Appendix A Cooperative Agreement between Two IRBs
Institutional Review Board Cooperative Agreement
In order to avoid duplication of effort and minimize time delays in the Institutional Review
Board (IRB) review process, the [name of Primary IRB] and [name of Secondary IRB] enter
into this Cooperative Agreement. The officials having signed below commit their respective
IRBs to the following binding agreement with regard to reliance upon each others’ Institutional
Review Boards for review of the [university’s] IRB Protocol # [insert number] entitled “[name
of study].”
The [name of Primary IRB] and the [name of Secondary IRB] hereby give assurance that each
IRB will comply with the principles and procedures for protecting human research subjects
specified below as well as those required by law. The officials in this document have designated,
in writing, that the [name of Primary IRB] will conduct the IRB review as the Primary IRB.
This designation must be reported to each of the IRBs at their next meeting. The Primary Board
will conduct the initial IRB review and continuing reviews utilizing their established policies and
procedures. The Secondary Board will not conduct a formal review(s) of the protocol but will
rely on the review(s) by the Primary Board. [optional phrase: The Secondary Board is also
responsible for the research conducted by the [name of secondary university] investigator on this
Protocol ([name of PI])]. [optional phrase: insert requirements for PI from secondary
university].
The participating institutions agree to comply with the following principles regarding research
involving human subjects:
A. [Primary IRB] and [Secondary IRB] are guided by the ethical principles regarding research
involving human subjects as set forth in the CFR 45, Part 46 and the Belmont Report. These
ethical principles shall guide these institutions in the conduct of their human subjects research.
B. In conducting a review as the Primary IRB institution, it will:
(1) recognize that all human subjects research must be conducted in accordance with the
United States Federal Policy for the Protection of Human Research Subjects.
(2) be responsible for the initial and continuing review of the project in accordance with
the requirements of 45 CFR 46.
(3) report promptly to the other party to this agreement and to any sponsoring agency:
(i) any unanticipated problems or injuries involving risks to subjects or others,
(ii) any serious or continuing noncompliance with the federal rules or with the
requirements or determinations of the Primary IRB,
(iii) any changes in a project which are reviewed and approved by the Primary
IRB, and
(iv) any suspension or termination of IRB approval by the Primary IRB.
C. The designated Primary IRB shall keep the Secondary IRB informed and, at a minimum,
shall provide copies of the submitted protocol, any revisions to the protocol, copies of continuing
reviews, and any minutes of meetings of the Primary IRB that include actions or discussions
regarding the referred protocol.
D. IRB disapprovals of any protocol referred under this cooperative agreement may not be
administratively overruled by either cooperating institution.
This cooperative agreement was agreed to on __________________________ by:
______________________________
[name]
Chairperson, [Primary IRB]
On behalf of the IRB
_______________________________
[name]
Chairperson, [Secondary IRB]
On behalf of the IRB