And in California...Author(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 1, No. 1 (Mar., 1979), p. 9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564465 .

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March 1979

added its own restrictions on the use of inmates under its jurisdiction in re- search. (Federal Register, Vol. 44, No. 9, January 12, i979). The Bureau is pro- posing to add Part 512-Research, and Part 549-Medical Services to 28 C.F.R. Chapter V.

Comments on the proposed rules must be submitted by March 22, 1979, to Mike Pearlman, Bureau of Prisons, Room 910, 320 1st Street, N.W., Wash- ington, DC 20534. No oral hearings are contemplated.

The Bureau takes this strong posi- tion: "The Bureau of Prisons does not permit medical experimentation or pharmaceutical testing on inmates. However, as warranted for diagnosis or treatment of a specific inmate, the Di- rector, Bureau of Prisons, may author- ize the use of, and collection of data related to, experimental diagnostic and therapeutic measures under condi- tions which have been approved by the United States Department of Health, Education and Welfare." Even such ex- perimental diagnostic and therapeutic measures may not be authorized by the Director without "a prior recommen- dation by the responsible physician and the prior full and informed consent of the affected inmate."

What types of research might be per- mitted? Part 512-Research states that a "research project is the systematic collection of information about or from former or present inmates or employ- ees, analysis of the information, and preparation of a report of findings." To be approved, research projects must "contribute to the advancement of knowledge about corrections."

ETTERS

Objections to the 'Interim Final Regulation'

The following letter, dated January 17, 1979, was written by Estelle A. Fishbein, General Counsel of The Johns Hopkins University, to Dr. Robert Backus, Acting Director, Office for Protection from Re- search Risks, National Institutes of Health. It is reprinted here with Mrs. Fishbein's permission.

On November 3, 1978, the Depart- ment of Health, Education and Wel- fare published in the Federal Register an "Interim Final Regulation" amend- ing the definition of "informed con- sent" in its regulations on protection of human subjects by requiring that prospective participants in biomedi- cal and behavioral research be ad- vised as to the availability or nonavailability of medical treatment or compensation for physical injuries incurred as the result of such par- ticipation. The Johns Hopkins Univer- sity is gravely concerned at both the manner in which the regulation was promulgated and the lack of delibera- tion it reflects. Accordingly, we submit the following comments reflecting our belief that the regulation is invalid and legally unenforceable, and that substantively it creates more prob- lems than it solves. We trust the De- partment will give serious consid- eration to our views.

Procedural Objections: The fact that the "Interim Final Regulation" be- came effective January 2, 1979, with- out prior notice to the public of the Department's intention to promulgate such a regulation, raises important questions of law and public policy. The Administrative Procedure Act clearly requires that, as a general rule, notice of proposed rule making be published in the Federal Register and that such notice shall include, among other things, "either the terms or sub- stance of the proposed rule or a de- scription of the subjects and issues involved." 5 U.S.C.?553(b). The Act further stipulates that "After notice required by this section, the agency

tunity to participate in the rule mak- ing through submission of written data, views, or arguments with or without opportunity for oral presenta- tion." 5 U.S.C. ?553(c). It appears, moreover, that the notice defect in this instance is not cured by publication of the interim final regulation with op-

portunity for comment before the effective date. The A.P.A. requires notice before rulemaking and not af- terwards: Wagner Electric Corp. v. Volpe, 466 F.2d 1013 (3rd Cir. 1972). Characterization of the rule as an "In- terim Final Regulation" also does not obviate the necessity for prior notice.

The exemptions from the require- ment of public notice of proposed rule making pertain

"(A) to interpretative rules, general statement of policy, or rules of agency organization, procedure, or practice; or

"(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons there- for in the rules issued) that notice and public procedure thereon are imprac- ticable, unnecessary, or contrary to the public interest." 5 U.S.C. ?553(b).

The narrowness of the exemptions from the necessity of providing the public with prior notice and an oppor- tunity for participation in rule making indicate that they were not meant to be invoked casually but only in ex- traordinary, unusual or emergency circumstances. As the regulation in question (45 C.F.R. ?46.103(c)(7)) can- not fairly be characterized as an inter- pretative rule, general statement of policy, or rule of agency organization, procedure or practice, the Department cannot claim exemption under 5 U.S.C. ?553(b)(A). Neither do we be- lieve that in this instance exemption from the requirement of publishing a notice of proposed rule making can be claimed under 5 U.S.C. ?553(b)(B). That section requires both a good cause finding that notice and public procedure are "impracticable, unnec- essary, or contrary to the public inter- est" and the setting forth of a statement of reasons for such a find- ing. The "Interim Final Regulation" contains no finding that notice and public procedure would be "imprac- ticable," "unnecessary" or "contrary to the public interest." Instead the "Interim Final Regulation" merely states that the public interest would be served by "adding this element of information to the Department's in- formed consent requirements as soon as possible" and, therefore, "good cause exists for issuing this as an In- terim Final Regulation." It is submit- ted that a belief that the public interest would be served by the addi- tion of the regulation "as soon as pos- sible" does not meet the statutory requirement of prior public notice of proposed rule making except where it is "contrary to the public interest."

9

And in California . . .

On the state level, California's sweeping legislation limiting biomedi- cal and behavioral research upon pris- oners (Chap. 1250, A.B. 1592, [Oct. 1, 1977]), goes into effect on July 1, 1979. The statute creates an institutional re- view board to oversee the conduct of biomedical and behavioral research on prisoners and to ensure that the rights and safety of prison research subjects are adequately protected.

Before approving a research pro- tocol, the IRB must determine, among other things, that benefits to consent- ing subjects and the value of the knowl- edge to be gained outweigh the risks involved, that there are adequate provisions for compensating research- related injuries, that remuneration of- fered prisoners is comparable to that offered nonprisoner volunteers, and that legally effective informed consent will be obtained. Carol Levine

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