PROTECTION OF HUMAN SUBJECTS
Modification of either of the above two
primary procedures. All such modifications
must be approved by the committee in the
minutes signed by the committee chairman.
Granting of permission to use modified
procedures imposes additional responsi-
bility upon the review committee and the
institution to establish that the risk to
any subject is minimum, that use of either
of the primary procedures for obtaining
informed consent would surely invalidate
objectives of considerable immediate
importance, and that any reasonable
alternative means for attaining these
objectives would be less advantageous to
the subject.
The committee's reasons for permitting
modification or elimination of any of the
six basic elements of informed consent,
or for altering requirements for a subject's
signature, or for signature of an auditor-
witness, or for substitution (e.g., de-
briefing), or other modification of full,
complete, written prior consent, must be
individually and specifically documented
in the minutes and in reports of committee
actions to the institutional files.
Approval of any such modifications should
be regularly reconsidered as a function
of continuing review and as required for
annual review, with documentation of
reaffirmation, revision, or discontinuation
as appropriate.
No routine reports to DHEW are required.
Significant changes in policy, procedure,
or committee structure shall, however, be
promptly reported to the DRG, NIH, for re-
view and acceptance. Review of these changes,
or of institutional and other records of
performance under the terms and conditions
of DHEW policy, may require renegotiation
of the assurance or such other action as
may be appropriate.
DEPARTMENTAL IMPLEMENTATION
Departmental Review of Assurances
All assurances submitted for approval are to be
forwarded to the DRG, NIH, for review and acceptance
on behalf of the Department. Review will be
principally concerned with the adequacy of the
proposed committee in the light of the probable
scope of the applicant institution's activities,
and with the appropriateness of the proposed initial
and continuing review in the light of the probable
risks to be encountered, the types of subject
populations involved, and the size and complexity
of the institution's administration. Institutions
submitting inadequate assurances will be informed
of deficiencies. The appropriate operating agency
will be kept informed, on request, of the status
and acceptance of an assurance.
Special assurances will be reviewed in close cooperation with the operating agency concerned, either along guidelines provided by the agency, or on an assuranceby-assurance basis.
All forms or other general means intended in whole
or in part for instruction of, or for obtaining infor-
mation from, institutional sources that pertain to
implementation of this policy, or related procedure,
require prior approval by the DRG, NIH.
The DRG, NIH, will periodically issue a cumulative
list of institutions which have filed acceptable
general assurances. If an institution has filed such
an assurance but has had no active grants or contracts
involving human subjects for a period of 3 years, the
assurance may be inactivated and administratively
deleted from the cumulative listing.
Review of Proposals Involving Human Subjects
Because of the wide variety and scope of DHEW
programs involving human subjects, no review
standards are established beyond those provided
in Section 1-40-20. 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
PROTECTION OF HUMAN SULJECTS
shall establish appropriate review procedures within
their respective agencies applicable to programs
identified in accordance with the provisions of
Section 1-40-30. These procedures shall be reported
to the Secretary, DHEW, for review by the Office
of the General Counsel and the Office of Grant
Administration Policy.
In the course of review of proposals, DHEW review
groups should apply review standards uniformly
regardless of the status of the proposal, or its
state or country of origin. Review groups may
(a) recommend disapproval if the hazards are so
grave as to be unacceptable; (b) recommend
approval without restrictions when the subject's
rights and welfare are not infringed; (c) recommend
approval but record expressions of concern to be
communicated to the institution sponsoring the
project or activity; or (d) recommend approval
contingent on limitation of the scope of the work
proposed, or the imposition of restrictions, or
on the elimination of objectionable procedures
involving human subjects.
When DHEW review of an application indicates that
it involves questionable procedures, DHEW staff
should ask the institution to provide the substance
of the rationale which led to the approval of these
procedures. inquiries should be directed to an
appropriate official of the institution and should
emphasize the initial review group's need to benefit
from the institutional review committee's opinions.
The DRG, NIH, will provide information as to the
identity of the institutional officials concerned
and, if requested, will assist in making inquiries.
Informing Institutions of Concern for Use of
Human Subjects
When the action on an unsolicited proposal results
in (a) approval, but indicates concern for activities
involving human subjects, or (b) contingent approval
with imposition of grant or contract restrictions
affecting or eliminating the scope of activities
involving human subjects, or (c) disapproval, and the
recommendation by the HEW reviewers indicates that
the proposal involves undue hazards to subject, this
information should be conveyed in writing by opera-
ting agency staff to both the official signing the
proposal and to the principal investigator concerned.
PROTECTION OF HUMAN SUBJECTS
Documentation for Information of the Division
of Research Grants
Copies of summary statements, memoranda, corres-
pondence with investigators and other institutional
personnel, and other documents identifying concern
for the welfare of subjects of specific proposals,
whether the final recommendation is for approval
or disapproval, should be forwarded to the DRG,
NIH.
Award of Grants and Contracts Involving Human Subjects
Assuming all other requirements are met, routine
awards for grants or contracts involving human
subjects received from institutions with accepted
assurances may be issued without further require-
ments within the year following the date of review
and approval certified on the proposal. On the
other hand, an agency may withhold funding and
request institutional re-review and re-consideration
before funding an activity involving human subjects
when in the considered judgment of the professional
staff of the agency:
Significant change in the circumstances has occurred or new knowledge or information has developed that may affect the rights or welfare of subjects or require the reevaluation of risks to subjects.
The risks inherent in the proposed activity are of such magnitude or concern that continuing review on a short-term basis is considered essential.
Agencies wishing to make an award prior to the
institutional review and approval date certified
on the proposal have the option of:
a. Asking the institution to arrange for earlier review and certification.
b. Making the award contingent on the nonuse of
grant or contract funds for any activity
involving human subjects.
PROTECTION OF HUMAN SUBJECTS
Management of Grants and Contracts Involving Human
Subjects
Staff of Department of Health, Education, and Welfare
operating agencies having program or project responsi-
bility for grants or contracts, should alert responsible
officials of proposing institutions to the necessity
for institutional review of research involving human
subjects, particularly in the case of proposals for
the development of cooperative research programs involving
work to be conducted by a number of institutions.
Staff should call to the attention of the operating agency and of the DRG, NIH, instances of possible noncompliance with established assurances or evidence of procedural deficiencies which should have been corrected by the institution's review committee.
The DRG, NIH, will follow up reports by reviewers,
evaluators, consultants, and staff of the DHEW
indicating concern for the welfare of subjects
involved in approved and funded grants or contracts
and of subjects potentially involved in activities
approved but not funded, and in disapproved proposals.
On the basis of these reports and of other sources
of information, the DRG, NIH, may, in collaboration
with the operating agency concerned, correspond with
or visit institutions to discuss correction of any
apparent deficiencies in its implementation of the
procedures described in its institutional assurance.
If, in the judgment of the Secretary, an institution
has failed in a material manner to comply with the
terms of this policy with respect to a particular
DHEW grant or contract, he may require that it be
terminated in the manner provided for in applicable
grant or procurement regulations. The institution
shall be promptly notified of such finding and of
the reason therefor.
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