'Committee of Concern' Presses Opposition to DHEW RegulationsAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 2, No. 1 (Jan., 1980), p. 9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563601 .

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January 1980

COIMMENTARY The Elusive Role of 'Neutral Observer' In Human Investigations by Robert A. Burt

In the first case presented, the medi- cal student might feel some special obligation to intervene because of his particular knowledge and nascent pro- fessional identity. But I agree with Dr. Swazey that this obligation is not tied to the student status; it arises (and should arise) from the inherent diffi- culty for all investigators in maintain- ing the "neutral observer" posture when the research subject appears em- barked toward seriously harmful con- sequences. The investigator may seek comfort and maintain passivity in the belief that the subject has independ- ently chosen these consequences. But interactions between investigator and subject readily raise powerful contrary suspicions.

In the first case, for example, the cli- ent-subject will know that the inves- tigator is observing his treatment by the nonmedical healer. Even if the sub- ject does not know that the investigator is a medical student, the subject might construe the investigator's silence as a confirmatory expression of faith in the healer's actions. This construction might arise because the subject gives some special weight to the investiga- tor's perceived status as a "research scientist." Or it may come simply from the "rapport" that will "inevitably" arise-as the medical student ex- plicitly notes-from the interviews themselves; the subject, that is, might come to feel during these interviews that the investigator has friendly feel- ings toward him and, like any friend, would not stand by silently while he rushes toward disaster.

The investigator might attempt to anticipate this problem by informing the subject in advance of the circum- stances (if any) in which he intends to intervene. This, however, would raise other problems. Such a statement could provoke doubts for the subject that might affect his faith in the healer, thus potentially harming the subject by diminishing the therapeutic trust on which cure might depend and harming the investigator by contaminating the research protocol through a reverse Hawthorne effect. These concerns ap- pear to underlie the IRB's decision that

Robert A. Burt, J.D., is professor of law, Yale Uni- versity, and co-chairman of the Commonwealth Fund Program in Law and Medicine at the Yale Law School.

the investigator could withhold the in- tervention statement from prospective subjects. The investigator's wish to withhold this statement might also come from his unwillingness to empha- size to the prospective subjects that he was in fact "neutral" toward them- that he might not share their faith in the nonmedical healer, that he might reach some independent judgment re- garding their treatment that, depend- ing on his view of circumstances, he would or would not share with them. The investigator might reasonably be- lieve that a declaration of ostentatious neutrality could interfere with the rap- port that he wanted to encourage in subjects so that they would confide their fears and hopes regarding the ill- ness that led them to the nonmedical healer.

The case thus presents consider- able dilemmas no matter what policy is adopted-dilemmas regarding whether or under what circumstances to intervene, whether to alert potential client-subjects or healer-subjects to the prospect of the investigator's interven- tion, and-as the second case study em- phasizes-the form of intervention. The IRB was right to alert investiga- tors to these dilemmas. It was wrong, however, to conclude that the dilem- mas could be adequately resolved by the specific procedures adopted in the protocols. No matter what advance procedures are adopted, contradictory expectations and potentially harmful misunderstandings will persist in the dealings between these investigators and research subjects.

In these cases, no matter what ad- vance notice the investigators give to the research subjects regarding the oc- casions for their intervention, it is more important to provide procedures that force the investigators to think about and to justify the propriety of interven- tion or passivity in specific cases after the research enterprise has begun. For this purpose, the IRB should have in- sisted at least that the investigators should establish some regularized for- mat for consulting with persons out- side the research project who will be alert to these problems and will assist the investigators in clarifying their in- evitably contradictory and confusing roles on a case-by-case basis. Ideally the IRB itself should serve this con-

sultative and supervisory role. This would, of course, considerably expand the IRB's jurisdiction and workload. But IRBs must come to see that the in- terests of research subjects and the eth- ical integrity of human investigations generally cannot be adequately as- sured by focusing attention solely on the initial moments of contact between investigator and subject. This static focus distorts the complex psychologi- cal forces at work on both sides of the research relationship and leads inves- tigators, research subjects, and IRB members to think about this relation- ship through false and harmful, though initially comforting, stereotypes. This distortion equally afflicts contempo- rary legal doctrines of "informed con- sent" regarding medical care generally, as I have developed in Taking Care of Strangers: The Rule of Law in Doctor- Patient Relations (New York: Free Press, 1979).

'Committee of Concern' Presses Opposition to DHEW Regulations

The "Committee of Concern on Human Subjects Regulation" has is- sued a bulletin continuing its cam- paign to marshal opposition among social scientists to the DHEW proposed regulations on research involving human subjects (see "Update," IRB, December 1979, p. 7). Ithiel de Sola Pool, the Committee's organizer, notes that, since the committee's formation, additional concerns have been raised about the regulations. He asserts: "If enforced, the regulations would de- stroy the millenium-old concept of the university as a collectivity of independ- ent scholars. Since any researcher (stu- dent or faculty) who violated the requirement of the regulations would jeopardize the right of his university to receive funds from DHEW, universities would be obliged to exercise strict con- trol over what research anyone in the university may do or not do."

Another concern, he states, is that the proposed regulations would divert IRBs from their main purpose of effec- tive control of "truly risky biomedical experimentation." According to de Sola Pool, "... the workload on the IRBs would be trebled or quadrupled."

Carol Levine

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