Public Citizen Health Research Group Criticizes DHEW/FDA Proposed Regulations

Public Citizen Health Research Group Criticizes DHEW/FDA Proposed RegulationsSource: IRB: Ethics and Human Research, Vol. 2, No. 3 (Mar., 1980), pp. 9-10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564494 .

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March 1980

advisable. The principal investigator will be invited to appear before the group as it meets to present any information desired and will be allowed to bring any witness he or she feels may add strength to the case. The decision of the two boards will be final and any ruling will be carried out under the same organizational structure as that established for monitoring the decisions of either committee separately.

G. A State University The principal investigator may ap-

peal the decision of the review committee when a protocol has been disap- proved or approved conditionally and mutual agreement cannot be reached as to an acceptable alternative. Upon written notification of appeal from the principal investigator, the review committee can either refer the protocol to the Policy Coordinating Committee for a second review or name an ad hoc committee of three or more faculty and/or consultants to review the protocol a second time. The composition of the ad hoc committee must be mutu- ally acceptable to the principal investigator and the review committee. In any case, the protocol will be reviewed in accordance with established guidelines and the decisidn of the Pol- icy Coordinating or ad hoc review committee will be final.

H. A Seven-Campus University Operat- ing under one General Assurance

1. Any investigator may appeal a decision of a review panel to the IRB. Any two members of a reviewing panel may request review of a decision within one month of receipt of such requests for review by the executive secretary.

2. Ad hoc subcommittees may be ap- pointed when considered appropriate for reconsideration, but no member of the original review panel can serve as part of the quorum on such a subcommittee or review panel, whichever method is used. Quorum and represen- tation requirements shall be described for original review in other sections. Any member of the full committee, however, is free to attend and participate in the discussion at the meeting.

The investigator may present in per- son to the committee information he or she believes relevant, but the investigator will be excluded from the committee's final discussion of action to be taken.

3. Action by the review panel or ad hoc subcommittee may be appealed to the full committee, whose action shall be final, except that such action may be reported to DHEW, which may request additional information or review.

4. Action taken by the review panel, subcommittee and/or full committee shall be reported by the executive secretary to the investigator and to each committee member.

These examples of appeals procedures show that institutions have a fairly wide range of options. To incor- porate an appeals procedure into a general assurance, the institutional official responsible for research should submit a statement to the OPRR describing the proposed procedure. As long as the procedure does not allow an im- properly accredited board power to override IRB decisions or as long as the original IRB retains final authority to approve (i.e., the appeal is advisory to the original IRB), the procedure should

be acceptable. OPRR expects that the procedures will be in accord with local institutional policies developed to en- sure appropriate due process and that they are acceptable to the IRB. REFERENCES 'Cooke, R.A.; Tannenbaum, A.S.; and Gray, B.;

A survey of Institutional Review Boards and research involving human subjects. In Commis- sion: Report and Recommendations: Institu- tional Review Boards, Appendix. U.S. DHEW Publication No. (OS) 78-0009, pp. 1-34 and 1-35, Washington, 1978.

2Commission: Report and Recommendations: In- stitutional Review Boards. DHEW Publication No. (OS) 78-0008 pp. 36-37, Washington, 1978.

3DHEW: Proposed regulations amending basic HEW policy for protection of human subjects. Federal Register 44 (No. 158), 47688-47698, August 14, 1979 (proposed rule).

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Public Citizen Health Research Group Criticizes DHEW/FDA Proposed Regulations

According to comments filed by the Public Citizen Health Research Group with the Office of Protection from Re- search Risks, the DHEW and FDA proposed regulations for protection of human research subjects would "en- danger participants in experiments and the general public in a disturbing number of respects." The comments, signed by Robert B. Leflar, Staff At- torney, and Sidney M. Wolfe, M.D., Di- rector, describe the proposed rules as a "significant retreat" from the ethical principles and recommendation of the National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research.

Citing testimony before the Senate Health Subcommittee in October 1979 that demonstrated disregard of ethical principles in drug testing, the Health Research Group calls for stricter rules governing research than those proposed.

The proposals governing IRBs, the group asserts, would "permit waivers of all requirements for IRB oversight in a significant category of potentially dangerous drug and medical device experiments"-phase 3 drug and device tests. Furthermore, the proposals would "perpetuate researcher domi- nation of review boards." Study pro-

tocols could be approved without a determination that treatment of test subjects' injuries would be provided, and without requiring proper follow- up.

In addition, the Health Research Group states, the rules might allow "disproportionate numbers of vulnera- ble subjects" to participate in research without justification. The rules "appear to condone, on a routine basis, testing of medical products providing no benefits whatever to test subjects beyond those available with existing approved therapy." Nor would the rules require continuing review so that subjects could receive knowledge gained from the research in order to choose whether or not to continue.

The proposals are described as "woefully inadequate" in the area of informed consent. They would not give test subjects adequate information about risks and benefits of experimental procedures and alternatives to enable the subjects to make informed choices; neither quantified risk/benefit comparison nor public information about FDA's assessments of new drugs' therapeutic significance would be made routinely available. According to the comments, subjects in DHEW-sup- ported research would receive even less information than under the FDA rules.

The proposed rules, the comments continue, make no effort to carry out the National Commission's recommendation that all information be commu- nicated to subjects in "language they can understand." The use of a "short

9



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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."

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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 ethics 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 subjects, 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) proposed 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 regulations, and to alert you to the publication of final regulations governing the clinical investigation of medical de- vices.

During September and October, FDA held three public hearings on the proposals, 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 addition, 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 regulations 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 meeting 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, director 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 research 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.



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Public Citizen Health Research Group Criticizes DHEW/FDA Proposed Regulations