THE PUBLIC HEALTH SERVICE

GUIDELINES GOVERNING RESEARCH INVOLVING HUMAN SUBJECTS:

An Analysis of the Policy-Making Process

Introduction

The Public Health Service (PHS), largely through its National Institutes of Health (NIH), is the federal government's chief agency for supporting and conducting medical research. For the 1970 fiscal year NIH appropriations totaled $1.5 billion1 and NIH support for medical research was approximately 53% of total federal support for such research." Thus, the tempo, character and direction of the nation's medical research effort is preeminently influenced by NIH programs and policies. Involved in this major research effort is a significant amount of clinical research using human subjects. In 1970 there were more than 11,000 research grants awarded by NIH and "slightly over 30%" of these involved human subjects.3

The NIH, of course, is responsible primarily for the support of a national program of research in the health sciences. In implementing this responsibility, the NIH maintains its own intramural research program, issues contracts for particular research studies, and distributes research grants to non-profit research institutions and their investigators.

1United States Department of Health, Education and Welfare, Public

Health Service, National Institutes of Health. NIH Almanac 1971 (Washington, D.C.: GPO, 1971), p. 99.

21bid., p. 109.

3Interview with Donald T. Chalkley, Chief, Institutional Relations Section, Division of Research Grants, NIH, Bethesda, Maryland, June 22, 1971.

While other PHS components maintain similar, though smaller programs,
policy related to the administration of the extramural research program
is largely determined by NIH. This study is concerned with one of these
policies, the PHS Guidelines regarding the protection of the individual
as a research subject. Part I of the study examines the evolution of
the first issuance of the PHS Guidelines and subsequent revisions through
the promulgation of the Protection Of The Individual As A Research Subject
on May 1, 1969. Part II of the study analyzes the process by which these
Guidelines were developed and examines the values, motivations and other
underlying factors which led to their formulation. This analysis is con-
structed in the context of various theoretical and conceptual frameworks
of decision-making and attempts to explain why the policy evolved as it
did. It is not the purpose of this study to evaluate the Guidelines in
principle or to assess their effectiveness. While the author recognizes

4

the worth of a study "testing" the validity of many of the key decisions as well as of evaluating the efficacy of the Guidelines, such an effort would probably require another study equal to or greater in scope than this

one.

The importance of the PHS Guidelines is found most of all in their relationship to society, its health and its values. The Guidelines represent the government's attempt to protect the interest and investment

"United States Department of Health, Education and Welfare, Public Health Service, Division of Research Grants. Protection Of The Individual As A Research Subject (Washington, D.C.: GPO, 1969), Publication No. 0-348-095.

5Dr. Bernard Barber and his Research Group on Human Experimentation at Barnard College, Columbia University, have made such a study. Their findings were presented in a series of four papers at the American Association for the Advancement of Science (A.A.A.S.) Annual Meeting in Chicago, Illinois, December 1970.

73-191 O - 72 -14

3

of the American people. Such interest and investment are evidenced by the nation's annual commitment of more than one billion dollars to the NIH, which

is "a decision by the American people, expressed through the Congress, to invest a substantial share of the nation's resources in research leading to

the improvement of health."6 But while the American people accept health as

an important value, they also recognize the value of individual worth and dignity. The Guidelines reflect the fact that society assigns great importance to protecting the individual against possible injury while simultaneously desiring to maximize the freedom of scientific inquiry. "This policy seeks to avoid the danger of direct federal intervention, case by case, on the one hand, and the dangers inherent in decision by an individual scientist on the other."7 The knowledge explosion has brought to the policy-making process a confrontation of scientific knowledge, ethical values and political responsibility. The Guidelines represent an attempt on the part of an administrative agency to reconcile those factors as they relate to a specific area of the quest for new knowledge and to develop a climate in which clinical research can prosper.

Examination of the Guidelines also focuses attention on public policy-making by a federal agency. By identifying the important substantive issues as well as the key decision-makers and the critical values which supported their policy decisions, one can more easily account for the

William H. Stewart, Former Surgeon General, United States Public Health Service, in Committee on Government Operations, National Commission on Health Science and Society. Hearings before the Subcommittee on Government Research, United States Senate, on S.J. Res. 145, 90th Congress, 2nd session, 1968, p. 210.

7Ibid., p. 211.

resultant policy. At a time when new scientific and technological developments have rekindled the debate regarding the merits and feasibility of various approaches to making public policy, an analysis of this policymaking process may help one to evaluate this debate. At the very least, it should provide valuable insight into one instance of public policy as it was actually developed.

5

PART I: THE EVOLUTION OF THE P.H.S. GUIDELINES

In the Foreword to the Protection of the Individual as a

Research Subject, former Surgeon General William H. Stewart wrote that "I believe that we have taken important steps toward protecting the

human being who is a subject of research, while encouraging the conduct ,,8

of excellent research on man. The steps of which Surgeon General Stewart wrote evolved over a long period of time. While the first official statement of government policy concerning its extramural research program was issued only in 1966, the issues underlying the development of the policy extend some years further back in time. In order to understand more fully the basis upon which recent policy decisions were made, it will be useful first to examine the thinking and practices relevant to medical research prior to the initiation of formal government involvement

Historical Antecedents

Experimentation on man for scientific purposes dates back to
Justification for such experimentation

the beginning of recorded history.

lies in the belief that, before any new technique may be considered acceptable medical practice or procedure for use in man, it must first be tested on a human being. "While prior experimentation in animals is

William H. Stewart, Protection of the Invididual as

a Research Subject,