32 CFR 2103.51 - Information Security Oversight Committee.

Science.gov (United States)

2010-07-01

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

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...

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 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.

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).

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.

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.

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

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.

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

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...

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

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...

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...

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 ...

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

Science.gov (United States)

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

2017-03-01

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

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...

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.

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

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.

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

Science.gov (United States)

2015-03-01

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

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...

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.

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

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...

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.

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...

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.

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...

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

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.

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.

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

Science.gov (United States)

2010-03-08

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

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

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.

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

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.

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.

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...

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…

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…

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

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...

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...

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.

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

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.

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

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

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.

15 CFR 2008.18 - Information Security Oversight Committee.

Science.gov (United States)

2010-01-01

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

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

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

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

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

Science.gov (United States)

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

2017-12-22

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

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

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...

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

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...

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

Science.gov (United States)

2010-03-04

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

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.

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

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

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.

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

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

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.

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.

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...

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.

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

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...

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.

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...

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…

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

Science.gov (United States)

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

2017-01-01

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

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...

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

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...

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

Science.gov (United States)

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

2017-12-12

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

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

International Nuclear Information System (INIS)

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

2014-01-01

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

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

International Nuclear Information System (INIS)

1995-01-01

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

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

Science.gov (United States)

2010-12-03

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

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

Science.gov (United States)

VanLandingham, Gary R.

2006-01-01

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

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

International Nuclear Information System (INIS)

Kuzma, Jennifer; Kuzhabekova, Aliya

2011-01-01

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

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

Science.gov (United States)

Kuzma, Jennifer; Kuzhabekova, Aliya

2011-04-01

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

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

Science.gov (United States)

2010-12-16

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

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

Science.gov (United States)

2010-04-01

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

Improving Defense Health Program Medical Research Processes

Science.gov (United States)

2017-08-08

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

Human factors in nuclear safety oversight

International Nuclear Information System (INIS)

Taylor, K.

1989-01-01

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

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

International Nuclear Information System (INIS)

2011-01-01

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

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.

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

Science.gov (United States)

2011-02-23

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

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

International Nuclear Information System (INIS)

1995-01-01

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

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

International Nuclear Information System (INIS)

2014-01-01

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

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

Science.gov (United States)

2010-12-28

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

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

Science.gov (United States)

2013-02-20

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

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

Science.gov (United States)

2012-01-18

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

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

Science.gov (United States)

2011-02-01

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

Regulatory oversight strategy for chemistry program at Canadian nuclear power plants

International Nuclear Information System (INIS)

Kameswaran; Ram

2012-09-01

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

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

Science.gov (United States)

2010-12-30

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

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

Science.gov (United States)

2001-02-28

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

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

Science.gov (United States)

2011-06-09

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

Regulatory Oversight of Safety Culture in Nuclear Installations

International Nuclear Information System (INIS)

2013-03-01

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

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

Science.gov (United States)

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

2011-03-21

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

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

Science.gov (United States)

2012-02-27

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

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

Science.gov (United States)

2010-01-21

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

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

Science.gov (United States)

2012-12-04

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

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

Science.gov (United States)

2011-08-24

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

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

OpenAIRE

Quigley, Fran

2017-01-01

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

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

African Journals Online (AJOL)

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

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

Science.gov (United States)

2010-01-01

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

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

Science.gov (United States)

2011-08-29

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

78 FR 67363 - Findings of Research Misconduct

Science.gov (United States)

2013-11-12

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

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

Science.gov (United States)

2011-07-12

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

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

Science.gov (United States)

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

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

Science.gov (United States)

Strand, Albert A.; Jackson, Darryl J.

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

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

Science.gov (United States)

Strand, Albert A.; Jackson, Darryl J.

1992-01-01

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

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

Science.gov (United States)

2011-07-12

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

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

International Nuclear Information System (INIS)

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

1990-01-01

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

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

Science.gov (United States)

1968-01-01

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

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

Science.gov (United States)

2010-10-01

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

Clinical oversight and the avoidance of repeat induced abortion.

Science.gov (United States)

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

2018-06-03

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

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

DEFF Research Database (Denmark)

Mortensen, Jens Ladefoged

2014-01-01

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

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

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

Science.gov (United States)

2016-09-30

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

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

International Nuclear Information System (INIS)

1994-01-01

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

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

Directory of Open Access Journals (Sweden)

Ogochukwu Nzewi

2014-03-01

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

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

International Nuclear Information System (INIS)

Bernard, B.

2016-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2013-07-01

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

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

International Nuclear Information System (INIS)

Schofield, R.S.

2003-01-01

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

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

Science.gov (United States)

2013-04-02

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

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

NARCIS (Netherlands)

A. Naudé Fourie (Andria)

2009-01-01

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

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.

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.

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

Science.gov (United States)

Epstein, Gerald L

2012-03-01

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

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

Science.gov (United States)

2009-05-27

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

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

Science.gov (United States)

2010-08-04

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

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

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

Directory of Open Access Journals (Sweden)

Rubén Guzmán Sánchez

2014-11-01

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

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

Science.gov (United States)

Khan, Anwar (Andy); Hancock, Philip

2001-01-01

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

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

International Nuclear Information System (INIS)

Elliott, Kevin C.; Volz, David C.

2012-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2012-01-15

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

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

Science.gov (United States)

Elliott, Kevin C.; Volz, David C.

2012-01-01

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

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

Science.gov (United States)

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

2012-01-01

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

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

International Nuclear Information System (INIS)

1992-01-01

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

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

International Nuclear Information System (INIS)

Goebel, V.; Heppell-Masys, K.

2016-01-01

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

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

Science.gov (United States)

Sheehan, Mark; Marti, Vernon; Roberts, Tony

2014-07-01

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

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

Science.gov (United States)

Spector-Bagdady, Kayte; Lombardo, Paul A

2013-01-01

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

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

NARCIS (Netherlands)

Six, F.E.

2013-01-01

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

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

Science.gov (United States)

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

2005-01-01

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

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

Science.gov (United States)

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

2014-07-01

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

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

Science.gov (United States)

Colwell, R. R.

2016-12-01

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

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

Science.gov (United States)

1984-05-23

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

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

International Nuclear Information System (INIS)

Douple, Evan B.

2006-01-01

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

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

International Nuclear Information System (INIS)

Horvath, K.

2016-01-01

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

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

Science.gov (United States)

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

2016-01-01

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

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.

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

Directory of Open Access Journals (Sweden)

CARLOS SANTISO

2015-09-01

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

A Study of Construction Reactor Oversight Process in US

International Nuclear Information System (INIS)

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

2015-01-01

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

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

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.

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

Directory of Open Access Journals (Sweden)

Mohamadfam

2015-01-01

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

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

International Nuclear Information System (INIS)

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

2005-03-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2005-03-01

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

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

Science.gov (United States)

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

2013-01-01

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

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

Directory of Open Access Journals (Sweden)

Vanessa Y. Hiratsuka

2017-10-01

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

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

National Research Council Canada - National Science Library

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

2008-01-01

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

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.

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

International Nuclear Information System (INIS)

1994-08-01

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

Public Attitudes toward Animal Research: A Review

Directory of Open Access Journals (Sweden)

Elisabeth H. Ormandy

2014-06-01

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

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

Science.gov (United States)

2014-03-01

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

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

International Nuclear Information System (INIS)

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

2011-01-01

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

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.

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.

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

Energy Technology Data Exchange (ETDEWEB)

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

1999-05-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

1992-02-01

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

Examples of NRC research products used in regulation

International Nuclear Information System (INIS)

Anderson, N.R.

1987-01-01

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

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

International Nuclear Information System (INIS)

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

1981-06-01

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

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

Science.gov (United States)

Plank, Linda S

2011-01-01

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

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.

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

International Nuclear Information System (INIS)

2009-04-01

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

Regulatory Oversight for New Projects - Challenges and Improvement in Regulation

International Nuclear Information System (INIS)

Lall, F.

2016-01-01

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

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

Science.gov (United States)

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

2015-05-01

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

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

Science.gov (United States)

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

2011-02-01

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

Challenges in Exploratory Methods for Tuberculosis Research in South Africa.

Science.gov (United States)

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

2016-07-01

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

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

Science.gov (United States)

McDonald, M

2001-01-01

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

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

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

2010-11-02

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

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.

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…

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.

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

International Nuclear Information System (INIS)

2008-01-01

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

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

International Nuclear Information System (INIS)

2010-04-01

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

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.

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

International Nuclear Information System (INIS)

2013-04-01

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

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.

Info Source | IDRC - International Development Research Centre

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

Info Source: Sources of Federal Government and Employee Information provides ... Bringing together the right partners around opportunities for impact, IDRC builds ... Internal services constitute groups of related activities and resources that are ... including planning, budgeting, accounting, reporting, control and oversight, ...

Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability.

Science.gov (United States)

DeMets, David L; Fleming, Thomas R; Geller, Gail; Ransohoff, David F

2017-08-01

When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their report entirely on one individual faculty member and made no comment on the institution's responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution's critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability.

Proceedings of the CSNI/IAEA workshop on maintaining oversight of licensee safety culture - methods and approaches. Held from 21 to 23 May 2007 in Chester, UK

International Nuclear Information System (INIS)

2008-01-01

Weaknesses in safety culture have contributed to a number of high profile events in the nuclear and other high hazard sectors. The nuclear industry also faces challenges such as deregulation, out-sourcing, phase-out, upgrading and new builds which, if not properly planned and implemented, have the potential to make a negative impact on safety culture. These factors have fostered an increasing awareness of the need for licensees to develop a strong safety culture to support successful and sustainable nuclear safety performance. Regulatory bodies are taking a growing interest in this issue, and several are actively working to develop and implement approaches to maintaining oversight of licensee safety culture. However, these approaches are not yet well-established, and it was considered prudent to share experiences and developing methodologies in order to disseminate good practices and avoid potential pitfalls. An NEA/CSNI/IAEA workshop was therefore held in Chester, UK, in May 2007 in order to explore and discuss the approaches that different regulatory bodies are taking to maintain oversight of licensee safety culture. It was organised by the UK Nuclear Installations Inspectorate on behalf of the CSNI's Working Group on Human and Organisational Factors. This report sets out the findings of the Chester workshop. The workshop was attended by 50 representatives of nuclear regulatory bodies in 20 countries plus IAEA, WANO, EU and NEA. It included both specialists in safety culture and site/resident inspectors, whose attendance was facilitated by the CNRA's Working Group on Inspection Practices. The workshop comprised structured discussion sessions, in which a set of issues were explored by small discussion groups and then discussed in plenary, complemented by short presentations on national regulatory positions. The workshop revealed a broad consensus that nuclear regulators should have processes in place to maintain oversight of licensee safety culture. The approaches

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

Directory of Open Access Journals (Sweden)

George Q. Daley

2016-06-01

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

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

Science.gov (United States)

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

2017-12-01

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

Per diems | IDRC - International Development Research Centre

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

Employee and Non-employee Travel Allowances All allowances described below are referred to in the IDRC Corporate Travel Policy. The allowances reflect current economic conditions and are calculated based on the standards and oversight that are applicable to departments and other entities of the Government of ...

Role of the Regulatory Body in Implementing Defence in Depth in Nuclear Installations - Regulatory Oversight in Egypt

Energy Technology Data Exchange (ETDEWEB)

El-Sheikh, B. M., E-mail: badawymel@yahoo.com [Egyptian Nuclear and Radiological Regulatory Authority Cairo (Egypt)

2014-10-15

The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are operated at all times in an acceptably safe manner including the safe conduct of decommissioning activities. Defence in depth is recognized as one of the fundamental safety principles that underlie the safety of nuclear power plants. Defence in depth is implemented to provide a graded protection against a wide variety of transients, incidents and accidents, including equipment failures and human errors within nuclear power plants and events initiated outside plants. The Regulator Body plays an important role in implementing defence in depth in nuclear installations in the context of a clear allocation of responsibilities with an operating organization. This role starting with setting safety objectives and by its own independent review and technical assessment of the safety justifications provided by the operating organization in addition to safety culture investigating within relevant organizations. This paper briefly reviews this role in normal operation and post accidents, and its effects on overall nuclear safety in nuclear installations with reference to Egyptian regulatory oversight. (author)

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.

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

Science.gov (United States)

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

2012-01-01

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

Oversight Hearing on Drug Abuse Education Programs. Hearing before the Subcommittee on Elementary, Secondary, and Vocational Education of the Committee on Education and Labor. House of Representatives, 101st Congress, 2nd Session (Vancouver, Washington, September 6, 1990).

Science.gov (United States)

Congress of the U.S., Washington, DC. House Committee on Education and Labor.

The text of an oversight hearing on Drug Abuse Resistance Education (DARE) programs is presented in this document. Introductory statements by Representatives Jolene Unsoeld and Dale E. Kildee are presented. Testimony by these witnesses is included: (1) Roy Bondurant, student, and Roy "Skip" Bondurant, parent, Tenino, Washington; (2) Paul…

Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

Science.gov (United States)

Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

2016-01-01

Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

A Strategic Vision and a New Management Approach for the Department of the Navy’s Research, Development, Test and Evaluation (RDT&E) Portfolio

Science.gov (United States)

2014-08-01

level. The two bolded and underlined aspects of this paradigm are the central topics of this paper. They will be explored and specific...accounts and that ties them together as a coherent whole. This should be of much greater concern than the lack of oversight of non-ACAT programs, the...Research and Engineering) [ ASD R&E]), and with Congress. It has shrunk noticeably over the last several decades as a percentage of the DON topline

Basic Science Research and the Protection of Human Research Participants

Science.gov (United States)

Eiseman, Elisa

2001-03-01

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

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

Science.gov (United States)

Roxland, Beth E

2012-05-01

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

Reflexive Research Ethics for Environmental Health and Justice: Academics and Movement-Building

Science.gov (United States)

Cordner, Alissa; Ciplet, David; Brown, Phil; Morello-Frosch, Rachel

2012-01-01

Community-engaged research on environmental problems has reshaped researcher-participant relationships, academic-community interaction, and the role of community partners in human subjects protection and ethical oversight. We draw on our own and others’ research collaborations with environmental health and justice social movement organizations to discuss the ethical concerns that emerge in community-engaged research. In this paper we introduce the concept of reflexive research ethics: ethical guidelines and decision-making principles that depend on continual reflexivity concerning the relationships between researchers and participants. Seeing ethics in this way can help scientists conduct research that simultaneously achieves a high level of professional conduct and protects the rights, well-being, and autonomy of both researchers and the multiple publics affected by research. We highlight our research with community-based organizations in Massachusetts, California, and Alaska, and discuss the potential impacts of the community or social movement on the research process and the potential impacts of research on community or social movement goals. We conclude by discussing ways in which the ethical concerns that surface in community-engaged research have led to advances in ethical research practices. This type of work raises ethical questions whose answers are broadly relevant for social movement, environmental, and public health scholars. PMID:22690133

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

Science.gov (United States)

McLennan, A

2007-08-01

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

Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics.

Science.gov (United States)

Dresser, Rebecca

2006-01-01

Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies' internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical companies' ethics materials and describe shortcomings in the companies' existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs.

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 importance of project networking for the replacement research reactor

International Nuclear Information System (INIS)

Whitbourn, G.

2003-01-01

When the HIFAR research reactor was commissioned in 1958 it was both constructed and regulated by the then Australian Atomic Energy Commission. The situation now is much more complicated, with an independent regulator, The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) and oversight by national security agencies and the Australian Safeguards and Non proliferation Organisation (ASNO). In July 2000 ANSTO contracted INVAP SE a suitably qualified and experienced nuclear organisation based in Argentina to provide the Replacement Research Reactor (RRR). INVAP subcontracted an Australian entity, a joint venture between John Holland and Evans Deakin Industries (JHEDI) to provide resources in Australia. There is an international network of over 100 subcontractors providing services, products and materials to INVAP and JHEDI and a significant number of contractors providing project support services to ANSTO. The interaction of all these entities to provide the RRR is a significant networking challenge, involving a complex network of legal, contractual and functional relationships and communication processes

Oversight and Influencing of Licensee Leadership and Management for Safety, Including Safety Culture - Regulatory Approaches and Methods. Proceedings of an NEA/IAEA Workshop, Chester, United Kingdom, 26-28 September 2011

International Nuclear Information System (INIS)

2012-01-01

Both regulators and the nuclear industry recognise the need for licensees to develop a strong, positive safety culture to support successful and sustainable nuclear safety performance. A number of reports have been issued by the IAEA and the NEA on the role of the regulator in relation to oversight of safety culture (References 1 to 5). There has been less clarity on how this should be achieved - in particular, with regard to strategies and practical approaches for maintaining oversight of, and influencing, those facets of licensee leadership and management which have a profound influence on safety culture. In recognition of this, the CSNI Working Group on Human and Organisational Factors (WGHOF), together with the CNRA Working Group on Inspection Practices (WGIP) and the IAEA, organised a workshop in Chester, United Kingdom, in May 2007 to provide a forum for gathering and sharing international experience, including good practices and learning points. The results of the workshop are reported in Reference 6. Workshop participants agreed that, in view of the rapidly developing approaches in this area, it would be sensible to hold a further workshop ('Chester 2') in 3-5 years in order to discuss how regulatory approaches have moved on and to share lessons learned from their application. In 2010, the WGIP hosted a workshop which included regulatory approaches for the assessment of licensee safety culture as a discussion topic. The outputs of the workshop included a list of commendable practices for monitoring and evaluating licensee safety culture (Reference 7). The 'Chester 2' workshop took place in September 2011. This report sets out the findings of the workshop, organised by the UK Office for Nuclear Regulation (ONR) on behalf of the CSNI/WGHOF and the IAEA. The workshop was attended by over 40 representatives of nuclear regulatory bodies and licensees from 15 countries plus IAEA and NEA. The workshop featured keynote papers on learning from major events, and from

Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

Science.gov (United States)

Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica

2018-02-27

Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question

A novel performance monitoring framework for health research systems: experiences of the National Institute for Health Research in England

Directory of Open Access Journals (Sweden)

Hallsworth Michael

2011-03-01

Full Text Available Abstract Background The National Institute for Health Research (NIHR was established in 2006 with the aim of creating an applied health research system embedded within the English National Health Service (NHS. NIHR sought to implement an approach for monitoring its performance that effectively linked early indicators of performance with longer-term research impacts. We attempted to develop and apply a conceptual framework for defining appropriate key performance indicators for NIHR. Method Following a review of relevant literature, a conceptual framework for defining performance indicators for NIHR was developed, based on a hybridisation of the logic model and balanced scorecard approaches. This framework was validated through interviews with key NIHR stakeholders and a pilot in one division of NIHR, before being refined and applied more widely. Indicators were then selected and aggregated to create a basket of indicators aligned to NIHR's strategic goals, which could be reported to NIHR's leadership team on a quarterly basis via an oversight dashboard. Results Senior health research system managers and practitioners endorsed the conceptual framework developed and reported satisfaction with the breadth and balance of indicators selected for reporting. Conclusions The use of the hybrid conceptual framework provides a pragmatic approach to defining performance indicators that are aligned to the strategic aims of a health research system. The particular strength of this framework is its capacity to provide an empirical link, over time, between upstream activities of a health research system and its long-term strategic objectives.

A novel performance monitoring framework for health research systems: experiences of the National Institute for Health Research in England.

Science.gov (United States)

El Turabi, Anas; Hallsworth, Michael; Ling, Tom; Grant, Jonathan

2011-03-24

The National Institute for Health Research (NIHR) was established in 2006 with the aim of creating an applied health research system embedded within the English National Health Service (NHS). NIHR sought to implement an approach for monitoring its performance that effectively linked early indicators of performance with longer-term research impacts. We attempted to develop and apply a conceptual framework for defining appropriate key performance indicators for NIHR. Following a review of relevant literature, a conceptual framework for defining performance indicators for NIHR was developed, based on a hybridisation of the logic model and balanced scorecard approaches. This framework was validated through interviews with key NIHR stakeholders and a pilot in one division of NIHR, before being refined and applied more widely. Indicators were then selected and aggregated to create a basket of indicators aligned to NIHR's strategic goals, which could be reported to NIHR's leadership team on a quarterly basis via an oversight dashboard. Senior health research system managers and practitioners endorsed the conceptual framework developed and reported satisfaction with the breadth and balance of indicators selected for reporting. The use of the hybrid conceptual framework provides a pragmatic approach to defining performance indicators that are aligned to the strategic aims of a health research system. The particular strength of this framework is its capacity to provide an empirical link, over time, between upstream activities of a health research system and its long-term strategic objectives.

PTSD: National Center for PTSD

Medline Plus

Full Text Available ... VA Research Services Programs News, Events and Media Research Topics For Veterans For Researchers Research Oversight Special Groups Caregivers Combat Veterans & their Families ...

Paternalism and utilitarianism in research with human participants.

Science.gov (United States)

Resnik, David B

2015-03-01

In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in research (such as significant injury to participants or death) is a crucial concern that must be taken into account when assessing the consequences of different policy options, because public backlash can lead to outcomes that have a negative impact on science, such as cuts in funding, overly restrictive regulation and oversight, and reduced willingness of individuals to participate in research. I argue that concern about the public reaction to adverse events justifies some restrictions on the risks that competent, adult volunteers can face in research that offers them no significant benefits. The paternalism defended here is not pure, because it involves restrictions on the rights of investigators in order to protect participants. It also has a mixed rationale, because individual autonomy may be restricted not only to protect participants from harm but also to protect other stakeholders. Utility is not the sole justification for paternalistic research policies, since other considerations, such as justice and respect for individual rights/autonomy, must also be taken into account.

Research and experience report 2016 - Developments in the technical and legal basis for nuclear oversight

International Nuclear Information System (INIS)

2017-04-01

Projects in the research programme of the Swiss Federal Nuclear Safety Inspectorate (ENSI) contribute to the clarification of outstanding issues, establish fundamentals and develop the tools required for its regulatory activities. International projects deliver results that Switzerland could not achieve on its own and encourage cross-border networking. The research on fuels and materials covers the reactor core and the multiple barriers for the retainment of radioactive materials especially concerning high burn-up rates and safety criteria. In 2016, the Studsvik Cladding Integrity Project in Sweden commissioned a new test facility to investigate the behaviour of fuel rods in loss of coolant accidents (LOCA). Research into structural materials focuses on ageing processes. In the NORA project at the Paul Scherrer Institute (PSI), platinum is injected into the cooling system with a view to reducing corrosion. Projects conducted under the auspices of the OECD's Nuclear Energy Agency (NEA) and relating to internal events and damage encourage the international exchange of information on incidents, accidents and component damage. Subject-specific databases are created on incidents involving fires or damage to passive metal components. In 2016 the OECD CODAP project prepared a report on reliability and integrity management in pressurised components. ENSI supports research projects on external events such as earthquakes, flooding, aircraft crashes and explosions. Within the OECD MECOS project, the behaviour of pipes subjected to powerful earthquakes was modelled; it showed improvements in the calculation of cyclic loading and on the limits for simulating elastic-plastic material behaviour under high loads. The impact of operator actions on incidents and accidents is the most important human factor in view of reducing uncertainty in probabilistic safety analyses, as well as the interfaces between humans and technical systems. System behaviour and accident sequences in

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

From global bioethics to ethical governance of biomedical research collaborations.

Science.gov (United States)

Wahlberg, Ayo; Rehmann-Sutter, Christoph; Sleeboom-Faulkner, Margaret; Lu, Guangxiu; Döring, Ole; Cong, Yali; Laska-Formejster, Alicja; He, Jing; Chen, Haidan; Gottweis, Herbert; Rose, Nikolas

2013-12-01

One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved. Copyright © 2013 Elsevier Ltd. All rights reserved.

What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials.

Directory of Open Access Journals (Sweden)

Louise Dudley

Full Text Available Patient and public involvement (PPI is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups and managerial (e.g. trial management groups roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees.Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

Research and experience report 2010 - Developments in the technical and legal basis of nuclear oversight

International Nuclear Information System (INIS)

2011-04-01

This comprehensive annual report presents a review of the activities carried out by the Swiss Federal Nuclear Safety Inspectorate (ENSI) in the year 2010. The inspectorate's fields of activity - fuels and materials, significant internal and external events and occurrences, human factors, system behaviour and accident sequences, radiological protection and waste disposal - are reviewed. Information on incidents in Swiss nuclear facilities are reviewed in the ENSI Surveillance Report. The Research and Experience Report also provides information on a selection of particularly instructive incidents in nuclear facilities outside Switzerland. Incidents are analysed with a view to identifying any potential relevance to Swiss nuclear facilities. International co-operation is mentioned and current changes and developments related to plant surveillance are noted. Organisational aspects are discussed and various guidelines and directives are presented and discussed

PTSD: National Center for PTSD

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Fundamental elements in examining a child’s right to education: A study of home education research and regulation in Australia

Directory of Open Access Journals (Sweden)

Glenda JACKSON

2010-07-01

Full Text Available Home education provides valuable educational and developmental opportunities for children. An examination of Australia’s research indicates many best educational practices, including more informed mediation, contextualised learning, and opportunities to exercise autonomy. Key features include learning embedded in communities and program modification in response to students’ needs. Current state and territory legal requirements are examined within the context of this research and Australia’s obligations to international human rights treaties. All jurisdictions accept home education as one way to meet compulsory education requirements. The extent to which respective laws then reflect understanding of home education research and practice varies. Most jurisdictions allow for a varietyof educational approaches. Some oversight regulation could however be modified to reflect a better understanding of home education. Consultation with home educators and reference to research would assist the development of more uniform legislation and policy across Australia, and enable better regulatory practice.

Public Opinion about the Importance of Privacy in Biobank Research

Science.gov (United States)

Kaufman, David J.; Murphy-Bollinger, Juli; Scott, Joan; Hudson, Kathy L.

2009-01-01

Concerns about privacy may deter people from participating in genetic research. Recruitment and retention of biobank participants requires understanding the nature and magnitude of these concerns. Potential participants in a proposed biobank were asked about their willingness to participate, their privacy concerns, informed consent, and data sharing. A representative survey of 4659 U.S. adults was conducted. Ninety percent of respondents would be concerned about privacy, 56% would be concerned about researchers having their information, and 37% would worry that study data could be used against them. However, 60% would participate in the biobank if asked. Nearly half (48%) would prefer to provide consent once for all research approved by an oversight panel, whereas 42% would prefer to provide consent for each project separately. Although 92% would allow academic researchers to use study data, 80% and 75%, respectively, would grant access to government and industry researchers. Concern about privacy was related to lower willingness to participate only when respondents were told that they would receive $50 for participation and would not receive individual research results back. Among respondents who were told that they would receive $200 or individual research results, privacy concerns were not related to willingness. Survey respondents valued both privacy and participation in biomedical research. Despite pervasive privacy concerns, 60% would participate in a biobank. Assuring research participants that their privacy will be protected to the best of researchers' abilities may increase participants' acceptance of consent for broad research uses of biobank data by a wide range of researchers. PMID:19878915

Research and experience report 2015 - Developments in the technical and legal basis for nuclear oversight

International Nuclear Information System (INIS)

2016-04-01

Projects in the research programme of the Swiss Federal Nuclear Safety Inspectorate (ENSI) contribute to the clarification of outstanding issues, establish fundamentals and develop the tools required for its regulatory activities. International projects deliver results that Switzerland could not achieve on its own and encourage international networking. The research on fuels and materials covers the reactor core and the multiple barriers for the retainment of radioactive materials. In 2015 the OECD Halden Reactor Project developed new methods for measuring the thermal conductivity of fuel and the creep of cladding materials during irradiation in the reactor and ageing processes. The PISA project of the Paul Scherrer Institute (PSI) focused on the deterministic and probabilistic assessment of the integrity of reactor pressure vessels. Under the auspices of the OECD's Nuclear Energy Agency, specific databases are being created on damage to passive metal components and electrical cables. The OECD FIRE project completed its report into the combination of fires with other events; half of these events are linked to electric arcing. ENSI research projects address external events such as earthquakes, flooding, aircraft crashes and explosions. A project of the American Society of Mechanical Engineers is investigating pre-stressed reinforced concrete slabs under explosive loads. Other OECD projects consider the effects of severe earthquakes on reinforced concrete walls and pipelines. The ROES PSI project is expanding the application of methods for assessing operator errors that can negatively influence the course of an accident. System behaviour and accident sequences in nuclear power plants are analysed in conditions ranging from normal operations through to accidents involving core meltdown. The results of computer models are used for the quantitative identification of plant risk in probabilistic safety analyses. The STARS PSI project improves the basic principles for

Family and physician influence on asthma research participation decisions for adolescents: the effects of adolescent gender and research risk.

Science.gov (United States)

Brody, Janet L; Scherer, David G; Annett, Robert D; Turner, Charles; Dalen, Jeanne

2006-08-01

There is considerable ethical and legal ambiguity surrounding the role of adolescents in the decision-making process for research participation. Depending on the nature of the study and the regulations involved, adolescents may have independent responsibility for providing informed consent, they may be asked to provide their assent, or they may be completely excluded from the decision-making process. This study examined parent and adolescent perceptions of decision-making authority and sources of influence on adolescent research participation decisions, and examined whether perceptions of influence differed based on adolescent gender and level of research risk. Adolescents (n = 36) with asthma and their parents reviewed 9 pediatric research protocols, decided whether they would choose to participate, rated the extent they would be responsible for the actual decision, and indicated the ability of family and physician to influence their decisions. Multivariate analyses of variance were used to evaluate differences in perceptions of decision-making authority and sources of influence on the decisions. Adolescents were less willing to cede decision making authority to parents than parents anticipated. Parents and adolescents acknowledged a greater openness to influence from physicians than from family for above minimal risk studies. Parents were more willing to consider opinions from male adolescents. Adolescents desire responsibility for research participation decisions, though parents may not share these views. Physicians' views on research participation are important to families, especially for above minimal risk studies. Parents may grant more decision-making autonomy to adolescent males than to females. Researchers, physicians, and institutions play a key role in facilitating the ethical enrollment of adolescents into biomedical research. Educational, policy, and oversight processes that support both adolescent autonomy and parental responsibility for research

The circuitous path of democracy : legislative control of the bureaucracy in presidential regimes : the case of Mexico

OpenAIRE

Ríos C., Alejandra

2010-01-01

My research identifies conditions for legislators in emerging presidential democracies to achieve bureaucratic accountability, one of the least studies aspects of legislative politics. To better explain legislators' ability to hold the bureaucracy accountable, I develop a theoretical model of oversight in which resource constraints (i.e., capabilities) and electoral motivations and policy preferences (i.e., incentives) explain legislators' behavior. The model shows that legislators' oversight...

MORT User's Manual for use with the Management Oversight and Risk Tree analytical logic diagram. [Contains a list of System Safety Development Center publications

Energy Technology Data Exchange (ETDEWEB)

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

1992-02-01

This report contains the User's Manual for MORT (Management Oversight and Risk Tree), a logic diagram in the form of a work sheet'' that illustrates a long series of interrelated questions. MORT is a comprehensive analytical procedure that provides a disciplined method for determining the causes and contributing factors of major accidents. Alternatively, it serves as a tool to evaluate the quality of an existing system. While similar in many respects to fault tree analysis, MORT is more generalized and presents over 1,500 specific elements of an ideal universal'' management program for optimizing environment, safety and health, and other programs. This User's Manual is intended to be used with the MORT diagram dated February 1992.

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

Development of the Young Brain

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Full Text Available ... Grants Application Process Managing Grants Clinical Research Training Small Business Research Labs at NIMH Labs at NIMH Home Research Areas Principal Investigators Administrative Oversight & Support Collaborations & Partnerships Join ...

Symptoms and Treatment of Depression

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Historic low-level radioactive waste federal policies, programs and oversight

International Nuclear Information System (INIS)

Blanchette, M.; Kenney, J.; Zelmer, B.

2011-01-01

'Full text:' The management of radioactive waste is one of the most serious environmental problems facing Canadians. From the early industrial uses of radioactive material in the 1930s to the development of nuclear power reactors and the medical and experimental use of radio-isotopes today, there has been a steady accumulation of waste products. Historic waste is low-level radioactive waste for which the federal government has accepted responsibility for long-term management. This paper will outline the policy framework used to govern institutional and financial arrangements for the disposal of radioactive waste by waste producers and owners and the major radioactive projects in which the Government of Canada is currently involved. It will provide an overview of the organizations established for the management of historic radioactive waste and NRCan's oversight role. Finally, an overview of the historic waste program activities managed on behalf of the federal government through these organizations in the Port Hope area, the Greater Toronto Area, in Fort McMurray, Alberta and along the Northern Transportation Route is provided. Canada's Policy Framework for Radioactive Waste, sets out principles that govern the institutional and financial arrangements for disposal of radioactive waste by waste producers and owners. According to the Policy Framework: The federal government will ensure that radioactive waste disposal is carried out in a safe, environmentally sound, comprehensive, cost-effective and integrated manner; The federal government has the responsibility to develop policy, to regulate, and to oversee producers and owners; and, The waste producers and owners are responsible, in accordance with the principle of 'polluter pays', for the funding, organization, management and operation of disposal and other facilities required for their wastes. Arrangements may be different for nuclear fuel waste, low-level radioactive waste and

PTSD: National Center for PTSD

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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.

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.

Promoting Healthy Growth or Feeding Obesity? The Need for Evidence-Based Oversight of Infant Nutritional Supplement Claims

Directory of Open Access Journals (Sweden)

Michelle Lampl

2016-11-01

Full Text Available The Developmental Origins of Health and Disease (DOHaD model recognizes growth in infancy and childhood as a fundamental determinant of lifespan health. Evidence of long-term health risks among small neonates who subsequently grow rapidly poses a challenge for interventions aiming to support healthy growth, not merely drive weight gain. Defining healthy growth beyond “getting bigger” is essential as infant and young child feeding industries expand. Liquid-based nutritional supplements, originally formulated for undernourished children, are increasingly marketed for and consumed by children generally. Clarifying the nature of the evidentiary base on which structure/function claims promoting “healthy growth” are constructed is important to curb invalid generalizations. Evidence points to changing social beliefs and cultural practices surrounding supplementary feeding, raising specific concerns about the long-term health consequences of an associated altered feeding culture, including reduced dietary variety and weight gain. Reassessing the evidence for and relevance of dietary supplements’ “promoting healthy growth” claims for otherwise healthy children is both needed in a time of global obesity and an opportunity to refine intervention approaches among small children for whom rapid subsequent growth in early life augments risk for chronic disease. Scientific and health care partnerships are needed to consider current governmental oversight shortfalls in protecting vulnerable populations from overconsumption. This is important because we may be doing more harm than good.

PTSD: National Center for PTSD

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Fostering child-centred approaches to transport research, planning and policy development: a pilot methodology

CSIR Research Space (South Africa)

Mashiri, M

2007-01-01

Full Text Available countries, this is a surprising oversight. Much of our knowledge of children and transport is gleaned from observation and anecdotal evidence. There has been little systematic study of the issues. Children are not seriously considered stakeholders...

Secondary uses and the governance of de-identified data: Lessons from the human genome diversity panel

Directory of Open Access Journals (Sweden)

Lee Sandra S-J

2011-09-01

Full Text Available Abstract Background Recent changes to regulatory guidance in the US and Europe have complicated oversight of secondary research by rendering most uses of de-identified data exempt from human subjects oversight. To identify the implications of such guidelines for harms to participants and communities, this paper explores the secondary uses of one de-identified DNA sample collection with limited oversight: the Human Genome Diversity Project (HGDP-Centre d'Etude du Polymorphisme Humain, Fondation Jean Dausset (CEPH Human Genome Diversity Panel. Methods Using a combination of keyword and cited reference search, we identified English-language scientific articles published between 2002 and 2009 that reported analysis of HGDP Diversity Panel samples and/or data. We then reviewed each article to identify the specific research use to which the samples and/or data was applied. Secondary uses were categorized according to the type and kind of research supported by the collection. Results A wide variety of secondary uses were identified from 148 peer-reviewed articles. While the vast majority of these uses were consistent with the original intent of the collection, a minority of published reports described research whose primary findings could be regarded as controversial, objectionable, or potentially stigmatizing in their interpretation. Conclusions We conclude that potential risks to participants and communities cannot be wholly eliminated by anonymization of individual data and suggest that explicit review of proposed secondary uses, by a Data Access Committee or similar internal oversight body with suitable stakeholder representation, should be a required component of the trustworthy governance of any repository of data or specimens.

Research Guidelines in the Era of Large-scale Collaborations: An Analysis of Genome-wide Association Study Consortia

Science.gov (United States)

Austin, Melissa A.; Hair, Marilyn S.; Fullerton, Stephanie M.

2012-01-01

Scientific research has shifted from studies conducted by single investigators to the creation of large consortia. Genetic epidemiologists, for example, now collaborate extensively for genome-wide association studies (GWAS). The effect has been a stream of confirmed disease-gene associations. However, effects on human subjects oversight, data-sharing, publication and authorship practices, research organization and productivity, and intellectual property remain to be examined. The aim of this analysis was to identify all research consortia that had published the results of a GWAS analysis since 2005, characterize them, determine which have publicly accessible guidelines for research practices, and summarize the policies in these guidelines. A review of the National Human Genome Research Institute’s Catalog of Published Genome-Wide Association Studies identified 55 GWAS consortia as of April 1, 2011. These consortia were comprised of individual investigators, research centers, studies, or other consortia and studied 48 different diseases or traits. Only 14 (25%) were found to have publicly accessible research guidelines on consortia websites. The available guidelines provide information on organization, governance, and research protocols; half address institutional review board approval. Details of publication, authorship, data-sharing, and intellectual property vary considerably. Wider access to consortia guidelines is needed to establish appropriate research standards with broad applicability to emerging forms of large-scale collaboration. PMID:22491085

76 FR 53255 - Responsibility of Applicants for Promoting Objectivity in Research for which Public Health...

Science.gov (United States)

2011-08-25

... rigorous approach to Investigator disclosure, institutional management of financial conflicts, and Federal... Financial Interests (SFIs), enhance regulatory compliance and effective institutional oversight and management of Investigators' financial conflicts of interests, as well as increase the Department of Health...

NASA's Spaceflight Visual Impairment and Intracranial Hypertension Research Plan: An accelerated Research Collaboration

Science.gov (United States)

Otto, Christian; Fogarty, J.; Grounds, D.; Davis, J.

2010-01-01

To date six long duration astronauts have experienced in flight visual changes and post flight signs of optic disc edema, globe flattening, choroidal folds, hyperoptic shifts and or raised intracranial pressure. In some cases the changes were transient while in others they are persistent with varying degrees of visual impairment. Given that all astronauts exposed to microgravity experience a cephalad fluid shift, and that both symptomatic and asymptomatic patients have exhibited optic nerve sheath edema on MRI, there is a high probability that all astronauts develop in-flight idiopathic intracranial hypertension to some degree. Those who are susceptible, have an increased likelihood of developing treatment resistant papilledema resulting in visual impairment and possible long-term vision loss. Such an acquired disability would have a profound mission impact and would be detrimental to the long term health of the astronaut. The visual impairment and increased intracranial pressure phenomenon appears to have multiple contributing factors. Consequently, the working "physiological fault bush" with elevated intracranial pressure at its center, is divided into ocular effects, and CNS and other effects. Some of these variables have been documented and or measured through operational data gathering, while others are unknown, undocumented and or hypothetical. Both the complexity of the problem and the urgency to find a solution require that a unique, non-traditional research model be employed such as the Accelerated Research Collaboration(TM) (ARC) model that has been pioneered by the Myelin Repair Foundation. In the ARC model a single entity facilitates and manages all aspects of the basic, translational, and clinical research, providing expert oversight for both scientific and managerial efforts. The result is a comprehensive research plan executed by a multidisciplinary team and the elimination of stove-piped research. The ARC model emphasizes efficient and effective

Development of the Young Brain

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Symptoms and Treatment of Depression

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Investigation and consideration on the framework of oversight-based safety regulation. U.S. NRC 'Risk-Informed, Performance-Based' Regulation

International Nuclear Information System (INIS)

Saji, Gen

2001-01-01

Regulation on safety, environment and health in Japan has before today been intended to correspond with an accident at forms of reinforcement of national standards and monitoring, if any. However, as it was thought that such regulation reinforcement was afraid to bring some social rigidity, and to weaken independent responsibility, as a result, because of anxiety of losing peoples' merits inversely, some fundamental directivity such as respect of self-responsibility principle' and 'necessary and least limit of regulation' were selected as a part of political innovation. On the other hand, at a background of wide improvements on various indexing values showing operation results of nuclear power stations in U.S.A., private independent effort on upgrading of safety is told to largely affect at beginning of INPO (Institute of Nuclear Power Operations), without regulation reinforcement of NRC side. This is a proof of concrete effect of transfer to oversight-based safety regulation. Here were introduced on nuclear safety in U.S.A. at a base of some references obtained on entering the 'MIT summer specialist program. Nuclear system safety', on focussing at new safety regulation of NRC and its effect and so on, and adding some considerations based on some knowledge thereafter. (G.K.)

Development of the Young Brain

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Symptoms and Treatment of Depression

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PTSD: National Center for PTSD

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PTSD: National Center for PTSD

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Public’s Approach to Surrogate Consent for Dementia Research: Cautious Pragmatism

Science.gov (United States)

De Vries, Raymond; Ryan, Kerry A.; Stanczyk, Aimee; Appelbaum, Paul S.; Damschroder, Laura; Knopman, David S.; Kim, Scott Y. H.

2011-01-01

Objectives To describe how members of the older general public deliberate with one another in finding solutions to the dilemma of involving decisionally incapable persons in dementia research. Design, Setting, and Participants 160 persons aged 50+ who participated in an all-day deliberative democracy (DD) session on the ethics of surrogate consent for dementia research. The DD day consisted of both extensive, interactive education with experts in clinical research and ethics, as well as small group deliberations. Measurements Audiotaped small group deliberations were transcribed and analyzed, and the main thematic elements were coded. Results During deliberation, participants acknowledged the limitations of advanced research directives and discussed ways to improve their use. Although there was consensus about the necessity of surrogate consent, the participants recognized potential pitfalls and looked for ways to safeguard the process. Participants supporting surrogate consent for research emphasized societal and individual benefit, the importance of assent, and trust in surrogates and the oversight system. Other participants felt that the high risk of some research scenarios was not sufficiently offset by benefits to patients or society. Conclusions Members of the older general public are able to make use of in-depth education and peer deliberation to provide reasoned and informed opinions on the ethical use of surrogate consent for dementia research. The public’s approach to surrogate consent is one of cautious pragmatism: an overall trust in science and future surrogates with awareness of the potential pitfalls, suggesting that their trust cannot be taken for granted. PMID:23498383

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.

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

[Sex and gender equity in research: rationale for the SAGER guidelines and recommended use].

Science.gov (United States)

Heidari, Shirin; Babor, Thomas F; De Castro, Paola; Tort, Sera; Curno, Mirjam

2018-05-03

Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literatura search on sex and gender policies in scientific publishing. The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

Conducting multicenter research in healthcare simulation: Lessons learned from the INSPIRE network.

Science.gov (United States)

Cheng, Adam; Kessler, David; Mackinnon, Ralph; Chang, Todd P; Nadkarni, Vinay M; Hunt, Elizabeth A; Duval-Arnould, Jordan; Lin, Yiqun; Pusic, Martin; Auerbach, Marc

2017-01-01

Simulation-based research has grown substantially over the past two decades; however, relatively few published simulation studies are multicenter in nature. Multicenter research confers many distinct advantages over single-center studies, including larger sample sizes for more generalizable findings, sharing resources amongst collaborative sites, and promoting networking. Well-executed multicenter studies are more likely to improve provider performance and/or have a positive impact on patient outcomes. In this manuscript, we offer a step-by-step guide to conducting multicenter, simulation-based research based upon our collective experience with the International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE). Like multicenter clinical research, simulation-based multicenter research can be divided into four distinct phases. Each phase has specific differences when applied to simulation research: (1) Planning phase , to define the research question, systematically review the literature, identify outcome measures, and conduct pilot studies to ensure feasibility and estimate power; (2) Project Development phase , when the primary investigator identifies collaborators, develops the protocol and research operations manual, prepares grant applications, obtains ethical approval and executes subsite contracts, registers the study in a clinical trial registry, forms a manuscript oversight committee, and conducts feasibility testing and data validation at each site; (3) Study Execution phase , involving recruitment and enrollment of subjects, clear communication and decision-making, quality assurance measures and data abstraction, validation, and analysis; and (4) Dissemination phase , where the research team shares results via conference presentations, publications, traditional media, social media, and implements strategies for translating results to practice. With this manuscript, we provide a guide to conducting quantitative multicenter

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...

Safety-Related Contractor Activities at Nuclear Power Plants. New Challenges for Regulatory Oversight

International Nuclear Information System (INIS)

Chockie, Alan

2005-09-01

The use of contractors has been an integral and important part of the design, construction, operation, and maintenance of nuclear power plants. To ensure the safe and efficient completion of contracted tasks, each nuclear plant licensee has developed and refined formal contract management processes to meet their specific needs and plant requirements. Although these contract management processes have proven to be effective tools for the procurement of support and components tailored to the needs of nuclear power plants, contractor-related incidents and accidents have revealed some serious weaknesses with the implementation of these processes. Identifying and addressing implementation problems are becoming more complicated due to organizational and personnel changes affecting the nuclear power industry. The ability of regulators and licensees to effectively monitor and manage the safety-related performance of contractors will likely be affected by forthcoming organization and personnel changes due to: the aging of the workforce; the decline of the nuclear industry; and the deregulation of nuclear power. The objective of this report is to provide a review of current and potential future challenges facing safety-related contractor activities at nuclear power plants. The purpose is to assist SKI in establishing a strategy for the proactive oversight of contractor safety-related activities at Swedish nuclear power plants and facilities. The nature and role of contractors at nuclear plants is briefly reviewed in the first section of the report. The second section describes the essential elements of the contract management process. Although organizations have had decades of experience with the a contract management process, there remain a number of common implantation weaknesses that have lead to serious contractor-related incidents and accidents. These implementation weaknesses are summarized in the third section. The fourth section of the report highlights the

Safety-Related Contractor Activities at Nuclear Power Plants. New Challenges for Regulatory Oversight

Energy Technology Data Exchange (ETDEWEB)

Chockie, Alan [Chockie Group International, Inc., Seattle, WA (United States)

2005-09-15

The use of contractors has been an integral and important part of the design, construction, operation, and maintenance of nuclear power plants. To ensure the safe and efficient completion of contracted tasks, each nuclear plant licensee has developed and refined formal contract management processes to meet their specific needs and plant requirements. Although these contract management processes have proven to be effective tools for the procurement of support and components tailored to the needs of nuclear power plants, contractor-related incidents and accidents have revealed some serious weaknesses with the implementation of these processes. Identifying and addressing implementation problems are becoming more complicated due to organizational and personnel changes affecting the nuclear power industry. The ability of regulators and licensees to effectively monitor and manage the safety-related performance of contractors will likely be affected by forthcoming organization and personnel changes due to: the aging of the workforce; the decline of the nuclear industry; and the deregulation of nuclear power. The objective of this report is to provide a review of current and potential future challenges facing safety-related contractor activities at nuclear power plants. The purpose is to assist SKI in establishing a strategy for the proactive oversight of contractor safety-related activities at Swedish nuclear power plants and facilities. The nature and role of contractors at nuclear plants is briefly reviewed in the first section of the report. The second section describes the essential elements of the contract management process. Although organizations have had decades of experience with the a contract management process, there remain a number of common implantation weaknesses that have lead to serious contractor-related incidents and accidents. These implementation weaknesses are summarized in the third section. The fourth section of the report highlights the

PTSD: National Center for PTSD

Medline Plus

Full Text Available ... Events Adaptive Sports Program Creative Arts Festival Golden Age Games Summer Sports Clinic Training - Exposure - Experience (TEE) ... Topics For Veterans For Researchers Research Oversight Special Groups Caregivers Combat Veterans & their Families Readjustment Counseling (Vet ...

Linking Environmental Sustainability, Health, and Safety Data in Health Care: A Research Roadmap.

Science.gov (United States)

Kaplan, Susan B; Forst, Linda

2017-08-01

Limited but growing evidence demonstrates that environmental sustainability in the health-care sector can improve worker and patient health and safety. Yet these connections are not appreciated or understood by decision makers in health-care organizations or oversight agencies. Several studies demonstrate improvements in quality of care, staff satisfaction, and work productivity related to environmental improvements in the health-care sector. A pilot study conducted by the authors found that already-collected data could be used to evaluate impacts of environmental sustainability initiatives on worker and patient health and safety, yet few hospitals do so. Future research should include a policy analysis of laws that could drive efforts to integrate these areas, elucidation of organizational models that promote sharing of environmental and health and safety data, and development of tools and methods to enable systematic linkage and evaluation of these data to expand the evidence base and improve the hospital environment.

A novel approach to enhance food safety: industry-academia-government partnership for applied research.

Science.gov (United States)

Osterholm, Michael T; Ostrowsky, Julie; Farrar, Jeff A; Gravani, Robert B; Tauxe, Robert V; Buchanan, Robert L; Hedberg, Craig W

2009-07-01

An independent collaborative approach was developed for stimulating research on high-priority food safety issues. The Fresh Express Produce Safety Research Initiative was launched in 2007 with $2 million in unrestricted funds from industry and independent direction and oversight from a scientific advisory panel consisting of nationally recognized food safety experts from academia and government agencies. The program had two main objectives: (i) to fund rigorous, innovative, and multidisciplinary research addressing the safety of lettuce, spinach, and other leafy greens and (ii) to share research findings as widely and quickly as possible to support the development of advanced safeguards within the fresh-cut produce industry. Sixty-five proposals were submitted in response to a publicly announced request for proposals and were competitively evaluated. Nine research projects were funded to examine underlying factors involved in Escherichia coli O157:H7 contamination of lettuce, spinach, and other leafy greens and potential strategies for preventing the spread of foodborne pathogens. Results of the studies, published in the Journal of Food Protection, help to identify promising directions for future research into potential sources and entry points of contamination and specific factors associated with harvesting, processing, transporting, and storing produce that allow contaminants to persist and proliferate. The program provides a model for leveraging the strengths of industry, academia, and government to address high-priority issues quickly and directly through applied research. This model can be productively extended to other pathogens and other leafy and nonleafy produce.

Oversight Hearing on Section 529 College Savings Plans: High Fees, Inadequate Disclosure, Disparate State Tax Treatment, and Questionable Broker Sales Practices. Hearing before the Financial Management, the Budget, and International Security Subcommittee of the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, Second Session (September 30, 2004) S. Hrg. 108-716

Science.gov (United States)

US Senate, 2004

2004-01-01

The Subcommittee conducted an oversight hearing on Section 529 College Savings Plans, State-sponsored investments that are designed to encourage families to save money for their children's college education. Section 529 refers to the Internal Revenue Code section that authorizes and confers special tax treatment on these entities. Section 529…

Progress of the United States foreign research reactor spent nuclear fuel acceptance program

International Nuclear Information System (INIS)

Huizenga, D.G.; Clapper, M.; Thrower, A.W.

2002-01-01

The United States Department of Energy (DOE), in consultation with the Department of State (DOS), adopted the Nuclear Weapons Nonproliferation Policy Concerning Foreign Research Reactor Spent Nuclear Fuel in May 1996. To date, the Foreign Research Reactor (FRR) Spent Nuclear Fuel (SNF) Acceptance Program has completed 23 shipments. Almost 5000 spent fuel assemblies from eligible research reactors throughout the world have been accepted into the United States under this program. Over the past year, another cross-country shipment of fuel was accomplished, as well as two additional shipments in the fourth quarter of calendar year 2001. These shipments attracted considerable safeguards oversight since they occurred post September 11. Recent guidance from the Nuclear Regulatory Commission (NRC) pertaining to security and safeguards issues deals directly with the transport of nuclear material. Since the Acceptance Program has consistently applied above regulatory safety enhancements in transport of spent nuclear fuel, this guidance did not adversely effect the Program. As the Program draws closer to its termination date, an increased number of requests for program extension are received. Currently, there are no plans to extend the policy beyond its current expiration date; therefore, eligible reactor operators interested in participating in this program are strongly encouraged to evaluate their inventory and plan for future shipments as soon as possible. (author)

PTSD: National Center for PTSD

Medline Plus

Full Text Available ... For Veterans For Researchers Research Oversight Special Groups Caregivers Combat Veterans & their Families Readjustment Counseling (Vet Centers) ... Professional Section: Prescribing for PTSD, Know Your Options . × What is PTSD? Right Click here to download "What ...

Clinical Trials

Medline Plus

Full Text Available ... harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ... of research studies at the NIH Clinical Center, America's research hospital, located on the NIH campus in ...

Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.

Science.gov (United States)

Angal, Jyoti; Petersen, Julie M; Tobacco, Deborah; Elliott, Amy J

2016-04-01

Increasingly, Tribal Nations are forming ethics review panels, which function separately from institutional review boards (IRBs). The emergence of strong community representation coincides with a widespread effort supported by the U.S. Department of Health & Human Services and other federal agencies to establish a single IRB for all multi-site research. This article underscores the value of a tribal ethics review board and describes the tribal oversight for the Safe Passage Study-a multi-site, community-based project in the Northern Plains. Our experience demonstrates the benefits of tribal ethics review and makes a strong argument for including tribal oversight in future regulatory guidance for multi-site, community-based research. © The Author(s) 2016.

Homeland Security and Counterterrorism Research and Development: Funding, Organization, and Oversight

National Research Council Canada - National Science Library

Knezo, Genevieve J

2003-01-01

... R&D appropriations totaling $1.050 billion, 16% more than the President requested. Policy issues include implementation and coordination of priority-setting among DHS, other agencies, and existing...

Long-term preservation and the concept of oversight (The start of this period is very speculative. It may begin at perhaps 1 000 years from closure)

International Nuclear Information System (INIS)

Claudel, Anne

2015-01-01

In line with the RK and M initiative's glossary, the 'long term' was introduced as the period of time after repository closure with no repository oversight, extending over hundreds of thousands of years. Anne Claudel focused on the RK and M initiative findings regarding markers. She explained that, although they have often been presented as the main method to preserve memory and deter human intrusion, the RK and M literature survey on markers shows that there are no straightforward, conclusive answers to the objectives, messages and methods of marking. Even if they remain physically intact and traceable over time, future neglect or misunderstanding of their meaning cannot be ruled out. It was thus announced that the potential role of markers for RK and M preservation should be studied within a systemic approach to RK and M preservation. For instance, RK and M will investigate further the interaction of markers with other methods and tools, and the potential of internationally standardised markers

Future Models for Federally Funded Research and Development Center Contracts

Science.gov (United States)

2016-10-20

the DBB 20 October 2016 Methodology  Review previous DoD and outside reports and studies  Interviews  OSD oversight officials (AT&L...work for other Federal agencies. Some FFRDCs support other Federal departments and agencies and a few have a broad base of business outside of DoD and...evaluating new science and technology that can enhance our military capabilities, avoid strategic or technological surprise, or counter a threat from our

A self-scaling, distributed information architecture for public health, research, and clinical care.

Science.gov (United States)

McMurry, Andrew J; Gilbert, Clint A; Reis, Ben Y; Chueh, Henry C; Kohane, Isaac S; Mandl, Kenneth D

2007-01-01

This study sought to define a scalable architecture to support the National Health Information Network (NHIN). This architecture must concurrently support a wide range of public health, research, and clinical care activities. The architecture fulfils five desiderata: (1) adopt a distributed approach to data storage to protect privacy, (2) enable strong institutional autonomy to engender participation, (3) provide oversight and transparency to ensure patient trust, (4) allow variable levels of access according to investigator needs and institutional policies, (5) define a self-scaling architecture that encourages voluntary regional collaborations that coalesce to form a nationwide network. Our model has been validated by a large-scale, multi-institution study involving seven medical centers for cancer research. It is the basis of one of four open architectures developed under funding from the Office of the National Coordinator of Health Information Technology, fulfilling the biosurveillance use case defined by the American Health Information Community. The model supports broad applicability for regional and national clinical information exchanges. This model shows the feasibility of an architecture wherein the requirements of care providers, investigators, and public health authorities are served by a distributed model that grants autonomy, protects privacy, and promotes participation.

Biodiesel Performance with Modern Engines. Cooperative Research and Development Final Report, CRADA Number CRD-05-153

Energy Technology Data Exchange (ETDEWEB)

McCormick, Robert [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2016-01-29

NREL and the National Biodiesel Board (NBB) will work cooperatively to assess the effects of biodiesel blends on the performance of modern diesel engines and emissions control systems meeting increasingly strict emissions standards. This work will include research to understand the impact of biodiesel blends on the operation and durability of particle filters and NOx control sorbents/catalysts, to quantify the effect on emission control systems performance, and to understand effects on engine component durability. Work to assess the impact of biodiesel blends on real world fleet operations will be performed. Also, research to develop appropriate ASTM standards for biodiesel quality and stability will be conducted. The cooperative project will involve engine testing and fleet evaluation studies at NREL using biodiesel from a variety of sources. In addition, NREL will work with NBB to set up an Industrial Steering Committee to design the scope for the various projects and to provide technical oversight to these projects. NREL and NBB will cooperatively communicate the study results to as broad an audience as possible.

Safety system upgrades to a research reactor: A regulatory perspective

International Nuclear Information System (INIS)

Lamarre, G.B.; Martin, W.G.

2003-01-01

The NRU (National Research Universal) reactor, located at the Chalk River Laboratories of Atomic Energy of Canada Limited (AECL), first achieved criticality November 3, 1957. AECL continues to operate NRU for research to support safety and reliability studies for CANDU reactors and as a major supplier of medical radioisotopes. Following a detailed systematic review and assessment of NRU's design and the condition of its primary systems, AECL formally notified the Canadian Nuclear Safety Commission's (CNSC) predecessor - the Atomic Energy Control Board - in 1992 of its intention to upgrade NRU's safety systems. AECL proposed seven major upgrades to provide improvements in shutdown capability, heat removal, confinement, and reactor monitoring, particularly during and after a seismic event. From a CNSC perspective, these upgrades were necessary to meet modern safety standards. From the start of the upgrades project, the CNSC provided regulatory oversight aimed at ensuring that AECL maintained a structured approach to the upgrades. The elements of the approach include, but are not limited to, the determination of project milestones and target dates; the formalization of the design process and project quality assurance requirements; the requirements for updated documentation, including safety reports, safety notes and commissioning reports; and the approval and authorization process. This paper details, from a regulatory perspective, the structured approach used in approving the design, construction, commissioning and subsequent operation of safety system upgrades for an existing and operating research reactor, including the many challenges faced when attempting to balance the requirements of the upgrades project with AECL's need to keep NRU operating to meet its important research and production objectives. (author)

Radiological air monitoring and sample analysis research and development progress report

International Nuclear Information System (INIS)

1992-01-01

Sponsored by a Department Of Energy (DOE) research and development grant, the State of Idaho INEL Oversight Program (OP) personnel designed an independent air monitoring system that provides detection of the presence of priority airborne contaminants potentially migrating beyond INEL boundaries. Initial locations for off-site ambient air monitoring stations were chosen in consultation with: DOE and NOAA reports; Mesodif modeling; review of the relevant literature; and communication with private contractors and experts in pertinent fields. Idaho State University (ISU) has initiated an Environmental Monitoring Program (EMP). The EMP provides an independent monitoring function as well as a training ground for students. Students learn research techniques dedicated to environmental studies and learn analytical skills and rules of compliance related to monitoring. ISU-EMP assisted OP in specific aspects of identifying optimum permanent monitoring station locations, and in selecting appropriate sample collection equipment for each station. The authorization to establish, prepare and install sampling devices on selected sites was obtained by OP personnel in conjunction with ISU-EMP personnel. All samples described in this program are collected by OP or ISU-EMP personnel and returned to the ISU for analysis. This report represents the summary of results of those samples collected and analyzed for radioactivity during the year of 1992

32 CFR 272.5 - Responsibilities.

Science.gov (United States)

2010-07-01

... Director of Defense Research and Engineering, under the Under Secretary of Defense for Acquisition, Technology, and Logistics (USD(AT&L)), shall: (1) Provide technical leadership and oversight, issue guidance...

Research on Integration of NPP Operational Safety Management Performance Systems

International Nuclear Information System (INIS)

Chi, Miao; Shi, Liping

2014-01-01

The operational safety management of Nuclear Power Plants demands systematic planning and integrated control. NPPs are following the well-developed safety indicator systems proposed by IAEA Operational Safety Performance Indicator Programme, NRC Reactor Oversight Process or the other institutions. Integration of the systems is proposed to benefiting from the advantages of both systems and avoiding improper application into the real world. The authors analyzed the possibility and necessity for system integration, and propose an indicator system integrating method

A National Coordinating Center for Prehospital Trauma Research Funding Transfusion Using Stored Fresh Whole Blood

Science.gov (United States)

2017-09-01

0.18 8% Regulatory oversight and coordination of reviews and reporting from site to NTI and from NTI to MRMC 4 Amy Flores Controller 0.6 5...Price at 2.5%. Monica Phillips worked on this project at 2% for 1.5 months. After 1.5 months of training, her role was filled by Amy Flores who

The Role of Ethics and Auditing in Restoring Public Trust in ...

African Journals Online (AJOL)

The Role of Ethics and Auditing in Restoring Public Trust in Corporate Reporting. ... PROMOTING ACCESS TO AFRICAN RESEARCH ... Inadequate audits, poor corporate governance, lax standards and insufficient regulatory oversight were ...

About the RAS Initiative

Science.gov (United States)

The RAS Initiative, a "hub and spoke" model, connects researchers to better understand and target the more than 30% of cancers driven by mutations in RAS genes. Includes oversight and contact information.

Ethics and mental illness research.

Science.gov (United States)

Roberts, Laura Weiss

2002-09-01

There are many tasks ahead in the area of ethics and mental illness research. We face unknown challenges in psychiatric genetics projects, studies of psychopharmacological interventions in children, controversial scientific designs (e.g., symptom challenge, medication-free interval), and cross-disciplinary research incorporating goals and methods of health services, epidemiology, and social and behavioral science endeavors. Boundaries between innovative clinical practices and research-related experimentation will become increasingly difficult to distinguish, as will the roles between clinicians, clinical researchers, and basic scientists. Moreover, the institutions and systems in which research occurs are being rapidly and radically revised, raising new questions about oversight responsibilities and standards. Our ability to identify and respond to the ethical questions arising in this uncharted territory will depend on our willingness to self-reflect, to integrate the observations and insights of the past century, to think with great clarity, and to anticipate novel ethical problems that keep company with scientific advancements. It will also depend on data. Empirical study of ethical dimensions of human research is essential to anchor and attune the intuitions and theoretical constructs that we develop. Science and ethics have changed over the past 100 years, as they will over the next century. It is ironic that the ethical acceptability of psychiatric research is so much in question at this time, when it holds so much promise for advancing our understanding of mental illness and its treatment. The tension between the duty to protect vulnerable individuals and the duty to perform human science will continue to grow, as long as ethics and science are seen as separable, opposing forces with different aims championed by different heroes. The profession of psychiatry is poised to move toward a new, more coherent research ethics paradigm in which scientific and

Regulation and construction of nuclear powerplants: South Texas Nuclear Project. Hearing before the Subcommittee on Oversight and Investigations of the Committee on Interstate and Foreign Commerce, House of Representatives, Ninety-sixth Congress, Second Session

International Nuclear Information System (INIS)

Anon.

1981-01-01

On September 23, 1980, the Subcommittee of Oversight and Investigation held a congressional hearing to discuss the regulation and construction of the South Texas Nuclear Power Plant project. Discussion included recommendations to prevent problems, like the problem encountered at Three Mile Island, from occurring during construction and operation. The chairman of the Nuclear Regulatory Commission discussed the procedure for inspection and regulation process. One power plant at the South Texas project experienced significant problems because of an inadequate quality assurance and quality control program. These difficulties caused delay in construction, increased cost, and raised questions of safety. The problems encountered at Three Mile Island and at the first plant of the South Texas project provided the reasons for this congressional hearing

The Regulatory Approach for the Assessment of Safety Culture in Germany: A Tool for Practical Use for Inspections

International Nuclear Information System (INIS)

Fassmann, W.; Beck, J.; Kopisch, C.

2016-01-01

Need for methods to assess licencees’ safety culture has been recognised since the Chernobyl accident. Several conferences organized by IAEA and OECD-NEA stated the need for regulatory oversight of safety culture and for suitable methods. In 2013, IAEA published a Technical Document (TECDOC 1707) on the process of safety culture oversight by regulatory authorities which leaves much room for regulators’ ways of performing safety culture oversight. In response to these developments, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) as the federal regulatory body commissioned GRS in 2011 to develop a practical guidance for assessing licencees’ safety culture in the process of regulatory oversight. This research and development project was completed just recently. The publicly available documentation comprises a shorter guidance document with the indispensable information for an appropriate, practical application and a report with more detailed information about the scientific basis of this guidance. To achieve best possible adaptation to regulators’ needs, GRS asked members of the regulatory authority of Baden-Wuerttemberg (one of the federal states of Germany) for comments on a draft of the guidance which was then finalised by duly considering this highly valuable and favorable feedback. Decisions regarding future use rest with German regulatory authorities.

Building a Bright Future. The Hydro Research Foundation's Fellowship Program

Energy Technology Data Exchange (ETDEWEB)

Vaughn, Brenna [Hydro Research Foundation, Inc., Evergreen, CO (United States); Linke, Deborah M. [Hydro Research Foundation, Inc., Evergreen, CO (United States)

2015-12-29

The Hydro Fellowship Program (program) began as an experiment to discover whether the hydropower industry could find mechanisms to attract new entrants through conducting relevant research to benefit the industry. This nationwide, new-to-the-world program was started through funding from the Wind and Water Power Technologies Office of the Energy Efficiency and Renewable Energy (EERE) Office of the Department of Energy (DOE). Between 2010-2015, the Hydro Research Foundation (HRF) designed and implemented a program to conduct valuable research and attract new entrants to the hydro workforce. This historic grant has empowered and engaged industry members from 25 organizations by working with 91 students and advisors at 24 universities in 19 states. The work funded answered pressing research needs in the fields of civil, mechanical, environmental, and electrical engineering, as well as law, energy engineering and materials innovation. In terms of number of individuals touched through funding, 148 individuals were supported by this work through direct research, mentorship, oversight of the work, partnerships and the day-to-day program administration. Based on the program results, it is clear that the funding achieved the hoped-for outcomes and has the capacity to draw universities into the orbit of hydropower and continue the conversation about industry research and development needs. The Foundation has fostered unique partnerships at the host universities and has continued to thrive with the support of the universities, advisors, industry and the DOE. The Foundation has demonstrated industry support through mentorships, partnerships, underwriting the costs and articulating the universities’ support through in-kind cost sharing. The Foundation recommends that future work be continued to nurture these graduate level programs using the initial work and improvements in the successor program, the Research Awards Program, while stimulating engagement of academia at the

Adult Attitudes Toward the Military: Poll Three

Science.gov (United States)

2002-07-01

develop research-based communications strategies and recommendations for each market . The Defense Manpower Data Center (DMDC) was responsible for this...regarding post-high school options, and research-based message strategies that would resonate with each market ; and (2) quantitative research – short... advertising program– market research, creative approaches, media tactics, contract management and program oversight. The consultants recommended that the

Gaps in monitoring systems for Implanon NXT services in South Africa

African Journals Online (AJOL)

signal weaknesses in monitoring systems in the family planning ... 2 Women's Health Research Unit, School of Public Health and Family Medicine, ..... HR: senior author, providing oversight and review. Funding. Funding was received from the ...

Overseeing oversight: governance of quality and safety by hospital boards in the English NHS.

Science.gov (United States)

Mannion, Russell; Davies, Huw; Freeman, Tim; Millar, Ross; Jacobs, Rowena; Kasteridis, Panos

2015-01-01

To contribute towards an understanding of hospital board composition and to explore board oversight of patient safety and health care quality in the English NHS. We reviewed the theory related to hospital board governance and undertook two national surveys about board management in NHS acute and specialist hospital trusts in England. The first survey was issued to 150 trusts in 2011/2012 and was completed online via a dedicated web tool. A total 145 replies were received (97% response rate). The second online survey was undertaken in 2012/2013 and targeted individual board members, using a previously validated standard instrument on board members' attitudes and competencies (the Board Self-Assessment Questionnaire). A total of 334 responses were received from 165 executive and 169 non-executive board members, providing at least one response from 95 of the 144 NHS trusts then in existence (66% response rate). Over 90% of the English NHS trust boards had 10-15 members. We found no significant difference in board size between trusts of different types (e.g. Foundation Trusts versus non-Foundation Trusts and Teaching Hospital Trusts versus non-Teaching Hospital Trusts). Clinical representation on boards was limited: around 62% had three or fewer members with clinical backgrounds. For about two-thirds of the trusts (63%), board members with a clinical background comprised less than 30% of the members. Boards were using a wide range and mix of quantitative performance metrics and soft intelligence (e.g. walk-arounds, patient stories) to monitor their organisations with regard to patient safety. The Board Self-Assessment Questionnaire data showed generally high or very high levels of agreement with desirable statements of practice in each of its six dimensions. Aggregate levels of agreement within each dimension ranged from 73% (for the dimension addressing interpersonal issues) to 85% (on the political). English NHS boards largely hold a wide range of attitudes and

Historical Perspectives: A Review and Evaluation of 76 Studies of the Defense Research Enterprise, 1945-2015

Science.gov (United States)

2016-08-01

support and contractor oversight. Recommendations Administration / Organizational Structure  SECDEF and CJCS should initiate high -level “Packard...relevant historical detail, and prominent policy tensions are emphasized. Views expressed in summaries and evaluations represent only those of the...capabilities; 2) Supporting the DoD Smart Buyer mission throughout the acquisition lifecycle (i.e. “the ability to collaborate with contractors and assess

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…

Symptoms and Treatment of Depression

Medline Plus

Full Text Available ... Research Areas Principal Investigators Administrative Oversight & Support Collaborations & Partnerships Join A Study News & Events News & Events Home Science News Meetings and Events Multimedia Social Media Press Resources Newsletters NIMH News Feeds About Us ...

Development of the Young Brain

Medline Plus

Full Text Available ... Research Areas Principal Investigators Administrative Oversight & Support Collaborations & Partnerships Join A Study News & Events News & Events Home Science News Meetings and Events Multimedia Social Media Press Resources Newsletters NIMH News Feeds About Us ...

Informed consent in paediatric critical care research--a South African perspective.

Science.gov (United States)

Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

2015-09-09

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both

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

Automation in an addiction treatment research clinic: computerised contingency management, ecological momentary assessment and a protocol workflow system.

Science.gov (United States)

Vahabzadeh, Massoud; Lin, Jia-Ling; Mezghanni, Mustapha; Epstein, David H; Preston, Kenzie L

2009-01-01

A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients' treatment needs and to accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with the provision of seamless methods for exporting, mining and querying the data. We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialised applications: the Automated Contingency Management (ACM) system for the delivery of behavioural interventions, the transactional electronic diary (TED) system for the management of behavioural assessments and the Protocol Workflow System (PWS) for computerised workflow automation and guidance of each participant's daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorised staff. ACM and the TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80 patient capacity, having an annual average of 18,000 patient visits and 7300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarise participant safety data for research oversight. When developed in consultation with end users, automation in treatment research clinics can enable more efficient operations, better communication among staff and expansions in research methods.

Development of the Young Brain

Medline Plus

Full Text Available ... NIMH Home Research Areas Principal Investigators Administrative Oversight & Support Collaborations & Partnerships Join A Study News & Events News & Events Home Science News Meetings and Events Multimedia Social Media Press Resources Newsletters NIMH News Feeds About ...

Symptoms and Treatment of Depression

Medline Plus

Full Text Available ... NIMH Home Research Areas Principal Investigators Administrative Oversight & Support Collaborations & Partnerships Join A Study News & Events News & Events Home Science News Meetings and Events Multimedia Social Media Press Resources Newsletters NIMH News Feeds About ...

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- ...

Investing today in energy for tomorrow. U.S. civilian nuclear industry: high-level oversight. Oil prices: getting close to the psychological threshold. The future of biofuels in question

International Nuclear Information System (INIS)

Anon.

2008-01-01

This issue of Alternatives newsletter features 4 main articles dealing with: 1 - Investing today in energy for tomorrow: Whether to increase or to replace generating capacity, the amount of investment needed in energy infrastructure to meet rising demand has been identified, but many obstacles must be overcome before they become a reality. A status report and personal perspective from Pierre Gadonneix, CEO of EDF, in the 'Expert opinion' section. 2 - U.S. civilian nuclear industry - high-level oversight: The approaches are clearly different, but the licensing processes for nuclear reactor development and operation in France and the United States are both strictly regulated. Alternatives delves further. 3 - Oil prices - getting close to the psychological threshold: Are we going to stop using oil sooner rather than later if crude prices keep going up? European commodities expert Philippe Chalmin shares his opinion. 4 - The future of biofuels in question In many countries, biofuels are seen as an alternative to oil. Still, farmland is not expandable forever and the economics of biofuels deserve some scrutiny

Researchers', Regulators', and Sponsors' Views on Pediatric Clinical Trials: A Multinational Study.

Science.gov (United States)

Joseph, Pathma D; Craig, Jonathan C; Tong, Allison; Caldwell, Patrina H Y

2016-10-01

The last decade has seen dramatic changes in the regulatory landscape to support more trials involving children, but child-specific challenges and inequitable conduct across income regions persist. The goal of this study was to describe the attitudes and opinions of stakeholders toward trials in children, to inform additional strategies to promote more high-quality, relevant pediatric trials across the globe. Key informant semi-structured interviews were conducted with stakeholders (researchers, regulators, and sponsors) who were purposively sampled from low- to middle-income countries and high-income countries. The transcripts were thematically analyzed. Thirty-five stakeholders from 10 countries were interviewed. Five major themes were identified: addressing pervasive inequities (paucity of safety and efficacy data, knowledge disparities, volatile environment, double standards, contextual relevance, market-driven forces, industry sponsorship bias and prohibitive costs); contending with infrastructural barriers (resource constraints, dearth of pediatric trial expertise, and logistical complexities); navigating complex ethical and regulatory frameworks ("draconian" oversight, ambiguous requirements, exploitation, excessive paternalism and precariousness of coercion versus volunteerism); respecting uniqueness of children (pediatric research paradigms, child-appropriate approaches, and family-centered empowerment); and driving evidence-based child health (advocacy, opportunities, treatment access, best practices, and research prioritization). Stakeholders acknowledge that changes in the regulatory environment have encouraged more trials in children, but they contend that inequities and political, regulatory, and resource barriers continue to exist. Embedding trials as part of routine clinical care, addressing the unique needs of children, and streamlining regulatory approvals were suggested. Stakeholders recommended increasing international collaboration

Amie Sluiter | NREL

Science.gov (United States)

dollar, cross-laboratory U.S. Department of Energy research projects. Excellent technical writing skills managing personnel and technical oversight. She is highly organized, with a technical background that lends itself to project participation and technical monitoring. Biofuels Sample Characterization Amie began

Group conflict and faculty engagement

DEFF Research Database (Denmark)

Selmer, Jan; Jonasson, Charlotte; Lauring, Jakob

2013-01-01

In educational settings, substantial scholarly interest has focused on student engagement as an antecedent for educational development and positive school outcomes. Very limited research, however, has focused on the engagement of academic staff members. This may be a crucial oversight because...

The Alaska Area Specimen Bank: a tribal-federal partnership to maintain and manage a resource for health research.

Science.gov (United States)

Parkinson, Alan J; Hennessy, Thomas; Bulkow, Lisa; Smith, H Sally

2013-01-01

Banked biospecimens from a defined population are a valuable resource that can be used to assess early markers for illness or to determine the prevalence of a disease to aid the development of intervention strategies to reduce morbidity and mortality. The Alaska Area Specimen Bank (AASB) currently contains 266,353 residual biologic specimens (serum, plasma, whole blood, tissue, bacterial cultures) from 83,841 persons who participated in research studies, public health investigations and clinical testing conducted by the U.S. Public Health Service and Alaska Native tribal health organisations dating back to 1961. The majority (95.7%) are serum specimens, 77% were collected between 1981 and 1994 and 85% were collected from Alaska Native people. Oversight of the specimen bank is provided by a working group with representation from tribal, state and federal health organisations, the Alaska Area IRB and a specimen bank committee which ensures the specimens are used in accordance with policies and procedures developed by the working group.

A tale of two perspectives: regulation versus self-regulation. A financial reporting approach (from Sarbanes-Oxley) for research ethics.

Science.gov (United States)

Richman, Vincent; Richman, Alex

2012-06-01

National Institutes of Health funding, adopting these research oversight enhancements first.

49 CFR 633.11 - Covered projects.

Science.gov (United States)

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Covered projects. 633.11 Section 633.11..., DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.11 Covered projects. The Administrator may contract for project management oversight services when the...

Automation in an Addiction Treatment Research Clinic: Computerized Contingency Management, Ecological Momentary Assessment, and a Protocol Workflow System

Science.gov (United States)

Vahabzadeh, Massoud; Lin, Jia-Ling; Mezghanni, Mustapha; Epstein, David H.; Preston, Kenzie L.

2009-01-01

Issues A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients’ treatment needs and accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with provision of seamless methods for exporting, mining, and querying the data. Approach We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialized applications: the Automated Contingency Management (ACM) system for delivery of behavioral interventions, the Transactional Electronic Diary (TED) system for management of behavioral assessments, and the Protocol Workflow System (PWS) for computerized workflow automation and guidance of each participant’s daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorized staff. Key Findings ACM and TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80-patient capacity having an annual average of 18,000 patient-visits and 7,300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarize participant-safety data for research oversight. Implications and conclusion When developed in consultation with end users, automation in treatment-research clinics can enable more efficient operations, better communication among staff, and expansions in research methods. PMID:19320669

Animal models in genomic research: Techniques, applications, and roles for nurses.

Science.gov (United States)

Osier, Nicole D; Pham, Lan; Savarese, Amanda; Sayles, Kendra; Alexander, Sheila A

2016-11-01

Animal research has been conducted by scientists for over two millennia resulting in a better understanding of human anatomy, physiology, and pathology, as well as testing of novel therapies. In the molecular genomic era, pre-clinical models represent a key tool for understanding the genomic underpinnings of health and disease and are relevant to precision medicine initiatives. Nurses contribute to improved health by collecting and translating evidence from clinically relevant pre-clinical models. Using animal models, nurses can ask questions that would not be feasible or ethical to address in humans, and establish the safety and efficacy of interventions before translating them to clinical trials. Two advantages of using pre-clinical models are reduced variability between test subjects and the opportunity for precisely controlled experimental exposures. Standardized care controls the effects of diet and environment, while the availability of inbred strains significantly reduces the confounding effects of genetic differences. Outside the laboratory, nurses can contribute to the approval and oversight of animal studies, as well as translation to clinical trials and, ultimately, patient care. This review is intended as a primer on the use of animal models to advance nursing science; specifically, the paper discusses the utility of preclinical models for studying the pathophysiologic and genomic contributors to health and disease, testing interventions, and evaluating effects of environmental exposures. Considerations specifically geared to nurse researchers are also introduced, including discussion of how to choose an appropriate model and controls, potential confounders, as well as legal and ethical concerns. Finally, roles for nurse clinicians in pre-clinical research are also highlighted. Copyright © 2016 Elsevier Inc. All rights reserved.

The Academic Mobility of Foreign Students in Russia

Science.gov (United States)

Gromov, A. D.

2017-01-01

This article presents statistics about the cohort of foreign students studying at Russian universities. It will interest researchers and a large number of higher education professionals, including university administrators and employees at state oversight agencies. [This article was translated by Kenneth Cargill.

78 FR 23263 - Administration for Children and Families

Science.gov (United States)

2013-04-18

... qualitative information through interviews with program staff, oversight boards, key stakeholders and parents... survey, site visits, and qualitative interviews include: a description of school readiness goals set by... and Head Start Program Functioning'' research project. The purpose of this study is to improve...

75 FR 48276 - Defense Federal Acquisition Regulation Supplement; Management of Unpriced Change Orders

Science.gov (United States)

2010-08-10

... to make requirements for DoD management and oversight of unpriced change orders consistent with those... management and oversight of undefinitized contract actions (UCAs). In the current DFARS, unpriced change... procedures. The rule makes requirements for DoD management and oversight of unpriced change orders consistent...

Preserving Records, Knowledge and Memory over Decades lessons from the NEA RK and M Project

International Nuclear Information System (INIS)

Pescatore, Claudio

2014-01-01

The RK and M Project 'Preservation of records, knowledge and memory across generations' is tasked with assembling evidence, information and carrying out research that will help the member organizations identify and implement a strategic plan for providing useful information to future generations concerning the disposal of radioactive waste in geological formations. The recent ICRP guidance [1] is adamant on maintaining oversight of these facilities for as long as practicable, even after closure. One should not plan the end of oversight, but only plan against the potential loss of oversight. One of the means to maintain oversight is to maintain records, knowledge and memory. In the case of long term storage, preservation of records, knowledge and memory is a key issue. Depending on the duration of long term storage there is an increasing probability that information relative to long term storage will be lost because of disruptions in society. This may result in a situation where the interim storage becomes a final disposal with inadequate safety features and therefore presents high risks to future generations. As part of its programme of work, the project has been seeking to gain insights on loss, misuse and also on recovery of records and knowledge from other areas than geological disposal. To this effect, a recent study under completion examines past experiences in the field of hazardous waste disposal. The final report should be available in Autumn 2013. This paper presents an overview of that study and its findings. (author)

Regulatory Expectations for Safety Culture

Energy Technology Data Exchange (ETDEWEB)

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

2014-05-15

The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety.

Regulatory Expectations for Safety Culture

International Nuclear Information System (INIS)

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

2014-01-01

The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety

75 FR 32845 - Consultative Examination-Annual Onsite Review of Medical Providers

Science.gov (United States)

2010-06-10

... determinations for us to provide comprehensive oversight management of its CE program with special emphasis on... 416.919. As part of its oversight management of the CE program, each State agency must conduct annual... also expressed concern that increasing the CE threshold amount may create the impression that oversight...

Expanding economic opportunities for women and youth in Africa ...

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

... countries in sub-Saharan Africa, involving national country teams. The country selection will be guided by careful consideration of geographic diversity, data availability, and potential for policy uptake. The University of Cape Town's Development Policy Research Unit (DPRU) will provide a coordination and oversight role.

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...

China Public Budget Reform Program (CPBR) - Phase II | IDRC ...

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

The Government of China has adopted a national reform program aimed at making budgeting more transparent and accountable through public involvement and enhanced oversight. Building on work carried out under Phase I (102965), the China Development Research Foundation (CDRF) will analyze China's current ...

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

Directory of Open Access Journals (Sweden)

Tahmineh Farajkhoda

2017-08-01

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

Consolidation and acceptance of Endesa independent safety supervision system; Consolidacion y aceptacion del sistema de supervision dependiente de la seguridad de Endesa

Energy Technology Data Exchange (ETDEWEB)

O' Doneell, P.; Lequerica, I.

2012-07-01

Creating multiple levels of independent oversight (Nuclear Oversight-NOS) in operating NPPs has consolidated in recent years. Therefore, within the strategic objectives of DGEN, include strengthening independent oversight mechanisms of nuclear power plants operated by ENDESA. Since its inception in early 2009, Endesa nuclear oversight supervision is working to improve its ability to influence, to impact positively in the operation of the plants, the valuation of its directors and the active response of the line to the issues identified in their activities. In this paper we review the enhancements of NOS.

The "demise" of diagnostic and research ocular pathology: temporary or forever?

Science.gov (United States)

Apple, David J; Werner, Liliana; Mamalis, Nick; Olson, Randall J

2003-01-01

Several authorities have documented a significant decrease in support for modern eye pathology/pathology research laboratories. Indeed, many laboratories have closed or suffered marked cutbacks. The purpose of this report is to ask why this is so and to seek a possible means for reversing this trend. Observations from the senior author's experience and a case from author's facility are analyzed. There are several reasons for ocular pathologists' difficulties, such as financial problems, lack of vision, personality conflicts, and problems with the departmental administration. Until recently, most research and development in several subspecialty fields of ophthalmology, including biodevices research, has been done primarily by engineers and in-house workers in industry. This precludes proper independent, nonbiased control and guidance from academia. Most ocular pathologists have not participated in this relatively new and wide-open field. We suggest a new realm of activity for today's newly trained ocular pathologists. Based on personal experience of two decades of fruitful collaboration with industry, we believe that ocular pathologists are uniquely trained to apply their expertise to various new fields of research that most pathologists today have not utilized. An important example is research on clinicopathological aspects of implantable biodevices. In addition, support and oversight should be provided by the major ophthalmic societies, such as the American Academy of Ophthalmology, in order to retain (even regain) control over this field. This is mandatory in order to control the safety and efficacy of new drugs and devices being introduced almost daily. Only then can clear differentiation between profit and patient welfare be achieved as potentially dangerous devices and techniques are let loose on the market. The field of "routine, descriptive" eye pathology is severely wounded and will return only in an attenuated fashion. In general, full-time support for

Regulatory control of nuclear safety in Finland. Annual report 2008

International Nuclear Information System (INIS)

Kainulainen, E.

2009-06-01

facilities is examined using the employees' individual doses, the collective doses, and the results of emission and environmental radiation control. Summaries are also included for the regulation of the storage of spent nuclear fuel and the processing and storage of reactor waste. For the Olkiluoto 3 plant unit currently under construction, the report includes descriptions of the regulation of design, construction, manufacturing, installation and implementation preparations, as well as regulation of the operations of organisations participating in the construction project. The nuclear safety indicator system is used to examine the efficiency and effects of the regulatory activities targeted at nuclear power plants. Appendices to the report include detailed data and conclusions related to the indicators (Appendix 1) and any significant operational events (Appendix 3). The chapter concerning the regulation of the final disposal project for spent nuclear fuel describes the preparations for the final disposal project and the related regulatory activities. In addition, the oversight of the design and construction of the research facilities (Onkalo) under construction in Olkiluoto, as well as the assessment and oversight of the research, development and design work being carried out to further specify the safety case for final disposal are included in the report. 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. Oversight of the nuclear test ban is also covered by the report. In addition to actual safety regulation, the report describes the enforcement of the regulatory oversight of nuclear facilities, regulatory indicators and the development of regulation, as well as safety research, emergency preparedness, communications and STUK's participation in international nuclear safety

Non-Traditional Commercial Defense Contractors

Science.gov (United States)

2013-11-01

on many of these newly developed and produced military programs ushered in a new management and oversight approach, to include the Planning...the DoD is susceptible to the “not-invented-here” syndrome , preferring items developed solely through DoD research, which is a prevalent attitude

Regulating the unknown: Managing the occupational health risks of nanomedical technologies and nanopharmaceuticals in the research laboratory

Science.gov (United States)

Ersin, Ozlem Hacer

Novel technologies and their resultant products demand fresh ways of thinking about pre-market risk analysis and post-market surveillance. A regulatory framework that is responsive to emerging knowledge about the hazards of novel technologies offers repeatable and transparent processes and remains economically and socially feasible. Workers are an especially vulnerable population who are exposed to unknown hazards of novel technologies and serve often as unwitting sentinels of impending risks. This Grounded Theory-based case study identifies gaps in our current ability to regulate novel technologies so as to minimize occupational health risks and offers necessary modifications for an environment that is conducive to proper regulation. Nanopharmaceuticals and the nano-based technologies at their base are used by way of exemplar technologies that are currently taxing the ability of the regulatory system to provide adequate oversight. Ambiguities of definition, absence of a tracking system (of who is doing nanotechnology research), and the paucity of scientific evidence to support risk management efforts are among the findings of the study and need to be addressed as ameliorative steps toward an effective regulatory structure.

The future of yogurt: scientific and regulatory needs1234

Science.gov (United States)

German, J Bruce

2014-01-01

Lactation biology, microbial selection, and human diversity are central themes that could guide investment in scientific research, industrial innovation, and regulatory policy oversight to propel yogurt into the central role for health-promoting food products. The ability of yogurt to provide the nourishing properties of milk together with the live microorganisms from fermentation provides a unique combination of food assets. Academic research must now define the various targets on which these biological assets act to improve health and develop the metrics that can quantitatively document their benefits. The food industry must reconcile that yogurt and its microorganisms cannot be expected to provide measurable benefits for all consumers, at all doses, and at all times. A supportive regulatory oversight must demand safety and yet encourage innovations that support a value proposition for yogurt in health. Health valuation in the marketplace will be driven by parallel innovations, including accurate assessment technologies, validated microbial ingredients, and health-aware consumers. PMID:24695899

The future of yogurt: scientific and regulatory needs.

Science.gov (United States)

German, J Bruce

2014-05-01

Lactation biology, microbial selection, and human diversity are central themes that could guide investment in scientific research, industrial innovation, and regulatory policy oversight to propel yogurt into the central role for health-promoting food products. The ability of yogurt to provide the nourishing properties of milk together with the live microorganisms from fermentation provides a unique combination of food assets. Academic research must now define the various targets on which these biological assets act to improve health and develop the metrics that can quantitatively document their benefits. The food industry must reconcile that yogurt and its microorganisms cannot be expected to provide measurable benefits for all consumers, at all doses, and at all times. A supportive regulatory oversight must demand safety and yet encourage innovations that support a value proposition for yogurt in health. Health valuation in the marketplace will be driven by parallel innovations, including accurate assessment technologies, validated microbial ingredients, and health-aware consumers.

Private security and military contractors: A troubling oversight

DEFF Research Database (Denmark)

Swed, Ori; Crosbie, Thomas Alexander

2017-01-01

Though private military and security companies (PMSCs) have been addressed extensively in the literature, little research has been done on the contractors themselves, leaving us in the dark as to who these individuals are. In this article, we focus on the critical case of the United States armed...... and concomitant evolution of the security sector, while noting a new trend that points to the need for moving from the macrosocial to the microsocial level of inquiry. Second, we indicate the challenges contractors pose to the sociological paradigm of military professionalism: These suggest a need to move from...

Report of ICRP Task Group 80: 'radiological protection in geological disposal of long-lived solid radioactive waste'.

Science.gov (United States)

Weiss, W

2012-01-01

The report of International Commission on Radiological Protection (ICRP) Task Group 80 entitled 'Radiological protection in geological disposal of long-lived solid radioactive waste' updates and consolidates previous ICRP recommendations related to solid waste disposal (ICRP Publications 46, 77, and 81). The recommendations given in this report apply specifically to geological disposal of long-lived solid radioactive waste. The report explains how the 2007 system of radiological protection, described in ICRP Publication 103, can be applied in the context of the geological disposal of long-lived solid radioactive waste. The report is written as a self-standing document. It describes the different stages in the lifetime of a geological disposal facility, and addresses the application of relevant radiological protection principles for each stage depending on the various exposure situations that can be encountered. In particular, the crucial factor that influences application of the protection system over the different phases in the lifetime of a disposal facility is the level of oversight that is present. The level of oversight affects the capability to reduce or avoid exposures. Three main time frames have to be considered for the purpose of radiological protection: time of direct oversight when the disposal facility is being implemented and active oversight is taking place; time of indirect oversight when the disposal facility is sealed and indirect oversight is being exercised to provide additional assurance on behalf of the population; and time of no oversight when oversight is no longer exercised because memory is lost. Copyright © 2012. Published by Elsevier Ltd.

Passing Notes: Learning from Efforts to Share Instructional Practices across District-Charter Lines

Science.gov (United States)

Maas, Tricia; Lake, Robin

2018-01-01

Through research and policy analysis, the Center on Reinventing Public Education (CRPE) seeks ways to make public education more effective, especially for America's disadvantaged students. CRPE helps redesign governance, oversight, and dynamic education delivery systems to make it possible for great educators to do their best work with students…

76 FR 68126 - Solicitation of Input From Stakeholders Regarding the Veterinary Medicine Loan Repayment Program...

Science.gov (United States)

2011-11-03

...: Paper, disk or CD-ROM submissions should be submitted to VMLRP, Policy and Oversight Division, National... a veterinarian's student loan debt per year if the veterinarian commits to at least three years to... passed into law adding section 1415A to the National Agricultural Research, Extension, and Teaching...

Procedure for hazards analysis of plutonium gloveboxes used in analytical chemistry operations

International Nuclear Information System (INIS)

Delvin, W.L.

1977-06-01

A procedure is presented to identify and assess hazards associated with gloveboxes used for analytical chemistry operations involving plutonium. This procedure is based upon analytic tree methodology and it has been adapted from the US Energy Research and Development Administration's safety program, the Management Oversight and Risk Tree

Communication of 7 August 2007 from the Permanent Mission of Pakistan to the IAEA concerning the establishment of the oversight Board to monitor the implementation of Pakistan's export control on goods, technologies, materials and equipment related to nuclear and biological weapons and their Delivery Systems Act (Act No.V) 2004

International Nuclear Information System (INIS)

2007-01-01

The Secretariat has received a Note Verbale dated 7 August 2007 from the Permanent Mission of Pakistan enclosing a copy of the Gazette of Pakistan S.R.O. No.693(I)/2007, dated 11 July 2007, regarding the establishment of the Oversight Board to monitor the implementation of Pakistan's Export Control on Goods, Technologies, Materials and Equipment related to Nuclear and Biological Weapons and their Delivery Systems Act (Act No.V) 2004, including the formation and functioning of Strategic Export Control Division. As requested in the Note Verbale, the Note Verbale and the enclosure thereto are circulated for the information of Member States

Oversight of High-Containment Biological Laboratories: Issues for Congress

Science.gov (United States)

2009-05-04

Laboratories: Issues for Congress Congressional Research Service 14 Industry and Non-Profit Laboratories Private sector companies and non-profit...resources for these endeavors. Whether public or private sector , high-containment laboratories are planned and designed to minimize the possibility of... equine encephalitis, and yellow fever. Some of the pathogens that cause these diseases have been considered as biological weapons.104 Expanding the number

Project Experiences in Research Reactor Ageing Management, Modernization and Refurbishment. Report of a Technical Meeting on Research Reactor Ageing Management, Modernization and Refurbishment

International Nuclear Information System (INIS)

2014-08-01

performance, or provide new products and services to existing or potential users and customers, as well as share information on the technical details of the work involved, will allow other organizations contemplating similar work to consider and better understand their own challenges. Such understanding can help to optimize future planning in terms of budget, schedule and resource expectations, and to enable informed decision making. The IAEA is working to systematically collect existing knowledge on research reactor ageing management, modernization and refurbishment to share within the community of reactor owners, operators and oversight authorities. To this end, experts from the research reactor community gathered at IAEA headquarters from 10–14 October 2011 for the Technical Meeting on Research Reactor Ageing, Modernization and Refurbishment. The outcomes of the meeting and the submissions of the participants are documented in this publication

Project Experiences in Research Reactor Ageing Management, Modernization and Refurbishment. Report of a Technical Meeting on Research Reactor Ageing Management, Modernization and Refurbishment

Energy Technology Data Exchange (ETDEWEB)

NONE

2014-08-15

performance, or provide new products and services to existing or potential users and customers, as well as share information on the technical details of the work involved, will allow other organizations contemplating similar work to consider and better understand their own challenges. Such understanding can help to optimize future planning in terms of budget, schedule and resource expectations, and to enable informed decision making. The IAEA is working to systematically collect existing knowledge on research reactor ageing management, modernization and refurbishment to share within the community of reactor owners, operators and oversight authorities. To this end, experts from the research reactor community gathered at IAEA headquarters from 10–14 October 2011 for the Technical Meeting on Research Reactor Ageing, Modernization and Refurbishment. The outcomes of the meeting and the submissions of the participants are documented in this publication.

Dispositions of Elite-Level Australian Rugby Coaches towards Game Sense: Characteristics of Their Coaching Habitus

Science.gov (United States)

Light, Richard L.; Evans, John Robert

2013-01-01

Bourdieu's analytic concept of "habitus" has provided a valuable means of theorising coach development but is yet to be operationalised in empirical research. This article redresses this oversight by drawing on a larger study that inquired into how the "coaching 'habitus'" of elite-level Australian and New Zealand rugby coaches…

Public health genomics and genetic test evaluation: the challenge of conducting behavioural research on the utility of lifestyle-genetic tests.

Science.gov (United States)

Sanderson, Saskia C; Wardle, Jane; Humphries, Steve E

2008-01-01

Human genetics research is increasingly concerned with multifactorial conditions such as diabetes and heart disease, which are influenced not only by genetic but also lifestyle factors such as diet and smoking. Although the results of 'lifestyle-genetic' tests using this information could conceivably motivate lifestyle changes in the future, companies are already selling such tests and related lifestyle advice commercially. Some academics and lobby groups have condemned the companies for selling these tests in advance of scientific support. Others are concerned that the tests may not motivate lifestyle improvements, instead causing distress in people receiving adverse test results and complacency in those receiving reassuring results. There is currently no regulatory oversight of genetic test utility, despite consensus in the Public Health Genomics community that clinical utility (including psychological and behavioural impact) of all emerging genetic tests should be evaluated before being introduced for individual use. Clearly, empirical data in this area is much needed, to inform understanding of the potential utility of these tests, and of whether stricter regulation of commercial exploitation is needed. In this article, we review the current situation regarding lifestyle-genetic tests, and discuss the challenges inherent in conducting this kind of behavioural research in the genomics era. Copyright 2008 S. Karger AG, Basel.

Training the Next Generation in Space Situational Awareness Research

Science.gov (United States)

Colpo, D.; Reddy, V.; Arora, S.; Tucker, S.; Jeffries, L.; May, D.; Bronson, R.; Hunten, E.

Traditional academic SSA research has relied on commercial off the shelf (COTS) systems for collecting metric and lightcurve data. COTS systems have several advantages over a custom built system including cost, easy integration, technical support and short deployment timescales. We at the University of Arizona took an alternative approach to develop a sensor system for space object characterization. Five engineering students designed and built two 0.6-meter F/4 electro-optical (EO) systems for collecting lightcurve and spectral data. All the design and fabrication work was carried out over the course of two semesters as part f their senior design project that is mandatory for the completion of their bachelors in engineering degree. The students designed over 200 individual parts using three-dimensional modeling software (SolidWorks), and conducted detailed optical design analysis using raytracing software (ZEMAX), with oversight and advice from faculty sponsor and Starizona, a local small business in Tucson. The components of the design were verified by test, analysis, inspection, or demonstration, per the process that the University of Arizona requires for each of its design projects. Methods to complete this project include mechanical FEA, optical testing methods (Foucault Knife Edge Test and Couder Mask Test), tests to verify the function of the thermometers, and a final pointing model test. A surprise outcome of our exercise is that the entire cost of the design and fabrication of these two EO systems was significantly lower than a COTS alternative. With careful planning and coordination we were also able to reduce to the deployment times to those for a commercial system. Our experience shows that development of hardware and software for SSA research could be accomplished in an academic environment that would enable the training of the next generation with active support from local small businesses.

NSB organizational changes

Science.gov (United States)

To increase its involvement in National Science Foundation (NSF) policy and program oversight, the National Science Board (NSB), which is the NSF governing body, has instituted a number of changes in its committee structure and operations.One reason for the changes, according to Roland Schmitt, senior vice president for corporate research and development at the General Electric Company and chairman of NSB, is to move away from approval of NSF awards as the primary mechanism for NSB oversight of NSF programs. By law, NSB must approve awards that are above a certain dollar value. Most awards above that limit come from only a few NSF programs. The new changes will allow NSB to review programs and projects throughout NSF earlier in the review process and to affect major program decisions when they are being made.

75 FR 47444 - Amendments to the Informal and Other Procedures, Rules of Organization and Program Management...

Science.gov (United States)

2010-08-06

... Practice; Interim Commission Review of Public Company Accounting Oversight Board Inspection Reports and... facilitate interim Commission review of Public Company Accounting Oversight Board [[Page 47445

Buscando Trabajo: Social Networking among Immigrants from Mexico to the United States

Science.gov (United States)

Garcia, Carlos

2005-01-01

The growth of the Latino population in the United States has placed a sharp focus on immigration. Previous research on immigration has taken for granted the existence of immigrant networks. This is a significant oversight given their importance in both conveying social capital and their contribution to the growth of immigrant communities. Using…

Research and experience report 2008. Developments in the technical and legal basis of nuclear oversight; Erfahrungs- und Forschungsbericht 2008. Entwicklungen im Bereich der Grundlagen der nuklearen Aufsicht

Energy Technology Data Exchange (ETDEWEB)

NONE

2009-04-15

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

Assessing the implementation and influence of policies that support research and innovation systems for health: the cases of Mozambique, Senegal, and Tanzania.

Science.gov (United States)

Mugwagwa, Julius; Edwards, Daniel; de Haan, Sylvia

2015-04-18

Without good policies it will be difficult to provide guidance to research and innovation systems. However, policies need to be followed through and implemented to have the desired effect. We studied the policies and strategies in place to support research and innovation systems for health in Mozambique, Senegal, and Tanzania, and looked at the extent to which these policies and strategies have been implemented. We reviewed documents and reports and conducted in-depth interviews with 16 key informants representing various actors of the national research for health systems. The results illustrate that there are various policies and strategies governing research and innovation for health in the three countries. However, implementation of these policies and strategies is generally rated as being poor. The reasons highlighted for this include lack of policy coherence, lack of enforcement and accountability mechanisms, and a lack of financing for implementing the policies. These contextual factors seem to be of such importance that even the increased stakeholder involvement and political leadership, as mentioned by the interviewees, cannot guarantee policy implementation. We conclude that due to the contextual realities of the study countries, there is need for greater focus on policy implementation than on developing additional policies. Government institutions should play a central role in all stages of the policy process, and should ensure implementation of defined policies. Strong mechanisms, including financing, that strengthen the position and role of government in policy coordination and the oversight of the policy process will help increase efficient and impactful implementation of research and innovation for health policies.

Comparative Approaches to Biobanks and Privacy.

Science.gov (United States)

Rothstein, Mark A; Knoppers, Bartha Maria; Harrell, Heather L

2016-03-01

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws. © 2016 American Society of Law, Medicine & Ethics.

Perceptions that influence the maintenance of scientific integrity in community-based participatory research.

Science.gov (United States)

Kraemer Diaz, Anne E; Spears Johnson, Chaya R; Arcury, Thomas A

2015-06-01

Scientific integrity is necessary for strong science; yet many variables can influence scientific integrity. In traditional research, some common threats are the pressure to publish, competition for funds, and career advancement. Community-based participatory research (CBPR) provides a different context for scientific integrity with additional and unique concerns. Understanding the perceptions that promote or discourage scientific integrity in CBPR as identified by professional and community investigators is essential to promoting the value of CBPR. This analysis explores the perceptions that facilitate scientific integrity in CBPR as well as the barriers among a sample of 74 professional and community CBPR investigators from 25 CBPR projects in nine states in the southeastern United States in 2012. There were variations in perceptions associated with team member identity as professional or community investigators. Perceptions identified to promote and discourage scientific integrity in CBPR by professional and community investigators were external pressures, community participation, funding, quality control and supervision, communication, training, and character and trust. Some perceptions such as communication and training promoted scientific integrity whereas other perceptions, such as a lack of funds and lack of trust could discourage scientific integrity. These results demonstrate that one of the most important perceptions in maintaining scientific integrity in CBPR is active community participation, which enables a co-responsibility by scientists and community members to provide oversight for scientific integrity. Credible CBPR science is crucial to empower the vulnerable communities to be heard by those in positions of power and policy making. © 2015 Society for Public Health Education.

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...

Market Oversight Games

NARCIS (Netherlands)

Schinkel, Maarten Pieter

2011-01-01

Big business plays cat & mouse with market regulators. Market participants try to avoid the competitive pressures that the regulators are working to keep up. Only if the latter play these games at least as cleverly as the former can we reap all the fruits of competition. A case in point is the

Market oversight games

NARCIS (Netherlands)

Schinkel, M.P.

2010-01-01

Big business plays cat & mouse with market regulators. Market participants try to avoid the competitive pressures that the regulators are working to keep up. Only if the latter play these games at least as cleverly as the former can we reap all the fruits of competition. A case in point is the

Evaluation of the Finnish nuclear safety research program 'SAFIR2010'

International Nuclear Information System (INIS)

2010-01-01

A panel of three members has been asked by the Ministry of Employment and the Economy (MEE) to evaluate SAFIR2010, the Finnish research program on nuclear power plant safety. The program was established for the period 2007-2010 to help maintain expertise in nuclear safety, to integrate young people into the research in order to help assure the future availability of expertise, and to support international collaborations. The program is directed by a Steering Group, appointed by MEE, with representatives from all organizations involved with nuclear safety in Finland. SAFIR2010 has consisted of approximately 30 projects from year to year that fall into eight subject areas: 1. Organization and human factors 2. Automation and control room 3. Fuel and reactor physics 4. Thermal hydraulics 5. Severe accidents 6. Structural safety of reactor circuit 7. Construction safety 8. Probabilistic safety analysis (PSA) For each of these areas there are Reference Groups that provide oversight of the projects within their jurisdiction. The panel carried out its evaluation by reviewing copies of relevant documents and, during a one-week period 17-22 January 2010, meeting with key individuals. The results of the panel are provided as general conclusions, responses to questions posed by MEE, challenges and recommendations and comments on specific projects in each subject area. The general conclusions reflect the panel's view that SAFIR2010 is meeting its objectives and carrying out quality research. The questions addressed are: (a.) Are the achieved results in balance with the funding? Are the results exploited efficiently in practice? (b.) How well does the expertise cover the field? Is the entire SAFIR2010 programme balanced to all different fields in nuclear safety? Does it raise efficiently new experts? (c.) Have the 2006 evaluation results been implemented successfully into SAFIR2010 program? (d.) Challenges and recommendations. In general the panel was very positive about SAFIR

Blurring Boundaries in Education: Context and Impact of MOOCs

Science.gov (United States)

Loeckx, Johan

2016-01-01

The opinions on MOOCs go to extremes, covering a wide variety of topics, affecting economy, pedagogy, and computer science which makes it hard to keep oversight. Despite the many excellent research reports and articles, an overview of the bigger picture, providing a holistic qualitative summary of the different opinions, is still very welcome.…

Nature, Nurture, and Attention Deficit Hyperactivity Disorder.

Science.gov (United States)

Faraone, Stephen V.; Biederman, Joseph

2000-01-01

Comments on Joseph's review of the genetics of attention deficit disorder, demonstrating errors of scientific logic and oversight of relevant research in Joseph's argument. Argues for the validity of twin studies in supporting a genetic link for ADHD and for the complementary role of nature and nurture in the etiology of the disorder. (JPB)

VA Health Care: Processes to Evaluate, Implement, and Monitor Organizational Structure Changes Needed

Science.gov (United States)

2016-09-01

their families , such as medallions and markers for headstones that signify veterans’ service. Page 3 GAO-16-803 VHA Organizational ... Research Oversight, and Chief Nursing Page 8 GAO-16-803 VHA Organizational Structure Officer. Also, the Chief Financial Officer and...VA HEALTH CARE Processes to Evaluate, Implement, and Monitor Organizational Structure Changes Needed Report to

Impact of observing hand hygiene in practice and research: a methodological reconsideration.

Science.gov (United States)

Gould, D J; Creedon, S; Jeanes, A; Drey, N S; Chudleigh, J; Moralejo, D

2017-02-01

The purpose of hand hygiene is to break the chain of healthcare-associated infection. In many countries hand hygiene is regularly audited as part of quality assurance based on recommendations from the World Health Organization. Direct observation is the recommended audit method but is associated with disadvantages, including potential for being observed to alter usual behaviour. The Hawthorne effect in relation to hand hygiene is analogous with productivity improvement by increasing the frequency with which hand hygiene is undertaken. Unobtrusive and/or frequent observation to accustom staff to the presence of observers is considered an acceptable way of reducing the Hawthorne effect, but few publications have discussed how to implement these techniques or examine their effectiveness. There is evidence that awareness of being watched can disrupt the usual behaviour of individuals in complex and unpredictable ways other than simple productivity effect. In the presence of auditors, health workers might defer or avoid activities that require hand hygiene, but these issues are not addressed in guidelines for practice or research studies. This oversight has implications for the validity of hand hygiene audit findings. Measuring hand hygiene product use overcomes avoidance tactics. It is cheaper and generates data continuously to assess the compliance of all clinicians without disrupting patient care. Disadvantages are the risk of overestimating uptake through spillage, wastage, or use by visitors and non-clinical staff entering patient care areas. Electronic devices may overcome the Hawthorne and avoidance effects but are costly and are not widely used outside research studies. Copyright © 2016 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

REFORM OF REGULATORY POLICY IN THE FIELD OF SUPERVISION OF AUDIT ACTIVITY

Directory of Open Access Journals (Sweden)

Iryna Kantsir

2017-12-01

Full Text Available Reforming the regulatory system and supervision of audit activity in Ukraine is a basic condition for Ukraine’s accession to the European Community, and the introduction of international standards in the field of audit and supervision of audit activity and quality assurance of audit services should be correlated with the standards of European and world audit practice. The dominant factor in the effective functioning of independent control is the choice of a model of supervision of the mechanism for its implementation; effectiveness of the system of monitoring the quality of audit services; effectiveness of legal and regulatory framework of audit activity. The regulation of audit activity is to coordinate direct and indirect actions aimed at the subject of audit activity with the purpose of ensuring the quality of audit services and minimizing the level of audit risk. The purpose of the research is: analysis of the basic models of regulation of audit activity aimed at improving the legal regulation of economic relations in general and subjects of audit activity in particular. Determination of expediency of implementation of public oversight as monitoring of the process of implementation of audit activity in the context of granting the right to conduct audit activities to individuals, implementation of standards of professional ethics and quality control of audit services, permanence of education and imposing sanctions for non-compliance by auditors with the requirements of the current legislation. Method (methodology. In the process of research, general scientific and special methods of scientific knowledge are used: abstract-logical (in the disclosure of theoretical and methodological foundations of public oversight; synthesis and system analysis (substantiation of the essential characteristics of the system of public oversight; system analysis and theoretical generalization (definition of institutional prerequisites for the introduction of

Three essays on research and development

Science.gov (United States)

Sanyal, Paroma

The impact of institutional changes and market structure on research and development (R&D) and technical progress is controversial. My dissertation investigates the determinants of R&D in the context of institutional change. The first two papers address the impact of deregulation in the US electric utility industry on R&D. The third paper investigates the linkage between patenting and different funding sources and patent office attributes. The first paper, "Deregulation, Restructuring and Changing R&D Paradigms in the US Electric Utility Industry", investigates the linkage between market structures and the conduct of R&D in the US electric utility industry. The primary finding of this paper is that institutional and competition factors interact in a way that suggest that the occurrence of full deregulation, coupled with effective retail competition in the market may mitigate the problem of declining R&D expenditures in the face of deregulation. The second paper, "Powering a Green Progress: Environmental Research in the Absence of Regulatory Oversight" analyzes the impact of changing market structure on environmental R&D expenditures by IOUs in the electric utility industry. Conventional wisdom holds that increased competition would lead firms to cut back on R&D funds directed towards social goals, such as the environment. But these arguments fail to take account the threat of future environmental regulations and its influence on disciplining firms. Theory and empirical results from this paper suggest that under certain conditions, even with high monitoring costs, an environmental regulatory agency's threat of stricter future regulations will successfully stem the decrease in environmental R&D expenditures. My third paper, "Birth of a Patent: the Role of Parents, Nursemaids and Constraints", presents an integrated theoretical and empirical approach that models the effects of different sources of R&D funding and patent office attributes on the patenting process. The

Guidelines for use of fishes in research

Science.gov (United States)

Use of Fishes in Research Committee (joint committee of the American Fisheries Society, the American Institute of Fishery Research Biologists

2014-01-01

mammals and other vertebrates, in general. Policies, regulations, and recommendations developed for research on mammals, birds, reptiles, or even amphibians are frequently inappropriate for research with fishes. The Guidelines also address some of the ethical concerns that motivate guidelines used for research with other vertebrates, while being mindful of the unique physiology and general nature of fishes. The Guidelines were developed for general use by investigators within the United States; therefore, the roles, responsibilities, and informational needs of Institutional Animal Care and Use Committees (IACUCs) were given specific attention. All United States institutions that use vertebrate animals for research, teaching, research training, and biological testing are required to create an IACUC to oversee and evaluate all aspects of the institution’s animal care and use program. Investigators from other nations who read this document may disregard specific references to U.S. state and federal laws and regulations, as their institutional infrastructure and processes may differ from those of an internal committee such as IACUCs. The principles described herein, however, are applicable to research on fishes regardless of geographic location. Investigators in other nations may benefit by modifying any of the specific provisions pertaining to the United States, thereby adopting guidelines consistent with the laws and regulations of their own government. The UFR Committee urges that the Guidelines be endorsed and adopted (adapted, where necessary) by those state and federal authorities with regulatory responsibilities for fishes, offices with federal oversight (e.g., National Institutes of Health, Office of Laboratory Animal Welfare; http://grants.nih.gov/grants/olaw/olaw.htm) as well as by universities and other institutions and authorities using fishes and aquatic animals within their research and teaching programs.

Material Parenting: How the Use of Goods in Parenting Fosters Materialism in the Next Generation

OpenAIRE

Marsha L. Richins; Lan Nguyen Chaplin

2015-01-01

This research introduces the concept of material parenting, in which parents use material goods to express their love or to shape children's behavior. Despite the common use of material goods for these purposes, possible long term effects of material parenting practices have not been studied. This article addresses this oversight by examining the potential effects of material parenting on the material values of children once they're grown. This research proposes and tests a material parenting...

76 FR 6636 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2011-02-07

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office... made for the following committee meeting. To discuss National Industrial Security Program policy...

76 FR 67484 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2011-11-01

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office... made for the following committee meeting to discuss National Industrial Security Program policy matters...

76 FR 28099 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2011-05-13

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office... made for the following committee meeting to discuss National Industrial Security Program policy matters...

75 FR 65526 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Science.gov (United States)

2010-10-25

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: Information Security Oversight Office..., announcement is made for the following committee meeting, to discuss National Industrial Security Program...

Research and experience report 2012. Developments in the technical and legal basis of nuclear oversight; Erfahrungs- und Forschungsbericht 2012. Entwicklungen im Bereich der Grundlagen der nuklearen Aufsicht

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-04-15

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

Research and experience report 2007. Developments in the technical and legal basis of nuclear oversight; Erfahrungs- und Forschungsbericht 2007. Entwicklungen im Bereich der Grundlagen der nuklearen Aufsicht

Energy Technology Data Exchange (ETDEWEB)

NONE

2008-07-01

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

Research and experience report 2007. Developments in the technical and legal basis of nuclear oversight; Erfahrungs- und Forschungsbericht 2007. Entwicklungen im Bereich der Grundlagen der nuklearen Aufsicht

Energy Technology Data Exchange (ETDEWEB)

NONE

2008-07-01

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

Death Valley Lower Carbonate Aquifer Monitoring Program Wells Down gradient of the Proposed Yucca Mountain Nuclear Waste Repository

International Nuclear Information System (INIS)

Inyo County

2006-01-01

Inyo County has participated in oversight activities associated with the Yucca Mountain Nuclear Waste Repository since 1987. The overall goal of these studies are the evaluation of far-field issues related to potential transport, by ground water, or radionuclides into Inyo County, including Death Valley, and the evaluation of a connection between the Lower Carbonate Aquifer (LCA) and the biosphere. Our oversight and completed Cooperative Agreement research, and a number of other investigators research indicate that there is groundwater flow between the alluvial and carbonate aquifers both at Yucca Mountain and in Inyo County. In addition to the potential of radionuclide transport through the LCA, Czarnecki (1997), with the US Geological Survey, research indicate potential radionuclide transport through the shallower Tertiary-age aquifer materials with ultimate discharge into the Franklin Lake Playa in Inyo County. The specific purpose of this Cooperative Agreement drilling program was to acquire geological, subsurface geology, and hydrologic data to: (1) establish the existence of inter-basin flow between the Amargosa Basin and Death Valley Basin; (2) characterize groundwater flow paths in the LCA through Southern Funeral Mountain Range, and (3) Evaluation the hydraulic connection between the Yucca Mountain repository and the major springs in Death Valley through the LCA

Is Sordac’s Rapid Acquisition Process Best Prepared To Field Solutions For Future Technological Challenges

Science.gov (United States)

2016-03-31

to leverage game changing technologies such as cyber, robotics, nanotechnology, and ISR to ensure our comparative advantage and ability to achieve...of Defense for Special Operations and Low Intensity Conflict ( ASD -SO/LIC) to provide oversight and advocacy for SOCOM. The result is SOCOM...CRADA ( Cooperative Research & Development Agreements) are legal agreements for RDT&E, 10 providing a collaborative effort with non-federal

Results of SSTC NRS Scientific and Technical Activities for 2014

International Nuclear Information System (INIS)

Nosovskij, A.V.; Valyigun, N.P.; Vorobej, I.I.; Kornijevska, O.S.

2015-01-01

The paper describes results of SSTC NRS scientific activities for 2014 in basic areas of activities. In particular, it addresses the development of nuclear regulatory control system, reviews, scientific and technical support to the SNRIU oversight function, research ampersand development and analytical efforts as well as scientific information and international activity. First-priority areas for SSTC NRS for the nearest years are identified

Women's Sport Leadership Styles as the Result of Interaction between Feminine and Masculine Approaches

Science.gov (United States)

Brown, Sue; Light, Richard L.

2012-01-01

There is a growing body of research focusing on women in the business sector using a transformational model of leadership that identifies the ways in which they lead yet little is known about the style of leadership women practise in sport. In attempting to redress this oversight in the literature, this article draws on data from a larger study to…

The Impact of the Dodd-Frank Act on Financial Stability and Economic Growth

Directory of Open Access Journals (Sweden)

Martin Neil Baily

2017-01-01

Full Text Available This article assesses the benefits and costs of key provisions of the Dodd-Frank Act that strengthened regulation following the financial crisis. The provisions are placed into five groupings: clear wins, clear losses, costly tradeoffs, unfinished business, and too soon to tell. Clear wins include higher prudential standards, including for capital; the single-point-of-entry resolution authority; creation of the Consumer Financial Protection Bureau; and greater transparency and oversight of derivatives. Clear losses are restrictions on Federal Reserve emergency lending authority and forcing the Federal Deposit Insurance Corporation to obtain permission from Congress before providing temporary liquidity guarantees. Costly tradeoffs are the Volcker Rule and the Lincoln Amendment. Unfinished business includes regulatory consolidation and more independence for the Financial Stability Oversight Council and the Office of Financial Research. Too soon to tell are requirements and standards for leverage ratios, capital buffers, stress testing, and liquidity requirements.

Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment

Science.gov (United States)

Henderson, Gail E; Peay, Holly L; Kroon, Eugene; Cadigan, Rosemary Jean; Meagher, Karen; Jupimai, Thidarat; Gilbertson, Adam; Fisher, Jill; Ormsby, Nuchanart Q; Chomchey, Nitiya; Phanuphak, Nittaya; Ananworanich, Jintanat; Rennie, Stuart

2018-01-01

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. PMID:29127137

Research and experience report 2012. Developments in the technical and legal basis of nuclear oversight; Erfahrungs- und Forschungsbericht 2012. Entwicklungen im Bereich der Grundlagen der nuklearen Aufsicht

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-04-15

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

75 FR 81612 - The Consumer Operated and Oriented Plan (CO-OP) Advisory Board; Office of Consumer Information...

Science.gov (United States)

2010-12-28

... and Insurance Oversight (OCIIO) on the Department's strategy to foster the creation of qualified... and Insurance Oversight (OCIIO) on the Department's strategy to foster the creation of qualified... of this notice. Individuals requiring sign language interpretation or other special accommodations...

Research and development of methods and tools for achieving and maintaining consensus processes in the face of change within and among government oversight agencies: Volume 1

Energy Technology Data Exchange (ETDEWEB)

1992-03-01

This progress report summarizes our research activities under our consensus grant. In year four of the grant, we continued to capitalize on and benefit from historical events which drove our early emphasis on group process studies. Following our work on various procedures for bringing together groups such as the State and Tribal Government Working Group and the Stakeholders' Forum (both of which provide input to the Five-Year Waste Plan), we continue to observe these groups and collect data. We also began a configuration study involving the complex modeling of DOE's Office of Environmental Restoration and Waste Management (EM). Related to group process studies is the issue of the information requirements for individuals making decisions in consensus groups. Our information studies examined the requirements for decision-related information, frameworks for such information, and the effectiveness of information portrayed for decision making. However, we were able not only to continue studying consensus groups in action and related information issues, but also to focus considerable attention on the fundamental side of our research. The fundamental or basic research conducted in year four included: (1) expanding our literature database; (2) beginning the writing of the literature review summary document and the consensus guide; (3) developing frameworks and models such as the Environmental Trilogy model and a structural equations model of the consensus process; and (4) conducting laboratory studies concerning the effects of the presence of an expert, met expectations, opportunity to express views, incentive structure and conflict type (competitive versus collaborative) on consensus outcomes.

Research and development of methods and tools for achieving and maintaining consensus processes in the face of change within and among government oversight agencies: Volume 1

International Nuclear Information System (INIS)

1992-03-01

This progress report summarizes our research activities under our consensus grant. In year four of the grant, we continued to capitalize on and benefit from historical events which drove our early emphasis on group process studies. Following our work on various procedures for bringing together groups such as the State and Tribal Government Working Group and the Stakeholders' Forum (both of which provide input to the Five-Year Waste Plan), we continue to observe these groups and collect data. We also began a configuration study involving the complex modeling of DOE's Office of Environmental Restoration and Waste Management (EM). Related to group process studies is the issue of the information requirements for individuals making decisions in consensus groups. Our information studies examined the requirements for decision-related information, frameworks for such information, and the effectiveness of information portrayed for decision making. However, we were able not only to continue studying consensus groups in action and related information issues, but also to focus considerable attention on the fundamental side of our research. The fundamental or basic research conducted in year four included: (1) expanding our literature database; (2) beginning the writing of the literature review summary document and the consensus guide; (3) developing frameworks and models such as the Environmental Trilogy model and a structural equations model of the consensus process; and (4) conducting laboratory studies concerning the effects of the presence of an expert, met expectations, opportunity to express views, incentive structure and conflict type (competitive versus collaborative) on consensus outcomes

Proposed plan for a JAEA internationalization initiative (JII) (Contract research)

Energy Technology Data Exchange (ETDEWEB)

Bolton, Paul R; Kawanishi, Shunichi [Japan Atomic Energy Agency, Photo-Medical Research Center, Kizugawa, Kyoto (Japan); Mizuki, Jun' ichiro [Japan Atomic Energy Agency, Quantum Beam Science Directorate, Sayo, Hyogo (Japan)

2011-01-15

Concepts for a JAEA Internationalization Initiative, JII are presented. Following a general discussion of issues and recommendations for JII, a 'fast startup JII' is proposed in the form of fast start action items (FSAI). The FSAI represent a clear set of action items that can be implemented at the KPSI/PMRC site which would serve as a seed site for test and evaluation. A JAEA Internationalization Initiative that is guided by evaluation and tailored for JAEA as a whole can be established with appropriate oversight and tracking at each JAEA site by local JII teams. In addition to recommendations for the KPSI/PMRC seed site, the roles of the Quantum Beam Science Directorate (QuBS) leadership and the International Affairs Department (IAD) of JAEA are also discussed. Current KPSI/PMRC activities that are consistent with a JII are briefly presented. (author)

Proposed plan for a JAEA internationalization initiative (JII) (Contract research)

International Nuclear Information System (INIS)

Bolton, Paul R.; Kawanishi, Shunichi; Mizuki, Jun'ichiro

2011-01-01

Concepts for a JAEA Internationalization Initiative, JII are presented. Following a general discussion of issues and recommendations for JII, a 'fast startup JII' is proposed in the form of fast start action items (FSAI). The FSAI represent a clear set of action items that can be implemented at the KPSI/PMRC site which would serve as a seed site for test and evaluation. A JAEA Internationalization Initiative that is guided by evaluation and tailored for JAEA as a whole can be established with appropriate oversight and tracking at each JAEA site by local JII teams. In addition to recommendations for the KPSI/PMRC seed site, the roles of the Quantum Beam Science Directorate (QuBS) leadership and the International Affairs Department (IAD) of JAEA are also discussed. Current KPSI/PMRC activities that are consistent with a JII are briefly presented. (author)

75 FR 70487 - Proposed Rules for Implementing the Whistleblower Provisions of Section 21F of the Securities...

Science.gov (United States)

2010-11-17

... authority, any self-regulatory organization, or the Public Company Accounting Oversight Board about a matter... Public Company Accounting Oversight Board, a law enforcement organization, or to persons who obtain their... available sources may include both sources that are widely disseminated (such as corporate press releases...

76 FR 37571 - Broker-Dealer Reports

Science.gov (United States)

2011-06-27

... ``review'' and appropriate tests of the broker-dealer's accounting system, internal accounting control and... further states that the scope of the audit and review of the accounting system, internal accounting... Accounting Oversight Board (the ``PCAOB'') to implement oversight of independent public accountants of broker...

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...

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...

13 CFR 120.1060 - Confidentiality of Reports, Risk Ratings and related Confidential Information.

Science.gov (United States)

2010-01-01

... other than SBA's Lender oversight and SBA's portfolio management purposes. An SBA Lender, Intermediary... conjunction with SBA's Lender Oversight Program and SBA's portfolio management (for purposes of this... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Confidentiality of Reports, Risk...

78 FR 64037 - Notice of Hearing

Science.gov (United States)

2013-10-25

... No. 7] Notice of Hearing AGENCY: Privacy and Civil Liberties Oversight Board (PCLOB). ACTION: Notice of a hearing. SUMMARY: The Privacy and Civil Liberties Oversight Board (PCLOB) will conduct a public hearing with current and former government officials and others to address the activities and...

Regulatory oversight report 2012 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2013-04-01

with spent fuel assemblies and vitrified residue packages as well as six casks with decommissioned waste from the experimental nuclear power plant at Lucens. Some 20% of the capacity of the HLW store was in use and about 24% of the ILW store. During the year, ZWILAG conducted two campaigns to incinerate and melt radioactive waste. ENSI is also responsible for the surveillance of the nuclear facilities at PSI: the research reactor PROTEUS, the hot laboratory, the collection point for radioactive waste from medicine, industry and research and the Federal Interim Storage Facility. During 2012, there were no further operational activities or radiation experiments at the PROTEUS research reactor. Two reportable events were recorded at the Paul Scherrer Institute (PSI), but no one at the research reactors at EPFL or the University of Basel. Last year, the amount of radioactive material released into the environment via waste water and exhaust air from the facilities under review was considerably less than the limits specified in the operating licenses. Analyses showed that the maximum doses were less than 1 % of the annual exposure to natural radiation. During 2012, spent fuel assemblies from Swiss nuclear power plants were reprocessed. The AREVA recycling facility in La Hague returned a consignment of high level waste. According to the Sectoral Plan for the deep geological repository, NAGRA proposed several different sites for surface facilities. ENSI provided information on the safety criteria for the selection process and on safety and geology, particularly in view of the Opalinus Clay Project. The geological research into the Opalinus clay continued during 2012. Every five years, the licensees of nuclear power plants are required by law to re-calculate the decommissioning and waste management costs. During 2012, ENSI evaluated the technical principles used in the 2011 cost study conducted by the licensees of nuclear power plants. ENSI is involved in its own projects and

Research and experience report 2009. Developments in the technical and legal basis of nuclear oversight; Erfahrungs- und Forschungsbericht 2009. Entwicklungen im Bereich der Grundlagen der nuklearen Aufsicht/Rapport sur la recherche et les experiences en 2009. Developpements dans les bases techniques et legales pour la surveillance nucleaire/Research and experience report 2009. Developments in the technical and legal basis of nuclear oversight

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-04-15

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

17 CFR 210.2-01 - Qualifications of accountants.

Science.gov (United States)

2010-04-01

..., chief financial officer, chief operating officer, general counsel, chief accounting officer, controller... person in the firm is in an accounting role or financial reporting oversight role at an audit client, or... or financial reporting oversight role at an audit client, unless the individual: (1) Does not...

75 FR 42390 - Orders Finding That the PJM WH Real Time Peak Contract and PJM WH Real Time Off-Peak Contract...

Science.gov (United States)

2010-07-21

.../market-oversight/mkt-electric/pjm/2010/05-2010-elec-pjm-archive.pdf . 1. Material Price Reference... commercial market (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act..., Industry Economist, Division of Market Oversight, Commodity Futures Trading Commission, Three Lafayette...

78 FR 51810 - Agency Information Collection Activity Under OMB Review

Science.gov (United States)

2013-08-21

... security oversight activities. States also submit annual grant applications for Federal transit assistance... the States to monitor implementation of the program. If a State fails to comply with Section 5330, FTA... collection: 49 CFR part 659--Rail Fixed Guideway Systems; State Safety Oversight The information collected...

76 FR 30213 - Privacy Act of 1974: Systems of Records

Science.gov (United States)

2011-05-24

... association, state accountancy board, or other Federal, State, local, or foreign licensing or oversight... state accountancy board, the Public Company Accounting Oversight Board, or any similar Federal, State... of Practice, 17 CFR 201.102(e). 7. To a bar association, state accountancy board, or other Federal...

78 FR 78864 - Comparability Determination for Australia: Certain Entity-Level Requirements

Science.gov (United States)

2013-12-27

... authority to support and enforce its oversight of the registrant. In this context, comparable does not... enforce its oversight of the registrant.\\18\\ \\18\\ 78 FR 45343. In making a comparability determination... effective systemic risk management for the overall swaps market. In making its comparability determination...

78 FR 78899 - Comparability Determination for Switzerland: Certain Entity-Level Requirements

Science.gov (United States)

2013-12-27

... enforce its oversight of the registrant. In this context, comparable does not necessarily mean identical... enforce its oversight of the registrant.\\18\\ \\18\\ 78 FR 45343. In making a comparability determination... with respect to their swaps activities,\\37\\ which is critical to effective systemic risk management for...

78 FR 78910 - Comparability Determination for Japan: Certain Entity-Level Requirements

Science.gov (United States)

2013-12-27

... the home jurisdiction's authority to support and enforce its oversight of the registrant. In this..., and The home jurisdiction's authority to support and enforce its oversight of the registrant.\\23\\ \\23... critical to effective systemic risk management for the overall swaps market. In making its comparability...

78 FR 78852 - Comparability Determination for Hong Kong: Certain Entity-Level Requirements

Science.gov (United States)

2013-12-27

... authority to support and enforce its oversight of the registrant. In this context, comparable does not..., and The home jurisdiction's authority to support and enforce its oversight of the registrant.\\18\\ \\18... critical to effective systemic risk management for the overall swaps market. In making its comparability...

49 CFR 659.27 - Internal safety and security reviews.

Science.gov (United States)

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Internal safety and security reviews. 659.27... State Oversight Agency § 659.27 Internal safety and security reviews. (a) The oversight agency shall... safety and security reviews in its system safety program plan. (b) The internal safety and security...

49 CFR 633.15 - Access to information.

Science.gov (United States)

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Access to information. 633.15 Section 633.15 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL TRANSIT ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROJECT MANAGEMENT OVERSIGHT Project Management Oversight Services § 633.15 Access to information. A recipient of FTA...

75 FR 42399 - Orders Finding That the PJM WH Real Time Peak Daily Contract, PJM WH Real Time Off-Peak Daily...

Science.gov (United States)

2010-07-21

...-electric/pjm.asp . \\30\\ http://www.ferc.gov/market-oversight/mkt-electric/pjm/2010/05-2010-elec-pjm-archive...Exchange, Inc. (``ICE''), an exempt commercial market (``ECM'') under sections 2(h)(3)-(5) of the Commodity... CONTACT: Gregory K. Price, Industry Economist, Division of Market Oversight, Commodity Futures Trading...

49 CFR 659.21 - System security plan: general requirements.

Science.gov (United States)

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false System security plan: general requirements. 659.21... State Oversight Agency § 659.21 System security plan: general requirements. (a) The oversight agency shall require the rail transit agency to implement a system security plan that, at a minimum, complies...

78 FR 78839 - Comparability Determination for Canada: Certain Entity-Level Requirements

Science.gov (United States)

2013-12-27

... authority to support and enforce its oversight of the registrant. In this context, comparable does not... jurisdiction's authority to support and enforce its oversight of the registrant.\\19\\ \\19\\ 78 FR 45343. The... with respect to their swaps activities,\\38\\ which is critical to effective systemic risk management for...

78 FR 78923 - Comparability Determination for the European Union: Certain Entity-Level Requirements

Science.gov (United States)

2013-12-27

... authority to support and enforce its oversight of the registrant. In this context, comparable does not... jurisdiction's authority to support and enforce its oversight of the registrant.\\23\\ \\23\\ 78 FR 45343. In... with respect to their swaps activities,\\41\\ which is critical to effective systemic risk management for...

Preventing DoS attacks in peer-to-peer media streaming systems

Science.gov (United States)

Conner, William; Nahrstedt, Klara; Gupta, Indranil

2006-01-01

This paper presents a framework for preventing both selfishness and denial-of-service attacks in peer-to-peer media streaming systems. Our framework, called Oversight, achieves prevention of these undesirable activities by running a separate peer-to-peer download rate enforcement protocol along with the underlying peer-to-peer media streaming protocol. This separate Oversight protocol enforces download rate limitations on each participating peer. These limitations prevent selfish or malicious nodes from downloading an overwhelming amount of media stream data that could potentially exhaust the entire system. Since Oversight is based on a peer-to-peer architecture, it can accomplish this enforcement functionality in a scalable, efficient, and decentralized way that fits better with peer-to-peer media streaming systems compared to other solutions based on central server architectures. As peer-to-peer media streaming systems continue to grow in popularity, the threat of selfish and malicious peers participating in such large peer-to-peer networks will continue to grow as well. For example, since peer-to-peer media streaming systems allow users to send small request messages that result in the streaming of large media objects, these systems provide an opportunity for malicious users to exhaust resources in the system with little effort expended on their part. However, Oversight addresses these threats associated with selfish or malicious peers who cause such disruptions with excessive download requests. We evaluated our Oversight solution through simulations and our results show that applying Oversight to peer-to-peer media streaming systems can prevent both selfishness and denial-of-service attacks by effectively limiting the download rates of all nodes in the system.

Regulatory oversight report 2015 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2016-06-01

The Swiss Federal Nuclear Safety Inspectorate (ENSI) assesses and monitors nuclear facilities in Switzerland. These include the five nuclear power plants (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt), the interim storage facilities based at each plant, the Central Interim Storage Facility (Zwilag) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI), the University of Basel and the Federal Institute of Technology in Lausanne (EPFL), as well as the transport of radioactive materials and the preparatory work for a deep geological repository for nuclear waste. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the required overview of nuclear safety in these facilities. ENSI maintains its own emergency organization. It provides the public with information on particular events and findings in nuclear facilities. ENSI publishes an annual Radiological Protection Report and a Research and Experience Report. Chapters 1 to 4 of this Surveillance Report deal with operational experience, systems technology, radiological protection and management of the 5 Swiss nuclear power plants. Chapter 5 deals with Zwilag. Chapters 6 and 7 are devoted to the nuclear facilities at PSI and the research reactor at EPFL as well as the decommissioned University of Basel’s research reactor. Chapter 8 covers the transport of radioactive materials. The subject of Chapter 9 is the deep geological storage of radioactive waste including work within the framework of the Sectoral Plan. Finally, Chapter 10 deals with generic issues relevant to all facilities such as probabilistic safety analyses. In 2015, all five nuclear power plants in Switzerland were safely operated and ENSI concluded that each had adhered to its approved operating conditions. There were 34 reportable events at the nuclear power plants; 32 events were rated at Level 0 on

Regulatory oversight report 2010 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2011-06-01

fuel assemblies and vitrified residue packages plus 6 casks with decommissioning waste from the experimental nuclear power plant at Lucens. About 17% of the capacity of the high level waste (HLW) store was in use and about 22% of the intermediate- and low-level (ILW) store capacity. During the year ZWILAG conducted two campaigns to incinerate and melt radioactive waste. ENSI recorded no notifiable events in ZWILAG during 2010. ENSI is also responsible for the surveillance of the nuclear facilities at PSI: the research reactor PROTEUS, the hot laboratory, the collection point for radioactive waste from medicine, industry and research. From the radiological standpoint, decommissioning work at the two research reactors DIORIT and SAPHIR continued correctly. The PROTEUS research reactor was operated in compliance with regulations. There were 2 notifiable incidents at PSI with a relevance to nuclear safety and both were rated as INES Level 0. ENSI recorded no notifiable events at the two research reactors at the Federal Institute of Technology in Lausanne and the University of Basel. In 2010, the amount of radioactive material released into the environment via waste water and gaseous exhaust from the nuclear power plants, ZWILAG, the PSI and the nuclear facilities at Basel and Lausanne was considerably lower than the limits specified in operating licenses. Analyses showed that the maximum doses, including those for residents in the immediate vicinity of a plant, were less than 1 % of the annual exposure to natural radiation. Several consignments of radioactive waste were returned to Switzerland following reprocessing at La Hague in France. All consignments of fuel assemblies and radioactive waste were transported in accordance with the regulations. In 2008, three companies each submitted a general license application to the Swiss Federal Office of Energy for a new nuclear power plant. After the accident at Fukushima (Japan) in March 2011, the Swiss Federal Council suspended

Regulatory oversight report 2011 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2012-06-01

as well as 6 casks with decommissioned waste from the experimental nuclear power plant at Lucens. About 17 % of the capacity of the high-level radioactive waste store had been used and about 23 % of the low- and intermediate-level waste store. During the year, ZWILAG conducted two campaigns to incinerate and melt radioactive waste. ENSI recorded no reportable events at ZWILAG during 2011. ENSI is also responsible for the surveillance of the nuclear facilities at PSI: the research reactor PROTEUS, the hot laboratory, the collection point for radioactive waste from medicine, industry and research, and ZWILAG. From the radiological standpoint, decommissioning work at the two research reactors DIORIT and SAPHIR progressed correctly. There were no further irradiation experiments during 2011 at PROTEUS and operational activities were restricted to routine maintenance and checks. During 2011, there were three reportable events at PSI relevant to nuclear safety. All were rated as INES Level 0. ENSI recorded one reportable event at the research reactor at the Federal Institute of Technology in Lausanne and none at the University of Basel. ENSI concluded that the nuclear facilities at PSI and the research reactors at Lausanne and Basel had complied with their approved operating conditions during 2011. Last year the amount of radioactive material released into the environment via waste water and exhaust air from nuclear power plants, ZWILAG, the PSI and the nuclear facilities at Basel and Lausanne was considerably less than the limits specified in the operating licenses. They resulted in maximum calculated doses, including for those residents in the immediate vicinity of a plant, of less than 1 % of the annual exposure to natural radiation. During 2011, two consignments of compacted reprocessing waste were transported from La Hague in France to ZWILAG. The consignments of fuel assemblies and radioactive waste were transported in accordance with the limits specified in the

Organizational Considerations for Implementing Systems Engineering and Integration in the Ares Projects Office

Science.gov (United States)

Thomas, LeAnn; Doreswamy, Rajiv N.

2008-01-01

Systems Engineering and Integration (SE&I) is a critical discipline in developing new space systems. In 2005, NASA performed an internal study of 24 agency and Department of Defense (DoD) programs to evaluate methods of integrating SE&I practices and determine their effectiveness. The goal of the study was to determine the best SE&I implementation strategy for the Ares Projects Office. The study identified six SE&I organizational structures: 1. Lead systems integrator (LSI) with SE&I responsibility and government technical insight. 2a. Integration contractor with government SE&I responsibility (government insight). 2b. Integration contractor with government SE&I responsibility (government oversight). 3a. Prime contractor with SE&I responsibility (government insight). 3b. Prime contractor with SE&I responsibility (government oversight). 3c. Prime contractor with SE&I responsibility (government/industry partnership). 4a.Prime contractor with government SE&I responsibility (government insight). 4b. Prime contractor with government SE&I responsibility (government oversight). 4d.Prime contractors with total system performance responsibility (TSPR). 5. Prime contractor with government SE&I responsibility and integration products through a Federally Funded Research and Development Center (FFRDC). 6. Government/FFRDC in-house development with SE&I responsibility and function. The organizational structure used most often was number 4, using a prime contractor with government SE&I responsibility and government technical insight. However, data analyses did not establish a positive relationship between program development costs and specific SE&I organizational types, nor did it positively determine the relationship between successful programs or projects and their SE&I structure. The SE&I study reached the following conclusions: (1) Large, long-duration, technically complex programs or projects reach their technical goals, but rarely meet schedule or cost goals. NASA's recent

Let Slip the Dogs of (CYBER) War: Progressing Towards a Warfighting U.S. Cyber Command

Science.gov (United States)

2013-04-01

requirements, nor a headquarters building (it is currently housed within NSA facilities on Fort George G. Meade , MD).22 In addition, the DOD cyber...Information Conflict: National Security Law in Cyberspace (Falls Church, VA: Aegis Research Corporation, 2000); Herbert Lin, “Offensive Cyber Operations...this legislation was pocket-vetoed by then President George H.W. Bush due to a lack of consistency between the stated intent of the oversight

Testing the Model: A Phase 1/11 Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin

Science.gov (United States)

2017-10-01

Approach” Mariana Morris , PI, Nova Southeastern University; Role: Co-PI, Clinical Core PI DOD September 2014-September 2017 $190,000 Gulf War Illness...VAMC 5. Director, Miami VAMC Allergy Clinic, Tuesday MD clinic, and oversight of RN clinic and RN and ARNP clinic 6. Medical Director NSU Neuro Immune...Principal Investigator: Mariana Morris Role: Co-I laboratory studies of immune and genomics in the animal and human subjects, 20% effort Research

Department of Energy Natural Phenomena Hazards Mitigation program

International Nuclear Information System (INIS)

Murray, R.C.

1993-01-01

This paper presents a summary of past and present accomplishments of the Natural Phenomena Hazards Program that has been ongoing at Lawrence Livermore National Laboratory since 1975. The Natural Phenomena covered includes earthquake; winds, hurricanes, and tornadoes; flooding and precipitation; lightning; and volcanic events. The work is organized into four major areas (1) Policy, requirements, standards, and guidance, (2) Technical support, research and development, (3) Technology transfer, and (4) Oversight

Comprehensive Study of Acute Effects and Recovery After Concussion

Science.gov (United States)

2015-10-01

MCW IRB regarding personality questionnaire changes and head impact sensor company changes • Amendment under review as of Sept 29, 2015 regarding...a large (3Tb) memory system, and four general purpose graphical processing unit (GPU) systems, each with four Nvidia K40 GPUs. Each of these... company changed prior to study implementation and MCW IRB provided oversight for Banyan Biomarkers’ research activities. Approved by MCW IRB Aug 24

A New Paradigm to Address Bid Protests

OpenAIRE

Melese, Francois; Angelis, Diana; Coughlan, Peter; Franck, Raymond; Kidalov, Max; LaCivita, C.J.; Gates, William

2010-01-01

Sponsored Report (for Acquisition Research Program) Approved for public release distribution unlimited. The goal of this study is to offer senior decision-makers a useful framework to evaluate, articulate, and recommend modifications of the government''s bid protest policy to improve procurement outcomes. Most countries allow disappointed bidders to protest public procurement decisions as an oversight mechanism to minimize fraud and errors by procurement officials. The expectation is...

76 FR 78216 - Organ Procurement and Transplantation Network

Science.gov (United States)

2011-12-16

..., tissues, and cellular and tissue-based products or HCT/Ps. The Food and Drug Administration (FDA... similar supporting statements for OPTN oversight. The commenters agreed that the use of the existing solid... comment stated that VCA do not fit as organs under HRSA oversight due to differences between solid organs...

12 CFR 1780.71 - Definitions.

Science.gov (United States)

2010-01-01

... Federal Housing Enterprise Oversight § 1780.71 Definitions. Practice before OFHEO for the purposes of this... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Definitions. 1780.71 Section 1780.71 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE OVERSIGHT, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT RULES...

76 FR 53713 - Notice of Request for the Extension of a Currently Approved Information Collection

Science.gov (United States)

2011-08-29

... to designate a State Safety Oversight (SSO) agency to oversee the safety and security of each rail... security oversight activities. FTA uses the annual information submitted by the States to monitor implementation of the program. If a State fails to comply with Section 5330, FTA may withhold up to five percent...

75 FR 70114 - Amendment to the Interim Final Rules for Group Health Plans and Health Insurance Coverage...

Science.gov (United States)

2010-11-17

... HEALTH AND HUMAN SERVICES Office of Consumer Information and Insurance Oversight 45 CFR Part 147 RIN 0950-AA17 [OCIIO-9991-IFC2] Amendment to the Interim Final Rules for Group Health Plans and Health Insurance... Administration, Department of Labor; Office of Consumer Information and Insurance Oversight, Department of Health...

Industry Presentation to Regulatory Workshop

International Nuclear Information System (INIS)

Treasure, Mark

2012-01-01

Mr. Mark Treasure from EDF NGL gave a presentation on industry perspectives on safety culture oversight. Mr. Treasure is the Nuclear Inspection and Oversight Manager within the Safety and Regulation Division. The presentation started with an explanation of the role of the nuclear inspection and oversight group (internal regulator), and their current approach to internal oversight of safety culture. A key element of the current internal regulatory oversight program is Management and Leadership Assessments. These are carried out by a team including management peers from other plants to enhance credibility. Findings can be linked to safety performance, and typically identify issues in areas such as accountability arrangements and strategic focus of the leadership team. Safety indicators have also been introduced to show trends in safety management and safety performance for each EDF UK nuclear power plant. A periodic nuclear safety culture survey is also carried out to identify focus areas and progress. The presentation included discussion on views of the role of the nuclear regulator. Important aspects were identified as: - Supporting the internal regulator by seeking to understand before taking enforcement action, maintaining an open dialogue and recognising that this area is complex and that there is rarely a 'silver bullet' solution. - Communication: being visible and actively discussing safety improvement, and use of language which emphasises nuclear safety rather than legal compliance. - Positive reinforcement to recognise efforts and encourage further improvement

Project Manager Performance and the Decision to Backsource the Project Management Office

Science.gov (United States)

Lively, William R.

2014-01-01

This paper reviews a management decision of an Information Technology Outsource (ITO) provider to backshore the management oversight of its Project Management Office (PMO) after only one year of offshore operations. Governance is a term used in project management to refer to management oversight. The review is a quantitative analysis of existing…

49 CFR 659.41 - Conflict of interest.

Science.gov (United States)

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Conflict of interest. 659.41 Section 659.41... Agency § 659.41 Conflict of interest. The oversight agency shall prohibit a party or entity from providing services to both the oversight agency and rail transit agency when there is a conflict of interest...

Development and oversight of ethical health promotion quality assurance and evaluation activities involving human participants.

Science.gov (United States)

Sainsbury, Peter

2015-12-01

This paper considers the role of ethics and ethics review processes in the development of health promotion quality assurance and evaluation activities involving human participants. The Australian National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and associated documents provide the framework for the ethical conduct and independent review of research (including quality assurance and evaluation) involving humans in Australia. Identifying the level of risk to which participants may be exposed by participation in quality assurance and evaluation activities is essential for health promotion workers undertaking such activities. Organisations can establish processes other than review by a Human Research Ethics Committee for negligible and low risk research activities. Health promotion quality assurance and evaluation activities often involve negligible and low risk to participants. Seven triggers that indicate the need for ethics review of quality assurance and evaluation activities and a procedural checklist for developing ethical quality assurance and evaluation activities are provided. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research. When ethical considerations underpin the planning and conduct of all quality assurance and evaluation from the very beginning, the activity is the better for it, independent 'ethics approval' can mostly be secured without much trouble and workers' frustration levels are reduced. So what? Health promotion quality assurance and evaluation activities must be ethically justified. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research and should use it when developing health promotion quality assurance and evaluation activities.

Genetics and Insurance in Australia: Concerns around a Self-Regulated Industry.

Science.gov (United States)

Newson, Ainsley J; Tiller, Jane; Keogh, Louise A; Otlowski, Margaret; Lacaze, Paul

2017-01-01

Regulating the use of genetic information in insurance is an issue of ongoing international debate. In Australia, providers of life and other mutually rated insurance products can request applicants to disclose all results from any genetic test. Insurers can then use this information to adjust premiums and make policy decisions. The Australian Financial Services Council (FSC; an industry body) developed and maintains the relevant industry standard, which was updated in late 2016. Aims/Objective: To review the 2016 FSC Standard in light of relevant research and determine the legitimacy of the Australian regulatory environment regarding use of genetic information by insurers. We identified five concerns arising from the 2016 FSC Standard: (1) use of results obtained from research; (2) the requirement for an applicant to disclose whether they are "considering" a genetic test; (3) failure to account for genome sequencing and other technology developments; (4) limited evidence regarding adverse selection; and (5) the inappropriateness of industry self-regulation. Industry self-regulation of the use of genetic information by life insurers, combined with a lack of government oversight, is inappropriate and threatens to impede the progress of genomic medicine in Australia. At this critical time, Australia requires closer government oversight of the use of genetic information in insurance. © 2017 S. Karger AG, Basel.

Inadequacies of Physical Examination as a Cause of Medical Errors and Adverse Events: A Collection of Vignettes.

Science.gov (United States)

Verghese, Abraham; Charlton, Blake; Kassirer, Jerome P; Ramsey, Meghan; Ioannidis, John P A

2015-12-01

Oversights in the physical examination are a type of medical error not easily studied by chart review. They may be a major contributor to missed or delayed diagnosis, unnecessary exposure to contrast and radiation, incorrect treatment, and other adverse consequences. Our purpose was to collect vignettes of physical examination oversights and to capture the diversity of their characteristics and consequences. A cross-sectional study using an 11-question qualitative survey for physicians was distributed electronically, with data collected from February to June of 2011. The participants were all physicians responding to e-mail or social media invitations to complete the survey. There were no limitations on geography, specialty, or practice setting. Of the 208 reported vignettes that met inclusion criteria, the oversight was caused by a failure to perform the physical examination in 63%; 14% reported that the correct physical examination sign was elicited but misinterpreted, whereas 11% reported that the relevant sign was missed or not sought. Consequence of the physical examination inadequacy included missed or delayed diagnosis in 76% of cases, incorrect diagnosis in 27%, unnecessary treatment in 18%, no or delayed treatment in 42%, unnecessary diagnostic cost in 25%, unnecessary exposure to radiation or contrast in 17%, and complications caused by treatments in 4%. The mode of the number of physicians missing the finding was 2, but many oversights were missed by many physicians. Most oversights took up to 5 days to identify, but 66 took longer. Special attention and skill in examining the skin and its appendages, as well as the abdomen, groin, and genitourinary area could reduce the reported oversights by half. Physical examination inadequacies are a preventable source of medical error, and adverse events are caused mostly by failure to perform the relevant examination. Copyright © 2015 Elsevier Inc. All rights reserved.

Management Oversight and Risk Tree (MORT): a new system safety program

International Nuclear Information System (INIS)

Clark, J.L.

Experiences of Aerojet Nuclear Company (ANC), in the development and implementation of a system safety program for ANC and for the Energy Research and Development Administration (ERDA) are discussed. Aerojet Nuclear is the prime operating contractor for ERDA, formerly AEC, at the Idaho National Engineering Laboratory. The ERDA sponsored ''MORT'' system safety program is described along with the process whereby formal system safety methods are incorporated into a stable organization. Specifically, a discussion is given of initial development of MORT; pilot program trials conducted at ANC; implementation methodology; and reaction of the ANC organization. (auth)

Nuclear Energy: Compendium of relevant GAO products on regulation, health, and safety

International Nuclear Information System (INIS)

1986-01-01

This report presents findings, conclusions, and recommendations in the areas of (1) protecting worker health and safety, (2) planning for nuclear emergencies and coordinating response mechanisms in the event of a serious nuclear accident, (3) ensuring the safe design of facilities, and (4) monitoring the environment. GAO points out that impaired organizational independence of the oversight function, a lack of headquarters authority, and the decentralized nature of the oversight activities may constitute serious problems over the long term. More recent GAO work indicates that organizational independence of the oversight function may still be a problem area and is likely to receive increased scrutiny in the aftermath of the Chernobyl nuclear reactor accident in the Soviet Union

77 FR 39141 - Defense Federal Acquisition Regulation Supplement: Applicability of Hexavalent Chromium Policy to...

Science.gov (United States)

2012-06-29

... final rule was published, DoD became aware of a drafting oversight and the need to correct the text of... Act, 5 U.S.C. 601, et seq., because this rule is just correcting a drafting oversight in rule 2009..., Technical Data--Commercial Items (DEC 2011), if applicable (see 227.7102-4(a)), if flow down is required in...

Disaster Response Contracting in a Post-Katrina World: Analyzing Current Disaster Response Strategies and Exploring Alternatives to Improve Processes for Rapid Reaction to Large Scale Disasters within the United States

Science.gov (United States)

2006-12-01

TELECOMMUTING / TELEWORKING..................................................60 E. NAVAL POSTGRADUATE SCHOOL GLOBAL INFORMATION NETWORK ARCHITECTURE...issues. Much concern points to DHS’s failure to provide the broad federal oversight required by the National Response Plan (NRP). The NRP had only...Acquisition Officer did urgently request assistance from the DHS Office of the Inspector General (DHS-IG) for procurement oversight , and DHS-IG assigned

Department of Defense Strategic Sustainability Performance Plan FY 2012

Science.gov (United States)

2012-01-01

interoperability of equipment; and the management and oversight of contingency basing. Improved contingency base sustainability will also enhance mission...with communicating classified information from alternate work locations. In FY 2011, NGA developed and began implementing a telecommuting policy...operating procedures. DLA Disposition Services strengthened its oversight of the electronics demanufacturing process in FY 2011 by tightening

Political Influence on Japanese Nuclear and Security Policy: New Forces Face Large Obstacles

Science.gov (United States)

2014-02-01

supported and sometimes even led by a strong bureaucracy, with oversight by but also much deference from the broader LDP majority in the Diet . During the...Research Council (PARC), a “shadow Diet committee” system in which DPJ legislators could engage in bureaucrat-led “study sessions,” something...303- 328. 62 Katsuhisa Furukawa, “Japan’s Policy and Views on Nuclear Weapons: A Historical Perspective,” Jebat: Malaysian Journal of History

Patient views on financial relationships between surgeons and surgical device manufacturers.

Science.gov (United States)

Camp, Mark W; Gross, Allan E; McKneally, Martin F

2015-10-01

Over the past decade, revelations of inappropriate financial relationships between surgeons and surgical device manufacturers have challenged the presumption that surgeons can collaborate with surgical device manufacturers without damaging public trust in the surgical profession. We explored postoperative Canadian patients' knowledge and opinions about financial relationships between surgeons and surgical device manufacturers. This complex issue was explored using qualitative methods. We conducted semistructured face-to-face interviews with postoperative patients in follow-up arthroplasty clinics at an academic hospital in Toronto, Canada. Interviews were audiotaped, transcribed and analyzed. Patient-derived concepts and themes were uncovered. We interviewed 33 patients. Five major themes emerged: 1) many patients are unaware of the existence of financial relationships between surgeons and surgical device manufacturers; 2) patients approve of financial relationships that support innovation and research but are opposed to relationships that involve financial incentives that benefit only the surgeon and the manufacturer; 3) patients do not support disclosure of financial relationships during the consent process as it may shift focus away from the more important risks; 4) patients support oversight at the professional level but reject the idea of government involvement in oversight; and 5) patients entrust their surgeons to make appropriate patient-centred choices. This qualitative study deepens our understanding of financial relationships between surgeons and industry. Patients support relationships with industry that provide potential benefit to current or future patients. They trust our ability to self-regulate. Disclosure combined with appropriate oversight will strengthen public trust in professional collaboration with industry.

Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment.

Science.gov (United States)

Henderson, Gail E; Peay, Holly L; Kroon, Eugene; Cadigan, Rosemary Jean; Meagher, Karen; Jupimai, Thidarat; Gilbertson, Adam; Fisher, Jill; Ormsby, Nuchanart Q; Chomchey, Nitiya; Phanuphak, Nittaya; Ananworanich, Jintanat; Rennie, Stuart

2018-04-01

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study nested in a Thai acute HIV research cohort.In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks.These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cool Science Explains a Warming World: Using Ice Core Science to Bridge the Gap Between Researchers and the K-12 Classroom

Science.gov (United States)

Huffman, L. T.

2017-12-01

Changing ice has urgent implications for people around the world. The Ice Drilling Program Office (IDPO) provides scientific leadership and oversight of ice coring and drilling activities funded by the US National Science Foundation and also has goals to enhance education and communication of current research information. In a time when misinformation is rampant and climate change science is suspect, it is essential that students receive accurate scientific information and engage in learning activities that model complex ideas through engaging and age appropriate ways, while also learning to validate and recognize reliable sources. The IDPO Education and Outreach (EO) office works to create resources, activities and professional development that bridge the gap between ice core science research and educators and their students. Ice core science is on the cutting edge of new discoveries about climate change and understanding better the past to predict the future. Hands-on inquiry activities based on ice core data allow teachers to lead their students to new discoveries about climate secrets hidden deep in the ice. Capitalizing on the inherent interest in the extremes of the Polar Regions, IDPO materials engage students in activities aligned with NGSS standards. Ice drilling technologies make an ideal platform for intertwining engineering concepts and practices with science research to meet the SEP (Science and Engineering Practices) in the NGSS. This session will highlight how the IDPO EO office has built a community of ice core scientists willing to take part in education and outreach projects and events and share some of the resources available to K-12 educators. We will highlight some of the successes and lessons learned as we continually evolve our work toward more effective science education and communication highlighting ice core and climate change science.

Report to Congress on the Activities of the DoD Office of Technology Transition

Science.gov (United States)

2006-08-01

protection, and protected remote access solutions for telecommuting . NetTop inventors/engineers of this technology will soon be engaged in a CRADA...from each Service and Defense Agency and representatives from the Joint Requirements Oversight Council. An annual call for TTI proposals is...Electronics Oversight Council proposed the start of the RH Microelectronics Advanced Technology Development (RHMATD) program. The program called for two

Human Capital. Corps of Engineers Needs to Update Its Workforce Planning Process to More Effectively Address Its Current and Future Workforce Needs

Science.gov (United States)

2008-05-01

Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia Committee on Homeland Security and...allows flex-time, telecommuting , or alternative work schedules. Page 17 GAO-08-596 Corps of Engineers Table 1: Examples of Human Capital...programs and policies; and provides analyses, recommendations, and other assistance to help Congress make informed oversight , policy, and funding

The Prioritization of Critical Infrastructure for a Pandemic Outbreak in the United States Working Group

Science.gov (United States)

2007-01-16

stems mostly from a lack of common understanding and oversight mechanism in government or business for what fully constitutes most sectors and sub...and priorities during a pandemic event. This alignment will require substantial executive-level sponsorship, governance, and oversight to ensure...increase in telecommuting during a pandemic. The sector continues to work diligently refining best practices, business continuity plans, and homeland

U.S. Army Acquisition Workforce: Reflecting Modern Structural Changes

Science.gov (United States)

2009-06-01

provisions ensuring oversight over a massive infusion of contracts, state grants and other measures. Interviews with acquisition workforce specialists... telecommuting .”3 Incentives for retaining qualified acquisition workforce members are discussed. Surveys were analyzed primarily for contextual...and the players who now have a voice in this expanded system. One major change was the use of the Joint Requirements Oversight Council (JROC

An Independent Review of the Design Plans for Walter Reed National Military Medical Center and the Fort Belvoir Community Hospital

Science.gov (United States)

2009-05-01

provide oversight , foster inclusion and develop an integrated healthcare delivery system within the current Service cultures. In May 2007, NCA military...provides oversight of IM/IT initiatives for the Joint Operating Area (JOA).” (Rowland, 2009) Membership for the JPG includes the Chief Information...professional development; and 4) offering services such as child and elder care programs, telecommuting , flexible work schedules, and employee

Towards a Theory of Fear Management in the Counter-Terrorism Domain

Directory of Open Access Journals (Sweden)

Edwin Bakker

2014-01-01

Full Text Available Since 9/11, the state of the art in counter-terrorism research, counter-terorism measures and counter-terrorism impacts has taken off. Nevertheless, countering terrorism as a branch of fear management is still a discipline to be developed. In this Research Paper, authors Prof. Dr. Edwin Bakker and Prof. Dr. Beatrice de Graaf attempt to lessen this gap. The Paper identifies and analyses governmental approaches to managing fear in relation to terrorist incidents. It is a stocktaking approach, offering a preliminary oversight of some central aspects and pointers on the way forward when constructing and testing such a theory.

Assessing implementation mechanisms for an international agreement on research and development for health products.

Science.gov (United States)

Hoffman, Steven J; Røttingen, John-Arne

2012-11-01

The Member States of the World Health Organization (WHO) are currently debating the substance and form of an international agreement to improve the financing and coordination of research and development (R&D) for health products that meet the needs of developing countries. In addition to considering the content of any possible legal or political agreement, Member States may find it helpful to reflect on the full range of implementation mechanisms available to bring any agreement into effect. These include mechanisms for states to make commitments, administer activities, manage financial contributions, make subsequent decisions, monitor each other's performance and promote compliance. States can make binding or non-binding commitments through conventions, contracts, declarations or institutional reforms. States can administer activities to implement their agreements through international organizations, sub-agencies, joint ventures or self-organizing processes. Finances can be managed through specialized multilateral funds, financial institutions, membership organizations or coordinated self-management. Decisions can be made through unanimity, consensus, equal voting, modified voting or delegation. Oversight can be provided by peer review, expert review, self-reports or civil society. Together, states should select their preferred options across categories of implementation mechanisms, each of which has advantages and disadvantages. The challenge lies in choosing the most effective combinations of mechanisms for supporting an international agreement (or set of agreements) that achieves collective aspirations in a way and at a cost that are both sustainable and acceptable to those involved. In making these decisions, WHO's Member States can benefit from years of experience with these different mechanisms in health and its related sectors.

The Development of Auditing Arena and Corporate Governance Landscape in Malaysia: An Initiative to Combat Fraud and Corruptions

OpenAIRE

Ahmad Noruddin Nur Adura; Norziaton I.K.

2017-01-01

This research provides two phases of discussions on the evolution in auditing arena and corporate governance (CG) landscape in Malaysia. Phase 1: Pre-Malaysian Code of Corporate Governance (MCCG) (1957-2000) and Phase 2: Post-Malaysian Code of Corporate Governance (2001-2015). MCCG was designed to increase oversight and regulation of the accounting profession and to strengthen CG practices and increase transparency of financial audits. The emergence of audit failures has focused the world’s a...

EFEKTIFITAS PENGAWASAN HAKIM OLEH KOMISI YUDISIAL

Directory of Open Access Journals (Sweden)

Oddie Moch Ikhsan

2018-01-01

Full Text Available Starting from the establishment of a suspect Candidate Former National Police Chief Pol Commissioner General Budi Gunawan then apply prapradilan to the South Jakarta District Court. Because the 77 Criminal Code stated determination of the suspect is not an object pretrial. In those articles which can be handled by pretrial regulated limitative, only for legitimate or not the arrest, detention, discontinuation or termination of the investigation and prosecution of compensation or rehabilitation for a criminal case was stopped at the level of investigation or prosecution. After a single judge South Jakarta District Court partially granted the petition Sarpin Rizaldi prapreadilan BG. In his judgment, Sarpin interprets the determination of the suspect as one of the pre-trial. Judge Sarpin Ats such action under the spotlight of the Judicial Commission for the above decision. The Judicial Commission then recommended to the Supreme Court Judge Sarpin to sanctions, but the Supreme Court rejected the recommendation because they have entered the realm of the judge's decision. The formulation of the problem in this study is How Model Judicial Oversight Committee, Oversight Problems To Know judge by the Judicial Commission, the Judicial Commission How the Implementation Monitoring and Oversight How effective implementation of the functions of the Judicial Commission in supervising judges and its influence on the judicial power. The method used in this research is using normative juridical approach, the specification of the research is descriptive analytical.Based on the findings of the Judicial Commission has the concept of preventive surveillance by the repressive, namely to prevent and then are giving emphasis and contain sanctions. The Judicial Commission has the authority to give the sanction of ethics recommendations to the Supreme Court but the repressive ie without the MA recommendations, the recommendations of the Judicial Commission to be worth sia

Regulatory oversight report 2007 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2008-04-01

This annual report issued by the Swiss Federal Nuclear Inspectorate (HSK) reports on the work carried out by the Inspectorate in 2007. This report reviews the regulatory activities in the four Swiss nuclear power stations and in four further nuclear installations in various Swiss research facilities. It deals with topics such as operational details, technologies in use, radiation protection, radioactive wastes, emergency dispositions and personnel and provides an assessment of operations from the point of view of safety. Also, the transportation of nuclear materials - both nuclear fuels and nuclear wastes - is reported on. General topics discussed include probabilistic safety analyses and accident management. Finally, the disposal of nuclear wastes and work done in the rock laboratories in Switzerland is commented on

Regulatory oversight report 2016 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2017-06-01

packages as well as one cask with the fuel assemblies from the shut down research reactor DIORIT of PSI and six casks with waste from the decommissioning of the experimental nuclear power plant at Lucens. During 2016 only one campaign to incinerate and melt radioactive waste was carried out. ENSI recorded no reportable events at Zwilag during the reporting year. The nuclear facilities at PSI consist of the hot laboratory, the three former research reactors SAPHIR, DIORIT and PROTEUS now in varying phases of decommissioning, the former experimental incineration plant and the facilities for the disposal of radioactive materials including the Federal Government's interim storage facility. During 2016, no events were reported at the PSI, at EPFL or at UniB. In 2016, the amount of radioactive material released into the environment via waste water and exhaust air from the nuclear power plants, Zwilag and the nuclear facilities at PSI, Basel and Lausanne was significantly less than the limits specified in the operating licenses. Analyses showed that the maximum dose for persons in the immediate vicinity of a plant was less than 1% of the annual exposure to natural radiation. The waste produced during reprocessing at the reprocessing facilities of La Hague (France) and Sellafield (United Kingdom) must be returned to Switzerland. In the reporting year, compacted, metallic, intermediate level waste and intermediate level vitrified residue packets were transported to Zwilag. All nuclear waste from Swiss fuel assemblies sent abroad for reprocessing is now stored at Zwilag. During 2016, all transports of radioactive substances to and from Swiss nuclear installations took place without any incidents. The site selection procedure for the storage of radioactive waste has been running since 2008. ENSI bears overall responsibility for the safety assessment of the geological site areas. The National Cooperative for the Disposal of Radioactive Waste (Nagra) submitted its suggestion for

Vision 2015: A Globally Networked and Integrated Intelligence Enterprise

Science.gov (United States)

2008-07-01

the third career (not job). • Telecommuting is a way of life, not an agency initiative. • Savvy in rapidly accessing and evaluating public...reinforced by policy and process. While we must have oversight into the full range of our partnership activities, their success ultimately comes down to...focused on product oversight and review. We will need leader- ship development programs, performance evaluation systems, and an incentive

Anticipating issues related to increasing preimplantation genetic diagnosis use: a research agenda.

Science.gov (United States)

Klitzman, Robert; Appelbaum, Paul S; Chung, Wendy; Sauer, Mark

2008-01-01

Increasing use of preimplantation genetic diagnosis (PGD) poses numerous clinical, social, psychological, ethical, legal and policy dilemmas, many of which have received little attention. Patients and providers are now considering and using PGD for a widening array of genetic disorders, and patients may increasingly seek 'designer babies.' In the USA, although governmental oversight policies have been discussed, few specific guidelines exist. Hence, increasingly, patients and providers will face challenging ethical and policy questions of when and for whom to use PGD, and how it should be financed. These issues should be better clarified and addressed through collection of data concerning the current use of PGD in the USA, including factors involved in decision making about PGD use, as well as the education of the various communities that are, and should be, involved in its implementation. Improved understanding of these issues will ultimately enhance the development and implementation of future clinical guidelines and policies.

Regulatory oversight report 2008 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2009-04-01

This annual report issued by the Swiss Federal Nuclear Inspectorate (ENSI) reports on the work carried out by the Inspectorate in 2008. This report reviews the regulatory activities in the four Swiss nuclear power stations and in four further nuclear installations in various Swiss research facilities. It deals with topics such as operational details, technologies in use, radiation protection, radioactive wastes, emergency dispositions, personnel and provides an assessment of operations from the safety point of view. Also, the transportation of nuclear materials - both nuclear fuels and nuclear wastes - is reported on. General topics discussed include probabilistic safety analyses and accident management, earthquake damage analysis and agreements on nuclear safety. The underground disposal of highly-radioactive nuclear wastes and work done in the rock laboratories are discussed, as are proposals for additional nuclear power stations

Environmental monitoring report, May 10, 1993--June 1, 1994

International Nuclear Information System (INIS)

1994-01-01

The Tennessee Department of Environment and Conservation (TDEC) DOE Oversight Division (DOE-O) monitoring effort will serve as oversight with ongoing compliance and ambient sampling by Oak Ridge Reservation (ORR), Department of Energy (DOE) and contractor staff programs. These sources provide a comprehensive database which must be reviewed and analyzed in order to streamline DOE-O sampling efforts. DOE-O monitoring is necessary to provide quality control, to ensure compliance, to ensure completeness, and to assure protection of public health and the environment. The Tennessee Oversight Agreement (TOA), includes a section on Environmental Monitoring as Attachment A. To accomplish these objectives, DOE-O will implement the following monitoring programs: surface waters; ground water; air; fish and wildlife. In addition, radiation monitoring has been conducted in all of these areas

Environmental Management Assessment of the Continuous Electron Beam Accelerator Facility (CEBAF)

International Nuclear Information System (INIS)

1993-03-01

This report documents the results of the Environmental Management Assessment performed at the Continuous Electron Beam Accelerator Facility (CEBAF) in Newport News, Virginia. During this assessment, activities and records were reviewed and interviews were conducted with personnel from the CEBAF Site Office; the CEBAF management and operating contractor (M ampersand O), Southeastern Universities Research Association, Inc. (SURA); the Oak Ridge Field Office (OR); and the responsible DOE Headquarters Program Office, the Office of Energy Research (ER). The onsite portion of the assessment was conducted from March 8 through March 19, 1993, by the US Department of Energy's (DOE's) Office of Environmental Audit (EH-24) located within the office of Environment, Safety and Health (EH). DOE 5482.1 B, ''Environment, Safety and Health Appraisal Program,'' and Secretary of Energy Notice (SEN)-6E-92, ''Departmental Organizational and Management Arrangements,'' establish the mission of EH-24 to provide comprehensive, independent oversight of Department-wide environmental programs on behalf of the Secretary of Energy. The ultimate goal of EH-24 is enhancement of environmental protection and minimization of risk to public health and the environment. EH-24 accomplishes its mission utilizing systematic and periodic evaluations of the Department's environmental programs within line organizations, and through use of supplemental activities which serve to strengthen self-assessment and oversight functions within program, field, and contractor organizations

AMTEX: A university, government, industry, partnership

Energy Technology Data Exchange (ETDEWEB)

Anderson, L.J. [Auburn Univ., AL (United States); Cheatham, R.L. [Pacific Northwest Lab., Richland, WA (United States); Peskin, A.M. [Brookhaven National Lab., Upton, NY (United States)

1993-12-01

The AMTEX Partnership is a research and development collaboration between the US Department of Energy (DOE), the DOE`s multiprogram laboratories, universities, and the integrated textile industry. The integrated industry includes fibers, textiles, apparel, and other fabricated products. The goal of AMTEX is to strengthen the competitiveness of this vital industry and thereby preserve and create new jobs. AMTEX is a role model for government, industry and universities working together to achieve a specified goal. Under the oversight of the Laboratory Technology Transfer Program in DOE`s Office of Energy Research, the multiprogram laboratories, universities and industry are pursuing a broad, industry-driven research agenda. It combines the research and development capabilities of industry and universities with the unique expertise and facilities of the DOE laboratory system.

Research and experience report 2016 - Developments in the technical and legal basis for nuclear oversight; Erfahrungs- und Forschungsbericht 2016 - Entwicklungen im Bereich der Grundlagen der nuklearen Aufsicht

Energy Technology Data Exchange (ETDEWEB)

NONE

2017-04-15

Projects in the research programme of the Swiss Federal Nuclear Safety Inspectorate (ENSI) contribute to the clarification of outstanding issues, establish fundamentals and develop the tools required for its regulatory activities. International projects deliver results that Switzerland could not achieve on its own and encourage cross-border networking. The research on fuels and materials covers the reactor core and the multiple barriers for the retainment of radioactive materials especially concerning high burn-up rates and safety criteria. In 2016, the Studsvik Cladding Integrity Project in Sweden commissioned a new test facility to investigate the behaviour of fuel rods in loss of coolant accidents (LOCA). Research into structural materials focuses on ageing processes. In the NORA project at the Paul Scherrer Institute (PSI), platinum is injected into the cooling system with a view to reducing corrosion. Projects conducted under the auspices of the OECD's Nuclear Energy Agency (NEA) and relating to internal events and damage encourage the international exchange of information on incidents, accidents and component damage. Subject-specific databases are created on incidents involving fires or damage to passive metal components. In 2016 the OECD CODAP project prepared a report on reliability and integrity management in pressurised components. ENSI supports research projects on external events such as earthquakes, flooding, aircraft crashes and explosions. Within the OECD MECOS project, the behaviour of pipes subjected to powerful earthquakes was modelled; it showed improvements in the calculation of cyclic loading and on the limits for simulating elastic-plastic material behaviour under high loads. The impact of operator actions on incidents and accidents is the most important human factor in view of reducing uncertainty in probabilistic safety analyses, as well as the interfaces between humans and technical systems. System behaviour and accident sequences in