National, independent oversight: Reinforcing the safety net for human subjects research*

This paper was originally presented at the 2nd National Ethics Conference on Research Involving Persons with Mental Disorders that may Affect Decisionmaking Capacity in Baltimore, MD, November 15, 1998. It has been modified in light of the subsequent finalization of the NBAC report, “Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity”; to accurately reflect the final recommendations contained therein.

National, independent oversight is vital to resolve the problems and inconsistencies in oversight of human subjects research. Three key functions that must be considered in any proposal for such a mechanism are (1) issue spotting, (2) guidance on identified issues, and (3) sampling and follow‐up. The 1998 report and recommendations of the National Bioethics Advisory Commission concerning research involving persons with mental disorders that may affect decisionmaking capacity address these functions in part, but application is limited to a small segment of the research population. Incorporation of these three key functions in a formal, national, independent oversight process is necessary in order to ensure accountability and maintain public trust in research.

Keywords:

• Ethics
• human subjects research
• oversight
• regulation
• NBAC
• government

Notes

This paper was originally presented at the 2nd National Ethics Conference on Research Involving Persons with Mental Disorders that may Affect Decisionmaking Capacity in Baltimore, MD, November 15, 1998. It has been modified in light of the subsequent finalization of the NBAC report, “Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity”; to accurately reflect the final recommendations contained therein.

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