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- What is the difference between a "multi-site" and "cooperative" human research project?
NIH uses the term "multi-site project" to describe a sub-set of cooperative non-exempt human research where the same research procedures (i.e., the “same protocol”) are conducted at two or more U.S. research sites under the control of a participating investigator at each site.
A multi-site project typically involves a lead site (lead PI) that manages the administrative functions of the project in addition to conducting the same research procedures as the participating sites. A multi-site project could be a clinical trial, an observational study, or a basic clinical research study.
A “cooperative” (or “collaborative”) project involves two or more U.S. research sites where each site is conducting a different part of a research protocol under the direction/control of the lead PI. An example would be a non-exempt study where U-M is the lead site and conducting the interaction/intervention with the human participants, but the analsyis of the data is being done by is an external institution/collaborator.
Under NIH and Common Rule sIRB guidelines, both multi-site and cooperative research projects may:
- Require the use of a single IRB for oversight.
- Have a lead site/PI who receives the grant or contract from a sponsor and then establishes a subaward or subcontract to each participating site.
- Require authorization (“reliance”) agreements to establish the contractual terms for IRB oversight and project management.