(1-40-50 continued)

PROTECTION OF HUMAN SUBJECTS

Page 22

F.

If, in the judgment of the Secretary, an institution
fails to discharge its responsibilities for the
protection of the rights and welfare of the individuals
in its care, whether or not DHE funds are involved,
he may question whether the institution and the individ-
uals concerned should remain eligible to receive future
DHEW funds for activities involving human subjects.
The institution and individuals concerned shall be
promptly notified of this finding and of the reasons
therefor.

Implementation Procedures

Operating agencies shall implement this policy within
60 days of its publication in accordance with the
general guidelines of Chapter 1-20. The initial
report required by Section 1-40-30 of this policy
should be forwarded to the Office of Grant Adminis-
tration Policy within 90 days of publication and in
following years by July 30. Procedures for the
internal review of proposals involving human subjects
as required by Section 1-40-50 B.1. shall be submitted
to the Office of Grant Administration Policy within
6 months of publication.

General assurances previously accepted by the DRG,
NIM, for the PMS and listed in its current "Cummulative
List..." will be considered acceptable for the purposes
of this policy. Application of the policy to ongoing
grants and contracts shall be made at the start of the
first budget period following operating agency imple-
mentation, but no later than July 1, 1972.

GRANTS ADMINISTRATION

TN 71.6 (4/15/71)

GRANTS

ADMINISTRATION

EXAMPLE OF A STATEMENT OF COMPLIANCE

Exhibit X1-40-1

PART ONE OF A GENEPAL INSTITUTIONAL ASSURANCE

The (name of institution) will comply with the policy for
the protection of human subjects participating in activities
supported directly or indirectly by grants or contracts from
the Department of Health, Education, and Welfare. In fulfill-
ment of its assurance:

This institution will establish and maintain a committee com-
petent to review projects and activities that involve human
subjects. The committee will be assigned responsibility to
determine for each activity as planned and conducted that:

The rights and welfare of subjects are adequately protected.
The risks to subjects are outweighed by potential benefits.
The informed consent of subjects will be obtained by
methods that are adequate and appropriate.

This institution will provide for committee reviews to be con-
ducted with objectivity and in a manner to ensure the exercise
of independent judgment of the members.
Members will be ex-

cluded from reviews of projects or activities in which they
have an active role or a conflict of interest.

This institution will encourage continuing constructive com-
munication between the committee and the project directors as
a means of safeguarding the rights and welfare of subjects.
This institution will provide for the facilities and profes-
sional attention required for subjects who may suffer physical,
psychological, or other injury as a result of participation
in an activity.

This institution will maintain appropriate and informative rec-
ords of committee reviews of applications and active projects,
of documentation of informed consent, and of other documentation
that may pertain to the selection, participation, and protection
of subjects and to reviews of circumstances that adversely af-
fect the rights or welfare of individual subjects.

This institution will periodically reassure itself through ap-
propriate administrative overview that the practices and pro-
cedures designed for the protection of the rights and welfare
of subjects are being effectively applied and are consistent
with its assurance as accepted by the Department of Health,
Education, and Welfare.

Official signing for the Institution
Signature

Title
Date

Enclosure: Implementing Guidelines, Part Two of a General
Institutional Assurance

HEW TN 71.6 (4/15/71)

"GRANTS

ADMINISTRATION

LE OF A STATEMENT OF COMPLIANCE

SPECIAL INSTITUTIONAL ASSURANCE IN CONNECTION WITH
SINGLE PROJECTS INVOLVING HUMAN SUBJECTS

(0) The

(1)

(name of institution) will comply with the policy for the protection of human subjects participating in projects or activities supported by grants and contracts made by the Department of Health, Education, and Welfare. This policy requires a review independent of the investigator or director to safeguard the rights and welfare of those subjects. An initial review of the application for a grant or contract identified as submitted by this institution on behalf of indicates that:

In the opinion of this committee the risks to the rights
and welfare of the subjects in this project or activity are:

(2)

The committee states that adequate safeguards against these risks have been provided.

In the opinion of the committee the potential benefits of this activity to the subjects outweigh any probable risks. This opinion is justified by the following reasons:

(3)

In the opinion of the committee the following informed
consent procedures will be adequate and appropriate.
Documentation is attached.

(4)

The committee agrees to arrange for a continuing exchange of information and advice between itself and the investigator or director, particularly to deal with proposed chances in project or activity design, or with emergent problems which may alter the investigational situation with regard to the criteria cited above. This exchange will be implemented through:

This institution will provide whatever professional at-
tention or facilities are required to safeguard the
rights and welfare of human subjects.

HEW TN 71.6 (4/15/71)

X1-40-2

EXAMPLE OF A STATEMENT OF COMPLIANCE

(5) The signatures, names, occupations, or titles of the
members of the committee are listed below.

Name

Page 2

Occupation or Title

Dr. DUVAL. This policy required that, prior to the beginning of any research project involving the use of human subjects, there must be review of each proposed course of study that would be carried out by a committee of institutional associates, to include consideration of (1) the protection of the rights and welfare of the individuals; (2) the relative weights of the risks and potential benefits of the investigations; and (3) the adequacy and appropriateness of the methods to be used to secure informed consent.

Senator KENNEDY. Of course, I haven't had an opportunity to review your written testimony, since you just brought it to us this morning. Perhaps you are going to get into how those three requirements are balanced against your earlier very elaborate expression of the kinds of opportunities and problems that exist within the whole range of human behavior.

You illustrated, I thought, marvelously well the whole range of questions and legitimate areas of inquiry. Then you give us the three kinds of institutional requirements for the protection of the rights and welfare of the individual, the relative weights of the risk, and potential benefits of the investigations, and the adequacy and appropriateness of the methods to be used to secure informed consent.

Those seem limited in scope, when measured against the wide range of opportunities. Later in your testimony, will you get to that?

Dr. DUVAL. To the extent the testimony treats that, the testimony will speak for itself. If you want to bring that up in the questioning, I would be glad to speak to it.

Senator KENNEDY. Fine.

Dr. DUVAL. This policy required the establishment of procedures in over 500 major U.S. institutions for a review of the ethical, legal, and moral questions raised by specific and immediate situations. On a dayto-day basis, these groups must confront such thorny and difficult present-day issues as research involving minors and the mentally retarded, the use of prisoner and student volunteers, the research use of diagnostic procedures such as biopsy and catheterization, and the legal problems associated with research on the effects of narcotics.

The NIH has also been concerned with the value questions, most broadly construed, which are raised by clinical investigation involving human beings. In 1963, the National Institute of General Medical Sciences awarded a grant to Boston University for a study of the place of clinical investigation in modern society, and the report of this study, "Clinical Investigation in Medicine," by Irving Ladimer and Roger W. Newman, is considered a classic reference in its field. In the spring of 1966. the National Heart Institute awarded a grant to the American Academy of Arts and Sciences to study the general problems posed by the use of human beings in biomedical research, the special problems of voluntary, informed consent, the need for new criteria of death, and other vital questions. An issue of Daedalus, in the spring of 1969, resulted from that study, "Ethical Aspects of Experimentation With Human Subjects."

Most recently, the John E. Fogarty International Center for Advanced Study in the Health Sciences of the NIH cosponsored with the Institute for Society, Ethics, and the Life Sciences, a 4-day conference on "Ethical Issues in Genetic Counseling and the Use of Genetic Knowledge," the second of a pair of conferences devoted to ethical issues in human genetics.