Conclusion

Chapter 1: The National Institutes of Health and The Veterans Administration

In the early 1950s NIH participated in some of the discussions preceding the issuance of the 1953 secretary of defense memorandum. At the request of a DOD official for information on NIH's approach to the use of human subjects, NIH responded with an April 1952 letter that included a draft statement on the "Ethical Principles Underlying Investigations Involving Human Beings." Among"chap1_ its other provisions, the April 28, 1952, draft states that

[t]he person who is competent to give consent to an investigative procedure must do so. He must have legal capacity to give consent and be able to exercise free choice, without the intervention of any element of force, fraud, deceit, duress, constraint or coercion. He must have sufficient knowledge and comprehension of the nature of the investigation to enable him to make an understanding and enlightened decision. He must therefore be told the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; the inconveniences and hazards reasonably to be expected; and the effects upon his health or person which can reasonably be expected to come from his participation in the investigation. He should understand, furthermore, that by his participation he becomes a co-investigator with the physician.[113]

Although it is not known what became of this draft statement, around this time NIH had good reason to develop a policy on the use of human subjects. In 1953 NIH opened the Clinical Center, a state-of-the-science research hospital. The center adopted a policy requiring "voluntary agreement based on informed understanding" from all research subjects and written consent from some patient-subjects involved in research that the physician believed to be unusually hazardous.[114] Written consent was required from all healthy, "normal" subjects of research beginning in 1954.[115] Additionally, NIH began a system of group review of proposed research that became a model for today's institutional review boards (IRBs).[116] Thus, the NIH policy appears to be the first instance of a single policy that expressly provides for consent from all subjects, be they healthy or sick. Even so, the policy was still limited to research at the Clinical Center and did not apply to the considerable amount of NIH-funded research being undertaken by grantees (extramural research).

The question of whether "patients," as well as healthy, "normal" volunteers, should give written consent arose in the development of the NIH policy. Legal counsel at NIH advised that, "from a legal point of view," there should be a "written statement . . . indicating the patient's awareness of the nature of the particular investigation in which he was to participate and acceptance of any particular inconvenience or risk inherent in his participation."[117] A signed form offered the best proof that a "policy" of "informed consent" was followed for all subjects enrolled in studies at the center.

The NIH attorney wrote that while the Clinical Center's Medical Advisory Board did not disagree with the principle, it did disagree with the need for a written statement:

[O]f the members that expressed their views, and most did so, all rejected such a proposal. The rejection was due, as I understand it, not to any particular detail but rather a more basic objection to written, as opposed to oral, statements. There was apparently, therefore, no objection to providing the patient with enough information to permit him to exercise an informed choice of participation or refusal as long as not reduced to writing for his signature.[118]

Nonetheless, the principle that all research subjects, including healthy subjects in the "normal volunteer" program and patient-subjects, should make an informed choice seems to be acknowledged in the Medical Advisory Board's position.

The NIH Clinical Center approach adopted by the mid-1950s--written consent from healthy subjects and from only certain patient-subjects--persisted through the early 1960s and was paralleled in policies of the DOD and the AEC. The view that written consent from patients might unnecessarily interfere with doctor-patient relationships prevailed.

Within the NIH, dialogue continued throughout the 1950s, setting the stage for the leading role DHEW was to take in formulating human research regulations in the 1960s (see chapter 3).[119]

Although the NIH was by far the dominant agency in research involving human subjects, a significant amount of radioisotope research occurred at the VA. The VA research program employing radioisotopes at VA medical centers began in 1948.[120] This program was limited to VA hospitals affiliated with medical schools. From its inception, this program involved a system of prior group review by local radioisotope committees, normally composed of non-VA-affiliated teaching staff of the affiliated medical school.[121] These committees reviewed all research proposals and approved all research conducted at VA radioisotope units.

In its formative years, the advisers to the new VA program included Stafford Warren, Shields Warren, and others who were likely to be familiar with the consent principles articulated by the AEC. Nonetheless, the earliest evidence of a consent policy at the VA comes in the form of a 1958 general counsel's opinion on whether the VA could participate in certain research. The general counsel asserted that

persons who participate [in human subject research] must voluntarily consent to the experiment on themselves. Such consent must rest upon an understanding of the hazards involved. The volunteer may withdraw from the experiment at any time. Moreover, before the experiment, steps to reduce the hazard, as for example, indicated research on animals, must be made.[122]

This opinion was written in response to two proposed research projects, and it is not known if it was implemented in the projects or applied to others.