Protect all participants, not just some of them
Final recommendations released in late summer
All human research participants should be afforded equal protection and welfare, not just those enrolled in federally-funded clinical trials. That’s the key conclusion from the National Bioethics Advisory Commission (NBAC) when it publishes the final version of a report later this summer. The commission reviewed the effectiveness of the current oversight system in preparation for its report: Ethical and Policy Issues in Research Involving Human Participants. The report will be sent to President Bush upon publication, says Eric M. Meslin, PhD, executive director of the Bethesda, MD-based NBAC.
The NBAC conducted a comprehensive examination of the various aspects of the oversight system, including the purpose and structure of research oversight, ethical issues relevant to research review, and the local structures. A result of the review is a set of recommendations that will be included in the report.
The proposals, according to Meslin, serve two purposes. First, they ensure the protection of those who volunteer for research. Secondly, they support the continued advance of science through research. "The recommendations view the oversight system as a whole, while providing a rationale for change and offering an interrelated set of proposals to improve the protection of human participants and enable the oversight system to operate more efficiently," he adds.
The report reflects four key concerns the NBAC initially identified in 1997:
• not all research participants are protected by the federal oversight system;
• a number of federal departments and agencies that sponsor primarily nonbiomedical research or modest amounts of research have failed to fully implement federal protections;
• federal protections do not always include specific provisions for especially vulnerable individuals;
• federal protections are difficult to enforce and improve effectively across the government because in part no single authority or office oversees research across all agencies and departments.
Because there currently is no entity with the authority to develop federal policy among the 17 agencies that are involved in human research, the NBAC will ask that legislation establish a single, independent federal office. The office, notes Meslin, would have responsibility for policy development, regulatory reform, research review and monitoring, research ethics education, and enforcement — "all vital parts of the oversight system," he says.
[Editor’s note: Ethical and Policy Issues in Research Involving Human Participants will be published later this summer. The recommendations also are available on-line. Web: www.bioethics.org. To obtain paper copies, contact the National Bioethics Advisory Commission, 6705 Rockledge Drive, Suite 700, MSC 7979, Bethesda, MD 20892-7979. Telephone: (301) 402-4242. Fax: (301) 480-6900.]
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