Expedited Review

Expedited review is an option available to some categories of research.

Definition

The requirements for applying expedited review under Common Rule implementations were later amended by a Federal Register Notice (November 9, 1998, volume 63, pages 60364-60367).

Expedited review is conducted by a subset of the Institutional Review Board.

An expedited review cannot disapprove of a research proposal. If the reviewers believe that a proposal is not approvable, it must be referred to a convened IRB.

Applicability

Human subject research that presents none-to-minimal risk and falls into a covered category may be reviewed by an IRB through expedited review.

If identification of subjects would place them at risk of criminal or civil liability, or at risk of damages, then reasonable and appropriate protections must be implemented to mitigate risks of leaking PII are none-to-minimal.

Classified research is never covered.

Covered Categories

Note that 1 through 7 apply to initial and continuing review.

1. Clinical studies of...
   1. drugs if an investigational new drug application is not required
   2. medical devices if an investigational device exemption application is not required, or the device is cleared/approved for marketing and is used in accordance with the clearance/approval
2. Collection of blood samples from healthy adults, or from adults/children with further restrictions
3. Non-invasive collection of biological specimens
4. Non-invasive data collection, wherein any medical devices used are cleared/approved for marketing
5. Research involving materials that have been collected or will be collected for non-research purposes
6. Collection of data from voice, video, digital, or image recordings
7. Behavioral research and survey research
8. Continuing review of research previously approved if..
   1. enrolment of subject and collection of data has ended except for long-term follow-up
   2. no further enrolment has occured and no additional risks have been identified
   3. all remaining activities are limited to data analysis
9. Continuing review of research not conducted under an investigational new drug application or investigational device exemption and the IRB has determined that there is none-to-minimal risk and no additional risks have been identified

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