NIH Reviews Normal Volunteer Program after Research DeathAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 2, No. 8 (Oct., 1980), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564001 .

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October 1980

NIH Reviews Normal Volunteer Program After Research Death

Repercussions continue in the after- math of the death of Bernadette Gill- crist, a twenty-three-year-old student nurse participating as a normal subject in an NIH sleep study (see "Update," IRB, June/July 1980, pp. 9-10). Gillcrist apparently concealed her past medical history of anorexia nervosa and two cardiac arrests precipitated by self-in- duced vomiting in order to be accepted into the research, a study of the effects of a combination of lithium and AMPT (alpha-methyl-paratyrosine) on sleep.

According to articles on the incident published in Science (July 25, 1980, pp. 475-78), and the Hastings Center Report (August 1980, pp. 5-6), NIH investiga- tions have uncovered deviations from the protocol although none, the agency claims, was so serious that it could have contributed to the death. The medical examiner's report did not re- veal a conclusive cause of death, al- though NIH presumes it was due to cardiac arrest. Gillcrist's serum po- tassium levels were below normal at the time of death, a condition that could have been induced by vomiting and exacerbated by lithium.

A committee headed by D. Lynn Loriaux, Chairman of the Medical Board at the NIH Clinical Center, to in- vestigate the death has recommended certain changes in procedures. Greater efforts will now be made to ensure that NIH investigators learn when subjects were former NIH patients (as was Gillcrist) and that a nurse be imme- diately available during future sleep studies (none was assigned to the lithium-AMPT study).

Furthermore, a committee headed by Jay Shapiro, associate director of the Clinical Center, is looking into the pay scales and financial backgrounds of normal volunteers, and exploring whether there are any psychological tests that would screen out people like Gillcrist. Carol Levine

LETTERS TO IRB

We welcome letters from our readers, and we publish as many as space permits. In general, shorter communications have a better chance of being published. We reserve the right to edit or abridge letters as necessary.

The Editors

- EETTERS-

Appealing Biased IRB Rulings

While reading Natalie Reatig's arti- cle "Can Investigators Appeal Adverse IRB Decisions?" (IRB, March 1980), I was struck by the fact that of the eight examples of appeal procedures, or lack thereof, mentioned, six were directed to a director or president of the institu- tion and one was directed to a board selected by the IRB.

Lack of a proper appeal process can allow the deliberate harassment of a researcher and the cessation of un- favored studies. If the IRB is set up by the director of an institution or in ac- cordance with his wishes, the members of the IRB are likely to reflect his de- sires and politics. Should the director desire to block another investigator's research for professional jealousy or personal dislike, the IRB can become a weapon of a single person.

All that the board need do is repeat- edly ask for modifications of the pro- tocol until the researcher is forced to refuse to make any further changes in order to maintain a proper experi- mental design. A researcher using human subjects is particularly vul- nerable to such action as the IRB repre- sents an ethical and altruistic concern for the patients' rights. The researcher is then cast in an irresponsible role.

To appeal such a biased ruling is use- less if the appeal process directs the in- vestigator to either the director who caused the ruling to be made or to an appeal board set up to perpetuate it.

This situation endangers the IRB process, as an investigator may well appeal through both the scientific and general press, on the grounds that he or she is being denied a fair hearing. The reputation of the IRB would suffer.

I suggest that all IRBs should have an appeal process as an established part of their bylaws. I further suggest that the IRB appeal process be extra- institutional. Every medical center should have an arrangement with a po- litically unattached institution so that an appeal can be handled by the sec- ond institution's IRB.

To speed up the appeal process, in- stead of personal appearances, the IRB and the investigator could send in writ- ten accounts of the review and the rea- sons for contention. The appeal board would make a binding decision based on the written submissions.

While this plan would not eliminate the possibility of directors influencing an appeal board's decision, it would make such influence less likely.

David S. Rubin Dept. of Lithium Studies N.Y. State Psychiatric Institute

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