irb members and liability: an exchange of views

IRB Members and Liability: An Exchange of ViewsAuthor(s): John RobertsonSource: IRB: Ethics and Human Research, Vol. 2, No. 1 (Jan., 1980), pp. 10-11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563602 .

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ETTERS

IRB Members and Liability: An Exchange of Views

In my view the National Commission for the Protection of Human Subjects' was legally correct in its analysis of the personal liability of IRB members for subject injuries. The Commission's Re- port did not claim that liability had been or should be imposed. It did point out legal reasons for thinking that liability could result, and suggested liability insurance for IRB members as a way to minimize the negative effects of possible suits.

Angela Holder, however, claims that "suggesting that an individual member of an IRB could be personally liable ... if a research subject is injured is ... unwarranted."2 Her argument, which does not focus on the legal merits of the question, is that none of the three cases cited in a footnote have held IRB members personally liable.3

It is important that readers of IRB do not conclude from her analysis, as some have,4 that legal liability is legally impossible. The courts have not yet directly faced the issue, but it is likely that liability will be imposed in an appropriate case. As a logical exten- sion of the tort principle that people who undertake to protect others have a duty to use care,5 it is certainly within the realm of reasonable legal possibility that courts will impose liability on IRB members for negligent review that permits injury to research subjects.

To illustrate the possibility, suppose that an IRB was presented with a protocol similar to the Tuskegee syphilis study, in which adults with a serious disease would be denied a known effec- tive therapy without their consent. Suppose that the IRB negligently fails to consider the interests of subjects and approves the study. Subjects later learn that therapy was available, that they were part of a research project, and that the IRB approved the project without requiring the consent that reasonable people faced with the information and the DHEW rules would have required (if they permitted the study at all). The lawyer seeking redress for the injured subjects might sue the members of the review committee that negligently approved the research, as well as the investigator and institution (par- ticularly if the institution has sovereign or charitable immunity). Despite the absence of reported cases to date on this precise question, the IRB members

who negligently disregarded subject interests are not likely to be exempt from this general principle of tort law.

Situations in which investigators un- lawfully injure subjects may be rare, and instances where negligent IRB review helped cause those injuries rarer still. But they are not impossible. Their frequency will depend on how consci- entiously IRBs and investigators ap- proach research that involves more than minimal risk. Because of the wide variability in IRB performance, researchers in some institutions might be permitted to conduct risky research without adequate consent procedures or protections for subjects. If injuries do occur, suits against investigators and institutions and even IRB members could be brought. In such situations IRB members can be held legally liable. After all, they undertook to protect subjects and then negligently car- ried out that role. Reasonably careful review could have averted the injury suffered by the subject.

Pointing out this legal possibility, as the Commission did, seems to me to be entirely appropriate. It was not in- tended nor should it propel IRBs into hasty overreaction or defensive review. But it should remind IRB members of their duty, sometimes forgotten in the informal pressures operating in some IRBs, to exercise due care in reviewing research that may injure subjects. In light of this possibility, some institutions may want to extend their liability insurance to IRB activities. Others may

find the need for insurance to be less than the cost. The proposed HEW regulations,6 by not making insurance man- datory, leave the matter to institutions. In making that decision institutions should not ignore the legal grounds for liability.

John Robertson Professor, Law School

Program in Medical Ethics, Medical School,

University of Wisconsin

REFERENCES 'National Commission for the Protection of

Human Subjects of Biomedical and Behav- ioral Research: Report and Recommenda- tions: Institutional Review Boards. DHEW Publication No. (OS) 78-0008, Washington, 1978. Reprinted in: Federal RegiSter 43 (No. 231): 56174-56198, November 30, 1978.

2Holder, A.R.: Liability and the IRB Member: The legal aspects. IRB: A Review of Human Subjects Research, 1 (3): 7-8, May 1979. The complete sentence stating this conclusion is: "Suggesting, however, that an individual member of an IRB could be personally liable for the payment of money damages if a research subject is injured is as unwarranted as suggesting that the hospital's trustees are personally liable to the patient with the broken hip," p. 8.

3While the footnote could have been more pre- cisely worded, the three cases cited were not irrelevant to the Commission's statement. Two involved situations in which IRB members were sued for review activities, and the third illustrated the general principle on which IRB liability could be based.

4Woodward, William E. Letter to IRB: A Review of Human Subjects Research, 1 (4): 10, Aug./ Sept., 1979.

5Restatement, 2d, Torts, ??323, and 324A. For il- lustrations of the principle see Indian Tow- ing Co. v. U.S., 350 U.S. 61 (1955); Nelson v. Union Wire Rope Co. 199 N.E. 2d 769 (1964);

CALENDAR

JANUARY 8: Deadline for filing comments on the report of the DHEW Ethics Advisory Board on HEW Support of Human In Vitro Fertilization. The comment period originally closed August 17, 1979, but was reopened when the Department learned that the Appendix volumes containing the reports and studies of the expert witnesses were not available to the public from the Gov- ernment Printing Office until after the comment period had closed. All comments received thus far are still on file and will be reviewed along with any new or amended comments. Comments or requests for additional information should be sent to: F. William Dommel, Jr., J.D., Assistant Director for Regula- tions, Office for Protection from Research Risks, National Institutes of Health, 5333 Westbard Avenue, Room 3A-18, Bethesda, MD 20205; phone (301) 496-7163.

FEBRUARY 1-2 (tentative): The DHEW Ethics Advisory Board will hold a public meeting to continue its discussion of the proposals by the Center for Disease Control and the National Institutes of Health for a limited exemption to the Freedom of Information Act (see "Update," IRB, November 1979, pp. 9-10. The Board will also begin discussion of the issues surrounding 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 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. See February calendar listing above for details.

IO



January 1980

Adams v. State, 555 P. 2d 235 (Alaska, 1976); Coffey v. Milwaukee, 74 Wis. 2d 526 (1976). See also Robertson, J.R.: The law of Institu- tional Review Boards. UCLA Law Review, 26:484-549, 1979.

644 Federal Register, Aug. 14, 1979, 47691.

Angela R. Holder replies: John Robertson and I probably agree

on the legal theory involved in this issue. Where we disagree is on the prac- tice. In the August 14, 1979, Federal Register' in fact, the discussion of proposed HEW Regulations for IRBs in- cludes: "Recommendation (3) (H) would not be implemented by the Regulations proposed below.

.... Fur-

thermore, the Department is not aware of any negligence action which has named an IRB Member as a defendant and therefore believes that liability protections might prove to be an unnecessary, yet costly, requirement."

The issue is not legal theory. It is a risk-benefit analysis. Anybody can lit- erally sue anyone else about any- thing-for example, the federal district court decision dismissing (for lack of jurisdiction) a petition attempting to enjoin Satan from doing evil.2 Winning a case is, however, another matter entirely. Most lawyers do not bring suits they do not think they can win and the complexities of this issue are such that marshalling evidentiary proof of the applicable standard of care of "the reasonably careful IRB Member" would require enormous effort. It is possible that IRB members may very well be sued sometime, but the risk of judgments against them is very min- ute. By contrast, negligent approval of a protocol may very well impose liability on the institution and the institutional standard would not be particu- larly difficult to establish.

There is more concern in the medical community about liability questions than is either necessary or desirable; it is unfortunate that the Commission's Report may have unnecessarily caused anxiety. If one person decided not to serve on an IRB or resigned from one for this reason, it would be most unfortunate indeed. While Mr. Robertson and I do agree on the theory, I do not think the Federal Register is the appropriate forum for such an abstract discussion of legal theory. Such discussions belong in law reviews or other scholarly journals, not offered as the basis of a suggested Regulation which would have been both unnecessary and expensive.

REFERENCES '44 Federal Register, Aug. 14, 1979, 4760. 2United States ex re Mayo v. Satan and his Staff, 54

FRD, 282, DC, Pa., 1971.

A NNOTATIONS

Hyers, Thomas M., and Scoggin, Charles H. "Ethical and Practical Problems of a High Risk to Benefit Ratio Study in Children." CLINICAL RE- SEARCH 27 (October 1979), 293-96 [T. M. Hyers, Denver Veterans Adminis- tration Medical Center and University of Colorado Medical Center, Denver, Colorado 80220 ].

This paper describes the clinical in- vestigation of children in Leadville, Colorado, who were known to be sus- ceptible to high altitude pulmonary edema (HAPE). The study was de- signed to show the relationship be- tween blood clotting and HAPE. After receiving standard doses of aspirin and dipyridamole or placebo, the children entered an altitude chamber. Several blood samples were taken at different times, and breathing was measured. The procedure was repeated three weeks later with opposite medication (drug or placebo).

Ethical problems arose from (1) hav- ing to obtain informed consent, espe- cially since very little direct benefit to the subject was expected; (2) avoiding claims of enticement (because the ex- perimenters entertained the young- sters during hours of inactivity); (3)

determining risk/benefit ratio; and (4) avoiding making the subjects sick.

Woodward, William E. "Informed Consent of Volunteers: A Direct Meas- urement of Comprehension and Reten- tion of Information." CLINICAL RE- SEARCH 27 (September 1979), 348-52 [W. E. Woodward, The University of Texas Medical School, Program in In- fectious Diseases, 244 Freeman Build- ing, P. O. Box 20708, Houston, Texas 77025.]

In an effort to measure volunteers' comprehension for a cholera study at the Center for Vaccine Development at the University of Maryland School of Medicine, a quiz was administered to subjects with no special medical edu- cation and to a group of medically trained individuals. The exam, taken after the volunteers had been "informed," dealt with specific questions about cholera. The volunteers com- prehended a large amount of technical information and scored significantly higher than the medically trained group. A smaller group, tested three months afterwards, retained their comprehension.

Mama Howarth 11

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irb members and liability: an exchange of views

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