UM-initiated human subject research may take place at, or otherwise involve, a non-UM institution and/or investigator. Unless such studies are considered exempt under 45 CFR 46.101 and/or 21 CFR 56.104(d) by the UM IRB, the involvement of a non-UM institution and/or investigator in UM-initiated human studies requires that the study approval process include an agreement or subcontract with the non-UM institution or investigator. If an agreement or subcontract is required, this agreement or subcontract must be signed by the appr3opriate institutional officials prior to IRB approval of the study and shall be submitted by the principal investigator to the IRB as part of the study materials available for IRB deliberations.
The requirement for a subcontract/agreement applies to studies with human subjects that include a non-UM institution and/or investigator regardless of source or plans for funding.
Unless other arrangements are approved by the Associate Vice Provost for Human Subject Research to ensure research oversight at collaborating institutions, it is the responsibility of the UM IRB to review UM studies that take place at, or otherwise involve non-UM institutions and/or investigators and to determine whether these studies and the subcontract/agreement ensure optimal human subject protection. It is the responsibility of the HSRO and the Associate Vice Provost for Human Subject Research to monitor this policy and facilitate subcontracts/agreements that are required for approval of this research.
For purposes of this policy, UM-initiated studies are those which fit any of the following criteria:
1) The University of Miami and the UM principal investigator are recipients of the prime award (i.e. the grant supporting the research)
2) The University of Miami and the UM principal investigator are prime recipients of the funds from sponsors supporting the research
3) The University of Miami and the UM principal investigator have initiated the research and/or provide the research leadership
NOTE – In situations where UM is a subcontractor of a study initiated by another institution, UM IRB review and approval is still required. Documentation relating to the conduct of the study with regard to human subjects must be submitted to the HSRO.
For purposes of this policy, a non-UM institution is defined as an institution (or an employee or agent of the institution) that is not under the authority of UM and is located within the United States or a United States territory. Examples include clinics, schools, other universities, consulting firms or other institutions where activities include interaction or intervention with human subjects and/or the collection or analysis of identifiable data.
For purposes of this policy a non-UM investigator is someone not employed by or under the legal authority of UM.
This policy does not apply to non-UM institutions or facilities that are located outside of the United States and for which the "International Research Policy Involving Foreign Institutions in UM Human Subject Research" shall apply.