When working with a community partner (e.g., an individual or group employed or volunteering at a community organization and/or self-employed), the first step is to determine whether IRB oversight is required for these partners. IRB oversight is required if they are engaged in human research, as defined by federal guidance (see HRP 311-WORKSHEET-Engagement Determination for details). Whether a community partner is engaged in human research determines whether IRB oversight is even required.

A community partner may be engaged in research, for example, if they are:

• Collecting data (e.g., administering surveys)
• Administering study interventions (e.g., conducting focus groups)
• Consenting participants and/or
• Analyzing identifiable data

A community partner may not be engaged in research if, for example, they are:

• Serving as a location for study activities conducted only by UW-Madison personnel
• Providing recruitment flyers to potential participants
• Referring potential participants to the UW-Madison study team

If a community partner is engaged in human research AND the study is non-exempt, then all personnel involved in the research must have their study activities covered by an IRB. Typically, UW-Madison will provide IRB oversight in these situations. When preparing your application, you will need to include an IRB of record request for these individuals. Note that these external personnel must complete human research training and be listed on the IRB application. See other sections for information on how to list them and what human research training options are available.

A formal agreement between UW-Madison and the external individual is required pursuant to federal regulations. One of the following agreements will be used to document that UW-Madison is providing

IRB oversight for the external individual:

• For federally funded studies, an individual investigator agreement (IIA) is required. This agreement requires signatures from both the external individual and UW-Madison’s institutional official.
• For non-federally funded studies, a collaborating investigator summary (CIS) is required. This agreement does not require any signatures and is simply provided to the external individual.

In both cases, RELIANT will assist you in putting these agreements in place. NOTE: If the study likely qualifies for exemption, neither type of agreement is required.