Research Review for Non-HEW-Funded ProjectsAuthor(s): Ithiel de Sola PoolSource: IRB: Ethics and Human Research, Vol. 2, No. 4 (Apr., 1980), pp. 10-11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563925 .

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fined not more than $100,000. The Act that this Bill would amend

provides for maximum penalties for all persons of not more than one year im- prisonment, fines of not more than $1,000, or both. It does not distinguish "negligent" from "knowing or willful" violations. It is tempting to speculate that this distinction reflects an under- standing on the part of the Senate that its language is becoming so difficult to understand that persons may act in vi- olation of it without even being aware that they have done so.

Epilogue

S. 1075 was developed by the same Senate Subcommittee (Health) that took the lead in developing P.L. 93-348, which created the National Commis- sion for the Protection of Human Sub- jects. P.L. 93-348 charged the Commis- sion to consider, among other things, "the nature and definition of informed consent in various research settings." The Commission did this, and the re- sults of its considerations may be found in each of its reports.

As they are considering S. 1075, members of Congress should carefully examine the Commission's extensive commentary and recommendations on the topic of informed consent. The Commission identified many subtleties in this field which are not accommo- dated in S. 1075. Most importantly, the Commission did not recommend the development of a statutory definition of informed consent or the require- ments for its documentation. I do not believe that this was an oversight; the Commission made several recommen-

dations for the development of legisla- tion, particularly in its report on IRBs. Rather, I believe that the Commission, after due deliberation, identified no need for new legislation on either the definition or documentation of in- formed consent.

In my opinion there is no need for a statutory definition of informed con- sent. I am aware of no important socie- tal objective that could be accom- plished through a statutory definition that can not now be achieved through more flexible expressions of public pol- icy-e.g., guidelines and, when neces- sary, regulations.

REFERENCES 'The Drug Regulation Reform Act of 1979 (S.

1075) was passed by the Senate on Septem- ber 26, 1979. In the House of Representatives this Bill was referred to the Committee on Interstate and Foreign Commerce; its Sub- committee on Health and the Environment is expected to hold hearings on this Bill early in 1980. In this essay, I shall refer to S. 1075 either by number or as "the Bill." Ref- erences to "the Act" are to the version cited in reference 2. All references to Section num- bers are to those specified in the Act, not the Bill (which has a different numbering sys- tem).

2Federal Food, Drug, and Cosmetic Act, as Amended October 1976. U.S. Govt. Printing Office Stock No. 017-012-00239-1, Washing- ton, D.C., 20402 (21 USC 301-392).

3Dorsen, N. and Miller, J.M.: The drug regulation process and the challenge of regulatory re- form. Annals of Internal Medicine 91: 908-913, 1979.

4Very similar language is used to define "in- formed consent" in DHEW Regulations (45 CFR 46.103).

5Levine, R.J.: Clarifying the concepts of research ethics. Hastings Center Report 9 (No. 3): 21-26, June, 1979.

6Levine, R.J.: Changing federal regulation of IRBs, Part II: DHEW's and FDA's proposed

regulations. IRB: A Review of Human Subjects Research. l(No. 7): 1-5, and 12, Nov. 1979.

7This is just one of many recent proposals to de- velop policies for the protection of human re- search subjects that are grounded in pre- sumptions that either investigators or IRB members are not to be trusted. Such pre- sumptions can be subjected to empirical test- ing; I believe that they ought to be before they are used to inform the development of public policy. Some of the social costs of presump- tions of mistrust are elaborated in: Levine, R.J.: The institutional review board, in Ap- pendix to Commission: Report and Recom- mendations: Institutional Review Boards. DHEW Publication No. (OS) 78-0009, Wash- ington, D.C., 1978.

sThe Act currently specifies no requirement for documentation. FDA and DHEW Regulations do, of course, require documentation of in- formed consent.

9For further discussion of this problem see refer- ence number 5; Brady, J.V.: A consent form does not informed consent make, IRB: A Re- view of Human Subjects Research. l(No. 7): 6-7, November, 1979; and Singer, E.: More on the limits of consent forms, IRB: A Review of Human Subjects Research 2(No. 3): 7, March, 1980.

"'Levine, R.J.: Advice on compensation: More re- sponses to DHEW's interim final regulation. IRB: A Review of Human Subjects Research. l(No. 2): 5-7, April, 1979.

"FDA: Protection of human subjects; informed consent. Fed. Register 44(No. 158): 47713-47729, August 14, 1979 (proposed rule).

CZ E C May 16-17: A meeting of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research will be held in Washington, D.C. The meeting is open to the public. For further information, contact the President's Commission, 2000 K Street, N.W., Suite 555, Washing- ton, DC 20006; phone (202) 653-8051.

July 6-12: The 1980 Workshop on Bioethics, cosponsored by The Hastings Cen- ter, Institute of Society, Ethics and the Life Sciences; Westminster Institute for Ethics and Human Values; and the Department of Philosophy, University of Western Ontario, will be held at Westminster College at The University of Western Ontario, London, Canada. The topics will cover major areas of bio- ethics: general ethical issues in genetics, informed consent, human experi- mentation, the physician-patient relationship, paternalism and truth-telling, the function of national commissions, health policy, behavior control, and mental health administrations. For more information, contact Michael D. Bayles, Director, Westminster Institute for Ethics and Human Values, West- minster College, London, Canada N6G 2M2; phone (519) 673-0040.

- ETTERS

Research Review for Non-HEW-Funded Projects

On January 24, 1980, Joan Z. Bern- stein, General Counsel of the Depart- ment of Health, Education and Wel- fare, in a letter to the New York Times, provided a most significant official in- terpretation of HEW human subjects rules. For some time it has been widely believed that HEW requires IRB re- view of all research using human sub- jects conducted by an institution re- ceiving HEW funds, whether or not the particular research was funded by HEW.

That is not so! Ms. Bernstein states that the present rules apply only to HEW funded research. I quote:

"The current policy applies only to research involving human subjects which is conducted or supported by H.E.W. The purpose of the policy is to assure that, at least for research funded by H.E.W., the rights and

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April 1980

welfare of subjects are adequately protected." Ms. Bernstein goes on to say that un-

der the new proposed rules, when, and if they ever come into effect, that would no longer be true. But for the present, no university is obliged by HEW to subject non-HEW research to IRB re- view. Research institutions are free to act as they deem proper.

This important official interpreta- tion by the General Counsel of HEW should be drawn to the attention of all IRBs, university administrations, and affected faculty members. Many uni- versities have adopted procedures un- der the misapprehension that they were obliged to do so by HEW regula- tions. Now that that error has been cor- rected, they may choose to revise their practices.

In particular, those social scientists who believe that prior review of inter- view or documentary research violates the First Amendment, now need only address themselves to assuring that the future rules do not contain any such clauses. There are no present regula- tions requiring them to submit to such review.

Ithiel de Sola Pool Department of Political Science Massachusetts Institute of Technology

'Conflicting Interests' in IRB Review

In section 46.107 of the Proposed Amendments to Part 46, of 45 CFR, published in the Federal Register for August 14, 1979, Paragraph (e) states: "No member of a Board may partici- pate in the Board's initial or continu- ing review of any project in which a member has a conflicting interest ... except to provide information re- quested by the Board." Clearly, this must apply to the Chairman of the Board whose signature is required on the documents indicating approval or disapproval of the protocol. At the Al- bert Einstein College of Medicine, the Dean has appointed a Vice-chairman for the IRB. When the Chairman has a "conflicting interest" (e.g., as an inves- tigator), the Vice-chairman presides over the discussion of and vote upon the protocol and then signs any neces- sary documentaion of the IRB's action (e.g., form HEW-596).

I. Herbert Scheinberg, M.D. Chairman,

Albert Einstein College of Medicine Committee on Clinical Investigations (IRB)

LNNOTATIONS Ackerman, Terrance F. "Fooling Our- selves with Child Autonomy and As- sent in Nontherapeutic Clinical Re- search." CLINICAL RESEARCH 27 (De- cember 1979), 345-48 [T. F. Ackerman, Assistant Director, Program on Human Values and Ethics, University of Ten- nessee Center for the Health Sciences, 800 Madison Avenue, Memphis, TN 38163].

Ackerman faults the National Com- mission for the Protection of Human Subjects of Biomedical and Behavioral Research for requiring that researchers secure the "unfettered assent" of chil- dren to participate in "nontherapeu- tic" research. He says that parents have a moral duty to guide children to make the choices that will contribute to helping the child become "the right kind of person." Children, especially those who are victims of catastrophic illness, need and follow parents' or physicians' guidance. To seek unguided assent is to misconstrue both parental duty and the capability of children to exercise autonomy.

Bonchek, Lawrence I. "Are Ran- domized Trials Appropriate for Eval- uating New Operations?" NEW ENG-

LAND JOURNAL OF MEDICINE 301 (July 5, 1979), 44-45 [L. I. Bonchek, The Medi- cal College of Wisconsin, Milwaukee, WI 53226].

In answer to his title question, Bonchek states: ".. .it may be impossi- ble to conduct meaningful, long-term, randomized studies of certain high-risk operations." Clinical trials designed for a brand-new surgical procedure will be made obsolete as surgeons perfect the technique or as technological advances are made (as occurred with aortic valve procedures). It is difficult to recon- struct the trial to accommodate the new developments. If a procedure is al- ready in widespread use, doctors will refer their patients to surgeons who will perform it and will therefore di- vert high-risk patients away from ran- domization. Further, Bonchek says that medicine can derive information from sources other than randomized clinical trials. Finally, he points out that referring primary physicians can act as intrinsic controls on the practice of surgery.

In the November 22, 1979, issue of NEJM, pp. 1181-83, four letters to the editor refute Bonchek's position that randomized clinical trials are not help-

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