Is National, independent oversight needed for the protection of human subjects?

Accountability in Research

Volumn 7, Issue 2-4, 1999, Pages 283-292

  Capron, Alexander Morgan ^a  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; DECISION MAKING; GOVERNMENT; GOVERNMENT REGULATION; HUMAN EXPERIMENT; LEGAL APPROACH; NATIONAL BIOETHICS ADVISORY COMMISSION; OFFICE FOR PROTECTION FROM RESEARCH RISKS; PEER REVIEW; POLICY; PROFESSIONAL STANDARD; SOCIAL CONTROL; STANDARD; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH; NATIONAL BIOETHICS ADVISORY COMMISSION; OFFICE FOR PROTECTION FROM RESEARCH RISKS;

ADVISORY COMMITTEES; DECISION MAKING; ETHICS COMMITTEES; ETHICS COMMITTEES, RESEARCH; FEDERAL GOVERNMENT; GOVERNMENT; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; PEER REVIEW; PUBLIC POLICY; REFERENCE STANDARDS; SOCIAL CONTROL, FORMAL; UNITED STATES;

EID: 0033291080     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989629908573959     Document Type: Article

References (11)

1. Recognizing that the ban on federal support for all forms of embryo research would mean that any attempt to apply to humans techniques like those that produced the famous sheep Dolly would take place in the private sector, we recommended a broad moratorium. But we also concluded that in the absence of a moratorium, any research trials of human cloning should be "governed by the twin protections of independent review and informed consent, consistent with existing norms of human subjects protection". CLONING HUMAN BEINGS: REPORT AND RECOMMENDATIONS OF THE NATIONAL BIOETHICS ADVISORY COMMISSION, Rockville, Maryland (June, 1997), at p. iv.
2. Sheryl Gay Stolberg, '"Unchecked' Research on People Raises Concern on Medical Ethics, " NY Times, 14 May 1997, at A1.
3. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, PROTECTING HUMAN SUBJECTS: THE ADEQUACY AND UNIFORMITY OF FEDERAL RULES AND THEIR IMPLEMENTATION, U.S. Government Printing Office, Washington, D.C. (1981) at p. 73.
4. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, PROTECTING HUMAN SUBJECTS: THE ADEQUACY AND UNIFORMITY OF FEDERAL RULES AND THEIR IMPLEMENTATION, U.S. Government Printing Office, Washington, D.C. (1981) at p. 73.
5. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, PROTECTING HUMAN SUBJECTS: THE ADEQUACY AND UNIFORMITY OF FEDERAL RULES AND THEIR IMPLEMENTATION, U.S. Government Printing Office, Washington, D.C. (1981) at p. 73.
6. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, PROTECTING HUMAN SUBJECTS: THE ADEQUACY AND UNIFORMITY OF FEDERAL RULES AND THEIR IMPLEMENTATION, U.S. Government Printing Office, Washington, D.C. (1981) at p. 73.
7. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, PROTECTING HUMAN SUBJECTS: THE ADEQUACY AND UNIFORMITY OF FEDERAL RULES AND THEIR IMPLEMENTATION, U.S. Government Printing Office, Washington, D.C. (1981) at p. 73.
8. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, PROTECTING HUMAN SUBJECTS: THE ADEQUACY AND UNIFORMITY OF FEDERAL RULES AND THEIR IMPLEMENTATION, U.S. Government Printing Office, Washington, D.C. (1981) at p. 73.
9. Under § 491 of the Health Research Extension Act of 1985, which updates provisions first enacted in the National Research Act of 1974 (including the requirements of prior IRB review and approval of protocols), the Secretary of HHS is required to have a "program... under which requests for clarification and guidance with respects to the ethical issues raised in connection with... research involving human subjects are responded to promptly and appropriately. " OPRR has not used this provision to establish a system of "appellate jurisprudence" or even publication of decisions about difficult or controversial protocols, which would foster a more nuanced and detailed understanding of the meaning and application of the Common Rule. OPRR has, from time to time, sponsored educational programs nationally and regionally.
10. In addition to a Human Subjects Protection Division, ORE would also have divisions dealing with laboratory animals and with scientific integrity; my discussion focuses solely on the first, which McCarthy divides into two branches, Education and Compliance.
11. On 8 July 1999 (after this article was in press) HHS Secretary Donna E. Shalala accepted the recommendation made to her on 3 June 1999 by the Advisory Committee to the Director, NIH, based on the report of the Office for Protection of Research Risks Review Panel, that OPRR be relocated in the Office of the Secretary. She also accepted the committee's recommendation that an independent advisory committee be established to provide scientific and ethical guidance to OPRR in its oversight role. Secretary Shalala also directed that the position of OPRR director be upgrade to Senior Executive Service level and that the resource needs of the office be reviewed as part of the relocation. See HHS Fact Sheet, protecting Research Subjects, U.S. Department of Health and Human Services, July 8, 1999.