President's Commission to Develop IRB 'Site Visit' CriteriaAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 3, No. 1 (Jan., 1981), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563814 .

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January 1981

VPDATE

Panelists at Workshop Urge Changes in FDA Surveillance Program

Panelists representing national or- ganizations such as the Association of American Medical Colleges, the Coun- cil on Governmental Relations, and the National Council of Community Hospi- tals urged the Food and Drug Adminis- tration (FDA) at a workshop held November 7 in Washington to recon- sider its policies regarding compliance with federal standards for the protec- tion of human subjects in research. The workshop was sponsored by the FDA to explore both positive and negative as- pects of its current program of ex- panded surveillance of IRBs begun in 1977, and to consider alternate meth- ods of evaluating IRB compliance, such as peer review, contracts with profes- sional organizations, or a modified FDA inspection.

Five of the six invited panelists, in- cluding Dr. Paul F. Wehrle of the Uni- versity of Southern California, Dr. Herman S. Wigodsky of the University of Texas, and Dr. Robert J. Levine of Yale University, called for a change in the relationship between the FDA and those institutions having general state- ments of assurance from NIH. They recommended that the FDA accept this mechanism for accreditation. If this were done, inspections would not be necessary except in response to a spe- cific complaint or other event that raised suspicion.

In summarizing the participants' concerns, FDA Acting Deputy Director Mark Novitch listed these views: there is a serious question about the validity of any mandated review of IRBs; efforts directed toward enforcement of standards ought not to be punitive, threatening, offensive or go beyond demonstrated needs; alternatives to ex- isting methods, especially peer review in close cooperation with NIH, ought to be carefully considered; only one set of rules ought to govern the operation of IRBs, ideally the general assurance mechanism used by NIH; education ought not to be confused with com- pliance; and different rules ought to govern large teaching institutions and smaller community hospitals.

While the FDA will take all these views into account, it plans to proceed with its current inspection program. As part of this program, an FDA investiga-

tor-training program is in the planning stage, John Petricciani, FDA Bio- research Monitoring Program Director, told the workshop. Eventually the pro- gram will be implemented in conjunc- tion with NIH's Office for Protection from Research Risks. According to FDA training official David Johnson, the program will "provide some special IRB education in the next year to those investigators most likely to visit IRBs and look at their activities." A more formal course may be instituted in the future.

President's Conunission to Develop IRB 'Site Visit' Criteria

At its November 7 meeting, the Presi- dent's Commission for the Study of Ethical Problems in Medicine and Bi- omedical and Behavioral Research de- cided to undertake a pilot study to "develop an agenda and criteria for site visits to IRBs" and to develop a loose-

leaf educational reference book, con- taining topics such as "children," "prisoners," "consent," and "financial remuneration," as an aid for IRBs in reviewing research protocols. The pilot study might focus on "criteria for eval- uating IRBs," Barbara Mishkin, Dep- uty Director for Policy Study, sug- gested. Commissioner Albert Jonsen posed one question that could be put on a site visit agenda as: "What has been your experience in getting suit- able faculty on an IRB?"

The President's Commission decided to study four issues relating to IRBs: the proper relation between the fund- ing agency and the IRB, randomized clinical trials, research conducted in foreign countries, and financial re- muneration for and undue inducement to participate in research.

The next meeting of the President's Commission will be held January 9-10 in Washington, D.C. and will deal prin- cipally with informed consent and the compensation of subjects injured in re- search.

Carol Levine

11I

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