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CRA IRB / Human Subjects Study Set

Terms in this set (49)

New Exempt Categories
The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The new Common Rule broadens the types of research that may be determined to be exempt from IRB review. For example, starting January 19, benign behavioral interventions conducted with adults may be determined to be exempt. Researchers must submit to the IRB program for a determination that activities are exempt from IRB review. Another example: the collection of identifiable, sensitive information from adults may also be exempt; however, this new category requires a limited IRB review to determine that appropriate privacy and confidentiality protections are in place.

Continuing Review Changes
Some minimal risk studies will no longer be required to renew their IRB approval on an annual basis (continuing review). Investigators conducting eligible studies will be informed of post-approval requirements at the time of initial approval.

Consent Form Changes
Consent forms will need to include a brief summary that explains the research to potential participants in an easy-to-understand and clear manner. It is now mandated that consent forms be concise while also giving the full context of a study, including its risks and benefits, so potential participants have all the information they need to make an informed decision. Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens.

In addition, there is a new requirement that cooperative research studies involving more than one institution to use a single IRB for review. The implementation date for this requirement is January 19, 2020.