RCAP Reviews

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.

What is the Difference Between RCAP and the IRB?

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.

Types of Review

A directed (for-cause) review:

  • Assesses a research study or investigator at the request of the IRB or institutional official to obtain or verify information to ensure compliance with regulations and institutional requirements
  • Addresses a concern, complaint, or allegation brought to the attention of HRPP staff or the IRB
  • Informs decisions about the conduct of human subjects research and/or human subjects protection

A routine (not-for-cause) review:

  • Assesses or examines a research-related practice or procedure with the possibility or intention of instituting change, if necessary
  • As a service to investigators
  • Provide feedback about study practices

Study Selection Process for Routine Review

Studies are identified for routine review using the list of all active protocols in the IRB database. Studies may be exempt if they:

  • Underwent RCAP review within the same calendar year
  • Are closing within 30 days of the scheduled review
  • Don’t include human research are exempt

Notification of Project Review

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:

  • RCAP Review Summary Information Sheet
  • Essentia Health Policy # EIRH 1001 Principal Investigator - Eligibility, Roles & Responsibilities
  • A request to select a date for the study review initial meeting

Principal Investigator and Research Staff Review Roles

Research staff are expected to:

  • Meet with RCAP staff during the review
  • Be available to answer questions throughout the review

Review Information

The following information will be required for the RCAP review:

IRB documentation

  • Initial reviews
  • Continuing reviews
  • Amendments/changes/updates
  • Event reports
  • Scientific review documentation
  • Related correspondence

General study documentation

  • Protocol – Approved only
  • Consent/assent forms – Approved and expired
  • Subject enrollment and/or screening logs
  • Study tracking logs
  • Recruitment materials
  • Applicable materials – Surveys, questionnaires, case report forms
  • Subject study records – Completed for the requested subjects
  • Consent/assent forms for all subjects
  • Regulatory documentation for drug/device trials (if applicable)
  • Investigator agreements and correspondence with the sponsor (if applicable)

    Review Findings

    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:

    • Ensuring all actions were appropriately taken or considered
    • Completing and signing the PI Response Form
    • Returning the PI Response Form to the RCAP office within the required timeframe

    Contact Us

    To request RCAP information or services, contact research compliance. Call 701-364-7843. Send an email.