Frequently Asked Questions about Exemptions, Not Human Subjects Research Projects, and Collaborative Research Requirements
Version date: March 2015
What is multisite/collaborative research?
If your project or study involves collaboration with any sites and/or personnel outside the UW-Madison/UW Health/Madison VA (i.e., external personnel), then it would be considered multisite research. As explained below, different IRB requirements pertain for studies that simply work with community-based sites as places for conducting research versus those that engage external personnel in research procedures. NOTE: See the OHRP guidance on engagement in research for more information on what constitutes engagement in research.
Can multisite research be exempt or determined not to constitute human subjects research (NHSR)?
Yes, depending upon the nature of the project. For additional information on exemptions and not human subjects research determinations, please see Exemption Guidance and Guidance on Exemption: Not Human Subjects Research .
What are the IRB requirements for exemptions that will simply be conducted at sites outside the UW-Madison/UW Health/Madison VA and do not engage personnel at those sites in human subjects research? Do those external sites need IRB approval? Should personnel at those sites be listed on the UW IRB application?
If the HS-IRBs do not consider external sites to be engaged in research, then the IRB application only needs to include a description of that site's involvement. A letter of support from the external site also is typically required. If the external site has its own IRB, then a representative of that site should consult with that IRB to determine if any additional action is needed. External personnel should not be listed on the study team member pages in the IRB application.
What are the IRB requirements for exemptions involving personnel who are engaged in human subjects research but who are not affiliated with the UW-Madison/UW Health/Madison? Will the HS-IRBs cover the research activities of those personnel? Should external personnel engaged in research for exempt research be listed on the UW IRB application?
If a project or study that qualifies for exemption involves personnel who are engaged in human subjects research but are not affiliated with the UW-Madison/UW Health/Madison VA, the HS-IRBs will not serve as IRB of record for these personnel unless they are affiliated with an institution that is part of an existing IRB Reliance Partners that allows for review of exempt projects. Personnel for whom the HS-IRBs are NOT serving as IRB of record should NOT be listed on the study team pages in the IRB application.
Before external personnel can participate in a project or study determined to be exempt by the HS-IRBs, they must do the following:
- If the external personnel are affiliated with an organization (e.g., university, hospital) with its own IRB, they must ask their own IRB to review their involvement in the project or study.
- If the external personnel are affiliated with an organization that does not have its own IRB, a letter of support from that organization should be provided to the HS-IRBs.
- If the external personnel are not affiliated with any organization (e.g., an independent consultant), no additional documentation is typically required.
Do external personnel or collaborators participating in exempt projects or studies need to complete UW-Madison or comparable human subjects research training?
Only personnel who are listed on the study team pages of the IRB application need to complete UW-Madison or comparable human subjects research training. Unless the exemption involves personnel affiliated with an IRB reliance partner for which the HS-IRBs are serving as IRB of record, external personnel should NOT be listed on the study team pages in the IRB application and do not need to comply with the UW-Madison human subjects research training requirements.
If the external personnel or collaborators are affiliated with an organization with its own IRB, however, they will need to ensure they meet the human subjects research training requirements of their own IRB.
What are the IRB requirements for external personnel or sites for projects that may not constitute human subjects research?
The requirements for projects that may be eligible for a not research or not human subjects determination are the same as those described above for exemptions. In the case of IRB applications for a not research determination, however, the study team should describe the role of any external sites or personnel in the body of the application or protocol.