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 additional
safeguards in research that involves: (1) fetuses, pregnant women,
or human ova in vitro fertilization (per 45 CFR
46 Subpart B), (2) prisoners (per 45 CFR 46 Subpart C), (3) children
(per 45 CFR 46 Subpart D), (4) the cognitively impaired, or (5)
other potentially vulnerable groups.
C. This institution, including all its named components
(see Appendix A), acknowledges and accepts its responsibilities
for protecting the rights and welfare of human subjects of research
covered by this Assurance.
D. This institution is responsible for acquiring
appropriate Assurances or Amendments, when requested, and certifications
of IRB review and approval for federally sponsored research from
all its standing affiliates (see Appendix B) and Assurances or
Agreements for all others, domestic or foreign, which may otherwise
become affiliated on a limited basis in such research.
E. 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.
F. In accordance with the compositional requirements
of 45 CFR 107, this institution has established the IRBs listed
in the attached rosters (see Appendix C). 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 IRBs include at least one person who is primarily
concerned with the welfare of handicapped children or mentally
disabled persons.
G. This institution will provide both meeting space
and sufficient staff to support the IRB’s review and record-keeping
duties.
H. This institution recognizes that involvement
in research activities of any OHRP-recognized Cooperative Protocol
Research Programs (CPRPs) will involve additional reporting and
record-keeping requirements related to human subject protections.
I. 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).
II. Research Subjects Review Board Office
(RSRBO)
A. The RSRBO will receive from investigators, or
through their supervisors, all research protocols which involve
human subjects, keep investigators informed of decisions and administrative
processing, and return all disapproved protocols to them.
B. The RSRBO is responsible for reviewing the preliminary
determinations of exemption by investigators and supervisors and
for making the final determination based on 45 CFR 101 of the
regulations. Notice of concurrence for all exempt research will
be promptly conveyed in writing to the investigator. All nonexempt
research will be forwarded to the appropriate IRB.
C. The RSRBO will make the preliminary determination
of eligibility for expedited review procedures (per 45 CFR 110).
Expedited review of research activities will not be permitted
where full board review is required.
D. Research that has been approved by the IRB may
be subject to further review by institutional officials, however,
research may not be approved or permitted to begin if it has not
been approved by the IRB. If approved by the IRB, but not permitted
by the institution, the disapproving institutional official will
promptly convey notice to the investigator, the RSRBO and the
IRB Chair.
E. The RSRBO will forward certification of IRB approval
of proposed research to ORPA only after all IRB-required modifications
have been incorporated to the satisfaction of the IRB. ORPA will
in turn forward it to the appropriate Federal department or agency
F. The RSRBO will designate procedures for the retention
of signed consent documents for at least three years past completion
of the research activity.
G. The RSRBO will maintain and arrange access for
inspection of IRB records as provided for in 45 CFR 115.
H. The RSRBO is responsible for promoting 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 RSRBO will arrange for and document in its
records that each individual who conducts or reviews human subject
research has first been provided with ready access to a copy of
this Assurance, copies of 45 CFR 46, 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 RSRBO will report promptly to the IRBs, appropriate
institutional officials, OHRP, 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 (for cause) of
IRB approval for research.
K. The RSRBO will ensure (a) solicitation (or confirmation
where applicable assurances 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 or agency authorities (e.g.,
OHRP for DHHS) as a condition for involvement of each site in
human subject research activities sponsored by DHHS or any other
Federal department or agency for which this Assurance applies.
L. The RSRBO 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).
M. When an IRB of this institution accepts responsibility
for review of research which is subject to this Assurance and
conducted by any independent investigator who is not otherwise
subject to the provisions of this Assurance, the RSRBO will either:
(a) obtain and retain an Noninstitutional Investigator Agreement
(NIA) for CPRP activities (with copy to the investigator and the
authorizing CPRP) or (b) obtain an Agreement for an Independent
Investigator (AII) for review and approval by the appropriate
Federal department or agency for non-CPRP activities to document
the investigator’s commitment to abide: (1) by the same requirements
for the protection of human research subjects as does this institution
and (2) the determinations of the IRBs.
N. The RSRBO assumes responsibility for ensuring
conformance with special reporting requirements for any OHRP-recognized
CPRPs in which the signatory institution participates.
O. The RSRBO 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.
P. The RSRBO will ensure compliance with the requirements
set forth in this Assurance and 45 CFR 114 regarding cooperative
research projects. In particular, where the IRB of another institution
with a DHHS MPA is relied upon, the RSRBO will ensure that documentation
of this reliance will be (a) in writing, (b) approved and signed
by the RSRBO, (c) approved and signed by the correlative officials
of each of the other cooperating institutions, and (d) retained
by the RSRBO for at least three years past completion of the research
project, if limited in scope to a specific research project or
retained as a permanent addendum to the MPA if not restricted
to a specific project. For all Cooperative Amendments (CAs),
the RSRBO will forward the original of the required signed understanding
to OHRP for approval and inclusion in this Assurance as an addendum.
III. Institutional Review Board (IRB)
A. The IRBs 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 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 in writing.
C. Initial and continuing convened IRB reviews and
approvals will occur in compliance with 45 CFR 46 and provisions
of this Assurance for each project unless properly found to be
exempt (45 CFR 101[b] or [i]) by the RSRBO. Continuing reviews
will be preceded by IRB receipt of appropriate progress reports
from the investigator, including available study-wide findings.
D. The IRBs will observe the quorum requirements
of 45 CFR 108(b). This institution’s IRBs 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
45 CFR 103(d), 107(a), 111, and 116.
E. The IRBs will determine, in accordance with the
criteria found at 45 CFR 46.111 and Federal policies and guidelines
for involvement of human subjects in HIV research, that protections
for human research subjects are adequate.
F. The IRBs will ensure that legally effective informed
consent will be obtained and documented in a manner that meets
the requirements of 45 CFR 116 and 117. The IRBs will have the
authority to observe or have a third party observe the consent
process.
G. Where appropriate, the IRBs will determine that
adequate additional protections are ensured for fetuses, pregnant
women, prisoners, and children, as required by Subparts B, C,
and D of 45 CFR 46. The RSRBO will notify OHRP promptly when IRB
membership is modified to satisfy requirements of 45 CFR 46.304
and when the IRB fulfills its duties under 45 CFR 46.305(c).
H. Scheduled meetings of the IRBs 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.
I. The IRBs will prepare and maintain adequate documentation
of its activities in accordance with 45 CFR 46.115 and in conformance
with RSRBO requirements.
J. The IRBs will forward to the University 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 (for cause) of
IRB approval.
K. In accordance with 45 CFR 113, the IRBs will
have the 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.
L. The IRBs for this institution will ensure effective
input (consultants or voting or nonvoting 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 lists in Appendix C include 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.
M. The IRBs will act with reasonable dispatch, upon
request, to provide full board review of protocols of OHRP-recognized
Cooperative Protocol Research Programs (CPRP). The IRB will not
employ expedited review procedures for CPRP 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
will not be counted as research subjects and resultant data will
not be used for research purposes.
N. Certifications of IRB review and approval will
be forwarded through the ORPA to the appropriate Federal department
or agency for research sponsored by such departments or agencies.
IV. Research Investigator
A. Research 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.
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 RSRBO.
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 RSRBO, as often as and in
the manner prescribed by the approving IRB on the basis of risks
to subjects, but not less than once per year.
F. Research investigators will promptly report to
the IRB any injuries or other unanticipated problems involving
risks to subjects or others.
G. No research investigator who is obligated by
the provisions of this Assurance, any associated Inter-Institutional
Amendment, or Noninstitutional 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 45 CFR 116[f]), however, such activities
will not be counted as research nor the data used in support of
research.
H. Research investigators will advise the IRB 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
admissions are a planned part of HHS-supported research, those
institutions must possess an applicable OHRP-approved Assurance
prior to involvement of such persons as human subjects in those
research protocols at those institutions.
V. Affiliated Institutions and Investigators
(i.e., all performance sites, with or without IIAs)
A. Each performance site to this institution that
is involved in federally sponsored research activities must provide
to the RSRBO an appropriate written assurance of compliance with
the Belmont Report and the Federal Policy, to include Subparts
B, C, and D or 45 CFR 46 where appropriate (or equivalent protections
if a foreign site), for review and approval, as specified by the
sponsoring Federal department or agency (e.g., by OHRP for DHHS),
prior to involvement of human subjects or expenditure of funds
or other support to do so.
B. Each institutional performance site must respond
to a request by the RSRBO of this institution for an Inter-Institutional
Amendment, SPA, or CPA (as appropriate), whichever is most suited
to the circumstances.
C. Each non-institutional performance site (e.g.,
a private practice physician not otherwise an employee of this
institution or who otherwise would not ordinarily be bound by
the provisions of this Assurance or any other applicable institutional
Assurance) who is involved in human subject research of this institution
must respond to a request by the RSRBO of this institution for
either an Agreement for an Independent Investigator or a Noninstitutional
Investigator Agreement, as appropriate, depending on the nature
of the research activity.
D. Performance sites that are legally separable
from this institution (whether an institutional or non-institutional
performance site) are not authorized to cite this Assurance.
PART 3 - SIGNATURES
I. Institutional Endorsement(s)
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