Chapter 3: The Development of Requirements for Human Subject Research in Other Federal Agencies

ACHRE Report

Part I

Chapter 3

The Development of Human Subject Research Policy at DHEW

The Development of Requirements for Human Subject Research in Other Federal Agencies

Supreme Court Dissents Invoke the Nuremberg Code: CIA and DOD Human Subjects Research Scandals

Chapter 3: The Development of Requirements for Human Subject Research in Other Federal Agencies

The history and evolution of human subject research policy in the federal government is well documented for DHEW. However, many other agencies, most notably the military services, have important but less well-documented and less well-studied histories. Some of this history is described in chapter 1 of this report. Here we continue with a brief treatment of that history in the context of the evolution of human subject research policy.

Army Policy

In 1962 the Army, for the first time, issued as a formal regulation, Army Regulation (AR) 70-25, the 1953 policy embodied in the Wilson memorandum. The regulation made explicit, as the 1953 DOD and Army policies had only left implicit, basic issues about the scope of the DOD's rules. Unlike the Wilson memorandum, the new regulation applied to all types of research, not simply that related to atomic, biological, and chemical warfare. However, the regulation specifically excluded clinical research, that is, the research likely to be performed with patients at the Army's many hospitals. In 1963, an ad hoc committee of Army and civilian personnel concluded that the rule applied where research was done by contractors; however, tracer research (which arguably posed minimal risk) was excluded.[59]AFEB members and commissioners, many of the members of the ad hoc panel were nonmilitary consultants to the DOD. Despite the committee's recommendations, no immediate changes were made to the regulation. In 1963, however, the Army issued a regulation for radioisotope use that required local institutions to convene review committees and obtain approval from the secretary of the Army pursuant to AR 70-25 when radioisotopes were to be used with "volunteer" experimental subjects.[60]

The regulatory void apparently persisted until 1973, when another rule (AR 40-38, "Medical Services--Clinical Investigation Program") closed the gap. That rule clearly applied to "any person who may be at risk because of participation . . . [in] clinical investigation," including "patients" and "normal individuals."[61] It required that subjects of research be given an explanation of the proposal in understandable language and sign a "volunteer agreement."[62] Moreover, clinical research with patients, as well as healthy people, was to be reviewed by a "Human Use Committee."[63]

Navy Policy

As we saw in chapter 1, the Navy had required oral consent from research volunteers since at least 1951. Some evidence suggests that written consent was required in the mid-1960s; in a 1964 proposal to study the effects of hypoxia on service personnel it is indicated that a "signed Consent to Voluntarily Participate in Research Experiment (NMRI Form 3)" would be used.[64] In 1967 a clear requirement for written consent appeared in the Navy's Medical Department manual.[65] It is unclear whether the policy drew a distinction between research on patients and research on healthy subjects. In 1969, in any event, the secretary of the Navy issued a comprehensive policy requiring written informed consent of research subjects, which appeared to cover both groups.[66]

Air Force Policy

In 1965 the Air Force promulgated AFR 169-8, "Medical Education and Research--Use of Volunteers in Aerospace Research," which required voluntary and written informed consent from all subjects in any "research, development, test, and evaluation" that may involve "distress, pain, damage to health, physical injury, or death."[67] As such, it seems inclusive of both healthy and patient-subjects.[68] Updating the language of the Nuremberg Code's first principle, the policy was based on the idea that the "voluntary informed consent of the human subject is absolutely essential."[69] Additionally, the regulation provided for the appointment of a committee to review all human research proposals at each originating facility.

NASA Policy

The National Aeronautics and Space Administration (NASA), created in 1958, inherited staff and research expertise from the DOD and other federal agencies. Before 1968, local centers at which research using radioisotopes was conducted--notably the Ames Research Center and the Manned Spacecraft Center (MSC)--were essentially autonomous. Each center established medical use subcommittees, as required by AEC rules.[70] Reorganization within NASA in 1968 combined the medical operations functions and the medical research functions at MSC into one medical research and operations directorate headed by Dr. Charles A. Berry.

By 1968, Ames had a policy requiring informed consent.[71] By definition, of course, the work of astronauts is frequently risky and experimental. The question of the proper boundary between experimental and occupational activities was one that could not be drawn easily. Consequently, the policy authorized the director of Ames to waive the consent requirement in several instances, including when obtaining consent would seriously hamper the research or when test pilots or astronauts were involved.[72]

Between 1968 and 1970, prior review for risk and subject consent was adopted at Ames in the form of the Human Research Experiments Review Board and indirectly at the MSC in accordance with the AEC requirements for a medical use committee.[73] In 1972 the prior review provisions and consent requirements of Ames and the MSC were reformulated in a NASA-wide policy.[74] This policy required voluntary and written informed consent from subjects prior to participation. The policy continued to provide waivers for "exceptional cases," as in the Ames policy, and did not apply to research conducted by NASA contractors or grantees.

The development of NASA's polices, like those at the PHS, NIH, and the DOD, appeared at a time when the public was becoming increasingly interested in biomedical research. In contrast with the 1940s and 1950s, bureaucratic developments during the 1960s and 1970s were mirrored by growing public debate about the adequacy of protections for human subjects.