IRB review of multi-institutional research
When a non-exempt research study is being carried out by collaborating personnel at more than one institution, the steps for IRB review grow a bit more complicated. The first question is which institutions must undergo IRB review of their activities. When it is determined which institutions must undergo IRB review of their activities, the next question is which IRB will review those activities. These two questions are discussed below.
A. Which institutions must undergo IRB review of their activities?
For each institution whose personnel are working on the research study, that institution has to determine if its personnel are “engaged” in the research. For investigators who are “engaged” in non-exempt human subjects research, IRB review is needed for their research activities. For investigators who are determined to be “not engaged” in human subjects research, IRB review of their activities is not usually required.
To determine which investigators are “engaged” in human subjects research, we rely on the HHS Guidance on Engagement of Institutions in Human Subjects Research (available online at http://www.hhs.gov/ohrp/policy/engage08.html).
In general, an institution is considered to be engaged in human subjects research when its employees or agents:
- obtain data about living individuals for research purposes through intervention or interaction with them, or
- obtain individually identifiable private information for research purposes, or
- obtain the informed consent of human subjects.
Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.
The HHS Guidance on Engagement walks through various examples of when institutions are considered engaged and not engaged in human subjects research – it does not cover every possible situation, but serves as a guide for analyzing when research activities rise to the level of being “engaged.”
The “engagement” determination depends on the specific facts of each study, and can be complex. The IRBs of the participating institutions will make the final determination regarding who is engaged in the research.
B. Which IRB reviews the activities of researchers in multi-institutional research?
The default rule is that the IRB at each institution reviews the activities of the researchers who are employees/agents of that institution. However, it is quite common in multi-institutional studies for the reviewing IRBs to enter into "ceding" agreements in which one or more IRBs cedes oversight authority to another IRB. Ceding review can help reduce the number of IRBs that are overseeing a particular project and the associated IRB paperwork that stems from multiple reviewing IRBs. In the IRB submission form, you will see a question that asks if another institution/researcher is requesting that the University of Chicago IRB serve as the IRB of record for their activities on the study -- if researchers at another institution would like the UChicago IRB to serve as the IRB reviewing their activities on the project, you would answer "Yes" to that question. You will also see a question that asks if you (the University of Chicago researchers) are requesting that an external IRB be the IRB of record for the study -- if you are requesting than a non-UChicago IRB serve as the IRB overseeing your activities on the study, you would answer "Yes" to that question. In either case, whether another IRB is ceding to the UChicago IRB or vice versa, paperwork must be done between the IRBs to document that ceding arrangement.
There are also situations where members of the research team are not affiliated with an institution that has an IRB (for example, they might be independent consultants assisting with the consent process and data collection). In those circumstances, if the activities of those members of the research team rise to the level of being "engaged" in the research, we can typically do paperwork that will extend our IRB's oversight to those members of the research team.
If your research study involves multiple institutions, please make sure that your IRB submission very clearly describes which activities each institution will be carrying out as part of the study, so that we can work through the questions of who needs IRB review of their activities and which IRBs will be reviewing the study.