Research Approval Committee Process

About the RAC

The UHS Research Approval Committee (RAC) is an organizational committee comprised of leaders within or affiliated with the UHS GME programs. The primary purpose of the RAC is to ensure that research conducted by GME faculty, fellows and residents upholds the standards of the UHS organization and GME programs, and is consistent with regulatory, risk, compliance, and procedural requirements. Members of the RAC include:

  • Administrative Director – GME (Committee Chair)

  • VP - Insurance

  • CMO/VP – Quality Management / CMO – Acute Care Division

  • Associate General Counsel

  • Product Director – Behavioral Health

  • Director – Compliance

  • Chief Academic Officer - Acute Care Division

Getting Your Project Approved

  • RAC approval is required for all projects that require IRB review. This may include clinical research projects, process improvement projects, quality improvement projects, or other scholarly work.

    If you are unsure if your project requires IRB review, refer to the “Is My Project Human Subjects Research?” job aid or complete the Request for Determination form and submit to WesternU IRB. *Note – QI or scholarly projects may be human subjects research and therefore may require IRB review.

  • The application and review process varies according to the approval category given to your project by the IRB:

    • If your project is IRB exempt OR IRB expedited complete the Expedited/Exempt Research Approval Form (eRAF).

    • If your project is IRB full review OR is a clinical trial, complete the Standard Research Approval Form (sRAF).

  • Complete appropriate RAF based on Step 2 and submit the form, along with other required documents (specified in RAF) to Barbara Wanciak (barbara.wanciak@uhsinc.com). Be sure to cc the SoCal MEC Director of Research (Susan Ropacki) and PI for the project.

    • sRAFs will be reviewed by the RAC at a convened meeting (meet twice per month).

    • eRAFs will be distributed to RAC members with request for approval by email.

    • RAC decisions will be communicated to PI, Sub/Co-I, and Director of Research via email from Barbara Wanciak.

Download Research Approval Form