Protecting Human Subjects in Student Inquiry Projects

Project rationale

This project is needed and timely for a variety of reasons, including:

• Increased emphasis on "high impact practices" which have engaged more students in gathering information from and about human subjects. Such practices include active learning, undergraduate research, study abroad, community-based learning, and capstone projects (Kuh et al, 2008;see AAC&U, High-Impact Educational Practices for a succinct summary). Research performed with and by undergraduates poses a specific set of ethical challenges, particularly in selective liberal arts institutions that actively promote such projects. However, there is little professional literature examining these challenges and little policy guidance from the federal Office of Human Research Protections.

• Increased dissemination of student work via websites, posters, and undergraduate conferences within and beyond the campus, which increases an institution's obligation to ensure appropriate protection of subjects' identities and information, and makes it harder to determine whether or not such projects constitute "research" subject to IRB review.

• Variation in institutional definitions, policies, and procedures for human subjects protection, both in general and with respect to student projects. This is particularly problematic for courses and programs that draw students from multiple institutions, and for projects undertaken in study abroad programs where jurisdictional issues are complicated (Wesche, Huynh, Nelson, and Ramachandran, 2010). There is considerable ambiguity in the application of the federal regulations concerning human subjects protections in such inquiries, and considerable differences across institutions in the regulatory interpretations and review procedures employed.

• Lack of professional development opportunities in human subjects protection for faculty assigning and/or supervising student projects. Though often expert in conducting their own human subjects research, these faculty often lack detailed knowledge of the implications of student projects that fall on the boundaries of IRB jurisdiction.

• The special challenges posed by student projects undertaken in study abroad programs, where jurisdictional issues are complicated for a number of reasons. First, projects are often developed after students are already on site with limited access to educational resources and institutional policies. Second, cultural norms affecting ethical imperatives may be very different from US norms. Third, program advisers are often lacking in knowledge of both human subjects protection principles and policies, and the cultural norms of the site where a project may be undertaken.

• Time demands on college IRB members.IRB members would be pressed for time even if all they did was review projects that fall clearly within the jurisdiction of the IRB. Given all the above trends, however, IRB members are increasingly asked both to review projects that arguably do not fall within the scope of their responsibilities, and to do the work of the instructor in educating students about human subjects protections so they can prepare "approvable" project applications. This leaves no time to develop or refine policies or procedures that could educate students, prepare faculty, avoid inter-institutional policy conflicts, and protect subjects more efficiently.