FDA Sets Final Rules on Prisoner ResearchAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 2, No. 7 (Aug. - Sep., 1980), p. 10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564366 .

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DI~ accountability when research is spon- sored by external agencies, and the re- sponsibilities and liabilities of spon- sors, investigators, local review com- mittees, and national authorities are frequently ill-defined.

The data collected so far by CIOMS indicate that there are three distinct approaches taken in developing coun- tries relating to ethical review of re- search involving human subjects: self- regulation by the medical profession; regulations by ethical review commit- tees (a new but growing mode); and regulation from within the national ad- ministration.

Several issues are controversial, in- cluding ethical issues relating to con- trolled clinical trials; the use of special categories of subjects (pregnant wo- men and women of child-bearing age, minor children, incompetent adults, prisoners and detainees, citizens of third states); the validity of informed consent; and financial protection of subjects, compensation and insurance, and strict liability and product lia- bility.

The project will continue collecting data through a questionnaire survey, a literature search, analysis of existing systems and their applicability to de- veloping countries, and field investiga- tions. A final report is scheduled to be issued in the fall of 1981.

FDA Sets Final Rules On Prisoner Research

The Food and Drug Administration (FDA) has issued final rules implement- ing the recommendations of the Na- tional Commission for the Protection of Human Subjects of Biomedical and Be- havioral Research governing research with prisoners. The rules, published in the Federal Register on May 30, 1980 (Vol. 45, No. 106, pp. 36386-36392), will go into effect June 1, 1981.

Defending the need for the regula- tions, the FDA stated that "there is sig- nificant evidence that additional regu- lations are necessary to protect ade- quately the interests of prisoners who participate as human subjects of re- search within its jurisdiction. ... The legislative history of the National Re- search Act indicates that it was passed in reaction to abuses in the field of human experimentation, including prison research."

The FDA also stated that it decided to prohibit the use of prisoners in re- search subject to its jurisdiction that is not related to the health or well-being of the subjects or to conditions par- ticularly affecting prisoners as a class

President's Commission Requests Data from IRBs As reported in the March 1980 issue of IRB, the President's Commission for

the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research is studying the question of compensation for injured research sub- jects. The Commission staff is now in the process of gathering data with re- spect to both the incidence of research injuries and existing practices concerning the provision of medical care and/or financial compensation to in- jured research subjects. The Commission is interested in hearing from IRBs with either (1) systematic records concerning the incidence of adverse effects (anticipated or unanticipated) to research subjects, (2) episodic reports of se- rious injuries to research subjects, or (3) experience providing care or financial compensation to injured research subjects through either a formalized mech- anism or an ad hoc process. Persons with such information should contact Barbara Mishkin or Alan J. Weisbard at the Commission's offices, 2000 K Street, N.W., Suite 555, Washington, D.C. 20006; phone (202) 653-8051.

because this prohibition is consistent with the regulations adopted by HHS. The agency believes that there is signif- icant value in adopting regulations compatible with, if not identical to, those of HHS, where appropriate.

Some of the comments received by the FDA on its tentative decision, an- nounced in 1978, to adopt the findings of the National Commission challenged the agency's right to take away a pris- oner's right to participate in research. The FDA rejected that argument, as- serting: "Any deprivation to prisoners that results is clearly outweighed by the fact that these regulations are nec- essary to assure that the interests of prisoners who participate in research subject to FDA's jurisdiction are ade- quately protected ... ." Furthermore, the FDA points out that medical and medically related research involving prisoners has already been prohibited in federal prisons, has been prohibited in eight states, and is conducted only in about seven of the states that either permit it or do not regulate it.

A majority of the members of IRBs set up to review those categories of re- search still permitted under the regula- tions must have no association with the prison, except for their membership on the IRB. Moreover, at least one mem- ber of the IRB must be a prisoner or a prisoner advocate. If more than one IRB is involved in reviewing the re- search, only one need have this cate- gory of member.

IRBs reviewing research involving prisoners must assure, in addition to other responsibilities, that the research under review represents one of the per- missible categories: that any possible advantages accruing to the prisoner through participation are not of such a magnitude to influence the prisoner's ability to assess the risks; that risks are commensurate with those that would be accepted by nonprisoner volunteers;

that procedures for selecting subjects are fair; that any information given to subjects is presented in appropriate language; that adequate assurance ex- ists that parole boards will not take into account a prisoner's research par- ticipation in its decision making; and that, where needed, adequate provision is provided for follow-up examination or care and that prisoners are informed of this fact.

Carol Levine

- ETTERS

On Queasiness and Research with the Brain-Dead

David H. Smith's "On Being Queasy," a commentary on John A. Robertson's "Research on the Brain- Dead,"--both in the April 1980 IRB- indicates that Smith feels queasy about Robertson's advocacy of using brain- dead subjects for medical research. Robertson, while noting that some may find such research objectionable even though the deceased specifically con- sented to it or the deceased did not spe- cifically object and the survivors con- sent, defends such research against the claim that it is unethical by pointing out that "Surely a legal policy based on the consent of those most directly af- fected by a practice is not unethical simply because it offends other peo- ple."

Robertson's defense leads Smith to wonder whether the sensibilities of the community are irrelevant to the prac- tices allowed by law. I take it that Smith thinks some people would be justifiably offended by using brain-

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