Version date: April 2019
If your project or study involves collaboration with any sites and/or personnel outside the UW-Madison, UW Health, or the 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.
An external site requires IRB oversight if it is engaged in non-exempt human subjects research as defined by federal guidance. Study teams are encouraged to consult with the Reliance Team (irbreliance @wisc.edu) when making this assessment.
If an external site is engaged in human subjects research, the HS-IRBs may consider serving as IRB of record for that site. Please see HS-IRBs Guidelines for Serving as IRB of Record for more information.
Yes, depending upon the nature of the project. For additional information on exemptions and not human subjects research determinations, please see our Exemptions guidance.
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, or Madison VA, the HS IRBs will generally not serve as IRB of record for these personnel. The reason for this is that federal regulations and guidance do not require ongoing IRB oversight for studies or projects determined to be exempt. 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 may be needed.
- If the external personnel are not affiliated with any organization (e.g., an independent consultant), no additional documentation is typically required.
External personnel for exempt human subjects research 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 institution.
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 may be needed, as outlined in Letters of Cooperation for Non-UW Institutions/Organizations. If the external site has its own IRB, then someone from that site should consult with their own 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.
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 UW-Madison study team should describe the role of any external sites or personnel in the body of the application or protocol.
For additional information, please see Sending or Receiving Specimens/Data/Images Guidance.