SAMPLE HUMAN SUBJECTS
ASSURANCE
FOR PARTICIPATION IN OPRR-RECOGNIZED
COOPERATIVE PROTOCOL RESEARCH
PROGRAMS
Attached is a sample Cooperative Project Assurance (CPA) for participation in OPRR-recognized Cooperative Protocol Research Programs by institutions which do not have a Multiple Project Assurance (MPA) on file with OPRR. This Assurance documents the institution's commitment to the protection of human research subjects in accordance with DHHS regulations at Title45, Part 46 of the Code of Federal Regulations ( 45 CFR 46 ). A copy of these regulations accompanies this sample. Also provided are copies of (a) the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ("The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research"), (b) the OPRR Guidance for Institutional Review Boards for AIDS Studies, and (c) the PHS Policy on Informing Those Tested about HIV Serostatus.
The CPA provides a simple and efficient format for assuring compliance with the DHHS human subjects regulations by institutions involved in OPRR-recognized Cooperative Protocol Research Programs. Such programs involve multi-protocol, multi-site research in which data from standardized protocols are pooled across institutions. These protocols, conducted or sponsored by DHHS, are approved and monitored by DHHS Protocol Review Committees which are recognized by OPRR as satisfactorily addressing the quality of human subject protections.
Once approved, the CPA is valid for participation in all OPRR-recognized Cooperative Protocol Research Programs. A current list of such programs accompanies this sample Assurance. The list of recognized programs may be modified periodically as deemed appropriate by OPRR. OPRR may be contacted for an updated list as needed.
Note that the CPA is valid only for participation in OPRR-recognized Cooperative Protocol Research Programs. Participation in other Federally-supported research involving human subjects requires a separate Assurance of Compliance.
CPA institutions are reminded that their Institutional Review Boards (IRBs) must be sufficiently qualified, by virture of the experience, expertise, and diversity of members, to review the types of research with which they will typically be presented. Should the nature of this research change (within the scope of their participation in Cooperative Protocol Research Programs), CPA institutions are obligated to modify the IRB roster accordingly. Such modifications must be approved by OPRR prior to implementation.
Please prepare your CPA on institutional letterhead according to the sample language attached. Supply, where indicated, information specific to your institution. Any deviations from the sample text should be clearly highlighted to facilitate timely review and approval by OPRR.
Institutions wishing to utilize the Institutional Review Board (IRB) of another institution should consult OPRR by telephone prior to submitting their Assurances. The institution with the IRB must have an OPRR-approved Multiple Project Assurance (MPA) or an OPRR-approved CPA. OPRR will determine whether utilization of the particular IRB is appropriate for the circumstances involved. Inquiries should be directed to the Assurance Branch, Division of Human Subject Protections (301-402-5709), should be identified as related to Cooperative Project Assurances (CPAs), and should specify the context of the inquiry (e.g., a new Cooperative Oncology Group institution).
Revised 1/13/98
COOPERATIVE PROTOCOL RESEARCH PROGRAMS RECOGNIZED BY OPRR
IMPORTANT: CONSULT OPRR
BEFORE SUBMISSION.
OPRR CANNOT ACCEPT UNSOLICITED ASSURANCES.
(NAME OF INSTITUTION)
ASSURANCE OF COMPLIANCE WITH
DHHS REGULATIONS
FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS
IN COOPERATIVE PROTOCOL RESEARCH PROGRAMS
(NAME OF INSTITUTION)______, hereinafter known as the "institution," hereby gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects at Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) as specified below.
PART 1
Ethical Principles GoverningResearch Involving Human subjects
| I. | Applicability |
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| Except for research in which
the only involvement of human subjects is in one or more
of the categories exempted or waived under DHHS
regulations at 45 CFR 46.101(b)
or 45 CFR 46.101(i),
Part 1 of this Assurance applies to all research
involving human subjects, and all other activities which
even in part involve such research, regardless of whether
the research is otherwise subject to federal regulation,
if: |
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| (a) | the research is sponsored by this institution, or | ||
| (b) | the research is conducted by or under the direction of any employee or agent of this institution in connection with institutional responsibilities, or | ||
| (c) | the research is conducted by or under the direction of any employee or agent using any property or facility of this institution, or | ||
| (d) | the research involves the
use of this institution's nonpublic information to
identify or contact human research subjects or
prospective subjects. |
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| II. | Ethical Principles
Governing Human Subjects Research |
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| This institution is guided
by the ethical principles regarding all research
involving humans as subjects as set forth in the report
of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research entitled
"The Belmont Report,
Ethical Principles and Guidelines for the Protection of
Human Subjects of Research" and as specified
below. |
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| A. | This institution recognizes
the principles of respect for persons, beneficence
(including minimization of harms and maximization of
benefits), and justice as stated in the Belmont Report
and will apply these principles in all research covered
by this Assurance. |
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| B. | This institution
acknowledges and accepts its responsibilities for
protecting the rights and welfare of human subjects of
research covered by this Assurance. |
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| C. | This institution
acknowledges that it and its investigators bear full
responsibility for the performance of all research
covered by this Assurance, including full responsibility
for complying with Federal, state, and local laws as they
may relate to such research. |
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| D. | This institution recognizes
that before human subjects are involved in research
covered by this Assurance, proper consideration must be
given to: |
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| (1) (2) (3) (4) |
the risks to the subjects, the anticipated benefits to the subjects and others, the importance of the knowledge that may reasonably be expected to result, and the informed consent process to be employed. |
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| E. | This institution recognizes
the need for appropriate safeguards in research involving
subjects who are likely to be vulnerable to coercion or
undue influence, such as children, prisoners, pregnant
women, mentally disabled persons, or economically or
educationally disadvantaged persons. |
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| F. | This institution encourages
and promotes constructive communication among
institutional officials, research administrators,
department heads, research investigators, clinical care
staff, human subjects, and all other relevant parties as
a means of maintaining a high level of awareness
regarding the safeguarding of the rights and welfare of
human research subjects. |
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| G. | This institution recognizes
that additional Assurances will be required for any
Federally-supported research not covered under Part2,
Section I of this Assurance. |
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| H. | This institution recognizes
the need for appropriate administrative overview to
insure that these principles are applied effectively. |
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PART 2
Institutional Compliance with 45 CFR 46
for Cooperative Protocol Research Programs
| I. | Applicability |
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| Part 2 of this Assurance
applies to all human subjects research conducted in
conjunction with any OPRR-recognized Cooperative Protocol
Research Program (CPRP). |
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| II. | Institutional
Responsibilities |
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| A. | This institution will comply
fully with the requirements set forth at Title 45, Part
46 of the Code of Federal Regulations (45 CFR 46) for all CPRP research. |
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| B. | This institution will comply
fully with the requirements of all applicable Federal
policies and guidelines, including those concerning
notification of sero-positivity, counseling, and
confidentiality of subjects for all CPRP research. |
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| C. | This institution will ensure
authorization by the appropriate DHHS Program Office or
its designee prior to accrual of subjects in CPRP
protocols. |
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| D. | This institution will review
and accept sponsorship of all CPRP protocols prior to
accrual of subjects. |
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| E. | When acting as a CPRP
participant with affiliated performance sites, this
institution will ensure authorization of each performance
site by OPRR and by the appropriate DHHS Program Office
or its designee prior to accrual of subjects at the
performance site. |
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| F. | In accordance with the
composition requirements of
45 CFR 46.107, this institution has designated the
Institutional Review Board (IRB) referenced in Part3 of
this Assurance to be responsible for the initial and
continuing review of all CPRP human subjects research. |
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| G. | This institution will
arrange for prompt reporting to OPRR and to the
appropriate DHHS Program Office or its designee of |
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| (1) | any unanticipated injuries or problems involving risks to subjects or others in CPRP research, | ||
| (2) | any serious or continuing noncompliance with the provisions of this Assurance or the determinations of the IRB, and | ||
| (3) | any suspension or termination of IRB
approval for CPRP protocols. |
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| H. | This institution will
arrange for each individual who conducts or reviews CPRP
research to be provided with a copy of this Assurance, as
well as with ready access to copies of 45 CFR 46, the Belmont Report, and
all pertinent Federal policies and guidelines. |
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| I. | This institution will
document that each of its investigators has accepted the
provisions of this Assurance prior to commencing accrual
of subjects in any CPRP protocol. |
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| III. | IRB Responsibilities |
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| A. | The IRB will review and
approve all CPRP protocols, and all changes in CPRP
protocols, before the accrual of subjects and not less
than annually at intervals appropriate to the degree of
risk to subjects. Both initial and continuing reviews
will be accomplished through convened full board
procedures that comply with the requirements set forth at
45 CFR 46. Expedited review
procedures will be utilized only for minor changes in
previously approved protocols during the period for which
approval has been authorized. |
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| B. | The IRB will act with
reasonable dispatch to provide the necessary full board
review of CPRP protocols. The IRB will not employ
expedited review procedures for such protocols when they
are to be entered into for the purpose of research.
Although emergency medical care based on such protocols
is permitted without prior IRB approval, patients
receiving emergency care under these conditions may not
be accrued as research subjects nor may resultant data be
included in research. |
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| C. | The IRB may be called into
an interim review session by the chairperson at the
request of any IRB member or appropriate institutional
official to consider any matter concerned with the rights
and welfare of any subject involved in CPRP research. |
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| D. | The IRB will observe the
quorum requirements of 45
CFR 46.108. |
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| E. | The IRB will review and have
the authority to approve, require modification in, or
disapprove all CPRP research as required at 45 CFR 46.109. |
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| F. | The IRB will determine, in
accordance with the criteria found at 45 CFR 46.111, that
protections for human research subjects are adequate. |
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| G. | The IRB will have the
authority to suspend or terminate approval of CPRP
research in accordance with 45
CFR 46.113. |
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| H. | The IRB will prepare and
maintain adequate documentation of its activities in
accordance with 45 CFR
46.115. |
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| I. | The IRB will determine that
legally effective informed consent will be obtained in a
manner and method which meets the requirements of 45 CFR 46.116 and 45 CFR 46.117. |
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| J. | Where appropriate, the IRB
will determine that adequate additional protections are
ensured for fetuses, pregnant women, prisoners, and
children, as required under Subparts B, C, and D of 45 CFR 46. The IRB
will notify OPRR promptly when IRB membership is modified
to satisfy the requirements at
45 CFR 46.304 and when the IRB fulfills its duties
under 46 CFR 46.305(c). |
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| K. | In reviewing CPRP research,
the IRB will comply fully with the requirements of all
applicable Federal policies and guidelines, including
those concerning notification of sero-positivity,
counseling, and confidentiality of subjects. |
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| L. | The IRB will ensure that
information used in obtaining informed consent includes
disclosure of appropriate alternatives, including the
availability of other CPRP protocols where applicable. |
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| M. | Where appropriate, the IRB
will require receipt of progress reports to include
program-wide findings on the pertinent protocols. |
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| N. | The IRB will report promptly
to institutional officials |
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| (1) | any unanticipated injuries or problems involving risks to subjects or others in CPRP research, | ||
| (2) | any serious or continuing noncompliance with the provisions of this Assurance or the determinations of the IRB, and | ||
| (3) | any suspension or termination of IRB
approval for CPRP protocols. |
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| O. | When the IRB accepts
responsibility for the conduct of CPRP research by any
noninstitutional investigator [i.e., any investigator who
is not covered under Part1, Section I(b) or Section I(c)
of this Assurance], the IRB will maintain written
documentation acceptable to OPRR of the investigator's
commitment to abide by the provisions of this Assurance
and the determinations of the IRB. |
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| P. | Certification of IRB review
and approval of CPRP protocols will be forwarded to the
appropriate DHHS Program Office or its designee. |
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| IV. | Responsibilities of
Investigators |
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| A. | Investigators acknowledge
and accept their responsibility for protecting the rights
and welfare of human research subjects and for complying
with all applicable provisions of this Assurance. |
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| B. | Investigators will advise
the appropriate officials of hospitals, clinics, or other
institutions of the intent to admit human subjects who
are engaged in CPRP protocols. When admission to such an
institution is planned, foreseen, or regular, that
institution must possess an applicable OPRR-approved
Assurance prior to involvement of persons as human
subjects and must obtain prior authorization from the
appropriate DHHS Program Office or its designee. |
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| C. | Investigators will not
delegate to others the treatment of subjects under CPRP
protocols without prior IRB notification. |
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| D. | Investigators will report
promptly to the IRB |
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| (1) | any proposed changes in IRB-approved CPRP protocols, | ||
| (2) | any injuries to subjects in CPRP protocols, and | ||
| (3) | any unanticipated problems involving
risks to subjects or others in CPRP protocols. |
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PART 3
Institutional Endorsements
and Health and Human Services Approval
| I. | Institutional
Endorsements |
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| The officials signing below
assure that all human subjects research conducted in
conjunction with OPRR-recognized Cooperative Protocol
Research Programs will be conducted in accordance with
DHHS regulations for the protection of human research
subjects (45 CFR 46), with this
Assurance, and with the stipulations of the designated
IRB. |
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| A dated roster listing the
current membership of the designated IRB is attached. The
institution with the IRB will report promptly to OPRR
(and if applicable to the institution providing this
Assurance), changes in IRB membership via submission of a
revised and dated roster. Such changes are subject to
OPRR approval. As required at 45 CFR 46.103, provisions
have been made for meeting space and sufficient staff to
support the IRB's review and record keeping duties. |
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| A. | Authorized Official
of the Institution Providing This Assurance |
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| This institution will abide
by all provisions of this Assurance. |
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| Signature |
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| Name (must be typed) | ||||
| Title |
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| Address |
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| Phone |
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| B. | Authorized Official
of the Institution with the IRB (if different from the institution above) |
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| This institution authorizes
the designation of its IRB for review of protocols to be
conducted under this Assurance. |
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| This IRB is constituted under OPRR-approved Assurance | ||||
| Number (insert MPA# or
CPA# if known) . |
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| Signature (indicate if not applicable) | Date |
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| Name (must be typed) | ||||
| Title |
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| Address |
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| Phone |
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| C. | Institutional Review
Board Chairperson |
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| I certify that each protocol
to be conducted under this Assurance will be reviewed and
approved by the designated IRB in accordance with the
requirements of Part 46, Title 45 of the Code of Federal
Regulations and this Assurance. |
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| Signature | Date |
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| Name (must be typed) | ||||
| Address |
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| Phone |
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********** SPACE BELOW FOR DHHS **********
| II. | Health and Human
Services Approving Official |
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| All parts of this Assurance
are in compliance with the requirements of Part 46, Title
45 of the Code of Federal Regulations. This Assurance is
valid only for participation in OPRR-recognized
Cooperative Protocol Research Programs. |
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| Signature | Date |
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| Name | |||
| Title | |||
| Address |
Division of Assurances and Quality Improvement Office for Human Research, OHRP The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 |
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| Phone | (301) 496-7005 | ||
| FAX | (301) 402-0527 |
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| ASSURANCE NUMBER |
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| EXPIRATION DATE |
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| Participation in OPRR-recognized Cooperative Protocol Research Programs may not continue beyond this expiration date unless authorized by OPRR. Please use the IRB roster format to report changes in membership, as they occur. | |||
8/15/95 |
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For the Institutional Review Board (IRB) Membership Roster, see: Cooperative Project Assurance, Institutional Review Board (IRB) Membership
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Updated August 26,2002