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The Essentia Health Research Compliance and Assistance Program (RCAP) ensures compliance with the study protocol, regulations and policies, and evaluates study conduct, organization, record keeping, and documentation.
Both RCAP and the Institutional Review Board (IRB) are integral to the Essentia Health Human Research Protection Program (HRPP). RCAP evaluates and enhances human research protection through education, training, and internal review. The IRB ensures that those individuals participating in research are not subject to undue or inappropriate risks, that participation remains a voluntary right, and that the conduct of research is upheld as a privilege.
A directed (for-cause) review:
A routine (not-for-cause) review:
Studies are identified for routine review using the list of all active protocols in the IRB database. Studies may be exempt if they:
The principal investigator (PI), research manager, and study contact receive notification of study review via email. If the review is for-cause (directed), the email notification includes an explanation of the reason for the review and notification of any hold or restrictions placed on the study.
The notification includes the following:
Research staff are expected to:
The following information will be required for the RCAP review:
The PI and study staff will receive the final report and corresponding PI Response Form via email. The PI (or designee) is required to address all required and recommended actions outlined in the PI Response Form. The PI is responsible for:
To request RCAP information or services, contact research compliance. Call 701-364-7843.
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