For Whose Protection? Another Moral ModelAuthor(s): Lisa NewtonSource: IRB: Ethics and Human Research, Vol. 5, No. 3 (May - Jun., 1983), pp. 9-10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564551 .

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May/June 1983

For Whose Protection? Another Moral Model by Lisa Newton

Douglas Lackey presents an interest- ing anomaly in IRB criteria for subject selection.' A VA hospital IRB requires that all subjects be given free medical care for any injury resulting from re- search; the neighboring medical school, collaborating in several studies, requires free treatment only for inju- ries resulting from negligence. The re- sult is that inadequately insured (in practice, nonveteran) candidates for such collaborative studies are ineligi- ble to participate at the VA hospital, but can freely sign on to the same study at the medical school. Is it reasonable, Lackey asks, to maintain such "higher standards" of protection when no sub- ject is in fact protected?

This is not an isolated case. Lackey goes on to point out that in the 1972 NIAID-mandated double blind study of Ara-A for herpes encephalitis, the one IRB that refused to approve the study (for probable lack of a null hypothesis, a problem that did not deter the other participant institutions) saved no lives thereby; the NIAID went right on with the study at 22 other locations, and seven patients on placebo died.2 Given that such "recalcitrance," as he calls it, can unfairly exclude one's own inves- tigators from work useful to their ca- reers,3 can the maintenance of atypi- cally high criteria of subject selection, or standards of protection generally, be defended?

The problem as set is an interesting one. Lackey's preliminary analysis, however, seems more to complicate than to illuminate it. He suggests that the answer to his question turns on which "moral model" of protection of subjects we decide is appropriate for IRBs. On one model, the IRB is to be conceived as a tool of policy "designed to produce the best ratio of costs to benefits in the course of medical re- search"-on this model, it is un- justified to set unusually stringent standards of protection, since the only result will be to drive research to other, less scrupulous, institutions and no subjects will be protected.

On the second model, the IRB is "a quasi-personal entity that enters into a special moral relationship with the subjects that fall under its jurisdic- tion," the ones "involved in the pro-

tocols it approves"; the IRB "feels bound to guarantee that 'its' subjects obtain morally acceptable treatment," regardless of what happens "else- where."4 Should the IRB protect all potential subjects or only its own ac- tual subjects (or all actual subjects or its own potential ones)? The question seems unanswerable, because mis- directed-the IRB is not only respon- sible for the protection of actual or potential subjects, there or elsewhere; it relates to the enterprise of research much more broadly, and is account- able for a much broader range of obli- gations. A brief sketch of the functions of an IRB (or IRBs in general) may show these relationships (hence obliga- tions) more clearly.

There is no doubt that it is in every investigator's long-term interest to pro- tect the welfare and respect the auton- omy of his subjects. First, he will get better cooperation in his purposes; sec- ond, he minimizes the chances of nasty rebellions, scandals, and externally im- posed hindrances to research; third, he contributes to a more respectful and concerned society, in which we all have an important stake. But it is undeni- able that in the short term, an inves- tigator may find that requirements of scrupulous concern for informed con- sent and continual surveillance of sub- ject well-being consume an inconve- niently large amount of time and sometimes endanger the very comple- tion of the research.

There is therefore a temptation to neglect the requirements, and if there is no third party watching out (at a dis- tance) for the subjects' welfare, the sub- jects may be at risk of injury or coercion. Because we, as the public at large, are very much aware of this temptation, we are very deeply (if spo- radically) concerned to arrange for the subjects' protection; we do not want to live in or support a society that rou- tinely "uses" human beings as objects, or as means to another's end (of publi- cation, in this case).

And because this concern, in the ab- sence of precut channels, takes unpre- dictable routes to the surface-through city councils, local newspapers, sud- denly concerned alumni-investigators also are at risk of having perfectly legit- imate, perhaps very significant, re- search stopped or changed in mid- stream, its value severely compro- mised. The IRB is inserted into this

process to prevent all these undesirable possibilities from materializing. Its first job is to review proposed research to ensure the protection of its subjects. Its next function is to validate such re- search to the public at large, providing assurances that this technical and ab- struse activity is being carried on in ac- cordance with the general moral norms of the society. And its consequent func- tion is to protect the investigators and their research from recurrent efforts by sincere but ignorant agencies to "pro- tect" the public by stopping or re- directing the research.

For whose protection, then, is the IRB accountable? Given the interlock- ing functions outlined above, it does no harm to say that the IRB is responsible first and last for the protection of the investigators at its own institution: first, as a body adjunct to the research process initiated by the investigators, it must be primarily responsible to and for them; last, as ensuring, through public assurance that proper standards of protection of subjects are observed, that research will be able to proceed without constant interruption from a worried citizenry. This is at least as ac- curate as saying that the IRB is respon- sible for protecting subject popula- tions, actual or potential, in its own institution or in the society at large. Probably the most economical way of answering the question is to say that the IRB protects the public, in several of the public's manifestations: as ac- tual or potential subjects, as actual or potential investigators, and above all as a morally concerned polity.

And that formulation yields the an- swer to the question posed at the out- set. Was there any point to the "re- calcitrant" IRB's refusal to approve the Ara-A study? Surely, there was. No subjects were protected from injury in that study by that refusal; but part of the responsibility of the IRB is to pro- tect the public and the investigators from the conduct of irresponsible or unnecessary research, and publicized unwillingness to approve such research ultimately serves that end very well. It is counterproductive to focus the atten- tion of the members of any given IRB solely on the protection of the subjects that will be involved in the research carried on under the protocols that cross their table. They should be aware that their audience is ultimately much broader than the present subject pool,

Lisa Newton is Professor of Philosophy, Fairfield University.

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and that their decisions ultimately shape the policy of the research enter- prise.

REFERENCES

'Lackey, D.P.: Which subjects should an IRB protect? Two moral models. IRB: A Review of Human Subjects Research 4(No. 7): 5-6, Au- gust/September, 1982.

2Lackey, p. 6., note 2: for details of the Ara-A case, see McCartney, J: Encephalitis and Ara-A: An ethical case study, Hastings Center Report 8(No. 6): 5-7, December 1978; also, in rebuttal, correspondence from the NIAID group and McCartney's reply: Hastings Cen- ter Report 9(No. 4): 4, 44-47, August 1979.

30n this point, see also Betak et al.: Risk/benefit analysis in a study of vehicle driving habits, IRB: A Review of Human Subjects Research 2(No. 9): 6-7, November 1980.

4Lackey, p. 5.

ID

- TTERS -

The IRB-IRG Conflict

While it is generally agreed that IRBs have the primary responsibility to pass judgment on the ethical accept- ability of research on human subjects, a government funding agency must re- tain a prerogative to satisfy itself that it is not supporting unethical projects. Even if the federal government wished to rely solely on IRBs for this purpose, the Initial Review Group (IRG, or "Study Section") members who wished to raise ethical concerns must have a mechanism to do so. Given that the IRG has a role to play, what is it and how should it be accomplished?

If IRBs function in the spirit of 45 CFR 46, only rarely should IRGs re- ceive a grant application for research on human subjects which proposes un- ethical procedures. That is not to say that individual IRG members will not have questions and concerns about eth- ical issues raised by the proposal. Rea- sonable people may differ on such matters; indeed, that is the rationale for local institutional review and ap- proval. However, the approach used by the Division of Research Grants of the National Institutes of Health is not consistent with the above philosophy. IRG members are encouraged, indeed required, to comment on all aspects of the ethical considerations. The follow- ing is quoted from a directive to re- viewers of DHHS grant applications dated April 1982.

"Involvement of Human Subjects Exemptions Claimed. Evaluate the appropriateness of the claimed ex- emptions, or

No Exemptions Claimed. Assess the appropriateness of the subject popu- lation. Explain any potential physi- cal, psychological, social, or legal risks to individuals who are par- ticipating as subjects in research, de- velopment, or related activities. De- scribe the procedures for protecting against or minimizing such risks, and discuss whether the risks are reasonable in relation to the antici- pated benefits to subjects and the im- portance of the knowledge that may reasonably be expected to result. As- sess the adequacy of the consent pro- cedures."

Furthermore, at the IRG meeting the ethical issues are reviewed along with issues of scientific merit, thus con- taminating scientific merit judgments.

In my experience most of the ethical problems cited by IRGs have already been dealt with by the IRB or the prob- lems represent misunderstandings. I have yet to encounter a case where our IRB reversed an earlier approval be- cause of an IRG communication. While it is a rare instance for an IRG to disap- prove an application solely on ethical grounds, it has happened! Of far greater concern is the uncertain impact of ethical criticisms on the "priority score" of approved applications, an in- creasingly sensitive matter in these days of high competition for reduced federal funding.

My suggested remedy is to clearly separate the scientific merit from ethi- cal considerations of IRGs by deferring discussion on the protection of human subjects until after the vote and pri- ority score notation reflecting scientific quality. This approach is similar to that used for budget considerations, ex- cept that ethical issues should be dis- cussed even if there is a vote for

disapproval on scientific grounds. Ethi- cal concerns of the IRG should be transmitted expeditiously to the IRB and Principal Investigator through the Office for Protection from Research Risks (OPRR). The institutional re- sponse should be analyzed by OPRR and forwarded with comment to the Council along with the Summary Statement. For approved applications, if the Council is not satisfied with re- sponse, it could refer the matter to an ad hoc committee for further discus- sion.

David A. Blake Associate Dean for Research The Johns Hopkins University

(Quoted from a letter to Dr. Charles McCarthy, Director - OPRR - June 29, 1982.)

Editor's note: Further discussion of the very serious problems created by IRGs as they repeat functions that are more properly in the domain of the IRB may be found in: Levine, R. J.: Ethics and Regulation of Clinical Re- search, Urban & Schwarzenberg, Bal- timore, 1981, at pp. 233-237. This discussion includes examples of du- bious decisions made by IRGs that were contrary to those made earlier by IRBs as well as a more elaborate list of the adverse consequences of such deci- sions. The remedy I proposed differs in some details from Blake's but has simi- lar objectives.

My experience is the same as that re- ported here by Blake. Almost all of the ethical problems identified by IRGs ei- ther have been already dealt with by the IRB or reflect the IRG's misunder- standings of the investigator's plans. Similarly, I can recall no case in which the IRB at Yale reversed its approval of a protocol because of a problem identi- fied by an IRG.

Robert J. Levine

CALENDAR

JUNE 19-24:The Hastings Center will sponsor a Workshop on Ethical Issues in the Health Professions and the Biomedical Sciences to be held at Vassar Col- lege, Poughkeepsie, New York. The purpose of the Workshop is to bring to- gether, for both formal and informal interchanges, those concerned with exploring some of the major ethical problems in health care. The basic as- sumption behind the Workshop is that ethical issues in health care cut across a number of varied professions and disciplines; and that it is valuable for those concerned with the issues to explore these problems in both a cross- disciplinary as well as a disciplinary way.

Workshop Co-directors are K. Danner Clouser, Ph.D., Professor of Human- ities, Pennsylvania State University Medical School; and Arthur Caplan, Ph.D., Associate for the Humanities, The Hastings Center. For a brochure, write Workshops, The Hastings Center, 360 Broadway, Hastings-on-Hudson, NY 10706 or phone (914) 478-0500.

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