This policy complements that contained in the previous section of the IRB Written Policies and Procedures entitled "Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve Non-UM Institutions or Investigators". The former presents general principles regarding the engagement or involvement of non-UM institutions or investigators in UM studies and it includes policies related specifically to domestic sites or investigators. The present (i.e. international) policy defines additional requirements for UM-initiated human subject research taking place at, or otherwise involving, a non-UM institution and/or investigator at international sites (i.e. sites outside of the 50 states or U.S. territories).
Unless other arrangements are approved by the Associate Vice Provost for Human Subject Research to ensure research oversight at collaborating international institutions or unless such studies are considered exempt under 45 CFR 46.101 and/or 21 CFR 56.104(d) by the UM IRB, 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 the provisions in place for such international research and the subcontract/agreements 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 that fit any of the following criteria:
a) The University of Miami and the UM principal investigator are recipients of the prime award (i.e. the grant supporting the research)
b) The University of Miami and the UM principal investigator are prime recipients of the funds from sponsors supporting the research
c) The University of Miami and the UM principal investigator have initiated the research and/or provide the research leadership
NOTE – In situations where UM and/or a UM employee is a subcontractor of a study initiated by a foreign 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, an international (or "foreign") institution or site is defined as an institution or site (or an employee or agent of that entity) that is not under the authority of UM and is located outside of 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 health information.
For purposes of this policy a non-UM investigator is someone not employed by or under the legal authority of UM.
Agreement or Subcontract: As in situations involving domestic non-UM institutions and/or investigators in UM-initiated human subject research, international involvements require 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 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.
Responsibilities: The principal investigator and the foreign institution or site are responsible for assuring that adequate resources and facilities are available for the research. Principal investigators and the foreign institution or site are also responsible for notifying the IRB promptly if a change of research activities alters the performance entity's engagement in the research.
Informed Consent Documents: Informed consent documents must be consistent with requirements as defined in UM IRB policies. These requirements include that informed consent must be sought in a language understandable to the subject and under conditions that minimize the possibility of coercion or undue influence. The UM IRB shall review the informed consent documents and translations as per its written policies. Informed consent documents and translations may not be used until approved by the UM IRB.