DHEW Asks Comments on Commission Recommendation to Adopt Belmont ReportAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 1, No. 4 (Jun. - Jul., 1979), p. 9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564216 .

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DHEW Asks Comments on Commission Recommendation to Adopt Belmont Report

In February 1976, the National Com- mission for the Protection of Human Subjects of Biomedical and Behavioral Research met for four days at the Smithsonian Institution's Belmont Conference Center to fulfill its charge to identify the basic ethical principles that should underlie the conduct of re- search involving human subjects. Un- like the other Commission reports, the Belmont Report does not make specific recommendations for administrative actions by the Secretary of DHEW. In- stead, the Commission recommended that the Department adopt the report in its entirety as a statement of policy.

The Secretary has now invited com- ment on this recommendation (44 Federal Register 23192-23197, April 18, 1978). Comments should be submitted by July 17, 1979, to: F. William Dom- mel, Jr., Assistant Director for Regula- tions, Office for Protection from Research Risks, National Institutes of Health, 5333 Westbard Avenue, Room 303, Bethesda, MD 20205; phone (301) 496-7005.

Copies of the Belmont Report, DHEW Publication No. (OS) 78-0012, and its two-volume Appendix, DHEW Publication No. (OS) 78-0013 and (OS) 78-0014, are for sale by the Superin- tendent of Documents, U.S. Govern- ment Printing Office, Washington, DC 20402.

Carol Levine

June/July 1979

of the project outweighs the risk to the individual that disclosure might bring. Copies of research records must be de- stroyed when no longer needed for the research, and researchers must avoid further disclosure.

The bill relating specifically to pri- vacy of medical records for research purposes would require a formal pledge of confidentiality to research subjects, stating that the researcher will withhold information about the subject except when given specific per- mission. An IRB could waive the re- quirement for such a statement.

An IRB would also have to approve a researcher's request to contact earlier research subjects. Researchers could not examine other researchers' records unless they first signed a pledge of con- fidentiality.

No immediate action on the bills is expected.

LETTERS

Boston's Response to the 'Interim Final Regulation'

It is the consensus of a number of the hospitals in the Boston area that DHEW's "interim final regulation"' is in need of a great deal of clarification. Principal concerns center around the following points:

1. Degree of physical injury. A full gamut of risks may be stated on con- sent forms, from the occurrence of a bruise after a venipuncture to the risk of an anaphylactic shock from an inves- tigational drug, or death from chemo- therapeutic treatments. Obviously, the various degrees of risk cannot be grouped into one category for purposes of the compensation statement.

2. Investigative vs. therapeutic proce- dures. In the majority of research pro- tocols, therapeutic or diagnostic proce- dures are intertwined with the re- search: in fact, in most cases the research component represents only a minor addition to a routine procedure or treatment. Often, it is very diffi- cult-and occasionally impossible-to separate one from the other for the pur- pose of determining the source of an in- jury.

3. Immediate vs. delayed manifesta- tion of injury. While some bodily inju- ries become manifest shortly following a procedure, others may be delayed for months or years and might not be easily attributable to the research.

4. Known or foreseeable risks vs. those unknown or unforeseeable. Recommen- dation 4F of the National Commis- sion's IRB Recommendations states that the consent formshould commu- nicate any reasonably foreseeable risks to subjects and whether treatment or compensation is available if harm oc- curs. Should an unforeseeable injury occur, would the compensation re- quirement then not apply? What about new drugs for which some side effects may be totally unknown? The policy of most research centers is to state only the likely or important risks on their consent forms and not mention those with a miniscule probability of occur- rence; otherwise the list could become enormously lengthy, unwieldy, and un- necessarily frightening. Would the compensation clause cover only those risks stated on the forms or also all those unknown and unstated?

Owing to the lack of clarity of the regulation, the hospitals in the Boston

area have interpreted its wording in various ways. A few have inserted a phrase on every consent form regard- less of the above considerations. Most, however, have decided to apply the regulation on a selected basis either in cases in which there is a reasonably foreseeable risk of substantial physical harm above and beyond that which might be sustained from a patient's treatment, or when there is a clear indication that the injury could be sus- tained from the research procedures.

Three hospitals have adopted the fol- lowing policy: The IRB will judge each protocol individually as to whether physical injury can be anticipated and, if so, whether a statement should be in- serted on the consent form. The criteria to be used in this judgment will be that the protocol presents a risk of substan- tial physical harm with no benefit to the subject.

Using this assessment, it appears that a statement will be included only in projects involving volunteers or con- trols or anyone for whom there would be no direct or indirect benefit. The ex- perience of these IRBs is that the ma- jority of the protocols they review clearly involve diagnostic or therapeu- tic procedures as well as investigative ones, and that it would be impossible to attribute physical injury to one or the other of these components. The statement to be inserted on the consent form will be composed by the IRB at the time of protocol review and will be tailored to the specific situation pre- sented by the study.

Although financial compensation is not available at any of these institu- tions, very often additional medical care or hospitalization would be of- fered free of charge. In addition, in cer- tain drug studies a drug company may in fact provide compensation for harm resulting from the drug trials. It is these variations that have caused some IRBs to reason that assessing each sit- uation individually is the only fair way to handle the regulation.

Two institutions have instead de- cided to include a statement on every consent form, regardless of degree of risk or presence of potential benefit. One consists of a paragraph explaining insurance mechanisms, as follows:

In accordance with the require- ments of the Department of Health, Education and Welfare, we are hereby informing you that in the

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