US and UK policies governing research with humans

Maschke, Karen J.

doi:10.1007/s00213-003-1666-9

Cited by 3 publications

(4 citation statements)

References 15 publications

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“…This regulation differs in other countries. For example, in the UK, the chair of the central ethics committee initially conducts the continuing review of a study and may decide, based on that review, that it does not require a full-board review (e.g., there have been no protocol amendments and a Data and Safety Monitoring Committee has indicated that there were no safety concerns) [19]. …”

Section: Problem 1: Continuing Reviews and Equivalent Protectionsmentioning

confidence: 99%

Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

et al. 2010

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Background A number of reports have highlighted problems of conducting publicly funded trials in Europe as a consequence of the European Union (EU) Clinical Trials Directive. The impact of the EU Directive on multi-national trials, which include sites in Europe that are funded by the US National Institutes of Health (NIH) have not been described. Methods Four problems in the conduct of two international HIV treatment trials funded by NIH in the EU are described: (1) conflicting regulations on the continuing review of protocols by Institutional Review Boards/Research Ethics Committees; (2) US regulations requiring Federalwide Assurances for sites which are only partially funded by NIH; (3) EU guidance on the designation of studies as a trial of an investigational medicinal product; and (4) EU guidance on trial sponsorship and the requirements for insurance and indemnification. Following the description of the problems, recommendations for improving global collaborations are made to the US Office of Human Research Protections, to NIH, and to the EU and its Member States. Results A lack of harmonization of regulations at multiple levels caused enrollment in one study to be interrupted for several months and delayed for one year the initiation of another study aimed at obtaining definitive evidence to guide the timing of the initiation of antiretroviral therapy for individuals infected with HIV. The delays and the purchase of insurance resulted in substantial increases in trial costs and caused substantial disruption at clinical sites among staff and study participants. Limitations The problems cited and recommendations made pertain to trials funded by NIH and conducted by sites in the EU. There are many other challenges in the conduct of international research, public and private, that global harmonization would alleviate. Conclusions Disharmony, at multiple levels, in international regulations and guidelines is stifling publicly funded global research. International scientific organizations and government groups should make the documentation and solution of these problems a priority.

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Section: Problem 1: Continuing Reviews and Equivalent Protectionsmentioning

confidence: 99%

Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

et al. 2010

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“…Ethical Conduct for Research Involving Humans with other countries implementing similar but not identical regulatory policies 6,7,8 .…”

Section: Introductionmentioning

confidence: 99%

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

Shiloff¹,

Magwood²,

Malisza³

2011

Camb Q Healthc Ethics

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The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).

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confidence: 99%

“…IRBs operate behind closed institutional doors and often report to the research office that promotes research and seeks funding for it-an institutional conflict of interest (Maschke, 2003). How is it possible that a profession with a tarnished human rights record became the ethical gatekeepers in research?…”

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confidence: 99%

Human Rights and the Failure of Research Governance

Wilson

2007

Journal of Disability Policy Studies

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and where the medical model of disability and an interventionist research trend has a strong presence. These governance bodies are part of a self-regulating professional culture that has been passive regarding the rights of research participants and whose values about what is appropriate research, who should bear the risks in research, and whether the risks are morally acceptable continue to clash with ethical codes (Sharav, 2003;Waring & Lemmens, 2004;Weijer, 2002).IRBs operate behind closed institutional doors and often report to the research office that promotes research and seeks funding for it-an institutional conflict of interest (Maschke, 2003). How is it possible that a profession with a tarnished human rights record became the ethical gatekeepers in research? The answer is that the medical profession is a powerful lobbying group and government was deferential to its self-regulating research interests (Sharav, 2003;Waring & Lemmens, 2004;Weijer, 2002).Related to this governance climate is the discipline of biomedical ethics. Singer rightly notes that the discipline is not homogenous in its ethical views. However, it did share a broad-based human rights pulse in its infancy that stemmed from concerns over research exploitation and abuse (Annas, 2005;Katz, 1993;Rothman, 1991). That pulse weakened over the years, and medical ethics never became an effective institutional human rights force within research centers. This is not to suggest that biomedical ethics lacks influence. Bioethics programs exist in leading academic research centers, and medical ethicists serve on national committees that inform public policy. But the human rights focus in medical ethics became less sharp in its institutional homes as the discipline became integrated into what is called the industrial medical research complex. Leading bioethics centers receive funding from corporate research sponsors, and ethics has become an effective marketing tool to recruit research participants and to promote research technology (Elliott, 2001). Universities, hospitals, and staff have become entrepreneurial and are producing, testing, and taking out patents on drugs and medical devices and advertise to recruit research participants by noting that research has been approved by a research ethics committee (Wilson, 2004). There is also a trend in

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US and UK policies governing research with humans

Cited by 3 publications

References 15 publications

Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

Human Rights and the Failure of Research Governance

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