Liability and the IRB Member: The Ethical AspectsAuthor(s): Robert M. VeatchSource: IRB: Ethics and Human Research, Vol. 1, No. 3 (May, 1979), pp. 8-9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564558 .

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specifically to provide remedies in sit- uations where the plaintiff could not be adequately compensated by an award of money damages. The whole field of law known as "equity" grew up around injunctions and other such nonmone- tary orders as dissolutions of mar- riages, probate of estates, and appointments of guardians for infants and incompetents. While the general civil courts in the United States have, in this century, had jurisdiction over both types of cases, even today in order to obtain an injunction, a plaintiff nor- mally must prove that an award of money will not provide adequate relief. For example, minority children in an inadequate, segregated school system do not want money, they want equal education, so they seek an injunction; similarly, homeowners confronted by construction of a factory do not want money, they want the factory removed and so seek an injunction.

A plaintiff seeking an injunction must name specific defendants. The de- fendants in this case are the Regents of the University and the members of the IRB, but no damages are being sought from them. Since the protocol was never implemented, no child ever par- ticipated. Therefore, no injuries have occurred, and there are no possible plaintiffs for a malpractice suit.

The Limits of IRB Liability

In the Commission's IRB Report, the discussion of tort law further states that "On the principle that one who undertakes to protect others must act responsibly, IRB members could be li- able if they did not exercise reasonable care in carrying out their review. This might occur if their approval led to a research activity and injuries that would not have occurred if a reason- able person, confronted with the same information, would have placed condi- tions on the research that would have prevented the injury. Thus, an injured subject could allege negligence by IRB members in assessing the risks and benefits of proposed research, or in ap- proving consent procedures not rea- sonably likely to assure legally effective consent." 1, at p. 83 These state- ments are not warranted by any cases or statutes cited in the Report.

The negligence standard of care ap- plied in medical malpractice, car acci- dents, plane crashes, or any other activities subject to tort claims is that the person involved did not act with the skill, care, and knowledge that the "reasonable man" confronted by the same situation would have used. In a malpractice case brought against a

medical professional, the standard of care is that which the reasonable phy- sician would have used in the same or a similar circumstance. If the "reason- able man," in this case, a physician, would have done the same thing the defendant did, there is no liability even though a mistake or error of judgment was made. 2, at pp.43-66

The standard of care in reviewing a protocol as stated in this discussion is "what the reasonably prudent IRB member would have done." It would be very interesting to debate how a court could define a "reasonably pru- dent IRB member." As the same Re- port indicates, only 50 percent of IRB members in the sample studied by the Commission were biomedical scien- tists; 21 percent were behavioral scien- tists. Thirty percent did not identify themselves as biomedical or behav- ioral scientists-this latter group in- cluded administrators, lawyers, mem- bers of the clergy, and others. 1, at p. 57

Therefore, the "reasonably prudent IRB member" might not be the same as the "reasonable physician" or the "reasonable investigator." What then might be the applicable standard of care for an IRB member asked to re- view the technical aspects of biomedi- cal research projects?

It is quite possible that an institution as a corporate entity can be liable for negligent approval of a research pro- tocol. Corporate liability would, however, be identical to that incurred by a hospital if a patient falls out of bed and fractures a hip. Suggesting, however, that an individual member of an IRB could be personally liable for the payment of money damages if a re- search subject is injured is as unwar- ranted as suggesting that the hospital's trustees are personally liable to the pa- tient with the broken hip.

REFERENCES 'National Commission for the Protection of

Human Subjects of Biomedical and Behav- ioral Research: Report and Recommendations: Institutional Review Board. DHEW Publica- tion No. (OS) 78-0008, Washington, 1978. Re- printed in: Federal Register 43 (No. 231): 56174-56198, November 30, 1978.

2Purcell v. Zimbelman, 500 P 2d, 335, Ariz., 1972. 3Holder, Angela R., Medical Malpractice Law, 2nd

Edition, New York, Wiley Press, 1978. 4Baily v. Mandel, unreported case, cited in refer-

ence 1, p. 91. STelephone conversations with Dr. Frank Iber, for-

mer IRB Chairman, University of Maryland, December 19, 1978, and January 3 and January 19, 1979.

6Nielsen v. Board of Regents, unreported case cited in reference 1, p. 91. For additional dis- cussion of this case, see Lowe, C.U.; Alexander, D. and Mishkin, B., Non-therapeutic research on children: an ethical dilemma, 84 Pediatrics 472, April, 1974.

Liability and the IRB Member: The Ethical Aspects by Robert M. Veatch

The idea that IRB members might be personally liable for their actions while serving in an official capacity is dis- turbing. Equally troublesome, how- ever, is the possibility that they could be totally immune from responsibility. The article by Angela Holder in this is- sue addresses the legal aspects of tort liability; there are, however, signifi- cant ethical dimensions to the question as well.

Certainly there are many opportuni- ties for IRB members to make mis- takes. For example, each member is responsible for assessing whether le- gally effective informed consent will be obtained in any protocol reviewed. It is now becoming clear (and the National Commission for the Protection of Human Subjects has affirmed) that subjects must be given information that they may reasonably be expected

to desire in considering whether or not to participate in the research.

Furthermore, this "reasonable sub- ject" standard clearly leaves open the possibility that what reasonable sub- jects may want to know (or find mate- rial) before making a judgment to participate may be different from what reasonable IRB members think these subjects would want to know. To the extent that IRB members differ in any way from the subjects in this assess- ment, they may make systematic mis- takes in carrying out their functions. Sooner or later some subject is going to argue--and perhaps in court-that even though the researchers and the IRB decided that he or she would not want a particular piece of information, that information was in fact precisely what the subject wanted to know. For example, researchers on an IRB might all agree that donors to a blood bank would not want to be told that the blood might be used for research. It is

Robert M. Veatch, Ph.D., is senior associate at The Hastings Center.

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May 1979

still very much an open question whether reasonable subjects would find that information material in de- ciding whether to donate blood. IRB members might be liable, legally or ethically, if they cannot demonstrate a good faith effort to show that they at- tempted to determine whether subjects would really want to know the infor- mation.

Holder's article stresses the existing limits of IRB members' legal liability. Policy makers and IRB members may also want to reflect, however, on what that liability ought to be. Here are some of the arguments being put for- ward.

Arguments on Protection

The arguments favoring protection of IRB members from personal lia- bility are obvious. Members of IRBs normally take on enormous burdens with little or no compensation, little professional reward, and often with great personal inconvenience and stress. In doing so, they are providing an important service that serves the long-term interests of both researchers and society. If IRB members are to do their job well, they should be encour- aged to act freely without fear of per- sonal liability. In short, the long-term greater good is served if individual members are protected.

On the other hand, so a counterargu- ment goes, if individual IRB members are personally liable, they will be more careful in their work and take greater personal responsibility to prevent any wrongs. The issue is really an empiri- cal one. Would greater good be served in the long run if individual members were liable or not?

Added to this argument from conse- quences is another related argument. If members of IRBs take on this respon- sibility, they deserve protection simply as a measure of compensation for the service rendered. Independent of whether this protection enables them to do a better job and therefore to serve social interests better, they might be said to have a right to be protected against personal liability.

But the notion of personal rights sug- gests some other ethical counterargu- ments. In fact the debate over whether IRB members should be personally li- able for their actions in a way recapitu- lates the more general ethical tension that permeates IRB activity. That ten- sion is not really between the task of serving the interests of the individual and serving the interests of society. It is, as the current DHEW regulations (45 CFR 46.102) state, between the one

responsibility of assuring that the total benefits of the research justify the risks and another responsibility of assuring that the rights of the subject are ade- quately protected. Doing what will produce the most benefits will not necessarily also protect the rights of the individual subjects.

This tension has radical implications for IRBs. In the general work of the IRB it means that in reviewing pro- tocols, judgments about protecting rights (the right to confidentiality, the right to consent) are independent of judgments about benefits and harms. For the more narrow problem of per- sonal liability it means that individual members cannot justifiably be shielded from liability-even if it would serve long-term social interests-if that pro- tection would violate important indi- vidual rights. Ought there be such a right to redress when the actions of IRB members violate the rights of sub- jects or researchers or anyone else? Do we want IRB members to act without any responsibility for their actions? The right of redress for subjects or re- searchers may lead to the policy con- clusion that IRB members cannot be totally immune from liability.

Two Principles for a Policy

In considering what ethical princi- ples might be used to formulate a pol- icy on protecting individual members from liability, two principles come im- mediately to mind.

The first is the principle of respon- sibility. The argument from respon- sibility assumes that individuals are in some way responsible for their actions and should be called to account when they do harm to others or violate their rights. This implies that individual IRB members should not be personally liable for harms or violations of rights beyond their responsibility. If we sepa- rate negligent and non-negligent ac- tions, most IRB members ought to be

personally responsible for negligence according to this view.

Of course, we may want to adopt a policy that would permit compensa- tion to researchers or subjects regard- less of whether the harm results from the IRB's negligence or not. Institu- tional or governmental insurance granting such recovery may be in order for harms resulting from IRB actions just as it is being proposed for harms resulting from the research. Such in- surance would leave for further discus- sion the question of whether IRB members should be personally respon- sible for reimbursing the insurance fund in cases where they are negligent.

Second, we might apply the princi- ple of equal protection. If there are pro- tections developed for individual IRB members for any of the reasons dis- cussed here, the protections ought to apply equally to all IRB members.

Insurance that protected physician members but not nonphysican mem- bers would be unacceptable if one adopted this principle. Similarly, pro- tections that extended to members on the payroll of the institution, but not to those outside the institution, would violate this principle. In fact, since in- dividuals who are outside the institu- tion are being added to IRBs because a variety of points of view is considered crucial to adequate review, those mem- bers are especially deserving of protec- tion. As a member of an IRB not on the institution's payroll, I find that argu- ment particularly persuasive.

The National Commission's warning on liability of IRB members should alert IRBs to take the problem se- riously. It seems likely that great social good would come from granting pro- tection. But it is also clear from the mandate IRBs have been given that serving the general welfare cannot be the only basis for judgment. The rights of researchers and the rights of sub- jects are crucial moral factors in this enterprise as well.

Clinical Guidelines for Investigations of Drugs in Humans Available from FDA

Six clinical guidelines that outline procedures and standards for investigating various classes of drugs in humans to determine the drugs' safety and effective- ness are available from FDA. The guidelines are intended to inform interested persons of what the agency's Bureau of Drugs views as acceptable procedures and standards for conducting clinical investigations of these drug classes: ant- acid drugs; G. I. mobility-modifying drugs; laxative drugs; bronchodilator drugs; drugs to prevent, control and/or treat periodontal disease; and drugs to prevent dental caries. For further information, contact Harold C. Kroma, Bu- reau of Drugs (HFD-102), FDA, 5600 Fishers Lane, Rockville, MD 20857.

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