The Essentia Health Research Compliance and
Assistance Program (RCAP) offers a variety of support services and education to
the Essentia Health research community in order to facilitate compliance with
federal regulations, state and local laws, and institutional policies. To request any of the services below, please
contact the RCAP office at RCAP@EssentiaHealth.org.
RCAP offers a variety of easy to use study
management tools to assist research sites in maintaining and organizing
essential study documents. These
templates can be downloaded and tailored to your specific study needs. Check our website regularly for new and
updated tools. See the Tools &
Templates and Manage Your Study sections.
At the request of the Principal Investigator
or a study staff member, RCAP is available to conduct on-site review of study
documentation to ensure regulatory compliance including protocol adherence,
accurate record keeping, and appropriate informed consent process. During the on-site review, RCAP will provide
corrective actions and offer quality improvement recommendations.
To facilitate the IRB review and approval
process, RCAP is available to pre-review IRB submission materials, help
navigate iRIS, and provide guidance for responding to questions posed by the
note: It is not the role of the RCAP office to complete and/or submit IRB
forms, consent, or protocol documents on behalf of the researcher.
At the time of study start-up or throughout
the life of the study, RCAP is available to meet with the research team and
help anticipate and resolve regulatory issues that may hinder the IRB review
and approval process.
RCAP offers educational sessions throughout
the year. Check out Education and Guidance for session topics and
Upon request, RCAP staff is available to
conduct small group or one-on-one training sessions on a variety of topics
relating to conducting research at Essentia Health.