Implementation of Current Policy:
Policy and Procedures for Research Involving Human Subjects
Muhlenberg College Institutional Review Board
October 2009
Between Fall 2008 and Fall 2009, the faculty members serving on the College’s Institutional Review Board (IRB) undertook a review of IRB policy and procedures. This involved examining the most recent version (2005) of the federal Health and Human Services Policy for the Protection of Human Research Subjects (CFR 45 Part 46, also known as the Common Rule), conducting a study of practices at benchmark liberal arts institutions, and updating our policy, which dates back to 1994. In accordance with federal guidelines, the Muhlenberg College IRB was also registered with the Office of Human Research Protections (OHRP). The College was also granted Federalwide Assurance (FWA), which states that whenever human subjects research that is supported by any federal department or agency that has adopted the Common Rule is conducted under the auspices of Muhlenberg College, the College will follow ethical guidelines and procedures outlined by the Common Rule and the Terms of the Federalwide Assurance.
In addition to considering federal guidelines, the committee thought deliberately about the role of the IRB at Muhlenberg, an environment in which faculty, staff, and students conduct human subjects research in a variety of disciplines. The committee recognized this liberal arts context as well as the fundamental principles of academic freedom in recommending changes to IRB policy and procedures. The proposed policy:
- - clarifies and streamlines the proposal submission and review processes. This is accomplished in part by providing new submission forms as well as questions to aid researchers in determining whether their work qualifies for expedited review or requires full review, or whether they may apply for an exemption (the limited review category has been dropped in accordance with federal guidelines). The policy articulates an educational role for IRB, encouraging researchers, including students, to consult with the IRB Chair or appropriate Departmental Coordinator prior to proposal submission.
- - considers the context of an undergraduate liberal arts institution in recognizing students as researchers and therefore strives to promote their agency and bring them more fully into the research process.
- - continues to empower Departmental Coordinators in the review process, as many ethical reviews may be appropriately carried out by a discipline-specific reviewer. Federal guidelines can be met by Departmental Coordinators and the IRB working together to ensure that there is consistency in the federally required processes of review and record keeping.
- - carefully considers IRB membership and training. The student member will be selected through an application process requiring faculty recommendation, in consultation with the Student Body President. All new IRB members and Coordinators will be required to complete standard training and all reviewers will be encouraged to engage in further training as appropriate.
Committee members for 2008-2009 academic year included: Hark (Biology), Sinno (Psychology), and Taub-Pervizpour (Media and Communication); Fall 2009 included: Shive (Education), Sinno (Psychology), and Taub-Pervizpour (Media and Communication).
