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Expedited Review

Research involving no more than minimal risk and meeting other categories of eligible expedited review may be reviewed by an expedited procedure.  The expedited procedure typically involves review by the IRB Chair and/or other designated member(s) of the IRB.  Expedited proposals should be submitted to irb@richmond.edu .

Action on expedited proposals is usually taken by the IRB Chair.  A proposal cannot be disapproved using the expedited process, but the Chair can return the proposal for more information and make suggestions on steps that might make the proposal eligible for expedited action.  If a proposal cannot be acted on using the expedited process, it will be taken to the full board at its next regularly scheduled convened meeting.

While there are 9 categories of research eligible for expedited review, most of these categories relate to biomedical research.  Generally, research proposals eligible for review using the expedited process at the University of Richmond tend to be minimal risk and fall into one of the forms of research defined by OHRP in "Category 7" of its guidelines on expedited review.

    (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.)

A downloadable Expedited Review Form in the "Expedited Review Form" folder of this website can be used for proposals eligible for expedited review. The expedited form should only be used for simple proposals involving minimal risk to participants.  The use of an expedited application may delay the application process if a regular application is required.

"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." This OHRP definition can be found at 45 CFR 46.102(i).

Proposals involving the use of deception will not be reviewed using the expedited process.

Research deception occurs when research subjects are provided false or misleading information as part of the study design.  Research deception requires waiving some of the elements of informed consent.  Deception is permissable under federal regulations.  However, it is the practice of the University of Richmond IRB that such proposals will only be reviewed by the convened IRB.  A succinct discussion of research deception is provided by the IRB of Oregon State University.

§46.116(d) states the following.

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

• The research involves no more than minimal risk to the subjects;

• The waiver or alteration will not adversely affect the rights and welfare of the subjects;

• The research could not practicably be carried out without the waiver or alteration; and

• Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Non-approval is not disapproval

The expedited review process can be used for any IRB action except for "disapproval."  However, the act of "not approving" a proposal does not constitute "disapproval."  For example, a proposal may be returned for more information, referred to the full board for action, or approved with conditions.  None of these actions is an approval of the proposal, but none of these actions constitutes "disapproval."

Use of expedited review for continuing review purposes

OHRP Guidance provides information on when the expedited review process can be used to renew projects.