Eligibility Criteria

Expedited review is an option when the research activity will expose participants to no more than minimal risk * and when the proposed study falls into a category of activity described in the federal regulations, subject to restrictions adopted by Duke's Academic Council.

Because the risks of participating in the research are no more than minimal, the regulations allow that the study need not be reviewed by the full committee, but rather by the chair of the IRB, an experienced member of the IRB, or a subcommittee of the IRB.

Expedited review may also be used for some requests to renew protocols and for minor amendments to approved protocols.

An expedited review covers the same issues as a full review. Also, the reviewer has the same options as the full IRB to approve, request modifications, or defer a protocol; however, an expediting reviewer may not disapprove a request. If an expediting reviewer believes that a protocol should not be approved, it must be referred to the full IRB for consideration.

When an expedited review procedure is used to approve a protocol, the IRB chair or member(s) conducting the review is required to inform the IRB at a convened meeting. At that time, any member of the IRB may request that the approved protocol be reviewed a second time by the full IRB. In theory, if this were to occur, the investigator would be notified and asked to suspend the study pending full review. In practice, expediting reviewers refer to the full committee if there is any question about the level of risk or the applicability of the activity categories before approving the protocol.

Duke restrictions on the use of use of expedited review:

1. If a researcher wishes to use students in his or her own classes as research subjects, or if a Duke employer wishes to use his or her employees as research subjects, the research must be reviewed by the full IRB.
2. Research involving deception or incomplete disclosure must be reviewed by the full IRB.

1. Under certain conditions, clinical studies of drugs and medical devices.
2. Under certain conditions, the collection of blood samples.
3. Prospective collection of biological specimens for research purposes by non-invasive means, e.g., mouth washing.
4. Under certain conditions, the collection of data through non-invasive procedures routinely employed in clinical practice, e.g., magnetic resonance imaging.
5. Research involving materials collected for non-research purposes.
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics employing survey, interview, oral history, focus groups (if not exempt).
8. Research in which the primary risk is breach of confidentiality and the risk has been managed so that it is no more than minimal.

The remainder of the categories apply to circumstances under which continuing review may be expedited.

Securing an Expedited Review

Investigators who wish to apply for expedited review should complete the Request for Protocol Approval form. On the first page of the request there is a box to check indicating that the investigator believes the study is eligible for expedited review.

Requests for expedited review may be submitted at any time. The text of the application may be submitted via email for pre-review to Holly Williams-Stafford.

Generally, an expedited review will take place within a week, but it is dependent upon the availability of the chair or an experienced IRB member. The length of the review process is also dependent upon the need for changes to the protocol.

When the protocol is approved the investigator(s) will be notified via email. The email will include an attached version of the approval notification in rich text format.

* 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. return