26

4. That research grant documentation relating to
clinical investigation using human subjects should
be identified for special consideration throughout
the NIH-PHS review process.

In his letter of transmittal to the Surgeon General, Shannon

agreed in principle with all four recommendations, and urged "that the highest priority be given [to] the rapid accomplishment of the objectives" of the first and fourth recommendations.57

However, he

gave evidence of his belief that the first recommendation "did not 1.58

constitute a means for executive action,

course of action.

and suggested an alternative

We are in full agreement with the advisory group that
there is a need for a widely acceptable statement of
principles relating to the moral and ethical aspects
of clinical investigation. The problem is to conceive
of a manner by which the statement of principles will
be assured of endorsement as a consensus position which
can serve as a positive guide to the conduct of clinical
research. The advisors recommend that this statement
of principles be developed by an appropriate professional
group. We are inclined to think a broader approach may
be necessary.

To win general acceptance within not only the medical
research community but also our society at large, the
final statement of principles should probably emerge
from a group which includes representatives of the whole
ethical, moral and legal interests of society. The
nature of this group and the manner of its convening
remains the critical question in acting upon recommendation
number one.
59
This question needs further discussion.

During 1965 Shannon continued discussion of this particular point with members of his own staff, with the hope of deriving a method by which to

57 James A. Shannon, letter of transmittal to the Surgeon General, "Moral and Ethical Aspects of Clinical Investigation," January 7, 1965 (Hereinafter referred to as "letter of transmittal").

27

establish such a statement of principles.

In the meantime, the issues

surrounding experimental research on man were receiving world-wide attention. The World Medical Association issued its "Declaration of Helsinki," which permitted experimentation, with the patient's consent,

60

The

if the experiment could be justified on therapeutic grounds. Medical Research Council of Great Britain declared that experimentation was permissible as long as "the true consent of the subject is explicitly obtained," at least in those cases where there is "no direct benefit to the individual and that, in consequence, if he is to submit to it he ,,61 must volunteer in the full sense of the world.

A decision was

subsequently made by Shannon and Surgeon General Terry to bring the

matter before the National Advisory Health Council (NAHC) at its September

1965 meeting. The Council, which had members representing both the

medical and scientific professions, was designed to take up issues within the health field which had very broad policy implications.

The feeling was that we ought to have this kind of
public concurrence for the procedural actions that
we were going to take. That is why it was submitted
to the Council. The report of the ad hoc committee
was never considered a sufficient basis of action
without some kind of broader concurrence. The National
Advisory Health Council provided that mechanism.62

Prior to that September meeting, however, another important

policy development occurred within the NIH. In March 1965, the National

60World Medical Association, "Declaration of Helsinki," Helsinki, Finland, 1964.

61 Medical Research Council of Great Britain, "Responsibility in Investigations on Human Subjects," British Medical Journal, vol. 2, July 18, 1964, pp. 178-79.

62Interview with Joseph S. Murtaugh.

28

Advisory Heart Council adopted for the National Heart Institute a

special procedure relating to cases involving hazardous clinical

research proposals.

The procedure stated that

it is the responsibility of the applicant or grantee
institution to furnish the Institute with a statement
of acceptance of its responsibility in the use of the
procedure or procedures in question. The Institute
has the responsibility for deciding whether to issue
a statement of grant award and whether to release
grant funds with or without first having obtained such
63
a statement.

Recognizing the problems faced by the NIH with respect to its

responsibilities in the area of moral and ethical aspects of clinical investigation, Dr. John Sherman, then NIH Associate Director for

Extramural Programs, urged that "each Institute adopt in principle the sense of the document as an interim measure until such time as it is

superseded by a definite PHS policy."64 At the July 1, 1965, meeting of

the NIH Executive Committee for Extramural Affairs a motion to adopt
the basic principles of the Heart Institute procedure was passed.
In a letter dated September 13, 1965, Congressman Cornelius

E. Gallagher (N.J.), who was Chairman, Special Inquiry of the House Committee on Government Operations, notified Surgeon General Terry that he was conducting an investigation regarding the problem of the invasion of privacy as it was related to certain investigative activities of the Federal Government. Gallagher wrote that

63"National Heart Institute Extramural Procedure In Case Of Hazardous Research Proposals," March 15, 1965.

64 John Sherman, Meeting of the NIH Executive Committee for Extramural Affairs, July 1, 1965.

29

One of our primary concerns has been the use of
personality tests, inventories and questionnaires in
research projects financed by grants and contracts
under the Federal Government. It is our belief
that the sponsoring agencies should adopt effective
policies and guidelines to make certain that the
protection of individual privacy is a matter of
paramount concern and that the testing is without
compulsion.65

Terry referred this letter to Dr. Philip R. Lee, then Assistant Secretary for Health and Scientific Affairs, Department of Health, Education

and Welfare, since the issues involved related not only to the activities supported by the PHS, but also to those of the Children's Bureau of the Welfare Administration and of the Vocational Rehabilitation Administration.

In his reply, Lee wrote that "I do not believe that there is any disagreement on the principles involved. In my view, the main question is how to implement the principles and protect the individual against an invasion of privacy. We believe that this can best be done by a 1166 voluntary cooperative effort. It is readily apparent, then, that

throughout all levels of Government concerned with health affairs-NIH, PHS, and the upper levels of the Department of Health, Education and Welfare (DHEW)--there was, by 1965, a manifest concern with respect to the potential problems of experimenting with human beings and to the proposition that any proposal regarding the restraint of such activity should involve a minimum of federal intervention.

65

Representative Cornelius E. Gallagher (N.J.), letter to Luther 'L. Terry, September 13, 1965.

66.

Philip R. Lee, letter to Representative Cornelius E. Gallagher, November 22, 1965.

30

The Government's Response

The general question of the ethical, moral and legal aspects

of clinical investigation was discussed with the NAHC at its meeting

on September 28, 1965. Shannon reviewed the issues that had been

discussed by his ad hoc advisory committee and his staff for the Council. 67

His remarks emphasized the following points: There was a general

awareness on the part of people engaged in clinical research activity that the present guidelines under which they operated were inadequate. The problems stemmed from the change in the nature of clinical investigation. In the past, such investigation was more in the line of observation and stemmed from the normal physician-patient relationship in an attempt to find a more accepted treatment.

However, observation was

being replaced by manipulation in not only the diseased individual but
also in normal individuals. Shannon stressed that

we have the feeling that since such investigation departs
from the conventional patient-physician relationship,
where the patient's good has been substituted for by the
need to develop new knowledge, that the physician is no
longer in the same relationship that he is in the
conventional medical setting and indeed may not be in a
position to develop a purely or a wholly objective
assessment of the moral nature or the ethical nature of
the act which he proposes to perform. We would think
that if indeed this is the case, that investigative
procedures that depart from those which are purely
therapeutic in nature perhaps might be the subject of
discussion before the fact with the investigator's peers,
so that the environment within which he resides could

568nd to

reach a sound judgment as to the worthwhileness,
the validity of the things that he chose to do.

67 This information has been taken from the Stenographic Transcript of

the National Advisory Health Council Meeting, September 28, 1965 (Hereinafter referred to as "Transcript, NAHC Meeting").

68Ibid.