Frequently Asked Questions (FAQs)
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1. I’m an investigator interested in conducting my own research project at UCI, CHOC and Miller’s Children’s Hospital in Long Beach. Where do I
go to obtain IRB approval?
2. If I am involved in a research project that is approved at multiple institutions in accordance with the CMU IRB Reliance Agreement, what
training requirements am I required to meet?
3. If I submit an application to UCI as the Reviewing IRB on a multiple site project (UCI, CHOC and MHS), do I have to comply with each
institution’s conflict of interest policy?
4. If I submit an application to UCI as the Reviewing IRB for a multiple site project that includes UCI, CHOC and MHS, what is my obligation to
other research oversight committees at the three institutions?
5. I am a MHS investigator. I am submitting an application to UCI as the Reviewing IRB for a multiple site clinical trial that is extramurally funded.
Do I need to submit a copy of the study budget to the Reviewing IRB?
6. Now that CHOC, UCI and MHS have the CMU IRB Reliance Agreement, if my study is approved by an IRB at one of those institutions, is that IRB
approval automatically valid at the other participating institutions?
7. I’m a UCI investigator who currently has UCI IRB approval to conduct a research study at UCI. I would like to work with a collaborator to
conduct this research at Saddleback Memorial Medical Center. How do we go about obtaining IRB approval to conduct this research at
Saddleback?
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1. I’m an investigator interested in conducting my own research project at UCI, CHOC and Miller’s Children’s Hospital in Long Beach. Where do I
go to obtain IRB approval?
Investigators conducting research at UCI, CHOC, and MHS should work with the Reviewing IRB to secure IRB approval. Because CHOC, MHS and UCI
have entering into an agreement for single IRB review, CHOC and MHS IRB may rely on UCI’s IRB approval. Investigators are still required to obtain all
other institutional approvals from CHOC and MHS before initiating the research at those sites.
It is recommended that you review the CMU flowchart that walks you through the IRB review process. Note that Relying Institutions review the IRB
application and confirm that institutional approvals are in place before research can begin at the site.
2. If I am involved in a research project that is approved at multiple institutions in accordance with the CMU IRB Reliance Agreement, what
training requirements am I required to meet?
Each institution in the CMU IRB Reliance Agreement has its own human subjects training requirements. When a research project is approved in
accordance with the CMU IRB Reliance Agreement, research team members must complete the human subjects training required by the institution where
they are performing the research. If a research team member is involved in the research project at the Reviewing IRB institution, he/she must fulfill the
training requirements of the Reviewing IRB institution; if a research team member is involved in the research project at one of the Relying IRB institutions,
he/she must fulfill the training requirements of that Relying IRB institution.
3. If I submit an application to UCI as the Reviewing IRB on a multiple site project (UCI, CHOC and MHS), do I have to comply with each
institution’s conflict of interest policy?
The details of each Institution’s interpretation of these new regulations, as described in the published policies, have some important differences. Because
conflict of interest is determined by a financial disclosure’s “relatedness” to your “institutional responsibilities”, each institution will require compliance with
the conflict of interest policy at that institution.
The following is a link to each Institution’s policy:
 CHOC: Research Conflict of Interest Policy
 MHS: Policy 250 Financial Conflict of Interest in Research
 UCI: Conflict of Interest Index
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The Federal Government has mandated important revisions for Financial Conflict of Interest in Research (FCOI-R) disclosure by researchers. To be
compliant with these regulations, researchers receiving federal monies are required to disclose any Significant Financial Interests (SFIs) related to their
“Institutional Responsibilities”.
The regulations can be found at:
 The Department of Health and Human Services COI regulations
 A helpful tutorial (that also satisfies the NIH requirement for training in this regulation) can be found here.
4. If I submit an application to UCI as the Reviewing IRB for a multiple site project that includes UCI, CHOC and MHS, what is my obligation to
other research oversight committees at the three institutions?
The CMU IRB Reliance Agreement addresses the review of human subjects research only. In addition to IRB review, a research project may require the
review of other oversight committees at each institution where the research takes place. Examples of other research oversight committees include the
Conflict of Interest Committee, Scientific Review Committee, Radiation Safety Committee, Institutional Biosafety Committee, Human Stem Cell Research
Oversight Committee, and Institutional Animal Care and Use Committee.
5. I am a MHS investigator. I am submitting an application to UCI as the Reviewing IRB for a multiple site clinical trial that is extramurally funded.
Do I need to submit a copy of the study budget to the Reviewing IRB?
No, the Reviewing IRB will not request study budgets. If the clinical trial includes compensation for study participants, the Reviewing IRB will consider the
level of compensation in the context of its review to ensure that consent is sought under circumstances that minimize the possibility of coercion or undue
influence.
The CMU IRB Reliance Agreement addresses the review of human subjects research only. The investigator should adhere to the pre- and post-award
processes at the institution that accepts the extramural award.
6. Now that CHOC, UCI and MHS have the CMU IRB Reliance Agreement, if my study is approved by an IRB at one of those institutions, is that IRB
approval automatically valid at the other participating institutions?
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No, having IRB approval from CHOC, UCI or MHS does not automatically equate to having IRB approval at the other CMU IRB Reliance institutions. The
CMU IRB Reliance agreement allows the participating institutions to rely on each other’s IRB to satisfy human subjects research review requirements, but
there is a process that must be followed and specific forms and templates that must be used in order to utilize the CMU IRB Reliance. For more
information about the CMU IRB Reliance process and required forms and templates please visit the website at http://research.uci.edu/ora/hrpp/choc.htm.
7. I’m a UCI investigator who currently has UCI IRB approval to conduct a research study at UCI. I would like to work with a collaborator to
conduct this research at Saddleback Memorial Medical Center. How do we go about obtaining IRB approval to conduct this research at
Saddleback?
Investigators conducting IRB-approved research should work with their primary institution’s IRB to secure approval to conduct research at another
institution. In this example, the UCI PI should submit an amendment to the current UCI IRB-approved study adding Saddleback as a research site. In
addition, the following documentation must be submitted with the amendment:
 The PPI Assurance Form, signed by the UCI PI
 The RI Assurance Form, signed by the MHS PI
 The RI Worksheet on Local Context as required by MHS
 If informed consent will be obtained at Saddleback,
o One (1) Consent Cover Sheet specific to MHS,
o One (1) Consent Part A (which in this example the current UCI IRB-approved consent text would be inserted where applicable), and
o One (1) Consent Part B. specific to MHS
These forms, worksheets and consent templates are available on the CMU web page.
The MHS IRB will review the amendment prior to IRB review and confirm that institutional approvals are in place before research can begin at the site. It is
recommended that you review the CMU flowchart that walks you through the IRB review process.
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