Avoiding Duplicate Review by Using IRB Authorization Agreements (IAAs)
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When and Why Should You Consider Using an IAA?
If two or more federally-assured institutions collaborate on human subjects research supported by a Common Rule agency, the institutions may rely on a single IRB (an “IRB of Record”) for review and continuing oversight of the research, in order avoid duplicate review.
The relationship between the two (or more) IRBs is established through an IRB Authorization Agreement (IAA). Investigators may request an IAA, but generally they are initiated by IRB administrators and require approval of the Institutional Official at each institution.
What Do You Need to Know about Using an IAA?
- IAAs may be designed to cover a single study or a group of studies.
- Institutions may use OHRP’s template [http://www.hhs.gov/ohrp/assurances/forms/iprotsup.rtf], or choose to develop their own agreement style (see links in “Sample IAA Templates” below).
- At minimum, agreements should include:
- title of the study (or studies);
- names of the investigators and institutional officials at each institution; and
- rights and responsibilities of each institution with regard to human subject research protections.
- Copies of the signed agreement must be kept at both institutions and be made available to any Common Rule agency upon request.
When Is It Appropriate to Use an IAA?
Some instances when an IAA may be appropriate include, but are not limited to:
- If an investigator leaves Institution A to work at Institution B and will continue research on a grant with a post-doctorate individual at Institution A, then Institution A may agree to (continue to) serve as the IRB of record for Institution B for the remainder of the project.
- If an investigator at Institution B collaborates on a project with Institution A and the investigator at Institution B’s involvement is limited to data analysis collected by investigators at Institution A, then Institution A may agree to serve as the IRB of record for Institution B for the project.
- If investigators at Institution A and Institution B are collaborating on a project and the IRB at Institution A is better-prepared to review the research – for example, if its members have more expertise in the subject area - then Institution A may agree to serve as the IRB of record for the project.
- If Institution B receives a grant and contracts-out all human subjects research to investigators at Institution A, then Institution A may agree to serve as the IRB of record.
When Is It Not Appropriate to Use an IAA?
Some instances when an IAA would not be appropriate include, but are not limited to:
- If the research is exempt [http://sites.nationalacademies.org/PGA/fdp/PGA_061069], an IAA is not necessary because there is no regulatory requirement for IRB review of exempt research.
- If an investigator is not affiliated with any institution OR is affiliated with a non-federally-assured institution, and is collaborating on research with an assured institution, an Individual Investigator Agreement (IIA) should be used instead [http://hrpp.umich.edu/policies/UM-individual-iInvestigator-agreement-template.pdf].
- If the research in question is not supported by a Common Rule agency, an IAA is not required but a similar agreement can be used to help the institutions involved establish roles and responsibilities of collaborating institutions.
Sample IAA Templates
Contact: Lois Brako or Sharon Stein
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