Protecting Human Subjects in Student Inquiry Projects
The Symposium will begin at 4 pm on Thursday, February 23 and conclude at 1.00 pm on Saturday, February 25. Prior to the symposium, an inter-institutional study group has been preparing a series of policy recommendations and sample educational and administrative documents that will serve as working papers for symposium sessions: Participants will review drafts addressing the following issues:
- What kinds of student projects should be considered "research" subject to federal regulations for human subjects protection? What are the indicators that a student project requires IRB review? Note:The draft policy document on this point is under review at the federal Office of Human Research Protections (OHRP), so we will have OHRP guidance in addressing these questions.
- What do students need to know about the basics of human subjects protection (risk, privacy, informed consent, etc.) when they are conducting a project that involves human subjects but is not subject to IRB review?
- How should faculty (serving variously as course/lab instructors, as program advisors, and as department chairs) and students be educated about the complicated issues involved in protecting human subjects? We are developing instructional and oversight materials that faculty and other project supervisors can use to ensure that student projects that DON'T require IRB review are still conducted in a manner which respects the core ethical principles of beneficence, justice, and respect.
- For those projects that involve human subjects but are not "research" as federally defined, what procedures can an institution follow to ensure that the subjects in such projects are still protected? How can these procedures operate effectively within the parameters of the short timelines that many student projects entail?
- How should responsibility for the oversight of student projects that involve human subjects be shared in cases where the project is being undertaken through an inter-institutional course or program, whether domestic or international?