Printer-friendly version
In the conduct of cooperative research projects, each institution (entity) is responsible for safeguarding the rights and welfare of human subjects and for complying with any applicable regulations. Federal regulations from DHHS and FDA [45 CFR 46.114 and 21 CFR 56.114] allow for cooperative research projects which involve more than one institution (or entity). To avoid duplication of review efforts by IRBs, institutions can choose to conduct joint reviews, rely upon the review of another qualified IRB, or make other arrangements to establish oversight responsibilities.
Discussion of how to assure the rights and welfare of human subjects in research at each entity involved in the research usually begins with an evaluation of whether or not each entity is “engaged” in human subjects research. An entity becomes “engaged” in human subjects research when its employees or agents (agents include all individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility):
- intervene or interact with living individuals for research purposes OR
- obtain individually identifiable private information for research purposes
An entity is automatically considered to be “engaged” in human subjects research whenever it receives a direct DHHS award to support such research. In these cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award.
OHRP has provided guidance and examples for when institutions are considered to be “engaged” in research and examples of when institutions are NOT “engaged” in research. The UI IRB makes a determination about whether or not a cooperating outside institution is engaged in human subjects research. This determination is made by the appropriate UI IRB Chair based on the outside institution’s role and whether or not that role meets any of the criteria for “engaged in research” as defined in the guidance above.
Any questions an IRB chair might have regarding making that determination are posed to OHRP by phone call or e- mail. Please call the HSO for more information if there is any question about the involvement of outside institutions in human subjects research.
Once the determination is made that the outside institution is engaged in human subjects research, the following are the UI IRB policies with regard to IRB oversight at those institutions.
When the outside institution is receiving federal funds through a subcontract with the UI, the UI Division of Sponsored Programs requires documentation that the outside institution holds a Federalwide Assurance (FWA) through the subcontract process. If the outside institution does not hold its own FWA, the UI requires that they obtain one prior to finalization of the subcontract. If this is the case, and the other institution obtains its own FWA, there are a few methods of IRB oversight that the UI IRB would consider acceptable based on the circumstances of the project and the role of the other institution.
The UI IRB could either:
- Accept a concurrent review of the research project with the other institution’s own IRB, or
- Be the IRB of record for the other institution. This agreement is formalized through the use of an IRB Authorization Agreement, or
- Accept the other institution’s IRB as the IRB of record for the project. This would be in cases where the UI determines that the outside institution’s IRB review will provide more appropriate expertise, oversight, and/or knowledge of local context for the UI role in the study. This agreement is formalized using an IRB Authorization Agreement or other equivalent agreement. The outside IRB is then added to the UI FWA. Research projects utilizing the VAHCS are not eligible to receive this type of deferred judgment.
Under limited circumstances, when the UI is able to assure understanding of the local context in relation to the proposed research and has sufficient resources to provide appropriate oversight during the conduct of the research, the UI may choose to extend its FWA to cover the outside institution’s role in the individual project. This agreement is formalized using an Individual Investigator’s Agreement.
There are two instances whereby this mechanism will NOT be allowed:
- If the non-assured institution is the primary awardee for an DHHS-funded project OR
- If the non-assured institution routinely engages in the conduct of human subjects research.
If either of the above conditions applies to the cooperating institution or investigator, the non-assured institution will be required to obtain its own OHRP-approved FWA.
When the outside institution is not receiving federal funding for the study through a subcontract with the UI, the UI IRB requires that the research be conducted under either the other institution’s IRB oversight or the UI IRB takes on oversight of the research. In the former instance, the IRB will require documentation that the outside IRB will provide this oversight. In the latter instance, this agreement is documented through a formal IRB Authorization Agreement.
The UI IRB will oversee research for an outside institution only when the UI IRB is able to assure understanding of local context in relation to the proposed research and has sufficient resources to provide appropriate oversight during the conduct of the research.
For each of these mechanisms of collaborative research oversight, the investigator must have the approval of the designated IRB(s) of record prior to conducting any research that involves human subjects. Documentation of complete contact information at each applicable collaborative site will also be required prior to the start of any research activity. The investigator must have the signed agreements and requirements finalized prior to receiving UI IRB approval and before conducting multi-institutional research projects that involve human subjects. The final determination to enter into any agreements described in this section is made by the UI Institutional Official.