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to a national objective.

Given this concept, the agency will

endeavor to optimize the conditions conducive to the advancement of knowledge, including maximal freedom of inquiry.

These, then, were the five basic values processed by the policy-makers and

subsequently incorporated into the resolution promulgated by the NAHC

108

on December 3, 1965. This resolution represents a fundamental decision in Etzioni's terms. The Council gave policy-makers the "broader concurrence" they thought necessary to effectuate their policy aims. The use of such a mechanism reflects what Dror has identified as the "organizational and social distance between the units" involved in policy-making. Such distance is necessary, according to Dror, in order that the units "operate at high quality"109 so that a policy will have a better opportunity to succeed.

The policy-makers agreed that

it was much more important for an external group to make pro-
nouncements that are going to be restrictive on themselves
as they appear as professionals within an institution than for
us as federal bureaucrats
to enunciate a restrictive

The Guidelines which subsequently evolved were a result of an effort by policy-makers to bring form and direction to their basic values in order to achieve their overall goal. That goal was to develop a mechanism that would both protect and promote the interests of the American people, and that would neither sacrifice the welfare of the individual nor deny the nation the benefits which would accrue from future research. In order to

107 Confrey, "PHS Grant-Supported Research," op. cit.

108Interview with Joseph S. Murtaugh.

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develop a policy that would assure optimum protection of human subjects

as well as achieve the goals of research, a consensus developed among

policy-makers that a detailed code of ethics that "did not apply generally"111 Restrictions that might be warranted

was neither practical nor desirable.

in a particular situation might be unjustified in another. The policyMakers reasoned, therefore, that "such control would be likely to inhibit, .112 delay and distort the carrying out of research." In their attempts to design a workable policy, within the context of their five basic values, the policy-makers were able to decide upon the basic direction that the Guidelines were to take: primary responsibility for executing the policy would reside at the local level. Of course, through the PHS-NIH review process federal officials maintained their responsibility of final judgment of all research proposals. It seems fair to conclude that in the case of this particular policy the five basic values specified by policy-makers formed the framework in which all later fundamental and incremental policy decisions were made. The construction of such a framework was an essential step because of the important role played by values in determining policy objectives, the kinds of implementing mechanisms that could be established to achieve them, and the resulting degree of success. General agreement among policymakers regarding basic values remained constant throughout this decisionmaking process, but, as Dror writes, "values can be specified and ordered to

111Shannon, Transcript, NAHC Meeting.

112Donald T. Chalkley, "Intent and Experience in the implementation of PIIS Regulations Concerning Projects Involving Human Subjects," speech before the American Psychological Association, San Francisco, California, August 31, 1968.

53

various degrees" and what is required on this continuum "depends very

"113

Since value

much on the particular policy that has to be made. considerations are intertwined with cognitive considerations and since both considerations may vary with changing conditions, policy-makers often choose to effect new policies through incremental changes. Incremental policy-making "proceeds through a sequence of approximations. A policy is directed at a problem; it is tried, altered, and tried in its altered form, altered again, and so forth."114 Dael Wolfle indicated in

a statement cited earlier that "research involving human subjects ranges over a wide variety of conditions with respect to the kind of information to be secured from the subject, the methods of treatment, and possible harm." It was unreasonable, therefore, to expect an accurate forecast of those myriad of conditions. The incremental approach to decision-making focuses on margins or increments of change so that only small changes from the status quo are evaluated. The approach is "deliberately exploratory. Rather than attempting to foresee all of the consequences of various alternate routes, one route is tried, and the unforeseen consequences are left to "115 be discovered and treated by subsequent increments.

Any attempt to

go beyond this, suggests Charles E. Lindblom, is usually unrealistic and perhaps unwise; policy-makers possess neither the knowledge to predict future outcomes, nor are they able to reach agreement on the ordering of

the various values involved.

Thus, by making policy decisions incrementally,

113Dror, op. cit., pp. 164 and 165.

114Lindblom and Braybrooke, op. cit., p. 73

115Etzioni, op. cit., p. 271.

54

variations in values and the degree to which they are valued by policy

makers, as well as new factual information, can more easily be incorporated into the decision-making process. As will be shown later, the policy revisions made subsequent to the initial and fundamental policy decisions to intervene and to intervene in a particular fashion reflected only incremental differences in the ranking of priorities rather than any deviation from the commitment to the primary values held by the policy-makers throughout the process under study.

Since the initial policy statement of February 8, 1966, represents the basic form of the Guidelines, it will be useful to examine that statement in light of the original decision made by the policy-makers concerning the direction that the policy would take. For the purposes of this analysis, it is important to see if the initial statement, as well as subsequent statements, reflect Etzioni's contention that "the cumulative value of the incremental decisions is greatly affected by the underlying fundamental decisions." Perhaps the most important substantive point in the initial statement was the requirement that each grantee institution provide for "prior review of the judgment of the principal investigator or program director by a committee of his institutional associates." This requirement was certainly consistent with the second through fifth values held by the policy-makers. It represents an attempt to avoid an unnecessarily restrictive "exercise of federal responsibility"116 and to create an "institutional awareness 117

116 Curran, op. cit., p. 439.

117Shannon, Transcript. NAHC Meeting.

55

regarding the responsibility of the institution to promote a favorable environment for clinical research. If the primary responsibility for overseeing experimental procedures was to rest with the individual institutions, their review committees and their investigators, it was necessary for the policy-makers to instill the values underlying the overall policy into those review committees and scientists. This attitude was clearly expressed

by one of the policy-makers: "We must use every opportunity in a continuing campaign of education among the grantees that . . . the grantee institution must accept and discharge in a forthright manner its responsibility for both scientific and administrative overview of grant-supported activities by its faculty or staff."118 Recognizing the diversity involved in clinical research, NIH officials sought to encourage the local review committee to solve their own problems. "We realized that we possibly ride herd on the multiple situations that would arise. Our responsibility was satisfied if we were convinced that the individual institution within which the research took place had an adequate review

couldn't

The review committees were given the responsibility to determine: (1) the rights and welfare of the individual involved; (2) the appropriateness of the methods used to secure informed consent; and (3) the risks and potential medical benefits of the investigation. Dror asserts that "policymaking must often leave the concrete definitions of the policy to be

118John Sherman, Memorandum to members of the Interbureau Advisory Committee for Extramural Programs, National Institutes of Health, "Statement of Assurance With Respect to Clinical Investigation," January 23, 1966.

119 Interview with James A. Shannon.