What is an expedited review?

What kinds of research are eligible for expedited review?

Are there any restrictions on the use of expedited review at Duke?

How is minimal risk defined?

What are the criteria for approval?

How do I request an expedited review?

How long does it take to get an expedited review?

Q. What is an expedited review?

A. An expedited review is conducted by one of more members of the IRB, often the Chair of the IRB. Expediting reviewers have 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.

Q. What kinds of research are eligible for expedited review?

A. 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.

The categories of activity include many of those used by social and behavioral scientists, including “research on individual or group characteristics employing survey, interview, oral history, focus groups (if not exempt).”

It also includes research in which the primary risk is breach of confidentiality and the risk has been managed so that it is no more than minimal.

A full list of activities is available, but some of them apply only to biomedical research or continuing review.

Q. Are there any restrictions on the use of expedited review at Duke?

A. There are two:

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 must be reviewed by the full IRB.

Q. How is minimal risk defined?

A. 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.”

Potential harms can be physical, psychological, social, or economic.

Risks involved in research participation are situation, culture, and age specific - just to mention a few factors to be considered in the assessment of risk. For example, a survey about sexually transmitted diseased would carry different risks for middle class suburban men, Catholic clergy, gang members (who in one study claimed to have STD’s when they did not).

Q. What are the criteria for approval?

A. The review criteria for expedited review are the same as those for full review:
1. Have the risks to subjects been minimized?
2. Are the risks reasonable in relation to anticipated benefits?
3. Is the selection of subjects equitable?
4. Are adequate procedures in place to ensure privacy and confidentiality?
5. Has informed consent been sought and appropriately documented?
6. Are safeguards in place to protect vulnerable populations?
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. If the research is externally funded, is the protocol consistent with the grant application?

Q. How do I request an expedited review?

A. Submit a Request for Protocol Approval at any time to the IRB staff. You may also send an electronic copy for pre-review.

Q. How long does it take to get an expedited review?

A. 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.