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VA Multiple Project Assurance Contract Assurance of Compliance For Protection of Human Research Subjects The
_________________________________, hereinafter known as the
"institution" (see Appendix A), hereby gives assurance, as
specified below, that it will comply with the Department of Veterans Affairs
(VA) regulations for the protection of human research subjects, 38 CFR Part
16 and Part 17, as amended to include provisions of the Federal Policy for
the Protection of Human Subjects (56FR28003), also known as the Common Rule,
and as described in VA Manual M3, Part I, Chapter 9 and as may be further
amended during the approval period for this Assurance. Where applicable it
will also comply with FDA regulations 21 CFR 50 and 56. PART 1 -PRINCIPLES, POLICIES, AND
APPLICABILITY I. Ethical Principles A. 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:
Ethical Principles and Guidelines for the Protection of Human Subjects of
Research [the "Belmont Report"]), regardless of whether the
research is subject to Federal regulation or with whom conducted or source of
support (i.e., sponsorship). B. All institutional and
non-institutional performance sites for this institution, domestic or
foreign, will be obligated by this institution to conform to ethical
principles which are at least equivalent to those of this institution, as
cited in the previous paragraph or as may be determined by the Department of
Veterans Affairs Undersecretary for Health. II. Institutional
Policy A. All requirements of
Title 38, Part 16 and Part 17, of the Code of Federal Regulations (38 CFR 16)
will be met for all federally-sponsored research, and all other human
subject research regardless of sponsorship, except as otherwise noted in this
Assurance. Federal (all departments and agencies bound by the Federal Policy)
funds for which this Assurance applies may not be expended for research
involving human subjects unless the requirements of this Assurance have been
satisfied. B. Except for those
categories specifically exempted or waived under 38 CFR 16 Section 101(b)
(1-6) or 101(i), all research covered by this Assurance will be reviewed and
approved by an Institutional Review Board (IRB) which has been established
under this Multiple Project Assurance Contract (MPA Contract) with VA
Headquarters (VAHQ), or as may otherwise be agreed to by VAHQ (see Part I,
II, G). The involvement of human subjects in research covered by this
Assurance will not be permitted until an appropriate IRB has reviewed and
approved the research protocol and informed consent has been obtained from
the subject or the subject's legal representative (see M3 Part I Chapter 9,
Sections 9.09, 9.10, 9.119.12 and appendix 9c), unless properly waived by the
IRB under Section 9.11 b (3) or by any applicable waiver under 38 CFR 16
Section 101(i). The referenced VA manual sections include and amplify on 38
CFR 16 Sections 111, 116 and 117. C. This institution
assures that before human subjects are involved in nonexempt research covered
by this Assurance, the IRB(s) will give proper consideration to: 1. The risks to the
subjects 2. The anticipated
benefits to the subjects and others, 3. The importance of the
knowledge that may reasonably expected to result, and 4. The informed consent
process to be employed. D. Certification of IRB review and approval for
all non-HHS sponsored research involving human subjects will be submitted to
the _______________ Office of Research Administration (ORA) for forwarding to
the appropriate Federal department or agency or other funding source.
Compliance will occur within the time and in the manner prescribed for
forwarding certifications of IRB review to VAHQ or other Federal departments
or agencies for which this Assurance applies. As provided for under 3 8 CFR 16 Section 118, applications and
proposals lacking definite plans for involvement of human subjects will not
require IRB review and approval prior to award. However, except for research
exempted or waived under section 3 8 CFR 16 Section 101 (b) or (i), no human
subjects may be involved in any project supported by such awards until IRB
review and approval has been certified to the appropriate Federal Department
or agency. As required under 38 CFR 16 Section 119, the IRB will review
proposed involvement of human subjects in Federal research activities
undertaken without prior intent for such involvement, but will not permit
such involvement until certification of IRBs review and approval is received
by the appropriate Federal department or agency E. Institutions that are
not signatories to this Assurance are not authorized to cite this Assurance.
This institution will ensure that such other institutions and investigators
not bound by the provisions of this Assurance will satisfactorily assure
compliance with 38 CFR 16, as required (see Part 2, 1, D and II, K), as a
prior condition for involvement in any human subject research which is under
the auspices of this institution (see part 1, IIIA). Institutions that have
entered into an Inter-Institutional Amendment (IIA) to this Assurance must
submit a Single Project Assurance (SPA) to the Office for Protection from
Research Risks (OPRR) for DHHS-sponsored research, or to VAHQ for other
research when that research is not conducted under the auspices of a
signatory institution to this Assurance. F. This institution will
ensure that any collaborating entities (i.e., those entities engaged in human
subject research by virtue of subject accrual, transfer of identifiable
information, and/or in exchange of something of value, such as material
support (e.g., money, drugs, or identifiable specimens), co-authorship,
intellectual property, or credits) materially engaged in the conduct of
non-federal sponsored research involving human subjects will possess
mechanisms to protect human research subjects that are at least equivalent to
those procedures provided for in the ethical principles to which this
institution is committed (see Part 1, 1). G. This institution will
exercise administrative overview to ensure that the institution's policies
and procedures designed for protecting the rights and welfare of human subjects
are being effectively applied in compliance with this Assurance. H. Descriptions of this
institution's policy for the protection of human subjects is contained in its
internal written procedures which are available to VAHQ and other Federal
departments or agencies, upon request. III. Applicability A. Except for research in
which the only involvement of humans is in one or more of the categories
exempted or waived under 38 CFR 16, Sections 101 (b) (1 -6) or 101 (i) and M3
Part 1, Section 9, appendix A, this Assurance applies to all research
involving human subjects, and all other activities which even in part involve
such research, regardless of sponsorship, if one or more of the following
apply: 1. The research is
sponsored by this institution, or 2. The research is conducted by or under the
direction of any employee or agent of this institution in connection with his
or her institutional responsibilities, or 3. The research is
conducted by or under the direction of any employee or agent of this institution,
or 4. The research involves
the use of this institution's non-public information to identify or contact
human research subjects or prospective subjects. B. All human subject
research which is exempt under M3 Part 1, Appendix 9A will be conducted in
accordance with: (1) the Belmont Report, (2) this institution's
administrative procedures to ensure valid claims of exemption, and (3)
orderly accounting for such activities. C. This Assurance may be
accepted by other Federal departments or agencies that are bound by the
Federal Policy for the Protection of Human Subjects with the exception of the
Department of Health and Human Services, when appropriate for the research in
question and therefore applies to all human subject research so sponsored. PART 2 -
RESPONSIBILITIES I. Institution A. This institution
acknowledges that it bears full responsibility for the performance of all
research involving human subjects, covered by this Assurance, including
complying with Federal, state, or local laws as they may relate to such
research. B. This institution will
require appropriate safeguards in research that involves the cognitively
impaired or other potentially vulnerable groups as provided in M3, Part 1,
Section 9.12. C. This institution
acknowledges and accepts its responsibilities for protecting the rights and
welfare of human subjects in research covered by this Assurance. D. This institution is
responsible for ensuring that no performance site cooperating in the conduct
of federally sponsored research for which this Assurance applies does so
without Federal department or agency approval of an appropriate assurance of
compliance, in whatever appropriate form, and satisfaction of IRB
certification requirements. E. In accordance with the
compositional requirements of M3, Part 1, Sections 9.08, and 38 CFR 16
Section 107, this institution has established the IRB(s) listed in the
attached roster(s) (See Appendix A). Certain research supported by the U.S.
Department of Education will be reviewed in accordance with the requirements
of Title 34 CFR Parts 350 and 356 which require that the IRB(s) include at
least one person who is primarily concerned with the welfare of handicapped
children or mentally disabled persons. F. This institution will
provide both meeting space and sufficient staff to support the IRB's review
and record-keeping duties. G. This institution is
responsible for ensuring that it and all its affiliates comply fully with all
applicable Federal policies and guidelines, including those concerning
notification of seropositivity, counseling, and safeguarding confidentiality
where research activities directly or indirectly involve the study of human
immunodeficiency virus (HIV). H. The Institution shall
provide appropriate medical care to a subject injured in connection with
participation in VA research under provisions of 38 CFR 17. II. Office of
Research Administration (ORA) Responsibilities A. The institution's ORA
will receive from investigators, through their supervisors, all research
protocols that involve human subjects, keep investigators informed of
decisions and administrative processing, and return all disapproved protocols
to them. B. The ORA is responsible
for reviewing the preliminary determination of exemption by investigators and
supervisors and for making the final determination based on 38 CFR 16 Section
101 and M3, Part 1, 9.06 and 9A of the regulations. Notice of concurrence for
all exempt research will be promptly conveyed in writing to the investigator;
such research may not commence until written concurrence is issued. All nonexempt research will be forwarded
to the appropriate IRB. C. The ORA will make the
preliminary determination of eligibility of expedited review procedures (see
38 CFR 16 Section 110, and 63FR60364). Expedited review of research
activities will not be permitted where full board review is required. D. The Research and
Development Committee (R&D) assisted by the ORA will review all research
(whether exempt or not) and recommend to the CEO whether the institution will
permit the research. If approved by the IRB, but not permitted by the CEO,
the ORA will promptly convey notice to the investigator and the IRB Chair.
Neither the ORA nor any other office or official of the institution may
approve a research activity that has been disapproved by the appropriate IRB. E. The ORA will forward
certification of IRB approval of proposed research to the appropriate Federal
department or agency only after all IRB-required modifications have been
incorporated to the satisfaction of the IRB. F. The ORA will designate
procedures for the retention of signed consent documents for at least three
years past completion of the research activity. G. The ORA will maintain
and arrange access for inspection of IRB records as provided for in 38 CFR 16
Section 115 and VA M3, Part I section 9.14. H. The ORA is responsible
for ensuring constructive communication among the research administrators,
department heads, research investigators, clinical care staff, human
subjects, and institutional officials as a means of maintaining a high level
of awareness regarding the safeguarding of the rights and welfare of the
subjects. I. The ORA will arrange
for and document in its records that each individual who conducts or reviews
human subject research has first been provided with a copy of this Assurance,
as well as with ready access to copies of 38 CFR 16, regulations of other
federal departments or agencies as may apply, the Belmont Report, and all
other pertinent federal policies and guidelines related to the involvement of
human subjects in research. J. The ORA will report
promptly to the IRB(s), appropriate institutional officials, the VAHQ, and
any other sponsoring federal department or agency head: 1. Any injuries to human subjects or other
unanticipated problems involving risks to subjects or others, 2. Any serious or
continuing noncompliance with the regulations or requirements of the IRB, and 3. Any suspension or
termination of IRB approval for research. K. The ORA will ensure
(a) solicitation (or confirmation where applicable assurances to comply
already exist), receipt, and management of all assurances of compliance
(whatever the appropriate format), and (b) certifications of IRB review
(where appropriate) for all performance sites to this institution (including
those listed in Appendix B) and subsequent submission of new documents to the
proper federal department of agency authorities (e.g., VAHQ for VA) or any
other Federal department or agency for which this Assurance applies. L. The ORA will ensure
that all affiliated performance sites that are not otherwise required to
submit assurances of compliance with Federal regulations for the protection
of research subjects at least document mechanisms to implement the equivalent
of ethical principles to which this institution is committed (see Part
1,I). The ORA is responsible for
assuring adequate numbers and training of staff to support IRB
functions. M. The ORA will be
responsible for procedural and record-keeping audits not less than once every
year for the purpose of detecting, correcting, and reporting (as required)
administrative and/or material breaches in uniformly protecting the rights
and welfare of human subjects as required at least by the regulations and as may
otherwise be additionally required by this institution(s) III. Institutional
Review Board (IRB) A The IRB(s) will
review, and have the authority to approve, require modification in, or
disapprove all research activities, including proposed changes in previously
approved human subject research. For approved research, the IRB will
determine which activities require continuing review more frequently than
every twelve months or need verification that no changes have occurred if
there was a previous IRB review and approval. B. IRB decisions and
requirements for modifications will be promptly conveyed to investigators and
the ORA, in writing. Written notification of decisions to disapprove will be
accompanied by reasons for the decision with provision of an opportunity for
reply by the investigator, in person or writing. C. Initial and continuing
convened IRB reviews and approvals will occur in compliance with 38 CFR 16
and provisions of this Assurance for each project unless properly found to be
exempt (Section 101(b) or (i) and M3 Part 1, Sections 9.06 and Appendix 9A by
the Office of Research Administration. Continuing reviews will be preceded by
IRB receipt of appropriate progress reports from the investigator, including
any available study-wide findings. D. The IRB(s) will
observe the quorum requirements of 38 CFR 16 Section 108(b). This
institution's IRB(s) must have effective knowledge of subject populations,
institutional constraints, differing legal requirements, and other factors
which can foreseeably contribute to a determination of risks and benefits to
subjects and subjects' informed consent and can properly judge the adequacy
of information to be presented to subjects in accordance with requirements of
38 CFR 16 Sections 103(d), 107(a), 111, and 116. E. The IRB(s) will
determine, in accordance with the criteria found at 38 CFR 16 Section 111 and
Federal policies and guidelines for involvement of human subjects in HIV
research, that protections for human research subjects are adequate. F. The IRB(s) will ensure
that legally effective informed consent will be obtained and documented in a
manner that meets the requirements of 38 CFR 16 Sections 116 and 117. The IRB will have the authority to observe
or have a third party observe the consent process. G. Scheduled meetings of
the IRB(s) for review of each research activity will occur not less than
every 12 months and may be more frequent, if required by the IRB on the basis
of degree of risk to subjects. The IRB may be called into an interim review
session by the Chairperson at the request of any IRB member or institutional
official to consider any matter concerned with the rights and welfare of any
subject. H. The IRB(s) will
prepare and maintain adequate documentation of its activities in accordance
with 38 CFR 16 Section 115 and in conformance with Office of Research
Administration requirements. I. The IRB(s) will
forward to the Office of Research Administration any significant or material
finding or action, at least to include the following: 1. Injuries or any other
unanticipated problems involving risks to subjects or others, 2. Any serious or
continuing noncompliance with the regulations or requirements of the IRB, and 3. Any suspension or
termination of IRB approval. J. In accordance with 38
CFR 16 Section 113, the IRB(s) will have the direct authority to suspend or
terminate previously approved research that is not being conducted in
accordance with the IRB(s) requirements or that has been associated with
unexpected serious harm to subjects. K. The IRB(s) for this
institution will ensure effective input (consultants or non-voting members)
for all initial and continuing reviews conducted on behalf of performance
sites where there will be human research subjects. IRB minutes will document
attendance of those other than regular voting members. The IRB list(s) in
Appendix A includes those who are identified as knowledgeable about any
affiliate institution having entered into an Inter-Institutional Amendment or
other institutional performance site for which an Assurance is required when
relying on one or more of the IRBs of this institution. L. Certifications of IRB
review and approval will be forwarded through the ORA to the appropriate
federal department or agency for research sponsored by such departments or
agencies. IV. Research
Investigator A. Research investigators
acknowledge and accept the responsibility for protecting the rights and
welfare of human research subjects and for complying with all applicable
provision of this Assurance. B. Research investigators
who intend to involve human research subjects will not make the final
determination of exemption from applicable federal regulations or provisions
of this Assurance. C. Research investigators
are responsible for providing a copy of the IRB approved and signed informed
consent document to each subject at the time of consent, unless the IRB has
specifically waived this requirement. All signed consent documents are to be
retained in a manner approved by the Office of Research Administration. D. Research investigators
will promptly report proposed changes in previously approved human subject
research activities to the IRB. The proposed changes will not be initiated
without IRB review and approval, except where necessary to eliminate apparent
immediate hazards to the subjects. E. Research investigators
are responsible for reporting progress of approved research to the Office of
Research Administration, as often as, and in the manner prescribed by the
approving IRB on the basis of risks to subjects, but no less than once per
year. F. Research investigators
will promptly report to the IRB any injuries or other unanticipated problems
involving risks to subjects and others. G. In the event of injury
to a subject, the research investigator shall seek to provide any necessary
emergency and continuing medical care.
Such care is authorized under 38 CFR 17. H. No research
investigator who is obligated by the provisions of the Assurance, any
associated Inter-institutional Amendment, or Non-institutional Investigator
Agreement will seek to obtain research credit for, or use data from, patient
interventions that constitute the provision of emergency medical care without
prior IRB approval. A physician may provide emergency medical care to a patient
without prior IRB review and approval, to the extent permitted by law (see 3
8 CFR 16 section 116(f)). However, such activities will not be counted as
research nor the data used in support of research. I. Research
investigators will advise the IRB, Office of Research Administration and the
appropriate officials of other institutions of the intent to admit human
subjects who are involved in research protocols for which this Assurance or
any related Inter-institutional Amendment or Noninstitutional Investigator
Agreement applies. When such admission is planned or a frequent occurrence,
those institutions must possess an applicable OPRR-approved Assurance prior
to involvement of such persons as human subjects in those research protocols. Part 3 - SIGNATURES Institutional Endorsements The officials signing below assure that any research activity
conducted, supported or otherwise subject to DVA or other Federal departments
or agencies that are authorized to rely on the Assurance (Parts 1,2,3 and
Appendices) or any other sources provided for in this Assurance, will be
reviewed and approved by the appropriate IRBs in accordance with the
requirements of all applicable subparts of Part 16 and Part 17, Title 38 Code
of the Federal Regulations, with this Assurance, and the stipulations of the
IRB(s). A. Primary Signatory Institution (if any) 1. AUTHORIZED INSTITUTIONAL OFFICIAL Signature: Name: Title: Chief Executive Officer Institution and
Address: Phone: FAX: E-mail: PRIMARY CONTACT Signature: Name: Title: ACOS/Research & Development Institution and
Address: Phone: FAX: E-mail: VHA Office of Research Compliance and Assurance Approval A. VHA Recommending Official AUTHORIZED INSTITUTIONAL OFFICIAL Signature:. Name: JOAN
P. PORTER, DPA, MPH Title: Associate
Director, Office of Research Compliance & Assurance Institution and Address: Veterans
Health Administration Office
of Research Compliance & Assurance 811
Vermont Ave., N.W., Room 574 (10R) Washington,
D.C. 20005 Phone: (202) 565-7191 FAX: (202) 565-9194 E-mail: joan.porter@mail.va.gov
<mailto:joan.porter@mail.va.gov> EFFECTIVE DATE OF ASSURANCE: EXPIRATION DATE OF ASSURANCE: B. VHA APPROVAL OFFICIAL AUTHORIZED INSTITUTIONAL OFFICIAL Signature:. Name: JOHN
H. MATHER, M.D. Title: Chief
Officer, Office of Research Compliance & Assurance Institution and Address: Veterans
Health Administration Office
of Research Compliance & Assurance 811
Vermont Ave., N.W., Room 574 (10R) Washington,
D.C. 20005 Phone: (202) 565-9080 FAX: (202) 565-9194 E-mail: john.mather@hq.med.va.gov <mailto:john.mather@hq.med.va.gov> |