OUTSIDE FACILITY AGREEMENT: (For Template of an Outside Facility Agreement, CLICK HERE)
This template agreement shall apply if the non-UM institution or investigator is involved but not engaged in UM research. NOTE – it is recognized that in certain circumstances, this agreement may not be suitable. In such situations, alternative documentation may be approved by the Associate Vice Provost for Human Subject Research. Investigators are encouraged to consult with the HSRO when drafting such an agreement.
An example of a non-UM institution being "involved" in UM human subject research occurs when the non-UM institution provides a facility in which the research is being conducted or provides a pool of research participants. This is in contrast to a non-UM institution being "engaged" in UM research because, in the former circumstance, the employees or agents of the outside facility are not intervening or interacting with living individuals for research purposes or are not obtaining identifiable private information for research purposes [45 CFR 46.102(d),(f); 21 CFR 56.102(c),(e); 21 CFR 50.3(c)(g)].