Information Sought about "Significant Risk" DecisionsAuthor(s): Erica HeathSource: IRB: Ethics and Human Research, Vol. 3, No. 2 (Feb., 1981), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563519 .

Accessed: 15/06/2014 04:17

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 185.2.32.110 on Sun, 15 Jun 2014 04:17:12 AMAll use subject to JSTOR Terms and Conditions

Febnmry 1981

the Early Treatment Diabetic Reti- nopathy Study (ETDRS), which will be aimed at answering four questions.

1. When, during the course of reti- nopathy, should laser treatment begin?

2. Which treatment protocol for photocoagulation is preferable?

3. Is photocoagulation effective in the treatment of macular edema?

4. Is aspirin effective in altering the course of diabetic retinopathy?

Patients in the ETDRS will be ran- domly assigned to either aspirin or a placebo, and one eye will be treated with one of four argon laser pho- tocoagulation techniques. The patients will be followed for 5-7 years to deter- mine the effectiveness of treatment. Pa- tient treatment and follow-up will be monitored as carefully as they were for the DRS .... [The letter further states that the respon- sibility for the medical care of each pa- tient will remain with his or her private physician and that all pertinent infor- mation regarding the patient will be shared with the private physician.]

Dear Dr. Kupfer: In reading over the request for refer-

rals to your Early Treatment Diabetic Retinopathy Study some questions arose about the ethical aspects of your protocol. The questions center around the treatment of only one eye.., using the other eye as a control.

We have been assured by a nurse practitioner who is involved in your study at the University of Illinois that treatment will not be withheld from the second eye should it develop pres- ently known treatable degrees of reti- nopathy. That is reassuring to hear, but who decides that the second eye has reached a presently known treatable degree of retinopathy? And who gives the treatment to the second eye?

Perhaps the answer to these two questions is that the private physician has the responsibility to decide and to recommend treatment. If so, this means that-the patient would have a separate doctor for each eye. Such an approach would fragment the con- tinuity of care more than is acceptable, even given that the patients are in- volved in an experimental protocol.

One of the criteria for ethical experi- ments with human subjects is that there must be some benefit to the sub- ject. It would therefore seem logical that the patients who are willing to en- ter the study should benefit from the expertise of those who are conducting it by receiving treatment for the second

eye from them. This would solve the problem of continuity of care as well as ensure some benefit to the subject.

We would appreciate your consid- eration of these questions and any re- sponse you have to our concerns.

Jorge Prieto, M.D.

Information Sought about "Significant Risk" Decisions

The IRB at the University of Califor- nia, San Francisco, has had several oc- casions recently to deal with FDA's new IDE regulations. These have caused the members anxiety, concern, and a great deal of aggravation. The principal reason, of course, is that IRBs are now empowered (?812.2b) to issue IDEs upon deciding that a device is a "non-significant risk" device.

This IRB has separated the decision to approve from the decision about sig- nificance of risk. We feel that the sec- ond decision is a bureaucratic decision having little to do with risk/benefit and appropriateness of proceeding. We are then left with four possible routes on the significant risk decision:

1. Decide on a case-by-case basis, 2. Arbitrarily call all devices poten-

tially high risk, 3. Arbitrarily call all devices no sig-

nificant risk, or

4. Refuse to make any decision. So far we are proceeding on a case-

by-case basis and agonizing over each decision because there are no guidelines for making it. (We have de- cided that one implant is a non-signifi- cant risk device.) Our inclination is to select option 4, but we recognize that this is contrary to the deregulation wave by forcing FDA to make all deci- sions centrally. Thus, our second in- clination is to select option 3 since, in the absence of data, we may assume there is no "known" risk though retain- ing the right to upgrade to significant risk if as the study progresses "serious" risks are shown to appear.

We have recently appointed a sub- committee to draw together informa- tion on significant risk decisions. We would be grateful to other IRBs if they could share information with us. Spe- cifically, we would like to know the type of device being used, the decision that has been made, and the criteria that have been used in reaching the de- cision. If there are trade secrets, please give us general information without identifiers.

Please send any information to Erica Heath, Committee on Human Re- search, Room C 116, University of Cal- ifornia, San Francisco, San Francisco, CA 94117.

Erica Heath Administrative Analyst, IRB Ul

Please enter my subscription to IRB: A Review of Human Subjects Research

0 INSTITUTIONAL $160 annually (20 copies mailed to the same address)

Additional copies included in same mailing @ $8 each annually (number)

0 INDIVIDUAL OR LIBRARY $20 annually (single copy) Prepayment is appreciated. Please make checks payable to: The Hastings Center, IRB

O My check for is enclosed. Ifyou enclose payment, we will extend your subscription to include one free issue. (Please detach the subscription form and mail with check in an envelope, addressed to: The Hastings Center, IRB, 360 Broadway, Hastings-on-Hudson, N.Y. 10706.)

OEl Please bill. E Please change my individual subscription to an institutional sub-

scription.

Name

Title

Institution

Address

citylstate/zip

This content downloaded from 185.2.32.110 on Sun, 15 Jun 2014 04:17:12 AMAll use subject to JSTOR Terms and Conditions