IRB: Academic Advisor Responsibilities Policy number: 805 References: AAHRPP III.2.B Date: 06/05/2014 Policy Owner: Executive Director, HRPP Cross References: 403 C Minnesota Laws that Affect Research 800 Principal Investigator Responsibilities 804 Student as Principal Investigators Appendix J Definitions: None 1.0 Reason for Policy To outline the requirements for all University of Minnesota academic advisors who mentor student researchers. ____________________________________________________________________________________ 2.0 Scope of Policy The scope of this policy is the University research community and its healthcare components. 3.0 Policy Statement The academic advisor must complete Appendix J “Student as Principal Investigator” and submit with any application being filed by a student. By completing Appendix J, an academic advisor assures the IRB of the following: The academic advisor will assume the roles and responsibilities required to oversee the conduct of the research, prevent harms and foster benefits to the subjects Any changes in the research project, adverse events, or incidents which may affect the conduct of research will be reported to the IRB The submitted IRB application has been thoroughly reviewed by the advisor for completion The project is appropriate for student research in topic and design The academic advisor will meet with the student researcher on a regular basis to monitor study progress. If the study procedures are carried out in a location away from the University of Page 1 of 3 Minnesota or regular channels of communication are not feasible, the advisor will make alternate arrangements to continue communication with the student researcher. The student researcher will promptly report unanticipated problems to the IRB The student researcher will adhere to all requirements for continuing review If the student leave the University, the advisor will provide all necessary documents for terminating the study or continuing review. If the advisor will be unavailable, he/she will arrange for an alternate faculty advisor to assume the above responsibilities, and will advise the IRB of this change The University of Minnesota Faculty Senate Committee on Academic Freedom and Tenure adopted the following statement at their meeting on October 23, 2009: Academic Freedom and the Institutional Review Board Statement by the Senate Committee on Academic Freedom & Tenure October 23, 2009 The University of Minnesota's Faculty Senate Committee on Academic Freedom and Tenure advises the Institutional Review Board (IRB) that it is not an infringement of academic freedom for the IRB to place restrictions on faculty members who permit or encourage inappropriate research by students using human subjects. Rather, faculty members who advise students have a responsibility to offer rigorous training and oversight consistent with IRB expectations when students are conducting research with human subjects. The Committee takes the position that the safety of the human subjects, and the safety of the students conducting the research, is paramount, and that the IRB does not infringe academic freedom when it acts to protect human health and well-being. The Committee is also of the view that the IRB may appropriately consider the qualifications of the faculty member to supervise the research proposed by the student and may, without infringing academic freedom, inquire about and ultimately not approve such student research if the proposed supervision appears inadequate. Finally, the Committee endorses the proposition that when questions arise, the IRB should work with the faculty member and the student to ensure that an appropriate research project will be undertaken. Ultimately, however, the Committee believes that the IRB must make a decision about whether or not it can approve the project. The faculty member and the student must be notified of their right to appeal the decision. Adopted unanimously Page 2 of 3 4.0 Required approvals for this document Title Executive Director, HRPP 5.0 Revision History Revision 06/05/14 07/23/12 01/04/11 01/29/10 Reason for change Update policy Clarification per audit finding Update AF&T statement Policy development Date of release 09/02/14 07/23/12 01/04/11 To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654 Page 3 of 3