VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R018

While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place. Different traditions, laws, mores, and institutions may require different research practices, particularly regarding informed consent, recruitment strategies, and documentation. Therefore, special attention must be given to local laws, customs, culture, and religious norms in designing protocols, drafting written consent documents or proposing alternative methods of obtaining informed consent. As a prerequisite to VCOM IRB approval, all research conducted in foreign countries by VCOM student researchers must have documentation of “local approval” as described further in this policy. VCOM researchers and the VCOM IRB share responsibility for ensuring that: • the same or equivalent protections are provided to human participants in research conducted in other countries; • researcher and IRB knowledge of local laws and cultural context is sufficient to inform decisions about how the research is conducted; • the consent process is appropriate to the population and procedures; and • adequate provisions are outlined for data and safety monitoring. 3. APPLYING FOR INTERNATIONAL RESEARCH APPROVAL All approvals must be secured, in the steps and order described below, a minimum of 90 days before the start of the student’s scheduled international clinical rotation. However, it is recommended that the approval process be started 120 days in advance of the rotation to ensure timely approvals in the US and abroad. • The student will first identify a faculty mentor who will serve as Principal Investigator (PI), providing long-term leadership on the project, including full involvement in all aspects of the student’s research, assignments, and time allocation. Students must submit the “Mentor Identification Form” to the Vice Provost for International and Appalachian Outreach. • The faculty mentor and student will complete the “Worksheet for Faculty and Student International Research,” available through IRBNet, and submit the completed worksheet to the Vice Provost for International and Appalachian Outreach. • The International Outreach Office will conduct an assessment to determine the feasibility of the proposed project and, if feasible, will sign the worksheet to provide approval to proceed with project planning. • Once the International Outreach Office has approved proceeding with project planning, the faculty mentor will work with the student to complete an IRB application for Human Subjects Research, and submit it to the appropriate in-country IRB office for approval. • Once the faculty mentor and the student receive approval from the in-country IRB, they must submit an IRB application for Human Subjects Research to the VCOM IRB through IRBNet. The signed “Worksheet for Faculty and Student International Research” and documentation of in country IRB approval must be submitted with the application to the VCOM IRB. Faculty mentors and students should reference Policy R004: VCOM Institutional Review Board Policies for more information. No research can begin until VCOM IRB provides approval. • Once VCOM IRB approval has been received, the faculty mentor and student must provide a copy of the approved IRB protocol to the Vice Provost for International and Appalachian Outreach.

VCOM Policy on Students Performing Research in an International Setting

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