RSP PROJECT: Renewal of Multiple Project Assurance
Submitted by: Eugene Hern
Date: February 10, 1998
Statement of the Problem/Issue
The Wright State University's Multiple Project Human Subject Assurance
needs to be renewed in order for research involving human subjects
to be allowed. This involves revising the current Assurance in
accordance with current OPRR recommendations.
1997 DHHS ASSURANCE DOCUMENT DRAFT (WORKING) COPY
Key to revisions from 1992 Assurance Document:
1.Deletions are indicated by italics (i.e., deletions)
2.Additions are indicated in underline (i.e., additions)
3.Site-specific wording pertaining to Wright State University
is indicated in underlined bold (i.e., site-specific insert)
Wright State University
Multiple Project Assurance of Compliance with DHHS Regulations
for Protection of Human Research Subjects
The Wright State University (and its off-campus academic
administrative units), hereinafter known as the "institution"
(See Appendix A), hereby gives assurance, as specified below,
that it will comply with the Department of Health and Human Services
(DHHS) regulations for the protection of human research subjects,
45 CFR Part 46, as amended to include provisions of the Federal
Policy for the Protection of Human Subjects (56FR28003) as Subpart
A, and as may be further amended during the approval period for
PART I - PRINCIPLES, POLICIES, AND APPLICABILITY
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 DHHS Secretary.
II. Institutional Policy
A. All requirements of Title 45, Part 46, of the Code of Federal
Regulations (45 CFR 46) will be met for all applicable DHHS
supported 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 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 a Multiple Project
Assurance (MPA) with OPRR or as may be agreed to by OPRR
(see Part 1, 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 infon-ned
consent has been obtained from the subject or the subject's legal
representative (see Sections 111, 116, and 117), unless properly
waived by the IRB under Section 116(c), (d) or by any applicable
waiver under Section 101(i).
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 be expected
to result, and
4.the informed consent process to be employed.
D. Certification of IRB review and approval for all Federally-sponsored
research involving human subjects will be submitted to the Office
of Research and Sponsored Programs (ORSP) for forwarding
to the appropriate Federal department or agency. Compliance will
occur within the time and in the manner prescribed for forwarding
certifications of IRB review to DHHS or other Federal departments
or agencies for which this Assurance applies.
As provided for under 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 101(b) or (i), no
human Subjects may be involved in any project supported by such
awards until IRB review and approval has been certifies to the
appropriate Federal Department or agency.
As required under Section 119, the IRB will review and recommend
approval for proposed involvement of human subjects
in Federal research activities for which there was no undertaken
without prior intent for such involvement, but will not permit
such involvement until certification of the IRB's review and approval
is received by the appropriate Federal department or agency.
E. Institutions that are not direct 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 for DHHS-sponsored research
will satisfactorily assure compliance with 45 CFR 46, as required
(see Part 2, 1, D and 11, K), as a prior condition for involvement
in DHHS-sponsored human subject research which is under
the auspices of this institution (see Part 1, III, A). 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) of DHHS
for DHHS-sponsored research, on request, when that research is
not conducted under the auspices of a signatory institution to
F. This institution will ensure that any of its affiliates
collaborating entities (i.e., those entities engaged in human
subject research by virtue of Subject accrual, transfer of identifiable
information, and/or in exchange for something of value, such as
material support [e.g., money, drugs, or identifiable specimens],
coauthorship, intellectual property, or credits) materially
engaged in the conduct of nonfederal sponsored research involving
human subjects will possess mechanisms to protect human research
subjects that are at least equivalent to those procedures provided
for the ethical principles to which this institution is committed
(see Part 1, I).
G. This institution will comply with the requirements set forth
in Section 114 of the regulations regarding cooperative research
projects. When research covered by this Assurance is conducted
at or in cooperation with another entity, all provisions of this
Assurance remain in effect for that research. This institution
may accept, for the purpose of meeting the IRB review requirements,
the review of an IRB established under another DHHS MPA. Such
acceptance must be (a) in writing, (b) approved and signed by
an official of this institution's Office of Research and Sponsored
Programs, and (c) approved and signed by correlative officials
of each of the other cooperating institutions (i.e., a Cooperative
Amendment to this MPA). A copy The original
of the signed understanding will serve as an addendum to this
Assurance and will be forwarded to the OPRR of DHHS by the ORSP
for OPRR approval.
H. This institution will exercise appropriate administrative overview
to insure 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.
I. Description of this institution's policy for the protection
of human subjects is contained in its internal written procedures
which are available to OPRR and other Federal department or agencies,
upon request. Appendix D to this Assurance abstracts pertinent
organizational, personnel, and reporting procedures sufficient
to describe the substance and relative prominence conferred upon
the protection of subjects.
A. Except for research in which the only involvement of humans
is in one or more of the categories exempted or waived under Section
101(b)(1-6) or 101(i), 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 using any property or facility
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
B. All human subject research which is exempt under Section 101(b)(1-6)
or 101(i) 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
C. Components of this institution are bound by the provisions
of this Assurance. Those components which can be expected to participate
in human subject research sponsored by DHHS or other Federal departments
or agencies for which this Assurance will apply are identified
in Appendix A. Appendix A will be revised as changes occur and
revisions forwarded to OPRR.
D. This Assurance must be accepted by other Federal departments
or agencies that are bound by the Federal Policy for the Protection
of Human Subjects when appropriate for the research in question
and therefore applies to all human subject research so sponsored.
Research that is neither conducted nor supported by a Federal
department or agency but is subject to regulation as defined in
Section 102(e) must be reviewed and approved, in compliance with
Sections 101, 102, and 107 through 117.
PART 2 - RESPONSIBILITIES
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 (see 45 CFR 46 Subpart B), (2) prisoners
(see 45 CFR 46 Subpart C, (3) children (see 45 CFR 46 Subpart
D), (4) the cognitively impaired, or (5) other potentially vulnerable
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
D. This institution is responsible for acquiring appropriate Assurances
or Amendments, when requested, and affiliates 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 affiliates
performance site cooperating in the conduct of federally
sponsored research for which this Assurance applies do 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 Section
107, this institution has established the IRB(S) listed in the
attached roster(s) (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 IRB(S) include one person who is primarily concerned
with the welfare of handicapped children or mentally disturbed
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 OPRR-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
J. This institution will encourage and promote constructive
communication among the research administrators, department heads,
research investigators, clinical care staff, IRB, other institutional
officials and human subjects as a means of maintaining a high
level of awareness regarding the safeguarding of the rights and
welfare of the subjects.
II Office of Research and Sponsored Programs (ORSP)
A. The ORSP will receive from investigators all research
protocols which involve human subjects, keep investigators informed
of decisions and administrative processing, and return all disapproved
protocols to them.
B. The ORSP is responsible for reviewing the preliminaa
determinations of exemption by investigators and the Screening
Committee (SC) IRB Coordinator is responsible
for making the final determination with the concurrence of
the Screening Committee (SC) based on Section 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 SC (expedited review) or IRB (full board
C. The ORSP will make the preliminary determination of eligibility
for expedited review procedures (see Section I 10). Expedited
review of research activities will not be permitted where full
board review is required (e.g., provision of emergency medical
care which also constitutes the conduct of more than minimal risk
research). Expedited review will be performed by the SC
which is a subcommittee of the IRB designated by the Chairman
[45 CFR 46.110(b)] and which submits its recommendations to the
full Board for ratification.
D. The ORSP will review all research (whether exempt or not) and
decide whether the institution will permit the research. If approved
by the IRB, but not permitted by the ORSP, the ORSP will promptly
convey notice to the investigator and the IRB Chair. Neither the
ORSP nor any other office of the institution may approve a research
activity that has been disapproved by the appropriate IRB.
E. The ORSP 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 IRIB and all IRB-required restrictions
have been removed to the satisfaction of the IRB.
F. The ORSP shall receive all requested appeals of IRB decisions
with attached protocols from the research investigators and initiate
the process of appeal. The appeals process allows for the appointment
of an ad hoc committee to review the protocol and report an advisory
opinion to the IRB which has final jurisdiction over all matters
pertaining to human subjects. This ad hoc committee shall consist
of three (3) or more faculty and/or consultants, be appointed
by the IRB, and be acceptable to both investigator(s) and the
G. The ORSP will designate procedures for the retention of signed
consent documents for at least three (3) years past completion
of the research activity.
H. The ORSP will maintain and arrange access for inspection of
IRB records as provided for in Section 115.
I. The ORSP 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.
J. The ORSP 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 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.
K. The ORSP will report promptly to the IRB, appropriate institutional
officials, the Office for Protection from Research Risks (OPRR),
and any other sponsoring Federal department 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.
L. The ORSP 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 affiliates performance
sites to this institution (including those listed in Appendix
B), and (b) subsequent submission of these new
documents to the proper Federal department or agency authorities
(e.g., OPRR 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
M. The ORSP 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,
N. 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 ORSP will either (a)
obtain and retain a 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 (All) 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(s)
and (2) the determinations of the IRB.
O. The ORSP assumes responsibility for ensuring performance with
special reporting requirements for any OPRR-recognized Cooperative
Protocol Research Programs CPRPs in which the signatory
P. The ORSP 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.
Q. The ORSP will ensure compliance with the requirements set forth
in this Assurance and Section 114 regarding cooperative research
projects. In particular, where the IRB of another institution
with a DHHS MPA is relied upon, the ORSP will ensure that
documentation of this reliance will be (a) in writing, (b) approved
and signed by the ORSP, (c) approved and signed by the correlative
officials of each of the other cooperating institutions, and (d)
retained by the ORSP for at least three years past completion
of the related research Project, if limited in scope
t eciric research project or retained as a permanent addendum
to the MPA if not restricted to a specific Project. For all Cooperative
Amendments (CAs),. Where an agreement between MPA
IRBs is planned, the ORSP will forward a copy the
original of the required signed understanding to OPRR for
approval and inclusion in this Assurance as an addendum.
III. Institutional Review Board (IRB)
A. The IRB 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. The SC, a standing subcommittee of the full board, shall
review and have the authority to recommend to the IRB: full board
approval, full board approval pending recommended changes, or
review by the full board or disapproval by the full
board of those research activities that are eligible
for expedited review as permitted by and defined in 45 CFR 46.
Review by the SC shall be subject to the following guidelines:
1. The eligibility of some research for review through the
expedited procedure is in no way intended to negate or modify
the policies of this institution or the other requirements of
45 CFR 46.
2. The IRB may use the expedited review procedure to review
minor changes in previously approved research during the period
for which approval is authorized.
3. When the expedited review procedure is used, the SC members
conducting the review shall inform IRB members of research protocols
which have been reviewed under the procedure and the SC's recommendations
for further action(s).
4. At a convened IRB meeting, any member may request that
an activity which has been reviewed and recommended for approval
under the expedited procedure be reviewed by the IRB in accordance
with non-expedited procedures. A vote of the members shall be
taken concerning the request and the majority shall decide the
C. IRB decisions and requirements for modifications will be promptly
conveyed to investigators and the ORSP, 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.
D. 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 (Section 101
[b] and [i]) by the Office of Research and Sponsored Programs.
Continuing reviews will be preceded by IRB receipt of appropriate
progress reports from the investigator, including available study-wide
E. The IRB will observe the quorum requirements of Section 108(b).
This institution's IRB has 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 Sections 103(d),
107(a), 111, and 116.
F. The IRB 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.
G. The IRB will ensure that legally effective informed consent
will be obtained and documented in a manner that meets the requirements
of Sections 116 and 117. The IRB will have the authority to observe
or have a third party observe the consent process.
H. Where appropriate, the IRB 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 IRB will notify OPRR 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).
I. Scheduled meetings of the IRB 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
J. The IRB will prepare and maintain adequate documentation of
its activities in accordance with Section 46.115 and in conformance
with the Office of Research and Sponsored Programs requirements.
K. The IRB will forward to the Office of Research and Sponsored
Programs 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.
L. In accordance with Section 109, the IRB 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.
M. The IRB 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 list(s) in
Appendix C 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.
N. The IRB will act with reasonable dispatch, upon request, to
provide full board review of protocols of OPRR-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.
O. Certifications of IRB review and approval will be forwarded
through the ORSP 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.
That determination shall be made by the IRB Coordinator
and the SC through ORSP.
C. Research investigators shall be responsible for ensuring
that all research involving human subjects is submitted to ORSP.
D. Research investigators shall prepare a protocol giving
a comp1ete description of the proposed research. In the protocol,
research investigators shall make provisions for the adequate
protection of the rights and welfare of prospective research subjects
and insure that pertinent laws and regulations are observed. This
requirement is applicable even in cases where the research is
exempt under 45 CFR 46.101. Research investigators shall include
proposed informed consent forms with the protocol.
E. Research investigators are responsible for providing a copy
of the IRB-approved and signed informed consent document to each
subject at the time of the 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 and Sponsored
F. 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.
G. Research investigators are responsible for reporting progress
of approved research to the Office of Research and Sponsored Programs,
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.
H. Research investigators will promptly report to the IRB any
injuries or other unanticipated problems involving risks to subjects
and or others.
I. 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 Section 116[f]). However, such activities
will not be counted as research nor the data used in support of
J. Research investigators will advise the IRB, Office of Research
and Sponsored Programs 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 these research protocols.
V. Affiliated Institutions and Investigators (i.e. all performance
sites, with or without IIAs)
A. Each affiliate performance site to this institution that is
involved in DHHS Federally sponsored research activities
must provide to the Office of Research and Sponsored Programs
an appropriate written assurance of compliance with the Belmont
Report and 45 CFR 46 the Federal policy, to include
Subparts B, C, and D or 45 CFR where appropriate (or equivalent
protections if a foreign site), for review.
B. Each affiliate institution institutional performance
site must respond to a request by the Office of Research and
Sponsored Programs of this institution for an Inter-Institutional
Amendment or for a Single Project Assurance (standard or modified),
when and, SPA, or CPA (as appropriate), which ever
is most suited to the circumstances.
C. Each non-institutional affiliate 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
Office of Research and Sponsored Programs of this institution
for either an Agreement for an Independent Investigator or
a Noninstitutional Investigator Agreement when required,
as appropriate, depending on the nature of the research activity.
D. Performance sites that are not legally inseparable components
of from this institution (whether an institutional
or non-institutional affiliate performance site)
are not authorized to cite this Assurance.
January 29, 1998
Memo for the Record:
Re: Institutional reporting requirement clause cited in NIH-OPRR's
Agreement for an Independent Investigator (All) and their Interinstitutional
During a review of an All, it was noted that one of the reporting
clauses found under the section detailing IRB responsibilities
stated that the IRB was responsible for reporting to the OPRR
"...any changes in this research activity that are reviewed
and approved by the IRB." (Item C. 4.). A review of the recent
IIA submission between DA-VAMC and WSU contained similar wording
(Part 2, Item 111. C. 3. reads that the cited MPA will report
promptly to OPRR "any changes in this research activity that
are reviewed and approved by the IRB and this Institution."
Further review indicates that this wording is in the current (1997)
OPRR IIA model but is NOT in our general assurances recently submitted
This clause could be interpreted to mean that OPRR would need
to be advised of ANY amendment, including administrative, to an
affected protocol under IRB review. This would be an impractical
burden on both the IRB and on the review facilities at the OPRR.
In a phone conversation with Dr. Katherine Duncan, Adjunct Medical
Officer, NIH-OPRR, on January 28, 1998, it was indicated that
OPRR did not mean the reporting of ALL amendments to protocols
and Dr. Duncan offered the following interpretations/clarifications:
1 .This item refers only to "major changes" in the research
activity [e.g., going from no human subjects to using human subjects,
initiating one of the other reporting requirements mentioned in
these sections (e.g., injuries to human, unanticipated problems
involving risks to subjects or others, leading to suspension or
termination of IRB approval)].
2 .It is subjective as to what OPRR intended to be reported but
they do not want what WSU calls routine amendments (e.g., minor
changes in consent forms, changes in populations, changes in procedures)
unless they meet the criteria above.
In the model IIA and in future draft documents, it is OK to insert
"major" before "changes" in this reporting
clauses. In addition, a statement of understanding/clarification
should be provided in cover letters submitted with existing documents
that contain this apparently more stringent wording.
DEPARTMENT OF HEALTH & HUMAN SERVICES
National Institutes of Health
Office for Protection from Research Risks
6100 Executive Boulevard, MSC 7507
Rockville, Maryland 20892-7507
February 10, 1998
Eugene P. Hern, Ph.D.
Research and Sponsored Programs
Room 122, Allyn hall
Wright State University
Dayton, Ohio 45435
Subject: Multiple Project Assurance M-1021
Dear Dr. Hern:
The Department of Health and Human Services (DHHS) has approved
the revision of your Multiple Project Assurance dated October
22, 1997 submitted by your institution in compliance with the
requirements for the protection of human subjects (45 CFR 46).
Your new Assurance became effective on November 1, 1997, and retains
the same identification number of M-1021. It will expire on October
31, 2002, and a new Assurance is to be negotiated with the Office
for Protection from Research Risks (OPRR) prior to that date.
Please reference your Multiple Project Assurance number with all
future correspondence to this office.
Your Institutional Review Board (IRB) has been assigned identification
number OINR. This IRB number, along with your Assurance number,
will be required in certain forms (e.g., PHS-2590) and other correspondence.
The Assurance defines the relationship of your institution to
DHHS since it sets out your responsibilities and the procedures
that will be used by your institution to protect human subjects.
Among the most important elements of the Assurance are the reporting
requirements to this office and your agreement to disseminate
the content of this Assurance to those individuals at your institution
who are in any way associated with human subject research.
A copy of the approved Assurance is enclosed, as is a blank format
sheet to facilitate the future reporting of changes in your IRB
If I can be of further help, please contact me.
Diane L. Aiken, MA
Assurance Coordinator, Assurance Branch
Division of Human Subject Protections
Office for Protection from Research Risks
cc: Joseph F. Thomas, Ph.D., Associate Provost for Research