Responsibilities apply to faculty supervising students/medical residents as a Principal Investigator (PI). The IRB holds the Faculty Advisor(s) responsible for the overall management of an approved research protocol in conjunction with the student PI. Management of the research encompasses the ethical, administrative, fiscal, and applied elements of a project. Faculty Advisors are required to:
- Acknowledge and accept their responsibility for protecting the rights and welfare of human research participants, by electronically signing the submission package and being listed as a research personnel on the protocol,
- Ensure the students/medical residents have sufficient training and experience to conduct the research in accord with the protocol, including, but not limited to any cultural sensitivities, cultural norms, and/ or dialect spoken,
- Fulfill the human subject research training requirement (CITI) and understand the ethical standards and regulatory requirements governing research activities with human participants,
- Collaborate with student/medical resident PIs during the preparation of an IRB proposal and ensure the proposed research complies with the ethical principles outlined in the Belmont Report, human subject research regulations including 45 CFR 46, institutional policies, and other applicable federal or state laws,
- Report any real or potential conflicts of interests in compliance with the conflict of interest policies,
- Make adequate time to consult with the student PI on a regular basis to monitor research progress,
- Assist and supervise the researcher in problem solving in the event a problem, emergent question or concern were to surface,
- Ensure all research activities have IRB approval and other ancillary approval required by the institution before human subjects are involved, and implement the research activity as it was approved by the IRB,
- Ensure all research activities are conducted in compliance with internal policies including IRB policy, applicable regulations and state law,
- Ensure the confidentiality and security of all information obtained from and about human subjects, and the privacy of subjects is maintained,
- Ensure student/medical resident PIs promptly report any Reportable Events to the UC Davis IRB in a timely manner,
- Ensure a Study Closure Report is be submitted to the IRB upon completion of the research. In the event that the PI is unable or unwilling to do so, the responsible Faculty Advisor will be required to do so prior to when the PI graduates or otherwise leaves UC Davis, and
- Ensure the student/medical resident PI is in compliance with the additional responsibilities listed as investigator responsibilities.
NOTE: Faculty Advisor responsibilities may only be carried out by a member of the University of California, Davis faculty that meets the qualifications to be a PI. The faculty member is considered the responsible party for assisting the PI in making ethical decisions throughout the life of the project.
For information on what may constitute a “Class Projects” click here.