In a "No-Risk" Protocol, Does the Purpose Count?Author(s): Erica HeathSource: IRB: Ethics and Human Research, Vol. 1, No. 6 (Oct., 1979), p. 5Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564244 .

Accessed: 12/06/2014 20:12

Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at .http://www.jstor.org/page/info/about/policies/terms.jsp

.JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range ofcontent in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new formsof scholarship. For more information about JSTOR, please contact support@jstor.org.

.

The Hastings Center is collaborating with JSTOR to digitize, preserve and extend access to IRB: Ethics andHuman Research.

http://www.jstor.org

This content downloaded from 185.44.77.89 on Thu, 12 Jun 2014 20:12:52 PMAll use subject to JSTOR Terms and Conditions

October 1979

CASE STUDY

In a "No-Risk" Protocol, Does the Purpose Count? by Erica Heath

Occasionally a very simple proposal is submitted to the Committee on Human Research of the University of California, San Francisco, that or- dinarily would be approved without question. Such protocols often are so straightforward and so frequently en- countered that, if expedited review were possible, they could easily qualify. However, if

expedited.review were now available, a very interesting question might never have surfaced.

Several years ago this IRB noticed frequent requests by investigators for receipt of anonymous tissue already excised for therapeutic reasons (abor- tuses, blood, biopsy tissues, etc.) that would otherwise have been disposed of as usual. In all such cases it was de- cided that, although subjects were in- volved as unknowing donors of tissue to be used in research, they were at no risk since there was no interaction or physical procedure and no loss of pri- vacy. Consent was not required, since to obtain consent would enhance sub- ject autonomy at the price of ano- nymity, which would otherwise be protected. The protocol in this case study fits into this general category, but with one added twist: the tissue taken would be used for genetic re- search using recombinant DNA tech- niques!

The question raised in committee (not exactly in these terms) was the price of autonomy. The right of a sub- ject to decide personally about par- ticipation had previously been sacrificed by the committee in favor of anonymity for that subject. In most cases the purposes were so innocuous that it was felt that reasonable persons (who had sought the services of this medical center) would not disagree. (The problem of protection of auton- omy for unreasonable people remained unaddressed.)

In this case it was thought that some reasonable people might disagree with the purpose and might refuse to partic- ipate in the research. Genetic engineer- ing and recombinant DNA have been discussed in public forums, and many people believe that this kind of re- search should be curtailed. Regardless of the lack of any risk, surely some of the patients whose excised tissue might be used in the research protocol

might refuse if they were given the choice.

This IRB decided that the donor sub- jects should be afforded the opportu- nity to make their own value judgements about participation, however distant, in this area of re- search. Consent was therefore re- quired. It would be interesting to know what other IRBs have done in similar circumstances.

The Effect of Expedited Review

Perhaps as interesting a concern as the decision itself is speculation on the effect that the expedited review proce- dures recommended by the National Commission For the Protection of Human Subjects of Biomedical and Behavioral Research might have had on the outcome.' With expedited re- view an IRB could, with concurrence of DHEW, establish a quick review mechanism with designated reviewers and designated categories of studies for which there is adequate IRB prece- dent. Conceivably this simple request would have been reviewed by one per- son who could have reported an ap- proval to the full committee with a note that the protocol fit the category of "no subjects at risk-anonymous use of previously excised tissue." The issue of the ultimate use and subjects' possi- ble objections on that basis would not have been raised unless the one re- viewer identified it. Certainly, decreas- ing the number of opinions increases the role of personal bias.

The purpose of the research is not mentioned by the Commission as a cri- terion for determining the appropriate-

ness of expedited review. In its IRB Report, the Commission simply listed a number of procedures appropriate for expedited review. The proposed re- quirements for approval are review by an experienced person to determine that the proposal meets specified con- ditions and that "the research involves no violation of the basic ethical princi- ples governing research involving human subjects." The full IRB is to be notified of approval. No mention is made about referring to the purpose of the study in any way, either in setting up categories of studies for expedited review, consideration of purpose in the review, or reporting of the purpose to the full IRB at the time it is notified of approval.

As a result of this experience, this IRB has extended its precedent that re- view of the purpose of a procedure is important in consideration of pro- tocols. In addition, we have noted a potential problem in the use of expe- dited review procedures.

REFERENCE 'National Commission for the Protection of

Human Subjects of Biomedical and Behav- ioral Research: Report and Recommenda- tions, Institutional Review Boards, DHEW Pub. No. (OS) 78-0008, Washington, 1978. Recommendation 5 at pp. 32-37.

POSTSCRIPT Proposed regulations from DHEW were pub-

lished in the Federal Register of August 14, 1979 (Vol. 44, No. 158). Under section 46.101(c) two alternative lists of studies are being considered for exemption from IRB re- view. This case would be exempt from IRB review under alternatives A-6 and B-5. It would appear that questions of autonomy of individuals or similar questions would not be raised by any reviewing body.

Erica Heath is administrative analyst for the Com- mittee on Human Research at the University of Cal- ifornia, San Francisco.

COMVIENTARY

Property Rights and Excised Tissue by Leonard H. Glantz

This case study presents a generic problem: may research be performed on tissue that is removed from a person for therapeutic reasons, without ob- taining that person's informed con- sent? This issue is further narrowed because in this case the tissue is to be

used anonymously, i.e., the researcher will not be able to connect any of the findings with the person from whom the tissue was removed.

This problem can be approached in two ways. First, does such research put human subjects at risk? Second, does the person from whom the tissue has been removed have some "quasi-prop- erty right" in it and therefore some authority to determine its use?

Leonard H. Glantz, JD., is assistant professor of law and medicine, Department of Socio-Medical Sciences and Community Medicine, Boston Uni- versity Medical Center.

1

This content downloaded from 185.44.77.89 on Thu, 12 Jun 2014 20:12:52 PMAll use subject to JSTOR Terms and Conditions