In Transition: Ethics Advisory Board &President's CommissionAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 2, No. 3 (Mar., 1980), p. 10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564495 .

Accessed: 17/06/2014 21:06

Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at .http://www.jstor.org/page/info/about/policies/terms.jsp

.JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range ofcontent in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new formsof scholarship. For more information about JSTOR, please contact support@jstor.org.

.

The Hastings Center is collaborating with JSTOR to digitize, preserve and extend access to IRB: Ethics andHuman Research.

http://www.jstor.org

This content downloaded from 185.44.77.34 on Tue, 17 Jun 2014 21:06:16 PMAll use subject to JSTOR Terms and Conditions

"a 3 NZ.IP

form consent" would provide no sub- stantive written information about the research and would be a "travesty" of the consent process. The rules would not even provide a period of time in which potential subjects could con- sider and consult with others about whether to participate in the research.

Unless these severe deficiencies are corrected, Leflar and Wolfe conclude, "the agencies' retreat from the ethical principles and recommendations set out by the National Commission will constitute a grave disservice to the cause of protection of the rights of human experimental subjects."

io

In Transition: Ethics Advisory Board & President's Commission

DHEW's Ethics Advisory Board will be winding up its work this spring, having lost its funding (see "Update," IRB, February 1980, p. 8). Some, but not all, of its functions will be taken over by the President's Commission for the Study of Ethical Problems in Medi- cine and Biomedical and Behavioral Research.

At its first meeting on January 14, the eleven-member President's Commis- sion reviewed its Congressional man- date, which calls for it to examine broad policy questions such as the eth- ics of gaps in the availability of health care in the United States determined by income or residence, ethical issues in genetic screening and prenatal diag- nosis, informed consent, and definition of death. The commission agreed to take up in addition the question of compensation for injured research sub- jects, which had been on the EAB agenda at the request of Secretary Pa- tricia Harris.

At its February 1-2 meeting, the EAB expressed its willingness to do prelimi- nary work on the subject, and to turn over its work to the President's Com- mission. The EAB expects to continue its review of the proposals by the Cen- ter for Disease Control and the Na- tional Institutes of Health for limited exemptions to the Freedom of Informa- tion Act at its March meeting (see Cal- endar).

What will happen to the EAB's pri- mary function-reviewing research protocols that require approval by a national ethics advisory board? No clear answer has emerged. The Presi- dent's Commission has said that it will not take on this role. One possibility is that NIH will create an ad hoc panel each time such a protocol comes up for review.

Carol Levine

S TTERS

A Letter from the FDA on the 'Transition Period'

Following the publication of FDA's IRB and Informed Consent (IC) pro- posed regulations on August 14, 1979, both FDA and HEW mailed copies to individuals and organizations and made available on request a side-by- side comparison of the two proposals.

The purpose of this letter is to update you on what happened in the IRB/IC area since then, to let you know our plans for the development of final regu- lations, and to alert you to the publica- tion of final regulations governing the clinical investigation of medical de- vices.

During September and October, FDA held three public hearings on the pro- posals, and a representative of HEW participated on the hearing panel. The exchange of views was 'very helpful in clarifying issues and in understanding various points of view.

We are now in the first stages of ana- lyzing over 200 written comments on the proposals. As we stated previously, FDA and HEW will jointly review the comments we have received. In addi- tion, we have agreed to attempt to rec- oncile the outstanding differences in our regulatory approach to IRBs in-

cluding the development of a common regulatory framework.

If, during the course of our review and analysis, it appears advisable to have further limited public discussion of specific topics, FDA and HEW will jointly sponsor such a meeting before the regulations are drafted in final form for approval by the Commissioner of FDA and the Secretary of HEW.

One final item. The FDA will very shortly publish in the Federal Register final regulations governing investiga- tional device exemptions (IDE). Those medical device regulations of necessity require IRB and IC sections in order to be completely operative. The Agency could not reasonably defer publication of the IDE regulations until the general IRB and IC regulations are finalized. You will notice that the IDE regulation does not reflect many of the provisions found in the August 14, 1979, IRB/IC proposals. These differences should not be taken to mean that we have made any decisions on the form or content of the Agency-wide IRB/IC regulations. The IRB/IC provisions found on the IDE regulation should be viewed as in- terim guidance to IRBs functioning in the review of medical device studies. Once FDA publishes final IRB/IC regu- lations later this year, they will replace those contained in the IDE regulations.

CALENDAR

MARCH 14-15(tentative): The Ethics Advisory Board will hold a public meet- ing to continue its discussions on exemptions from the Freedom of Informa- tion Act and compensation for injured research subjects. For more information, contact Amanda MacKenzie, Westwood Building, Room 125, 5333 Westbard Avenue, Bethesda, MD 20016; phone (301) 496-7526.

MARCH 27-28: A Conference on "Federal Regulations and Institutional Re- view Boards" will be held at the Harvard School of Public Health in Boston. Sponsored by Public Responsibility in Medicine and Research, the conference will focus on understanding, communicating, and implementing the content of federal regulations. Among the speakers will be Dr. Charles McCarthy, di- rector of the Office for Protection from Research Risks, DHEW; Dr. Robert Levine, editor of IRB: A Review of Human Subjects Research, and chairman of the IRB at Yale; Edward L. Pattullo, chairman of the IRB at Harvard, and Judith P. Swazey, director of Medicine in the Public Interest. In addition, other experts in the fields of research, regulation, industry, bioethics, and re- search administration will participate in small group discussions, topical workshops, and plenary sessions. For more information, contact Joan Rachlin, Executive Director, PRIM&R, 65 Franklin Street, Suite 402, Boston, MA 02110; phone (617) 426-4401; or 482-5656.

This content downloaded from 185.44.77.34 on Tue, 17 Jun 2014 21:06:16 PMAll use subject to JSTOR Terms and Conditions