Departmental Review of Research Involving Human Subjects
The department or unit head is responsible for appointing a faculty member or faculty members within the department/unit as Departmental Reviewer(s). The appointment must be confirmed by the IRB, and the Departmental Reviewer must complete the necessary CITI training. (See Certified Departmental Reviewers).
Departments that have a high volume of IRB applications may decide to establish a Departmental Review Committee (DRC) consisting of a number of certified Departmental Reviewers. The DRC in the department establishes its own rules and procedures, within the scope of this IRB policy. The DRC reviews proposals for research (by IRB definition) involving human subjects, and determines the level of review to be conducted for each research project.
Departmental Review Procedures. Departmental Reviewers must thoroughly evaluate each IRB application to provide an initial assessment of risk of harm to the participants as a result of the research. The Departmental Reviewers are responsible for determining the level of review necessary for the application in accordance with 45CFR46, and they will be responsible for the execution of the project. Each department or unit may establish its own procedures for review of research proposals that exceed those outlined in the TTU IRB policies and student classroom activities. The IRB has made available an optional IRB Flow Chart and Determination Form which may be of assistance in the review process. Each department or unit is free to adapt or modify the form in any way it desires. Use of the form is optional.
Conflict of Interest. In its approval processes, the DRC must avoid potential conflict of interest by reusing a DRC member from the decision process regarding any project under his/her own supervision.
Training Requirements. Only Certified Departmental Reviewers can review IRB applications. In addition to being appointed by the department or unit head, a Departmental Reviewer can only become certified through confirmation from the IRB Chairperson and after successful completion of the Departmental Reviewer Training completed through the CITI training modules.
Student Activities with Human Subjects. “Classroom Projects” and “Student Assignments” are “research-like” activities involving human subjects, which do not meet the definition of research according to the OHRP/IRB definition. Such projects include those undertaken by students with faculty oversight and supervision. Responsibility for the ethical conduct of these activities rests with the department head of the sponsoring department or unit. The IRB does not review, monitor, or take responsibility for the conduct of these non-research activities. (See Student Activities Involving Human Subjects.)