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JUNE 11, 1998

Mr. Chairman and Honorable Members of this Subcommittee, I am Eric Meslin, Executive Director of the National Bioethics Advisory Commission, NBAC. I am pleased to have been invited to appear before you today to discuss NBAC's on-going work in the area of human subjects research. The subject of this hearing is very much in line with the NBAC's on-going interests in the structure and function of the federal system of overseeing human subjects research in this country, and we are pleased to know that the Office of the Inspector General has completed its report.

NBAC was established by President Clinton through Executive Order #12975, and met for the first time in October 1996. It is charged with advising and making recommendations to the National Science and Technology Council (NSTC), chaired by the President and to other appropriate government entities, regarding the appropriateness of governmental policies, guidelines, and regulations as they relate to bioethical issues arising from research on human biology and behavior.

The Commission also is charged with identifying broad principles to govern the ethical conduct of research. NBAC is not authorized to review or approve specific research projects. In addition to responding to requests for advice and recommendations from the NSTC, NBAC also may accept suggestions of issues for consideration from both the Congress and the public. In this spirit, the Commission has held its regular meetings both in the Washington DC area and in other parts of the country. These meetings are announced in advance in accordance with the Federal Advisory Committee Act. Public comments are invited at all Commission meetings and have proven to be very helpful. NBAC has established a which, as of Monday afternoon, had more than 32,000 visits since we first established the site in January of this year.

The Commission was directed by the President's Executive Order, as a first priority, to examine issues in the protection of human subjects. As this subcommittee is aware, the announcement in February 1997 of the birth of the apparently cloned sheep Dolly led the President to request that NBAC advise him within 90 days of the ethical, legal, and scientific issues arising from this technology. Once this report was completed, the Commission returned to its original agenda.

Mr. Chairman, NBAC's commitment to issues in human subjects research is evidenced in the resolution it adopted unanimously at its May 1997 meeting:

"No person in the United States should be enrolled in research without the twin protections of informed consent by an authorized person and independent review of the risks and benefits of the research."
In adopting this resolution, the Commission understood the opportunity it has to provide thoughtful and timely advice about a system that has been functioning for more than two decades. The Commission is currently completing two projects relating to human subjects research ethics, both of which address, in part, Institutional Review Boards. The first project is examining issues in research involving persons with mental disorders that may affect decision-making capacity. This population is felt by many to be doubly vulnerable: first, federal regulations do not explicitly provide protections specific to the needs of these individuals; indeed, one of NBAC's historical relatives, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, recommended more than two decades ago that individuals institutionalized as mentally infirm be afforded particular protections in regulation. Second, given the importance for scientific and medical progress on diseases such as schizophrenia and Alzheimer's, some of these individuals are vulnerable to discrimination because they lack the capacity to give an informed consent to participate in research. NBAC has heard testimony from investigators, clinicians, subjects of research, federal and state officials and regulators.

Although the Commission has not issued its final report on this subject--it will be releasing an interim report within the next three weeks on its website in order to solicit public comment, and a final report is expected in the Fall--there are a number of issues that NBAC has considered during the course of its deliberations. In the most recent staff draft to the Commission, which I hasten to add has not been adopted by the Commission as yet, the following recommendations have been proposed:

(1) The Common Rule should be amended to address a number of issues concerning this vulnerable population, one of which is a requirement to include on IRBs at least two members who are familiar with the nature of these disorders and with the concerns of this population, one of whom shall be a member of this population, or a family member or representative of an advocacy organization for this population. It has been proposed that, since it will take time to amend the Common Rule, the IRB system might adopt these recommendations on a voluntary basis.

(2) Other recommendations being considered for adoption by the Commission not related to the Common Rule include: the requirement that IRBs require of investigators that they justify the need for certain controversial study designs, for example, studies which provoke symptoms (challenge studies); that IRBs and the institutions in which they operate publicly disclose their policies and procedures that characterize key aspects of their work; that IRBs provide, on an annual basis, summary statistics regarding the overall scope and nature of their activities; and each institution with an IRB adopt appropriate internal audit procedures to assure itself that its IRB is complying with appropriate rules and regulations.

The Commission's second project underway is developing recommendations for the research use of human biological materials. Like the report on research involving persons with mental disorders, the study of human biological materials has raised important questions about the appropriateness of consent forms and the process used to obtain informed consent; and how institutional review boards assess the risks of non-physical harms, such as dignitary or psychosocial harms resulting from discrimination or stigmatization to individuals and groups. We expect this report to be available for public comment by early Fall.

The Commission's research agenda includes two other projects, both of which will involve consideration of human subjects issues generally, and IRB issues in particular. One of these focuses on international research, specifically the rules that ought to apply when the United States conducts or supports research in other countries.

The other project is a comprehensive assessment of the federal system of oversight of human subjects protections. We have already begun the first phase of this effort, by surveying federal agencies to determine the extent to which they are implementing the Common Rule. NBAC's report will also assess various structural aspects of the system, including the location and jurisdiction of oversight offices; whether reforms may be necessary to the existing IRB system; and whether the existing system should be extended to protect research subjects in non-federally funded research. This project is scheduled to be completed by the Spring of 1999.

Thank you very much, Mr. Chairman. I would be pleased to answer any questions you may have.


Eric M. Meslin, Ph.D
Executive Director
National Bioethics Advisory Commission
6100 Executive Blvd. Suite 5B01
Rockville, MD 20892-7508
(301) 402-4242 (phone)
(301) 480-6900 (fax)


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