NIH Issues "Points to Consider" in Gene Therapy ProtocolsAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 7, No. 2 (Mar. - Apr., 1985), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564149 .

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- NNOTATIONS

Appelbaum, Paul S.; Roth, Loren H.; and Detre, Thomas. "Researchers' Ac- cess to Patient Records: An Analysis of the Ethical Problems." CLINICAL RE- SEARCH 32(4) (October 1984), 399-403 [P. S. Appelbaum, Massachusetts Men- tal Health Center, 74 Fenwood Rd., Boston, MA 02115 ].

Ethical concerns of the IRB of the Western Psychiatric Institute and Clinic in Pittsburgh regarding re- searchers' access to current patients' records led to the hospital's reassess- ment of consent policy. The investiga- tors decided to inform patients at admission that their records might be screened. Patients had the option to maintain privacy. After the policy was in place for a month the results were reviewed. Just under one third of the patients objected to investigators hav- ing access to their records.

Korn, James H. "Coverage of Research Ethics in Introductory and Social Psy- chology Textbooks." TEACHING OF PSY- CHOLOGY 11 (October 1984), 146-49 [J. H. Korn, Department of Psychology, Saint Louis Unversity, 221 N. Grand Boulevard, St. Louis, MO 63103 1.

Korn did a content analysis of forty- one psychology textbooks published since 1979 to determine how much ma- terial on research ethics is available to students. He concludes that the texts contain very little on this subject, espe- cially in the area of deception in re- search. He provides suggestions for psychology instructors in order to make students more aware of the rights of research participants regarding risk, informed consent, confidentiality, free- dom from coercion, and the right either to refuse or to withdraw from par- ticipation.

Kramer, Michael S., and Shapiro, Stanley H. "Scientific Challenges in the Application of Randomized Tri- als." JOURNAL OF THE AMERICAN MEDI- CAL ASSOCIATION 252 (November 16, 1984), 2739-45 [M.S. Kramer, Depart- ment of Epidemiology and Health, McGill University, Purvia Hall, 1020 Pine Avenue W., Montreal, Quebec, Canada H3A IA2].

The authors reappraise six aspects of randomized clinical trial design: indi- vidual versus group randomization, blinding and unblinding, the effect of

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March/April 1985

PDATE

NIH Issues "Points to Consider" in Gene Therapy Protocols

Anticipating that research in human gene therapy will begin within the next year or so, the National Institutes of Health (NIH) has issued a series of "Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols" (Federal Reg- ister, Vol. 50, No. 14, Jan. 22, 1985, pp. 2940-45). If the final guidelines follow this proposal, investigators will be asked to respond to questions about the social implications of their research. Moreover, the Recombinant DNA Advi- sory Committee (RAC) that will review the protocols, after they have passed lo- cal IRB review, will consider other so- cial aspects.

Investigators will be asked to de- scribe the steps that will be taken to en- sure that accurate information will be made available to the public about the study, and to address the possible hin- drance to scientific communication that may arise from attempts to pro- tect under patent or trade secret laws the products or procedures that will be developed in the proposed study.

The RAC and its working group will consider, in addition, questions relat- ing to the possible effect on the re- productive cells of patients; whether the proposed research represents a dis- tinct departure from present treat- ments of disease; and whether it is likely to lead to germ-line gene ther- apy, the enhancement of human ca- pabilities through genetic means, or eugenic programs encouraged or even mandated by governments.

The other issues addressed in the proposal are more commonly dis- cussed by IRBs: objectives and ration- ale of the proposed research, research design and its anticipated risks and benefits, qualifications of investigators, selection of subjects, informed consent, and privacy and confidentiality.

The guidelines resulted from recom- mendations made by the RAC Working Group for Development of Response to President's Commission's Report on Social and Ethical Issues. LeRoy Wai- ters, Director of the Center for Bio- ethics at Georgetown University, was chairman.

The comment period closed Febru- ary 21; no date has been announced for the publication of final guidelines.

---Carol Levine

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