When a foreign institution, site or investigator will become involved in non-exempt, UM-initiated research, the study approval process shall include an agreement or subcontract with the non-UM institution or investigator. This agreement or subcontract must be signed by the appropriate officials of the foreign entity and the University prior to IRB approval of the study and shall be submitted by the principal investigator to the IRB. The requirement for a subcontract/agreement applies to studies with human subjects regardless of source or plans for funding.
Principal Investigators must select and ensure completion and approval of an appropriate subcontract from the two template subcontracts referenced in this policy (note- see links to these subcontracts in the text below). These templates are suggested but may be modified to meet specific circumstances.
Although IRB policies do not require a subcontract/agreement for exempt research involving a non-UM institution, such research may require a subcontract or other agreement from other institutional departments (e.g. UM Research Administration). It is the responsibility of the Principal Investigator to comply with such requirements.
The HSRO suggests that the UM principal investigator of an exempt study obtain a letter of permission to conduct the research activity at the non-UM institution and/or to use the resources of the non-UM institution. This documentation may be requested by the IRB during the exempt review process.
Selection of the appropriate subcontract depends on whether the foreign institution or site is "engaged" or "involved in the UM-initiated study. An institution is "engaged" with UM in human subject research when its employees or agents intervene or interact with living individuals for research purposes or when its employees or agents obtain identifiable private information for research purposes [45 CFR 46.102(d),(f); 21 CFR 56.102(c),(e); 21 CFR 50.3(c),(g)]. Involvement in research occurs when an outside institution and/or its employees or agents are not intervening or interacting with living individuals for research purposes or are not obtaining identifiable private information for research purposes (but research may be ongoing on the premises) [45 CFR 46.102(d),(f); 21 CFR 56.102(c),(e); 21 CFR 50.3(c),(g)].
For a foreign institution/site engaged in UM human subject research, the subcontract should be constructed from the template labeled "INTERNATIONAL 1". This requires that the foreign institution hold an FWA and that it conduct individual IRB or IEB or equivalent reviews and give approval for the study. If the non-UM institution or individual has no means to conduct this review, the subcontract may define that UM has agreed to act as the IRB of record for the study for that institution. The terms by which UM agrees to act as the IRB of record for each individual study require prior approval from the Vice Provost for Research.
For a foreign institution/site "involved" but "not engaged" in UM human subject research, the template agreement labeled INTERNATIONAL 2 is suggested although 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.