PROTECTION OF HUMAN SUBJECTS

(1-40-40 continued)

Page 12

The procedures to be followed must be made a
matter of record in the institutional files for
the grant or contract before funds are released
by the grantee or contractor for the cooperative
project. There are three relationships that may
govern in reference to the cooperating institution:

a.

b.

Cooperating institutions with accepted general

assurances.

When the cooperating institution has on file
with the DHEW an accepted general assurance,
the grantee or contractor may request the
cooperator to conduct its own independent
review and to report to the grantee's or
contractor's committee the cooperating
committee's recommendations on those aspects
of the activity that concern individuals
for whom the cooperating institution has
responsibility in accordance with its own
assurance. The grantee or contractor may, at
its discretion, concur with or further
restrict the recommendations of the co-
operating institution. It is the responsi-
bility of the grantee or contractor to maintain
communication with the cooperating institu-
tional committees. The cooperating institution
should promptly notify the grantee or cor-
tracting institution whenever the cooperating
institution finds the conduct of the project
or activity within its purview unsatisfactory.

Cooperating institution with no accepted general

assurance.

When the cooperating institution does not have an accepted assurance on file with the DHEW, the awarding agency concerned may request the DRG, NIH, to negotiate an assurance.

ADMINISTRATION

TN 71.6 (4/15/71/

Page 13

c.

2.

PROTECTION OF HUMAN SUBJECTS

Interinstitutional Joint Reviews.

1-40-40F.2

The grantee or contracting institution may
wish to develop an agreement with cooperating
institutions to provide for a review committee
with representatives from cooperating institu-
tions. Representatives of cooperating institu-
tions may be appointed as ad hoc members of
the grantee or contracting Institution's
existing review committee or, if cooperation
is on a frequent or continuing basis as between
a medical school and a group of affiliated
hospitals, appointments may be made permanent.
Under some circumstances component subcommittees
may be established within cooperating institu-
tions. All such cooperative arrangements must
be accepted by the Department as part of a
general assurance, or as an amendment to a
general assurance, or in unusual situations as
determined by the DPG, NIH, as a special

assurance.

Institutions with Special Assurances

While responsibility for initial and continuing review necessarily lies with the contractor, the DHEW will also require acceptable assurances from those cooperating institutions having immediate responsibility for subjects.

If the cooperating institution has on file with
the DIEW an accepted general assurance, the
contractor shall request the cooperator to conduct
its own independent review of those aspects of the
project or activity which will involve human
subjects for which it has immediate responsibility.
Such a request shall be in writing and should
provide for direct notification of the contractor's
committee in the event that the cooperator's
committce finds the conduct of the activity
unsatisfactory.

If the cooperating institution does not have an accepted general assurance on file with the DHEW, the operating agency concerned must request the DRG, NIH, to negotiate an assurance.

TN 71.6 (4/15/71)

GRANTS ADMINISTRATION

2.

Institutional Responsibility

The grantee or contracting institution's
administration is accountable to the Depart-
ment for effectively carrying out the provisions
of the institutional assurance for the protection
of human subjects as accepted and recognized by
the Department. Revisions in the institutional
assurance, including the implementing procedures,
are to be reported to the Department prior to the
date such revisions become effective. Revision
without prior notification may result in with-
drawal of Departmental recognition of the
institution's assurance.

Executive Functions

Specific executive functions to be conducted by
the institutional administration include institu-
tional policy formulation, development, promul-
gation, and continuing indoctrination of personnel.
Appropriate administrative assistance and support
must be provided for the committee's functions.
Implementation of the committee's recommendations
through appropriate administrative action and
follow-up is a condition of acceptance of an
assurance. Committee approvals and recommenda-
tions are, of course, subject to review and to
disapproval or futher restriction by institutional
officials. Committee disapprovals, restrictions,
or conditions cannot be rescinded or removed
except by action of the committee or another
appropriate review group as described and
accepted in the assurance filed with the
Department.

GRANTS ADMINISTRATION

TN 71.6 (4/15/71)

Page 15

3.

4.

TN 71.6 (4/15/71)

1-40-40G.4.a

Assurance Implementation

Under no circumstances shall proposed activity
plans, not approved by the committee, be imple-
mented with Department funds. The principal
investigator, program or project director, or
other responsible staff must be notified as
promptly as possible of committee actions, in-
cluding any restrictive recommendations made by
the institutional committee or the administration.
They must also be informed and reminded of their
continuing responsibility to bring to the at-
tention of the committee any proposed significant
changes in project or activity plans or any
emergent problems that will affect human subjects.
Where continuing review of projects involves the
channels of administrative authority in the in-
stitution, notification of committee actions
should be sent through these channels. Establish-
ment of mechanisms for consultation and appeal
by investigators and subjects may be an impor-
tant condition of acceptance of an assurance by
the Department.

Development of appropriate documentation and reporting procedures is an essential administrative function. The files must include copies of all documents presented or required for initial and continuing review by the institutional review committee and transmittals on actions, instructions, and conditions resulting from review committee deliberations addressed to the activity director are to be made part of the official organizational files for the supported activity. Committee meeting minutes including records of discussions of substantive issues and their resolution are to be retained by the institution and be made available upon request to representatives of the DHEW.

CRANTS ADMINISTRATION

(1-40-40 Continued)

b.

GRAITS ADMINISTRATION

PROTECTION OF HUMAN SUBJECTS

Page 16

Informed Consent

An institution proposing to place any individual
at risk is obligated to obtain and document his
informed consent; the terms "at risk" and
"informed consent" will apply as defined in
Section 1-40-10.

The actual procedure in obtaining informed consent and the basis for committee determinations that the procedures are adequate and appropriate are to be fully documented. The documentation will follow one of the following three forms:

(1)

(2)

Provision of a written consent document embodying all of the basic elements of informed consent. This form is to be signed by the subject or his authorized representative. A sample of the form as approved by the committee is to be retained in its records. Completed forms are to be handled in accordance with institutional practice.

Provision of a "short" form written con-
sent document indicating that the basic
elements of informed consent have been
presented orally to the subject or his
authorized representative. Written sum-
maries of what is to be said to the patient
are to be approved by the committee. The
"short" form is to be signed by the subject
or his authorized representative and an
auditor-witness to the oral presentation
and to the subject's signature.
A copy of
the approved summary, annotated to show any
additions, is to be signed by the persons
obtaining the consent on behalf of the
institution and by the auditor-witness.
Sample copies of the consent form and of
the summaries as approved by the committee
are to be retained in its records.
pleted forms are to be handled in accordance
with institutional practice.

Com

TN 71.6 (4/15/71)