The American Association of University Professors (AAUP) recently released a report titled “Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board”. The AAUP’s report is based on an analysis of responses from various professional societies (including LSA) to a July 2011 document released by the Department of Health and Human Services, the ANPRM (advance notice of proposed rule-making), which set out some proposals for IRB reform and asked for feedback.
Here, I discuss one of the report’s recommendations, which is relevant for linguists, but wasn’t the focus of the LSA’s official response to the ANPRM. I hope this can start a conversation following up on the earlier (August 2011) discussion on this blog.
The AAUP report recommends that all minimal-risk research on autonomous adults be included in the “exempt” category, not just the short list of procedures (such as survey forms, interviews, and observational research) that is currently included. This would include much of what currently qualifies for expedited review. Furthermore, the report proposes that the determination of “exempt” status no longer be subject to IRB review, but rather should be determined by the researchers themselves.
This is similar to one of the proposals in the ANPRM — a new category of “excused” research to replace the “exempt” category. This category would similarly expand the scope of the exempt category, but the researcher would still have to “register” their project with the IRB. The registration forms would then be subject to possible random audit later, but the researcher would be allowed to begin research right away without waiting for approval.
I think that both proposals would enhance academic freedom and relieve administrative burdens from researchers and IRBs. Of particular value for linguists is the expansion of the exempt category to include additional types of minimal-risk research. For example, my own experimental protocols, which consist in adult participants speaking sentences and/or pressing buttons in response to linguistic stimuli, are non-exempt under the current guidelines. Under either set of revised guidelines, most types of psycholinguistic experiments and other low-risk methods would become exempt. This would be a welcome change for me, since I would no longer have to wait for approval (which sometimes takes several weeks) every time I need to make a minor change in the protocol.
Would this revised system for exempt research provide adequate protection for participants?
In a recent email to the Ethics Committee, James Crippen brought up two potential problems regarding the proposed expansion of the exempt category: (1) how to define low-risk methods for each discipline; and (2) how to take into account subject matter in addition to the actual methods.
The AAUP solution to both problems is to allow researchers themselves to make those determinations, with the help of a standardized list of exempt methods and the advice of the IRB or a departmental representative as to how discipline-specific methods should fit into the standardized categories. But does this give too much discretion to researchers?
I think the idea of having researchers on exempt projects register their projects with the IRB is a good idea, and helps ensure appropriate protection of participants in minimal-risk studies. Registration of the project forces researchers to explain their procedures and how the rights of participants will be protected (just as in the current system). This would encourage researchers to make a careful, reasoned decision about whether a particular project qualifies as exempt and to seek advice from the IRB or other experts when needed. I believe that the threat of a random audit would discourage people from inappropriately stretching the definition of exempt status.
What do you all think? Do you agree with the proposal to expand the list of exempt categories of research to a larger number of minimal-risk procedures? Would simple registration of exempt projects be enough to ensure appropriate protection of participants? If the proposed changes go through, should the LSA provide their own guidelines for how to interpret the new exempt categories with respect to common research protocols in linguistics?
Please post your comments here!
Junior Co-Chair, LSA Ethics Committee