can investigators appeal adverse irb decisions?

Can Investigators Appeal Adverse IRB Decisions?Author(s): Natalie ReatigSource: IRB: Ethics and Human Research, Vol. 2, No. 3 (Mar., 1980), pp. 8-9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564493 .

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INQUIRY Can Investigators Appeal Adverse IRB Decisions?

by Natalie Reatig

Although current regulations do not specifically address the issue of appeals procedures, a careful reading of the text at 45 CFR 46.118 reveals the general acceptability of such a mechanism:

Board disapprovals, restrictions, or conditions cannot be rescinded or removed except by action of a Board described in the assurance approved by DHEW. (emphasis added) The Office for Protection from Re-

search Risks (OPRR) at NIH estimates that approximately 65 percent of institutions with general assurances have included in their assurance statements some procedure for appeal by investigators. The Report on Institutional Review Boards submitted to the Na- tional Commission for the Protection of Human Subjects of Biomedical and Be- havioral Research found that 13 percent of the sample of IRBs surveyed automatically provided a second review for rejected proposals. Almost half (48 percent) of the IRBs reported allowing investigators to appeal their decisions. "The group or individual to whom appeal was to be made varied widely among institutions-appeals might be made to various individuals and groups, including, in some cases, the board which originally rejected the proposal. Half of those comittees which had had decisions appealed within the past year had a rejection reversed by subsequent review."' Appeals procedures were reported most frequently from institutions for the mentally in- firm and from universities.

The Commission did not recommend a special mechanism for appeals in its report on IRBs. To maintain respect for the IRB's proper authority, they sug- gested that appeals processes should "be restricted to investigation of preju- dice or unfairness and that the appeals board not be given authority to conduct a secondary review of the protocol or to reverse the IRB decision."2

The DHEW proposed rulemaking on IRBs3 makes no mention of appeals procedures; the language of 46.118 has not been retained in the new draft. The OPRR considers that the language of

proposed 46.108 implicitly allows what is explicit in 46.118. Apparently DHEW does not intend to prohibit institutions from utilizing appropriately constituted appeals mechanisms; there- fore, I hope that the final regulations will speak more directly to this matter.

It is generally recognized that, although institutions may have the final authority to refuse to support or allow the conduct of research which has been approved by the IRB, the power to approve and sanction research rests ex- clusively with the IRB. Appeals procedures are currently acceptable to OPRR only if the final decision to approve research is made 'by a properly constituted IRB-either the original IRB or one that has been approved by OPRR for this purpose. Most appeals procedures call for a second body to review the proposal and make a recommendation to the original IRB for a reconsideration of their finding.

The OPRR does not require the in- clusion of an appeals procedure in a general assurance; on occasion, they will suggest that an institution might want to consider establishing one. Since an appeals procedure is not required in a general assurance, it is likely that many institutions have such a mechanism but have not described it in their assurance document. Some examples of procedures which have been described follow:

A. An Institution for the Mentally Retarded

If the investigator and the committee are unable to reach a satisfactory reso- lution of disputed issues, the investigator can present the issue to the director of the center or superintendent of the school. The director or superintendent shall, upon the request of the investigator, appoint an' ad hoc committee of three, none of whom shall be school or center staff, to review the matter. This ad hoc committee shall make recommendations to the Human Studies Committee for considerations. Com- mittee disapprovals or restrictions are binding and can be removed only by action of the committee. Committee approvals and favorable actions are subject to disapproval or restriction by the director or superintendent. B. An Institute for Social Behavior Research

Adverse decisions of the IRB regard- ing any proposed activity may be appealed to the IRB by the principal investigator through the executive director of the institute. The executive director reserves the right to review all

proposed modifications and/or additional information provided by the principal investigator and to request additional review by the IRB. The executive director may determine that such modifications and/or additional information may not be presented to the IRB for examination and a review of a prior decision. Adverse decisions or restrictions imposed by the IRB can be reversed or modified only by a two- thirds majority of the IRB.

The findings of the IRB are final, except that the executive director may impose more stringent restrictions than those required by IRB approval, if, in his or her opinion, such additional restrictions are needed to provide adequate protection to human subjects.

C. A Medical Research Institution Unfavorable recommendations, re-

strictions, or conditions cannot be removed except by the IRB. Appeals may be made through the office of the president or other delegated official for reconsideration by the committee as the final authority for granting accept- ances.

D. A Hospital and Medical Center Adverse decisions of the IRB regard-

ing any proposed activity may be appealed by the principal investigator through the director of research. Ad- verse decisions or restrictions imposed by the IRB, however, can be reversed or modified only by a two-thirds majority of the IRB.

E. A State University All statements requiring modifica-

tion or denial of an application shall contain specific committee (IRB) sug- gestions to the applicant and a brief statement of appeal procedure. [This example demonstrates the liberal policy of the OPRR in accepting any appeals procedure developed by an IRB in cases where the final authority re- mains with that IRB. Although it is not clear from the text, the OPRR assured me that this is the case here. It is also interesting to note the self-imposed ob- ligation by this IRB to inform investigators of the existence of the appeals procedure.]

F. A State University Principal investigators disagreeing

with a ruling of the IRB may appeal the ruling to the vice-president for research. The vice-president will then convene a joint meeting of both com- mittees and such members of the ad- ministration or specialists in the par- ticular discipline involved as may seem

Natalie Reatig is a Health Science Administrator, Division of Extramural Research Programs, Na- tional Institute of Mental Health.



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 experi- mental 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

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can investigators appeal adverse irb decisions?

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