UR IRB Process and Required Materials
The University of Richmond IRB reviews research proposals in accordance with federal policies and the UR IRB Policy Guide.
- The IRB's process begins with the receipt of a research protocol or a query delievered via email to irb@richmond.edu. The email should indicate the type of project being submitted: an educational project, a request for exemption from the requirements of 45 CFR 46, or a research protocol. In most cases, a completed protocol and supporting documents (e.g., consent forms, recruitment messages) are required for the review process.
- Upon receipt of a protocol, the IRB Office will determine if the project is reviewable, eligible for limited review, eligible for expedited review, or requires review by the convened board. To qualify for expedited review, a project must pose no more than minimal risk* to subjects and meet one of the nine categories that OHRP has determined can be reviewed using an expedited process. The IRB office will also verify that all personnel in the project have completed required training in the protection of human participants in research.
- If the study qualifies for expedited review, the IRB chair or a member of the IRB will review the study's protocol, consent form, and data management procedures. The Chair or designated review can approve the proposal; require modifications to the study protocol and documents prior to approva;l or return an incomplete or unclear proposal for more information . The expedited process can not be used to disapprove a proposal. The Chair informs the researcher of the determination by email. All expedited actions are reported in writing to the IRB convened board at its next meeting. At that time, the board could intervene to adjust the expedited action.
- If a protocol cannot be reviewed through an expedited process, it is reviewed by the convened board at a regularly scheduled meeting. See Schedules and Deadlines for IRB meetings and deadlines for submission. The board is authorized to take actions including approval, disapproval, requests for changes, approval with conditions, and other actions as specified by OHRP. OHRP specifies criteria for an IRB's approval of research.
- If a protocol has been approved, the research can begin upon receipt of the notice of action sent by the IRB Chair. If modification are required, the researcher must resubmit the proposal, addressing the conditions of approval stipulated in the notice of action. Typically the board will authorize the Chair to take expedited action on revisions. Consequently, the convened board usually does not have to re-review a proposal. That said, it is not uncommon for the convened board to require a full board review of revisions. When the researcher receives a final approval from the IRB Chair, research on the project may begin.
Full Board Review
Reviewable proposals that are not expeditable must be reviewed by the full IRB at a convened meeting. See the IRB schedule for meeting dates. Note that copies of completed proposals must be submitted to the IRB at least one week before the board meets. This requirement ensures that IRB members have adequate time to review submitted proposals. Downloadable instructions in the "Submitting Proposals" section of this website can be used as a guide for preparing a regular proposal for full IRB review.
Expedited Review
Research involving no more than minimal risk and meeting other categories of eligible research may be reviewed by an expedited procedure. The expedited procedure typically involves review by the IRB Chair and/or another designated members of the IRB. To be eligible for an expedited review, a proposal must be of minimal risk and generally fall into one of the forms of research defined by OHRP in "Category 7" of its guidance on expedited review.
The federal definition of "minimal risk" follows. "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." (From paragraph (i) of §46.102 Definitions.)
Language from "Category 7" of OHRP Guidance on expedited review follows.
"(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)"
Not Reviewable Projects
At times, researchers will engage in activities that are determined to be "not reviewable research." Guidance on research that is not reviewable can be found at Section 3.6 of the IRB Policy Guide.
A person conducting a survey or collecting information that they believe is not reviewable research can receive a written determination on the matter from the IRB by submitting in writing summary information on the topic. The person should submit a detailed email to the IRB Chair explaining the project. In some cases, the IRB may ask for the submission of additional information including a completed IRB Review Form. Examples of research that is "not reviewable" may include the following: minimal risk surveys that collect no personally identifiable information (e.g. a food preference survey at the dining hall), research that uses information about people from already published sources, and surveys used by professors for the purpose of teaching survey design and development.
Generally, investigators should not themselves make the determination as to whether or not a project constitutes "not reviewable" human subject research. Such determinations should be made by the University of Richmond IRB.