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CONTENTS

CHRONOLOGICAL LIST OF WITNESSES

TUESDAY, NOVEMBER 9, 1971

Mondale, Hon. Walter F., a U.S. Senator from the State of Minnesota.__
Duval, Merlin K., M.D., Assistant Secretary for Health and Scientific
Affairs, Department of Health, Education, and Welfare, accompanied
by Robert Marston, M.D., Director, National Institutes of Health,
and professional staff members. --

Beecher, Henry K., M.D., Harvard Medical School, Cambridge, Mass-
Chayes, Prof. Abram, Harvard Law School, Cambridge, Mass..
Najarian, Dr. John, chairman, department of surgery, University of
Minnesota Medical School..

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Callahan, Daniel, Ph. D., director, Institute of Society, Ethics, and the
Life Sciences..

114

Jonas, Dr. Hans, professor of philosophy, the New School for Social
Research, New York.

119

Sinsheimer, Robert L., chairman, division of biology, California Institute of Technology-

124

Text of:

S.J. Res. 75...........

STATEMENTS

Introductory remarks by Senator_Mondale on the floor of the
Senate (from the Congressional Record, March 24, 1971)___
Beecher, Henry K., M.D., Harvard Medical School, Cambridge, Mass..
Callahan, Daniel, Ph. D., director, Institute of Society, Ethics, and the
Life Sciences..

Chayes, Prof. Abram, Harvard Law School, Cambridge, Mass..
Duval, Merlin K., M.D., Assistant Secretary for Health and Scientific
Affairs, Department of Health, Education, and Welfare, accompanied
by Robert Marston, M.D., Director, National Institutes of Health,
and professional staff members..
Prepared statement__

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Jonas, Dr. Hans, professor of philosophy, the New School for Social
Research, New York..

119

Mondale, Hon. Walter F., a U.S. Senator from the State of Minnesota___
Najarian, Dr. John, chairman, department of surgery, University of
Minnesota Medical School..

8

103

Sinsheimer, Robert L., chairman, division of biology, California Institute of Technology -

124

ADDITIONAL INFORMATION

Articles, publications, etc.:

"An Analysis of the Policymaking Process," the Public Health Service
guidelines governing research involving human subjects, February
1972____.

203

"Chimp's Brain Signals Itself by Computer," by Robert Reinhold,
from the New York Times, September 15, 1970...
"Choices on Our Conscience," a call to action from the Kennedy
International Symposium on Human Rights, Retardation and
Research..

156

190

"DNA and the Sorcerer's Apprentice," from the Washington Post,
February 4, 1971..

168

Articles, publications, etc.-Continued

"Definition of Death: A Double Standard," by Eliot Corday, M.D., from the Hospital Tribune, May 4, 1970..

"Excerpts from Potential Consequences of Experimentation with Human Eggs," by J. D. Watson...

From the Washington Post, February 24, 1971..
"FDA Warns Against Uses of 'Behavior' Amphetamines," by Robert
C. Maynard, from the Washington Post, September 30, 1970-----
"Gene Implant Seen Step to Cell Control," by Victor Cohn, from the
Washington Post, March 12, 1971..

"Human Reproduction," by Leon R. Kass, M.D., from the Wash-
ington Post, December 26, 1970 Letter to the editor_
"Institutional Assurance on Investigations Involving Human Subjects,
Including Clinical Research," from the Public Health Service.
Origins of the DHEW Policy on Protection of Human Subjects_
Protection of Human Subjects, chapters 1-40, from Manual-Grants
Administration, Part 1, HEW, TN 71.6, 4–15–71.

"RX for Child's Learning Malady," by Robert Reinhold, from the
New York Times, July 3, 1970.

"Scientists Create First Gene in a Test Tube," by Victor Cohn, from
the Washington Post, June 3, 1970-
"Social and Scientific Priorities in the Use of Genetic Knowledge," by
James V. Neel, Lee R. Dice University professor of human genetics,
department of human genetics, University of Michigan Medical
School, Ann Arbor, Mich..

"The New Genetics: Man Into Superman," from Time, April 19,

1971__

Communications to:

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Mondale, Hon. Walter F., a U.S. Senator from the State of Minnesota, from:

Edsall, John T., The Biological Laboratories, Harvard University,
Cambridge, Mass., November 23, 1971.

125

Neel, James V., M.D., Lee R. Dice University professor of human
genetics, Medical School, University of Michigan, Ann Arbor,
Mich. (with enclosure).

Memorandums:

"Clinical Investigations Using Human Subjects," U.S. Public Health
Service, Division of Research Grants, Bethesda, Md., PPO No. 129
Policy, February 8, 1966.
"Clinical Research and Investigation Involving Human Beings," to
the heads of institutions conducting research with Public Health
Service grants, from the Surgeon General, Public Health Service,
HEW, William H. Stewart, February 8, 1966-
"Investigation Involving Human Subjects, Including Clinical Re-
search: Requirements for Review To Insure the Rights and Welfare
of Individuals," U.S. Public Health Service, Division of Research
Grants, Bethesda, Md., PPO No. 129, revised policy, July 1, 1966-
"Revised Procedure on Clinical Research and Investigation Involving
Human Subjects," to the heads of institutions receiving Public
Health Service grants, from the Surgeon General, Public Health
Service, July 1, 1966.

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NATIONAL ADVISORY COMMISSION ON HEALTH

SCIENCE AND SOCIETY, 1971

TUESDAY, NOVEMBER 9, 1971

U.S. SENATE,

THE SUBCOMMITTEE ON HEALTH

WITH THE SPECIAL

SUBCOMMITTEE ON NATIONAL SCIENCE FOUNDATION

OF THE COMMITTEE ON LABOR AND PUBLIC WELFARE,

Washington, D.C. The subcommittees met at 9:15 a.m., pursuant to notice, in room 4232, New Senate Office Building, Senator Edward M. Kennedy (chairman) presiding.

Present: Senators Kennedy, Mondale, Javits, and Dominick.

Committee staff present: Elilis R. Mottur, scientific adviser; Roy H. Millenson, minority professional staff member, and Jay B. Cuttler, minority counsel, Health Subcommittee.

Senator KENNEDY. The subcommittees will come to order.

The hearing today is part of a series of studies which we are conducting on the problems of health, science, and human rights.

Advances in modern medical science have lengthened the span and changed the quality and very meaning of human life. At the same time, these advances have opened a Pandora's box of ethical, social, and legal issues. The hearings will focus on these problems in areas such as heart transplants, artificial kidneys, test tube babies, genetic intervention, and experiments on humans.

For example, just last week a hospital in Virginia was sued for allegedly allowing a black laborer to die so that his heart could be used in a transplant operation. It would not be appropriate to comment on the merits of that particular case, but it illustrates the range of difficult questions which must be faced: When heart beat and other vital signs can be maintained by artificial means, how is death to be defined? Under what circumstances may the organs of the deceased be used for transplants? Who should give permission for such transplants? Did racial considerations affect the decision to use this heart, as alleged in the suit?

Another example occurred last month when the press reported that the Defense Department was sponsoring research on radiation effects on human beings, without adequately informing the individuals concerned of the military purpose of their irradiation. The news story charged further that the subjects of these experiments were charity cases with little education and low IQ's, implying that these factors limited their understanding of the purpose of the experiments.

I do not wish to comment on the validity of these charges until we complete our investigation of the case, but it illustrates the dangers involved in human experimentation. Does the whole body radiation

used in this project shorten the patients' life span? Does it increase their suffering or discomfort? How should answers to such questions be determined? And by whom? What information and guidance should be provided to the potential subjects of the experiment? How should their consent be obtained? And how should their rights be safeguarded?

Other difficult ethical and social questions arise:

Should carriers of hereditary diseases be allowed to have children? Should retarded persons be segregated from members of the opposite sex? Should they be sterilized?

What are the ethical implications of test tube babies? What will happen to society when men and women are free to determine the sex of their children?

Which individuals should receive the benefits of artificial kidney facilities? How should we choose among those who need this help? How should society regulate the use of behavior modification drugs and other techniques to control human behavior? How can we control the controllers?

How should the Nation allocate scarce medical resources between organ transplants for a few individuals versus research and services which help many?

The solutions to these problems cannot be found within science alone. Dr. Jerome Wiesner put it simply when he said: "Science is no substitute for thought." These issues cannot be resolved by complex mathematical formulas or high-speed computers.

They fundamentally involve questions of ethics and social responsibility. To come to grips with them, we must focus the full range of human talent and imagination-from the natural and social sciences, the arts and humanities, religion and philosophy, and the professions of law, medicine, and public service.

We must draw on all the resources mankind has to offer; for, after all, it is man's fate which is at stake.

Last month the Joseph P. Kennedy, Jr., Foundation sponsored an international symposium on these questions in Washington. The symposium drew together 1,200 outstanding scientists, scholars, and social activists from all over the world, from all disciplines and professions, to explore these problems and stimulate research and action on these issues.

Following the symposium 84 of the leading participants urged the establishment of programs that "improve the quality of our thinking and acting in matters so laden with potential for human welfare or woe, for human decency or human callousness."

These hearings are intended to carry forward the important work begun at the symposium, and to determine specific policies and legislative proposals which are needed to cope with these problems.

The hearing today will focus on the joint resolution to establish a National Advisory Commission on Health Science and Society, Senate Joint Resolution 75. This resolution was introduced last March by Senator Mondale who has provided leadership in this whole area. I cosponsored it along with Senator Mondale and 16 other Senators. Since its introduction, Senators Cranston, Eagleton, Stevens, and Stevenson have been added as cosponsors.

At this point in the record we will enter a copy of the resolution. (A copy of S.J. Res. 75 follows:)

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IN THE SENATE OF THE UNITED STATES

MARCH 24 (legislative day, MARCH 23), 1971

Mr. MONDALE (for himself, Mr. BAYн, Mr. BROOKE, Mr. CASE, Mr. FONG, Mr. HARRIS, Mr. HART, Mr. HUGHES, Mr. HUMPHREY, Mr. JAVITS, Mr. KENNEDY, - Mr. McGEE, Mr. MoGOVERN, Mr. Moss, Mr. NELSON, Mr. PELL, Mr. RANDOLPH, and Mr. SCHWEIKER) introduced the following joint resolution; which was read twice and referred to the Committee on Labor and Public Welfare

JOINT RESOLUTION

To provide for a study and evaluation of the ethical, social, and legal implications of advances in biomedical research and technology.

1,

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Resolved by the Senate and House of Representatives

2 of the United States of America in Congress assembled,

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3 That this joint resolution may be cited as the "National

4 Advisory Commission on Health Science and Society 5 Resolution".

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ESTABLISHMENT OF COMMISSION

7 SEC. 2. There is hereby established a National Advisory

8 Commission on Health Science and Society (hereinafter

9 referred to as the "Commission").

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