irb jurisdiction and limits on irb actions

IRB Jurisdiction and Limits on IRB ActionsAuthor(s): Nathan HersheySource: IRB: Ethics and Human Research, Vol. 7, No. 2 (Mar. - Apr., 1985), pp. 7-9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564145 .

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March/April 198S

IRB Jurisdiction and Limits on IRB Actions by Nathan Hershey

In their article in the July/August 1984 issue of IRB: A Review of Human Subjects Research, Cristina Cann and Kenneth Rothman describe practices of some IRBs in connection with epidemiologic research. The authors charge IRBs with imposing unjustified requirements or conditions (those not required by the current federal regulations). They call on investigators to challenge aggressively imposition of such requirements on their research, both to minimize their own burdens and to avoid precedents that will be adverse to other investigators.

Cann and Rothman have highlighted two difficult issues confronting IRBs: deciding whether a proposal requires review and, what, if anything, an IRB should do when a proposal meets the exemption criteria, but contains deficiencies that the IRB believes should not be ignored.

Jurisdiction of the IRB

Federal regulations exempt certain research activities from review.1 In- cluded as exempt is research involving survey or interview procedures, unless all three stated conditions are present:

(i) responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the subject's responses, if they be- came known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sex- ual behavior, or use of alcohol.2

For discussion purposes, I will assume that these three stated conditions are not present and that, based on the regulations, a proposal meets the exemption criteria in the federal regulations.

Cann and Rothman argue that an IRB has no jurisdiction over a proposal that qualifies as exempt according to the federal regulations. Since IRB approval is not required, the authors assert an IRB cannot condition approval on changes in the proposal and the forms to be employed in the study, and investigators should not comply with any conditions imposed by the IRB.

Nathan Hershey is Professor of Health Law, Graduate School of Public Health, University of Pittsburgh.

Jurisdiction of an IRB is not determined solely by federal regulations. While the minimum jurisdiction is determined by those regulations, the gov- erning authorities of an institution may grant an expanded jurisdiction to an IRB. One required element of an institutional assurance is:

(1) A statement of principles govern- ing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or spon- sored by the institution, regardless of source of funding. This may include an appropriate existing code, decla- ration, or statement of ethical principles, or a statement formulated by the institution itself. This require- ment does not preempt provisions of these regulations applicable to Department-funded research and is not applicable to any research in an exempt category listed in ? 46.101.

According to the last quoted sentence, a statement of principles for an institutional assurance need not apply to research that is exempt under the federal regulations. However, institutional authorities are not barred from having an IRB apply such principles as these authorities deem appropriate to both funded and unfunded research that meets the exemption criteria of the federal regulations. Either by design or inadvertence, the content of an institutional assurance may grant the IRB an approval role relating to exempt research. The federal agency establishing exemptions cannot bar an institution from granting responsibility to its IRB beyond that required by federal law or regulations.

The proper target of the Cann-Roth- man article may well be the institutional authorities who have conferred a review and approval responsibility beyond that necessary for the protection of human research subjects. Per- haps the IRB is perceived by institutional authorities as the appropriate body to control or eliminate deficiencies in proposals, and information sheets and forms provided to potential participants, even if protection to human subjects is not necessarily sub- stantially enhanced thereby.

It must also be noted that an institution must employ some mechanism for determining whether a particular proposal qualifies as exempt based on the criteria of the federal regulations. Whether such determinations need be made by an IRB, or should be made by

one or more designated administrators, is a question to be resolved by the institution. The federal regulations do not require that the exemption question be determined by an IRB, but it would not be surprising for some insti- tutions, at least, to place that responsibility upon the IRB.

Cann and Rothman have presented examples of what they deem inappropriate IRB requirements being imposed and the adverse consequences to epidemiologic research that com- pliance by the investigators with such requirements may cause. The article reports that some cooperating hospitals permitted investigators to contact only those patients and controls who had returned cards to the attending physician stating their willingness to participate in an epidemiologic case- control interview study of lymphoma. Cann and Rothman assert that such a procedure will lead to far less participation than permitting the investigator to seek participation by direct contact with patients and controls, and thus compromise the research study.

The authors do not explore the question of possible breach of patient confidentiality in the context of the lymphoma study, but address it subse- quently in their article, with references to the literature. This issue is at the heart of many concerns about the conduct of epidemiologic research and the subject of spirited debate.4 Physicians and hospital personnel normally have access to patients' records, and patients understand that such access in the therapeutic relationship is for their benefit. Whether patients understand and accept that others, not involved with their diagnostic and therapeutic needs, are to be informed of their medical condition as part of research activities, is less likely. The question of whether the patient will object if asked, or if he or she later learns of such disclosure, is different from the question of whether the custodian of such information is free to make the information available to investigators in order to facilitate research, without authorization from the patient.

A distinction must be recognized be- tween the assigned or perceived roles of an academic institution's IRB and the IRB of a patient- or a client-care (clinical) institution. The former ordinarily is aware of, or assumes that, some review of a proposal for conform- ity with academic requirements has been conducted prior to the proposal reaching the IRB. Thus, it may be less

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~Ii~3 likely to impose requirements on an investigator when the federal exemption criteria are met than the IRB of a clinical institution, which is granted specifically, or assumes, added. responsibility for protection of patient or client. Some medical conditions raise more concern about confidentiality and possible patient sensitivity to disclosure than others. Although some individuals freely discuss their medical conditions with relatives and friends, and, for that matter, strangers, others seek to limit those who will know of their particular condition, especially if it is one that has sensitive aspects. One can readily envision a situation where a proposal meets the criteria for exemption, but the clinical institution's IRB believes that, given the nature of the condition of the patient, no disclosure should be made of the patient's condition to an investigator without the patient's prior authorization.

What is the IRB to do in such cir- cumstances? If the institutional assurance gives a clear mandate to the IRB to review and approve all proposals, including those that qualify as exempt under the federal regulations, then the IRB is not exceeding its jurisdiction if it imposes conditions for its approval that may prejudice subject recruitment, but that the IRB believes are justified. The situation is less clear when the institutional assurance does not grant the IRB jurisdiction, once the decision is made that the research qualifies as exempt. As Cann and Roth- man apparently view this situation, the most that an IRB could do is to recom- mend or suggest some modifications in the study; it would lack the authority to prevent the study from being conducted as presented, if the investigator rejected its recommendations.

Confounding the situation are the requirements of state law on the subject. All hospitals are subject to one or more provisions in statutes and regulations describing the requirements for con- trolling access to patient records and the information contained therein. These vary to some extent from state to state, but their basic thrust is that specific authorization from the patient, or someone who by law is permitted to provide authorization in place of the patient, ordinarily is necessary for the release of information to anyone not involved with the patient's care. The clinical institution's IRB may decide that it should require that limits on disclosure of information be met, based on its interpretation of state law, before it "grants approval," even if it does not have a legal review responsibility by specific mandate in the institutional

assurance. A hospital IRB in particular would probably assume that it is to concern itself with all issues related to access to hospital record data.

IRB membership requirements include having a person knowledgeable on "applicable law" as an IRB member.5 If an attorney member expresses the view that there is a possible breach of legal standards of confidentiality in permitting an investigator to make contact with a patient without the patient's authorization (the basis for the contact is the investigator's knowledge that the patient has had, or is currently suffering from, a particular illness), the clinical institution's IRB may decide to condition approval upon a contact procedure that is cumbersome, costly, and accepting the Cann-Rothman view, in- consistent with effective research.

Institutional Reputation

Even if an IRB lacks jurisdiction over studies that meet the criteria for exemption under federal regulations and no legal issue of maintaining confidentiality is present, an IRB may, nevertheless, face some difficult questions because of its mere access to exempt research proposals, particularly proposals for unfunded research. Cann and Rothman do not address these questions, but they pose additional, practi- cal problems IRBs encounter that raise the issue of the proper scope of IRB business.

Assume a proposal is submitted to conduct a questionnaire or interview survey that clearly falls within the exemption provisions and, in the review of the proposal to determine exemption, it becomes obvious that the pur- pose of the study is not accurately portrayed to the potential participants in the informational material supplied to them. This error may be the result of poor drafting or reflect a conscious plan to mislead. Or, the review to determine exemption reveals a substan- tial number of spelling and grammati- cal errors, and other failings that raise the IRB's concern that those who receive introductory letters, or other in-

formational material about the study, are likely to draw negative conclusions about academic standards of the institution. These failings are found in faculty submissions, as well as proposals from students, and are often accom- panied by methodological deficiencies.

The argument can be made that if criteria for exemption are met, the IRB, unless given specific, additional authority, should refrain from any activity in regard to failings and deficiencies discussed above. Protecting institutional reputation and maintaining academic standards differ from protection of subjects. In the case of funded research, the peer review processes of granting organizations and agencies, rather than oversight by the IRB of an academic institution, should be relied upon to respond to such failings, although institutional reputation may well suffer when outsiders note defects of the nature mentioned. In the situation where a clinical institution's IRB reviews a proposal by investigators from an academic institution, the IRB may believe its duty to its patients is to not make them available as possible participants unless accurate information is furnished to them, regardless of the position of the IRB, of the academic institution, or of a funding agency. With respect to poor spelling and grammar, the clinical institution's IRB may believe ignoring such failings will be taken to indicate it did not recognize the presence of such errors, and, there- fore, require them to be corrected to avoid such an inference.

For unfunded research, outside peer review is the exception, not the rule. The clinical institution's IRB would have no reason to be less strict in its review than it is in reviewing funded research proposals; its duty to patients and clients is exactly the same. The academic institution's IRB situation is more delicate. To assume an oversight responsibility, and to exercise it, for deficiencies beyond its apparent purview can be viewed as interference with de- partmental and school prerogatives. In reviewing a student proposal, the academic institution's IRB should avoid

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Reply: Overcoming Hurdles to Epidemiologic Research by Cristina I. Cann and Kenneth J. Rothman

Nathan Hershey defends the right of an IRB to extend its purview beyond the limits of federal regulatory guidelines. Nevertheless, he also argues contrarily in his concluding paragraph, characterizing the extension of IRB authority as an "intrusion" motivated by frustration with flagging academic standards. While we wonder about his actual position, we are concerned that the rhetoric may obscure the crucial issue.

Epidemiologists have made clear their concerns for safeguarding confidentiality and privacy.'-3 What is less clear is that the hurdles to epidemiologic research erected by IRBs, sometimes needlessly and inappro- priately, have consequences beyond the loss of a few subjects to a research study: unlike experiments, many epidemiologic studies require close to full participation of potential subjects to avoid insuperable biases that under- mine the validity of the conclusions. At stake is the feasibility of a major current of epidemiologic research. In its role of protecting the rights of individuals, IRBs should consider the right of all individuals in society to benefit from such research. Some of the requirements imposed by many IRBs are now abridging that right.

Cristina I. Cann is Senior Project Coordinator, Department of Family and Community Medicine, University of Massachusetts Medical School. Kenneth J. Rothman, Dr. P.H., is Professor of Family and Community Medicine, University of Massachusetts Medical School.

Hershey interprets our article as a recommendation to investigators to "challenge aggressively (the) imposition" of unnecessary requirements made by IRBs. Aggressive challenges lead to confrontation, hostility, intran- sigence and entrenchment of opposite views, a situation hardly conducive to meaningful dialogue and exchange of ideas. We stated that although each IRB dictates its own requirements, many of these go beyond the guidelines of federal regulations. We advocated that such requirements, when hinder- ing research, be appealed. We hope that, as investigators become familiar with the "Final Regulations," they will be able to communicate to IRB members the rationale of epidemiologic methods and the lack of deleterious effects on potential participants when inter-view study procedures are fol- lowed as intended in the "Final Regu- lations."

Hershey raises the question of whether a "custodian" of medical records is "free to make the information available to investigators... without authorization from the patient." This question is addressed in the Report of the Privacy Protection Commission, which guides such decisions through- out the country. The Report, released in 1978, clearly states that the consent of the individual patient must be ob- tained before access to medical records is allowed, with one specific exception, namely for researchers conducting "a biomedical or epidemiological re-

search project." William J. Curran,4 in his review of this Report, advised that "[T]he text of the Commission Report indicates that the exception applies not only to record examination without later contact with the patients, but to follow-up studies where patients are contacted by the researchers for fur- ther information."

In an earlier commentary, Hersheys suggested that overhead funds from research grants should be used to hire lawyers to advise investigators on problems that may arise when their ap- plications are submitted to IRBs for review. Sad would be the day when an epidemiologist will have to hire a law- yer to assist him or her in obtaining IRB approval for a research project, rather than consulting directly with the chairperson of the IRB at his or her institution or at the institution where the research is to take place.

REFERENCES

1Gordis, L., and Gold, E.: Privacy, confidentiality, and the use of medical records in research. Science, 207:153-156, 1980.

2Kelsey, J.L.: Privacy and confidentiality in epidemiologic research involving patients. IRB: A Review of Human Subjects Research 3:1-4, February 1981.

3Cann, C.I., and Rothman, K.J.: IRBs and epidemiologic research: how inappropriate re- strictions hamper studies. IRB: A Review of Human Research 6:5-7, July/August 1984.

4Curran, W.J.: The privacy protection report and epidemiological research. Am. J. Public Health 68:173, 1978.

SHershey, N.: Putting the lamentations of epidemiologists in perspective. Am. J. Public Health 72:1155-1157, 1982.

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March/April 1985

assuming the responsibilities of the student's advisor and committee, unless the IRB is specifically so charged by institutional policy.

Intrusions by an academic institution's IRB into areas of activity not mandated by federal regulations and explicit institutional policy may reflect the frustration caused by a perception that academic standards are not being maintained, and a desire on the part of IRB members to serve institutional in- terests. As understandable as the mo- tives may be, activity spurred by them may adversely affect the IRB's accom-

plishing its objectives, by diverting its attention from its assigned functions and creating avoidable conflict. The IRB should concentrate on its functions, with the expectation that, by bringing to the academic administrators' attention its concern about deficiencies beyond the area of human subject protection, such administrators will respond appropriately and fulfill their responsibilities. REFERENCES 145 CFR 46.101 245 CFR 46.101(b)(3) 345 CFR 46.103(b)(1)

4See Cowan, D.H. and Adams, B.R.: Ethical and legal considerations for IRBs: Research with medical records. IRB: A Review of Human Subjects Research 1(8): 1-4, 8, December, 1979; Kelsey, J.L.: Privacy and confidentiality in epidemiological research involving patients. IRE: A Review of Human Subjects Research 3 (2) 1-4, February, 1981; Hershey, N.: Using patient records for research: the response from federal agencies and the State of Pennsyl- vania. IRB: A Review of Human Subjects Re- search 3 (8): 7-8, October, 1981; Pattulo, E.L.: The limits of the "right" of privacy. IRE: A Review of Human Subjects Research 4 (4) 3-5, April, 1982; Veatch, R.M.: Responses, Limits to the right of privacy: reason, not rhetoric.

IRB: A Review of Human Subjects Research 4 (4) 5-7, April, 1982.

-45 CFR 46.107(c)



irb jurisdiction and limits on irb actions

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