Academic research involving human subjects — from a straightforward interview to advanced biomedical testing — raises a host of difficult technical and ethical questions. To ensure that students and researchers on Brown's campus work effectively and conscientiously, and to comply with federal law, Brown requires that all individuals seeking to conduct research involving human subjects operate with the approval and oversight of the Institutional Review Board.
The Herald reported last Wednesday that the IRB has begun implementing reforms recommended in a report issued last spring by a Research Advisory Board subcommittee. These reforms are primarily intended to improve the IRB's Web site, and to clarify and streamline the IRB approval process for undergraduates.
The IRB approval process involves significant paperwork, as well as a four to six hour online course complete with quizzes on which the researcher must score at least 80 percent. For undergraduates trying to complete a thesis in a single year, the IRB approval process is lengthy and the paperwork is burdensome. If the student's project hinges on information obtained from human subjects, any long delay could seriously hamper his or her ability to complete the thesis. Since about 20 to 30 undergraduates usually seek IRB approval each year, we appreciate recent efforts to make the IRB more friendly to undergraduates.
One of the central questions the subcommittee faced was whether undergraduate theses count as "research" as defined by federal law. If undergraduate theses do meet this definition, then the researcher is legally required to go through the IRB process. Otherwise, the University might consider creating an alternate approval process tailored to undergraduates that focuses less on compliance with statutory requirements and more on training students to work with human subjects.
The subcommittee suggested that in the future, the University may want to transition to a system where all undergraduate projects are considered through a separate, undergraduate-specific review process. We believe this is an important long-term reform. A main barrier to this reform, however, is the ambiguity surrounding the federal definition of "research" as it applies to undergraduate work. Therefore, we call on the Office of the Vice President for Research to seek clarification from the Department of Health and Human Services. This could best be accomplished through collaboration with similar offices at peer institutions. The University should work with other schools to design a set of principles for undergraduate research involving human subjects and then approach HHS as a group.
Under the current research protocol, a student's faculty adviser, in conjunction with the Research Protections Office, determines whether or not the specific project falls under the federal definition of research. This, however, creates inconsistent standards across departments, and leaves some undergraduates unprepared for research on human subjects. As such, we also support the subcommittee's recommendation to immediately create some formal avenue by which even those student researchers deemed exempt from IRB review receive appropriate training and education.
We also call on departments to provide undergraduates with the guidance they need to navigate the IRB process. The subcommittee's report noted that familiarity with the IRB process is present in some, but not all, departments. In particular, departments must offer all potential thesis-writers early warning about the IRB approval process, so that the requirements do not sneak up on students in their senior year.
Given Brown's growing reputation as a research university, and a culture that tries to ease administrative burdens on students, we are hopeful that the University will continue to reform the IRB review process. The overarching goal should be to better balance the need for training and oversight with the time constraints student researchers face.
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