Activities of the research committee

Energy Technology Data Exchange (ETDEWEB)

Hasegawa, A.; Shirai, T.; Nakagawa, M.; Osugi, T.; Ikeda, Y.; Ishida, T.; Shimazaki, J. [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

2000-01-01

The department of Nuclear Energy System serves as a secretarial of the following four research committees organized by JAERI; Japanese Nuclear Data Committee, Atomic and Molecular Data Research Committee, Research Committee on Reactor Physics and Research Committee on Marine Reactors. The purpose and the expected task of each committee are summarized here. The detailed activities of each committee are presented in this paper. (author)

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...

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…

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.

The audit committee : Management watchdog or personal friend of the CEO?

NARCIS (Netherlands)

Bruynseels, L.M.L.; Cardinaels, E.

2014-01-01

To ensure that audit committees provide sufficient oversight over the auditing process and quality of financial reporting, legislators have imposed stricter requirements on the independence of audit committee members. Although many audit committees appear to be “fully” independent, anecdotal

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

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...

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.

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

78 FR 38077 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2013-06-25

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office [NARA-13-0030] National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and... following committee meeting to discuss National Industrial Security Program policy matters. DATES: The...

78 FR 64024 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2013-10-25

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office [NARA-2014-001] National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and... following committee meeting to discuss National Industrial Security Program policy matters. DATES: The...

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

Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.

Science.gov (United States)

Calis, Karim A; Archdeacon, Patrick; Bain, Raymond; DeMets, David; Donohue, Miriam; Elzarrad, M Khair; Forrest, Annemarie; McEachern, John; Pencina, Michael J; Perlmutter, Jane; Lewis, Roger J

2017-08-01

Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project. Methods The data monitoring committee project team included 16 individuals charged with (1) clarifying the purpose of data monitoring committees, (2) identifying best practices for independent data monitoring committee conduct, (3) describing effective communication practices, and (4) developing strategies for training data monitoring committee members. Evidence gathering included a survey, a series of focus group discussions, and a 2-day expert meeting aimed at achieving consensus opinions that form the foundation of our data monitoring committee recommendations. Results We define the role of the data monitoring committee as an advisor to the research sponsor on whether to continue, modify, or terminate a trial based on periodic assessment of trial data. Data monitoring committees should remain independent from the sponsor and be composed of members with no relevant conflicts of interest. Representation on a data monitoring committee generally should include at least one clinician with expertise in the therapeutic area being studied, a biostatistician, and a designated chairperson who has experience with clinical trials and data monitoring. Data monitoring committee meetings are held periodically to evaluate the unmasked data from ongoing trials, but the content and conduct of

Factors influencing the effectiveness of research ethics committees.

Science.gov (United States)

Schuppli, C A; Fraser, D

2007-05-01

Research ethics committees - animal ethics committees (AECs) for animal-based research and institutional research boards (IRBs) for human subjects - have a key role in research governance, but there has been little study of the factors influencing their effectiveness. The objectives of this study were to examine how the effectiveness of a research ethics committee is influenced by committee composition and dynamics, recruitment of members, workload, participation level and member turnover. As a model, 28 members of AECs at four universities in western Canada were interviewed. Committees were selected to represent variation in the number and type of protocols reviewed, and participants were selected to include different types of committee members. We found that a bias towards institutional or scientific interests may result from (1) a preponderance of institutional and scientist members, (2) an intimidating atmosphere for community members and other minority members, (3) recruitment of community members who are affiliated with the institution and (4) members joining for reasons other than to fulfil the committee mandate. Thoroughness of protocol review may be influenced by heavy workloads, type of review process and lack of full committee participation. These results, together with results from the literature on research ethics committees, suggested potential ways to improve the effectiveness of research ethics committees.

75 FR 39582 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2010-07-09

... Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office..., announcement is made for a meeting of the National Industrial Security Program Policy Advisory Committee. The meeting will be held to discuss National Industrial Security Program policy matters. DATES: The meeting...

Human research ethics committees in technical universities.

Science.gov (United States)

Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

2014-07-01

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. © The Author(s) 2014.

12 CFR 363.5 - Audit committees.

Science.gov (United States)

2010-01-01

... committee shall include the appointment, compensation, and oversight of the independent public accountant... public accountant the basis for the reports issued under this part. (1) Each insured depository... members who are large customers of the subsidiary institution. (c) Independent public accountant...

An investigation into the effectiveness of audit committees

Directory of Open Access Journals (Sweden)

Zandile Virtue Dlamini

2017-09-01

Full Text Available The fundamental purpose of this study was to investigate the effectiveness of audit committees in the eThekwini municipality within the province of KwaZulu Natal. The target population for the study was all the standing and audit committee members totalling 20, thus taking a census-based approach. The descriptive sections adopted a positivist paradigm employing quantitative methodology was used to examine information through techniques that revealed patterns, trends and relationships. Hence, a mixed methodology was the case in this study. The study revealed that the eThekwini audit committee was generally effective in discharging its oversight role in the council, though there were areas of concern, which include control frameworks and financial management to improve corporate governance. The study revealed that there was, to a large extent compliance with legal requirements regarding audit committees, as well as best practice processes. It is therefore important to point out that, this study outlines good practices of audit committees that are worthy of emulation and further improvement by the research community as a framework for good governance in local governments.

Human research ethics committees: examining their roles and practices.

Science.gov (United States)

Guillemin, Marilys; Gillam, Lynn; Rosenthal, Doreen; Bolitho, Annie

2012-07-01

Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.

Inter-Society Research Committee

International Nuclear Information System (INIS)

Akiyama, Mamoru; Higuchi, Masahisa.

1996-01-01

World-wide tendencies and circumstances for nuclear power cannot be said to be moving full of sail with a favorable wind, due to nuclear power plant accidents and comparatively little economical benefit. The present Nuclear Power Plant situation is that some personnel understand a need for the development from the viewpoint of efficient energy usage in the world and environmental problems like global warming. At the same time others oppose future nuclear development from the viewpoint of safety problems and economic cost. These issues may end nuclear development worldwide. Nuclear development must be considered from an international viewpoint and other various aspects. Therefore, all countries concerned should cooperative in the adjustment of research carried out by each country. Nuclear power's future must be efficient in the utilization of limited resources (money, manpower and facilities). It is concluded that the ISRC should only discuss technical matters on nuclear engineering, independent from political influence. Societies agreeing to this idea, provide the ISRC with money and/or manpower and/or facilities. The ISRC will consist of a research program committee and research task forces. Members of the Research Program Committee are the chairmen of the research task forces who are also society representatives. The Committee will discuss research programs and resources. The research task forces will consist of one society representative chairman and specialists on the program

Nuclear Safety Research Review Committee

International Nuclear Information System (INIS)

Todreas, N.E.

1990-01-01

The Nuclear Safety Research Review Committee has had a fundamental difficulty because of the atmosphere that has existed since it was created. It came into existence at a time of decreasing budgets. For any Committee the easiest thing is to tell the Director what additional to do. That does not really help him a lot in this atmosphere of reduced budgets which he reviewed for you on Monday. Concurrently the research arm of Nuclear Regulatory Commission has recognized that the scope of its activity needed to be increased rather than decreased. In the last two-and-a-half-year period, human factors work was reinstated, radiation and health effects investigations were reinvigorated, research in the waste area was given significant acceleration. Further, accident management came into being, and the NRC finally got back into the TMI-2 area. So with all of those activities being added to the program at the same time that the research budget was going down, the situation has become very strained. What that leads to regarding Committee membership is a need for technically competent generalists who will be able to sit as the Division Directors come in, as the contractors come in, and sort the wheat from the chaff. The Committee needs people who are interested in and have a broad perspective on what regulatory needs are and specifically how safety research activities can contribute to them. The author summarizes the history of the Committee, the current status, and plans for the future

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.

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

Measuring inconsistency in research ethics committee review.

Science.gov (United States)

Trace, Samantha; Kolstoe, Simon Erik

2017-11-28

The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called "Shared Ethical Debate" (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes. We present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published "mystery shopper" exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise. Our analysis highlights qualitative differences between the ShED 19, ShED 20 and "mystery shopper" exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises. ShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.

77 FR 16894 - Financial Research Advisory Committee

Science.gov (United States)

2012-03-22

... reported and collected; --Performing applied research and essential long-term research; --Developing tools... economics, financial institutions and markets, statistical analysis, financial markets analysis... is essential to the effective operation of the Committee. Application for Advisory Committee...

77 FR 12623 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2012-03-01

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and Records... discuss National [[Page 12624

Research Award: Advisory Committee on Research Ethics Deadline ...

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

Jean-Claude Dumais

2012-09-12

Sep 12, 2012 ... Research Award: Advisory Committee on Research Ethics. Deadline: ... The Research Awardee will spend one year at IDRC and work approximately 50% of the time on her/his own research and 50% on ACRE-related tasks.

75 FR 80082 - State, Local, Tribal, And Private Sector Policy Advisory Committee (SLTPS-PAC)

Science.gov (United States)

2010-12-21

..., Tribal, And Private Sector Policy Advisory Committee (SLTPS-PAC) AGENCY: Information Security Oversight... State, Local, Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC). The SLTPS-PAC will..., Tribal, and Private Sector Entities, as specified in Executive Order 13549 and its implementing directive...

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

77 FR 42298 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2012-07-18

... Biomass Research and Development Technical Advisory Committee (Technical Advisory Committee). DATES: The... 9008(d) established the Biomass Research and Development Technical Advisory Committee and lays forth... nomination. Appointments to the Biomass Research and Development Technical Advisory Committee will be made by...

Nuclear committee plays it straight: and draws criticism from all quarters

International Nuclear Information System (INIS)

Lanouette, W.J.

1981-01-01

The Nuclear Safety Oversight Committee appointed after the 1979 accident at Three Mile Island angered everyone, but succeeded in highlighting many of the operating and regulatory problems plaguing nuclear power. The now defunct committee received mixed reviews, some calling it a waste of time and money, and others seeing it as a model for solving policy disputes. A review of the committee members and their two controversial studies describes the areas of disagreement

Ethics committees in India: Facing the challenges!

Science.gov (United States)

Kadam, Rashmi; Karandikar, Shashikant

2012-04-01

The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

Ethics committees in India: Facing the challenges!

Directory of Open Access Journals (Sweden)

Rashmi Kadam

2012-01-01

Full Text Available The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC. The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

78 FR 6087 - Biological and Environmental Research Advisory Committee

Science.gov (United States)

2013-01-29

... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Office of... the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory Committee... Federal Officer, BERAC, U.S. Department of Energy, Office of Science, Office of Biological and...

Measuring inconsistency in research ethics committee review

OpenAIRE

Trace, Samantha; Kolstoe, Simon Erik

2017-01-01

Background The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Sha...

Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates.

Science.gov (United States)

Abdulrahman, Mahera; Nair, Satish Chandrasekhar

2017-04-01

Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.

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.

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

Committees for Ethics in Research involving human subjects.

Science.gov (United States)

Hossne, William Saad; Vieira, Sonia; De Freitas, Corina Bontempo Duca

2008-01-01

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Enhanced governance committees in South Africa’s national government departments: A conceptual exploration

Directory of Open Access Journals (Sweden)

Tankiso Moloi

2015-04-01

Full Text Available This paper argues that almost all other non-governmental institutions for instance banks and pension funds, in addition to the risk and audit committees, have credit committees in respect of banks and investment committees in respect of pension funds. These committees provide oversight on the core businesses of these institutions. In a similar manner, national government departments should not only have universal governance committees such as the audit and risk committees, instead the study envisions governance committees modelled around the idea parliamentary portfolio committees. The envisaged committees will remain governance committees with defined roles and responsibilities similar to the audit and risk committees that are already in existence in the national government departments.

76 FR 36102 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2011-06-21

... vacancies on the Biomass Research and Development Technical Advisory Committee (Technical Advisory Committee..., 2008, H.R. 6124]. FCEA section 9008(d) establishes the Biomass Research and Development Technical... committee are ineligible for nomination. Appointments to the Biomass Research and Development Technical...

77 FR 41204 - State, Local, Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC)

Science.gov (United States)

2012-07-12

..., Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC) AGENCY: Information Security Oversight..., announcement is made for the committee meeting of the State, Local, Tribal, and Private Sector Policy Advisory..., Local, Tribal, and Private Sector Entities. DATES: The meeting will be held on July 25, 2012, 10:00 a.m...

78 FR 64932 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2013-10-30

... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY: Energy... announces an open meeting of the Biomass Research and Development Technical Advisory Committee under Section... Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral...

77 FR 64970 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2012-10-24

... Biomass Research and Development Technical Advisory Committee. The Federal Advisory Committee Act (Pub. L... observe the business of the Biomass Research and Development Technical Advisory Committee. To attend the... DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Biomass Research and...

75 FR 6651 - Biological and Environmental Research Advisory Committee

Science.gov (United States)

2010-02-10

... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Department... meeting of the Biological and Environmental Research Advisory Committee (BERAC). Federal Advisory.... Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown...

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.

78 FR 40098 - Emerging Technology and Research Advisory Committee;

Science.gov (United States)

2013-07-03

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Assistant Secretary for Export Administration on emerging technology and research activities, including...

77 FR 4028 - Biological and Environmental Research Advisory Committee

Science.gov (United States)

2012-01-26

... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Department... meeting of the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory.... Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown...

78 FR 9431 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2013-02-08

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and Records... meeting to discuss National Industrial Security Program policy matters. DATES: The meeting will be held on...

77 FR 63893 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2012-10-17

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and Records... meeting to discuss National Industrial Security Program policy matters. DATES: The meeting will be held on...

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...

Knowledge about the research and ethics committee at Makerere ...

African Journals Online (AJOL)

Background: All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to protect ...

78 FR 16357 - Research, Engineering and Development Advisory Committee

Science.gov (United States)

2013-03-14

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development... hereby given of a meeting of the FAA Research, Engineering and Development (R,E&D) Advisory Committee. Name: Research, Engineering & Development Advisory Committee. Time and Date: April 24--8:30 a.m. to 4...

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...

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

An analysis of audit committee effectiveness at the largest listed companies in South Africa from a CFO and audit committee perspective

Directory of Open Access Journals (Sweden)

Ben Marx

2009-12-01

Full Text Available Purpose: The purpose of the study is to investigate and analyse the effective functioning of audit committees at the largest listed companies in South Africa. Problem investigated: The modern audit committee is often seen as the panacea of the corporate world and as such is looked upon to cure all the financial reporting and control-related problems of entities. Audit committees are, however, not always as effective as they are held to be, as is evidenced by the many well-known corporate scandals and business failures that occurred where audit committees existed and fraudulent financial reporting, audit failures, internal control breakdowns and other irregularities prevailed. The modern audit committee will be of value only if it is properly constituted, is functioning effectively and if its role is clearly understood by all the parties concerned. The research problem investigated stems precisely from this issue, and the paper therefore aims to analyse the effective functioning of the audit committees at the largest listed companies in South Africa. Methodology: The study empirically tested the audit committee practices at the largest listed companies in South Africa. This was done through questionnaires addressed to the CFOs and audit committee chairs. Findings: The study found that audit committees at the largest listed companies in South Africa are well established, properly constituted, have the authority and resources to effectively discharge their responsibilities and consist of members who act independently and who have the right mix of appropriate experience, financial literacy and financial expertise amongst their members. The audit committee's role was found to be generally well understood and supported by the board and the Chief Financial Officers. It was further found that the audit committees are effective in discharging their oversight responsibilities on the board's behalf, with the only real exception being their effectiveness

Stating the Case for Nursing Research Ethics Committees: A Discussion Paper.

Science.gov (United States)

Mitchell, Theresa; Fletcher, Ian

1998-01-01

Nurse-led research ethics committees are generally more tolerant of diversity in research proposals than are medical committees steeped in empirical traditions. However, national trends in nursing in Britain may influence a preference for multidisciplinary over nurse-led committees. (SK)

78 FR 46331 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2013-07-31

... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY: Energy.... Appointments to the Biomass Research and Development Technical Advisory Committee will be made by the Secretary... Energy is soliciting nominations for candidates to fill vacancies on the Biomass Research and Development...

75 FR 56525 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2010-09-16

... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... business of the Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or...

78 FR 29125 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2013-05-17

... Biomass Research and Development Technical Advisory Committee. The Federal Advisory Committee Act (Pub. L... public are welcome to observe the business of the Biomass Research and Development Technical Advisory... DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Biomass Research and...

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

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...

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...

Human Research Ethics Committees in Technical Universities

NARCIS (Netherlands)

Koepsell, D.R.; Brinkman, W.P.; Pont, S.C.

2014-01-01

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although

Report of the summative evaluation by the advisory committee on nuclear safety research

International Nuclear Information System (INIS)

2005-03-01

The Research Evaluation Committee of the Japan Atomic Energy Research Institute (JAERI) set up an Advisory Committee on Nuclear Safety Research in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations. The Advisory Committee on Nuclear Safety Research evaluated the adequacy of the plans of nuclear safety research to be succeeded from JAERI to a new research institute which will be established by integration of JAERI and the Japan Nuclear Cycle Development Institute (JNC). The Advisory Committee consisted of eight specialists from outside the JAERI conducted its activities from June 2004 to August 2004. The evaluation was performed on the basis of the materials submitted in advanced and of the oral presentations made at the Advisory Committee meeting which was held on July 27, 2004, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Advisory Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on December 1, 2004. This report describes the result of the evaluation by the Advisory Committee on Safety Research. (author)

Report of the Review Committee on valuation of the research subjects in the fields of advanced science research

International Nuclear Information System (INIS)

2000-07-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods, etc. the Ad Hoc Review Committee composed of eight experts was set up under the Research Evaluation Committee of the JAERI in order to review the research theme completed in FY1998 and those planned for five years starting in FY2000 in the Advanced Science Research Center. The Ad Hoc Review Committee meeting was held on September 17, 1999. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research results/plan documents submitted in advance and presentations by the Research Group Leaders. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on March 14, 2000. As a result, the Research Evaluation Committee acknowledged appropriateness of the review results. This report describes the review results. (author)

Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee.

Science.gov (United States)

Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

2015-08-01

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social-psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168-175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants (Federman et al. in Responsible research: a systems approach to protecting research participants. National Academies Press, Washington, 2003, p. 36). The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2

77 FR 20377 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2012-04-04

... Biomass Research and Development Technical Advisory Committee under Section 9008(d) of the Food... DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Biomass Research and Development Technical Advisory Committee AGENCY: Office of Energy Efficiency and Renewable Energy, Department...

77 FR 26276 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2012-05-03

... business of the Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or... DEPARTMENT OF ENERGY Energy Efficiency and Renewable Energy Biomass Research and Development Technical Advisory Committee AGENCY: Energy Efficiency and Renewable Energy, Department of Energy. ACTION...

78 FR 44105 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2013-07-23

... Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral statements... DEPARTMENT OF ENERGY Energy Efficiency and Renewable Energy Biomass Research and Development Technical Advisory Committee AGENCY: Energy Efficiency and Renewable Energy, Department of Energy. ACTION...

76 FR 63614 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2011-10-13

... Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral... DEPARTMENT OF ENERGY Energy Efficiency and Renewable Energy Biomass Research and Development Technical Advisory Committee AGENCY: Energy Efficiency and Renewable Energy, Department of Energy. ACTION...

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.

77 FR 6791 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2012-02-09

... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY: Energy... announces an open meeting of the Biomass Research and Development Technical Advisory Committee. The Federal... leading to the production of biobased fuels and biobased products. Tentative Agenda Update on USDA Biomass...

78 FR 8500 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2013-02-06

... DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Biomass Research and... Biomass Research and Development Technical Advisory Committee. The Federal Advisory Committee Act (Pub. L... fuels and biobased products. Tentative Agenda: Agenda will include the following: Update on USDA Biomass...

Committee on Military Nutrition Research Proposal

National Research Council Canada - National Science Library

Poos, Mary

1999-01-01

This publication, Military Sfrategies for Sustainment of Nufrition and Immune Function in the Field, is the latest in a series of reports based on workshops sponsored by the Committee on Military Nutrition Research (CMNR...

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...

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...

Homeland Security: Compendium of Recommendations Relevant to House Committee Organization and Analysis of Considerations for the House

National Research Council Canada - National Science Library

Koempel, Michael L

2005-01-01

.... The original report was not changed; its summary follows: The 9/11 Commission and other commissions and think tanks studying homeland security recommended congressional committee reorganization to increase Congress's policy and oversight coordination...

Report of the summative evaluation by the advisory committee on fusion research and development

International Nuclear Information System (INIS)

2005-03-01

The Research Evaluation Committee of the Japan Atomic Energy Research Institute (JAERI) set up an Advisory Committee on Fusion Research and Development in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations. The Advisory Committee on Fusion Research and Development evaluated the adequacy of the plans of fusion research and development to be succeeded from JAERI to a new research institute which will be established by integration of JAERI and the Japan Nuclear Cycle Development Institute (JNC). The Advisory Committee consisted of eight specialists from outside the JAERI conducted its activities from June 2004 to August 2004. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Advisory Committee meeting which was held on July 23, 2004, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Advisory Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on December 1, 2004. This report describes the result of the evaluation by the Advisory Committee on Fusion Research and Development. (author)

Report of the summative evaluation by the advisory committee on research for radiation applications

International Nuclear Information System (INIS)

2005-03-01

The Research Evaluation Committee of the Japan Atomic Energy Research Institute (JAERI) set up an Advisory Committee on Research for Radiation Applications in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations. The Advisory Committee on Research for Radiation Applications evaluated the adequacy of the plans of research for radiation applications to be succeeded from JAERI to a new research institute which will be established by integration of JAERI and the Japan Nuclear Cycle Development Institute (JNC). The Advisory Committee consisted of nine specialists from outside the JAERI conducted its activities from June 2004 to August 2004. The evaluation was performed on the basis of the materials submitted in advanced and of the oral presentations made at the Advisory Committee meeting which was held on July 29, 2004, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Advisory Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on December 1, 2004. This report describes the result of the evaluation by the Advisory Committee on Research for Radiation Applications. (author)

76 FR 41826 - State, Local, Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC)

Science.gov (United States)

2011-07-15

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office State, Local, Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC) AGENCY: National Archives and Records... Information Program for State, Local, Tribal, and Private Sector Entities. DATES: The meeting will be held on...

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...

A cross-sectional survey to investigate community understanding of medical research ethics committees.

Science.gov (United States)

Fritschi, Lin; Kelsall, Helen L; Loff, Bebe; Slegers, Claudia; Zion, Deborah; Glass, Deborah C

2015-07-01

Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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.

Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

Science.gov (United States)

2012-01-01

Background Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies. Methods The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning. Results The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research. Conclusion The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. PMID:22873761

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).

Report of the review committee on evaluation of the research subjects in the field of advanced science research (FY2000)

International Nuclear Information System (INIS)

2000-10-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee, the Ad Hoc Review Committee composed of eight experts was set up under the Research Evaluation Committee of the JAERI in order to review the research themes completed in FY1999, those to be ended through FY2000, and those planned for five years starting in FY2001 in the Advanced Science Research Center. The Ad Hoc Review Committee meeting was held on July 17, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research result/plan documents submitted in advance and presentations by the Research Group Leaders. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

Ethical Evaluation of Mental Health Social Research: Agreement Between Researchers and Ethics Committees.

Science.gov (United States)

Mondragón Barrios, Liliana; Guarneros García, Tonatiuh; Jiménez Tapia, Alberto

2017-07-01

The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.

75 FR 48411 - Research, Engineering and Development Advisory Committee; Notice of Meeting

Science.gov (United States)

2010-08-10

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development.... 2), notice is hereby given of a meeting of the FAA Research, Engineering and Development (R, E&D) Advisory Committee. Name: Research, Engineering & Development Advisory Committee. Time and Date: September...

77 FR 31071 - Research Advisory Committee on Gulf War Veterans' Illnesses, Notice of Meeting

Science.gov (United States)

2012-05-24

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses, Notice... Advisory Committee Act) that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... Asia theater of operations during the Gulf War. The Committee will review VA program activities related...

75 FR 28686 - Research Advisory Committee on Gulf War Veterans' Illnesses; Notice of Meeting

Science.gov (United States)

2010-05-21

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses; Notice... Advisory Committee Act) that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... Asia theater of operations during the Gulf War. The Committee will review VA program activities related...

76 FR 9407 - Research Advisory Committee on Gulf War Veterans' Illnesses; Notice of Meeting

Science.gov (United States)

2011-02-17

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses; Notice... Advisory Committee Act) that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... Southwest Asia theater of operations during the Gulf War. The Committee will review VA program activities...

75 FR 65405 - Research Advisory Committee on Gulf War Veterans' Illnesses; Notice of Meeting

Science.gov (United States)

2010-10-22

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses; Notice... Advisory Committee Act) that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... Asia theater of operations during the Gulf War. The Committee will review VA program activities related...

Report of the summative evaluation by the advisory committee on research support and collaborative activities

International Nuclear Information System (INIS)

2005-03-01

The Research Evaluation Committee of the Japan Atomic Energy Research Institute (JAERI) set up an Advisory Committee on Research Support and Collaborative Activities in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations. The Advisory Committee on Research Support and Collaborative Activities evaluated the adequacy of the plans of research support and collaborative activities to be succeeded from JAERI to a new research institute which will be established by integration of JAERI and the Japan Nuclear Cycle Development Institute (JNC). The Advisory Committee consisted of nine specialists from outside the JAERI conducted its activities from June 2004 to August 2004. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Advisory Committee meeting which was held on July 21, 2004, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Advisory Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on December 1, 2004. This report describes the result of the evaluation by the Advisory Committee on Research Support and Collaborative Activities. (author)

75 FR 8789 - Research Advisory Committee on Gulf War Veterans' Illnesses; Notice of Meeting

Science.gov (United States)

2010-02-25

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses; Notice... Advisory Committee Act) that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... theater of operations during the Gulf War. The Committee will review VA program activities related to Gulf...

76 FR 31018 - Research Advisory Committee on Gulf War Veterans' Illnesses; Notice of Meeting

Science.gov (United States)

2011-05-27

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses; Notice... Advisory Committee Act) that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... consequences of military service in the Southwest Asia theater of operations during the Gulf War. The Committee...

77 FR 2353 - Research Advisory Committee on Gulf War Veterans' Illnesses; Notice of Meeting

Science.gov (United States)

2012-01-17

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses; Notice... Advisory Committee Act) that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... consequences of military service in the Southwest Asia theater of operations during the Gulf War. The Committee...

78 FR 77205 - Research Advisory Committee on Gulf War Veterans' Illnesses; Notice of Meeting

Science.gov (United States)

2013-12-20

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses; Notice... Advisory Committee Act) that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... service in the Southwest Asia theater of operations during the Gulf War. The Committee will review VA...

Scientific committee 83 on indentification of research needs

International Nuclear Information System (INIS)

Adelstein, S.J.

1991-01-01

Scientific committee 83 was appointed to identify research needs for radiation protection in response to the Nuclear Regulatory Commissions requires that follows on a Presidential inquiry to the Council asking it to identify critical questions in research including laboratory and epidemiologic research related to radiation protection and requiring resolution at this time. The answers overwhelmingly identified low dose, low dose rate, LET, and radiation risk being the most important. Aspects of the problems that were singled out had to do with fractionation and protraction, shape of the dose response curve, molecular mechanism, decrement in risk with time as revealed by epidemiologic study, and the reality of hormesis. Against this background, the Committee formulated its scope and an outline of this report, as well as the time table and the mechanism to react with its consultant s who will also be asked to serve as its critical reviewers. The scope of the Committee was taken to be the identification of areas for additional research to improve the bases for making recommendations for protection against ionizing radiation. This paper has five parts, one dealing with sources and environmental transport, one with dosimetry and measurement, one with biologic consequences, epidemiology and risk estimates and one with public perception and policy

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.

Protecting vulnerable research participants: a Foucault-inspired analysis of ethics committees.

Science.gov (United States)

Juritzen, Truls I; Grimen, Harald; Heggen, Kristin

2011-09-01

History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault's ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed - not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

Homeland Security: Compendium of Recommendations Relevant to House Committee Organization and Analysis of Considerations for the House, and 109th and 110th Congresses: Epilogue

National Research Council Canada - National Science Library

Koempel, Michael L

2007-01-01

...: The 9/11 Commission and other commissions and think tanks studying homeland security recommended congressional committee reorganization to increase Congress's policy and oversight coordination...

77 FR 6826 - Advisory Committee for Environmental Research and Education; Notice of Meeting

Science.gov (United States)

2012-02-09

... NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research and Education; Notice of... environmental research and education. Agenda: Wednesday, March 14, 2012 Update on NSF environmental research and... Science Foundation announces the following meeting: Name: Advisory Committee for Environmental Research...

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.

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

Directory of Open Access Journals (Sweden)

Bouësseau Marie-Charlotte

2008-03-01

Full Text Available Abstract Background Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Discussion Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices. The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Conclusion Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of

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

Co-design and implementation research: challenges and solutions for ethics committees.

Science.gov (United States)

Goodyear-Smith, Felicity; Jackson, Claire; Greenhalgh, Trisha

2015-11-16

Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials. Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally (through training) and informally (by promoting debate and discussion); without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with

Familiar ethical issues amplified: how members of research ethics committees describe ethical distinctions between disaster and non-disaster research.

Science.gov (United States)

Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa; Hunt, Matthew

2017-06-28

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster

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.

Payment of research participants: current practice and policies of Irish research ethics committees.

LENUS (Irish Health Repository)

Roche, Eric

2013-09-01

Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking.

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.

75 FR 50009 - Advisory Committee for Environmental Research and Education; Notice of Meeting

Science.gov (United States)

2010-08-16

... NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research and Education; Notice of... support for environmental research and education. Agenda September 8, 2010 Update on recent NSF... Science Foundation announces the following meeting: Name: Advisory Committee for Environmental Research...

76 FR 7881 - Advisory Committee for Environmental Research and Education; Notice of Meeting

Science.gov (United States)

2011-02-11

... NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research and Education; Notice of... support for environmental research and education. Agenda March 16 Update on recent NSF environmental... Science Foundation announces the following meeting: Name: Advisory Committee for Environmental Research...

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

Rebuilding a Research Ethics Committee

Science.gov (United States)

Biggs, John S. G.; Marchesi, August

2013-01-01

The principal ethics committee in Australia's Capital, Canberra, underwent a major revision in the last three years based on changes debated in the literature. Committee or Board structure varies widely; regulations determining minimum size and membership differ between countries. Issues such as the effectiveness of committee management,…

78 FR 70917 - Emerging Technology and Research Advisory Committee; Notice of Open Meeting

Science.gov (United States)

2013-11-27

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Open Meeting The Emerging Technology and Research Advisory Committee (ETRAC) will meet... Secretary for Export Administration on emerging technology and research activities, including those related...

77 FR 39209 - Emerging Technology and Research Advisory Committee; Notice of Open Meeting

Science.gov (United States)

2012-07-02

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Open Meeting The Emerging Technology and Research Advisory Committee (ETRAC) will meet... Secretary for Export Administration on emerging technology and research activities, including those related...

77 FR 59374 - Emerging Technology and Research Advisory Committee; Notice of Open Meeting

Science.gov (United States)

2012-09-27

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Open Meeting The Emerging Technology and Research Advisory Committee (ETRAC) will meet... Secretary for Export Administration on emerging technology and research activities, including those related...

75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

Science.gov (United States)

2010-08-02

... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0125] Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an...

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...

75 FR 59720 - Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI)

Science.gov (United States)

2010-09-28

... GOVERNMENT ACCOUNTABILITY OFFICE Methodology Committee of the Patient-Centered Outcomes Research... responsibility for appointing not more than 15 members to a Methodology Committee of the Patient- Centered Outcomes Research Institute. In addition, the Directors of the Agency for Healthcare Research and Quality...

76 FR 44648 - Research, Engineering and Development Advisory Committee

Science.gov (United States)

2011-07-26

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development....S.C. App. 2), notice is hereby given of a meeting of the FAA Research, Engineering and Development.... Name: Research, Engineering & Development Advisory Committee. Time and Date: September 21, 2011--9 a.m...

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.

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

Ethics approval: responsibilities of journal editors, authors and research ethics committees.

Science.gov (United States)

Bain, Luchuo Engelbert

2017-01-01

Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

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...

Exploring the role and function of trial steering committees: results of an expert panel meeting.

Science.gov (United States)

Harman, Nicola L; Conroy, Elizabeth J; Lewis, Steff C; Murray, Gordon; Norrie, John; Sydes, Matt R; Lane, J Athene; Altman, Douglas G; Baigent, Colin; Bliss, Judith M; Campbell, Marion K; Elbourne, Diana; Evans, Stephen; Sandercock, Peter; Gamble, Carrol

2015-12-30

The independent oversight of clinical trials, which is recommended by the Medical Research Council (MRC) Guidelines for Good Clinical Practice, is typically provided by an independent advisory Data Monitoring Committee (DMC) and an independent executive committee, to whom the DMC makes recommendations. The detailed roles and function of this executive committee, known as the Trial Steering Committee (TSC), have not previously been studied or reviewed since those originally proposed by the MRC in 1998. An expert panel (n = 7) was convened comprising statisticians, clinicians and trial methodologists with prior TSC experience. Twelve questions about the role and responsibilities of the TSC were discussed by the panel at two full-day meetings. Each meeting was transcribed in full and the discussions were summarised. The expert panel reached agreement on the role of the TSC, to which it was accountable, the membership, the definition of independence, and the experience and training needed. The management of ethical issues, difficult/complex situations and issues the TSC should not ask the DMC to make recommendations on were more difficult to discuss without specific examples, but support existed for further work to help share issues and to provide appropriate training for TSC members. Additional topics discussed, which had not been identified by previous work relating to the DMCs but were pertinent to the role of the TSC, included the following: review of data sharing requests, indemnity, lifespan of the TSC, general TSC administration, and the roles of both the Funder and the Sponsor. This paper presents recommendations that will contribute to the revision and update of the MRC TSC terms of reference. Uncertainty remains in some areas due to the absence of real-life examples; future guidance on these issues would benefit from a repository of case studies. Notably, the role of a patient and public involvement (PPI) contributor was not discussed, and further work is

77 FR 14462 - Research, Engineering and Development Advisory Committee

Science.gov (United States)

2012-03-09

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development....S.C. App. 2), notice is hereby given of a meeting of the FAA Research, Engineering and Development.... Name: Research, Engineering & Development Advisory Committee. Time and Date: April 18, 2012--9:30 a.m...

78 FR 47049 - Research, Engineering and Development Advisory Committee

Science.gov (United States)

2013-08-02

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development...; 5 U.S.C. App. 2), notice is hereby given of a meeting of the FAA Research, Engineering and.... Name: Research, Engineering & Development Advisory Committee. Time and Date: September 18--8:30 a.m. to...

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

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.

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...

77 FR 54648 - Research, Engineering and Development Advisory Committee

Science.gov (United States)

2012-09-05

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development....S.C. App. 2), notice is hereby given of a meeting of the FAA Research, Engineering and Development...: Research, Engineering & Development Advisory Committee. TIME AND DATE: September 26, 2012--9 a.m. to 4 p.m...

76 FR 12404 - Research, Engineering and Development Advisory Committee

Science.gov (United States)

2011-03-07

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering and Development....S.C. App. 2), notice is hereby given of a meeting of the FAA Research, Engineering and Development...: Research, Engineering & Development Advisory Committee. Time and Date: April 20, 2011--9:30 a.m. to 4 p.m...

75 FR 14243 - Research, Engineering And Development Advisory Committee

Science.gov (United States)

2010-03-24

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Research, Engineering And Development....S.C. App. 2), notice is hereby given of a meeting of the FAA Research, Engineering and Development...: Research, Engineering & Development Advisory Committee. Time and Date: April 21, 2010--9 a.m. to 5 p.m...

Committee on Interagency Radiation Research and Policy Coordination 10th anniversary report

International Nuclear Information System (INIS)

1994-06-01

Ten years ago, on April 9, 1984, the Science Advisor to the President, and Director of the Office of Science and Technology Policy, established the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC) to meet the need for an interagency committee to address Congressionally mandated and agency-identified issues related to radiation research and policy. CIRRPC replaced the Committee on Interagency Radiation Policy, a committee of the Federal Coordinating Council for Science, Engineering and Technology, and assumed the responsibilities of the Interagency Radiation Research Committee and the Radiation Policy Council, whose charters had expired. Since then, CIRRPC has been recognized as an effective and respected mechanism for coordinating radiation policy among Federal agencies and as an efficient coordinator and evaluator of Federal efforts on designated radiation research projects. In the last 10 years, CIRRPC has established various Policy and Science Subpanels to undertake the oftentimes difficult task of resolving and coordinating agency policies and responses to issues dealing with radiation. These subpanels addressed such issues as the metrication of radiation units, the policy impact of the radioepidemiological tables, naturally occurring and accelerator-produced radioactive materials, radon protection and health effects, predisaster planning for human health effects research, and ionizing radiation risk assessment. These subpanels and their work represent CIRRPC's continuing effort to seek a common position on issues of national significance and interest

Report of the summative evaluation by the advisory committee on research and development of nuclear energy technology

International Nuclear Information System (INIS)

2005-03-01

The Research Evaluation Committee of the Japan Atomic Energy Research Institute (JAERI) set up an advisory Committee on Research and Development of Nuclear Energy Technology in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations. The Advisory Committee on Research and Development of Nuclear Energy Technology evaluated the adequacy of the plans of safety research to be succeeded from JAERI to a new research institute which will be established by integration of JAERI and the Japan Nuclear Cycle Development Institute (JNC). The Advisory Committee consisted of nine specialists from outside the JAERI conducted its activities from July 2004 to August 2004. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Advisory Committee meeting which was held on August 10, 2004, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Advisory Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on December 1, 2004. This report describes the result of the evaluation by the Advisory Committee on Research and Development on Nuclear Energy Technology. (author)

76 FR 10004 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2011-02-23

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... the Assistant Secretary for Export Administration on emerging technology and research activities...

76 FR 54734 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2011-09-02

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... the Assistant Secretary for Export Administration on emerging technology and research activities...

76 FR 30647 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2011-05-26

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... the Assistant Secretary for Export Administration on emerging technology and research activities...

75 FR 41439 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2010-07-16

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... the Assistant Secretary for Export Administration on emerging technology and research activities...

75 FR 18484 - Emerging Technology and Research Advisory Committee; Notice of Open Meeting

Science.gov (United States)

2010-04-12

... Emerging Technologies Analysis. 2. ETRAC Panel on Emerging Technologies. 3. History of the Laser. 4... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Open Meeting The Emerging Technology and Research Advisory Committee (ETRAC) [[Page...

75 FR 72792 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2010-11-26

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Office of the Assistant Secretary for Export Administration on emerging technology and research...

77 FR 70140 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2012-11-23

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Export Administration on emerging technology and research activities, including those related to deemed...

75 FR 5952 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2010-02-05

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Office of the Assistant Secretary for Export Administration on emerging technology and research...

76 FR 72902 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2011-11-28

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Office of the Assistant Secretary for Export Administration on emerging technology and research...

75 FR 62508 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2010-10-12

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Office of the Assistant Secretary for Export Administration on emerging technology and research...

78 FR 21346 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting

Science.gov (United States)

2013-04-10

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Office of the Assistant Secretary for Export Administration on emerging technology and research...

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 ...

78 FR 20696 - NASA Advisory Council; Human Exploration and Operations Committee; Research Subcommittee; Meeting

Science.gov (United States)

2013-04-05

... topics: --Overview of Research in Space Life and Physical Sciences --Space Station and Future Exploration... Exploration and Operations Committee; Research Subcommittee; Meeting AGENCY: National Aeronautics and Space... of the Research Subcommittee of the Human Exploration and Operations Committee (HEOC) of the NASA...

75 FR 30804 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2010-06-02

... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... public are welcome to observe the business of the Biomass Research and Development Technical Advisory...

75 FR 11526 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2010-03-11

... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... public are welcome to observe the business of the Biomass Research and Development Technical Advisory...

75 FR 74026 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2010-11-30

... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... participation. This notice announces the meeting of the Biomass Research and Development Technical Advisory...

Safety Committees for Argentinean Research Reactor - Regulatory Issues

International Nuclear Information System (INIS)

Perrin, Carlos D.

2009-01-01

In the field of radiological and nuclear safety, the Nuclear Regulatory Authority (ARN) of Argentina controls three research reactors and three critical assemblies, by means of evaluations, audits and inspections, in order to ensure the fulfillment of the requirements established in the Licenses, in the Regulatory Standards and in the Mandatory Documentation in general. From the Nuclear Regulatory Authority's point of view, within the general process of research reactors safety management, the Operational Organization self verification of radiological and nuclear safety plays an outstanding role. In this aspect the ARN has established specific requirements in the Regulatory Standards, in the Operation Licenses and in the Operational Limits and Conditions. These requirements include the figure of different safety committees, which act as reviewers or advisers in diverse situations. This paper describes the main characteristics of the committees, their function, scope and the regulatory documents where the requirements are included. (author)

78 FR 36309 - Research Advisory Committee on Gulf War Veterans' Illnesses, Notice of Meeting

Science.gov (United States)

2013-06-17

... DEPARTMENT OF VETERANS AFFAIRS Research Advisory Committee on Gulf War Veterans' Illnesses, Notice... Act, 5 U.S.C. App., that the Research Advisory Committee on Gulf War Veterans' Illnesses will meet on... operations during the Gulf War. [[Page 36310

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...

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...

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...

76 FR 22091 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2011-04-20

... DEPARTMENT OF ENERGY Energy Efficiency and Renewable Energy Biomass Research and Development Technical Advisory Committee AGENCY: Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of Open Meeting. SUMMARY: This notice announces an open meeting of the Biomass Research and...

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.

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.

Establishing the relationship between an effective audit committee and infusion of a good control environment

Directory of Open Access Journals (Sweden)

Zandile Virtue Dlamini

2017-12-01

Full Text Available Audit Committees are a vital component of accountability and good governance for any serious organisation and have progressively been perceived as an integral part of modern control structures and control practices in both the public and private sectors. However, Audit Committees can only discharge such gigantic responsibilities in a conducive environment to provide its effective performance of certain key functions in the areas of oversight of risk management, reporting, and internal controls. Nonetheless, the enablement of such conducive environments has become a challenge to many Audit Committees. It is against this background that this study investigates the relationship between an effective audit committee and infusion of a good control environment. The study used structured and unstructured questions to investigate population comprising standing committee members and Audit Committee members. Thus this study made use of a mixed methodology to collect quantitative data as well as reviewing audit documents, such as, the Audit Committee Charter and minutes of meetings in order to ascertain the environment under which such august practices are performed. The outcome concludes that the Audit Committee which was selected for the study has the good working environment.

Evaluation of the work of hospital districts' research ethics committees in Finland.

Science.gov (United States)

Halila, Ritva

2014-12-01

The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

Science.gov (United States)

Begum, Rasheda; Kolstoe, Simon

2015-07-25

Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias. As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications. Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32%. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57%) of the published studies. This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

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.

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.

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

76 FR 9339 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2011-02-17

... DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Biomass Research and... Biomass Research and Development Technical Advisory Committee under Section 9008(d) of the Food.... Tentative Agenda: Agenda will include the following: Update on USDA Biomass R&D Activities. Update on DOE...

Committee on Interagency Radiation Research and policy coordination - first annual report, June 30, 1985

International Nuclear Information System (INIS)

1985-01-01

This is the first annual report of the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC). CIRRPC was established on April 9, 1984, by Dr. George A. Keyworth, II, Science Advisor to the President and Director of the Office of Science and Technology Policy (OSTP). CIRRPC replaced the Committee on Interagency Radiation Policy and was assigned responsibilities of the former Interagency Radiation Research Committee and former Radiation Policy Council. CIRRPC is chartered under the Federal Coordinating Council for Science, Engineering and Technology (FCCSET). Its overall charge is to coordinate radiation matters between agencies, evaluate radiation matters between agencies, evaluate radiation research, and provide advice on the formulation of radiation policy

E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

Science.gov (United States)

Dainesi, Sonia Mansoldo; Goldbaum, Moisés

2012-12-01

The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

[The role of bioethics committees in the systems protecting scientific biomedical research participants in France and in Poland].

Science.gov (United States)

Czarkowski, Marek; Sieczych, Alicja

2013-08-01

Bioethics committees are along with ethic regulations and rules of law one of three main pillars in the system of protection of scientific biomedical research participants. Although principal directives for bioethics committees are established by international guidelines, detailed regulations may differ in particular states. The aim of this article was to compare two bioethic committees systems: French and Polish one. Historical beginnings of the bioethics committees system in France and in Poland are briefly mentioned, Subsequently, the networks of bioethics committees in both countries are compared. Although the number of bioethics committees (Research Ethic Committees) in both countries is comparable, the procedure of their establishment varies. French committees are based on administrative division of the country and divide on regional and interregional committees. In Poland, bioethics committees are established by medical universities, medical research and development units or regional chambers of physicians and dentists. In France there is no equivalent of Appeal Bioethics Committee, however one could appeal from the negative bioethics committee's opinion. The composition of French bioethics committees is more diverse and half of the members are not related to medical professions. Members of French committees are named on indefinite term by headmaster of Regional Health Agency after having been chosen in competition for the post. In Poland members are called on three-year-term but the rotation of members is not overwhelming since there is no limit of terms for one member. French legal solutions seems more secure for scientific bioethics research participants. For this reason, a detailed research on legislation in other countries is necessary before introducing any new regulations in Polish law.

Report from the research committee of digital imaging standardization in nuclear medicine

International Nuclear Information System (INIS)

Nakamura, Yutaka; Ise, Toshihide; Isetani, Osamu; Ichihara, Takashi; Ohya, Nobuyoshi; Kanaya, Shinichi; Fukuda, Toshio; Horii, Hitoshi.

1994-01-01

Since digital scintillation camera systems were developed in 1982, digital imaging is rapidly replacing analog imaging. During the first year, the research committee of digital imaging standardization has collected and analyzed basic data concerning digital examination equipment systems, display equipments, films, and hardware and software techniques to determine items required for the standardization of digital imaging. During the second year, it has done basic phantom studies to assess digital images and analyzed the results from both physical and visual viewpoints. On the basis of the outcome of the research committee's activities and the nationwide survey, the draft of digital imaging standardization in nuclear medicine has been presented. In this paper. the analytical data of the two-year survey, made by the research committee of digital imaging standardization, are presented. The descriptions are given under the following four items: (1) standardization digital examination techniques, (2) standardization of display techniques, (3) the count and pixel of digital images, and (4) standardization of digital imaging techniques. (N.K.)

Report of the review committee on evaluation of the R and D subjects in the field of nuclear safety research

International Nuclear Information System (INIS)

2000-09-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee and Research Evaluation Committee, the Ad Hoc Review Committee on Nuclear Safety Research composed of twelve experts was set up under the Research Evaluation Committee of the JAERI in order to review the R and D subjects to be implemented for five years starting in FY2000 in the Nuclear Safety Research Center (Department of Reactor Safety Research, Department of Fuel Cycle Safety Research and Department of Safety Research Technical Support). The Ad Hoc Review Committee meeting was held on January 20, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

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.

Report of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. Result evaluation in fiscal year 2000

International Nuclear Information System (INIS)

2001-06-01

The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Nuclear Safety Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of Reactor Safety Research, Department of Fuel Cycle Safety Research, Department of Environmental Safety Research and Department of Safety Research Technical Support in Tokai Research Establishment at JAERI. The Ad Hoc Review Committee consisted of 11 specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to February 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 11, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. (author)

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.

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...

Research governance: new hope for ethics committees?

Science.gov (United States)

Frew, Deborah; Martlew, Ainsley

2007-01-01

For many years there has been discussion regarding the problems confronting our current ethics review system. Commentators have identified numerous issues that threaten the sustainability of Australia's voluntary HREC system. Various ad hoc solutions to these problems have been posed, but have not resulted in any significant advances. However, in recent years, discourse regarding research governance has become prominent in the Australian research environment. The application of research governance principles is gaining momentum amongst the regulators of research, including research institutions and their governing bureaucracies. We argue that this is potentially the most significant development in several years towards creating a sustainable HREC system in Australia. The recognition by research institutions and their governing bureaucracies that the responsibility for overall research governance lies with them, rather than solely with their HRECs, is leading to a range of initiatives which should significantly lessen the burden on Australian ethics committees, and improve their ability to undertake their core task of reviewing the ethical aspects of research proposals.

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

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.

"The Project Cannot Be Approved in Its Current Form": Feminist Visual Research Meets the Human Research Ethics Committee

Science.gov (United States)

Pitt, Penelope

2014-01-01

This article reflects on a university human research ethics committee's unease regarding a feminist visual pilot study within the field of education. The small exploratory study proposed to explore a migrant mother's production of her son's identity through her family photograph collection. The committee requested substantial…

Report of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. Result evaluation in fiscal year 2000

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-06-01

The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Nuclear Safety Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of Reactor Safety Research, Department of Fuel Cycle Safety Research, Department of Environmental Safety Research and Department of Safety Research Technical Support in Tokai Research Establishment at JAERI. The Ad Hoc Review Committee consisted of 11 specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to February 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 11, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. (author)

Why to audit to research ethics committees?

OpenAIRE

Quiroz, Estela; Médica oftalmóloga, docente de ética y metodología de la investigación, Coordinadora de la Red Peruana de Comités de Ética de la Investigación. Hospital Nacional Hipólito Unanue. Lima, Perú.

2010-01-01

Ethics committees in biomedical research have the responsibility to ensure the protection of human participants in the studies. In order to improve the quality of their work they must undergo audit procedures commissioned by the sponsors and inspections done by the regulatory authorities. Through these procedures, improvement of their functions should be guaranteed, so they can optimize their tasks and accomplish in the best way the purpose for which they were created. Los comités de ét...

Ethical assessment of research protocols: the experience of the Research Ethics Committee of the Hospital Israelita Albert Einstein (HIAE

Directory of Open Access Journals (Sweden)

Sonia Maria Oliveira de Barros

2005-03-01

Full Text Available This is a review article on the origin of the ethical analysis ofresearch protocols, the Brazilian and International legislation,including the Research Ethics Committee of Hospital IsraelitaAlbert Einstein. Since 1997, when the Committee was validatedits role has been recognized as that of a consultant and educator,participating on local and national scientific events andcollaborating with researchers in order to improve their projectsand learn to recognize ethical dilemmas in their protocols.

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

Whose Ethics, Whose Accountability? A Debate about University Research Ethics Committees

Science.gov (United States)

Hoecht, Andreas

2011-01-01

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other…

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...

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

Report of the review committee on evaluation of the R and D subjects in the field of nuclear fusion research

International Nuclear Information System (INIS)

2000-10-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee, the Ad Hoc Review Committee composed of 12 experts was set up under the Research Evaluation Committee of the JAERI in order to review the whole R and D subjects in fusion research, including post-review for those completed in FY1998, intermediate-review for those started in FY1999, and pre-review for those to be implemented in FY2001. The Ad Hoc Review Committee meeting was held on March 9, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research result/plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

Report of the evaluation by the Ad Hoc Review Committee on Materials Science Research. Ex-post evaluation in fiscal year 2003

International Nuclear Information System (INIS)

2004-06-01

The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Materials Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D results achieved for five years until Fiscal Year 2002 at Department of Materials Science in Tokai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from October 2003 to February 2004. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on November 14, 2003, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 8, 2004. This report describes the result of the evaluation by the Ad Hoc Review Committee on Materials Science Research. (author)

Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University.

Science.gov (United States)

Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki

2015-01-01

The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.

Report of the second joint Research Committee for Fusion Reactor and Materials. July 12, 2002, Tokyo, Japan

Energy Technology Data Exchange (ETDEWEB)

NONE

2003-05-01

Joint research committees in purpose of the discussion on DEMO blanket in view point of the both of reactor technology and materials were held by the Research Committee for Fusion Reactor and Fusion Materials. The joint research committee was held in Tokyo on July 12, 2002. In the committee, the present status of development of solid and liquid breeding blanket, the present status of development of reduced activation structure materials, and IFMIF (International Fusion Materials Irradiation Facility) program were discussed based on the discussions of the development programs of the blanket and materials at the first joint research committee. As a result, it was confirmed that high electric efficiency with 41% would be obtained in the solid breeding blanket system, that neutron radiation data of reduced activation ferritic steel was obtained by HFIR collaboration, and that KEP (key element technology phase) of IFMIF would be finished at the end of 2002 and the data base for the next step, i.e. EVEDA (engineering validation/engineering design activity) was obtained. In addition, the present status of ITER CTA, which was a transient phase for the construction, and the outline of ITER Fast Track, which was an accelerated plan for the performance of the power plants, were reported. This report consists of the summary of the discussion and the viewgraphs which were used at the second joint research committee, and these are very useful for the researchers of the fusion area in Japan. (author)

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...

Report of the evaluation by the Ad Hoc Review Committee on Materials Science Research. In-advance evaluation in fiscal year 2002

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-11-01

The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Materials Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs to be implemented for five years starting in Fiscal Year 2003 at Department of Materials Science in Tokai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from April 2002 to August 2002. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 5th, 2002, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 5th, 2002. This report describes the result of the evaluation by the Ad Hoc Review Committee on Materials Science Research. (author)

Report of the evaluation by the Ad Hoc Review Committee on Materials Science Research. In-advance evaluation in fiscal year 2002

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-11-01

The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Materials Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs to be implemented for five years starting in Fiscal Year 2003 at Department of Materials Science in Tokai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from April 2002 to August 2002. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 5th, 2002, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 5th, 2002. This report describes the result of the evaluation by the Ad Hoc Review Committee on Materials Science Research. (author)

Report of the evaluation by the ad hoc review committee on radiation application research. In-advance evaluation in fiscal year 2001

International Nuclear Information System (INIS)

2001-11-01

The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Radiation Application Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs to be implemented for five years starting in Fiscal Year 2002 at Department of Material Development, at Department of Ion-Beam-Applied Biology and at Advanced Radiation Technology Center in Takasaki Radiation Chemistry Research Establishment of JAERI. The Ad Hoc Review Committee consisted of ten specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 25, 2001, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on July 12, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Radiation Application Research. (author)

Report of the review committee on evaluation of the R and D subjects in the field of high-temperature engineering and research

International Nuclear Information System (INIS)

2000-09-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee and Research Evaluation Committee, the Ad Hoc Review Committee on High-Temperature Engineering and Research composed of nine experts was set up under the Research Evaluation Committee of the JAERI in order to review the R and D subjects to be implemented for five years starting in FY 2000 in the Departments of HTTR Project and Advanced Nuclear Heat Technology. The Ad Hoc Review Committee meeting was held on December 27, 1999. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

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.

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.

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.

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...

76 FR 47611 - Advisory Committee for Environmental Research And Education; Notice of Meeting

Science.gov (United States)

2011-08-05

... NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research And Education; Notice of... support for environmental research and education. Agenda September 8, 2011 Update on NSF environmental research and education activities; Update on national and international collaborations; Meeting with the...

78 FR 9743 - Advisory Committee for Environmental Research and Education; Notice of Meeting

Science.gov (United States)

2013-02-11

... NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research and Education; Notice of... concerning support for environmental research and education. Agenda March 13, 2013 Update on NSF environmental research and education activities Update on national and international collaborations Update on...

White House Communications Agency

National Research Council Canada - National Science Library

Gimble, Thomas

1995-01-01

The Chairman, House Committee on Government Reform and Oversight; the Chairman, House Subcommittee on National Security, International Affairs, and Criminal Justice, Committee on Government Reform and Oversight...

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.

Activities of the research committee on thorium cycle in atomic energy society of Japan

International Nuclear Information System (INIS)

Hohki, Shiro

1985-01-01

In 1978 the Research Committee on Thorium Cycle was established as one of committees of the Atomic Energy Society of Japan, and the Committee published a report titled 'The Thorium Cycle - Present Status and Future Prospect' in October 1980 as a result of investigations on the status of the thoirum cycle in Japan as well as that in overseas. Based on this investigation, the Committee is intending to evaluate synthetically the thorium utilization in Japan under the prospect for the middle and long term by intensifying the activities of the Committee. Furthermore, from this viewpoint, the author supplements comments on following three points: (1) Reasons why the thorium utilization has not received positive evaluation in Japan; (2) Reasons why Japan has to pay attention to thorium; (3) How the technology on thorium should be developed in Japan. (author)

78 FR 48200 - Advisory Committee for Environmental Research and Education; Notice of Meeting

Science.gov (United States)

2013-08-07

... NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research and Education; Notice of... Research and Education, 9487. Dates: September 11, 2013, 9:00 a.m.-5:00 p.m., and September 12, 2013, 9:00... research and education. Agenda September 11, 2013 Update on NSF environmental research and education...

Organizing Committee Advisory Committee 187

Indian Academy of Sciences (India)

Organizing Committee. V M Datar (Chairman). Bhabha Atomic Research Centre, Mumbai, India. D C Biswas (Convener). Bhabha Atomic Research Centre, Mumbai, India. K Mahata (Secretary). Bhabha Atomic Research Centre, Mumbai, India. Z Ahmed. Bhabha Atomic Research Centre, Mumbai, India. P V Bhagwat.

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.

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...

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

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

Report of the evaluation by the Ad Hoc Review Committee on High-Temperature Engineering and Research. Result evaluation in fiscal year 2000

International Nuclear Information System (INIS)

2001-06-01

The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on High-Temperature Engineering and Research in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of HTTR Project and Department of Advanced Nuclear Heat Technology in Oarai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of nine specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to February 2001. The evaluation was performed on the basis of the materials submitted in advanced and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 8, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on High-Temperature Engineering and Research. (author)

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.

34 CFR 350.34 - Which Rehabilitation Engineering Research Centers must have an advisory committee?

Science.gov (United States)

2010-07-01

... 34 Education 2 2010-07-01 2010-07-01 false Which Rehabilitation Engineering Research Centers must... Engineering Research Centers Does the Secretary Assist? § 350.34 Which Rehabilitation Engineering Research Centers must have an advisory committee? A Rehabilitation Engineering Research Center conducting research...

Young people's views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study.

Science.gov (United States)

Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

2016-09-02

Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees. Digitally recorded interviews were conducted with 48 participants aged 17-19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management. The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to 'jury duty'. There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance

77 FR 50532 - Advisory Committee for Environmental Research and Education; Notice of Meeting

Science.gov (United States)

2012-08-21

... NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research and Education; Notice of... Environmental Research and Education, 9487. Dates: September 12, 2012, 9 a.m.-5 p.m. September 13, 2012, 9 a.m... concerning support for environmental research and education. Agenda September 12, 2012 Update on NSF...

Towards beneficence for young children in research: challenges for bioethics committees.

Science.gov (United States)

Farrell, Ann

2010-09-01

Bioethics committees are the focus of international scrutiny, particularly in relation to their application of the principle of beneficence, ensuring that risks incurred in research are outweighed by benefits to those involved directly and to the broader society. Beneficence, in turn, has become an international focus in research with young children, who hitherto had been rarely seen or heard in their own right in research. Twenty years ago, The United Nations Convention on the Rights of the Child 1989 raised global awareness of children's human rights to both participation and protection, and articulation of children's rights came to inform understandings of young children's rights in research. In the intervening period, countries such as Australia came to favour child protection and risk minimisation in research over the notion of children's bone fide participation in research. A key element of the protection regime was the theoretical understanding of young children as developmentally unable and, therefore, unfit to understand, consent to and fully participate as research participants. This understanding has been challenged in recent decades by new theoretical understandings of children's competence, where children can be seen to demonstrate competence, even at an early age, in consenting to, participating in and withdrawing from research. The paper draws on these understandings to provide insights for human research gatekeepers, such as bioethics committees, to deal with the challenges of research with young children and to realize the benefits that may accrue to children in research.

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.

Evaluation in health promotion: thoughts from inside a human research ethics committee.

Science.gov (United States)

Allen, Judy; Flack, Felicity

2015-12-01

Health promotion research, quality improvement and evaluation are all activities that raise ethical issues. In this paper, the Chair and a member of human resear ch ethics committees provide an insiders' point of view on how to demonstrate ethical conduct in health promotion research and quality improvement. Several common issues raised by health promotion research and evaluation are discussed including researcher integrity, conflicts of interest, use of information, consent and privacy.

Validation of contractor HMA testing data in the materials acceptance process.

Science.gov (United States)

2010-08-01

"This study conducted an analysis of the SCDOT HMA specification. A Research Steering Committee comprised of SCDOT, FHWA, and Industry representatives provided oversight of the process. The research process included a literature review, a brief surve...

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)

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

Payment of research participants: current practice and policies of Irish research ethics committees.

Science.gov (United States)

Roche, Eric; King, Romaine; Mohan, Helen M; Gavin, Blanaid; McNicholas, Fiona

2013-09-01

Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Postal survey of all RECs in Ireland. Response rate was 62.5% (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants.

Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

Science.gov (United States)

Smith, T; Moore, E J; Tunstall-Pedoe, H

1997-05-31

To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. Tayside, Scotland (mixed rural and urban population). 30 research projects approved by Tayside local medical research ethics committee. Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.

Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings

NARCIS (Netherlands)

de Jong, Jean Philippe; van Zwieten, Myra C. B.; Willems, Dick L.

2012-01-01

Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We

75 FR 9001 - Advisory Committee for Environmental Research and Education; Notice of Meeting

Science.gov (United States)

2010-02-26

... NATIONAL SCIENCE FOUNDATION Advisory Committee for Environmental Research and Education; Notice of... Research and Education (9487). Dates: March 18, 2010, 8:30 a.m.-5 p.m. March 19, 2010, 8:30 a.m.-1 p.m... support for environmental research and education. Agenda March 18, 2010 Update on recent NSF environmental...

A National Research Agenda for Virtual Reality: Report by the National Research Council Committee on VR R&D

OpenAIRE

Pausch, Randy; Aviles, Walter; Durlach, Nathaniel; Robinett, Warren; Zyda, Michael

1995-01-01

In 1992, at the request of a consortium of federal agencies, the National Research Council established a committee to "recommand a national research and development agenda in the area of virtual reality" to set U.S. government R&D funding priorities for virtual reality (VR) for the next decade....

Report of the evaluation by the ad hoc review committee on advanced photon and synchrotron radiation research. In-advance evaluation in fiscal year 2001

International Nuclear Information System (INIS)

2001-11-01

The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Advanced Photon and Synchrotron Radiation Research in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs to be implemented for five years starting in Fiscal Year 2002 at Advanced Photon Research Center and at Synchrotron Radiation Research Center in Kansai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of ten specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2001. The evaluation was performed on the basis of the materials submitted in advanced and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 21, 2001, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on July 12, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Advanced Photon and Synchrotron Radiation Research. (author)

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.

Antibody Scientific Committee | Office of Cancer Clinical Proteomics Research

Science.gov (United States)

The Antibody Scientific Committee provides scientific insight and guidance to the NCI's Antibody Characterization Program. Specifically, the members of this committee evaluate request from the external scientific community for development and characterization of antibodies by the program. The members of the Antibody Scientific Committee include:

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

[Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics].

Science.gov (United States)

Valdez-Martínez, Edith; Lifshitz-Guinzberg, Alberto; Medesigo-Micete, José; Bedolla, Miguel

2008-08-01

To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n=437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n=167) and to the Mexican Ministry of Health's most important health care centers (n=15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. In all, 116 committees were identified, with various names. Of these, 101 (87.1%) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4%) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0%) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5%), followed by nursing staff (11.9%). Among the members of the active committees, 77.9% had not received training in ethics. Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.

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.

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.

76 FR 46781 - Biomass Research and Development Technical Advisory Committee

Science.gov (United States)

2011-08-03

..., 2011: 7:30 a.m.-2 p.m.; August 24, 2011: 7:30 a.m.-12:30 p.m. ADDRESSES: I Hotel, 1900 S. First Street... welcome to observe the business of the Biomass Research and Development Technical Advisory Committee. To... ext. 220; E- mail: hq.com ">[email protected] hq.com at least 7 business days prior to the meeting. Members...

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.

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.

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.

Ethics Committee or Community? Examining the identity of Czech Ethics Committees in the period of transition.

Science.gov (United States)

Simek, Jiri; Zamykalova, Lenka; Mesanyova, Marie

2010-09-01

Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research team took part at six regular voluntary meetings of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic.

[Bioethical Approach for Nursing Research -Focused on the Use of Research Ethics Committees].

Science.gov (United States)

Jeong, Ihn Sook

2015-06-01

This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.

Clinical studies of the Research Committee on Intractable Vasculitides, the Ministry of Health, Labour and Welfare of Japan.

Science.gov (United States)

Makino, Hirofumi; Sada, Ken-Ei

2013-10-01

In Japan, the Research Committee on Intractable Vasculitides, supported by the Ministry of Health, Labour and Welfare, has been promoting basic and clinical research on vasculitis since 1972. The present Research Committee on Intractable Vasculitides comprises 4 subcommittees under the direction of a Principal Investigator: Basic and Pathological Research Subcommittee, Clinical Research Subcommittee of Small and Medium-sized Vessel Vasculitis, Clinical Research Subcommittee of Large-sized Vessel Vasculitis, and International Cooperation Research Subcommittee. Since 2008, 9 nationwide clinical studies for vasculitis have been conducted and 8 clinical and basic studies are in progress.

Report of the evaluation by the Ad Hoc Review Committee on advance science research. Result evaluation, interim evaluation, in-advance evaluation in fiscal year 2003

International Nuclear Information System (INIS)

2003-11-01

The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Advanced Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the accomplishments of the research completed in Fiscal Year 2002, the accomplishments of the research started in Fiscal Year 2001, and the adequacy of the programs of the research to be started in Fiscal Year 2004 at Advanced Science Research Center of JAERI. The Ad Hoc Review Committee consisted of nine specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2003. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 24, 2003, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 4, 2003. This report describes the result of the evaluation by the Ad Hoc Review Committee on Advanced Science Research. (author)

Report of the evaluation by the Ad Hoc Review Committee on Advance Science Research. Result evaluation, interim evaluation, in-advance evaluation in fiscal year 2002

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-11-01

The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Advanced Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the accomplishments of the research completed in Fiscal Year 2001, the accomplishments of the research started in Fiscal Year 2000, and the adequacy of the programs of the research to be started in Fiscal Year 2003 at Advanced Science Research Center of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2002. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 4, 2002, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 5, 2002. This report describes the result of the evaluation by the Ad Hoc Review Committee on Advanced Science Research. (author)

IAEA technical committee meeting on research using small fusion devices (abstracts)

International Nuclear Information System (INIS)

1999-12-01

The thirteenth IAEA technical committee meeting on research using small fusion devices are held in Chengdu, P. R. China on 18-20 Oct. , 1999. 41 articles are received and the content includes toroidal systems, helical systems, plasma focus, diagnostic systems, theory and modeling, improving confinement, numerical simulation, innovative concepts and others

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...

Final report of the Committee on Interagency Radiation Research and Policy Coordination, 1984-1995

International Nuclear Information System (INIS)

1995-09-01

This document is the final report of the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC). The committee was established to address national and international issues involving ionizing and nonionizing radiation. Three sections are included in the report: a summary of CIRRPC's history structure, and operations; CIRRPC's most significant activities, findings and recommendations on national radiation issues of sufficient importance and scope to require interagency attention; topics for future consideration by Federal agencies

Committee on Interagency Radiation Research and Policy Coordination second annual report, July 1, 1985--June 30, 1986

Energy Technology Data Exchange (ETDEWEB)

Young, A.L.

1996-06-30

This is the second annual report of the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC). CIRRPC was established on April 9, 1984, to replace the Committee on Interagency Radiation Policy and was assigned responsibilities of the former Interagency Radiation Research Committee and former Radiation Policy Council. CIRRPC is chartered under the Federal Coordinating Council for Science, Engineering and Technology (FCCSET) and reports to the Office of Science and Technology Policy (OSTP), Executive Office of the President. Its overall charge is to coordinate radiation matters between agencies, evaluate radiation research, and provide advice on the formulation of radiation policy. During CIRRPC`s second year, the member agencies have called upon this interagency resource to assist in coordinating science and policy issues and to provide a vehicle to accomplish multiagency tasks.

Committee on Interagency Radiation Research and Policy Coordination second annual report, July 1, 1985--June 30, 1986

International Nuclear Information System (INIS)

Young, A.L.

1996-01-01

This is the second annual report of the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC). CIRRPC was established on April 9, 1984, to replace the Committee on Interagency Radiation Policy and was assigned responsibilities of the former Interagency Radiation Research Committee and former Radiation Policy Council. CIRRPC is chartered under the Federal Coordinating Council for Science, Engineering and Technology (FCCSET) and reports to the Office of Science and Technology Policy (OSTP), Executive Office of the President. Its overall charge is to coordinate radiation matters between agencies, evaluate radiation research, and provide advice on the formulation of radiation policy. During CIRRPC's second year, the member agencies have called upon this interagency resource to assist in coordinating science and policy issues and to provide a vehicle to accomplish multiagency tasks

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.

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…

76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

Science.gov (United States)

2011-07-29

.... FDA-2010-N-0002] Advisory Committee; Medical Imaging Drugs Advisory Committee; Re- Establishment... (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging...

Minutes of 'Technical Committee for Geological Isolation Research and Development (1st time)'

International Nuclear Information System (INIS)

Sasaki, Yasuo; Torata, Shinichiro

2007-03-01

In order to plan and conduct a program of research and development (R and D) for geological disposal of high-level radioactive waste in JAEA-Tokai, JAEA decided to receive technical comments and advices from the Technical Committee for geological isolation R and D. This committee, which is constituted of specialists who do not belong to JAEA, has evaluated the program, taking into account of the status of geological disposal technology in Japan as well as foreign countries. This report compiles the minutes of the first meeting held in July 2006. (author)

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

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.

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...

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…

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.

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.

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

Final report of the Committee on Interagency Radiation Research and Policy Coordination, 1984-1995

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-09-01

This document is the final report of the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC). The committee was established to address national and international issues involving ionizing and nonionizing radiation. Three sections are included in the report: a summary of CIRRPC`s history structure, and operations; CIRRPC`s most significant activities, findings and recommendations on national radiation issues of sufficient importance and scope to require interagency attention; topics for future consideration by Federal agencies.

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...

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...

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

Science.gov (United States)

Newcombe, J P; Kerridge, I H

2007-01-01

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

[Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

Science.gov (United States)

Gonorazky, Sergio E

2008-01-01

The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

Phronesis: Beyond the Research Ethics Committee-A Crucial Decision-Making Skill for Health Researchers During Community Research.

Science.gov (United States)

Greeff, Minrie; Rennie, Stuart

2016-04-01

Health researchers conducting research in the community are often faced with unanticipated ethical issues that arise in the course of their research and that go beyond the scope of ethical approval by the research ethics committee. Eight expert researchers were selected through extreme intensity purposive sampling, because they are representative of unusual manifestations of the phenomenon related to their research in the community. They were selected to take part in a semi-structured focus group discussion on whether practical wisdom (phronesis) is used as a decision-making skill to solve unanticipated ethical issues during research in the community. Although the researchers were not familiar with the concept phronesis, it became obvious that it formed an integral part of their everyday existence and decision making during intervention research. They could balance research ethics with practical considerations. The capacity of practical wisdom as a crucial decision-making skill should be assimilated into a researcher's everyday reality, and also into the process of mentoring young researchers to become phronimos. Researchers should be taught this skill to handle unanticipated ethical issues. © The Author(s) 2016.

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...

Audit Committee Accounting Expert and Earnings Management with “Status” Audit Committee as Moderating Variable

Directory of Open Access Journals (Sweden)

Edy Suprianto

2017-12-01

Full Text Available This research aims to analyze the effect of accounting expert of audit committee on earnings management. This research also assesses the role of audit committee on earnings management with audit committee status as moderating variable. The population is all of firm’s which listed in Indonesia Stock Exchange. Purposive sampling is used to collect data. Data used financial statements and annual report companies from Indonesia Stock Exchange website. Moderated regression analysis (MRA is used to analyze the hypothesis. The result shows that accounting expert of audit committee has negative effect on earnings management. Yet, variable of audit committee status cannot moderate the relationship between accounting expert of audit committee and earnings management in Indonesia.

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...

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

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.

Research on prisoners - a comparison between the IOM Committee recommendations (2006) and European regulations.

Science.gov (United States)

Elger, Bernice S; Spaulding, Anne

2010-01-01

The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki.

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.

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

75 FR 59242 - Privacy Act of 1974; System of Records

Science.gov (United States)

2010-09-27

... Homeland Security and Governmental Affairs, the Chair of the House Committee on Oversight and Government... Chair of the House of Representatives Committee on Oversight and Government Reform. A system of records... (National SMART) Grant Program, the Teacher Education Assistance for College and Higher Education (TEACH...

75 FR 12554 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Science.gov (United States)

2010-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH... priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C...

Perspectives on animal welfare legislation and study considerations for field-oriented studies of raptors in the United States

Science.gov (United States)

Boal, C.W.; Wallace, M.C.; Strobel, B.

2010-01-01

Concern for the welfare of animals used in research and teaching has increased over the last 50 yr. Animal welfare legislation has resulted in guidelines for the use of animals in research, but the guidelines can be problematic because they focus on animals used in laboratory and agriculture research. Raptor biologists can be constrained by guidelines, restrictions, and oversight that were not intended for field research methods or wild animals in the wild or captivity. Field researchers can be further hampered by not understanding animal welfare legislation, who is subject to oversight, or that oversight is often provided by a committee consisting primarily of scientists who work with laboratory animals. Raptor researchers in particular may experience difficulty obtaining approval due to use of various species-specific trapping and handling methods. We provide a brief review of animal welfare legislation and describe the basic components and responsibilities of an Institutional Animal Care and Use Committee (IACUC) in the United States. We identify topics in raptor research that are especially problematic to obtaining IACUC approval, and we provide insight on how to address these issues. Finally, we suggest that all raptor researchers, regardless of legal requirements, abide by the spirit of the animal welfare principles. Failure to do so may bring about further regulatory and permitting restrictions. ?? 2010 The Raptor Research Foundation, Inc.

Research Ethics Committees and Participatory Action Research With Young People: The Politics of Voice.

Science.gov (United States)

Yanar, Zeynep M; Fazli, Mehria; Rahman, Jahanara; Farthing, Rys

2016-04-01

Participatory action research (PAR) is a methodological approach that seeks to maximize the participation of people whose lives it researches. It is underpinned by an ethical concern to research "with" people, rather than "on" people. However, this ethical approach to research is often, paradoxically, problematized by universities' research ethics committees (RECs). This article explores one site of tension between PAR and RECs-the requirement for anonymity for below 18-year-olds. It explores this tension by exploring a case study of a peer-to-peer research project undertaken by young women in East London, and using our own experiences and perspectives, it argues that anonymity can be unjust, disempowering, and unnecessary, and can reduce "pride." Without wanting to develop specific recommendations, given the limited scope of our case study, this article uses firsthand experiences to add weight to the broader discussions calling for a critical rethink of REC guidelines. © The Author(s) 2016.

Energy Materials Coordinating Committee (EMaCC) annual technical report, fiscal year 1984 with fiscal year 1985 data

Energy Technology Data Exchange (ETDEWEB)

None

1985-07-01

The Department of Energy funded about 374 million dollars of materials science and technology activities in both fiscal years 1984 and 1985. These funds and the commensurate program management responsibilities resided in 21 DOE program offices, each of which has its own mission and responsibilities. The Energy Materials Coordinating Committee (EMaCC) provides a formal mechanism to insure coordinated planning and maximum programmatic effectiveness for the Department's 374 million dollar per year materials effort. The EMaCC reports to the Director of the Office of Energy Research who in turn has oversight responsibilities for proper coordination of the technical programs of the Department. In carrying out this responsibility, EMaCC hosts meetings, organizes working groups, and publishes an annual technical report. This report is mandated by the EMaCC Terms of Reference. Its purpose is to disseminate information on the DOE materials programs for more effective coordination. It describes the materials research programs of various offices and divisions within the Department for FY 1984, contains funding information for FYs 1984 and 1985, and summarizes EMaCC activities for FY 1985.

Energy Materials Coordinating Committee (EMaCC) annual technical report, fiscal year 1984 with fiscal year 1985 data

International Nuclear Information System (INIS)

1985-07-01

The Department of Energy funded about 374 million dollars of materials science and technology activities in both fiscal years 1984 and 1985. These funds and the commensurate program management responsibilities resided in 21 DOE program offices, each of which has its own mission and responsibilities. The Energy Materials Coordinating Committee (EMaCC) provides a formal mechanism to insure coordinated planning and maximum programmatic effectiveness for the Department's 374 million dollar per year materials effort. The EMaCC reports to the Director of the Office of Energy Research who in turn has oversight responsibilities for proper coordination of the technical programs of the Department. In carrying out this responsibility, EMaCC hosts meetings, organizes working groups, and publishes an annual technical report. This report is mandated by the EMaCC Terms of Reference. Its purpose is to disseminate information on the DOE materials programs for more effective coordination. It describes the materials research programs of various offices and divisions within the Department for FY 1984, contains funding information for FYs 1984 and 1985, and summarizes EMaCC activities for FY 1985

Developmental process and early phases of implementation for the United States Interagency Committee on Human Nutrition Research National Nutrition Research Roadmap

Science.gov (United States)

The United States Congress first called for improved coordination of human nutrition research within and among federal departments and agencies in the 1977 Farm Bill. Today, the Interagency Committee on Human Nutrition Research (ICHNR) is charged with improving the planning, coordination, and commu...

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

76 FR 76937 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting-Room Change

Science.gov (United States)

2011-12-09

... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting--Room Change The Emerging Technology and Research Advisory... emerging technology and research activities, including those related to deemed exports. Agenda Wednesday...

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.

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.

Perspectives of Egyptian research ethics committees regarding their effective functioning.

Science.gov (United States)

Matar, Amal; Silverman, Henry

2013-02-01

The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.

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

Research using small tokamaks. Proceedings of a technical committee meeting

International Nuclear Information System (INIS)

1997-09-01

The technical reports in these proceedings were presented at the IAEA Technical Committee Meeting on research Using Small Tokamaks, held in Ahmedabad, India, 6-7 December 1995. The purpose of this annual meeting is to provide a forum for the exchange of information on various small and medium sized plasma experiments, not only for tokamaks. The potential benefits of these research programmes are to: test theories, such as effects of the plasma rotation; check empirical scalings, such as density limits; develop fusion technology hardware; develop plasma diagnostics; such as tomography; and to train scientists, engineers, technicians, and students, particularly in developing IAEA Member States

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.

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

Clinical Trials

Medline Plus

Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... provide guidance and oversight to the IRBs, develop educational programs and materials, and offer advice on research- ...

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.

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...

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.

78 FR 40743 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Science.gov (United States)

2013-07-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH... Director, NIOSH, on priorities in mine safety and health research, including grants and contracts for such...

History of the research ad hoc committee on 'dissemination of information' and the special ad hoc committee on 'dissemination of information' of the Atomic Energy Society of Japan

Energy Technology Data Exchange (ETDEWEB)

Itabashi, Keizo [Japan Atomic Energy Agency, Intellectual Resources Department, Tokai, Ibaraki (Japan)

2010-06-15

The Research ad hoc committee on 'Dissemination of information' of the Atomic Energy Society of Japan was held 15 times from Oct. 1970 to Mar 1973. After that, The Special ad hoc committee on 'Dissemination of information' of the Atomic Energy Society of Japan was held 115 times from Apr. 1973 to Mar 2009. The history of these two committees is described. Activity report is arranged including the information on change of the member and topics of the meeting, and the minutes. Furthermore, the document list on International Nuclear Information System (INIS) from Japan is included. (author)

History of the research ad hoc committee on 'dissemination of information' and the special ad hoc committee on 'dissemination of information' of the Atomic Energy Society of Japan

International Nuclear Information System (INIS)

Itabashi, Keizo

2010-06-01

The Research ad hoc committee on 'Dissemination of information' of the Atomic Energy Society of Japan was held 15 times from Oct. 1970 to Mar 1973. After that, The Special ad hoc committee on 'Dissemination of information' of the Atomic Energy Society of Japan was held 115 times from Apr. 1973 to Mar 2009. The history of these two committees is described. Activity report is arranged including the information on change of the member and topics of the meeting, and the minutes. Furthermore, the document list on International Nuclear Information System (INIS) from Japan is included. (author)

Environmental components of OCS policy committee recommendations regarding national oil spill prevention and response program

International Nuclear Information System (INIS)

Groat, C.G.; Thorman, J.

1991-01-01

The Exxon Valdez oil spill of March 24, 1989 resulted in thousands of pages of analytical reports assessing the environmental, organizational, legal, procedural, social, economic, and political aspects of the event. Even though the accident was a transportation incident, it had a major impact on the public and political perception of offshore oil operations. This caused the OCS Policy Committee, which advises the Secretary of the Interior and the Minerals Management Service on Outer Continental Shelf resource development and environmental matters, to undertake a review of the reports for the purpose of developing recommendations to the secretary for improvements in OCS operations that would insure maximum efforts to prevent spills and optimal ability to deal with any that occur. The Committee felt strongly that 'a credible national spill prevention and response program from both OCS and non-OCS oil spills in the marine environment is needed to create the political climate for a viable OCS program.' The report of the Committee described eight essential elements of this program; four of these focused on the environmental aspects of oil spills, calling for (1) adequate characterization of the marine and coastal environment, including both information and analysis, accessible to decision makers, (2) the capacity to restore economic and environmental resources as quickly as possible if damage occurs, (3) a mechanism for research on oil spill impacts, and (4) a meaningful role for all interested and responsible parties, including the public, in as many of these activities as possible, from spill prevention and contingency planning to environmental oversight of ongoing operations and participation in clean-up and restoration activities

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

78 FR 48156 - Notice of Commissioner and Staff Attendance at North American Electric Reliability Corporation...

Science.gov (United States)

2013-08-07

... Committee and Board of Trustees Meetings Board of Trustees Corporate Governance and Human Resources Committee, Compliance Committee, Finance and Audit Committee, and Standards Oversight and Technology...

Members of research ethics committees accepted a modification of the randomized consent design

NARCIS (Netherlands)

Schellings, Ron; Kessels, Alfons G.; ter Riet, Gerben; Kleijnen, Jos; Leffers, Pieter; Knottnerus, J. André; Sturmans, Ferd

2005-01-01

Background and Objective: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what

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

78 FR 37242 - Draft Report and Recommendations Prepared by the Research Committee of the Scientific Working...

Science.gov (United States)

2013-06-20

... Recommendations Prepared by the Research Committee of the Scientific Working Group on Medicolegal Death... Justice Programs, National Institute of Justice, Scientific Working Group for Medicolegal Death Investigation will make available to the general public a document entitled, ``Research in Forensic Pathology...

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...

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

What's the Harm in Asking about Suicidal Ideation?

Science.gov (United States)

Mathias, Charles W.; Furr, Michael; Sheftall, Arielle H.; Hill-Kapturczak, Nathalie; Crum, Paige; Dougherty, Donald M.

2012-01-01

Both researchers and oversight committees share concerns about patient safety in the study-related assessment of suicidality. However, concern about assessing suicidal thoughts can be a barrier to the development of empirical evidence that informs research on how to safely conduct these assessments. A question has been raised if asking about…

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...

Health Research Ethics Committees in South Africa 12 years into democracy

Directory of Open Access Journals (Sweden)

Myer Landon

2007-01-01

Full Text Available Abstract Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56% are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

Report of Research Cooperation Sub-Committee 46 on research and development of methods for inelastic (EPICC: Elastic-PlastIC-Creep) structural analysis

International Nuclear Information System (INIS)

Yamada, Yoshiaki

1977-05-01

This report succeeds the preceding one on ''Verification and Qualification of Nonlinear Structural Analysis Computer Program''. PNC (Power Reactor and Nuclear Fuel Development Corporation) decided to sponsor an extended research project on inelastic structural analysis for a period spanning September, 1976 to May, 1978. Responding to PNC proposal, RC Sub-Committee 46 was formed in Japan Society of Mechanical Engineers and plunged into the cooperative work from October, 1976. Besides the verification and/or qualification of available general purpose computer programs which were the major objectives of previous contract, the Committee executed the research on the topics categorized into the following three fields of interests: 1. Material data for use in elastic analysis, 2. Inelastic analysis procedure and computer program verification, 3. Design code and processing of computer solutions. This report summarizes the efforts during the first year of the Sub-Committee and consists of three parts each corresponding to the research topics stated above. Part I. Inelastic constitutive equations for materials under high temperature service conditions Part II. EPICC standard benchmark test problem and solutions Part III. Examination of postprocessors and development Although the research is still in the intermediate stage, the features of research being actively under way are 1. Evaluative review and nationwide collection of material data, recommendation of tentative constitutive equations for elastic-plastic and creep analyses of benchmark test problem, 2. Revision and augmentation of EPICC standard benchmark test problem and competitive and/or cooperative execution of solutions, 3. Review of existing prototypical post processors, and development of a processor for piping design. (author)

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

Low-frequency electrical dosimetry: research agenda of the IEEE International Committee on Electromagnetic Safety.

Science.gov (United States)

Reilly, J Patrick; Hirata, Akimasa

2016-06-21

This article treats unsettled issues in the use of numerical models of electrical dosimetry as applied to international limits on human exposure to low-frequency (typically  IEEE-ICES (International Committee on Electromagnetic Safety) Technical Committee 95. The paper discusses 25 issues needing attention, fitting into three general categories: induction models; electrostimulation models; and human exposure limits. Of these, 9 were voted as 'high priority' by members of Subcommittee 6. The list is presented as a research agenda for refinements in numerical modeling with applications to human exposure limits. It is likely that such issues are also important in medical and electrical product safety design applications.

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...

Criticality accident in uranium fuel processing plant. Questionnaires from Research Committee of Nuclear Safety

International Nuclear Information System (INIS)

Kataoka, Isao; Sekimoto, Hiroshi

2000-01-01

The Research Committee of Nuclear Safety carried out a research on criticality accident at the JCO plant according to statement of president of the Japan Atomic Energy Society on October 8, 1999, of which results are planned to be summarized by the constitutions shown as follows, for a report on the 'Questionnaires of criticality accident in the Uranium Fuel Processing Plant of the JCO, Inc.': general criticality safety, fuel cycle and the JCO, Inc.; elucidation on progress and fact of accident; cause analysis and problem picking-up; proposals on improvement; and duty of the Society. Among them, on last two items, because of a conclusion to be required for members of the Society at discussions of the Committee, some questionnaires were send to more than 1800 of them on April 5, 2000 with name of chairman of the Committee. As results of the questionnaires contained proposals and opinions on a great numbers of fields, some key-words like words were found on a shape of repeating in most questionnaires. As they were thought to be very important nuclei in these two items, they were further largely classified to use for summarizing proposals and opinions on the questionnaires. This questionnaire had a big characteristic on the duty of the Society in comparison with those in the other organizations. (G.K.)

Proceedings of RIKEN BNL Research Center Workshop, Volume 91, RBRC Scientific Review Committee Meeting

Energy Technology Data Exchange (ETDEWEB)

Samios,N.P.

2008-11-17

The ninth evaluation of the RIKEN BNL Research Center (RBRC) took place on Nov. 17-18, 2008, at Brookhaven National Laboratory. The members of the Scientific Review Committee (SRC) were Dr. Dr. Wit Busza (Chair), Dr. Miklos Gyulassy, Dr. Akira Masaike, Dr. Richard Milner, Dr. Alfred Mueller, and Dr. Akira Ukawa. We are pleased that Dr. Yasushige Yano, the Director of the Nishina Institute of RIKEN, Japan participated in this meeting both in informing the committee of the activities of the Nishina Institute and the role of RBRC and as an observer of this review. In order to illustrate the breadth and scope of the RBRC program, each member of the Center made a presentation on his/her research efforts. This encompassed three major areas of investigation, theoretical, experimental and computational physics. In addition the committee met privately with the fellows and postdocs to ascertain their opinions and concerns. Although the main purpose of this review is a report to RIKEN Management (Dr. Ryoji Noyori, RIKEN President) on the health, scientific value, management and future prospects of the Center, the RBRC management felt that a compendium of the scientific presentations are of sufficient quality and interest that they warrant a wider distribution. Therefore we have made this compilation and present it to the community for its information and enlightenment.

[Accreditation of Independent Ethics Committees].

Science.gov (United States)

Ramiro Avilés, Miguel A

According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. National and regional legislation governing biomedical research was analysed. No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

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

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.

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.

A Case-Study of the Resources and Functioning of Two Research Ethics Committees in Western India.

Science.gov (United States)

Chenneville, Tiffany; Menezes, Lynette; Kosambiya, Jayendrakumar; Baxi, Rajendra

2016-12-01

Assessing the resources and functioning of research ethics committees (RECs) in low-resource settings poses many challenges. We conducted a case study of two medical college RECs (A and B) in Western India utilizing the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT) as well as in-depth interviews with representative members to evaluate REC effectiveness. REC A and B obtained 62% and 67% of allowable points on the RECQASAT. These scores together with findings from the in-depth interviews suggest the need for significant improvement in REC effectiveness particularly in the areas of membership and educational training, organizational aspects, recording minutes, communicating decisions, and REC resources. Developing evidence-based best practices and strengthening infrastructure are essential to enhancing REC efficacy in low-resource countries.

77 FR 57567 - Single Source Cooperative Agreement Award for World Health Organization

Science.gov (United States)

2012-09-18

... Organization AGENCY: Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and... Organization for a grant titled: ``Smallpox Research Oversight Activities: WHO Advisory Committee on Variola... notification to World Health Organization (WHO) as soon as possible, and any confirmed smallpox case would...

A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance.

Science.gov (United States)

Hedgecoe, Adam

2014-02-01

Focusing on the high-profile drug disaster at London's Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

[Responsibilities of ethics committees].

Science.gov (United States)

von Bergmann, K

2000-05-01

Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

77 FR 40622 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Science.gov (United States)

2012-07-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH..., oxygen supply partnership, safety culture, occupational health and safety management systems, preventing...

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

Competency, Programming, and Emerging Innovation in Graduate Education within Schools of Pharmacy: The Report of the 2016-2017 Research and Graduate Affairs Committee.

Science.gov (United States)

Poloyac, Samuel M; Block, Kirsten F; Cavanaugh, Jane E; Dwoskin, Linda P; Melchert, Russell B; Nemire, Ruth E; O'Donnell, James M; Priefer, Ronny; Touchette, Daniel R

2017-10-01

Graduate education in the pharmaceutical sciences is a cornerstone of research within pharmacy schools. Pharmaceutical scientists are critical contributors to addressing the challenges of new drug discovery, delivery, and optimal care in order to ensure improved therapeutic outcomes in populations of patients. The American Association of Colleges of Pharmacy (AACP) charged the 2016-2017 Research and Graduate Affairs Committee (RGAC) to define the competencies necessary for graduate education in the pharmaceutical sciences (Charge 1), recommend collaborative curricular development across schools of pharmacy (Charge 2), recommend AACP programing for graduate education (Charge 3), and provide guidance on emerging areas for innovation in graduate education (Charge 4). With respect to Charges 1 and 2, the RGAC committee developed six domains of core competencies for graduate education in the pharmaceutical sciences as well as recommendations for shared programming. For Charge 3, the committee made 3 specific programming recommendations that include AACP sponsored regional research symposia, a professional development forum at the AACP INterim Meeting, and the addition of a graduate research and education poster session at the AACP Annual Meeting. For Charge 4, the committee recommended that AACP develop a standing committee of graduate program deans and directors to provide guidance to member schools in support of graduate program representation at AACP meetings, develop skills for interprofessional teamwork and augment research through integration of Pharm.D., Ph.D., postdoctoral associates, resident, and fellow experiences. Two proposed policy statements by the committee are that AACP believes core competencies are essential components of graduate education and AACP supports the inclusion of research and graduate education focuses in its portfolio of meetings and programs.

47 CFR 0.701 - Intergovernmental Advisory Committee.

Science.gov (United States)

2010-10-01

...); two elected county officials (county commissioners or council members); one elected or appointed local...) Commission support and oversight. The Chairman of the Commission, or Commissioner designated by the Chairman... oversight for its activities. The IAC will also communicate directly with the Chief, Consumer & Governmental...

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

Genetic screening: programs, principles, and research--thirty years later. Reviewing the recommendations of the Committee for the Study of Inborn Errors of Metabolism (SIEM).

Science.gov (United States)

Simopoulos, A P

2009-01-01

Screening programs for genetic diseases and characteristics have multiplied in the last 50 years. 'Genetic Screening: Programs, Principles, and Research' is the report of the Committee for the Study of Inborn Errors of Metabolism (SIEM Committee) commissioned by the Division of Medical Sciences of the National Research Council at the National Academy of Sciences in Washington, DC, published in 1975. The report is considered a classic in the field worldwide, therefore it was thought appropriate 30 years later to present the Committee's modus operandi and bring the Committee's recommendations to the attention of those involved in genetics, including organizational, educational, legal, and research aspects of genetic screening. The Committee's report anticipated many of the legal, ethical, economic, social, medical, and policy aspects of genetic screening. The recommendations are current, and future committees should be familiar with them. In 1975 the Committee stated: 'As new screening tests are devised, they should be carefully reviewed. If the experimental rate of discovery of new genetic characteristics means an accelerating rate of appearance of new screening tests, now is the time to develop the medical and social apparatus to accommodate what later on may otherwise turn out to be unmanageable growth.' What a prophetic statement that was. If the Committee's recommendations had been implemented on time, there would be today a federal agency in existence, responsive and responsible to carry out the programs and support research on various aspects of genetic screening, including implementation of a federal law that protects consumers from discrimination by their employers and the insurance industry on the basis of genetic information. Copyright 2008 S. Karger AG, Basel.

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.

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

Science.gov (United States)

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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.

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

76 FR 48117 - Committee on Rulemaking

Science.gov (United States)

2011-08-08

... accommodations for persons with disabilities), and how to submit comments to the committee can be found in the ``Research'' section of the Conference's Web site, at http:// [email protected] Click on ``Research,'' then on... committee will discuss topics such as using agency Web sites and social media to promote participation in...

A new research reactor? Report by the Select Committee for an inquiry into the contract for a new reactor at Lucas Heights

International Nuclear Information System (INIS)

2001-05-01

On 15 August 2000, the Senate resolved to establish the Select Committee for an Inquiry into the Contract for a New Reactor at Lucas Heights and report to the Parliament. The Select committee majority report is divided into three parts: the need for a new reactor; the tendering process and the nature of the contract; and Australia's nuclear waste management strategy and public health and safety. There is a final chapter which brings together the major issues examined in the report. Based on the evidence presented to it, the Committee notes that some Australian scientists and engineers present a strong case for the new reactor. While the Committee is of the view that nuclear science and technology is not backward looking and does offer opportunities for researchers to keep at the forefront of important areas in scientific research and development it does not automatically follow that the best way to promote scientific and medical research in this country is by spending substantial amounts of public funds for the next forty years on a single research reactor. Nevertheless, the Committee recommends that before the Government proceeds any further with the proposed reactor, it undertake a thorough and comprehensive public review of funding for medical and scientific research in Australia with a view to assessing priorities including the role, if any, a research reactor would have in contributing to Australia's scientific, medical and industrial interests. The Committee also requested that the Australian National Audit Office consider examining the tender and contract documents for the new reactor at Lucas Heights with a view to determining: whether further investigation of the tendering process and the contract is warranted; whether, during the tendering process, ANSTO ensured that there was adequate and appropriate independent verification and validation of the tenderers claims. Two supplementary report are included: one from the Liberal and National members (minority

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

Ethics creep or governance creep? Challenges for Australian Human Research Ethics Committees (HRECS).

Science.gov (United States)

Gorman, Susanna M

2011-09-01

Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.

Plasma Science Committee (PLSC)

International Nuclear Information System (INIS)

1990-01-01

The Plasma Science Committee (PLSC) is a standing committee under the auspices of the Board on Physics and Astronomy, Commission on Physical Sciences, Mathematics, and Applications of the National Academy of Sciences--National Research Council. Plasma sciences represent a broad and diverse field. The PLSC has accepted the responsibility of monitoring the continuing development and assessing the general health of the field as whole. Although select advisory bodies have been created to address specific issues that affect plasma science, such as the Fusion Policy Advisory Committee (FPAC), the PLSC provides a focus for the plasma science community that is unique and essential. The membership of the PLSC is drawn from research laboratories in universities, industry, and government. Areas of expertise on the committee include accelerators and beams, space physics, astrophysics, computational physics and applied mathematics, fusion plasmas, fundamental experiments and theory, radiation sources, low temperature plasmas, and plasma-surface interactions. The PLSC is well prepared to respond to requests for studies on specific issues. This report discusses ion of the PLSC work

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

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...

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.

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.

Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

OpenAIRE

Smith, T.; Moore, E. J.; Tunstall-Pedoe, H.

1997-01-01

OBJECTIVE: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. DESIGN: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. SETTING: Tayside, Scotland (mixed rural and urban population). SUBJECTS: 30 research projects app...

78 FR 9988 - Sunshine Act; Meeting Notice

Science.gov (United States)

2013-02-12

.... Report of the Finance, Rates, and Portfolio Committee A. Financial Performance Update 4. Report of the Nuclear Oversight Committee 5. Report of the People and Performance Committee A. Corporate Goals 6. Report...

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.

Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

OpenAIRE

Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

2018-01-01

Background Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of...

75 FR 36136 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Change To Amend...

Science.gov (United States)

2010-06-24

... is the practice of NYSE Euronext's Global Risk and Audit Services Department (``RAS''), which...) and Section 401(a) of the Exchange's Bylaws To Eliminate the Exchange's Audit Committee, Compensation... eliminate the Exchange's Audit Committee, Compensation Committee, and Regulatory Oversight Committee. The...

CIRRPC (Committee on Interagency Radiation Research and Policy Coordination) sixteenth quarterly report, April 1-June 30, 1988

International Nuclear Information System (INIS)

Young, A.L.

1988-01-01

The document is a summary of the Committee on Interagency Radiation Research and Policy Coordination activities for the period April 1 through June 30, 1988. During the reporting period, the Executive Committee met with the staff concerned with the radiation matters of the Department of the Interior on May 20 and with the Department of Defense on May 23 to review current CIRRPC activities and issues of particular interest to those agencies. The meetings were a part of CIRRPC's program of visits to member agencies on a two-year cycle

75 FR 9616 - Committee Management Renewals

Science.gov (United States)

2010-03-03

... NATIONAL SCIENCE FOUNDATION Committee Management Renewals The NSF management officials having... follows consultation with the Committee Management Secretariat, General Services Administration... Industrial Innovations and Partnerships, 28164. Proposal Review Panel for Emerging Frontiers in Research and...

77 FR 12086 - Committee Management Renewals

Science.gov (United States)

2012-02-28

... NATIONAL SCIENCE FOUNDATION Committee Management Renewals The NSF management officials having... follows consultation with the Committee Management Secretariat, General Services Administration... Industrial Innovations and Partnerships, 28164 Proposal Review Panel for Emerging Frontiers in Research and...

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...

Personality and culture, the Social Science Research Council, and liberal social engineering: the Advisory Committee on Personality and Culture, 1930-1934.

Science.gov (United States)

Bryson, Dennis

2009-01-01

The field of personality and culture was given a significant impetus during the 1930s with the establishment of the Advisory Committee on Personality and Culture (1930-1934) by the Social Science Research Council. This committee provided an early formulation of personality and culture that emphasized the interdisciplinary focus on the processes of personality formation within small-scale social settings. The committee's formulation also coupled personality and culture with a liberal social engineering approach geared toward cultural reconstruction. Major social scientists and clinicians were involved in the activities of the committee, including Edward Sapir, W. I. Thomas, E. W. Burgess, E. A. Bott, Robert S. Woodworth, Harry Stack Sullivan, C. M. Hincks, and Adolf Meyer.

Determinants of nomination committee: New Zealand evidence

Directory of Open Access Journals (Sweden)

Md. Borhan Uddin Bhuiyan

2011-09-01

Full Text Available A sizable volume of corporate governance literature documents that an independent and competent board of directors matter for organizational success. In order to function effectively, board comprises of different sub-committees and the three most common sub-committees are audit committees, compensation committees and nomination committees. Surprisingly, there is a paucity of research in understanding the determinants of nomination committee notwithstanding the importance of an independent nomination committee in board selection process. We contribute to the nomination committee literature by investigating the factors associated with the determination of nomination committees in New Zealand. We find that cross-sectional variation in the firm-specific characteristics affect the existence of nomination committees. This finding casts doubt on the „one-size-fits all‟ approach of corporate governance. Our logistic regression of the nomination committee determinants indicates that firm size, governance regulation and busy directors are positively associated with the existence of nomination committees, whereas firm leverage, controlling shareholders, and director independence are negatively related to the formation of nomination committees.

75 FR 55306 - Smart Grid Advisory Committee

Science.gov (United States)

2010-09-10

... accommodate Committee business. The final agenda will be posted on the Smart Grid Web site at http://www.nist.... The Committee shall provide input to NIST on the Smart Grid Standards, Priority, and Gaps. The... research and standards activities. 5. Upon request of the Director of NIST, the Committee will prepare...

77 FR 29595 - New England Fishery Management Council; Public Meeting

Science.gov (United States)

2012-05-18

... with the Groundfish Committee (these measures are part of Omnibus Essential Fish Habitat Amendment 2... Management Council (Council) is scheduling a public meeting of its Habitat Oversight Committee to consider... Habitat Committee consideration at this meeting. First, the Committee will recommend updated boundaries...

Do committees ru(i)n the bio-political culture? On the democratic legitimacy of bioethics committees.

Science.gov (United States)

Friele, Minou Bernadette

2003-08-01

Bioethical and bio-political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision-making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific-technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision-making procedures--if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible.

[International regulation of ethics committees on biomedical research as protection mechanisms for people: analysis of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of the Council of Europe].

Science.gov (United States)

de Lecuona, Itziar

2013-01-01

The article explores and analyses the content of the Council of Europe's Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research regarding the standard legal instrument in biomedical research, issued by an international organization with leadership in bioethics. This implies ethics committees are mechanisms of protection of humans in biomedical research and not mere bureaucratic agencies and that a sound inescapable international regulatory framework exists for States to regulate biomedical research. The methodology used focuses on the analysis of the background, the context in which it is made and the nature and scope of the Protocol. It also identifies and analyses the characteristics and functions of ethics committees in biomedical research and, in particular, the information that should be provided to this bodies to develop their functions previously, during and at the end of research projects. This analysis will provide guidelines, suggestions and conclusions for the awareness and training of members of these committees in order to influence the daily practice. This paper may also be of interest to legal practitioners who work in different areas of biomedical research. From this practical perspective, the article examines the legal treatment of the Protocol to meet new challenges and classic issues in research: the treatment of human biological samples, the use of placebos, avoiding double standards, human vulnerability, undue influence and conflicts of interest, among others. Also, from a critical view, this work links the legal responses to develop work procedures that are required for an effective performance of the functions assigned of ethics committees in biomedical research. An existing international legal response that lacks doctrinal standards and provides little support should, however, serve as a guide and standard to develop actions that allow ethics committees -as key bodies for States- to advance in

External evaluation on Monju Core Confirmation Test in FY 2010 (the Technical Committee on Monju Research Utilization)

International Nuclear Information System (INIS)

2011-06-01

This report describes the review made by the 'Technical Committee on Monju Research Utilization' on the results of Core Confirmation Test conducted from May to July in 2010. The committee consists of technical specialists in the relevant engineering domains from various Japanese industries and universities. The Committee was convened twice in 2010, in August and December, where the each item of the Core Confirmation Test was explained by individual personnel in charge, and the outline and the detailed analysis were discussed, respectively. Evaluations were made by the Committee after the questions and answers. Main points of the evaluations are listed below: After the 14 year stand-by, the Core Confirmation Test has been successfully completed within a brief duration of 3 months, with provision of precious technical data for future development and commercialization of FBRs. Safety has been confirmed and valuable data for analysis code validation have been acquired on an FBR core containing 1.5%wt of Am-241. It is significant that the newly released nuclear data library, JENDL-4.0 has been validated based on studies of capture cross section of Am-241 and of fission cross section of Pu-239. Finally, the chief examiner of the Committee stated his expectation for advancement of Japanese FBR technologies with the JAEA's leadership based of achievements on Monju, to be reflected on subsequent FBR developments. (author)

Whether Audit Committee Financial Expertise Is the Only Relevant Expertise: A Review of Audit Committee Expertise and Timeliness of Financial Reporting

Directory of Open Access Journals (Sweden)

Saeed Rabea Baatwah

2013-06-01

Full Text Available This study reviews the literature on audit committee expertise and financial reporting timeliness. Financial reporting timeliness and audit committee expertise are two areas of research gaining the attention of a large number of stakeholders because they contribute to the reliability and the  relevancy of financial reporting. Indeed, the focus of this review is primarily on the recent developments in the pertinent literature in order to show the limitations of such research and encourage future research to overcome these limitations. By also looking at the development of the audit committee expertise literature, this study concludes that (1 like most audit committee literature, financial reporting timeliness literature continues to assume the absence of the contribution of expertise other than financial expertise, and ignore the role of audit committee chair; (2 most of this literature fails to find a significant effect because it ignores the interaction among corporate governance mechanisms. Accordingly, this study posits that ignoring the issues raised in such research by future research would lead to major mistakes in reforms relating to how the quality of financial reporting can be enhanced.

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.

Institutional Ethics Committee Regulations and Current Updates in India.

Science.gov (United States)

Mahuli, Amit V; Mahuli, Simpy A; Patil, Shankargouda; Bhandi, Shilpa

2017-08-01

The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.

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)

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

HIV/AIDS research conducted in the developing world and sponsored by the developed world: reporting of research ethics committee review in two countries.

Science.gov (United States)

Chin, Lisa Judy; Rifai-Bashjawish, Hoda; Kleinert, Kelly; Saltman, Alexandra; Leu, Cheng-Shiun; Klitzman, Robert

2011-09-01

We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.

The Efforts of the American Geophysical Union Space Physics and Aeronomy Section Education and Public Outreach Committee to Use NASA Research in Education and Outreach

Science.gov (United States)

Bering, E. A., III; Dusenbery, P.; Gross, N. A.; Johnson, R.; Lopez, R. E.; Lysak, R. L.; Moldwin, M.; Morrow, C. A.; Nichols-Yehling, M.; Peticolas, L. M.; Reiff, P. H.; Scherrer, D. K.; Thieman, J.; Wawro, M.; Wood, E. L.

2017-12-01

The American Geophysical Union Space Physics and Aeronomy Section Education and Public Outreach Committee (AGU SPA-EPO Committee) was established in 1990 to foster the growth of a culture of outreach and community engagement within the SPA Section of the AGU. The SPA was the first AGU Section to establish an EPO Committee. The Committee has initiated several key Section EPO programs that have grown to become Union programs. NASA sponsored research is central to the mission of the SPE-EPO. Programs highlighting NASA research include the Student Paper Competition, Exploration Station, a precursor to the GIFT workshops, the Student mixer, and more. The Committee played a key role in coordinating the AGU's outreach activities relating to the International Heliophysical Year in 2007-2008. This paper will review the triumphs, the failures, and the lessons learned about recruiting colleagues to join with us from the last quarter century of effort.

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...

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...

10 CFR 1.19 - Other committees, boards, and panels.

Science.gov (United States)

2010-01-01

... philosophy of nuclear regulatory research. The committee conducts specialized studies when requested by the... Mile Island, Unit 2. (c) The Nuclear Safety Research Review Committee (NSRRC) was established by the... of Nuclear Regulatory Research on important management matters in the direction of the Commission's...

The committee of scientific expertise coordination

International Nuclear Information System (INIS)

2003-01-01

Placed under the MIES control, the Committee of scientific expertise coordination defines the needs, the contain and the planing of expertises realized in function of Climate national and international decisions and negotiations calendars. The Committee verifies the different expertises and offers the administrations, scientific tools and techniques useful for the negotiations. It can also define long-dated research needs which require the scientific community mobilization. This paper provides some document of the Committee: objectives, operating and priorities of the Committee, scenarios ''Factor 4'' and ''crack technology'', perceptions and practices, developing countries (China, India...), Euromed. (A.L.B.)

A requirement for Australian research: access to 'big science' facilities, a report by the Australian National Committee for crystallography

International Nuclear Information System (INIS)

1989-03-01

Two types of 'Big Science' research facility - synchrotron radiation sources and intense neutron beams - are now recognised as essential resources for a wide range of research activities in chemistry, physics and biology. The cost of such facilities and the lack of a sufficiently large user base will probably preclude their construction in Australia in the foreseeable future. The needs of Australian crystallographers for access to such facilities are assessed. In relation to synchrotron radiation sources, the Committee considered only the question of access to such facilities overseas. In relation to neutron beam sources, the Committee's inquiries included not only the question of access to powerful facilities overseas but also the special problems which confront Australian crystallographers as a result of the obsolescence of the HIFAR reactor. The arguments about, and options for, funding Australian use of facilities overseas are presented. The Committee concluded there is a strong case for the purchase of a beam-line at an overseas synchrotron radiation facility and a strong, though less urgent, case for substantial Australian involvement in an overseas neutron beam facility. The Committee recommended that the Australian HIFAR reactor be refurbished in its present shell, retaining the present flux and power levels, and that in the upgrading of the neutron scattering instrumentation at HIFAR special consideration be given to including items which are sufficiently specialised to attract the international neutron scattering community

[Management committees in health services: an empirical study].

Science.gov (United States)

Cecilio, Luiz Carlos de Oliveira

2010-03-01

The aim of the article, based on field data collected from a continuing education program for primary health clinic administrators, was to analyze the functioning of a health service management strategy called "management committees". Different meanings and operational modalities emerged in the committees. Various antimonies appeared in the way the committees operate (autonomy versus heteronomy, reproduction of "instituted" versus "instituting" processes, and communicative versus instrumental reasoning), thus reflecting the level of complexity in this management mechanism. Healthcare provision per se by the clinics only appeared occasionally on the committees' agenda, which mainly focused on administrative issues. The article suggests that further research is needed on the coordinator's involvement in the field of forces constituting the management committee, besides developing pedagogical strategies to support the clinic coordinators and health teams in building the committees. The primary data were submitted to an epistemological discussion anchored in the idea of double hermeneutics, multiple validation of research results, and the relationship between theory and practice.

78 FR 7773 - Notice of Commissioner and Staff Attendance at North American Electric Reliability Corporation...

Science.gov (United States)

2013-02-04

... Board of Trustees Meetings, Board of Trustees Compliance Committee, Corporate Governance and Human Resources Committee, and Standards Oversight and Technology Committee Meetings. Hotel del Coronado, 1500... Association, Inc. v. Western Electric Coordinating Council and North American Electric Reliability Corporation...

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.

Final Report - BRER Core Support

International Nuclear Information System (INIS)

Evan B. Douple

2007-01-01

This contract provided core support for activities of the advisory committee of experts comprising the Board on Radiation Effects Research (BRER), in The National Academies Division on Earth and Life Studies. That committee met two times during the funding period. The committee members provided oversight and advice regarding ongoing BRER projects and also assisted in the identification of potential committee members for new studies and the development of proposals for projects in the radiation sciences worthy for future study. In addition, funding provided support for the planning, advertisement, and invited speakers travel-expense reimbursement for the Third and Fourth Gilbert W. Beebe Symposia held at The National Academies on December 1, 2004 and on November 30, 2005, respectively

Fusion Policy Advisory Committee (FPAC)

International Nuclear Information System (INIS)

1990-09-01

This document is the final report of the Fusion Policy Advisory Committee. The report conveys the Committee's views on the matters specified by the Secretary in his charge and subsequent letters to the Committee, and also satisfies the provisions of Section 7 of the Magnetic Fusion Energy Engineering Act of 1980, Public Law 96-386, which require a triennial review of the conduct of the national Magnetic Fusion Energy program. Three sub-Committee's were established to address the large number of topics associated with fusion research and development. One considered magnetic fusion energy, a second considered inertial fusion energy, and the third considered issues common to both. For many reasons, the promise of nuclear fusion as a safe, environmentally benign, and affordable source of energy is bright. At the present state of knowledge, however, it is uncertain that this promise will become reality. Only a vigorous, well planned and well executed program of research and development will yield the needed information. The Committee recommends that the US commit to a plan that will resolve this critically important issue. It also outlines the first steps in a development process that will lead to a fusion Demonstration Power Plant by 2025. The recommended program is aggressive, but we believe the goal is reasonable and attainable. International collaboration at a significant level is an important element in the plan

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…

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...

Symposium 'Methodology in Medical Education Research' organised by the Methodology in Medical Education Research Committee of the German Society of Medical Education May, 25th to 26th 2013 at Charité, Berlin.

Science.gov (United States)

Schüttpelz-Brauns, Katrin; Kiessling, Claudia; Ahlers, Olaf; Hautz, Wolf E

2015-01-01

In 2013, the Methodology in Medical Education Research Committee ran a symposium on "Research in Medical Education" as part of its ongoing faculty development activities. The symposium aimed to introduce to participants educational research methods with a specific focus on research in medical education. Thirty-five participants were able to choose from workshops covering qualitative methods, quantitative methods and scientific writing throughout the one and a half days. The symposium's evaluation showed participant satisfaction with the format as well as suggestions for future improvement. Consequently, the committee will offer the symposium again in a modified form in proximity to the next annual Congress of the German Society of Medical Education.

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…

Education of ethics committee members: experiences from Croatia.

Science.gov (United States)

Borovecki, A; ten Have, H; Oresković, S

2006-03-01

To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. Before/after cross-sectional study using a self administered questionnaire. Educational workshop for members of hospital ethics committees, Zagreb, 2003. Knowledge and attitudes of participants before and after the workshop; everyday functioning of hospital ethics committees. The majority of the respondents came from committees with at least five members. The majority of ethics committees were appointed by the governing bodies of their hospitals. Most committees were founded after the implementation of the law on health protection in 1997. Membership structure (three physicians and two members from other fields) and functions were established on the basis of that law. Analysis of research protocols was the main part of their work. Other important functions-education, case analysis, guidelines formation-were neglected. Members' level of knowledge was not sufficient for the complicated tasks they were supposed to perform. However, it was significantly higher after the workshop. Most respondents felt their knowledge should be improved by additional education. Their views on certain issues and bioethical dilemmas displayed a high level of paternalism and over protectiveness, which did not change after the workshop. The committees developed according to bureaucratic requirements. Furthermore, there are concerns about members' knowledge levels. More efforts need to be made to use education to improve the quality of the work. Additional research is necessary to explore ethics committees' work in Croatia especially in the hospital setting.

Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

Science.gov (United States)

Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan

2014-12-01

Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.

Report on the proposal for a Council directive (EURATOM) on the management of spent nuclear fuel and radioactive waste - Committee on Industry, External Trade, Research and Energy

International Nuclear Information System (INIS)

2006-01-01

By letter of 13 May 2003 the Council consulted Parliament, pursuant to Articles 31 and 32 of the EURATOM Treaty, on the proposal for a Council directive (EURATOM) on the management of spent nuclear fuel and radioactive waste (COM(2003) 32 - 2003/0022(CNS)). At the sitting of 15 May 2003 the President of Parliament announced that he had referred the proposal to the Committee on Industry, External Trade, Research and Energy as the committee responsible and the Committee on the Environment, Public Health and Consumer Policy for its opinion (C5-0229/2003). The Committee on Industry, External Trade, Research and Energy appointed Alejo Vidal-Quadras Roca Rapporteur at its meeting of 22 May 2003. The committee considered the Commission proposal and draft report at its meetings of 9 July, 9 September, 6 October, 3 November and 27 November 2003. At the last meeting it adopted the draft legislative resolution by 36 votes to 7, with 2 abstentions. The opinion of the Committee on the Environment, Public Health and Consumer Policy is attached. The report was tabled on 1 December 2003

Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

Science.gov (United States)

De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W

2016-01-01

Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.

Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

Directory of Open Access Journals (Sweden)

Elisabeth De Smit

2016-02-01

Full Text Available Background Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. Aims To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs and Research Governance Offices (RGOs across Australia. Methods In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA, for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Results Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a “National Ethics Application Form” and three a “Low Negligible Risk” form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22 and panel review turnaround time (range nine to 136 days. Conclusion We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently

The Ethics of Traditional Chinese and Western Herbal Medicine Research: Views of Researchers and Human Ethics Committees in Australia

Directory of Open Access Journals (Sweden)

Caroline A. Smith

2011-01-01

Full Text Available Despite the growth of traditional Chinese medicine (TCM and western herbal medicine (WHM research in Australia, little is known about how ethics committees (HRECs assess the ethics of TCM or WHM research. The objectives of this study were to examine the experiences of TCM and WHM researchers and HRECs with the evaluation of ethics applications. Two cross-sectional surveys were undertaken of HRECs and TCM and WHM researchers in Australia. Anonymous self-completion questionnaires were administered to 224 HRECs and 117 researchers. A response confirming involvement in TCM or WHM research applications was received from 20 HRECs and 42 researchers. The most frequent ethical issues identified by HRECs related to herbal products including information gaps relating to mode of action of herbal medicines and safety when combining herbal ingredients. Researchers concurred that they were frequently requested to provide additional information on multiple aspects including safety relating to the side effects of herbs and herb-drug interactions. Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers although our study did identify the need for additional information regarding assessment of risk and risk management.

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...

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...

Youth Voice in Nigerian School-based Management Committees

Directory of Open Access Journals (Sweden)

Bashiru Bako Umar

2017-01-01

Full Text Available In Nigeria, School-Based Management Committees (SBMCs aim to provide an opportunity for all stakeholders, particularly the vulnerable groups in the school’s host communities such as young people and women to partake in school governance. Research on the experiences of youth voice in the committees is scant, however, as much of the existing literature on SBMCs focuses on program outcomes. Using qualitative research interviews, observations, and document analysis, this study addressed this gap by exploring how youth participate and express themselves in two SBMCs in Niger State, Nigeria. The findings, which were derived from 19 youth and adult participants, were drawn from SBMC members out of which 12 were youth between the ages 13 and 25, while 7 were adults aged 40 and above. The participants revealed that youth committee members expressed their voice in the committees through participating in a number of committee activities. Specifically, the youth participated in decision-making during meetings, aided in the construction of committee projects, undertook administrative/managerial functions and monitored the committee’s projects. They also participated in revenue generation, planning, school visits and supervision, advocacy, and sensitization campaigns.

Research reactor instrumentation and control technology. Report of a technical committee meeting

International Nuclear Information System (INIS)

1997-10-01

The majority of research reactors operating today were put into operation 20 years ago, and some of them underwent modifications, upgrading and refurbishing since their construction to meet the requirements for higher neutron fluxes. However, a few of these ageing research reactors are still operating with their original instrumentation and control systems (I and C) which are important for reactor safety to guard against abnormal occurrences and reactor control involving startup, shutdown and power regulation. Worn and obsolete I and C systems cause operational problems as well as difficulties in obtaining replacement parts. In addition, satisfying the stringent safety conditions laid out by the nuclear regulatory bodies requires the modernization of research reactors I and C systems and integration of additional instrumentation units to the reactor. In order to clarify these issues and to provide some guidance to reactor operators on state-of-art technology and future trends for the I and C systems for research reactors, a Technical Committee Meeting on Technology and Trends for Research Reactor Instrumentation and Controls was held in Ljubljana, Slovenia, from 4 to 8 December 1995. This publication summarizes the discussions and recommendations resulting from that meeting. This is expected to benefit the research reactor operators planning I and C improvements. Refs, figs, tabs

Report of research and investigation committee for infrared radiation heating technology. Sekigai hosha kanetsu gijutsu kenkyu chosa iinkai hokoku

Energy Technology Data Exchange (ETDEWEB)

Matsui, M. (Fukuyama Univ., Hiroshima (Japan). Faculty of Engineering)

1994-07-01

The committee was established in July 1990 for research and investigation of infrared (IR) heating technology and finished its activity in March 1993. This report describes the committee members and the results of research and investigation. (1) Application of IR radiation (sensing): the research and investigation results were reported on the following items; the recognition of letters and patterns on cultural properties by IR radiation, the passive sensor (detecting the IR radiated from the object without emitting from the sensor), the IR image system, and the diagnosis of outer wail of buildings. (2) The following were researched on the IR radiation source and IR emitting material; multi-functional heating element having far infrared radiation function and deodorant function, the emissivity of far IR radiation, and the evaluation of the functions by the difference in emissivity. (3) The IR heating technology was described on the following: drying the persimmon using far IR radiation, the present situation of research on IR heating done by foreign power supply companies, and the feature and the application of far IR heater. In addition to these, the following were also reported; (4) measurement of IR radiation and (5) effect of living body and organism.

South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

Science.gov (United States)

Essack, Zaynab; Wassenaar, Douglas R

2018-04-01

HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

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

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

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

Report to NASA Committee on Aircraft Operating Problems Relative to Aviation Safety Engineering and Research Activities

Science.gov (United States)

1963-01-01

The following report highlights some of the work accomplished by the Aviation Safety Engineering and Research Division of the Flight Safety Foundations since the last report to the NASA Committee on Aircraft Operating Problems on 22 May 1963. The information presented is in summary form. Additional details may be provided upon request of the reports themselves may be obtained from AvSER.

76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-07-22

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research...

Committee for International Conference on Mechanical Engineering Research (ICMER 2011)

Science.gov (United States)

Yusoff, Ahmad Razlan Bin

2012-09-01

Scientific Advisory Committee: 1) Prof. Dr. Ahmad Kamal Ariffin (UKM) 2) Prof. Dr. Hj. Rosli Abu Bakar (UMP) 3) Prof. Dr. Hanafi Ismail (USM) 4) Prof. Ir. Dr. Mohd Jailani Mohd Nor (MoHE) 5) Prof. Dr. Zahari Taha (UMP) 6) Prof. Dr. Masjuki Haji Hassan 7) Prof. Ir. Dr. Ramesh Singh (UNITEN) 8) Prof. Dr. Razali Ayob (UTEM) 9) Prof. Dr. Wan Khairuddin (UTM) 10) Prof. Dr. Sulaiman Hj. Hasan (UTHM) 11) Prof. Dr. Zuraidah Mohd. Zain (UniMAP) 12) Prof. Dr. Horizon Gitano (USM) 13) Prof. Dr. K.V Sharma (UMP) 14) Prof. Dr. Shahrani Anuar (UMP) 15) Assoc. Prof. Dr. Abd Rashid Abd. Aziz (UTP) 16) Assoc. Prof. Dr. Aidy Ali (UPM) 17) Assoc. Prof. Dr. Saidur Rahman (UM) 18) Assoc. Prof. Dr. Md Abdul Maleque (UIA) Organizing Committee Chairman: Prof. Dr. Hj. Rosli Abu Bakar Co-Chair: Prof. Dr. Zahari Taha Co-Chair: Prof. Ir. Dr. Jailani Salihon Secretary: Dr. Rizalman Mamat Committee on Keynote Speaker 1) Kumaran Kadirgama (Chair) 2) Prof. Dr. K.V. Sharma 3) Haji Amirruddin Abdul Kadir 4) Miminorazeansuhaila Loman 5) Mohd Akramin Mohd Romlay Technical Committee (Peer Review & Proceedings) 1) Dr. Abdul Adam Abdullah (Chair) 2) Dr. Ahmad Razlan Yusoff 3) Mohd Yusof Taib 4) Dr. Md. Mustafizur Rahman 5) Dr. Hjh. Yusnita Rahayu 6) Dr. Gigih Priyandoko 7) Dr. Agung Sudrajad 8) Muhammad Hatifi Mansor 9) Mohd Fadzil Abdul Rahim Technical Committee (Panels & Session Chairs) 1) Dr. Mahadzir Ishak (Chair) 2) Prof. Dr. Shahrani Anuar 3) Dr. Maisara Mohyeldin Gasim Mohamed 4) Muhammad Ammar Nik Mu'tasim 5) Ahmad Basirul Subha bin Alias Technical Committee (Journal Publication) 1) Dr. Ahmad Razlan bin Yusoff (Chair) 2) Mohd Yusof Taib 3) Dr. Mahadzir Ishak 4) Dr. Abdul Adam Abdullah 5) Hj. Amirruddin Abdul Kadir 6) Hadi Abdul Salaam Bureau of Publicity & Website 1) Dr. Muhamad Arifpin Mansor (Chair) 2) Amir Abdul Razak 3) Idris Mat Sahat 4) Prof. Dr. Hj. Rosli Abu Bakar 5) Muhamad Zuhairi Sulaiman 6) Dr. Sugeng Ariyono 7) Asnul Hadi Ahmad 8) Mohd Tarmizy Che Kar 9) Mohd Padzly Radzi Bureau of

Committee on Atomic, Molecular, and Optical Sciences (CAMOS)

International Nuclear Information System (INIS)

1992-01-01

The Committee on Atomic, Molecular, and Optical Sciences is a standing committee under the auspices of the Board on Physics and Astronomy, Commission on Physical Sciences, Mathematics, and Applications of the National Academy of Sciences -- National Research Council. The atomic, molecular, and optical (AMO) sciences represent a broad and diverse field in which much of the research is carried out by small groups. These groups generally have not operated in concert with each other and, prior to the establishment of CAMOS, there was no single committee or organization that accepted the responsibility of monitoring the continuing development and assessing the general public health of the field as a whole. CAMOS has accepted this responsibility and currently provides a focus for the AMO community that is unique and essential. The membership of CAMOS is drawn from research laboratories in universities, industry, and government. Areas of expertise on the committee include atomic physics, molecular science, and optics. A special effort has been made to include a balanced representation from the three subfields. (A roster is attached.) CAMOS has conducted a number of studies related to the health of atomic and molecular science and is well prepared to response to requests for studies on specific issues. This report brief reviews the committee work of progress

77 FR 65679 - Notice of Commissioner and Staff Attendance at North American Electric Reliability Corporation...

Science.gov (United States)

2012-10-30

... Board of Trustees Meetings Board of Trustees Compliance Committee and Standards Oversight and Technology Committee Meetings JW Marriott New Orleans Hotel 614 Canal Street New Orleans, La 70130. Nov. 6 (7:00 a.m.-5...

77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-01-25

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...

78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-04-05

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...

78 FR 40816 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule...

Science.gov (United States)

2013-07-08

... committee has an oversight role with respect to internal audit and risk management, it is appropriate for that newly-constituted committee to have a significant role in the design and implementation of the... committee an opportunity to become familiar with the internal controls and risk management of the company...

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...

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.

78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

Science.gov (United States)

2013-11-22

.... FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is...

76 FR 58237 - Committee on Rulemaking