VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R018

4. CONDUCTING INTERNATIONAL RESEARCH 4.1. Student Responsibilities

It is the student’s responsibility to ensure that they have read, understood, and comply with VCOM’s policies and procedures related to international research. When conducting international research, the student must: • Seek approval through the International Outreach Office and obtain an appropriate VCOM faculty mentor to serve as the Principal Investigator (PI) for their research. • Comply with all requirements and responsibilities of their assigned international clinical rotation as specified by the International Outreach Office. • Ensure that the CITI training for the Protection of Human Research Subjects and OSHA Bloodborne Pathogens is still valid and will be valid throughout the length of their research project. If not valid, students will need to complete a refresher course. • Meet with the faculty mentor regularly to establish and maintain a satisfactory timetable for the research. • Keep written records of their work, which may form the basis of progress reports required by the faculty mentor or VCOM. • Submit written work to the faculty mentor regularly and in good time, in accordance with the agreed timetable. • Take note of any guidance and feedback offered by the faculty mentor. • Discuss any problems (e.g., access to data, information, facilities, equipment, or supervisory relationship) with the faculty mentor at the time they occur. The early identification and resolution of problems can prevent difficulties later. If the student feels unable to raise the problem with the faculty mentor, then the Vice Provost for International and Appalachian Outreach should be consulted. 4.2. Faculty Mentor (PI) Responsibilities The PI supervises all aspects of student research, including data collection at international sites, either by going to the site or through other appropriate arrangements. When conducting international research the PI must: • Provide equivalent protections to human subjects in foreign countries. The protections need not be the same as provided in the U.S. but should be equal in function or effect (see Belmont Report). • Comply with any applicable regulations of the country in which the research will take place (refer to The International Compilation of Human Research Standards). • Have sufficient knowledge of the local context (laws, regulations, culture, political and socio economic factors) to enable the design and conduct of the research in ways that protect the rights and welfare of subjects. The IRB recommends that a local collaborator be included on the research team to ensure that the design and conduct of the research conform to local regulations/customs. • Be aware of and adhere to any additional international guidelines that may be applicable when conducting biomedical research (e.g., Declaration of Helsinki, International Conference on Harmonization - Good Clinical Practice E6). It should be noted that the Health Insurance Portability and Accountability Act (HIPAA) regulations do not apply to countries outside the U.S. However, once identifiable health information is transferred to a HIPAA-covered entity all U.S. HIPAA regulations apply. • Arrange for the training of all research team members, including those involved in data collection at the local site.

VCOM Policy on Students Performing Research in an International Setting

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