71-40-10 continued)

PROTECTION OF HUMAN SUBJECTS

C.

Informed Consent

Page 2

D.

Informed consent is the agreement obtained from a
subject, or from his authorized representative, to
the subject's participation in an activity.

The basic elements of informed consent are:

1.

2.

3.

4.

5.

6.

A fair explanation of the procedures to be
followed, including an identification of those
which are experimental;

A description of the attendant discomforts and
risks;

A description of the benefits to be expected;

A disclosure of appropriate alternative pro-
cedures that would be advantageous for the
subject;

An offer to answer any inquiries concerning
the procedures;

An instruction that the subject is free to withdraw his consent and to discontinue participation in the project or activity at any time.

In addition, the agreement, written or oral, entered into by the subject, should include no exculpatory language through which the subject is made to waive, or to appear to waive, any of his legal rights, or to release the institution or its agents from liability for negligence.

Informed consent must be documented. (See Documentation, Section 1-40-40 G.4.)

Institution

Any corporation, institution, organization, agency,
or other legally accountable person, other than an
individual.

GRANTS ADMINISTRATION

TN 71.6 (4/15/71)

Page 3

PROTECTION OF HUMAN SUBJECTS

1-40-20A

1-40-20

A.

POLICY

Safeguarding the rights and welfare of human subjects
involved in activities supported by grants or contracts
from the Department of Health, Education, and Welfare
is the responsibility of the institution which
receives or is accountable to the DHEW for the funds
awarded for the support of the activity.

In order to provide for the adequate discharge of this institutional responsibility, it is the policy of the Department that no grant or contract for an activity involving human subjects shall be made unless the application for such support has been reviewed and approved by an appropriate institutional committee.

This review shall determine that the rights and wel-
fare of the subjects involved are adequately protected,
that the risks to an individual are outweighed by the
potential benefits to him or by the importance of the
knowledge to be gained, and that informed consent is
to be obtained by methods that are adequate and
appropriate. 1/

In addition the committee must establish a basis for continuing review of the activity in keeping with these determinations.

The institution must submit to the DHEW, for its review,
approval, and official acceptance, an assurance of its
compliance with this policy. The institution must also
provide with each proposal involving human subjects
a certification that it has been or will be reviewed
in accordance with the institution's assurance.

No grant or contract involving human subjects at risk will be made to an individual unless he is affiliated with or sponsored by an institution which can and does assume responsibility for the protection of the subjects involved.

TN 71.6 (4/15/71)

1/ In the United States, adherence to the regulations of the Food and Drug Administration (21 CFR 130.37) governing consent in projects involving investigative new drugs (IND) is required by law.

GRANTS ADMINISTRATION

PROTECTION OF HUMAN SUBJECTS

71-40-20 continued)

B.

1-40-30

Page 4

Since the welfare of subjects is a matter of concern
to the Department of Health, Education, and Welfare
as well as to the institution, no grant or contract
involving human subjects shall be made unless the
proposal for such support has been reviewed and
approved by an appropriate professional committee
within the responsible component of the Department.
This review must establish that the activity, as
described in the proposal, will not interfere with
or impair the rights and welfare of the subjects,
nor involve risks that outweigh either potential
benefits to the subjects or the expected value of
the knowledge sought, nor deny the rights of the
subject to adequate and appropriate informed consent.
The committee may recommend to the operating agency,
and the operating agency may require, the imposition
of specific grant or contract terms providing for
the protection of human subjects, including require-
ments for informed consent.

APPLICABILITY

This policy applies to all grants and contracts
which support activities in which subjects may be
at risk. Since the identification of such programs
requires the application of sound professional
judgment, such determination should involve pro-
fessional staff within the component agencies of
the Department.

The Assistant Secretary for Administration, the
Assistant Secretary for Health and Scientific
Affairs, the Commissioner of Education, the
Administrator of the Social and Rehabilitation
Service, and the Commissioner of Social Security
shall report annually to the Secretary, DHEW, the
identity of those programs within their respective
agencies which shall be subject to the provisions
of this policy. The agency involved should be
prepared to document its purpose and objectives
in including or excluding a program from the list.

DHEW staff and consultants serving programs included in the list shall be responsible for identifying those specific projects or activities which require application of the policy. Nothing shall prevent DHEW staff and consultants, however, from identifying individual projects in excluded programs which, in their opinion, also require the application of this policy. The Division of Research Grants, NIH, PHS, will be responsible for implementation and enforcement of this policy.

GRANTS ADMINISTRATION

TN 71.6 (4/15/71)

Page 5

1-40-40

A.

B.

PROTECTION OF HUMAN SUBJECTS

1-40-40B

GRANTEE IMPLEMENTATION

Negotiation of Assurances

An institution applying to the DHEW for a grant or contract involving human subjects must provide written assurance that it will abide by DHEW policy. The assurance shall embody a statement of compliance with DHEW requirements for initial and continuing committee review of the supported activities; a set of implementing guidelines, including identification of the committee; and a description of its review procedures or, in the case of special assurances concerned with single projects or activities, a report of initial findings and proposed continuing review procedures. Institutions that have not previously filed assurances should request instructions for the preparation of an assurance from the Division of Research Grants, NIH.

Negotiation of assurances is the responsibility of
the DRG, NIH. Negotiation will be initiated on
receipt of a copy of a grant application, a contract
proposal, or other documentation identifying the
project and the offeror or sponsoring institution.
Assurances will not be accepted from institutions
or institutional components which do not have
control over the expenditure of DHEW grant or
contract funds unless they are an active part of a
cooperative project or activity.

An assurance will be accepted only after review and
approval by the DRG, NIH.

Types of Assurance

Assurances may be one of two types:

1. General Assurance.

A general assurance describes the review and
implementation procedures applicable to ali
DHEW-supported activities within an institution,
regardless of the number, location, or types of
its components. (See Exhibit X1-40-1.) Gencral
assurances will be required from institutions
having a significant number of concurrent DHEW
projects or activities involving human subjects.

TN 71.6 (4/15/71)

CRANTS ADMINSTRATION

2.

Statement of Compliance.

A formal statement of compliance with DHEW policy must be executed by an appropriate institutional official.

Implementing Guidelines.

The institution must include as part of its
assurance implementing guidelines that specifi-
cally provide for:

a. The statement of principles that will assist
the institution in the discharge of its
responsibilities for protecting the rights
and welfare of subjects. This may be an
appropriate existing code or declaration
or one formulated by the institution itself.
It is to be understood that no such principles
supersede DHEW policy or applicable law.

b.

A committee or committee structure which will
conduct initial and continuing reviews.
Committee members shall be identified by
name, occupation or position, and by other
pertinent indications of experience and
competence in areas pertinent to the areas
of review such as earned degrees, board
certifications, licensures, memberships,

etc.

OPINTS ADMINISTRATION

TN 71.6 (4/25/72)