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task force emphasized the importance of maintaining an appropriate balance within the institution.

Mr. VOLKMER. Thank you very much, Dr. Levine.

This will conclude our second panel. I thank all of you for being here and for being very helpful to us.

We will recess until about 5 minutes after 1. We will start with the third panel at that time, after a short lunch break.

AFTERNOON SESSION

Mr. VOLKMER. The subcommittee will resume its sitting, and we'll start with panel 3, considering the rights of patients and research subjects in the development and marketing of biomedical products from human biological materials.

The witnesses are Dr. Charles R. McCarthy, Director, Office of Protection From Research Risks, National Institutes of Health; Dr. David Blake, associate dean for research, Johns Hopkins; Dr. Levine, institutional review board, Yale School of Medicine; and also Dr. Murray from the Institute for the Medical Humanities, University of Texas medical branch.

We'll begin with Dr. McCarthy, and before you begin I'd like to say that, again, your statement-as all statements—will be made a part of the record at your point in the record, and you may either summarize or review the statement, however you so desire. STATEMENT OF CHARLES R. McCARTHY, Ph.D., DIRECTOR,

OFFICE FOR PROTECTION FROM RESEARCH RISKS, NATIONAL INSTITUTES OF HEALTH

Dr. MCCARTHY. Thank you, Mr. Chairman, and I'm pleased to be here. What I think I will do, with your permission, is summarize the full statement that I've submitted for the record. And even my testimony, the statement I've delivered, is a summary of the regulations of the Department of Health and Human Services for the protection of human subjects.

For nearly 20 years this Department has been responding to the moral and social imperative to provide for protection of human subjects. To that end, we have issued policies; the first policy was issued in 1966. It's been revised many times; it became departmentwide policy in 1971 and, after 3 years of hearings in the Senate, it became a regulation of the Department in 1974.

The policy was turned into regulation as a result of the National Research Act, which was signed July 12, 1974, and in anticipation of that act we took our policy and published it in regulatory form. So the policy has been developing gradually over a period of-it will be 20 years in February 1986. In the course of that time, we have modified it many times.

The National Research Act not only required us to publish regulations, but it also created the National Commission for the Protection of Human Subjects, which began its hearings in December 1974, and continued, roughly on a monthly basis, to hold public hearings for 4 years. And in the course of each of those public hearings, at least some portion of every meeting of that Commission was given over to public comment, so the public had a great

deal to do with the development of the findings of that Commission.

Similarly, the Commission commissioned many reports from experts, particularly dealing with the matter of informed consent of research subjects.

According to the National Research Act, the Department of Health and Human Services—then HEW—was required either to accept the findings of the Commission and incorporate them into its regulations, or to publish reasons why the findings of the Commission were not acceptable. In fact, virtually all the recommendations of the Commission were accepted and incorporated into our regulations, which were published in 1981. But they were published only after we held three public hearings in addition to those held by the National Commission, and only after we had examined and evaluated some 700 sets of public comments on the proposed rules.

So I think it is fair to say that these regulations, perhaps more than any others that I know of that are promulgated by the Federal Government, did receive enormous public attention from the Congress, from not one but two congressionally mandated commissions—the National Commission and the subsequent President's Commission for the Study of Ethical Problems in Medicine. And all of those commissions basically endorsed and formed the regulations that we have for the protection of human subjects.

The regulations, in their broad outline, are rather easy to understand. Each institution that receives an award from any component of the Department of Health and Human Services must submit an assurance to our office that it will protect human subjects, and it must set forth the mechanisms for protection that will be afforded to those subjects. The principal mechanism is the creation of the institutional review board that must review and approve each research project prior to its being funded by the Department, and then that review must be continued so long as the research continues at intervals. of no less than 1 year. The board itself is composed of a combination of individuals, both scientific and lay members; it is created in such a way that it is expected to command respect for its decisions, and it has as its primary duty to see that research involving subjects is carried out in such a way that the risks are minimized and that they are reasonable in the light of benefits that may be expected as a result of the research.

The board also has responsibility to see that the procedure for obtaining informed consent from subjects is carried out in such a way that the consent is voluntary and reasonably well informed. The IRB, the institutional review board, must review not only the procedures for informed consent but it also must approve the document to be signed and a copy given to each subject participating in the research.

In accord with the recommendations of the National Commission, the informed consent requirements set forth in the Department's regulations require first that a statement be given to the subject that the study involves research, an explanation of the purposes of the research, the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

Second, the subject must have a description of any reasonably foreseeable risks or discomforts. And third, a description of any benefits to the subject or to others which may reasonably be expected from the research.

There are many other elements of informed consent, but, I think, those are the three that are most germane to the purposes of this hearing so I'm not going to read into the record all the other elements of informed consent.

These elements of informed consent were distilled from hundreds of hours of deliberation by the National Commission; and in the course of our experience in administering regulations which reflect those deliberations, we have found no explicit situations in the course of our experience that parallel the case that has occasioned-or at least, was part of the occasion-for this hearing. The only case that has come to our attention where a subject has felt that he or she was denied the benefits—the financial or fiscal benefits from the marketability of research products is the case that has occasioned this hearing, so that in nearly 20 years of experience in administering our policies, we know of no parallel case.

The regulations say that we are required to or that the investigator is required to-disclose to his subject any reasonably foreseeable risks and information that the subject may reasonably wish to know. Consequently, not every remote possibility needs to be disclosed; we think that actually would overburden the consent process. And in most cases, we feel that investigators would not or could not know of financial benefits that would result from the research so that in most cases we think that disclosure of this kind would be inappropriate. There may be some cases where there is something unique or unusual about this particular subject that will be involved in the research, and that can be foreseen even in the beginning, that commercial benefits might result. In such a case, we think that the regulations describing the purpose of the research could, indeed, contain such information.

So, I think, with that, Mr. Chairman, I would simply like to submit for the record a copy of our regulations, a copy of the Belmont Report—which includes the principles upon which the regulations are developed-and then a copy of the report of the National Commission dealing with institutional review boards and specifically with informed consent issues. So if we could submit those for the record, I think that would complete my statement and I would be pleased to answer any questions.

[The prepared statement of Dr. McCarthy, plus materials referred to follow:]

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MR. CHAIRMAN AND MEMBERS OF THE COMMITTEE, I AM PLEASED

TO HAVE THIS OPPORTUNITY TO PRESENT TO YOU IN SUMMARY

FASHION A DESCRIPTION OF THE DEPARTMENT OF HEALTH AND
HUMAN SERVICES REGULATIONS FOR THE PROTECTION OF HUMAN

SUBJECTS INVOLVED IN BIOMEDICAL AND BEHAVIORAL RESEARCH:

FOR NEARLY TWENTY YEARS THIS DEPARTMENT HAS BEEN RESPONDING

TO THE MORAL AND SOCIAL IMPERATIVE TO PROVIDE FOR THE

PROTECTION OF HUMAN SUBJECTS.

IT HAS DONE SO THROUGH A

VARIETY OF EFFORTS INCLUDING THE PROMULGATION OF POLICIES

AND REGULATIONS THAT REQUIRE BIOMEDICAL AND BEHAVIORAL

RESEARCHERS TO RECOGNIZE AND FULFILL THEIR RESPONSIBILITIES

FOR PROTECTING THE RIGHTS AND WELFARE OF RESEARCH VOLUNTEERS.

THESE POLICIES AND REGULATIONS HAVE GROWN AND CHANGED

AS CLINICAL RESEARCH HAS DEVELOPED, AS OUR UNDERSTANDING

OF THE RIGHTS AND WELFARE OF HUMAN SUBJECTS HAS IMPROVED

AND AS OUR EXPERIENCE IN ADMINISTERING THIS NATIONWIDE

AND, IN FACT, WORLDWIDE POLICY HAS GROWN.

IN DEVELOPING

THESE POLICIES AND REGULATIONS, THE DEPARTMENT HAS ACKNOWLEDGED

THE VITAL CONTRIBUTIONS OF RESEARCH VOLUNTEERS WITHOUT

WHOM THE REMARKABLE ACHIEVEMENTS OF MEDICAL SCIENCE IN

ALLEVIATING HUMAN SUFFERING COULD NOT HAVE TAKEN PLACE.

THE FIRST POLICY FOR THE PROTECTION OF HUMAN RESEARCH

SUBJECTS ISSUED BY THE PUBLIC HEALTH SERVICE WAS PROMULGATED

BY SURGEON GENERAL STEWART IN FEBRUARY OF 1966, NEARLY

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