00-32200. National Bioethics Advisory Committee Request; International Research Ethical and Policy Issues; Comment Request

ACTION:

Notice for comment on the draft report of the National Bioethics Advisory Commission (NBAC), Ethical and Policy Issues in the Oversight of Human Research.

SUMMARY:

Pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is given for comment on a draft report written by the National Bioethics Advisory Commission (NBAC). The Commission will consider all comments it receives as part of its ongoing deliberations in finalizing this report.

Purpose of the Report

In October 1995, President Clinton established NBAC to advise on bioethics and public policy issues related to conducting human research. NBAC makes recommendations to the White House and other departments and agencies. This report, therefore, falls within NBAC's mandate.

Prior to NBAC's creation, in 1994, the Advisory Committee on Human Radiation Experiments (ACHRE) was created to investigate reports of federally sponsored human research involving radioactive materials and to assess the current state of protections for research participants. With regard to the latter charge they found, “evidence of serious deficiencies in some parts of the current system.” Specifically, ACHRE was concerned with variability in the quality of IRBs, persistent confusion among human participants as to whether they were involved in research or therapy, and insufficient attention to the implications of diminished decision-making capacity in the consent process. ACHRE also recommended the creation of a national advisory group to examine these issues. When NBAC was established, one of its first priorities was to examine the system for protecting human research participants.

In May of 1997, NBAC unanimously resolved that “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.” The following year, NBAC wrote to the President indicating areas of concern and preliminary findings regarding the oversight of human research in the United States. The key concerns identified were:

• Federal protections for persons serving as subjects in research do not yet extend to all Americans.
• Despite widespread implementation of federal regulations by those departments and agencies sponsoring substantial amounts of biomedical research, a number of departments and agencies who sponsor primarily non-biomedical research or little research overall have failed to implement fully these federal protections.
• Federal protections do not always include specific provisions for especially vulnerable populations of research subjects.
• Many federal agencies find the interpretation and implementation of the Common Rule confusing and/or unnecessarily burdensome.
• Federal protections are difficult to enforce and improve effectively throughout the Federal Government, in part because no single authority or office oversees research protections across all government agencies and departments.
• New techniques are needed to ensure implementation at the local level.

In October 1999, Dr. Neal Lane, Assistant to the President for Science and Technology, reinforced the request that NBAC examine the federal system of oversight. This report addresses the basic purpose, structure, and implementation of research oversight. We recommend broad, strategic changes to the oversight system. This report is not intended to be a rewrite of federal regulations but instead to provide the guidance, direction, and justification for change. Providing Comments to the Draft Report.

You may provide written comments electronically or through mail or fax. Electronic submissions (by email or by website) are preferred as they will be processed more efficiently. The following are addresses for submitting comments: e-mail: [e-mail], NBAC website: www.bioethics.gov,, mail: 6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979, fax: [phone].

If your comments are not postmarked by February 17, 2001, we can not guarantee they will be given full consideration.

TO RECEIVE A COPY OF THIS DRAFT REPORT CONTACT:

National Bioethics Advisory Commission, 6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979, telephone [phone], fax number [phone], or visit the website at www.bioethics.gov.

SUPPLEMENTARY INFORMATION:

The President established the National Bioethics Advisory Commission (NBAC) on October 3, 1995 by Executive Order 12975 as amended. The mission of the NBAC is to advise and make recommendations to the National Science and Technology Council, its Chair, the President, and other entities on bioethical issues arising from the research on human biology and behavior, and from the applications of that research.

Dated: December 13, 2000.

Eric M. Meslin,

Executive Director, National Bioethics Advisory Commission.