Resources on the Need for IRB Review of Class Assignments
In schools of public policy and management, questions about the borderline between "research" and "non-research" arise as we instruct students in research methods and professional skills. Unfortunately, OHRP - the federal agency that could provide clarification - has not provided much guidance on the status of educational/classroom activities.
University policies on the need for IRB review of class assignments
Absent explicit federal guidance, some universities have interpreted the regulations for themselves, and have developed formal policies regarding the status of classroom projects. An internet search shows that most universities do not have policies posted online. However, of those that have posted, most have deemed that class assignments generally do not require IRB review.
A particularly thoughtful piece - and one that could be a good start for a model policy, if your institution does not already have one, or if it is in search of a policy upgrade - comes from the University of Michigan.
The bottom-line message of the University of Michigan's policy is that while most classroom activities do not require IRB review, instructors are obliged to ensure that their students perform their work in an ethical fashion. We find this document to be particularly helpful because it provides some suggestions and resources for faculty.
Duke University's policy is also quite explicit and helpful.
Development of a level of review beyond the IRB
Some have argued that student research should receive review, even when that review is not strictly required by the regulations. Those holding this position say that this extra review of student work accomplishes other important aims. For instance, this PowerPoint presentation from the Social and Behavioral Sciences Working Group on Human Research Protections argues that early training in research ethics has benefits, and that different levels of review - at the departmental level, for example - may be appropriate in some cases. The argument for other levels of review is developed in more detail in a Working Group approved report.
The Need for IRB Review for the Teaching of Professional Skills (e.g. Capstone Courses)
Often, schools of public policy and management require out-of-the-classroom professional training experiences, allowing students to hone their professional skills. In the course of these activities, students may interview, survey, hold focus groups, analyze data, and so on. At Wagner, this is our "capstone" course.
After discussing the need for review of our capstone course with our university IRB, Jan Blustein wrote this document. In it, she argues that it would be inappropriate and infeasible to require IRB review for such courses, for four reasons:
1. the projects do not meet the federal criteria for research, because they are not designed to create generalizable knowledge;
2. the projects do not meet the federal criteria for research, because they are not hypothesis-driven, structured exercises; in fact, they are quite open ended;
3. because the projects are open ended and evolving, it is not possible to specify a protocol in advance , and so pre-review is not feasible; and
4. it would be inequitable to require IRB review for MPA clinical training, while not requiring it for training in other professions (business, medicine, law)
* Blustein, Jan. Should Capstone Course Activities Undergo Human Subjects Review? Journal of Policy Analysis and Management, Vol. 23, No. 4, 921-928 (2004)
Erica Foldy, a member of the management faculty at Wagner, co-directs our capstone course. She has prepared this document to introduce students to some of the key ethical issues that they may face in the course of their client-based capstone projects.
An Important Note on the Need for IRB Review Prior to Analysis of Secondary Data
Since secondary data are often used to teach statistical analysis in schools of policy and management, it is helpful that OHRP recently clarified that the analysis of de-identified publicly available data (for example, the kind of public use datafiles that are typically provided by ICPSR) is not subject to IRB review.
* Research Involving Coded Private Information or Biological Specimens (August 2004)
If your IRB is unaware of this relatively recent development, you may wish to bring it to their attention.