The following expectations apply to Faculty Advisors on Clark University IRB protocols, where a graduate or undergraduate student is the Principal Investigator (PI).
The faculty advisor is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student. 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. In keeping with these responsibilities, faculty advisors are required to complete the same CITI training required of all PIs on human subjects research protocols.
Faculty Advisors are required to:
- Acknowledge and accept their responsibility for protecting the rights and welfare of human research participants, by electronically signing the IRB Protocol Submission in Mentor and being listed as a research personnel on the protocol,
- Ensure that the students 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 dialects spoken,
- Fulfill the human subjects research training requirement (CITI Training) and understand the ethical standards and regulatory requirements governing research activities with human subjects,
- Collaborate with student PIs during the preparation of the IRB proposal and ensure the proposed research complies with the ethical principles outlined in the Belmont Report, human subject research regulations including 45CFR46, institutional policies, and other applicable laws and regulations,
- Report real or potential conflicts of interests,
- Consult with the student PI on a regular basis to monitor research progress and ensure ongoing compliance with the approved protocol,
- Assist and supervise the student PI in problem solving in the event a problem, emergent question or concern were to surface,
- Ensure all research activities have IRB approval and any other ancillary approvals 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 and regulations including 45CFR46,
- Ensure that the confidentiality and security of all information obtained from and about human subjects, and that the privacy of subjects is maintained, as specified in the approved protocol,
- Ensure that student PIs promptly report any any adverse events, protocol deviations, or other unanticipated problems involving risks to participants or others and other reportable events to the Clark IRB in a timely manner,
- Ensure that a Termination Report is submitted to the IRB upon completion of the research. If the student 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 Clark, and
- Ensure the student PI complies with the additional responsibilities listed as investigator responsibilities.
Faculty Advisor responsibilities may only be carried out by a member of the Clark faculty who meets the qualifications to be a PI. The faculty member is considered the responsible party for assisting the student PI in making ethical decisions throughout the life of the project.