molecular biology and genomics has enabled genome-wide measurements of single cells - the fundamental unit of immunity. These new advances are expected to boost detection of less frequent cell types and fuzzy intermediate cell states, greatly expanding the resolution of current available classifications. This new era of single-cell genomics in immunology research holds great promise for further understanding of the mechanisms and circuits regulating hematopoiesis and immunity in both health and disease. In the near future, the accuracy of single-cell genomics will ultimately enable precise diagnostics and treatment of multiple hematopoietic and immune related diseases. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Center for Fuel Cell Research and Applications development phase. Final report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-01

    The deployment and operation of clean power generation is becoming critical as the energy and transportation sectors seek ways to comply with clean air standards and the national deregulation of the utility industry. However, for strategic business decisions, considerable analysis is required over the next few years to evaluate the appropriate application and value added from this emerging technology. To this end the Houston Advanced Research Center (HARC) is proposing a three-year industry-driven project that centers on the creation of ``The Center for Fuel Cell Research and Applications.`` A collaborative laboratory housed at and managed by HARC, the Center will enable a core group of six diverse participating companies--industry participants--to investigate the economic and operational feasibility of proton-exchange-membrane (PEM) fuel cells in a variety of applications (the core project). This document describes the unique benefits of a collaborative approach to PEM applied research, among them a shared laboratory concept leading to cost savings and shared risks as well as access to outstanding research talent and lab facilities. It also describes the benefits provided by implementing the project at HARC, with particular emphasis on HARC`s history of managing successful long-term research projects as well as its experience in dealing with industry consortia projects. The Center is also unique in that it will not duplicate the traditional university role of basic research or that of the fuel cell industry in developing commercial products. Instead, the Center will focus on applications, testing, and demonstration of fuel cell technology.

  18. Pluripotent Stem Cells in Research and Treatment of Hemoglobinopathies

    Science.gov (United States)

    Arora, Natasha; Daley, George Q.

    2012-01-01

    Pluripotent stem cells (PSCs) hold great promise for research and treatment of hemoglobinopathies. In principle, patient-specific induced pluripotent stem cells could be derived from a blood sample, genetically corrected to repair the disease-causing mutation, differentiated into hematopoietic stem cells (HSCs), and returned to the patient to provide a cure through autologous gene and cell therapy. However, there are many challenges at each step of this complex treatment paradigm. Gene repair is currently inefficient in stem cells, but use of zinc finger nucleases and transcription activator-like effector nucleases appear to be a major advance. To date, no successful protocol exists for differentiating PSCs into definitive HSCs. PSCs can be directly differentiated into primitive red blood cells, but not yet in sufficient numbers to enable treating patients, and the cost of clinical scale differentiation is prohibitively expensive with current differentiation methods and efficiencies. Here we review the progress, promise, and remaining hurdles in realizing the potential of PSCs for cell therapy. PMID:22474618

  19. Nonverbal contention and contempt in U.K. parliamentary oversight hearings on fiscal and monetary policy.

    Science.gov (United States)

    Schonhardt-Bailey, Cheryl

    2017-01-01

    In parliamentary committee oversight hearings on fiscal policy, monetary policy, and financial stability, where verbal deliberation is the focus, nonverbal communication may be crucial in the acceptance or rejection of arguments proffered by policymakers. Systematic qualitative coding of these hearings in the 2010-15 U.K. Parliament finds the following: (1) facial expressions, particularly in the form of anger and contempt, are more prevalent in fiscal policy hearings, where backbench parliamentarians hold frontbench parliamentarians to account, than in monetary policy or financial stability hearings, where the witnesses being held to account are unelected policy experts; (2) comparing committees across chambers, hearings in the House of Lords committee yield more reassuring facial expressions relative to hearings in the House of Commons committee, suggesting a more relaxed and less adversarial context in the former; and (3) central bank witnesses appearing before both the Lords and Commons committees tend toward expressions of appeasement, suggesting a willingness to defer to Parliament.

  20. 2012 PLANT CELL WALLS GORDON RESEARCH CONFERENCE AND GORDON RESEARCH SEMINAR, AUGUST 4-10, 2012

    Energy Technology Data Exchange (ETDEWEB)

    Rose, Jocelyn

    2012-08-10

    The sub-theme of this year’s meeting, ‘Cell Wall Research in a Post-Genome World’, will be a consideration of the dramatic technological changes that have occurred in the three years since the previous cell wall Gordon Conference in the area of DNA sequencing. New technologies are providing additional perspectives of plant cell wall biology across a rapidly growing number of species, highlighting a myriad of architectures, compositions, and functions in both "conventional" and specialized cell walls. This meeting will focus on addressing the knowledge gaps and technical challenges raised by such diversity, as well as our need to understand the underlying processes for critical applications such as crop improvement and bioenergy resource development.

  1. Human cloning, stem cell research. An Islamic perspective.

    Science.gov (United States)

    Al-Aqeel, Aida I

    2009-12-01

    The rapidly changing technologies that involve human subjects raise complex ethical, legal, social, and religious issues. Recent advances in the field of cloning and stem cell research have introduced new hopes for the treatment of serious diseases. But this promise has raised many complex questions. This field causes debate and challenge, not only among scientists but also among ethicists, religious scholars, governments, and politicians. There is no consensus on the morality of human cloning, even within specific religious traditions. In countries in which religion has a strong influence on political decision making, the moral status of the human embryo is at the center of the debate. Because of the inevitable consequences of reproductive cloning, it is prohibited in Islam. However, stem cell research for therapeutic purposes is permissible with full consideration, and all possible precautions in the pre-ensoulment stages of early fetus development, if the source is legitimate.

  2. Research and experience report 2008. Developments in the technical and legal basis of nuclear oversight

    International Nuclear Information System (INIS)

    2009-04-01

    This annual report issued by the Swiss Federal Nuclear Inspectorate (ENSI) reviews research into regulatory safety and the work done during 2008. In the area of reactor safety, research - in addition to research into materials - was concentrated primarily on safety and reliability analyses. ENSI supports projects looking at ageing mechanisms such as fatigue, corrosion, embrittlement and the development of cracks under a range of environmental conditions. Topics such as the interaction between core meltdown and water and concrete as well as the development of methods and computer codes are covered. In the area of transport and waste management, ENSI is focussing its efforts on research into the geological strata suitable for the final storage of highly radioactive, long-lived waste. Human and organisational factors and safety culture now account for an increasing part of the work of this regulatory body. Appendices present an overview of work done, international activities, publications and the basic principles of the new ENSI guidelines

  3. New perspectives in human stem cell therapeutic research

    Directory of Open Access Journals (Sweden)

    Trounson Alan

    2009-06-01

    Full Text Available Abstract Human stem cells are in evaluation in clinical stem cell trials, primarily as autologous bone marrow studies, autologous and allogenic mesenchymal stem cell trials, and some allogenic neural stem cell transplantation projects. Safety and efficacy are being addressed for a number of disease state applications. There is considerable data supporting safety of bone marrow and mesenchymal stem cell transplants but the efficacy data are variable and of mixed benefit. Mechanisms of action of many of these cells are unknown and this raises the concern of unpredictable results in the future. Nevertheless there is considerable optimism that immune suppression and anti-inflammatory properties of mesenchymal stem cells will be of benefit for many conditions such as graft versus host disease, solid organ transplants and pulmonary fibrosis. Where bone marrow and mesenchymal stem cells are being studied for heart disease, stroke and other neurodegenerative disorders, again progress is mixed and mostly without significant benefit. However, correction of multiple sclerosis, at least in the short term is encouraging. Clinical trials on the use of embryonic stem cell derivatives for spinal injury and macular degeneration are beginning and a raft of other clinical trials can be expected soon, for example, the use of neural stem cells for killing inoperable glioma and embryonic stem cells for regenerating β islet cells for diabetes. The change in attitude to embryonic stem cell research with the incoming Obama administration heralds a new co-operative environment for study and evaluation of stem cell therapies. The Californian stem cell initiative (California Institute for Regenerative Medicine has engendered global collaboration for this new medicine that will now also be supported by the US Federal Government. The active participation of governments, academia, biotechnology, pharmaceutical companies, and private investment is a powerful consortium for

  4. Regulatory Oversight for New Projects - Challenges and Improvement in Regulation

    International Nuclear Information System (INIS)

    Lall, F.

    2016-01-01

    From inception, there has been rise in number of Nuclear Power Plants (NPP) even though very few accidents / events led to intermittent setbacks. However these accidents / events have posed challenges towards enhancement of safety and scope of regulation in all phases of NPP such as siting, design, construction, commissioning and decommissioning. It is essential to ensure compliance to these enhanced safety requirements during all phases of NPP. New and evolutionary reactors are under threshold for regulatory consideration world over. The variety of technologies and genres by themselves pose challenges to regulatory bodies. These challenges are to be addressed through systematic enhancement of the regulation including updating of regulatory documents. The paper touches upon some key elements to be considered towards such enhancement of regulation during all stages of NPP. These being; ensuring quality assurance, regulatory oversight especially over supply chain and contractors, counterfeit material specifically in case of international dealings, emergency handling in case of multi-unit site, feedback and associated enhancements from international events, construction experience database and feedback for safety enhancement, qualification and acceptance of first of a kind systems, regulatory enforcement specifically in case of imported reactors and maintaining interface between safety and security. Regulation in present context has become dynamic and Regulatory bodies need to continue enhancement of its current regulation taking into account the technological developments, feedback from construction, operation and accidents in the current fleet of plants. The paper touches upon some of these elements and highlights the challenges and improvements in regulation. (author)

  5. Present status of intermediate band solar cell research

    International Nuclear Information System (INIS)

    Cuadra, L.; Marti, A.; Luque, A.

    2004-01-01

    The intermediate band solar cell is a theoretical concept with the potential for exceeding the performance of conventional single-gap solar cells. This novel photovoltaic converter bases its superior theoretical efficiency over single-gap solar cells by enhancing its photogenerated current, via the two-step absorption of sub-band gap photons, without reducing its output voltage. This is achieved through a material with an electrically isolated and partially filled intermediate band located within a higher forbidden gap. This material is commonly named intermediate band material. This paper centres on summarising the present status of intermediate band solar cell research. A number of attempts, which aim to implement the intermediate band concept, are being followed: the direct engineering of the intermediate band material, its implementation by means of quantum dots and the highly porous material approach. Among other sub-band gap absorbing proposals, there is a renewed interest on the impurity photovoltaic effect, the quantum well solar cells and the particularly promising proposal for the use of up- and down-converters

  6. Building research capacity with members of underserved American Indian/Alaskan Native communities: training in research ethics and the protection of human subjects.

    Science.gov (United States)

    Jetter, Karen M; Yarborough, Mark; Cassady, Diana L; Styne, Dennis M

    2015-05-01

    To develop a research ethics training course for American Indian/Alaskan Native health clinic staff and community researchers who would be conducting human subjects research. Community-based participatory research methods were used in facilitated discussions of research ethics centered around topics included in the Collaborative Institutional Training Initiative research ethics course. The community-based participatory research approach allowed all partners to jointly develop a research ethics training program that was relevant for American Indian/Alaskan Native communities. All community and clinic partners were able to pass the Collaborative Institutional Training Initiative course they were required to pass so that they could be certified to conduct research with human subjects on federally funded projects. In addition, the training sessions provided a foundation for increased community oversight of research. By using a collaborative process to engage community partners in research ethics discussions, rather than either an asynchronous online or a lecture/presentation format, resulted in significant mutual learning about research ethics and community concerns about research. This approach requires university researchers to invest time in learning about the communities in which they will be working prior to the training. © 2014 Society for Public Health Education.

  7. Induced pluripotent stem cells in research and therapy of diseases: review article

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Noori Daloii

    2014-10-01

    Full Text Available Differentiated cells can change to embryonic stem cells by reprograming. Generation of induced pluripotent stem cells (iPSCs has revolutionized the field of regenerative and personalized medicine. iPSCs can self-renew and differentiate into many cell types. iPSC cells offer a potentially unlimited source for targeted differentiation. Through the expression of a set of transcription factors, iPSCs can be generated from different kinds of embryonic and adult cells. This technology for the first time enabled the researchers to take differentiated cells from an individual, and convert them to another cell type of interest, which is particularly to that person. When the set of master transcription factors containing OCT4, SOX2, KLF4, and MYC is expressed ectopically in somatic cells, the transcriptional network is propelled to organize itself in such a way as to maintenance a pluripotent state. Since iPSCs are similar to Embryonic Stem Cell (ESC, they can be considered as sources for modeling different diseases. iPSCs which are induced from somatic cells of patient can be useful for screening and drugs selection, and also introduce treatment via grafting the cells. Although this technology has been successful in different fields, the tumorigenesis of viral vectors during induction of reprogramming is a major challenge. Nevertheless, iPSCs are valuable for clinical applications and research. By discovery of these cells many challenges related to the safety, efficacy, and bioethics of ESCs are solved. Pluripotency is defined in two aspect of functional and molecular, by which functional regards the capacity of cell is generate three kinds of embryonic layers and germ line, and molecular aspect regards the identifying of molecules and genes that support functional features. Identification of these genes has been placed at the center of fields related to development and stem cell research. In this review, we discuss the process of generation of these

  8. Informed consent in research to improve the number and quality of deceased donor organs.

    Science.gov (United States)

    Rey, Michael M; Ware, Lorraine B; Matthay, Michael A; Bernard, Gordon R; McGuire, Amy L; Caplan, Arthur L; Halpern, Scott D

    2011-02-01

    Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research.

  9. Social Responsibility in Stem Cell Research - Is the News All Bad?

    Science.gov (United States)

    Benjaminy, Shelly; Lo, Cody; Illes, Judy

    2016-06-01

    Transparent public discourse about translational stem cell research promotes informed hope about scientific progress and the sustainable development of biotechnologies. Using an a priori coding scheme, we surveyed articles from leading news media about stem cell interventions for neurodegenerative diseases (1991-2014) from United States (n = 83), Canada (n = 29), and United Kingdom (n = 65). While, this analysis of translational contexts in the news demonstrates a lingering tendency to celebrate the benefits of research with little context of its caveats even for chronic neurologic diseases, in a departure from many previous studies, the data also reveal conscientious reporting about stem cell tourism and timeframe estimates for the development of relevant therapeutics.

  10. 2009 Plant Cell Walls Gordon Research Conference-August 2-7,2009

    Energy Technology Data Exchange (ETDEWEB)

    Mohnen, Debra [Univ. of Georgia, Athens, GA (United States)

    2009-08-07

    Plant cell walls are a complex cellular compartment essential for plant growth, development and response to biotic and abiotic stress and a major biological resource for meeting our future bioenergy and natural product needs. The goal of the 2009 Plant Cell Walls Gordon Research Conference is to summarize and critically evaluate the current level of understanding of the structure, synthesis and function of the whole plant extracellular matrix, including the polysaccharides, proteins, lignin and waxes that comprise the wall, and the enzymes and regulatory proteins that drive wall synthesis and modification. Innovative techniques to study how both primary and secondary wall polymers are formed and modified throughout plant growth will be emphasized, including rapid advances taking place in the use of anti-wall antibodies and carbohydrate binding proteins, comparative and evolutionary wall genomics, and the use of mutants and natural variants to understand and identify wall structure-function relationships. Discussions of essential research advances needed to push the field forward toward a systems biology approach will be highlighted. The meeting will include a commemorative lecture in honor of the career and accomplishments of the late Emeritus Professor Bruce A. Stone, a pioneer in wall research who contributed over 40 years of outstanding studies on plant cell wall structure, function, synthesis and remodeling including emphasis on plant cell wall beta-glucans and arabinogalactans. The dwindling supply of fossil fuels will not suffice to meet our future energy and industrial product needs. Plant biomass is the renewable resource that will fill a large part of the void left by vanishing fossil fuels. It is therefore critical that basic research scientists interact closely with industrial researchers to critically evaluate the current state of knowledge regarding how plant biomass, which is largely plant cell walls, is synthesized and utilized by the plant. A final

  11. Regulatory landscape for cell therapy--EU view.

    Science.gov (United States)

    McBlane, James W

    2015-09-01

    This article addresses regulation of cell therapies in the European Union (EU), covering cell sourcing and applications for clinical trials and marketing authorisation applications. Regulatory oversight of cell sourcing and review of applications for clinical trials with cell therapies are handled at national level, that is, separately with each country making its own decisions. For clinical trials, this can lead to different decisions in different countries for the same trial. A regulation is soon to come into force that will address this and introduce a more efficient clinical trial application process. However, at the marketing authorisation stage, the process is pan-national: the Committee for Human Medicinal Products (CHMP) is responsible for giving the final scientific opinion on all EU marketing authorisation applications for cell therapies: favourable scientific opinions are passed to the European Commission (EC) for further consultation and, if successful, grant of a marketing authorisation valid in all 28 EU countries. In its review of applications for marketing authorisations (MAAs) for cell therapies, the CHMP is obliged to consult the Committee for Advanced Therapies (CAT), who conduct detailed scientific assessments of these applications, with assessment by staff from national regulatory authorities and specialist advisors to the regulators. Copyright © 2015.

  12. [Mechanism research on the lupeol treatment on MCF-7 breast cancer cells based on cell metabonomics].

    Science.gov (United States)

    Shi, Dongdong; Kuang, Yuanyuan; Wang, Guiming; Peng, Zhangxiao; Wang, Yan; Yan, Chao

    2014-03-01

    The objective of this research is to investigate the suppressive effects of lupeol on MCF-7 breast cancer cells, and explore its mechanism on inhibiting the proliferation of MCF-7 cells based on cell metabonomics and cell cycle. Gas chromatography-mass spectrometry (GC-MS) was used in the cell metabonomics assay to identify metabolites of MCF-7 cells and MCF-7 cells treated with lupeol. Then, orthogonal partial least squares discriminant analysis (OPLS-DA) was used to process the metabolic data and model parameters of OPLS-DA were as follows: R2Ycum = 0.988, Q2Ycum = 0.964, which indicated that these two groups could be distinguished clearly. The metabolites (VIP (variable importance in the projection) > 1) were analyzed by t-test, and finally, metabolites (t metabonomics.

  13. Challenges in Exploratory Methods for Tuberculosis Research in South Africa.

    Science.gov (United States)

    Macdonald, Helen; Abney, Kate; Abrams, Amber; Truyts, Carina

    2016-07-01

    Haunted by a legacy of apartheid governance that left millions in material poverty, South Africa has among the highest tuberculosis (TB) morbidity and mortality rates in the world. Our Social Markers of TB research project shared a vision of working with ethnographic research methods to understand TB-infected persons, their families, care providers, and social networks. We argue that felt and enacted TB stigma and the related HIV-TB stigma impaired our ability to collect the necessary data for a full portrait of TB-infected persons and their lived conditions. To circumvent this limitation, each researcher improvised and augmented conventional anthropological methods with more creative, directed, and at times destabilizing methods. We present three case studies as useful illustrations of the complexities and challenges we encountered in our attempts to conduct ethically sound TB research. We discuss the implications of our call for "improvisation" for the politics of research and ethical oversight. © The Author(s) 2015.

  14. Paramagnetic particles carried by cell-penetrating peptide tracking of bone marrow mesenchymal stem cells, a research in vitro

    International Nuclear Information System (INIS)

    Liu Min; Guo Youmin; Wu Qifei; Yang Junle; Wang Peng; Wang Sicen; Guo Xiaojuan; Qiang Yongqian; Duan Xiaoyi

    2006-01-01

    The ability to track the distribution and differentiation of stem cells by high-resolution imaging techniques would have significant clinical and research implications. In this study, a model cell-penetrating peptide was used to carry gadolinium particles for magnetic resonance imaging of the mesenchymal stem cells. The mesenchymal stem cells were isolated from rat bone marrow by Percoll and identified by osteogenic differentiation in vitro. The cell-penetrating peptides labeled with fluorescein-5-isothiocyanate and gadolinium were synthesized by a solid-phase peptide synthesis method and the relaxivity of cell-penetrating peptide-gadolinium paramagnetic conjugate on 400 MHz nuclear magnetic resonance was 5.7311 ± 0.0122 mmol -1 s -1 , higher than that of diethylenetriamine pentaacetic acid gadolinium (p < 0.05). Fluorescein imaging confirmed that this new peptide could internalize into the cytoplasm and nucleus. Gadolinium was efficiently internalized into mesenchymal stem cells by the peptide in a time- or concentration-dependent fashion, resulting in intercellular T1 relaxation enhancement, which was obviously detected by 1.5 T magnetic resonance imaging. Cytotoxicity assay and flow cytometric analysis showed the intercellular contrast medium incorporation did not affect cell viability and membrane potential gradient. The research in vitro suggests that the newly constructed peptides could be a vector for tracking mesenchymal stem cells

  15. Cell phone use among homeless youth: potential for new health interventions and research.

    Science.gov (United States)

    Rice, Eric; Lee, Alex; Taitt, Sean

    2011-12-01

    Cell phone use has become nearly ubiquitous among adolescents in the United States. Despite the potential for cell phones to facilitate intervention, research, and care for homeless youth, no data exists to date on cell phone use among this population. In 2009, a survey of cell phone use was conducted among a non-probability sample of 169 homeless youth in Los Angeles, CA. Levels of ownership and use, instrumental uses (connecting to case workers, employers) and patterns of connecting to various network types were assessed (family, home-based peers, street-based peers). Differences in socio-demographic characteristics and cell phone ownership were assessed via t test and chi-square statistics. Sixty-two percent of homeless youth own a cell phone; 40% have a working phone. Seventeen percent used their phone to call a case manager, 36% to call either a potential or current employer. Fifty-one percent of youth connected with home-based peers on the phone and 41% connected to parents. Cell phones present new opportunities for intervention research, connecting homeless youth to family and home-based peers who can be sources of social support in times of need. Moreover, cell phones provide researchers and providers with new avenues to maintain connections with these highly transient youth.

  16. Canadian governance of health research involving human subjects: is anybody minding the store?

    Science.gov (United States)

    McDonald, M

    2001-01-01

    From an ethical perspective, good governance involves the translation of collective moral intentions into effective and accountable institutional actions. With respect to the use of human subjects in Canadian health research, I contend that there have been many good intentions but very little in the way of appropriate governance arrangements. Hence, the question, "who minds the store?" is especially acute with respect to the protection of vulnerable individuals and groups that are typically recruited as subjects for health research in Canada. Beyond diagnosing failures in governance and their causes, I offer suggestions for significant reforms, including evidence-based ethics assessment, independent oversight, and greater participation of research subjects in governance. I will close with some more general reflections on ethics, law, and governance.

  17. Board of Governors | IDRC - International Development Research ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    2010-11-02

    Nov 2, 2010 ... ... direction;; review and approve the Centre's budget and financial statements; ... Chairman, Accounting Standards and Oversight Council, Canadian ... Kingston, Jamaica (appointed May 29, 2009) Principal, University of the ...

  18. Contributions of 3D Cell Cultures for Cancer Research.

    Science.gov (United States)

    Ravi, Maddaly; Ramesh, Aarthi; Pattabhi, Aishwarya

    2017-10-01

    Cancer cell lines have contributed immensely in understanding the complex physiology of cancers. They are excellent material for studies as they offer homogenous samples without individual variations and can be utilised with ease and flexibility. Also, the number of assays and end-points one can study is almost limitless; with the advantage of improvising, modifying or altering several variables and methods. Literally, a new dimension to cancer research has been achieved by the advent of 3Dimensional (3D) cell culture techniques. This approach increased many folds the ways in which cancer cell lines can be utilised for understanding complex cancer biology. 3D cell culture techniques are now the preferred way of using cancer cell lines to bridge the gap between the 'absolute in vitro' and 'true in vivo'. The aspects of cancer biology that 3D cell culture systems have contributed include morphology, microenvironment, gene and protein expression, invasion/migration/metastasis, angiogenesis, tumour metabolism and drug discovery, testing chemotherapeutic agents, adaptive responses and cancer stem cells. We present here, a comprehensive review on the applications of 3D cell culture systems for these aspects of cancers. J. Cell. Physiol. 232: 2679-2697, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  19. US DOE-EM On-Site Disposal Cell Working Group - Fostering Communication On Performance Assessment Challenges

    Energy Technology Data Exchange (ETDEWEB)

    Seitz, Roger R. [Savannah River Site (SRS), Aiken, SC (United States); Suttora, Linda C. [U.S. Department of Energy, Office of Site Restoration, Germantown, MD (United States); Phifer, Mark [Savannah River Site (SRS), Aiken, SC (United States)

    2014-03-01

    On-site disposal cells are in use and being considered at several U.S. Department of Energy (USDOE) sites as the final disposition for large amounts of waste associated with cleanup of contaminated areas and facilities. These facilities are typically developed with regulatory oversight from States and/or the US Environmental Protection Agency (USEPA) in addition to USDOE. The facilities are developed to meet design standards for disposal of hazardous waste as well as the USDOE performance based standards for disposal of radioactive waste. The involvement of multiple and different regulators for facilities across separate sites has resulted in some differences in expectations for performance assessments and risk assessments (PA/RA) that are developed for the disposal facilities. The USDOE-EM Office of Site Restoration formed a working group to foster improved communication and sharing of information for personnel associated with these Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) disposal cells and work towards more consistent assumptions, as appropriate, for technical and policy considerations related to performance and risk assessments in support of a Record of Decision and Disposal Authorization Statement. The working group holds teleconferences, as needed, focusing on specific topics of interest. The topics addressed to date include an assessment of the assumptions used for performance assessments and risk assessments (PA/RAs) for on-site disposal cells, requirements and assumptions related to assessment of inadvertent intrusion, DOE Manual 435.1-1 requirements, and approaches for consideration of the long-term performance of liners and covers in the context of PAs. The working group has improved communication among the staff and oversight personnel responsible for onsite disposal cells and has provided a forum to identify and resolve common concerns.

  20. How to do human-subjects research if you do not have an institutional review board.

    Science.gov (United States)

    Rice, Todd W

    2008-10-01

    Biomedical research with human subjects has expanded outside of traditional medical centers and hospitals into other health care entities, such as rehabilitation facilities, free-standing out-patient treatment centers, and even home-health agencies. Regardless of the location, federal regulations mandate that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee to ensure the research abide by the Code of Federal Regulations. Consequently, all human-subjects research must be reviewed and approved by an IRB prior to initiation of any research procedures. Unfortunately, many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt from federal oversight. Clinicians at these facilities have viable options for obtaining IRB approval and legally conducting such research. This paper outlines the available options and their pros and cons.

  1. Application of ac impedance in fuel cell research and development

    Energy Technology Data Exchange (ETDEWEB)

    Selman, J R; Lin, Y P [Illinois Inst. of Tech., Chicago, IL (United States). Dept. of Chemical Engineering

    1993-10-01

    In applying ac impedance to fuel cells and their porous (gas diffusion) electrodes the emphasis lies on different fuel cell components, and their properties, according to the fuel cell type. The focus has been directed at the electrode/electrolyte interface in MCFC and PAFC, whereas in SOFC and PEMFC the ionic/electronic conductivity of the electrolyte or the characteristics of its composite with the electrocatalyst is of primary interest. The limitations of ac impedance in fuel cell application are in part due to difficulties of interpretation and in part due to experimental difficulties because of the generally fast electrode reaction kinetics. Further research directions are indicated. (author)

  2. PS3 CELL Development for Scientific Computation and Research

    Science.gov (United States)

    Christiansen, M.; Sevre, E.; Wang, S. M.; Yuen, D. A.; Liu, S.; Lyness, M. D.; Broten, M.

    2007-12-01

    The Cell processor is one of the most powerful processors on the market, and researchers in the earth sciences may find its parallel architecture to be very useful. A cell processor, with 7 cores, can easily be obtained for experimentation by purchasing a PlayStation 3 (PS3) and installing linux and the IBM SDK. Each core of the PS3 is capable of 25 GFLOPS giving a potential limit of 150 GFLOPS when using all 6 SPUs (synergistic processing units) by using vectorized algorithms. We have used the Cell's computational power to create a program which takes simulated tsunami datasets, parses them, and returns a colorized height field image using ray casting techniques. As expected, the time required to create an image is inversely proportional to the number of SPUs used. We believe that this trend will continue when multiple PS3s are chained using OpenMP functionality and are in the process of researching this. By using the Cell to visualize tsunami data, we have found that its greatest feature is its power. This fact entwines well with the needs of the scientific community where the limiting factor is time. Any algorithm, such as the heat equation, that can be subdivided into multiple parts can take advantage of the PS3 Cell's ability to split the computations across the 6 SPUs reducing required run time by one sixth. Further vectorization of the code can allow for 4 simultanious floating point operations by using the SIMD (single instruction multiple data) capabilities of the SPU increasing efficiency 24 times.

  3. Clinical perspectives of cancer stem cell research in radiation oncology

    International Nuclear Information System (INIS)

    Bütof, Rebecca; Baumann, Michael; Dubrovska, Anna

    2013-01-01

    Radiotherapy has a proven potential to eradicate cancer stem cells which is reflected by its curative potential in many cancer types. Considerable progress has been made in identification and biological characterisation of cancer stem cells during the past years. Recent biological findings indicate significant inter- and intratumoural and functional heterogeneity of cancer stem cells and lead to more complex models which have potential implications for radiobiology and radiotherapy. Clinical evidence is emerging that biomarkers of cancer stem cells may be prognostic for the outcome of radiotherapy in some tumour entities. Perspectives of cancer stem cell based research for radiotherapy reviewed here include their radioresistance compared to the mass of non-cancer stem cells which form the bulk of all tumour cells, implications for image- and non-image based predictive bio-assays of the outcome of radiotherapy and a combination of novel systemic treatments with radiotherapy

  4. Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations.

    Science.gov (United States)

    Rosemann, Achim; Bortz, Gabriela; Vasen, Federico; Sleeboom-Faulkner, Margaret

    2016-10-01

    In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.

  5. Concise review: carbon nanotechnology: perspectives in stem cell research.

    Science.gov (United States)

    Pryzhkova, Marina V

    2013-05-01

    Carbon nanotechnology has developed rapidly during the last decade, and carbon allotropes, especially graphene and carbon nanotubes, have already found a wide variety of applications in industry, high-tech fields, biomedicine, and basic science. Electroconductive nanomaterials have attracted great attention from tissue engineers in the design of remotely controlled cell-substrate interfaces. Carbon nanoconstructs are also under extensive investigation by clinical scientists as potential agents in anticancer therapies. Despite the recent progress in human pluripotent stem cell research, only a few attempts to use carbon nanotechnology in the stem cell field have been reported. However, acquired experience with and knowledge of carbon nanomaterials may be efficiently used in the development of future personalized medicine and in tissue engineering.

  6. Preventing Teen Pregnancy: Coordinating Community Efforts. Hearing before the Subcommittee on Human Resources and Intergovernmental Relations of the Committee on Government Reform and Oversight. House of Representatives, One Hundred Fourth Congress, Second Session.

    Science.gov (United States)

    Congress of the U.S., Washington, DC. House Committee on Government Reform and Oversight.

    The Subcommittee on Human Resources and Intergovernmental Relations of the House of Representatives Committee on Government Reform and Oversight met to consider the causes of and solutions to teen pregnancy and the role of community organizations in prevention efforts. Opening remarks by Representative Christopher Shays were followed by statements…

  7. The contribution of human/non-human animal chimeras to stem cell research

    Directory of Open Access Journals (Sweden)

    Sonya Levine

    2017-10-01

    Full Text Available Chimeric animals are made up of cells from two separate zygotes. Human/non-human animal chimeras have been used for a number of research purposes, including human disease modeling. Pluripotent stem cell (PSC research has relied upon the chimera approach to examine the developmental potential of stem cells, to determine the efficacy of cell replacement therapies, and to establish a means of producing human organs. Based on ethical issues, this work has faced pushback from various sources including funding agencies. We discuss here the essential role these studies have played, from gaining a better understanding of human biology to providing a stepping stone to human disease treatments. We also consider the major ethical issues, as well as the current status of support for this work in the United States.

  8. Patently controversial: markets, morals, and the President's proposal for embryonic stem cell research.

    Science.gov (United States)

    Fins, Joseph J; Schachter, Madeleine

    2002-09-01

    This essay considers the implications of President George W. Bush's proposal for human embryonic stem cell research. Through the perspective of patent law, privacy, and informed consent, we elucidate the ongoing controversy about the moral standing of human embryonic stem cells and their derivatives and consider how the inconsistencies in the president's proposal will affect clinical practice and research.

  9. Human Pluripotent Stem Cell-Derived Cardiomyocytes as Research and Therapeutic Tools

    Directory of Open Access Journals (Sweden)

    Ivana Acimovic

    2014-01-01

    Full Text Available Human pluripotent stem cells (hPSCs, namely, embryonic stem cells (ESCs and induced pluripotent stem cells (iPSCs, with their ability of indefinite self-renewal and capability to differentiate into cell types derivatives of all three germ layers, represent a powerful research tool in developmental biology, for drug screening, disease modelling, and potentially cell replacement therapy. Efficient differentiation protocols that would result in the cell type of our interest are needed for maximal exploitation of these cells. In the present work, we aim at focusing on the protocols for differentiation of hPSCs into functional cardiomyocytes in vitro as well as achievements in the heart disease modelling and drug testing on the patient-specific iPSC-derived cardiomyocytes (iPSC-CMs.

  10. Research and Recovery of Snake River Sockeye Salmon, 1992 Annual Report.

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Keith A.

    1993-05-01

    Significant changes were made in the fish rearing facilities at the Idaho Department of Fish and Game`s (IDFG) Eagle Hatchery during the contract period. Rearing and develop sampling protocols for genetics and pathology were developed. The rearing protocol was derived with assistance of the Technical Oversight Committee, the scientific advisory group, and several fish culturists and nutritionists who were consulted informally. The standards were incorporated into the Research and Propagation Permit from National Marine Fisheries Service was applied for during this project period. Pathology and genetics samples have been taken and processed from each fish which died during the rearing phase.

  11. Research Progress of Photoanodes for Quantum Dot Sensitized Solar Cells

    Directory of Open Access Journals (Sweden)

    LI Zhi-min

    2017-08-01

    Full Text Available This paper presents the development status and tendency of quantum dot sensitized solar cells. Photoanode research progress and its related technologies are analyzed in detail from the three ways of semiconductor thin films, quantum dot co-sensitization and quantum dot doping, deriving from the approach that the conversion efficiency can be improved by photoanode modification for quantum dot sensitized solar cells. According to the key factors which restrict the cell efficiency, the promising future development of quantum dot sensitized solar cells is proposed,for example,optimizing further the compositions and structures of semiconductor thin films for the photoanodes, exploring new quantum dots with broadband absorption and developing high efficient techniques of interface modification.

  12. Stem cell research and therapies in Argentina: the legal and regulatory approach.

    Science.gov (United States)

    de Arzuaga, Fabiana C

    2013-12-01

    Argentina has a significant number of researchers in public and private institutions conducting research in regenerative medicine and stem cells. There is not specific legislation in this area; however, the National Ministry of Health has issued regulations under the scope of the Transplant Act and the Medicines Act. Alongside the groups doing research, it is possible to find professionals offering experimental stem cell therapies to patients. These professionals take refuge in the term "medical practice" and sell experimental treatment to patients with no guarantee of safety and security given that they were not tested in clinical research. These practices offered to patients in a scheme, apparently legal, are generating an important number of judicial actions requesting the payment of said treatments. The decisions of the courts ordering payment in most cases are generating a transfer of funds from patients, social welfare systems, and the state to medical centers offering stem cell experimental therapies. This article describes the current regulations as well as the course of action to solve the emerging problems of these new technologies at legislative level.

  13. Cost Effective Polymer Solar Cells Research and Education

    Energy Technology Data Exchange (ETDEWEB)

    Sun, Sam-Shajing [Norfolk State Univ, Norfolk, VA (United States)

    2015-10-13

    The technical or research objective of this project is to investigate and develop new polymers and polymer based optoelectronic devices for potentially cost effective (or cost competitive), durable, lightweight, flexible, and high efficiency solar energy conversion applications. The educational objective of this project includes training of future generation scientists, particularly young, under-represented minority scientists, working in the areas related to the emerging organic/polymer based solar energy technologies and related optoelectronic devices. Graduate and undergraduate students will be directly involved in scientific research addressing issues related to the development of polymer based solar cell technology.

  14. Research and experience report 2007. Developments in the technical and legal basis of nuclear oversight

    International Nuclear Information System (INIS)

    2008-01-01

    This annual report issued by the Swiss Federal Nuclear Inspectorate (HSK) reviews the aims, duties and responsibilities of the inspectorate and the work done during 2007. In the area of reactor safety, the research covered materials and the deterministic and probabilistic analysis of incidents and their consequences. In the area of radiation protection, the protection of persons and the environment in the vicinity of nuclear facilities from ionising radiation is addressed. In this area, accurate metrology and research to improve dosimetry and radiation analysis is discussed. In the area of transport and waste management, the HSK is focussing its efforts on research into the geological strata suitable for the final storage of highly radioactive, long-lived waste. Human factors, organisation and safety culture are quoted as playing a major role in nuclear safety. According to the report, greater attention is being given to these factors by those bodies responsible for nuclear regulation. Appendices present an overview of work done, international activities and publications along with the ENSI's guidelines

  15. Benefiting from 'evil': an incipient moral problem in human stem cell research.

    Science.gov (United States)

    Green, Ronald M

    2002-11-01

    When does benefiting from others' wrongdoing effectively make one a moral accomplice in their evil deeds? If stem cell research lives up to its therapeutic promise, this question (which has previously cropped up in debates over fetal tissue research or the use of Nazi research data) is likely to become a central one for opponents of embryo destruction. I argue that benefiting from wrongdoing is prima facie morally wrong under any of three conditions: (1) when the wrongdoing is one's agent; (2) when acceptance of benefit directly encourages the repetition of the wrongful deed (even though no agency relationship is involved); and (3) when acceptance of a benefit legitimates a wrongful practice. I conclude by showing that, because of the ways in which most embryonic stem cell lines come into being, people who oppose embryo destruction may use human embryonic stem cells without incurring moral blame.

  16. Research and experience report 2009. Developments in the technical and legal basis of nuclear oversight

    International Nuclear Information System (INIS)

    2010-04-01

    In terms of research into regulatory safety, ENSI awards and coordinates research projects designed to develop current scientific knowledge and expertise and to make the results available to the regulatory process. ENSI currently supports research in four different areas: Reactor Safety; Radiological Protection; Transport and Waste Management; and Human Influence, Organisation and Safety Culture. Research in reactor safety focuses on materials research of relevance to the monitoring of ageing mechanisms such as fatigue, corrosion, embrittlement and the development of cracks, together with research into incidents and accidents and their relevance to improvements in safety analyses. It investigates issues such as the interaction between core meltdown and water and concrete, as well as the development of methodologies and software. In addition, ENSI is a partner in a range of international database projects giving it access to information on the causes, frequency and characteristics of individual incidents. The aim of radiological protection is to protect personnel, local people and the environment in the vicinity of nuclear facilities from ionising radiation. ENSI supports research into dosimetry and radio analysis. Another area of particular importance is research designed to improve the methodologies used to monitor the release of radioactive materials into the environment. In the area of transport and waste management, ENSI investigates the suitability of geological strata for the deep storage of radioactive waste. Experiments are being conducted at the Mont Terri Rock Laboratory into the geological, hydro-geological, geochemical and rock-mechanical properties of the Opalinus clay. ENSI is supporting an experiment designed to characterise the fracture generation in the excavation damage zone of a gallery triggered by stress changes in the surrounding rock. The research is also looking at the chemical reactions occurring in a deep repository, together with the

  17. Expand and Regularize Federal Funding for Human Pluripotent Stem Cell Research

    Science.gov (United States)

    Owen-Smith, Jason; Scott, Christopher Thomas; McCormick, Jennifer B.

    2012-01-01

    Human embryonic stem cell (hESC) research has sparked incredible scientific and public excitement, as well as significant controversy. hESCs are pluripotent, which means, in theory, that they can be differentiated into any type of cell found in the human body. Thus, they evoke great enthusiasm about potential clinical applications. They are…

  18. The contribution of human/non-human animal chimeras to stem cell research.

    Science.gov (United States)

    Levine, Sonya; Grabel, Laura

    2017-10-01

    Chimeric animals are made up of cells from two separate zygotes. Human/non-human animal chimeras have been used for a number of research purposes, including human disease modeling. Pluripotent stem cell (PSC) research has relied upon the chimera approach to examine the developmental potential of stem cells, to determine the efficacy of cell replacement therapies, and to establish a means of producing human organs. Based on ethical issues, this work has faced pushback from various sources including funding agencies. We discuss here the essential role these studies have played, from gaining a better understanding of human biology to providing a stepping stone to human disease treatments. We also consider the major ethical issues, as well as the current status of support for this work in the United States. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  19. Setting global standards for stem cell research and clinical translation : The 2016 ISSCR guidelines

    NARCIS (Netherlands)

    Daley, George Q.; Hyun, Insoo; Apperley, Jane F.; Barker, Roger A.; Benvenisty, Nissim; Bredenoord, Annelien L.; Breuer, Christopher K.; Caulfield, Timothy; Cedars, Marcelle I.; Frey-Vasconcells, Joyce; Heslop, Helen E.; Jin, Ying; Lee, Richard T.; McCabe, Christopher; Munsie, Megan; Murry, Charles E.; Piantadosi, Steven; Rao, Mahendra; Rooke, Heather M.; Sipp, Douglas; Studer, Lorenz; Sugarman, Jeremy; Takahashi, Masayo; Zimmerman, Mark; Kimmelman, Jonathan

    2016-01-01

    The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of

  20. Research Data Curation Pilots: Lessons Learned

    Directory of Open Access Journals (Sweden)

    David Minor

    2014-07-01

    Full Text Available In the spring of 2011, the UC San Diego Research Cyberinfrastructure (RCI Implementation Team invited researchers and research teams to participate in a research curation and data management pilot program. This invitation took the form of a campus-wide solicitation. More than two dozen applications were received and, after due deliberation, the RCI Oversight Committee selected five curation-intensive projects. These projects were chosen based on a number of criteria, including how they represented campus research, varieties of topics, researcher engagement, and the various services required. The pilot process began in September 2011, and will be completed in early 2014. Extensive lessons learned from the pilots are being compiled and are being used in the on-going design and implementation of the permanent Research Data Curation Program in the UC San Diego Library. In this paper, we present specific implementation details of these various services, as well as lessons learned. The program focused on many aspects of contemporary scholarship, including data creation and storage, description and metadata creation, citation and publication, and long term preservation and access. Based on the lessons learned in our processes, the Research Data Curation Program will provide a suite of services from which campus users can pick and choose, as necessary. The program will provide support for the data management requirements from national funding agencies.

  1. A supporting role of Chinese National Immortalized Cell Bank in life science research.

    Science.gov (United States)

    Xu, Chong-feng; Duan, Zi-yuan

    2017-01-20

    A biorepository of human samples is essential to support the research of life science. Lymphoblastoid B cell line (LCL), which is easy to be prepared and can reproduce indefinitely, is a convenient form of sample preservation. LCLs are established from human B cells transformed by Epstein-Barr virus (EBV). Chinese National Immortalized Cell Bank has preserved human LCLs from different ethnic groups in China. As there are many studies on the nature of LCLs and public available resources with genome-wide data for LCLs, they have been widely applied in genetics, immunology, pharmacogenetics/genomics, regenerative medicine, cancer pathogenesis and immunotherapy, screening and generation of fully human neutralizing monoclonal antibodies and study on EBV pathogenesis. Here, we review the characteristics of LCLs and their contributions to scientific research, and introduce preserved samples in Chinese National Immortalized Cell Bank to the scientific community. We hope this bank can support more areas in the scientific research.

  2. Plant cell engineering: current research, application and future prospects

    International Nuclear Information System (INIS)

    Wang Xunqing; Liu Luxiang

    2008-01-01

    This paper reviewed the current status of basic research in plant cell engineering, highlighted the application of embryo culture, double haploid (DH) technology, protoplast culture and somatic hybridization, somaclonal variation, rapid propagation, and bio-products production of plant-origin, and t he prospects. (authors)

  3. Electrical research on solar cells and photovoltaic materials

    Science.gov (United States)

    Orehotsky, J.

    1985-01-01

    A systematic study of the properties of various polymer pottant materials and of the electrochemical corrosion mechanisms in solar cell materials is required for advancing the technology of terrestrial photovoltaic modules. The items of specific concern in this sponsored research activity involve: (1) kinetics of plasticizer loss in PVB, (2) kinetics of water absorption and desorption in PVB, (3) kinetics of water absorption and desorption in EVA, (4) the electrical properties at PVB as a function of temperature and humidity, (5) the electrical properties of EVA as a function of temperature and humidity, (6) solar cell corrosion characteristics, (7) water absorption effects in PVB and EVA, and (8) ion implantation and radiation effects in PVB and EVA.

  4. Research and experience report 2012. Developments in the technical and legal basis of nuclear oversight

    International Nuclear Information System (INIS)

    2013-04-01

    The Swiss Federal Nuclear Safety Inspectorate (ENSI) acts upon the basis of the latest developments in science and technology. ENSI supports and coordinates safety research, the results of which influence directly its Guidelines, individual decisions and resources. Research projects also serve training purposes and maintain competence within ENSI and its experts. The research in fuels and materials covers the reactor core and the graded approach to barriers used for the confinement of radioactive materials. Based on test results from accidents involving a loss of coolant ENSI instructed the operators of Swiss nuclear power plants to review whether they were relevant to their own facilities. Ageing mechanisms affecting structural materials are crucial to the long-term operation of nuclear power plants. Specialised thematic databases are being created in order to facilitate a systematic analysis of relevant operating experience from numerous countries. In addition to damage that may result from events within nuclear power plants, the safety analyses also reflect external events. ENSI supports international projects conducting complex experiments and simulations of aircraft accidents and earthquakes. It is involved in some projects relating to flood risks. The effect of operator behaviour on accidents in nuclear power plants is the focus point of research into human factors which identifies and analyses certain operator errors influencing negatively the course of an accident. Proposals to improve accident procedures were developed. This research area also focuses on the influence of the control room layout on the performance of operating staff. System behaviour and accident sequences in nuclear power plants are analysed in conditions ranging from normal operations through to accidents resulting in core melt-down. The results are used for the quantitative evaluation of the plant risk in probabilistic safety analyses. Applied research in radiological protection ranges

  5. The use of radiochemical techniques in fuel cell research

    International Nuclear Information System (INIS)

    Meier, H.

    1975-01-01

    The utilization of metal chelates as catalysts in fuel cell research gives rise to special problems which cannot be solved by the usual methods, but may be well clarified by isotope technical methods. The electrocatalytic efficiency of polymer iron phthalocyanine (on carbon carriers) can be proved by the plotting of potential-current density curves. Two questions, however, remain unanswered: a) What is the solubility behaviour of the catalyst, and b) is there an additional stabilizing interaction between the metal chelate catalyst and the carbon electrode. To answer the first question, the iron phthalocyanine was labelled with Fe-59 and the dissolving time of the complexed Fe ions measured; the results were compared with the potential time behaviour of the oxygen cathodes. To check the interactions between phthalocyamine catalysts and carbon carrier, Moessbauer spectroscopy was used. The evidence obtained suggest the application of isotope technical methods to an ever greater extent than up to now in fuel cell and battery research. (RB/LH) [de

  6. Stem Cell Research: A Novel Boulevard towards Improved Bovine Mastitis Management

    Science.gov (United States)

    Sharma, Neelesh; Jeong, Dong Kee

    2013-01-01

    The dairy industry is a multi-billion dollar industry catering the nutritional needs of all age groups globally through the supply of milk. Clinical mastitis has a severe impact on udder tissue and is also an animal welfare issue. Moreover, it significantly reduces animal value and milk production. Mammary tissue damage reduces the number and activity of epithelial cells and consequently contributes to decreased milk production. The high incidence, low cure rate of this highly economic and sometimes deadly disease is an alarming for dairy sector as well as policy makers. Bovine mammary epithelial cells (MECs) and their stem cells are very important in milk production and bioengineering. The adult mammary epithelium consists of two main cell types; an inner layer of luminal epithelial cells, which produce the milk during lactation, and an outer layer of myoepithelial cells resting on a basement membrane, which are responsible for pushing the milk through the ductal network to the teat cistern. Inner layer of columner/luminal cells of bovine MECs, is characterized by cytokeratin18, 19 (CK18, CK19) and outer layer such as myoepithelial cells which are characterized by CK14, α-smooth muscle actin (α-SMA) and p63. Much work has been done in mouse and human, on mammary gland stem cell research, particularly in cancer therapy, but stem cell research in bovine is still in its infancy. Such stem/progenitor cell discoveries in human and mouse mammary gland bring some hope for application in bovines. These progenitors may be therapeutically adopted to correct the structural/cytological defects in the bovine udder due to mastitis. In the present review we focused on various kinds of stem/progenitor cells which can have therapeutic utility and their possibilities to use as a potential stem cell therapy in the management of bovine post-mastitis damage in orders to restore milk production. The possibilities of bovine mammary stem cell therapy offers significant potential for

  7. Congressional hearing reviews NSF major research and facilities projects

    Science.gov (United States)

    Showstack, Randy

    2012-03-01

    An 8 March congressional hearing about the U.S. National Science Foundation's Major Research Equipment and Facilities Construction (NSF MREFC) account focused on fiscal management and accountability of projects in that account and reviewed concerns raised by NSF's Office of Inspector General (OIG). NSF established the MREFC account in 1995 to better plan and manage investments in major equipment and facilities projects, which can cost from tens of millions to hundreds of millions of dollars, and the foundation has funded 17 MREFC projects since then. The Obama administration's proposed fiscal year (FY) 2013 budget includes funding for four MREFC projects: Advanced Laser Gravitational-Wave Observatory (AdvLIGO), Advanced Technology Solar Telescope (ATST), National Ecological Observatory (NEON), and Ocean Observatories Initiative (OOI). The hearing, held by a subcommittee of the House of Representatives' Committee on Science, Space, and Technology, reviewed management oversight throughout the life cycles of MREFC projects and concerns raised in recent OIG reports about the use of budget contingency funds. NSF's February 2012 manual called "Risk management guide for large facilities" states that cost contingency is "that portion of the project budget required to cover `known unknowns,'" such as planning and estimating errors and omissions, minor labor or material price fluctuations, and design developments and changes within the project scope. Committee members acknowledged measures that NSF has made to improve the MREFC oversight process, but they also urged the agency to continue to take steps to ensure better project management.

  8. Single cell biology beyond the era of antibodies: relevance, challenges, and promises in biomedical research.

    Science.gov (United States)

    Abraham, Parvin; Maliekal, Tessy Thomas

    2017-04-01

    Research of the past two decades has proved the relevance of single cell biology in basic research and translational medicine. Successful detection and isolation of specific subsets is the key to understand their functional heterogeneity. Antibodies are conventionally used for this purpose, but their relevance in certain contexts is limited. In this review, we discuss some of these contexts, posing bottle neck for different fields of biology including biomedical research. With the advancement of chemistry, several methods have been introduced to overcome these problems. Even though microfluidics and microraft array are newer techniques exploited for single cell biology, fluorescence-activated cell sorting (FACS) remains the gold standard technique for isolation of cells for many biomedical applications, like stem cell therapy. Here, we present a comprehensive and comparative account of some of the probes that are useful in FACS. Further, we illustrate how these techniques could be applied in biomedical research. It is postulated that intracellular molecular markers like nucleostemin (GNL3), alkaline phosphatase (ALPL) and HIRA can be used for improving the outcome of cardiac as well as bone regeneration. Another field that could utilize intracellular markers is diagnostics, and we propose the use of specific peptide nucleic acid probes (PNPs) against certain miRNAs for cancer surgical margin prediction. The newer techniques for single cell biology, based on intracellular molecules, will immensely enhance the repertoire of possible markers for the isolation of cell types useful in biomedical research.

  9. [SONG's theory on mast cells and meridian-acupoint and its research prospect].

    Science.gov (United States)

    Li, Yongming

    2016-10-12

    The historical origin of researches regarding acupuncture and mast cells (MCs) is reviewed, and the hypothesis that dermal MCs might be correlated with the acupuncture phenomena proposed by SONG Jimei in 1977 is introduced. This hypothesis, for the first time, suggests MCs could be the cellular basis of meridian sensation and arrival of qi ( deqi ) of acupoints. With independent tests of several research institutes, currently sufficient evidences prove the scientific values of SONG 's theory as well as its potential values for the basic research and clinical practice of acupuncture. It is reported recently that MCs might receive signals from central nerve system and acupoint stimulation, showing cross-talk effects, therefore, MCs can be sensitized at acupoints. In this paper, with a review of 40-year research evidence, 15 biological characteristics regarding mast cells and acupuncture phenomena are identified, in the meanwhile, 10 key questions and research direction, including the distribution of MCs in skin and its general relationship with meridian-acupoint, etc. are proposed.

  10. [Breakthrough in research on pluripotent stem cells and their application in medicine].

    Science.gov (United States)

    Valdimarsdóttir, Guðrún; Richter, Anne

    2015-12-01

    Embryonic stem cells are, as the name indicates, isolated from embryos. They are pluripotent cells which can be maintained undifferentiated or induced to differentiate into any cell type of the body. In 1998 the first isolation of human embryonic stem cells was successful and they became an interesting source for stem cell regenerative medicine. Only 8 years later pluripotent stem cells were generated by reprogramming somatic cells into induced pluripotent stem cells (iPSCs). This was a revolution in the way people thought of cell commitment during development. Since then, a lot of research has been done in understanding the molecular biology of pluripotent stem cells. iPSCs can be generated from somatic cells of a patient and therefore have the same genome. Hence, iPSCs have great potential application in medicine, as they can be utilized in disease modelling, drug screening and cell replacement therapy.

  11. CFD method research on characteristics cells in rod bundle fuel assembly

    International Nuclear Information System (INIS)

    Chen Jie; Chen Bingyan; Zhang Hong

    2011-01-01

    Two characteristic cells are in AFA-3G fuel assembly, that is typical cell and control rod guide cell. And there are some rules on the arrangement of mixing vanes. For the two characteristic cells, mixing capability is evaluated axially from the point of the first and second kind of sub-channel with CFD method. Mass mixing and heat mixing are interaction but different with each other. Although the mass mixing in the first kind of sub-channel is stronger, the thermal capability of the two is to some tune from the point of heat transfer. In the experiment research on thermal-hydraulic performance of AFA-3G fuel assembly, the arrangements of mixing vanes should refer to the two spacer grids of characteristic cells. (authors)

  12. Info Source | IDRC - International Development Research Centre

    International Development Research Centre (IDRC) Digital Library (Canada)

    Info Source: Sources of Federal Government and Employee Information provides ... Bringing together the right partners around opportunities for impact, IDRC builds ... Internal services constitute groups of related activities and resources that are ... including planning, budgeting, accounting, reporting, control and oversight, ...

  13. Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability.

    Science.gov (United States)

    DeMets, David L; Fleming, Thomas R; Geller, Gail; Ransohoff, David F

    2017-08-01

    When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their report entirely on one individual faculty member and made no comment on the institution's responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution's critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability.

  14. An analysis of the NIH-supported sickle cell disease research portfolio.

    Science.gov (United States)

    Gavini, Nara; Hoots, W Keith; Mensah, George A; Hanspal, Manjit

    2015-02-01

    Sickle cell disease (SCD), an inherited blood disorder is due to a single amino acid substitution on the beta chain of hemoglobin, and is characterized by anemia, severe infections, acute and chronic pain, and multi-organ damage. The National Institutes of Health (NIH) is dedicated to support basic, translational and clinical science research to improve care and ultimately, to find a cure for SCD that causes such suffering. This report provides a detailed analysis of grants funded by the NIH for SCD research in Fiscal Years 2007 through 2013. During this period, the NIH supported 247 de novo grants totaling $272,210,367 that address various aspects of SCD. 83% of these funds supported research project grants investigating the following 5 scientific themes: Pathology of Sickle Red Blood Cells; Globin Gene Expression; Adhesion and Vascular Dysfunction; Neurological Complications and Organ-specific Dysfunction; and Pain Management and Intervention. The remaining 17% of total funds supported career development and training grants; Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants; large Center grants; and Conference grants. Further analysis showed that the National Heart, Lung, and Blood Institute (NHLBI) is the largest funder of SCD research within NIH with 67% of total grants, contributing 77% of total funds; followed by the National Institute for Digestive Diseases and Kidney (NIDDK) that is funding 19% of grants, contributing 13% of total funds. The remaining 14% of grants totaling 10% of the funds were supported by all other NIH Institutes/Centers (ICs) combined. In summary, the NIH is using multiple funding mechanisms to support a sickle cell disease research agenda that is intended to advance the detection, treatment, and cure of this debilitating genetic disease. Published by Elsevier Inc.

  15. Status of dye solar cell technology as a guideline for further research.

    Science.gov (United States)

    Hinsch, Andreas; Veurman, Welmoed; Brandt, Henning; Jensen, Katrine Flarup; Mastroianni, Simone

    2014-04-14

    Recently, the first commercial dye solar cell (DSC) products based on the mesoscopic principle were successfully launched. Introduction to the market has been accompanied by a strong increase in patent applications in the field during the last four years, which is a good indication of further commercialization activity. Materials and cell concepts have been developed to such extent that easy uptake by industrial manufacturers is possible. The critical phase for broad market acceptance has therefore been reached, which implies focusing on standardization-related research topics. In parallel the number of scientific publications on DSC is growing further (>3500 since 2012), and the range of new or renewed fundamental topics is broadening. A recent example is the introduction of the perovskite mesoscopic cell, for which an efficiency of 14.1% has been certified. Thus, a growing divergence between market introduction and research could be the consequence. Herein, an attempt is made to show that such an unwanted divergence can be prevented, for example, by developing suitable reference-type cell and module concepts as well as manufacturing routes. An in situ cell manufacturing concept that can be applied to mesoscopic-based solar cells in a broader sense is proposed. As a guideline for future module concepts, recent results for large-area, glass-frit-sealed DSC modules from efficiency studies (6.6% active-area efficiency) and outdoor analysis are discussed. Electroluminescence measurements are introduced as a quality tool. Another important point that is addressed is sustainability, which affects both market introduction and the direction of fundamental research. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  16. Proceedings of the CSNI/IAEA workshop on maintaining oversight of licensee safety culture - methods and approaches. Held from 21 to 23 May 2007 in Chester, UK

    International Nuclear Information System (INIS)

    2008-01-01

    Weaknesses in safety culture have contributed to a number of high profile events in the nuclear and other high hazard sectors. The nuclear industry also faces challenges such as deregulation, out-sourcing, phase-out, upgrading and new builds which, if not properly planned and implemented, have the potential to make a negative impact on safety culture. These factors have fostered an increasing awareness of the need for licensees to develop a strong safety culture to support successful and sustainable nuclear safety performance. Regulatory bodies are taking a growing interest in this issue, and several are actively working to develop and implement approaches to maintaining oversight of licensee safety culture. However, these approaches are not yet well-established, and it was considered prudent to share experiences and developing methodologies in order to disseminate good practices and avoid potential pitfalls. An NEA/CSNI/IAEA workshop was therefore held in Chester, UK, in May 2007 in order to explore and discuss the approaches that different regulatory bodies are taking to maintain oversight of licensee safety culture. It was organised by the UK Nuclear Installations Inspectorate on behalf of the CSNI's Working Group on Human and Organisational Factors. This report sets out the findings of the Chester workshop. The workshop was attended by 50 representatives of nuclear regulatory bodies in 20 countries plus IAEA, WANO, EU and NEA. It included both specialists in safety culture and site/resident inspectors, whose attendance was facilitated by the CNRA's Working Group on Inspection Practices. The workshop comprised structured discussion sessions, in which a set of issues were explored by small discussion groups and then discussed in plenary, complemented by short presentations on national regulatory positions. The workshop revealed a broad consensus that nuclear regulators should have processes in place to maintain oversight of licensee safety culture. The approaches

  17. A Shielding Analysis of Hot Cell for a 10 MW Research Reactor

    International Nuclear Information System (INIS)

    Alnajjar, Alaaddin; Park, Chang Je; Roh, Gyuhong; Lee, Byunchul

    2013-01-01

    In this paper, a shielding analysis has been performed for the hot cell in a 10 MW research reactor. Two kinds of shielding analysis code systems are used such as MCNPX2.7 and M-Shield7. The first one is Monte Carlo stochastic code and the second one is a deterministic point kernel code. The results are compared in this study. In order to obtain source term, the ORIGEN-S code is used for different kinds of source. Four kinds of sources are taken into consideration. From the simulation, it is also proposed that the proper thickness of shielding material and the maximum source capacity in the hot cell. This study shows preliminary analysis results of hot cell shielding for 10MW research reactor. Total four different source terms are considered such as spent fuel assembly, Ir-192, Mo-99, and I-131. For shielding material, general concrete, heavy concrete, and lead are used. MCNPX code is mainly used for a simplified hot cell model and the result are nearly consistent when compared with M-Shield code. Required shielding thickness and the hot cell capacity are also obtained for various criterion of surface dose rates

  18. Research and development for evaluation system of solar cell

    Energy Technology Data Exchange (ETDEWEB)

    1986-08-01

    In order to evaluate the performance and capability of solar cell properly and impartially, the evaluation systems for the performance and reliability have been assured. The results are as follows. 1. Development for performance evaluation method; (1) The international comparisons of standard solar cell calibration methods and our method has been assured to be mostly near to the average value. (2) Experimental solar cell has been made and the indoors and outdoors evaluation of solar cell module have become to be possible with same accuracy. (3) As the spectro-radiometer of high performance have been developed, the measurements of the output of the solar cell module have become possible, monitering spectrum of wide range of natural solar beam. (4) With use of several kinds of standard solar cell, measurement errors have been assured. (5) As for nominal operating cell temperature of module, experimental researches have been done indoors and outdoors and the diffeneces have been assured. 2. Development of reliability evaluation method; (1) In outdoor exposure test, the basic data of the accelerating degradation test have been accumulated and it has been assured that the degradation of crystal type is few. (2) By the acceleration degradation test with use of weathermeter, and temperature and humidity cycling test device, the proceses of degradation have been assured. (3) In the processes of enviromental tests and mechanical strength tests, remarkable degradation has not been recognized.(1 tab)

  19. Globalization of Stem Cell Science: An Examination of Current and Past Collaborative Research Networks

    Science.gov (United States)

    Luo, Jingyuan; Matthews, Kirstin R. W.

    2013-01-01

    Science and engineering research has becoming an increasingly international phenomenon. Traditional bibliometric studies have not captured the evolution of collaborative partnerships between countries, particularly in emerging technologies such as stem cell science, in which an immense amount of investment has been made in the past decade. Analyzing over 2,800 articles from the top journals that include stem cell research in their publications, this study demonstrates the globalization of stem cell science. From 2000 to 2010, international collaborations increased from 20.9% to 36% of all stem cell publications analyzed. The United States remains the most prolific and the most dominant country in the field in terms of publications in high impact journals. But Asian countries, particularly China are steadily gaining ground. Exhibiting the largest relative growth, the percent of Chinese-authored stem cell papers grew more than ten-fold, while the percent of Chinese-authored international papers increased over seven times from 2000 to 2010. And while the percent of total stem cell publications exhibited modest growth for European countries, the percent of international publications increased more substantially, particularly in the United Kingdom. Overall, the data indicated that traditional networks of collaboration extant in 2000 still predominate in stem cell science. Although more nations are becoming involved in international collaborations and undertaking stem cell research, many of these efforts, with the exception of those in certain Asian countries, have yet to translate into publications in high impact journals. PMID:24069210

  20. One cell, one love: a journal for microbial research

    Directory of Open Access Journals (Sweden)

    Didac Carmona-Gutierrez

    2014-01-01

    Full Text Available With their broad utility for biotechnology, their continuous menace as infectious pathogens, and as an integral part of our bodies (intestinal flora, unicellular organisms remain in the focus of global research. This interest has been further stimulated by the challenge to counteract the emergence of multi-resistant microbes, as well as by the recent advances in establishing unicellular organisms as valid models for human diseases. It is our great pleasure to launch the inaugural issue of Microbial Cell (MIC, an international, open-access, peer-reviewed journal dedicated to microbial research. MIC is committed to the publication of articles that deal with the characterization of unicellular organisms (or multicellular microorganisms in their response to internal and external stimuli and/or in the context of human health and disease. Thus, MIC covers heterogeneous topics in diverse areas ranging from microbial and general cell biology to molecular signaling, disease modeling and pathogen targeting. MIC’s Editorial Board counts with world-class leaders in a wide variety of fields, including microbiology, aging, evolution, biotechnology, ecology, biochemistry, infection biology, and human pathophysiology. We are convinced that MIC will appeal to readers from a broad scientific and medical background, including basic researchers, microbiologists, clinicians, educators and – we hope – policy makers as well as to any interested individual.

  1. Fundamental research in the area of high temperature fuel cells in Russia

    Energy Technology Data Exchange (ETDEWEB)

    Dyomin, A.K.

    1996-04-01

    Research in the area of molten carbonate and solid oxide fuel cells has been conducted in Russia since the late 60`s. Institute of High Temperature Electrochemistry is the lead organisation in this area. Research in the area of materials used in fuel cells has allowed us to identify compositions of electrolytes, electrodes, current paths and transmitting, sealing and structural materials appropriate for long-term fuel cell applications. Studies of electrode processes resulted in better understanding of basic patterns of electrode reactions and in the development of a foundation for electrode structure optimization. We have developed methods to increase electrode activity levels that allowed us to reach current density levels of up to 1 amper/cm{sup 2}. Development of mathematical models of processes in high temperature fuel cells has allowed us to optimize their structure. The results of fundamental studies have been tested on laboratory mockups. MCFC mockups with up to 100 W capacity and SOFC mockups with up to 1 kW capacity have been manufactured and tested at IHTE. There are three SOFC structural options: tube, plate and modular.

  2. [Advances in the research of function of Merkel cells in tactile formation of skin].

    Science.gov (United States)

    You, X; Wei, Z R

    2018-01-20

    Skin is the largest sense organ of human, with many mechanoreceptor cells under epidermis or dermis of skin and Merkel cell is one of them. It has been confirmed that Merkel cells play an important role in the process of mechanical transmission of mammalian soft tactile stimulation. Researches showed that Merkel cells had close relation to tactile formation and functioned by Merkel cell-neurite complexes and ion channels Piezo2. This article reviews Merkel cells and the function, problem and prospect of Merkel cells in tactile formation.

  3. Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care

    Directory of Open Access Journals (Sweden)

    Paola Frati

    2017-01-01

    Full Text Available The latest research achievements in the field of stem cells led in 2016 to the publication of “Guidelines for Stem Cell Research and Clinical Translation” by the International Society for Stem Cell Research (ISSCR. Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient’s welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

  4. How can ethics relate to science? The case of stem cell research.

    Science.gov (United States)

    Carvalho, Ana Sofia; Ramalho-Santos, João

    2013-06-01

    We live in an era of an important turning point in the relationship between ethics (or, more accurately, bioethics) and science, notably due to both public interest and the gradual tightening of the gap in time between scientific discoveries and ethical reflection. The current bioethics debates of emerging situations (pluripotent stem cells, gene therapy, nanotechnology) have undoubtedly contributed to this change. Today, science happens and bioethics reflects on the possibilities, considers the risks, and advances proposals, which, without being scientific, can also imprint a mark on the path of scientific development. In this article, through the narrative of stem cell research, we will try to illustrate how bringing a bioethical viewpoint to the scientific debate can become a healthy exercise in both ethics and science, especially as narratives shift, as was the case in this field due to the introduction of induced pluripotent stem cells, the advent of which is not easily dissociated from the controversies related to embryo research. We should perhaps welcome this trend as promising for the future relationship between ethics and scientific research, providing a stimulus (and not a block) to the ever-evolving scientific discourse.

  5. The SH-SY5Y cell line in Parkinson's disease research: a systematic review.

    Science.gov (United States)

    Xicoy, Helena; Wieringa, Bé; Martens, Gerard J M

    2017-01-24

    Parkinson's disease (PD) is a devastating and highly prevalent neurodegenerative disease for which only symptomatic treatment is available. In order to develop a truly effective disease-modifying therapy, improvement of our current understanding of the molecular and cellular mechanisms underlying PD pathogenesis and progression is crucial. For this purpose, standardization of research protocols and disease models is necessary. As human dopaminergic neurons, the cells mainly affected in PD, are difficult to obtain and maintain as primary cells, current PD research is mostly performed with permanently established neuronal cell models, in particular the neuroblastoma SH-SY5Y lineage. This cell line is frequently chosen because of its human origin, catecholaminergic (though not strictly dopaminergic) neuronal properties, and ease of maintenance. However, there is no consensus on many fundamental aspects that are associated with its use, such as the effects of culture media composition and of variations in differentiation protocols. Here we present the outcome of a systematic review of scientific articles that have used SH-SY5Y cells to explore PD. We describe the cell source, culture conditions, differentiation protocols, methods/approaches used to mimic PD and the preclinical validation of the SH-SY5Y findings by employing alternative cellular and animal models. Thus, this overview may help to standardize the use of the SH-SY5Y cell line in PD research and serve as a future user's guide.

  6. Global Regulatory T-Cell Research from 2000 to 2015: A Bibliometric Analysis.

    Directory of Open Access Journals (Sweden)

    Yin Zongyi

    Full Text Available We aimed to analyze the global scientific output of regulatory T-cell (Treg research and built a model to qualitatively and quantitatively evaluate publications from 2000 to 2015. Data were obtained from the Web of Science Core Collection (WoSCC of Thomson Reuters on January 1, 2016. The bibliometric method and Citespace III were used to analyze authors, journals, publication outputs, institutions, countries, research areas, research hotspots, and trends. In total, we identified 35,741 publications on Treg research from 2000 to 2015, and observed that the annual publication rate increased with time. The Journal of Immunology published the highest number of articles, the leading country was the USA, and the leading institute was Harvard University. Sakaguchi, Hori, Fontenot, and Wang were the top authors in Treg research. Immunology accounted for the highest number of publications, followed by oncology, experimental medicine, cell biology, and hematology. Keyword analysis indicated that autoimmunity, inflammation, cytokine, gene expression, foxp3, and immunotherapy were the research hotspots, whereas autoimmune inflammation, gene therapy, granzyme B, RORγt, and th17 were the frontiers of Treg research. This bibliometric analysis revealed that Treg-related studies are still research hotspots, and that Treg-related clinical therapies are the research frontiers; however, further study and collaborations are needed worldwide. Overall, our findings provide valuable information for the editors of immunology journals to identify new perspectives and shape future research directions.

  7. Indium phosphide solar cell research in the United States: Comparison with non-photovoltaic sources

    Science.gov (United States)

    Weinberg, I.; Swartz, C. K.; Hart, R. E., Jr.

    1989-01-01

    Highlights of the InP solar cell research program are presented. Homojunction cells with efficiencies approaching 19 percent are demonstrated, while 17 percent is achieved for ITO/InP cells. The superior radiation resistance of the two latter cell configurations over both Si and GaAs cells has been shown. InP cells aboard the LIPS3 satellite show no degradation after more than a year in orbit. Computed array specific powers are used to compare the performance of an InP solar cell array to solar dynamic and nuclear systems.

  8. [Research progress of intervertebral disc endogenous stem cells for intervertebral disc regeneration].

    Science.gov (United States)

    Liang, Hang; Deng, Xiangyu; Shao, Zengwu

    2017-10-01

    To summarize the research progress of intervertebral disc endogenous stem cells for intervertebral disc regeneration and deduce the therapeutic potential of endogenous repair for intervertebral disc degeneration. The original articles about intervertebral disc endogenous stem cells for intervertebral disc regeneration were extensively reviewed; the reparative potential in vivo and the extraction and identification in vitro of intervertebral disc endogenous stem cells were analyzed; the prospect of endogenous stem cells for intervertebral disc regeneration was predicted. Stem cell niche present in the intervertebral discs, from which stem cells migrate to injured tissues and contribute to tissues regeneration under certain specific microenvironment. Moreover, the migration of stem cells is regulated by chemokines system. Tissue specific progenitor cells have been identified and successfully extracted and isolated. The findings provide the basis for biological therapy of intervertebral disc endogenous stem cells. Intervertebral disc endogenous stem cells play a crucial role in intervertebral disc regeneration. Therapeutic strategy of intervertebral disc endogenous stem cells is proven to be a promising biological approach for intervertebral disc regeneration.

  9. Prostate Cancer Stem-Like Cells | Center for Cancer Research

    Science.gov (United States)

    Prostate cancer is the third leading cause of cancer-related death among men, killing an estimated 27,000 men each year in the United States. Men with advanced prostate cancer often become resistant to conventional therapies. Many researchers speculate that the emergence of resistance is due to the presence of cancer stem cells, which are believed to be a small subpopulation

  10. Per diems | IDRC - International Development Research Centre

    International Development Research Centre (IDRC) Digital Library (Canada)

    Employee and Non-employee Travel Allowances All allowances described below are referred to in the IDRC Corporate Travel Policy. The allowances reflect current economic conditions and are calculated based on the standards and oversight that are applicable to departments and other entities of the Government of ...

  11. FY 1998 annual report on the development of fuel cell power generation techniques. Research and development of solid electrolyte fuel cells (research results); 1998 nendo nenryo denchi gijutsu kaihatsu. Kotai denkaishitsugata nenryo denchi no kenkyu kaihatsu

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-03-01

    Described herein are the FY 1998 research and development results of solid electrolyte fuel cells. For R and D of the tubular type cell by the wet processing technique, the tests are conducted to evaluate the initial performance and long-term durability for continuous operation of the single tubular cell. For development of the several-kW class modules, computer-aided simulations are conducted. For R and D of material and substrate techniques, the thermal cycle characteristics, cell characteristics and stress of the cell modules are evaluated, in order to evaluate their reliability. The thermal cycle test results indicate that performance of the single-stage cell is unaffected by the thermal cycles. It is found by the stress evaluation that use of the separator plate having a higher thermal expansion coefficient than the electrolyte plate and use of the sealant having a thermal expansion coefficient close to that of the electrolyte plate are effective means to reduce stresses. For the research to reduce costs of the cell materials, their chemical, mechanical and thermal characteristics are evaluated. For the system research, the areas for which the compact systems are suitable and their optimization are studied. (NEDO)

  12. Role of the Regulatory Body in Implementing Defence in Depth in Nuclear Installations - Regulatory Oversight in Egypt

    Energy Technology Data Exchange (ETDEWEB)

    El-Sheikh, B. M., E-mail: badawymel@yahoo.com [Egyptian Nuclear and Radiological Regulatory Authority Cairo (Egypt)

    2014-10-15

    The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are operated at all times in an acceptably safe manner including the safe conduct of decommissioning activities. Defence in depth is recognized as one of the fundamental safety principles that underlie the safety of nuclear power plants. Defence in depth is implemented to provide a graded protection against a wide variety of transients, incidents and accidents, including equipment failures and human errors within nuclear power plants and events initiated outside plants. The Regulator Body plays an important role in implementing defence in depth in nuclear installations in the context of a clear allocation of responsibilities with an operating organization. This role starting with setting safety objectives and by its own independent review and technical assessment of the safety justifications provided by the operating organization in addition to safety culture investigating within relevant organizations. This paper briefly reviews this role in normal operation and post accidents, and its effects on overall nuclear safety in nuclear installations with reference to Egyptian regulatory oversight. (author)

  13. Synthetic biology in mammalian cells: Next generation research tools and therapeutics

    Science.gov (United States)

    Lienert, Florian; Lohmueller, Jason J; Garg, Abhishek; Silver, Pamela A

    2014-01-01

    Recent progress in DNA manipulation and gene circuit engineering has greatly improved our ability to programme and probe mammalian cell behaviour. These advances have led to a new generation of synthetic biology research tools and potential therapeutic applications. Programmable DNA-binding domains and RNA regulators are leading to unprecedented control of gene expression and elucidation of gene function. Rebuilding complex biological circuits such as T cell receptor signalling in isolation from their natural context has deepened our understanding of network motifs and signalling pathways. Synthetic biology is also leading to innovative therapeutic interventions based on cell-based therapies, protein drugs, vaccines and gene therapies. PMID:24434884

  14. Sewage epidemiology and illicit drug research: the development of ethical research guidelines.

    Science.gov (United States)

    Prichard, Jeremy; Hall, Wayne; de Voogt, Pim; Zuccato, Ettore

    2014-02-15

    To discuss the need to develop ethical guidelines for researchers using sewage epidemiology to monitor drug use in the general population and specific precincts, including prisons, schools and workplaces. Describe current applications of sewage epidemiology, identify potential ethical risks associated with this science, and identify key means by which these risks may be mitigated through proportionate ethical guidance that allows this science to be fully developed. A rapidly advancing field of research is sewage epidemiology (SE) - the analysis of wastewater samples to monitor illicit drug use and other substances. Typically this research involves low ethical risks because individual participants cannot be identified and, consequently, review has been waived by human research ethics committees. In the absence of such oversight, ethical research guidelines are recommended for SE teams, peer reviewers and journal editors; guidelines will assist them to mitigate any risks in general population studies and studies of prisons, schools and workplaces. Potential harms include the stigmatisation of participants and, in the prison setting, austere policy responses to SE data that impact negatively upon inmate-participants. The risk of harm can be managed through research planning, awareness of the socio-political context in which results will be interpreted (or, in the case of media, sensationalised) and careful relations with industry partners. Ethical guidelines should be developed in consultation with SE scholars and be periodically amended. They should include publication processes that safeguard scientific rigour and be promulgated through existing research governance structures. Guidelines will assist to promote an ethical research culture among SE teams and scholars involved in the publication process and this will work to protect the reputation of the field. Copyright © 2014 Elsevier B.V. All rights reserved.

  15. Preliminary research developing a theory of cell phone distraction and social relationships.

    Science.gov (United States)

    LaVoie, Noelle; Lee, Yi-Ching; Parker, James

    2016-01-01

    Motor vehicle crashes remain the leading cause of death and injury for people aged 5-34, accounting annually for over 3000 deaths, and 100 times as many injuries. It is well established that distracted driving, and cell phone use while driving in particular, pose significant crash risk to drivers. Research has demonstrated that drivers are well aware of this danger but over 90% of drivers report using a cell phone while driving. Given the likely role that social influence plays in how people use cell phones while driving surprisingly little research has been conducted investigating to whom drivers are talking or texting. We report the results of a national survey to determine who drivers are most likely to call or text when behind the wheel and compared these results with general cell phone calling and texting patterns as well as previous findings on the prevalence of calling and texting while driving. The results suggest that social distance is a key factor in cell phone use while driving: Teens are more likely to talk with parents, and adults are more likely to talk with spouses than general calling patterns would suggest. We discuss whether the purpose of calls made while driving, such as coordination, could help explain these patterns. We propose next steps for further examining the role social relationships play in cell phone use while driving to potentially reduce teen driver cell phone use by lowering the number of calls from parents. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Publication trends of research on diabetes mellitus and T cells (1997-2016: A 20-year bibliometric study.

    Directory of Open Access Journals (Sweden)

    Ye Gao

    Full Text Available Diabetes Mellitus (DM is a huge burden for human health. Recent studies show the close relationship between DM and T cells. We investigated the trend in DM and T cells research.Using the Web of Science database, we searched the publications on DM and T cells in 1997-2016, and studied the source data using bibliometric methodology. Excel 2016, GraphPad Prism 5, and VOSviewer software were used to analyze the publication trend in DM and T cells research.We found a total of 1077 publications with 38109 citations up to January 23, 2017. The highest contribution came from the United States, with 48.38% of the publications, 61.44% of the citations and the highest H-index (74. China had the 5th place for total publications, but ranked 11th both for citation frequency (604 and H-index (13. The inflection point of the global DM and T cells publications was in 2000. Journal of Immunology published the most related articles (164. Santamaria P. was the leading scholar in this field with the most publications (35. The keywords "regulatory T cell" and "autoimmune diabetes" were mentioned more than 300 times. Furthermore, type 2 (T2DM, T cell immunoglobulin and mucin domain (TIM and obesity are becoming popular research topics in this field.The quantity of publications on DM and T cells grew rapidly around year 2000, but has relatively decreased recently. The United States had the leading position in global research. There was a discrepancy between productivity and quality of publications from China. Latest progress is most likely first published by the Journal of Immunology. Santamaria P., Roep B.O. and Peakman M. were the pioneer scholars in this field. Most researchers have focused on "regulatory T cell" and "autoimmune diabetes" research. In future, T2DM, TIM and obesity may be the popular areas.

  17. Oversight Hearing on Drug Abuse Education Programs. Hearing before the Subcommittee on Elementary, Secondary, and Vocational Education of the Committee on Education and Labor. House of Representatives, 101st Congress, 2nd Session (Vancouver, Washington, September 6, 1990).

    Science.gov (United States)

    Congress of the U.S., Washington, DC. House Committee on Education and Labor.

    The text of an oversight hearing on Drug Abuse Resistance Education (DARE) programs is presented in this document. Introductory statements by Representatives Jolene Unsoeld and Dale E. Kildee are presented. Testimony by these witnesses is included: (1) Roy Bondurant, student, and Roy "Skip" Bondurant, parent, Tenino, Washington; (2) Paul…

  18. Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

    Science.gov (United States)

    Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

    2016-01-01

    Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

  19. Recent advances in Echinococcus genomics and stem cell research.

    Science.gov (United States)

    Koziol, U; Brehm, K

    2015-10-30

    Alveolar and cystic echinococcosis, caused by the metacestode larval stages of the tapeworms Echinococcus multilocularis and Echinococcus granulosus, respectively, are life-threatening diseases and very difficult to treat. The introduction of benzimidazole-based chemotherapy, which targets parasite β-tubulin, has significantly improved the life-span and prognosis of echinococcosis patients. However, benzimidazoles show only parasitostatic activity, are associated with serious adverse side effects and have to be administered for very long time periods, underlining the need for new drugs. Very recently, the nuclear genomes of E. multilocularis and E. granulosus have been characterised, revealing a plethora of data for gaining a deeper understanding of host-parasite interaction, parasite development and parasite evolution. Combined with extensive transcriptome analyses of Echinococcus life cycle stages these investigations also yielded novel clues for targeted drug design. Recent years also witnessed significant advancements in the molecular and cellular characterisation of the Echinococcus 'germinative cell' population, which forms a unique stem cell system that differs from stem cells of other organisms in the expression of several genes associated with the maintenance of pluripotency. As the only parasite cell type capable of undergoing mitosis, the germinative cells are central to all developmental transitions of Echinococcus within the host and to parasite expansion via asexual proliferation. In the present article, we will briefly introduce and discuss recent advances in Echinococcus genomics and stem cell research in the context of drug design and development. Interestingly, it turns out that benzimidazoles seem to have very limited effects on Echinococcus germinative cells, which could explain the high recurrence rates observed after chemotherapeutic treatment of echinococcosis patients. This clearly indicates that future efforts into the development of

  20. Recent results from advanced research on space solar cells at NASA

    Science.gov (United States)

    Flood, Dennis J.

    1990-01-01

    The NASA program in space photovoltaic research and development encompasses a wide range of emerging options for future space power systems, and includes both cell and array technology development. The long range goals are to develop technology capable of achieving 300 W/kg for planar arrays, and 300 W/sq m for concentrator arrays. InP and GaAs planar and concentrator cell technologies are under investigation for their potential high efficiency and good radiation resistance. The Advanced Photovoltaic Solar Array (APSA) program is a near term effort aimed at demonstrating 130 W/kg beginning of life specific power using thin (62 pm) silicon cells. It is intended to be technology transparent to future high efficiency cells and provides the baseline for development of the 300 W/kg array.

  1. Analysis of Trends and Emerging Technologies in Water Electrolysis Research Based on a Computational Method: A Comparison with Fuel Cell Research

    Directory of Open Access Journals (Sweden)

    Takaya Ogawa

    2018-02-01

    Full Text Available Water electrolysis for hydrogen production has received increasing attention, especially for accumulating renewable energy. Here, we comprehensively reviewed all water electrolysis research areas through computational analysis, using a citation network to objectively detect emerging technologies and provide interdisciplinary data for forecasting trends. The results show that all research areas increase their publication counts per year, and the following two areas are particularly increasing in terms of number of publications: “microbial electrolysis” and “catalysts in an alkaline water electrolyzer (AWE and in a polymer electrolyte membrane water electrolyzer (PEME.”. Other research areas, such as AWE and PEME systems, solid oxide electrolysis, and the whole renewable energy system, have recently received several review papers, although papers that focus on specific technologies and are cited frequently have not been published within the citation network. This indicates that these areas receive attention, but there are no novel technologies that are the center of the citation network. Emerging technologies detected within these research areas are presented in this review. Furthermore, a comparison with fuel cell research is conducted because water electrolysis is the reverse reaction to fuel cells, and similar technologies are employed in both areas. Technologies that are not transferred between fuel cells and water electrolysis are introduced, and future water electrolysis trends are discussed.

  2. A Strategic Vision and a New Management Approach for the Department of the Navy’s Research, Development, Test and Evaluation (RDT&E) Portfolio

    Science.gov (United States)

    2014-08-01

    level. The two bolded and underlined aspects of this paradigm are the central topics of this paper. They will be explored and specific...accounts and that ties them together as a coherent whole. This should be of much greater concern than the lack of oversight of non-ACAT programs, the...Research and Engineering) [ ASD R&E]), and with Congress. It has shrunk noticeably over the last several decades as a percentage of the DON topline

  3. Application of biomaterials to advance induced pluripotent stem cell research and therapy

    Science.gov (United States)

    Tong, Zhixiang; Solanki, Aniruddh; Hamilos, Allison; Levy, Oren; Wen, Kendall; Yin, Xiaolei; Karp, Jeffrey M

    2015-01-01

    Derived from any somatic cell type and possessing unlimited self-renewal and differentiation potential, induced pluripotent stem cells (iPSCs) are poised to revolutionize stem cell biology and regenerative medicine research, bringing unprecedented opportunities for treating debilitating human diseases. To overcome the limitations associated with safety, efficiency, and scalability of traditional iPSC derivation, expansion, and differentiation protocols, biomaterials have recently been considered. Beyond addressing these limitations, the integration of biomaterials with existing iPSC culture platforms could offer additional opportunities to better probe the biology and control the behavior of iPSCs or their progeny in vitro and in vivo. Herein, we discuss the impact of biomaterials on the iPSC field, from derivation to tissue regeneration and modeling. Although still exploratory, we envision the emerging combination of biomaterials and iPSCs will be critical in the successful application of iPSCs and their progeny for research and clinical translation. PMID:25766254

  4. Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent.

    Science.gov (United States)

    Lowenthal, Justin; Lipnick, Scott; Rao, Mahendra; Hull, Sara Chandros

    2012-05-01

    Induced pluripotent stem cells (iPSCs) have elicited excitement in both the scientific and ethics communities for their potential to advance basic and translational research. They have been hailed as an alternative to derivation from embryos that provides a virtually unlimited source of pluripotent stem cells for research and therapeutic applications. However, research with iPSCs is ethically complex, uniquely encompassing the concerns associated with genomics, immortalized cell lines, transplantation, human reproduction, and biobanking. Prospective donation of tissue specimens for iPSC research thus requires an approach to informed consent that is constructed for this context. Even in the nascent stages of this field, approaches to informed consent have been variable in ways that threaten the simultaneous goals of protecting donors and safeguarding future research and translation, and investigators are seeking guidance. We address this need by providing concrete recommendations for informed consent that balance the perspectives of a variety of stakeholders. Our work combines analysis of consent form language collected from investigators worldwide with a conceptual balancing of normative ethical concerns, policy precedents, and scientific realities. Our framework asks people to consent prospectively to a broad umbrella of foreseeable research, including future therapeutic applications, with recontact possible in limited circumstances. We argue that the long-term goals of regenerative medicine, interest in sharing iPSC lines, and uncertain landscape of future research all would be served by a framework of ongoing communication with donors. Our approach balances the goals of iPSC and regenerative medicine researchers with the interests of individual research participants.

  5. Reflexive Research Ethics for Environmental Health and Justice: Academics and Movement-Building

    Science.gov (United States)

    Cordner, Alissa; Ciplet, David; Brown, Phil; Morello-Frosch, Rachel

    2012-01-01

    Community-engaged research on environmental problems has reshaped researcher-participant relationships, academic-community interaction, and the role of community partners in human subjects protection and ethical oversight. We draw on our own and others’ research collaborations with environmental health and justice social movement organizations to discuss the ethical concerns that emerge in community-engaged research. In this paper we introduce the concept of reflexive research ethics: ethical guidelines and decision-making principles that depend on continual reflexivity concerning the relationships between researchers and participants. Seeing ethics in this way can help scientists conduct research that simultaneously achieves a high level of professional conduct and protects the rights, well-being, and autonomy of both researchers and the multiple publics affected by research. We highlight our research with community-based organizations in Massachusetts, California, and Alaska, and discuss the potential impacts of the community or social movement on the research process and the potential impacts of research on community or social movement goals. We conclude by discussing ways in which the ethical concerns that surface in community-engaged research have led to advances in ethical research practices. This type of work raises ethical questions whose answers are broadly relevant for social movement, environmental, and public health scholars. PMID:22690133

  6. The role of nanotechnology in induced pluripotent and embryonic stem cells research.

    Science.gov (United States)

    Chen, Lukui; Qiu, Rong; Li, Lushen

    2014-12-01

    This paper reviews the recent studies on development of nanotechnology in the field of induced pluripotent and embryonic stem cells. Stem cell therapy is a promising therapy that can improve the quality of life for patients with refractory diseases. However, this option is limited by the scarcity of tissues, ethical problem, and tumorigenicity. Nanotechnology is another promising therapy that can be used to mimic the extracellular matrix, label the implanted cells, and also can be applied in the tissue engineering. In this review, we briefly introduce implementation of nanotechnology in induced pluripotent and embryonic stem cells research. Finally, the potential application of nanotechnology in tissue engineering and regenerative medicine is also discussed.

  7. Drosophila's contribution to stem cell research [v1; ref status: indexed, http://f1000r.es/5h7

    Directory of Open Access Journals (Sweden)

    Gyanesh Singh

    2015-06-01

    Full Text Available The discovery of Drosophila stem cells with striking similarities to mammalian stem cells has brought new hope for stem cell research. A recent development in Drosophila stem cell research is bringing wider opportunities for contemporary stem cell biologists. In this regard, Drosophila germ cells are becoming a popular model of stem cell research. In several cases, genes that controlled Drosophila stem cells were later discovered to have functional homologs in mammalian stem cells. Like mammals, Drosophila germline stem cells (GSCs are controlled by both intrinsic as well as external signals. Inside the Drosophila testes, germline and somatic stem cells form a cluster of cells (the hub. Hub cells depend on JAK-STAT signaling, and, in absence of this signal, they do not self-renew. In Drosophila, significant changes occur within the stem cell niche that contributes to a decline in stem cell number over time. In case of aging Drosophila, somatic niche cells show reduced DE-cadherin and unpaired (Upd proteins. Unpaired proteins are known to directly decrease stem cell number within the niches, and, overexpression of upd within niche cells restored GSCs in older males also . Stem cells in the midgut of Drosophila are also very promising. Reduced Notch signaling was found to increase the number of midgut progenitor cells. On the other hand, activation of the Notch pathway decreased proliferation of these cells. Further research in this area should lead to the discovery of additional factors that regulate stem and progenitor cells in Drosophila.

  8. Ethical, legal and practical issues of establishing an adipose stem cell bank for research.

    Science.gov (United States)

    West, C C; Murray, I R; González, Z N; Hindle, P; Hay, D C; Stewart, K J; Péault, B

    2014-06-01

    Access to human tissue is critical to medical research, however the laws and regulations surrounding gaining ethical and legal access to tissue are often poorly understood. Recently, there has been a huge increase in the interest surrounding the therapeutic application of adipose tissue, and adipose-derived stem cells. To facilitate our own research interests and possibly assist our local colleagues and collaborators, we established a Research Tissue Bank (RTB) to collect, store and distribute human adipose tissue derived cells with all the appropriate ethical approval for subsequent downstream research. Here we examine the legal, ethical and practical issues relating to the banking of adipose tissue for research in the UK, and discuss relevant international guidelines and policies. We also share our experiences of establishing an RTB including the necessary infrastructure and the submission of an application to a Research Ethics Committee (REC). Copyright © 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  9. Perspective role of stem cells application in neuropsychiatric research

    Czech Academy of Sciences Publication Activity Database

    Syková, Eva

    2003-01-01

    Roč. 13, č. 4 (2003), s. 148 ISSN 0924-977X. [Congress of the European College of Neuropsychopharmacology /16./. Prague, 20.09.2003-24.09.2003] R&D Projects: GA MŠk LN00A065; GA ČR GA304/03/1189 Institutional research plan: CEZ:AV0Z5039906; CEZ:MSM 111300004 Keywords : stem cells Subject RIV: FH - Neurology Impact factor: 2.842, year: 2003

  10. Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics.

    Science.gov (United States)

    Dresser, Rebecca

    2006-01-01

    Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies' internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical companies' ethics materials and describe shortcomings in the companies' existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs.

  11. Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells

    Directory of Open Access Journals (Sweden)

    Karen Bieback

    2010-01-01

    Full Text Available It sounds simple to obtain sufficient numbers of cells derived from fetal or adult human tissues, isolate and/or expand the stem cells, and then transplant an appropriate number of these cells into the patient at the correct location. However, translating basic research into routine therapies is a complex multistep process which necessitates product regulation. The challenge relates to managing the expected therapeutic benefits with the potential risks and to balance the fast move to clinical trials with time-consuming cautious risk assessment. This paper will focus on the definition of mesenchymal stromal cells (MSCs, and challenges and achievements in the manufacturing process enabling their use in clinical studies. It will allude to different cellular sources, special capacities of MSCs, but also to current regulations, with a special focus on accessory material of human or animal origin, like media supplements. As cellular integrity and purity, formulation and lot release testing of the final product, validation of all procedures, and quality assurance are of utmost necessity, these topics will be addressed.

  12. Genome editing in pluripotent stem cells: research and therapeutic applications

    Energy Technology Data Exchange (ETDEWEB)

    Deleidi, Michela, E-mail: michela.deleidi@dzne.de [German Center for Neurodegenerative Diseases (DZNE) Tübingen within the Helmholtz Association, Tübingen (Germany); Hertie Institute for Clinical Brain Research, University of Tübingen (Germany); Yu, Cong [Department of Microbiology and Immunology, School of Medicine and Biomedical Sciences, University at Buffalo, New York (United States)

    2016-05-06

    Recent progress in human pluripotent stem cell (hPSC) and genome editing technologies has opened up new avenues for the investigation of human biology in health and disease as well as the development of therapeutic applications. Gene editing approaches with programmable nucleases have been successfully established in hPSCs and applied to study gene function, develop novel animal models and perform genetic and chemical screens. Several studies now show the successful editing of disease-linked alleles in somatic and patient-derived induced pluripotent stem cells (iPSCs) as well as in animal models. Importantly, initial clinical trials have shown the safety of programmable nucleases for ex vivo somatic gene therapy. In this context, the unlimited proliferation potential and the pluripotent properties of iPSCs may offer advantages for gene targeting approaches. However, many technical and safety issues still need to be addressed before genome-edited iPSCs are translated into the clinical setting. Here, we provide an overview of the available genome editing systems and discuss opportunities and perspectives for their application in basic research and clinical practice, with a particular focus on hPSC based research and gene therapy approaches. Finally, we discuss recent research on human germline genome editing and its social and ethical implications. - Highlights: • Programmable nucleases have proven efficient and specific for genome editing in human pluripotent stem cells (hPSCs). • Genome edited hPSCs can be employed to study gene function in health and disease as well as drug and chemical screens. • Genome edited hPSCs hold great promise for ex vivo gene therapy approaches. • Technical and safety issues should be first addressed to advance the clinical use of gene-edited hPSCs.

  13. Genome editing in pluripotent stem cells: research and therapeutic applications

    International Nuclear Information System (INIS)

    Deleidi, Michela; Yu, Cong

    2016-01-01

    Recent progress in human pluripotent stem cell (hPSC) and genome editing technologies has opened up new avenues for the investigation of human biology in health and disease as well as the development of therapeutic applications. Gene editing approaches with programmable nucleases have been successfully established in hPSCs and applied to study gene function, develop novel animal models and perform genetic and chemical screens. Several studies now show the successful editing of disease-linked alleles in somatic and patient-derived induced pluripotent stem cells (iPSCs) as well as in animal models. Importantly, initial clinical trials have shown the safety of programmable nucleases for ex vivo somatic gene therapy. In this context, the unlimited proliferation potential and the pluripotent properties of iPSCs may offer advantages for gene targeting approaches. However, many technical and safety issues still need to be addressed before genome-edited iPSCs are translated into the clinical setting. Here, we provide an overview of the available genome editing systems and discuss opportunities and perspectives for their application in basic research and clinical practice, with a particular focus on hPSC based research and gene therapy approaches. Finally, we discuss recent research on human germline genome editing and its social and ethical implications. - Highlights: • Programmable nucleases have proven efficient and specific for genome editing in human pluripotent stem cells (hPSCs). • Genome edited hPSCs can be employed to study gene function in health and disease as well as drug and chemical screens. • Genome edited hPSCs hold great promise for ex vivo gene therapy approaches. • Technical and safety issues should be first addressed to advance the clinical use of gene-edited hPSCs.

  14. Stem cell research: licit or complicit? Is a medical breakthrough based on embryonic and fetal tissue compatible with Catholic teaching?

    Science.gov (United States)

    Branick, V; Lysaught, M T

    1999-01-01

    In November 1998 biologists announced that they had discovered a way to isolate and preserve human stem cells. Since stem cells are capable of developing into any kind of human tissue or organ, this was a great scientific coup. Researchers envision using the cells to replace damaged organs and to restore tissue destroyed by, for example, Parkinson's disease, diabetes, or even Alzheimer's. But, since stem cells are taken from aborted embryonic and fetal tissue or "leftover" in vitro embryos, their use raises large ethical issues. The National Institutes of Health (NIH) recently decided to fund research employing, not stem cells, but "cell lines" derived from them. The NIH has essentially made an ethical determination, finding sufficient "distance" between cell lines and abortion. Can Catholic universities sponsoring biological research agree with this finding? Probably not. In Catholic teaching, the concept of "complicity" would likely preclude such research. However, Catholic teaching would probably allow research done with stem cells obtained from postpartum placental tissue and from adult bone marrow and tissue. These cells, which lack the pluripotency of embryonic and fetal stem cells, are nevertheless scientifically promising and do not involve the destruction of human life.

  15. Fuel Cell Demonstration Project - 200 kW - Phosphoric Acid Fuel Cell Power Plant Located at the National Transportation Research Center: FINAL REPORT

    Energy Technology Data Exchange (ETDEWEB)

    Berry, JB

    2005-05-06

    Oak Ridge National Laboratory (ORNL) researches and develops distributed generation technology for the Department of Energy, Energy Efficiency and Renewable Energy Distributed Energy Program. This report describes installation and operation of one such distributed generation system, a United Technology Corporation fuel cell located at the National Transportation Research Center in Knoxville, Tennessee. Data collected from June 2003 to June of 2004, provides valuable insight regarding fuel cell-grid compatibility and the cost-benefit of the fuel cell operation. The NTRC fuel cell included a high-heat recovery option so that use of thermal energy improves project economics and improves system efficiency to 59% year round. During the year the fuel cell supplied a total of 834MWh to the NTRC and provided 300MBtu of hot water. Installation of the NTRC fuel cell was funded by the Distributed Energy Program with partial funding from the Department of Defense's Climate Change Fuel Cell Buy Down Program, administered by the National Energy Technology Laboratory. On-going operational expenses are funded by ORNL's utility budget and are paid from operational cost savings. Technical information and the benefit-cost of the fuel cell are both evaluated in this report and sister reports.

  16. Human Induced Pluripotent Stem Cells from Basic Research to Potential Clinical Applications in Cancer

    Directory of Open Access Journals (Sweden)

    Teresa de Souza Fernandez

    2013-01-01

    Full Text Available The human induced pluripotent stem cells (hiPSCs are derived from a direct reprogramming of human somatic cells to a pluripotent stage through ectopic expression of specific transcription factors. These cells have two important properties, which are the self-renewal capacity and the ability to differentiate into any cell type of the human body. So, the discovery of hiPSCs opens new opportunities in biomedical sciences, since these cells may be useful for understanding the mechanisms of diseases in the production of new diseases models, in drug development/drug toxicity tests, gene therapies, and cell replacement therapies. However, the hiPSCs technology has limitations including the potential for the development of genetic and epigenetic abnormalities leading to tumorigenicity. Nowadays, basic research in the hiPSCs field has made progress in the application of new strategies with the aim to enable an efficient production of high-quality of hiPSCs for safety and efficacy, necessary to the future application for clinical practice. In this review, we show the recent advances in hiPSCs’ basic research and some potential clinical applications focusing on cancer. We also present the importance of the use of statistical methods to evaluate the possible validation for the hiPSCs for future therapeutic use toward personalized cell therapies.

  17. A Citation Tracking System to Facilitate Sponsoring Institution Oversight of ACGME-Accredited Programs.

    Science.gov (United States)

    Long, Timothy R; Poe, John D; Zimmerman, Richard S; Rose, Steven H

    2012-12-01

    The Accreditation Council for Graduate Medical Education (ACGME) requires the graduate medical education committee and the designated institutional official to ensure that citations for noncompliance with the accreditation standards and institutional trends in citations are reviewed and corrected. To describe a citation tracking system (CTS) that uses Microsoft Office Access to efficiently catalogue, monitor, and document resolution of citations. The CTS was implemented in a sponsoring institution with oversight of 133 ACGME-accredited programs. The designated institutional official and the graduate medical education committee review all program letters of notification and enter citations into the CTS. A program-correction plan is required for each citation and is entered into the database. Open citations and action plans are reviewed by the graduate medical education committee and the designated institutional official on a quarterly basis, with decisions ranging from "closing" the citation to approving the action plan in process to requiring a new or modified action plan. Citation categories and subcategories are accessed on the ACGME website and entered into the CTS to identify trends. All 236 citations received since the 2006 Mayo School of Graduate Medical Education institutional site visit were entered into the CTS. On November 22, 2011, 26 of 236 citations (11%) were in active status with ongoing action plans, and 210 (89%) citations had been resolved and were closed. The CTS uses commercially available software to ensure citations are monitored and addressed and to simplify analysis of citation trends. The approach requires minimal staff time for data input and updates and can be performed without institutional information technology assistance.

  18. The importance of project networking for the replacement research reactor

    International Nuclear Information System (INIS)

    Whitbourn, G.

    2003-01-01

    When the HIFAR research reactor was commissioned in 1958 it was both constructed and regulated by the then Australian Atomic Energy Commission. The situation now is much more complicated, with an independent regulator, The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) and oversight by national security agencies and the Australian Safeguards and Non proliferation Organisation (ASNO). In July 2000 ANSTO contracted INVAP SE a suitably qualified and experienced nuclear organisation based in Argentina to provide the Replacement Research Reactor (RRR). INVAP subcontracted an Australian entity, a joint venture between John Holland and Evans Deakin Industries (JHEDI) to provide resources in Australia. There is an international network of over 100 subcontractors providing services, products and materials to INVAP and JHEDI and a significant number of contractors providing project support services to ANSTO. The interaction of all these entities to provide the RRR is a significant networking challenge, involving a complex network of legal, contractual and functional relationships and communication processes

  19. Multilineage Potential Research of Bovine Amniotic Fluid Mesenchymal Stem Cells

    Directory of Open Access Journals (Sweden)

    Yuhua Gao

    2014-02-01

    Full Text Available The use of amnion and amniotic fluid (AF are abundant sources of mesenchymal stem cells (MSCs that can be harvested at low cost and do not pose ethical conflicts. In human and veterinary research, stem cells derived from these tissues are promising candidates for disease treatment, specifically for their plasticity, their reduced immunogenicity, and high anti-inflammatory potential. This work aimed to obtain and characterize bovine amniotic fluid mesenchymal stem cells (AFMSC. The bovine AF from the amniotic cavity of pregnant gilts in the early stages of gestation (3- and 4-m-old bovine embryos was collected. AFMSCs exhibit a fibroblastic-like morphology only starting from the fourth passage, being heterogeneous during the primary culture. Immunofluorescence results showed that AFMSCs were positive for β-integrin, CD44, CD73 and CD166, but negative for CD34, CD45. Meanwhile, AFMSCs expressed ES cell markers, such as Oct4, and when appropriately induced, are capable of differentiating into ectodermal and mesodermal lineages. This study reinforces the emerging importance of these cells as ideal tools in veterinary medicine; future studies aimed at a deeper evaluation of their immunological properties will allow a better understanding of their role in cellular therapy.

  20. International stem cell collaboration: how disparate policies between the United States and the United Kingdom impact research.

    Science.gov (United States)

    Luo, Jingyuan; Flynn, Jesse M; Solnick, Rachel E; Ecklund, Elaine Howard; Matthews, Kirstin R W

    2011-03-08

    As the scientific community globalizes, it is increasingly important to understand the effects of international collaboration on the quality and quantity of research produced. While it is generally assumed that international collaboration enhances the quality of research, this phenomenon is not well examined. Stem cell research is unique in that it is both politically charged and a research area that often generates international collaborations, making it an ideal case through which to examine international collaborations. Furthermore, with promising medical applications, the research area is dynamic and responsive to a globalizing science environment. Thus, studying international collaborations in stem cell research elucidates the role of existing international networks in promoting quality research, as well as the effects that disparate national policies might have on research. This study examined the impact of collaboration on publication significance in the United States and the United Kingdom, world leaders in stem cell research with disparate policies. We reviewed publications by US and UK authors from 2008, along with their citation rates and the political factors that may have contributed to the number of international collaborations. The data demonstrated that international collaborations significantly increased an article's impact for UK and US investigators. While this applied to UK authors whether they were corresponding or secondary, this effect was most significant for US authors who were corresponding authors. While the UK exhibited a higher proportion of international publications than the US, this difference was consistent with overall trends in international scientific collaboration. The findings suggested that national stem cell policy differences and regulatory mechanisms driving international stem cell research in the US and UK did not affect the frequency of international collaborations, or even the countries with which the US and UK most

  1. Oversight and Influencing of Licensee Leadership and Management for Safety, Including Safety Culture - Regulatory Approaches and Methods. Proceedings of an NEA/IAEA Workshop, Chester, United Kingdom, 26-28 September 2011

    International Nuclear Information System (INIS)

    2012-01-01

    Both regulators and the nuclear industry recognise the need for licensees to develop a strong, positive safety culture to support successful and sustainable nuclear safety performance. A number of reports have been issued by the IAEA and the NEA on the role of the regulator in relation to oversight of safety culture (References 1 to 5). There has been less clarity on how this should be achieved - in particular, with regard to strategies and practical approaches for maintaining oversight of, and influencing, those facets of licensee leadership and management which have a profound influence on safety culture. In recognition of this, the CSNI Working Group on Human and Organisational Factors (WGHOF), together with the CNRA Working Group on Inspection Practices (WGIP) and the IAEA, organised a workshop in Chester, United Kingdom, in May 2007 to provide a forum for gathering and sharing international experience, including good practices and learning points. The results of the workshop are reported in Reference 6. Workshop participants agreed that, in view of the rapidly developing approaches in this area, it would be sensible to hold a further workshop ('Chester 2') in 3-5 years in order to discuss how regulatory approaches have moved on and to share lessons learned from their application. In 2010, the WGIP hosted a workshop which included regulatory approaches for the assessment of licensee safety culture as a discussion topic. The outputs of the workshop included a list of commendable practices for monitoring and evaluating licensee safety culture (Reference 7). The 'Chester 2' workshop took place in September 2011. This report sets out the findings of the workshop, organised by the UK Office for Nuclear Regulation (ONR) on behalf of the CSNI/WGHOF and the IAEA. The workshop was attended by over 40 representatives of nuclear regulatory bodies and licensees from 15 countries plus IAEA and NEA. The workshop featured keynote papers on learning from major events, and from

  2. Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

    Science.gov (United States)

    Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica

    2018-02-27

    Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question

  3. Eliminating cancer stem cells: an interview with CCR’s Steven Hou | Center for Cancer Research

    Science.gov (United States)

    Steven Hou, Ph.D., senior investigator in the Basic Research Laboratory at the Center for Cancer Research describes his latest research that has uncovered potential ways to eliminate cancer stem cells and may offer hope to patients with reoccurring tumors.  Learn more...

  4. Ovarian stem cells and neo-oogenesis: A breakthrough in reproductive biology research

    Directory of Open Access Journals (Sweden)

    S Mooyottu1

    2011-04-01

    Full Text Available The concept of ovarian stem cells which can replenish the ovarian reserve in postnatal mammalian females is a revolutionary breakthrough in reproductive biology. This idea overturned the central dogma existed in female reproductive physiology. Contradicting the popular belief that oogenesis does not occur in post natal life, researchers proved the existence of putative stem cells in ovary, which can supply functional follicles in post natal ovaries. Even though the idea of neo-oogenesis in postnatal ovaries in normal conditions is controversial, the isolation and manipulation of ovarian stem cells have got tremendous application in medical, veterinary and animal production fields. [Veterinary World 2011; 4(2.000: 89-91

  5. A novel performance monitoring framework for health research systems: experiences of the National Institute for Health Research in England

    Directory of Open Access Journals (Sweden)

    Hallsworth Michael

    2011-03-01

    Full Text Available Abstract Background The National Institute for Health Research (NIHR was established in 2006 with the aim of creating an applied health research system embedded within the English National Health Service (NHS. NIHR sought to implement an approach for monitoring its performance that effectively linked early indicators of performance with longer-term research impacts. We attempted to develop and apply a conceptual framework for defining appropriate key performance indicators for NIHR. Method Following a review of relevant literature, a conceptual framework for defining performance indicators for NIHR was developed, based on a hybridisation of the logic model and balanced scorecard approaches. This framework was validated through interviews with key NIHR stakeholders and a pilot in one division of NIHR, before being refined and applied more widely. Indicators were then selected and aggregated to create a basket of indicators aligned to NIHR's strategic goals, which could be reported to NIHR's leadership team on a quarterly basis via an oversight dashboard. Results Senior health research system managers and practitioners endorsed the conceptual framework developed and reported satisfaction with the breadth and balance of indicators selected for reporting. Conclusions The use of the hybrid conceptual framework provides a pragmatic approach to defining performance indicators that are aligned to the strategic aims of a health research system. The particular strength of this framework is its capacity to provide an empirical link, over time, between upstream activities of a health research system and its long-term strategic objectives.

  6. A novel performance monitoring framework for health research systems: experiences of the National Institute for Health Research in England.

    Science.gov (United States)

    El Turabi, Anas; Hallsworth, Michael; Ling, Tom; Grant, Jonathan

    2011-03-24

    The National Institute for Health Research (NIHR) was established in 2006 with the aim of creating an applied health research system embedded within the English National Health Service (NHS). NIHR sought to implement an approach for monitoring its performance that effectively linked early indicators of performance with longer-term research impacts. We attempted to develop and apply a conceptual framework for defining appropriate key performance indicators for NIHR. Following a review of relevant literature, a conceptual framework for defining performance indicators for NIHR was developed, based on a hybridisation of the logic model and balanced scorecard approaches. This framework was validated through interviews with key NIHR stakeholders and a pilot in one division of NIHR, before being refined and applied more widely. Indicators were then selected and aggregated to create a basket of indicators aligned to NIHR's strategic goals, which could be reported to NIHR's leadership team on a quarterly basis via an oversight dashboard. Senior health research system managers and practitioners endorsed the conceptual framework developed and reported satisfaction with the breadth and balance of indicators selected for reporting. The use of the hybrid conceptual framework provides a pragmatic approach to defining performance indicators that are aligned to the strategic aims of a health research system. The particular strength of this framework is its capacity to provide an empirical link, over time, between upstream activities of a health research system and its long-term strategic objectives.

  7. A Survey of Italian Physicians' Opinion about Stem Cells Research: What Doctors Prefer and What the Law Requires

    Directory of Open Access Journals (Sweden)

    Paola Frati

    2014-01-01

    Full Text Available To evaluate the Italian physicians' knowledge/information level about the therapeutic potential of stem cells, the research choice between embryonic and cordonal stem cells, and the preference between autologous and heterologous storage of cordonal stem cells, we performed a national survey. The questionnaire—distributed to 3361 physicians—involved physicians of different religious orientations and of different medical specialities. Most of the physicians involved (67% were Catholics, and the majority were gynaecologists and paediatricians (43% who are mainly in charge to inform future mothers about the possibility of cordonal stem cells conservation. The majority of the physicians interviewed do not have specific knowledge about stem cells (59%, most of them having only generic information (92%. The largest part of physicians prefer to use umbilical cord blood cells rather than embryonic stem cells. Nevertheless, a large percentage of physicians were in favour of embryo research, especially when embryos are supernumerary (44% versus 34%. Eighty-seven % of the physicians interviewed proved to have a general knowledge about stem cells and believe in their therapeutic potential. They prefer research on cordonal stem cells rather than on embryo stem cells. Although they are in favour of heterologous stem cells donation, they still prefer cryopreservation for personal use.

  8. Sickle Cell Research: Symptoms, Diagnosis, Treatment and Recent Developments | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... cell disease should have regular checkups to detect eye damage. And a simple ultrasound test of the head can identify children at high risk for strokes. Recent Developments Research on bone marrow transplants, gene therapy, and new medicines for sickle cell anemia is ongoing. The hope is that these ...

  9. The early career researcher's toolkit:translating tissue engineering, regenerative medicine and cell therapy products

    OpenAIRE

    Rafiq, Qasim A.; Ortega, Ilida; Jenkins, Stuart I.; Wilson, Samantha L.; Patel, Asha K.; Barnes, Amanda L.; Adams, Christopher F.; Delcassian, Derfogail; Smith, David

    2015-01-01

    Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in...

  10. Human iPSC-derived neurons and lymphoblastoid cells for personalized medicine research in neuropsychiatric disorders.

    Science.gov (United States)

    Gurwitz, David

    2016-09-01

    The development and clinical implementation of personalized medicine crucially depends on the availability of high-quality human biosamples; animal models, although capable of modeling complex human diseases, cannot reflect the large variation in the human genome, epigenome, transcriptome, proteome, and metabolome. Although the biosamples available from public biobanks that store human tissues and cells may represent the large human diversity for most diseases, these samples are not always sufficient for developing biomarkers for patient-tailored therapies for neuropsychiatric disorders. Postmortem human tissues are available from many biobanks; nevertheless, collections of neuronal human cells from large patient cohorts representing the human diversity remain scarce. Two tools are gaining popularity for personalized medicine research on neuropsychiatric disorders: human induced pluripotent stem cell-derived neurons and human lymphoblastoid cell lines. This review examines and contrasts the advantages and limitations of each tool for personalized medicine research.

  11. Research progresses in treating diabetic foot with autologous stem cell transplantation

    International Nuclear Information System (INIS)

    Qin Hanlin; Gao Bin

    2010-01-01

    Because the distal arteries of lower extremities become narrowed or even occluded in diabetic foot, the clinical therapeutic results for diabetic foot have been unsatisfactory so far. Autologous stem cell transplantation that has emerged in recent years is a new, safe and effective therapy for diabetic foot, which achieves its excellent clinical success in restoring the blood supply of ischemic limb by way of therapeutic angiogenesis. Now autologous stem cell transplantation has become one of the hot points in medical research both at home and abroad, moreover, it has brought a new hope of cure to the patients with diabetic foot. (authors)

  12. PTSD: National Center for PTSD

    Medline Plus

    Full Text Available ... VA Research Services Programs News, Events and Media Research Topics For Veterans For Researchers Research Oversight Special Groups Caregivers Combat Veterans & their Families ...

  13. Paternalism and utilitarianism in research with human participants.

    Science.gov (United States)

    Resnik, David B

    2015-03-01

    In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in research (such as significant injury to participants or death) is a crucial concern that must be taken into account when assessing the consequences of different policy options, because public backlash can lead to outcomes that have a negative impact on science, such as cuts in funding, overly restrictive regulation and oversight, and reduced willingness of individuals to participate in research. I argue that concern about the public reaction to adverse events justifies some restrictions on the risks that competent, adult volunteers can face in research that offers them no significant benefits. The paternalism defended here is not pure, because it involves restrictions on the rights of investigators in order to protect participants. It also has a mixed rationale, because individual autonomy may be restricted not only to protect participants from harm but also to protect other stakeholders. Utility is not the sole justification for paternalistic research policies, since other considerations, such as justice and respect for individual rights/autonomy, must also be taken into account.

  14. A global comparative overview of the legal regulation of stem cell research and therapy: Lessons for South Africa

    Directory of Open Access Journals (Sweden)

    Melodie Slabbert

    2015-09-01

    Full Text Available Stem cell research and its potential translation to regenerative medicine, tissue engineering and cell and gene therapy, have led to controversy and debates similar to the calls nearly 25 years ago for a ban involving recombinant DNA. Global legislative efforts in this field have been characterised by many legal, ethical and practical challenges, stemming from conflicting views regarding human embryonic research and cloning. National policy and regulatory developments have primarily been shaped by different understandings of relevant scientific objectives, as well as those relating to the moral and legal status of the human embryo, which have been used to justify or limit a range of permissible activities. Legal obscurity in this field, a consequence of inconsistent or vague legislative responses at a national and international level, leads to negative results, which include, among others, ethical violations; lack of collaboration and co-operation among researchers across national borders; stunted scientific progress; lack of public trust in stem cell research; proliferation of untested ‘stem cell therapies’; and safety issues. The purpose of this article is to explore the legal regulation of stem cell research and therapy globally, by comparing the permissibility of specific stem cell research activities in 35 selected jurisdictions, followed by a comparison of the regulatory approaches with regard to stem cell-based products in the European Union and the USA. A clearer understanding of the global regulatory framework will assist in formulating more effective legal responses at a national level and in navigating the uncertainties and risks associated with this complex and evolving scientific field.

  15. Research and experience report 2016 - Developments in the technical and legal basis for nuclear oversight

    International Nuclear Information System (INIS)

    2017-04-01

    Projects in the research programme of the Swiss Federal Nuclear Safety Inspectorate (ENSI) contribute to the clarification of outstanding issues, establish fundamentals and develop the tools required for its regulatory activities. International projects deliver results that Switzerland could not achieve on its own and encourage cross-border networking. The research on fuels and materials covers the reactor core and the multiple barriers for the retainment of radioactive materials especially concerning high burn-up rates and safety criteria. In 2016, the Studsvik Cladding Integrity Project in Sweden commissioned a new test facility to investigate the behaviour of fuel rods in loss of coolant accidents (LOCA). Research into structural materials focuses on ageing processes. In the NORA project at the Paul Scherrer Institute (PSI), platinum is injected into the cooling system with a view to reducing corrosion. Projects conducted under the auspices of the OECD's Nuclear Energy Agency (NEA) and relating to internal events and damage encourage the international exchange of information on incidents, accidents and component damage. Subject-specific databases are created on incidents involving fires or damage to passive metal components. In 2016 the OECD CODAP project prepared a report on reliability and integrity management in pressurised components. ENSI supports research projects on external events such as earthquakes, flooding, aircraft crashes and explosions. Within the OECD MECOS project, the behaviour of pipes subjected to powerful earthquakes was modelled; it showed improvements in the calculation of cyclic loading and on the limits for simulating elastic-plastic material behaviour under high loads. The impact of operator actions on incidents and accidents is the most important human factor in view of reducing uncertainty in probabilistic safety analyses, as well as the interfaces between humans and technical systems. System behaviour and accident sequences in

  16. Antecedents of cell aging research.

    Science.gov (United States)

    Hayflick, L

    1989-01-01

    Our observation that normal human and animal cells have a limited capacity to divide and function in vitro overturned a dogma held since the turn of the century. The dogma held that cultured normal cells are immortal and gerontologists interpreted this to mean that aging, therefore, could not be the result of intracellular events. We concluded that longevity and aging do result from intracellular events, and, in the subsequent 30 years, the validity of our finding has been widely confirmed. Other major findings have been made: (a) The number of population doublings and functional events that a cultured normal cell can undergo is inversely proportional to donor age and, probably, directly proportional to species longevity; (b) the limit on cell division and function also occurs in vivo when normal cells are transplanted seriatim; (c) as cell doublings or functional events reach their limit, changes occur in hundreds of variables from the molecular to the whole cell. Most importantly, many of these changes are identical to those seen in intact humans and animals as they age; (d) WI-38, the first widely distributed normal human cell strain has retained its memory of population doubling level during 27 years of cryogenic storage. This is the longest time that any normal human cell has ever been preserved. Evidence that longevity is determined by genetic events is overwhelming but evidence that age changes are the result of gene expression is not. Normal age changes must be distinguished from disease. Because few feral animals ever become old, natural selection could not have favored the development of a genetically programmed aging process. In the 2 or 3 million years of human existence, too few old humans existed to have provided a selective advantage favoring the development of a genetic program that would determine age changes. The selective advantage of maintaining physiological vigor for as long as possible in order to insure maximum reproductive success may be

  17. NASA Glenn Research Center Solar Cell Experiment Onboard the International Space Station

    Science.gov (United States)

    Myers, Matthew G.; Wolford, David S.; Prokop, Norman F.; Krasowski, Michael J.; Parker, David S.; Cassidy, Justin C.; Davies , William E.; Vorreiter, Janelle O.; Piszczor, Michael F.; Mcnatt, Jeremiah S.; hide

    2016-01-01

    Accurate air mass zero (AM0) measurement is essential for the evaluation of new photovoltaic (PV) technology for space solar cells. The NASA Glenn Research Center (GRC) has flown an experiment designed to measure the electrical performance of several solar cells onboard NASA Goddard Space Flight Center's (GSFC) Robotic Refueling Missions (RRM) Task Board 4 (TB4) on the exterior of the International Space Station (ISS). Four industry and government partners provided advanced PV devices for measurement and orbital environment testing. The experiment was positioned on the exterior of the station for approximately eight months, and was completely self-contained, providing its own power and internal data storage. Several new cell technologies including four-junction (4J) Inverted Metamorphic Multi-junction (IMM) cells were evaluated and the results will be compared to ground-based measurement methods.

  18. The Microscope against Cell Theory: Cancer Research in Nineteenth-Century Parisian Anatomical Pathology.

    Science.gov (United States)

    Loison, Laurent

    2016-07-01

    This paper examines the reception of cell theory in the field of French anatomical pathology. This reception is studied under the lens of the concept of the cancer cell, which was developed in Paris in the 1840s. In the medical field, cell theory was quickly accessible, understood, and discussed. In the wake of research by Hermann Lebert, the cancer cell concept was supported by a wealth of high-quality microscopic observations. The concept was constructed in opposition to cell theory, which appears retrospectively paradoxical and surprising. Indeed, the biological atomism inherent in cell theory, according to which the cell is the elementary unit of all organs of living bodies, appeared at the time incompatible with the possible existence of pathological cells without equivalent in healthy tissues. Thus, the postulate of atomism was used as an argument by Parisian clinicians who denied the value of the cancer cell. This study shows that at least in the field of anatomical pathology, cell theory did not directly result from the use of the microscope but was actually hindered by it. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  19. For love or money? The saga of Korean women who provided eggs for embryonic stem cell research.

    Science.gov (United States)

    Baylis, Françoise

    2009-01-01

    In 2004 and 2005, Woo-Suk Hwang achieved international stardom with publications in Science reporting on successful research involving the creation of stem cells from cloned human embryos. The wonder and success all began to unravel, however, when serious ethical concerns were raised about the source of the eggs for this research. When the egg scandal had completely unfolded, it turned out that many of the women who provided eggs for stem cell research had not provided valid consents and that nearly 75% of the women egg providers had received cash or in-kind payments. Among those who did not receive direct benefits, some cited patriotism as their reason for participating in embryonic stem cell research, hence the question "for love or money?"--namely, patriotism versus payment. This paper summarizes the Hwang debacle with particular attention to the egg scandal and ends with some preliminary thoughts on patriotism as a motive for research participation.

  20. The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

    Directory of Open Access Journals (Sweden)

    Matthew Hunt

    Full Text Available Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs, in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries.We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques.Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process.Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be

  1. From global bioethics to ethical governance of biomedical research collaborations.

    Science.gov (United States)

    Wahlberg, Ayo; Rehmann-Sutter, Christoph; Sleeboom-Faulkner, Margaret; Lu, Guangxiu; Döring, Ole; Cong, Yali; Laska-Formejster, Alicja; He, Jing; Chen, Haidan; Gottweis, Herbert; Rose, Nikolas

    2013-12-01

    One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved. Copyright © 2013 Elsevier Ltd. All rights reserved.

  2. Challenging the FDA's authority to regulate autologous adult stem cells for therapeutic use: Celltex therapeutics' partnership with RNL Bio, substantial medical risks, and the implications of United States v. Regenerative Sciences.

    Science.gov (United States)

    Drabiak-Syed, Katherine

    2013-01-01

    This Article examines the convergence of three corporations that have attempted to capitalize on translating emerging research into clinical procedures by manufacturing and facilitating the process for patients to obtain mesenchymal stem cell (MSC) injections. Although the Food and Drug Administration (FDA) has asserted its authority to regulate somatic cell therapy products like MSCs under the Public Health Service Act and the Food, Drug, and Cosmetic Act, some manufacturers have attempted to circumvent FDA regulation through various mechanisms and argue that their products do not fall within the definition of a biological product or drug. However, scientific knowledge of using MSCs for clinical therapy remains in its infancy, and MSCs pose a number of serious risks to patients. This Article focuses on the development of Celltex, a company based in Sugar Land, Texas that manufactures and facilitates the injection of autologous MSCs; RNL Bio, a company that licenses its operations technology to Celltex; and Regenerative Sciences, a company based in Broomfield, Colorado that was recently involved in litigation with the FDA. Corporate circumvention of intended regulatory oversight exposes patients to potentially inefficacious products that could contribute to serious medical injuries such as viruses, myocardial infarction, cancer, or death.

  3. Research progress in muscle-derived stem cells: Literature retrieval results based on international database.

    Science.gov (United States)

    Zhang, Li; Wang, Wei

    2012-04-05

    To identify global research trends of muscle-derived stem cells (MDSCs) using a bibliometric analysis of the Web of Science, Research Portfolio Online Reporting Tools of the National Institutes of Health (NIH), and the Clinical Trials registry database (ClinicalTrials.gov). We performed a bibliometric analysis of data retrievals for MDSCs from 2002 to 2011 using the Web of Science, NIH, and ClinicalTrials.gov. (1) Web of Science: (a) peer-reviewed articles on MDSCs that were published and indexed in the Web of Science. (b) Type of articles: original research articles, reviews, meeting abstracts, proceedings papers, book chapters, editorial material and news items. (c) Year of publication: 2002-2011. (d) Citation databases: Science Citation Index-Expanded (SCI-E), 1899-present; Conference Proceedings Citation Index-Science (CPCI-S), 1991-present; Book Citation Index-Science (BKCI-S), 2005-present. (2) NIH: (a) Projects on MDSCs supported by the NIH. (b) Fiscal year: 1988-present. (3) ClinicalTrials.gov: All clinical trials relating to MDSCs were searched in this database. (1) Web of Science: (a) Articles that required manual searching or telephone access. (b) We excluded documents that were not published in the public domain. (c) We excluded a number of corrected papers from the total number of articles. (d) We excluded articles from the following databases: Social Sciences Citation Index (SSCI), 1898-present; Arts & Humanities Citation Index (A&HCI), 1975-present; Conference Proceedings Citation Index - Social Science & Humanities (CPCI-SSH), 1991-present; Book Citation Index - Social Sciences & Humanities (BKCI-SSH), 2005-present; Current Chemical Reactions (CCR-EXPANDED), 1985-present; Index Chemicus (IC), 1993-present. (2) NIH: (a) We excluded publications related to MDSCs that were supported by the NIH. (b) We limited the keyword search to studies that included MDSCs within the title or abstract. (3) ClinicalTrials.gov: (a) We excluded clinical trials that were

  4. Leading research report for fiscal 1998. Research and study of 3-dimensional cell structure module engineering; 1998 nendo sendo chosa kenkyu hokokusho. Sanjigen saibo soshiki module kogaku chosa kenkyu

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-03-01

    For the formation of cellular tissues to replace bionic tissues, researches were conducted about technologies of forming bionic tissue modules by culturing various kinds of cells. As for the materials and methods for constructing cellular tissues, researches were conducted about the trends of research and development of 3-dimensional tissue culturing matrices and materials for micromanipulation. As for the development of technologies for the functionalization of 3-dimensionally structured cells, research and study were conducted about the technology of 3-dimensional cell structure organization through application of physical stimulation, the biochemical technology of differentiation inducing, and the differentiation inducing technology for hetero tissue culturing. As for the development of technologies for evaluation using 3-dimensionally structured cells, light CT (computer tomography), analysis and evaluation using spectroscopy and the like, feasibility of the biochemical analysis of the cell state using biosensors, technologies for measuring the secretion of carcinogenic and toxic substances, etc., were studied. In addition, the development of organic models to replace test animals, industrial evolution of 3-dimensional tissue module engineering, etc., were investigated. (NEDO)

  5. HA Cells monitoring at the Underground Research Laboratory (URL) in the CMHM (Andra)

    International Nuclear Information System (INIS)

    Gay, Olivier; Allagnat, Dominique; Morel, Jacques; Armand, Gilles

    2010-01-01

    The experimental monitoring program of the HA (High Activity) cells was carried out at the Underground Research Laboratory (URL) in the Meuse Haute Marne department in France (CMHM Andra). Inspections made by video and photographs, section measurements and geo-referenced trajectories, in addition to measurements of convergence, temperature and hygrometry over time, allowed a better analysis of the behaviour of the HA cells after excavation, and subsequently over the long term. (authors)

  6. Study of the application potential of synthetic and natural polymeric coatings in stem cell research

    OpenAIRE

    Perestrelo, Ana Rubina

    2014-01-01

    Self-renewability and the ability to differentiate into various functional cells are characteristics of embryonic stem cells (ESCs) that make them attractive for applications in biomedical field, namely in restoring the function of damaged cells/tissues. In research, ESCs are usually cultured in gelatin or over a monolayer of mitotically inactivated mouse embryonic fibroblasts (MEFsi). The latter is the gold standard to maintain pluripotent ESCs in culture. A variety of alterna...

  7. Research of aquatic organism addition influence on the reproduction of yeast cells in the dough

    Directory of Open Access Journals (Sweden)

    Дмитро Павлович Крамаренко

    2016-12-01

    Full Text Available The analysis of the research results of influence of various amounts of aquatic organism additions on the reproduction of yeast cells is given. A positive impact of aquatic organism addition of animal and plant origin in investigated quantities on the reproduction of yeast cells is revealed. The influence of the chemical composition of the aquatic organism additives on the reproduction of yeast cells is proved

  8. Isolation of a strong Arabidopsis guard cell promoter and its potential as a research tool

    Science.gov (United States)

    Yang, Yingzhen; Costa, Alex; Leonhardt, Nathalie; Siegel, Robert S; Schroeder, Julian I

    2008-01-01

    Background A common limitation in guard cell signaling research is that it is difficult to obtain consistent high expression of transgenes of interest in Arabidopsis guard cells using known guard cell promoters or the constitutive 35S cauliflower mosaic virus promoter. An additional drawback of the 35S promoter is that ectopically expressing a gene throughout the organism could cause pleiotropic effects. To improve available methods for targeted gene expression in guard cells, we isolated strong guard cell promoter candidates based on new guard cell-specific microarray analyses of 23,000 genes that are made available together with this report. Results A promoter, pGC1(At1g22690), drove strong and relatively specific reporter gene expression in guard cells including GUS (beta-glucuronidase) and yellow cameleon YC3.60 (GFP-based calcium FRET reporter). Reporter gene expression was weaker in immature guard cells. The expression of YC3.60 was sufficiently strong to image intracellular Ca2+ dynamics in guard cells of intact plants and resolved spontaneous calcium transients in guard cells. The GC1 promoter also mediated strong reporter expression in clustered stomata in the stomatal development mutant too-many-mouths (tmm). Furthermore, the same promoter::reporter constructs also drove guard cell specific reporter expression in tobacco, illustrating the potential of this promoter as a method for high level expression in guard cells. A serial deletion of the promoter defined a guard cell expression promoter region. In addition, anti-sense repression using pGC1 was powerful for reducing specific GFP gene expression in guard cells while expression in leaf epidermal cells was not repressed, demonstrating strong cell-type preferential gene repression. Conclusion The pGC1 promoter described here drives strong reporter expression in guard cells of Arabidopsis and tobacco plants. It provides a potent research tool for targeted guard cell expression or gene silencing. It is also

  9. Australia's bio-regulatory framework: leading the way for stem cell research.

    Science.gov (United States)

    Hill, Helen

    2004-01-01

    Biotechnology in Australia has flourished over the past five years. During this time the number of companies has doubled to over 370, and over 40 companies are now publicly listed. The total market capitalization of the biotechnology companies listed on the Australian Stock Exchange (ASX) in 2003 was US$1.5 billion. Total market capitalization of the health and biotech companies on the ASX was US$13 billion. The size of the total Australian pharmaceutical market in 2003 was US$9 billion. This article highlights the role of Australia in advancing stem cell research and its contribution to biotechnology research, development and commercialization.

  10. What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Louise Dudley

    Full Text Available Patient and public involvement (PPI is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups and managerial (e.g. trial management groups roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees.Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

  11. Stem Cells of Dental Origin: Current Research Trends and Key Milestones towards Clinical Application

    Directory of Open Access Journals (Sweden)

    Athina Bakopoulou

    2016-01-01

    Full Text Available Dental Mesenchymal Stem Cells (MSCs, including Dental Pulp Stem Cells (DPSCs, Stem Cells from Human Exfoliated Deciduous teeth (SHED, and Stem Cells From Apical Papilla (SCAP, have been extensively studied using highly sophisticated in vitro and in vivo systems, yielding substantially improved understanding of their intriguing biological properties. Their capacity to reconstitute various dental and nondental tissues and the inherent angiogenic, neurogenic, and immunomodulatory properties of their secretome have been a subject of meticulous and costly research by various groups over the past decade. Key milestone achievements have exemplified their clinical utility in Regenerative Dentistry, as surrogate therapeutic modules for conventional biomaterial-based approaches, offering regeneration of damaged oral tissues instead of simply “filling the gaps.” Thus, the essential next step to validate these immense advances is the implementation of well-designed clinical trials paving the way for exploiting these fascinating research achievements for patient well-being: the ultimate aim of this ground breaking technology. This review paper presents a concise overview of the major biological properties of the human dental MSCs, critical for the translational pathway “from bench to clinic.”

  12. Research and experience report 2010 - Developments in the technical and legal basis of nuclear oversight

    International Nuclear Information System (INIS)

    2011-04-01

    This comprehensive annual report presents a review of the activities carried out by the Swiss Federal Nuclear Safety Inspectorate (ENSI) in the year 2010. The inspectorate's fields of activity - fuels and materials, significant internal and external events and occurrences, human factors, system behaviour and accident sequences, radiological protection and waste disposal - are reviewed. Information on incidents in Swiss nuclear facilities are reviewed in the ENSI Surveillance Report. The Research and Experience Report also provides information on a selection of particularly instructive incidents in nuclear facilities outside Switzerland. Incidents are analysed with a view to identifying any potential relevance to Swiss nuclear facilities. International co-operation is mentioned and current changes and developments related to plant surveillance are noted. Organisational aspects are discussed and various guidelines and directives are presented and discussed

  13. PTSD: National Center for PTSD

    Medline Plus

    Full Text Available ... and Media Research Topics For Veterans For Researchers Research Oversight Special Groups Caregivers Combat Veterans & their Families Readjustment Counseling (Vet Centers) War Related Illness & Injury ...

  14. Fundamental elements in examining a child’s right to education: A study of home education research and regulation in Australia

    Directory of Open Access Journals (Sweden)

    Glenda JACKSON

    2010-07-01

    Full Text Available Home education provides valuable educational and developmental opportunities for children. An examination of Australia’s research indicates many best educational practices, including more informed mediation, contextualised learning, and opportunities to exercise autonomy. Key features include learning embedded in communities and program modification in response to students’ needs. Current state and territory legal requirements are examined within the context of this research and Australia’s obligations to international human rights treaties. All jurisdictions accept home education as one way to meet compulsory education requirements. The extent to which respective laws then reflect understanding of home education research and practice varies. Most jurisdictions allow for a varietyof educational approaches. Some oversight regulation could however be modified to reflect a better understanding of home education. Consultation with home educators and reference to research would assist the development of more uniform legislation and policy across Australia, and enable better regulatory practice.

  15. Discarded human fetal tissue and cell cultures for transplantation research

    International Nuclear Information System (INIS)

    Hay, R.J.; Phillips, T.; Thompson, A.; Vilner, L.; Cleland, M.; Tchaw-ren Chen; Zabrenetzky, V.

    1999-01-01

    A feasibility study has been performed to explore the utility of various tissues from discarded human abortuses for transplantation and related research. Specifically, aborted fetuses plus parental blood samples and all relevant clinical data were obtained through a local hospital complex. Whenever possible, pancreas, skin and skeletal muscle, heart, liver, kidney, cartilage and lung tissues were removed, dissociated and subfractionated for cryopreservation, characterization and cultivation trials in vitro. Existing protocols for these manipulations were compared and improved upon as required. Clonal culture, cell aggregate maintenance techniques and use of feeder cell populations have been utilized where appropriate to develop quantitative comparative data. Histological and biochemical assays were applied both to evaluate separation/cultivation methods and to identify optimal culture conditions for maintaining functional cells. Immunochemical and molecular biological procedures were applied to study expression of Major Histocompatibility Vomplex (MHC) class 1 and 11 molecules on cell lines derived. Tissue and cell culture populations were examined for infections with bacteria, ftingi, mycoplasma, HIV, CMV, hepatitis B and other viruses. Only 1% of the abortuses tested were virally infected. Cytogenetic analyses confin-ned the normal diploid status in the vast majority (>98%) of lines tested. A total of over 250 abortuses have been obtained and processed. Only 25 were found to be contaminated with bacteria or fungi and unsuitable for further cultivation trials. A total of over 200 cell populations were isolated, characterized and cryopreserved for further study. Included were kidney, lung, liver and epidermal epithelia: cartilage-derived cells from the spine and epiphyses plus myogenic myoblasts. Selected lines have been immortalized using HPV I 6E6/E7 sequences. Epithelia from the liver and pancreas and cardiac myocytes were the most problematic in that initial

  16. Use of "excess" human embryos for stem cell research: protecting women's rights and health.

    Science.gov (United States)

    Cohen, C B

    2000-01-01

    Proposed National Institutes of Health guidelines for stem cell research are too narrowly drawn and do not adequately protect the freedom of choice and health of women who donate embryos. They need to be expanded to cover not only the point of embryo donation, but also that of embryo creation. Guidelines are provided to ensure that donors undergoing hyperstimulation and egg retrieval gave voluntary informed consent to the production of embryos that might later prove in excess. A standard for determining when embryos have been overproduced is presented to address the possibility that additional embryos will be created for stem cell research in violation of the guidelines and at risk to women's health.

  17. “Just one animal among many?” Existential phenomenology, ethics, and stem cell research

    Science.gov (United States)

    2010-01-01

    Stem cell research and associated or derivative biotechnologies are proceeding at a pace that has left bioethics behind as a discipline that is more or less reactionary to their developments. Further, much of the available ethical deliberation remains determined by the conceptual framework of late modern metaphysics and the correlative ethical theories of utilitarianism and deontology. Lacking, to any meaningful extent, is a sustained engagement with ontological and epistemological critiques, such as with “postmodern” thinking like that of Heidegger’s existential phenomenology. Some basic “Heideggerian” conceptual strategies are reviewed here as a way of remedying this deficiency and adding to ethical deliberation about current stem cell research practices. PMID:20521117

  18. Achievement report for 1st phase (fiscal 1974-80) Sunshine Program research and development - Hydrogen energy. Research on fuel cell (Research on high-temperature solid electrolyte fuel cell); 1974-1980 nendo suiso energy seika hokokusho. Nenryo denchi no kenkyu (koon kotai denkaishitsu nenryo denchi no kenkyu)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1981-03-01

    Relative to the research and development of technologies for fabricating, and assessing, materials for the constitution of high-temperature solid electrolyte fuel cells, stabilized zirconia solid electrolyte fuel cell manufacturing technologies are developed by use of thin film formation techniques such as high-frequency sputtering, plasma CVD (chemical vapor deposition), and the thermolysis of organic zirconia compound coating. As the result, it is found that high-frequency sputtering produces thin film which is satisfying in terms of cost efficiency. Furthermore, it is found that defects in solid electrolytic thin film formed by the high-frequency sputtering method, that is, pinholes and cracks, will be remedied when the coating thermolysis method is jointly applied. In the research on fuel cell power systems, column-type high-temperature solid electrolyte fuel cells are built, and a power generation test is conducted. The test is successfully completed when the output of a fuel cell of the 9-column module structure gradually increases until a maximum output of 110W is achieved. (NEDO)

  19. Test of Hydrogen-Oxygen PEM Fuel Cell Stack at NASA Glenn Research Center

    Science.gov (United States)

    Bents, David J.; Scullin, Vincent J.; Chang, Bei-Jiann; Johnson, Donald W.; Garcia, Christopher P.; Jakupca, Ian J.

    2003-01-01

    This paper describes performance characterization tests of a 64 cell hydrogen oxygen PEM fuel cell stack at NASA Glenn Research Center in February 2003. The tests were part of NASA's ongoing effort to develop a regenerative fuel cell for aerospace energy storage applications. The purpose of the tests was to verify capability of this stack to operate within a regenerative fuel cell, and to compare performance with earlier test results recorded by the stack developer. Test results obtained include polarization performance of the stack at 50 and 100 psig system pressure, and a steady state endurance run at 100 psig. A maximum power output of 4.8 kWe was observed during polarization runs, and the stack sustained a steady power output of 4.0 kWe during the endurance run. The performance data obtained from these tests compare reasonably close to the stack developer's results although some additional spread between best to worst performing cell voltages was observed. Throughout the tests, the stack demonstrated the consistent performance and repeatable behavior required for regenerative fuel cell operation.

  20. Public Opinion about the Importance of Privacy in Biobank Research

    Science.gov (United States)

    Kaufman, David J.; Murphy-Bollinger, Juli; Scott, Joan; Hudson, Kathy L.

    2009-01-01

    Concerns about privacy may deter people from participating in genetic research. Recruitment and retention of biobank participants requires understanding the nature and magnitude of these concerns. Potential participants in a proposed biobank were asked about their willingness to participate, their privacy concerns, informed consent, and data sharing. A representative survey of 4659 U.S. adults was conducted. Ninety percent of respondents would be concerned about privacy, 56% would be concerned about researchers having their information, and 37% would worry that study data could be used against them. However, 60% would participate in the biobank if asked. Nearly half (48%) would prefer to provide consent once for all research approved by an oversight panel, whereas 42% would prefer to provide consent for each project separately. Although 92% would allow academic researchers to use study data, 80% and 75%, respectively, would grant access to government and industry researchers. Concern about privacy was related to lower willingness to participate only when respondents were told that they would receive $50 for participation and would not receive individual research results back. Among respondents who were told that they would receive $200 or individual research results, privacy concerns were not related to willingness. Survey respondents valued both privacy and participation in biomedical research. Despite pervasive privacy concerns, 60% would participate in a biobank. Assuring research participants that their privacy will be protected to the best of researchers' abilities may increase participants' acceptance of consent for broad research uses of biobank data by a wide range of researchers. PMID:19878915

  1. Research and experience report 2015 - Developments in the technical and legal basis for nuclear oversight

    International Nuclear Information System (INIS)

    2016-04-01

    Projects in the research programme of the Swiss Federal Nuclear Safety Inspectorate (ENSI) contribute to the clarification of outstanding issues, establish fundamentals and develop the tools required for its regulatory activities. International projects deliver results that Switzerland could not achieve on its own and encourage international networking. The research on fuels and materials covers the reactor core and the multiple barriers for the retainment of radioactive materials. In 2015 the OECD Halden Reactor Project developed new methods for measuring the thermal conductivity of fuel and the creep of cladding materials during irradiation in the reactor and ageing processes. The PISA project of the Paul Scherrer Institute (PSI) focused on the deterministic and probabilistic assessment of the integrity of reactor pressure vessels. Under the auspices of the OECD's Nuclear Energy Agency, specific databases are being created on damage to passive metal components and electrical cables. The OECD FIRE project completed its report into the combination of fires with other events; half of these events are linked to electric arcing. ENSI research projects address external events such as earthquakes, flooding, aircraft crashes and explosions. A project of the American Society of Mechanical Engineers is investigating pre-stressed reinforced concrete slabs under explosive loads. Other OECD projects consider the effects of severe earthquakes on reinforced concrete walls and pipelines. The ROES PSI project is expanding the application of methods for assessing operator errors that can negatively influence the course of an accident. System behaviour and accident sequences in nuclear power plants are analysed in conditions ranging from normal operations through to accidents involving core meltdown. The results of computer models are used for the quantitative identification of plant risk in probabilistic safety analyses. The STARS PSI project improves the basic principles for

  2. Isolation of a strong Arabidopsis guard cell promoter and its potential as a research tool

    Directory of Open Access Journals (Sweden)

    Siegel Robert S

    2008-02-01

    Full Text Available Abstract Background A common limitation in guard cell signaling research is that it is difficult to obtain consistent high expression of transgenes of interest in Arabidopsis guard cells using known guard cell promoters or the constitutive 35S cauliflower mosaic virus promoter. An additional drawback of the 35S promoter is that ectopically expressing a gene throughout the organism could cause pleiotropic effects. To improve available methods for targeted gene expression in guard cells, we isolated strong guard cell promoter candidates based on new guard cell-specific microarray analyses of 23,000 genes that are made available together with this report. Results A promoter, pGC1(At1g22690, drove strong and relatively specific reporter gene expression in guard cells including GUS (beta-glucuronidase and yellow cameleon YC3.60 (GFP-based calcium FRET reporter. Reporter gene expression was weaker in immature guard cells. The expression of YC3.60 was sufficiently strong to image intracellular Ca2+ dynamics in guard cells of intact plants and resolved spontaneous calcium transients in guard cells. The GC1 promoter also mediated strong reporter expression in clustered stomata in the stomatal development mutant too-many-mouths (tmm. Furthermore, the same promoter::reporter constructs also drove guard cell specific reporter expression in tobacco, illustrating the potential of this promoter as a method for high level expression in guard cells. A serial deletion of the promoter defined a guard cell expression promoter region. In addition, anti-sense repression using pGC1 was powerful for reducing specific GFP gene expression in guard cells while expression in leaf epidermal cells was not repressed, demonstrating strong cell-type preferential gene repression. Conclusion The pGC1 promoter described here drives strong reporter expression in guard cells of Arabidopsis and tobacco plants. It provides a potent research tool for targeted guard cell expression or

  3. Family and physician influence on asthma research participation decisions for adolescents: the effects of adolescent gender and research risk.

    Science.gov (United States)

    Brody, Janet L; Scherer, David G; Annett, Robert D; Turner, Charles; Dalen, Jeanne

    2006-08-01

    There is considerable ethical and legal ambiguity surrounding the role of adolescents in the decision-making process for research participation. Depending on the nature of the study and the regulations involved, adolescents may have independent responsibility for providing informed consent, they may be asked to provide their assent, or they may be completely excluded from the decision-making process. This study examined parent and adolescent perceptions of decision-making authority and sources of influence on adolescent research participation decisions, and examined whether perceptions of influence differed based on adolescent gender and level of research risk. Adolescents (n = 36) with asthma and their parents reviewed 9 pediatric research protocols, decided whether they would choose to participate, rated the extent they would be responsible for the actual decision, and indicated the ability of family and physician to influence their decisions. Multivariate analyses of variance were used to evaluate differences in perceptions of decision-making authority and sources of influence on the decisions. Adolescents were less willing to cede decision making authority to parents than parents anticipated. Parents and adolescents acknowledged a greater openness to influence from physicians than from family for above minimal risk studies. Parents were more willing to consider opinions from male adolescents. Adolescents desire responsibility for research participation decisions, though parents may not share these views. Physicians' views on research participation are important to families, especially for above minimal risk studies. Parents may grant more decision-making autonomy to adolescent males than to females. Researchers, physicians, and institutions play a key role in facilitating the ethical enrollment of adolescents into biomedical research. Educational, policy, and oversight processes that support both adolescent autonomy and parental responsibility for research

  4. The circuitous path of democracy : legislative control of the bureaucracy in presidential regimes : the case of Mexico

    OpenAIRE

    Ríos C., Alejandra

    2010-01-01

    My research identifies conditions for legislators in emerging presidential democracies to achieve bureaucratic accountability, one of the least studies aspects of legislative politics. To better explain legislators' ability to hold the bureaucracy accountable, I develop a theoretical model of oversight in which resource constraints (i.e., capabilities) and electoral motivations and policy preferences (i.e., incentives) explain legislators' behavior. The model shows that legislators' oversight...

  5. MORT User's Manual for use with the Management Oversight and Risk Tree analytical logic diagram. [Contains a list of System Safety Development Center publications

    Energy Technology Data Exchange (ETDEWEB)

    Knox, N.W.; Eicher, R.W.

    1992-02-01

    This report contains the User's Manual for MORT (Management Oversight and Risk Tree), a logic diagram in the form of a work sheet'' that illustrates a long series of interrelated questions. MORT is a comprehensive analytical procedure that provides a disciplined method for determining the causes and contributing factors of major accidents. Alternatively, it serves as a tool to evaluate the quality of an existing system. While similar in many respects to fault tree analysis, MORT is more generalized and presents over 1,500 specific elements of an ideal universal'' management program for optimizing environment, safety and health, and other programs. This User's Manual is intended to be used with the MORT diagram dated February 1992.

  6. Achievement report on research and development in the Sunshine Project in fiscal 1979. Research on fuel cells (Research on aqueous alkaline solution electrolyte fuel cells); 1979 nendo nenryo denchi no kenkyu seika hokokusho. Arukari suiyoeki denkaishitsu nenryo denchi no kenkyu

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1980-03-01

    This paper describes achievements in fiscal 1979 in research on aqueous alkaline solution electrolyte fuel cells. Trial fabrication and tests for an oxygen electrode were performed on a catalytic electrode added with silver using carbonblack and graphites as carriers having excellent corrosion resistance and large surface area. Characteristics not inferior to electrodes using activated carbon as a carrier were obtained in both of the initial characteristics and continuous discharge characteristics. A platinum added electrode also showed the same performance as the silver added electrode. A hydrogen electrode containing Zr and iron among those containing Raney-Ni was found to have high oxidation resistance and stability in terms of life. A platinum added electrode using graphite as a carrier provided satisfactory initial characteristics as a hydrogen electrode. Research on a single cell construction has used and tested eight-cell laminated cells with an area of 1,000 cm{sup 2} using bipolar sheets made of carbon. The test verified appropriate the removal of produced water and heat using mainly the hydrogen circulation, which has been discussed in the summary design. The paper describes heat cycles, for which tests of ten and odds times in total were performed to have demonstrated that they are free of any anomaly. Furthermore, a manifold was attached as a means to improve the volume efficiency. Its function was also tested. (NEDO)

  7. Nuclear weapons facilities. Hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, Ninety-Ninth Congress, Second Session, March 6, 1986

    International Nuclear Information System (INIS)

    Anon.

    1987-01-01

    A hearing to review evidence that security at DOE weapons facilities is not adequate to protect against a potential terrorist attack focused on incidents in which security personnel performances reveal weaknesses in the Inspection and Evaluation (I and E) program. Criticism of the program cited DOE credibility, personnel training and possible drug use by plant personnel, poor coordination, and inadequate protection for physical plants and classified information. Reduced budgeting for security contributed to the problem. The hearing record includes an exchange of correspondence between the Oversight Committee and government officials, the testimony of DOE officials responsible for defense programs, and other material submitted for the record

  8. Stem cells engineering for cell-based therapy.

    Science.gov (United States)

    Taupin, Philippe

    2007-09-01

    Stem cells carry the promise to cure a broad range of diseases and injuries, from diabetes, heart and muscular diseases, to neurological diseases, disorders and injuries. Significant progresses have been made in stem cell research over the past decade; the derivation of embryonic stem cells (ESCs) from human tissues, the development of cloning technology by somatic cell nuclear transfer (SCNT) and the confirmation that neurogenesis occurs in the adult mammalian brain and that neural stem cells (NSCs) reside in the adult central nervous system (CNS), including that of humans. Despite these advances, there may be decades before stem cell research will translate into therapy. Stem cell research is also subject to ethical and political debates, controversies and legislation, which slow its progress. Cell engineering has proven successful in bringing genetic research to therapy. In this review, I will review, in two examples, how investigators are applying cell engineering to stem cell biology to circumvent stem cells' ethical and political constraints and bolster stem cell research and therapy.

  9. Development of the Young Brain

    Medline Plus

    Full Text Available ... Grants Application Process Managing Grants Clinical Research Training Small Business Research Labs at NIMH Labs at NIMH Home Research Areas Principal Investigators Administrative Oversight & Support Collaborations & Partnerships Join ...

  10. Symptoms and Treatment of Depression

    Medline Plus

    Full Text Available ... Grants Application Process Managing Grants Clinical Research Training Small Business Research Labs at NIMH Labs at NIMH Home Research Areas Principal Investigators Administrative Oversight & Support Collaborations & Partnerships Join ...

  11. T-Cell Warriors—Equipped to Kill Cancer Cells | Center for Cancer Research

    Science.gov (United States)

    When the body recognizes tumor cells as foreign, a natural immune response arises to attack them. Unfortunately, tumors have ways to evade immune surveillance systems and antitumor responses are often too weak to defeat the disease. Rather than relying on the body’s natural response, scientists can now manipulate a patient’s own immune cells so that they latch on to tumor cells by recognizing specific proteins on their surface. A type of immune cell that has been explored for this purpose is the killer (cytotoxic) T cell, which eliminates cells infected by viruses, damaged cells, and tumor cells.

  12. Research and development of CdTe based thin film PV solar cells

    Science.gov (United States)

    Diso, Dahiru Garba

    The motivation behind this research is to bring cheap, low-cost and clean energy technologies to the society. Colossal use of fossil fuel has created noticeable pollution problems contributing to climate change and health hazards. Silicon based solar cells have dominated the market but it is cost is high due to the manufacturing process. Therefore, the way forward is to develop thin films solar cells using low-cost attractive materials, grown by cheaper, scalable and manufacturable techniques.The aim and objectives of this work is to develop low-cost, high efficiency solar cell using electrodeposition (ED) technique. The material layers include CdS and ZnTe as the window materials, while the absorber material is CdTe. Fabricating a suitable devices for solar energy conversion (i.e. glass/conducting glass/window material/absorber material/metal) structure. Traditional way of fabricating this structure is to grow window material (CdS) using chemical bath deposition (CBD) and absorber material (CdTe) using electrodeposition. However, CBD is a batch process and therefore creates large volumes of Cd-containing waste solutions each time adding high cost in manufacturing process. This research programme is therefore on development of an "All ED-solar cells" structure.Material studies were carried out using photoelectrochemical (PEC) studies, UV-Vis spectrophotometry, X-ray diffraction (XRD), X-ray fluorescence (XRF), scanning electron microscopy (SEM), atomic force microscopy (AFM), Raman spectroscopy and X-ray photoelectron spectroscopy (XPS). Furthermore, the electrical characterisation of fully fabricated devices was performed using current-voltage (I-V) and capacitance-voltage (C-V) measurements.This research programme has demonstrated that CdS and ZnTe window materials can be electrodeposited and used in thin film solar cell devices. The CdS electrolytic bath can be used for a period of 7 months without discarding it like in the CBD process which usually has life

  13. Chimeric antigen receptor T cell therapy in pancreatic cancer: from research to practice.

    Science.gov (United States)

    Jindal, Vishal; Arora, Ena; Masab, Muhammad; Gupta, Sorab

    2018-05-04

    Chimeric antigen receptor (CAR) T cell therapy is genetically engineered tumor antigen-specific anticancer immunotherapy, which after showing great success in hematological malignancies is currently being tried in advanced solid tumors like pancreatic cancer. Immunosuppressive tumor microenvironment and dense fibrous stroma are some of the limitation in the success of this novel therapy. However, genetic modifications and combination therapy is the topic of the research to improve its efficacy. In this article, we summarize the current state of knowledge, limitations, and future prospects for CAR T cell therapy in pancreatic cancer.

  14. Progress in human embryonic stem cell research in the United States between 2001 and 2010.

    Directory of Open Access Journals (Sweden)

    Keyvan Vakili

    Full Text Available On August 9th, 2001, the federal government of the United States announced a policy restricting federal funds available for research on human embryonic stem cell (hESCs out of concern for the "vast ethical mine fields" associated with the creation of embryos for research purposes. Until the policy was repealed on March 9th, 2009, no U.S. federal funds were available for research on hESCs extracted after August 9, 2001, and only limited federal funds were available for research on a subset of hESC lines that had previously been extracted. This paper analyzes how the 2001 U.S. federal funding restrictions influenced the quantity and geography of peer-reviewed journal publications on hESC. The primary finding is that the 2001 policy did not have a significant aggregate effect on hESC research in the U.S. After a brief lag in early 2000s, U.S. hESC research maintained pace with other areas of stem cell and genetic research. The policy had several other consequences. First, it was tied to increased hESC research funding within the U.S. at the state level, leading to concentration of related activities in a relatively small number of states. Second, it stimulated increased collaborative research between US-based scientists and those in countries with flexible policies toward hESC research (including Canada, the U.K., Israel, China, Spain, and South Korea. Third, it encouraged independent hESC research in countries without restrictions.

  15. Historic low-level radioactive waste federal policies, programs and oversight

    International Nuclear Information System (INIS)

    Blanchette, M.; Kenney, J.; Zelmer, B.

    2011-01-01

    'Full text:' The management of radioactive waste is one of the most serious environmental problems facing Canadians. From the early industrial uses of radioactive material in the 1930s to the development of nuclear power reactors and the medical and experimental use of radio-isotopes today, there has been a steady accumulation of waste products. Historic waste is low-level radioactive waste for which the federal government has accepted responsibility for long-term management. This paper will outline the policy framework used to govern institutional and financial arrangements for the disposal of radioactive waste by waste producers and owners and the major radioactive projects in which the Government of Canada is currently involved. It will provide an overview of the organizations established for the management of historic radioactive waste and NRCan's oversight role. Finally, an overview of the historic waste program activities managed on behalf of the federal government through these organizations in the Port Hope area, the Greater Toronto Area, in Fort McMurray, Alberta and along the Northern Transportation Route is provided. Canada's Policy Framework for Radioactive Waste, sets out principles that govern the institutional and financial arrangements for disposal of radioactive waste by waste producers and owners. According to the Policy Framework: The federal government will ensure that radioactive waste disposal is carried out in a safe, environmentally sound, comprehensive, cost-effective and integrated manner; The federal government has the responsibility to develop policy, to regulate, and to oversee producers and owners; and, The waste producers and owners are responsible, in accordance with the principle of 'polluter pays', for the funding, organization, management and operation of disposal and other facilities required for their wastes. Arrangements may be different for nuclear fuel waste, low-level radioactive waste and

  16. 1997 Gordon Research Conference on Plant Cell Walls. Final progress report

    Energy Technology Data Exchange (ETDEWEB)

    Staehelin, A.

    1999-08-25

    The Gordon Research Conference (GRC) on Plant Cell Walls was held at Tilton School, Tilton, New Hampshire, July 18-22, 1997. The conference was well attended with 106 participants. The attendees represented the spectrum of endeavor in this field coming from academia, industry, and government laboratories, both US and foreign scientists, senior researchers, young investigators, and students. In designing the formal speakers program, emphasis was placed on current unpublished research and discussion of the future target areas in this field. There was a conscious effort to stimulate lively discussion about the key issues in the field today. Time for formal presentations was limited in the interest of group discussions. In order that more scientists could communicate their most recent results, poster presentation time was scheduled. In addition to these formal interactions, free time was scheduled to allow informal discussions. Such discussions are fostering new collaborations and joint efforts in the field.

  17. PTSD: National Center for PTSD

    Medline Plus

    Full Text Available ... Topics For Veterans For Researchers Research Oversight Special Groups Caregivers Combat Veterans & their Families Readjustment Counseling (Vet Centers) War Related Illness & Injury Study Center ...

  18. Animal research ethics in Africa: is Tanzania making progress?

    Science.gov (United States)

    Seth, Misago; Saguti, Fredy

    2013-12-01

    The significance of animals in research cannot be over-emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and interventions for human use pass through a similar development process and must be tested pre-clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised. © 2012 John Wiley & Sons Ltd.

  19. Chromatin Configuration Determines Cell Responses to Hormone Stimuli | Center for Cancer Research

    Science.gov (United States)

    Ever since selective gene expression was established as the central driver of cell behavior, researchers have been working to understand the forces that control gene transcription. Aberrant gene expression can cause or promote many diseases, including cancer, and alterations in gene expression are the goal of many therapeutic agents. Recent work has focused on the potential

  20. The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products.

    Science.gov (United States)

    Rafiq, Qasim A; Ortega, Ilida; Jenkins, Stuart I; Wilson, Samantha L; Patel, Asha K; Barnes, Amanda L; Adams, Christopher F; Delcassian, Derfogail; Smith, David

    2015-11-01

    Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.