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Use of Human Volunteers in Experimental Research


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Use of Human Volunteers in Experimental Research

Government document

By: Charles E. Wilson


Date: February 26, 1953

Source: Department of Energy. "DOE: Openness: Human Radiation Experiments."

About the Author: Charles E. Wilson (1890–1961) left the presidency of General Motors to serve as Secretary of Defense for President Dwight D. Eisenhower from 1953 to 1957. As a business executive of some note in the administration of a former United States Army general, Wilson was expected to concentrate on defense management rather than formulation of basic national security policy. Wilson reorganized the Department of Defense and attempted to run the Pentagon like a business corporation with much authority decentralized to allow for greater civilian control. He also implemented Eisenhower's New Look program for the military that reduced conventional weapons and increased the number of nuclear weapons in an effort to do more with less money. The Wilson-Eisenhower effort to curb defense expenditures provoked criticism from military leadership and Congress. In 1957, Wilson resigned his office and retired to Michigan.

INTRODUCTION

From 1944 to 1974, the U.S. government prepared for possible war with the Soviet Union by attempting to determine the effects of radiation on the human body. Military and government leaders assumed that as both the United States and the Soviet Union possessed nuclear weapons, any war between the countries would likely involve nuclear attacks on major cities with hundreds of thousands of people likely suffering heavy radiation exposure.

While radiation experiments were conducted in San Francisco, Chicago, and Rochester, New York, the experiments at Cincinnati General Hospital are perhaps the best known. For eleven years beginning in 1960, University of Cincinnati physicians at the hospital irradiated ninety unwitting patients as research for the Department of Defense. This project needed subjects who could be irradiated over their whole bodies as if for treatment of cancer. The radiation was given in one continuous dose in an effort to stimulate the exposure of soldiers in nuclear war. Twenty men and women died within a month of exposure.

The experience of Lula Tarlton was typical. Tarlton, an elderly African American domestic worker, had a recurrence of breast cancer. After receiving total body radiation in the basement of the hospital, she vomited profusely for weeks, then fell into convulsions and died. Like other patients in the experiment, Tarlton received no follow-up care, such as help with nausea or pain. Additionally, no consent form had been offered to Tarlton and no one in her family knew that she had participated in an experiment. According to the doctors, patients were told only that they were being treated for their disease.

In 1972, University of Cincinnati English professor Martha Stephens read an account in The Village Voice about radiation experiments. Wondering about possible tests done at her own school, she headed over to the University of Cincinnati medical school and convinced the director to share six hundred pages of files. Shocked, she helped author a report by the Junior Faculty Association that put an immediate halt to the experiments but the findings were almost completely ignored by the Cincinnati media. The researchers hotly denied any wrongdoing and the media regarded them as more credible.

PRIMARY SOURCE

26 February 1953
Memorandum for the Secretary of the Army
Secretary of the Navy
Secretary of the Air Force
Subject: Use of Human Volunteers in Experimental Research

1. Based upon a recommendation of the Armed Forces Medical Policy Council, that human subjects be employed, under recognized safeguards, as the only feasible means for realistic evaluation and/or development of effective preventive measures of defense against atomic, biological, or chemical agents, the policy set forth below will govern the use of human volunteers by the Department of Defense in experimental research in the fields of atomic, biological and/or chemical warfare.

2. By reason of the basic medical responsibility in connection with the development of defense of all types against atomic, biological and/or chemical warfare agents, Armed Services personnel and/or civilians on duty at installations engaged in such research shall be permitted to actively participate in all phases of the program, such participation shall be subject to the following conditions:

a. The voluntary consent of the human subject is absolutely essential.

1) This means that the person involved should have legal capacity to give consent; should also be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment….

f) No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur….

h) Proper preparation should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death….

k) During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

l) The established policy, which prohibits the use of prisoners of war in human experimentation, is continued and they will not be used under any circumstances.

3. The Secretaries of the Army, Navy, and Air Force are authorized to conduct experiments in connection with the development of defenses of all types against atomic, biological and/or chemical warfare agents involving the use of human subjects within the limits prescribed above….

/signed/
C. E. Wilson
copies furnished:
Joint Chiefs of Staff
Research and Development Board
TOP SECRET
Downgraded to UNCLASSIFIED
22 Aug 75


SIGNIFICANCE

While the U.S. government had protections in place for the protection of human subjects since the issuing of the 1953 Wilson Memorandum, these protections were kept secret from the public. By the time that the government made the protections public in 1973, a number of Americans had received exposure to radiation, often in the form of injections of plutonium and uranium. Scientists claimed that the subjects were terminally ill anyway and would not survive the ten years required to be significantly affected by a small radiation dose.

In late 1993, Hazel O'Leary, Secretary of the Department of Energy in the administration of President Bill Clinton, became concerned about possible human rights violations in connection with Cold War-era radiation research experiments. Like all radiation research in the early Cold War, the results had been classified secret but the information was declassified and made generally available in the 1960s. However, the media missed the story and the research remained largely unknown to the general public. O'Leary formed the Presidential Advisory Committee on Human Radiation Experiments. In October 1995, the committee recommended that financial compensation be made to the surviving family members of the radiation subjects.

The families of radiation test subjects who received plutonium injections received a $4.8 million settlement from the U.S. government in 1996. Physicians were uncertain whether the deaths of the subjects were directly related to the experiments. However, plutonium exposure causes painful osteoporosis and autopsies on patients injected with plutonium revealed bones that "looked like Swiss cheese" according to a lawyer for the plaintiffs. Survivors and next-of-kin of the Cincinnati radiation subjects sued the University of Cincinnati, the researchers, and, as one-time owner of the hospital, the city of Cincinnati for fraud and violation of civil rights. In 1999, they won a $3.5 million settlement and the erection of a small memorial on the college campus.

The Department of Energy established the Office of Human Radiation Experiments in March 1994 to address the government's role in radiation research. It is charged with identifying and cataloging 3.2 million cubic feet of records scattered across the country.

FURTHER RESOURCES

Books

Stephens, Martha. The Treatment: The Story of Those Who Died in the Cincinnati Radiation Tests. Durham: Duke University Press, 2002.

Department of Energy. "DOE: Openness: Human Radiation Experiments."

Wilson Memorandum.



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