RAC Oversight of Gene Transfer Research: A Model Worth Extending?

2002 ◽  
Vol 30 (3) ◽  
pp. 381-389 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Gene Transfer ◽  
Recombinant Dna ◽  
Human Subjects ◽  
The United States ◽  
Layered System ◽  
Institutional Review ◽  
Research Oversight ◽  
Significant Addition ◽  
Protection Of Human Subjects ◽  
Oversight System

Clinical gene transfer research (GTR) has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee (RAC). This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board (IRB) whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration (FDA).

scholarly journals The Suitability of IRB Liability

2005 ◽  
Vol 67 (2) ◽  
Author(s):  
Sharona Hoffman ◽  
Jessica Wilen Berg
Keyword(s):  
United States ◽  
Biomedical Research ◽  
Clinical Studies ◽  
Human Subjects ◽  
The United States ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Institutional Review ◽  
Research Oversight ◽  
Oversight System

The biomedical research oversight system in the United States delegates most responsibilities to local review entities known as institutional review boards (IRBs). The IRBs are charged with responsibility for safeguarding the welfare of research participants and ensuring that clinical studies involving human subjects comply with federal regulations.

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

2004 ◽  
Vol 12 ◽  
pp. 65 ◽  
Author(s):  
Frederic Jacobs ◽  
Arina Zonnenberg
Keyword(s):  
Behavioral Treatment ◽  
Human Subjects ◽  
Financial Burden ◽  
The United States ◽  
Research Activities ◽  
Policies And Procedures ◽  
The Social ◽  
Research Oversight ◽  
Protection Of Human Subjects ◽  
The Impact

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.

Revolution or Reform in Human Subjects Research Oversight

2012 ◽  
Vol 40 (4) ◽  
pp. 922-929 ◽  
Author(s):  
Steven Joffe
Keyword(s):  
New England ◽  
Human Subjects ◽  
The United States ◽  
National Commission ◽  
Human Subjects Research ◽  
Prior Review ◽  
Independent Review ◽  
Protection Of Human Subjects ◽  
Oversight System ◽  
The U.S

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service (PHS) in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report.

Research Ethics as Social Policy. Some Lessons from Experiences in Canada and in the United States

2003 ◽  
Vol 24 (2) ◽  
pp. 61-85
Author(s):  
Michael McDonald ◽  
Eric Meslin
Keyword(s):  
United States ◽  
Human Subjects ◽  
Ethics Committees ◽  
The United States ◽  
Prior Review ◽  
Emerging Trends ◽  
Policies And Procedures ◽  
Behavioural Research ◽  
Individual Informed Consent ◽  
Protection Of Human Subjects

For more than tlrree decades, Canada and the United States have used similar mechanisms for ensuring the protection of human subjects involved in biomedical and behavioural research: written guidelines that specify the substantive and procedural requirements of investigators and institutions; individual informed consent, and prior review and approval by interdisciplinary committees. Given the proximity of the countries to one another and the massive amount of trade and commerce that transpires between them, it is not surprising that these countries share a number of values in research. During the past fifteen years, however, both countries have experienced new challenges to their systems. Sorne of the challenges relate to new trends in research, such as genetics studies and massively increased private sector funding for pharmacological research. Other challenges relate to emerging trends in oversight policies and procedures, such as accreditation of ethics committees. Research reflects a country's particular social policies. The responses to emerging trends illustrate how such policies are evolving in sometimes quite different ways in both countries. This reflects the related but distinct political cultures and structures in the two countries. This paper will explore these trends and emerging responses, drawing lessons from each.

Biobanking Research and Privacy Laws in the United States

2016 ◽  
Vol 44 (1) ◽  
pp. 106-127 ◽  
Author(s):  
Heather L. Harrell ◽  
Mark A. Rothstein
Keyword(s):  
Human Subjects ◽  
The United States ◽  
Common Rule ◽  
State Laws ◽  
Privacy Rule ◽  
Biobank Research ◽  
Privacy Laws ◽  
The Us ◽  
Protection Of Human Subjects ◽  
Hipaa Privacy Rule

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

Educational Research and the Protection of Human Subjects

1977 ◽  
Vol 2 (2) ◽  
pp. 477-519 ◽  
Author(s):  
Benjamin S. DuVal
Keyword(s):  
Educational Research ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Legal Restrictions ◽  
Research On Human Subjects ◽  
Protection Of Human Subjects ◽  
Judicial Recognition ◽  
Review Boards

Educational research is increasingly subject to legal restrictions designed for the protection of human subjects of research. In this article the author discusses legal restrictions–both in the courts and under HEW regulations–on educational research, comparing these restrictions with those on biomedical research. He finds that although educational research in particular instances may give rise to suits for damages for invasion of privacy or intentional infliction of psychological distress, the legal issues relating to educational research will most often be resolved in proceedings before institutional review boards charged by HEW with the responsibility for passing upon proposals to conduct research on human subjects. He argues that the interests protected in proceedings before institutional review boards are not limited to those that have received judicial recognition in suits for damages. The author finds that the requirement that the informed consent of subjects be obtained presents difficult issues for educational research. He notes in particular the problems presented by research proposals that as an element of the research design contemplate the observation of subjects without their knowledge and the use of children as research subjects.

Pediatric Participation in Non-Therapeutic Research

2012 ◽  
Vol 40 (3) ◽  
pp. 665-672 ◽  
Author(s):  
Marilyn C. Morris
Keyword(s):  
Medical Condition ◽  
Human Subjects ◽  
National Commission ◽  
Institutional Review Boards ◽  
Minimal Risk ◽  
Research Risks ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
A Minor ◽  
Therapeutic Research

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards (IRBs) to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses (Table 1).

scholarly journals Regulatory flexibility for COVID-19 research

2020 ◽  
Vol 7 (1) ◽  
Author(s):  
Holly Fernandez Lynch ◽  
Neal W Dickert ◽  
Patricia J Zettler ◽  
Steven Joffe ◽  
Emily A Largent
Keyword(s):  
Human Subjects ◽  
Improve Patient Care ◽  
Institutional Review Board ◽  
Emergency Research ◽  
Regulatory Requirements ◽  
High Quality Evidence ◽  
Institutional Review ◽  
Research Oversight ◽  
Regulatory Flexibility ◽  
Improve Patient

Abstract Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding institutional review board (IRB) review and approval, informed consent, emergency research, and research involving incarcerated people. Our proposals for regulatory flexibility in these areas seek to satisfy the goals of protecting participants and promoting the development of high-quality evidence to improve patient care. These recommendations may have relevance beyond the COVID-19 pandemic to enhance the efficiency of research oversight and participant protection more broadly.

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