The resources below are intended for those who serve in the department reviewer role. Department review is the step in the IRB process that comes after the principal investigator (PI) submits the study, but before the study is routed to the IRB for review.
Click through the accordions below to learn more about department review. The “Resources for Department Reviewers” section contains guides and tools to assist department reviewers in conducting department reviews.
Department review is required for all expedited and full board studies submitted to the IRB. Exempt studies do not require department review, though PIs are instructed to select a department reviewer when submitting an exempt study, in the event that the study is upgraded to expedited for full board review. If that occurs, the study will be routed for department review prior to returning to the IRB.
Department review is the step that comes after the PI submits the study, but before the study is routed to the IRB review.
The purpose of department review is twofold. First, it is for the department reviewer to review aspects of a study that impact participant rights and welfare, but which are outside the scope or expertise of the IRB. For example, reviewing for scientific merit requires someone familiar with the specific discipline, and scientific merit can impact the risk/benefit calculation for a study (i.e., it is not worth exposing participants to risk for a non-meritorious study). Likewise, departmental resources can also impact the potential success of the research, thus impacting the risk/benefit ratio of the research, but the IRB has no way of knowing the details of resources within a given department.
Second, department review provides departments with the opportunity to become aware of and track the research going on in their departments. For example, tracking space and equipment usage, tracking the proportion of student-initiated studies, or tracking sources of funding may be of importance or may be useful to departments.
A department reviewer should be external to the study. By default, the department chair should serve as the department reviewer, but if the department chair is involved in the study, then the next choice for department reviewer should be the applicable dean. Department chairs and deans are allowed to designate another individual as department reviewer, but they should follow these guidelines when selecting a designee:
A department reviewer reviews for:
A common delay in IRB review relates to the designation of the project’s PI, so department reviewers are asked to confirm that a PI is eligible to serve in the role of PI, and has enough training/experience to conduct the research ethically and effectively.
Resource considerations include things like space/equipment, financial resources, and personnel. For example, a study working with Limited English Proficiency individuals might require a translator/interpreter to be on staff.
Reviewing for scientific merit helps assure the IRB that the studies it reviews are designed appropriately, conform to discipline best practices, and have a reasonable chance of answering the research questions or achieving the research aims.
The VCU IRB offers training to those who serve in the department reviewer role. To learn more, contact the education and outreach manager at email@example.com
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