Public Citizen Group Criticizes FDA Advisory Panel Support of Intraocular Lens StudySource: IRB: Ethics and Human Research, Vol. 2, No. 6 (Jun. - Jul., 1980), p. 10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564013 .

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unteer, a computer check of the Clin- ical Center's records did not reveal her previous hospitalization there. She had also been under treatment by a psychi- atrist for anorexia nervosa. From the information released so far, it appears that her private physicians did not know of her participation in the drug study, nor did the study personnel know of her complete medical history.

Shortly after her death, Charles R. McCarthy, Director of the Office for Protection from Research Risks, sent a letter to 600 institutions receiving federal research funds asking for a sec- ond IRB review on any projects involv- ing these two drugs or any similar project. Furthermore, McCarthy stated, "Careful and detailed screening of normal volunteers is imperative. ... Wherever possible, medical histories obtained from potential subjects should be supported and corroborated by written documents and thorough physical examination. Physical exam- inations may need to be repeated in the case of research which extends over a long period of time."

The FDA, NIH, and NIMH are inves- tigating the death. IRB will report fur- ther on the results of the investigations and implications for research review.

Public Citizen Group Criticizes FDA Advisory Panel Support of Intraocular Lens Study

Although the FDA Ophthalmic De- vices Advisory Panel has given a vote of confidence to the current regulatory procedures for investigating intraocu- lar lenses (IOLs) (see IRB, April 1980, p. 3), the question is by no means settled.

Robert B. Leflar, Staff Attorney, and Sidney M. Wolfe, M.D., Director of the Public Citizen Health Research Group, have written to Secretary Patricia Har- ris asking for an independent analysis of available information rather than re- lying on the "factually unsupported conclusions" of David Link, outgoing Director of the Bureau of Medical De- vices, and the FDA Advisory Panel. Lef- lar and Wolfe were instrumental in bringing the question to the attention of Commissioner Jere Goyan, who asked for the Advisory Panel review. Leflar and Wolfe believe that an inde- pendent analysis is necessary because those who conducted the FDA review also framed the agency policy.

Leflar and Wolfe believe that the ad- visory panel came to useful conclusions in three areas: that current informed consent materials for patients are inad- equate; that recent medical literature

tentatively "indicates that the inci- dence of surgical reintervention [to cor- rect problems resulting from lens im- plantation] is higher than seen in comparable routine cataract surgery without intraocular lens implanta- tion"; and that Medicare data should be collected to check on the accuracy of FDA's data and to ascertain long-term complication rates.

However, they charge that the panel failed to obtain data about other key is- sues: most significantly, the "design and conduct of FDA's study of IOLs," as

well as patient selection criteria and physician training and competence.

Goodbye, HEW; Hello, HHS

On May 7 the Department of Health, Education and Welfare (HEW) of- ficially became the Department of Health and Human Services (HHS). The Department of Education (ED) now enjoys independent status as the thirteenth Cabinet-level department.

Carol Levine

S BOOK EVIEW

Research with Deviant Subjects: The 'Dirty Hands' Problem

by Eleanor Singer

Carl B. Klockars and Finbarr W. O'Connor, eds., DEVIANCE AND DE- CENCY: THE ETHICS OF RESEARCH WITH

HUMAN SUBJECTS. Beverly Hills, CA: Sage Publications, 1979.

Discussions of ethical and legal is- sues posed by social research and by the regulation of such research are fast generating a not inconsiderable litera- ture. Within the past two to three years, for example, at least two full- scale conferences have resulted in pub- lished volumes of papers (Paul M. Ne- jelski, ed., Social Research in Conflict with Law and Ethics, Cambridge, MA; Ballinger, 1976; Robert F. Boruch, Jer- ry Ross, and Joe S. Cecil, eds., Proceed- ings and Background Papers: Con- ference on Ethical and Legal Problems in Applied Social Research, Evanston, IL: Northwestern University, April 1979). A special session at an AAAS an- nual meeting resulted in yet another published collection (Murray L. Wax and Joan Cassell, eds., Federal Regula- tions: Ethical Issues and Social Re- search, Boulder, CO: Westview Press, 1979). Several other books dealing with this same general topic (e.g., E. Diener and R. Crandall, Ethics in Social and Behavioral Research, Chicago: Univer- sity of Chicago Press, 1978) have like-

Eleanor Singer, Ph.D., is a Senior Research Asso- ciate at the Center for the Social Sciences at Colum- bia University, and editor of the Public Opinion Quarterly.

wise been published recently. Although there is, inevitably, overlap

among them, each of these collections has a somewhat different theme and a somewhat different emphasis, depend- ing on the editors' or authors' special interest, competence, and philosophy. So, for example, Boruch, himself a methodologist, includes a number of papers on technical solutions to ethical problems-e.g., variations on the ran- domized response technique and other statistical methods for assuring the confidentiality of data; whereas Paul Nejelski, a legal scholar, emphasizes shield laws for social researchers as a way of accomplishing this objective.

Deviance and Decency, the most re- cent in this spate of books on ethical is- sues in social research, is edited by a criminologist (Klockars) and a philoso- pher (O'Connor); and from its title as well as the editors' introduction, the reader is led to expect consideration of the special ethical problems associated with research on deviant subjects. In- deed, four of the best papers in the col- lection-those by Klockars, O'Connor, Reiman, and Albert Reiss--do provide just such a perspective. (A fifth one, by Bradford Gray, although not directly relevant to research on deviance, pro- vides an excellent summary of the work of the National Commission for the Protection of Human Subjects. These four papers, taken individually and together, sharply pose the ethical dilemmas of research with deviant sub- jects. They are worth the price of ad- mission, although the book as a whole would have benefited considerably from the pruning of a number of medi- ocre contributions.

In what is perhaps the most provoca- tive of the four papers mentioned

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