VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

previously had no plans, or only indefinite plans, for subject involvement and will acquire the approval of the IRB prior to the involvement of any subjects. The Principal Investigator will promptly report to the IRB any serious or continuing noncompliance with the requirements of this policy or of the IRB on any research with which he or she is associated. The Principal Investigator will cooperate with the IRB in notifying the Food and Drug Administration when he or she anticipates that an investigational new drug or device exemption will be required. 20.3. Student Research All student research requires a faculty sponsor / faculty Co-PI. Faculty sponsors are required to (i) provide the specific assurance that the student is knowledgeable about the regulations and policies governing research with human subjects; (ii) provide the specific assurance that the student has sufficient training, and experience to conduct the proposed study in accordance with the approved protocol; and (iii) thoroughly review the research proposal and deem it ready for submission to the VCOM IRB. Additional assurances required of faculty sponsors include agreement to: • Meet with the student on a regular basis to monitor study progress. • Be personally available to supervise the student in solving problems should they arise during the course of the study. • Promptly report significant adverse events and adhere to all requirements for continuing review. • Arrange for an alternate faculty sponsor to assume responsibility if/when the original faculty sponsor is unavailable (e.g., sabbatical leave, vacation, or resignation from VCOM). Any changes in faculty sponsorship must be submitted as a modification request to the VCOM IRB. 21. DURATION OF POLICY The VCOM Institutional Review Board Policies and Procedures established by the Department of Research is effective as of the date above and shall remain effective until amended or terminated by the President and Provost.

VCOM Institutional Review Board Policies and Procedures

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