The faculty advisor serves as an active mentor to a student researcher and shares responsibility for ensuring student-led research is conducted in a responsible and ethical manner. In general, the faculty advisor is expected to 1) discuss the general principles of research ethics prior to the initiation of any project involving human subjects, 2) help the student determine whether the project requires Insitutional Review Board (IRB) review, 3) guide the student Principle Investigator (PI) through the IRB application process, and 4) provide support to the student PI in conducting research after IRB approval has been attained.
DOES MY STUDENT'S PROJECT REQUIRE IRB APPROVAL?
Not all student research activities that involve people, their data, or specimens require IRB oversight. See the IRB Policies and Procedures for the definition of Human Subjects Research and specific categories of student projects that do not require IRB approval including:
- Class Projects - Activities that are intended for educational purposes to teach research methods or demonstrate course concepts. A class project is an academic project or student assignment that may involve collection of data from human subjects when the data is used solely for the purpose of teaching course content and is not intended to be used to develop or contribute to generalizable knowledge.
- Student Internships - Student activities associated with internships may or may not require IRB oversight depending on the design of the activity and whether it is such that there is a systemic investigation involving human subjects and a contribution being made to generalizable knowledge.
Contact the IRB office directly at 607-777-3818 or firstname.lastname@example.org if you are unsure if your project requires IRB review.
WHAT ARE THE FACULTY ADVISOR RESPONSIBILITIES FOR STUDENT-LED HUMAN SUBJECTS RESEARCH?
- Acknowledge and accept responsibility for protecting the rights and welfare of human research participants by completing and signing the Faculty Advisor Letter submitted by student PI's as part of the IRB application process, and being listed as a member of the study team;
- Fulfill the human subjects research training requirement (CITI) and understand the ethical standards and regulatory requirements governing research activities with human participants;
- Ensure the student PI has sufficient training and experience to conduct the research in accordance with the proposed protocol including, but not limited to, addressing cultural sensitivities or norms, and/or dialect spoken;
- Collaborate with student 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;
- Ensure all research activities have IRB approval and other ancillary approval required by the institution before human subjects are involved, and that the research is implemented as it was approved by the IRB;
- Assist and supervise the researcher in problem solving in the event a problem, emergent question, or concern surfaces;
- Ensure the confidentiality and security of all information obtained from and about human subjects, and the privacy of subjects is maintained;
- Ensure student PIs promptly report any Reportable Events to the IRB in a timely manner;
- Ensure a Study Closure is submitted to the IRB upon completion of the research. In the event that the PI is unable or unwilling to do so, the Faculty Advisor will be required to do so prior to when the PI graduates or otherwise leaves Binghamton University.
NOTE: Faculty Advisor responsibilities may only be carried out by a member of the Binghamton University faculty that 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 cycle of the research project.