McCarthy Reassures IRBs on Compensation RuleSource: IRB: Ethics and Human Research, Vol. 1, No. 7 (Nov., 1979), p. 9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563659 .

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McCarthy Reassures IRBs on Compensation Rule

Charles McCarthy, director of DHEW's Office for the Protection from Research Risks, has stated "flatly" that "no consideration is being given to is- suing final regulations requiring com- pensation to individuals injured in the course of HEW-supported research." McCarthy's statement was in the form of a letter to the editor published in Science (August 31, 1979), correcting an assertion in an article on ethics boards (Science, July 20, 1979), that the de-

partment will require such compensa- tion and furthermore that individuals and their IRBs will have to "foot the bill."

In denying both assertions, McCar- thy said that HEW has been consider- ing the "feasibility" of requiring such compensation. However, he continued, "no issuance of proposed rules (NPRM) is contemplated in the near future; and not until the publication of an NPRM and consideration of public comment on the notice, will HEW consider issu- ing final regulations." In addition, he said that no institution or IRB would be required to "foot the bill"; all the al- ternative mechanisms that HEW has considered for any compensation pro- gram provide for federal funding.

DHEW is now studying the report of the HEW Secretary's Task Force on the Compensation of Injured Research Subjects to determine whether the Ethics Advisory Board is an appropri- ate forum for the study of the compen- sation issue.

November 1979

qJPDATE President's Bioethics Commission Members Are Nominated by White House

Last October Congress created a President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, a successor to the National Commis- sion for the Protection of Human Sub- jects of Biomedical and Behavioral Research. Unlike the Ethics Advisory Board, whose jurisdiction is limited to the Department of Health, Education and Welfare, the new commission can take on ethical problems that arise within any federal agency.

The White House has nominated eleven people to serve on the commis- sion. They are: Morris Abram (chair- man), a lawyer and former President of Brandeis University; Ren6e Fox, a sociologist from the University of Pennsylvania; Mario Garcia-Palmieri, University of Puerto Rico Medical School; Albert R. Jonsen, an ethicist from the University of California School of Medicine, San Francisco; Pa- tricia A. King, a lawyer from the Georgetown University Law Center; Mathilde Krim, a scientist from Sloan- Kettering Institute for Cancer Re- search; Donald M. Medearis, Massa- chusetts General Hospital and Harvard University; Arno G. Motulsky, a geneti- cist from the Center for Inherited Dis- eases, University of Washington; Fritz C. Redlich, professor of psychiatry at the University of California, Los An- geles; Anne A. Scitovsky, an economist at the Palo Alto Medical Research Foundation; and Charles J. Walker, a physician in private practice, Nash- ville. Commissioners Jonsen and King also served on the National Commis- sion.

EAB Considers Exclusions from Freedom of Information Act for CDC and NIH

At its June meeting DHEW's Ethics Advisory Board (EAB) began consid-

eration of the problems posed by dis- closure of epidemiologic and research data under the Freedom of Information Act. The Center for Disease Control (CDC) monitors the occurrence of dis- ease and conducts epidemiologic stud- ies to identify causes and to recom- mend preventive measures where pos- sible. The agency depends on voluntary reporting by health care providers for its information. Such information has been obtained from the CDC through the Freedom of Information Act by in- vestigative reporters, whose stories about a particular hospital's problems or disease rates have resulted in law- suits and adverse publicity. The EAB is now considering a CDC proposal to amend the Public Health Service Act to protect from disclosure the identity of health care providers that voluntarily provide CDC with information for pur- poses of disease investigation, epi- demiologic monitoring or study.

The National Institutes of Health (NIH) wants a similar amendment to prevent disclosure of data from its clin- ical trials and observational epidemio- logical studies which are preliminary, incomplete, or not yet validated.

NIH argues that premature dis- closure of research data may be un- desirable because the scientist has a "proprietary interest in being allowed to develop his or her own ideas and to control the release of those ideas," which may ultimately deserve com-

CALENDAR

NOVEMBER 8-A "Cancer Control Workshop on Informed Consent" will be held at Stouffers Inn on the Square in Cleveland, Ohio, in connection with the meeting of the Eastern Cooperative Oncology Group. Dale H. Cowan, M.D., of the Division of Hematology/Oncology, Saint Luke's Hospital, and School of Medicine of Case Western Reserve University, will moderate the session. Pres- entations will be made by Robert J. Levine, M.D., Robert Veatch, Ph.D., Charles McCarthy, Ph.D., and William J. Curran. For more information con- tact Dr. Cowan, St. Luke's Hospital, 11311 Shaker Boulevard, Cleveland, Ohio; phone (216) 368-7793.

NOVEMBER 12-Deadline for filing comments on DHEW's proposed rules amending basic HEW policy for protection of human research subjects. Com- ments should be addressed to F. William Dommel, Jr., J.D., Assistant Director for Regulations, Office for Protection from Research Risks, National Institutes of Health, 5333 Westbard Avenue, Room 3A18, Bethesda, MD 20205; phone (301) 496-7163.

NOVEMBER 12-Deadline for filing comments on FDA's reproposed rule on standards for Institutional Review Boards for clinical investigations. Written comments should be directed to the Hearing Clerk (HFA-305), Food and Drug Administration, Rm 4-65, 5600 Fishers Lane, Rockville, MD 20857. For more information, contact John C. Petricciani, Bureau of Biologics, FDA, 8800 Rock- ville Pike, Bethesda, MD 20205; phone (301) 496-9320. Public hearings were scheduled for September 18 (Bethesda), October 2 (San Francisco), and Octo- ber 16 (Houston). The same dates for hearings and comment apply to the FDA's proposed definition of informed consent.

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