Study Location: General
Question 1.1: A multi-site study includes:
- A study involving research activities conducted at a UW-Madison site AND at least 1 other site NOT affiliated with or covered by a UW-Madison IRB.
- Multi-site research includes the involvement of sites or personnel that are NOT under UW-Madison IRB purview or covered by an agreement (IIA or IAA) with UW-Madison;
- The following examples are NOT considered multi-site studies, and the answer to this question (1.1) should be No.
- Studies conducted by someone covered by a UW-Madison IRB at truly public sites;
- Studies conducted at many sites, all under the purview of a UW-Madison IRB.
- A study which includes study team members that are not affiliated with UW-Madison.
- All personnel not affiliated with UW-Madison who are engaged in human subjects research for a study reviewed by the UW-Madison IRBs must arrange for IRB oversight for their activities.
- In some cases, the the UW-Madison IRB may consider serving as IRB of record for individuals or entities not affiliated with UW-Madison.
- A study involving sending or receiving data/specimens to outside collaborators.
If any of the above apply, please check Yes.
Question 1.2: If any outside collaborators will be relying on UW-Madison as the reviewing IRB (ie. ceding/deferring review to UW), please check Yes.
Question 1.4: If any sites or outside collaborators will be providing IRB approval from their own institution, please check Yes.