The terms "Expedited" and "Minimal Risk Review" refer to a specific type of review in which an HSRB review is required but review by a full committee is not required. An expedited review procedure consists of a review by the HSRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the HSRB. Research eligible for review by "expedited procedures" is generally that in which direct contact with human subjects is minimal or non-existent. Although minimal risk review is conducted by expedited procedures, this does not mean that it takes less time than review by a full committee. Because it is only available to eligible activities, anything submitted for expedited review must be reviewed not only for its adherence to usual ethical and regulatory requirement, but to ensure that it does not exceed the permissible minimal risk categories. Consequently, a minimal risk review may take as long, if not longer, to review than a full review.
To qualify for expedited review, research must be limited to federally approved activities. See Health and Human Services Source: 63 FR 60364-60367, November 9, 1998, for a full listing. The researcher must demonstrate in the application how the proposed project falls into one or more of the categories.
An Expedited Review requires research activities that present no more than minimal risk to human subjects AND involve (as pertinent)
Archival/previously collected data that does not contain identifiers
Survey, interview, focus group, or programmed evaluation methodologies.
The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review expedited or full utilized by the HSRB. The criteria apply to both initial and continuing HSRB review.