Working with Community Partners
Version date: September 2018
The Health Sciences IRBs review a wide variety of research, including projects involving community partners. A community partner is typically an individual employed or volunteering at a community organization and/or an individual that is self-employed, in private practice or is otherwise involved where research is being conducted by a UW-Madison researcher. Community partners also may be community organizations with which UW-Madison investigators are conducting research projects. IRB applications for any project involving community partners must specify which external sites are involved in the study and describe how IRB oversight will be provided, including whether you are requesting that UW-Madison serve as IRB of Record.
Whether IRB oversight is required for community partners depends on whether community partners are engaged in human subjects research, as defined by federal guidance. A community partner may be engaged in research if they are involved in research activities such as data collection, recruiting participants, consenting participants, or analyzing identifiable data. A community partner may not be engaged in research if, for example, it is simply serving as a location for study activities or providing recruitment flyers to potential participants. Determining whether an external site or individual is engaged in human subjects research can be difficult, especially for community-engaged research. Study teams are encouraged to consult with the HS IRBs’ Reliance Team for assistance in making this determination when preparing an IRB application. All personnel engaged in research must have their study activities covered by an IRB.
IRB requirements for community partners NOT engaged in human subjects research:
If a community partner is determined not to be engaged in human subjects research, that community partner does not need to be listed as a study team member in the IRB application and does not need to complete human subjects research training. Community partners should still be listed in the study protocol (if any). A letter of support from the community partner also may need to be uploaded in the IRB application (see Letters of Support for External Sites). Community partner personnel who are not engaged in research but are still conducting activities in support of the research project should be provided appropriate training to conduct those activities, as determined by the UW-Madison study team.
IRB requirements for community partners engaged in human subjects research:
If a community partner is engaged in research activities, UW-Madison may agree to serve as the IRB of record for the community partner if it does not have its own IRB. The HS IRBs Office makes this decision on a per study basis. The HS IRBs cannot provide IRB oversight for non UW-Madison organizations that are not collaborating with a UW-Madison PI. For assistance in ascertaining whether the HS IRBs can serve as IRB of record for a community partner, please contact the Reliance Team.
If the HS IRBs will serve as IRB of record for a community partner, community partner personnel must complete human subjects training and be listed on the IRB protocol application. In addition, a formal agreement between UW-Madison and the community partner may be required pursuant to federal regulations. Whether a signed agreement is required is contingent on several factors. The main types of agreements include:
- Individual Investigator Agreement (IIA): An IIA is used when the UW-Madison HS-IRBs agrees to serve as the IRB of record for community partners who are affiliated with organizations that do not have an IRB and the study is federally funded. The HS-IRBs Office will work with study teams to facilitate processing of IIAs when needed.
- Collaborating Investigator Summary: A collaborating investigator summary is used when the HS-IRB agrees to serve as the IRB of record for community partners who are affiliated with organizations without an IRB and the study is not federally funded. The HS-IRB Office will work with study teams to facilitate distribution of collaborating investigator summaries when needed.
- IRB Authorization Agreement (IAA): An IAA is used when the UW-Madison HS-IRBs agrees to serve as the IRB of record for community partners who are affiliated with organizations that have an IRB and/or Federalwide Assurance (FWA). This type of agreement is used rarely with community-engaged research. The HS-IRBs Office will work with study teams to facilitate processing of IAAs when needed.