Protocol Review and Education Program

The Protocol Review and Education Program (PREP) provides principal investigators with education and quality improvement after Institutional Review Board (IRB) approval of their research protocols.  Members are appointed by the Chancellor. The PREP program is endorsed by the Vice Chancellor for the Division of Research and Economic Development (DORED), who serves as the Institutional Official (IO) for human subjects research.

Goals

  • Assessing investigator management of human subjects research
  • Assessing investigator needs in complying with human subjects research regulations
  • Providing the IRB with information to support education and quality improvement

Methods

PREP accomplishes it goals by:

  • Ensuring an organized plan for reviewing protocols and IRB files
  • Providing feedback for investigators through education
  • Providing quality improvement information to the IRB through aggregated data
  • Identifying and reporting issues of non-compliance without making punitive decisions

Process

Selection of protocols for review

A percentage of IRB-approved protocols in active research projects will be randomly selected for
not-for-cause review each year.

Communication with principal investigators

Principal investigators will receive an initial notice via email. The notice will explain the PREP program and the selection of their protocol for review. It also will include instructions for preparing for an initial interview.

Review of results

When the initial review is complete, the PI will be provided with a report and given an opportunity to respond, as necessary, in writing. A final meeting will be held with the PI, and a final report will be prepared and sent to the institutional official, Director of the Office of Research Compliance and Ethics, and the PI.

Time frame

The PREP committee will strive to complete protocol reviews and produce final reports within six weeks.

Final report

Protocol review findings and observations will be reported to the Vice Chancellor of DORED and the IRB through the Compliance Office.

  • Findings not reportable to the Office of Human Research Protections (OHRP) will be reported in aggregated form, revealing no identifying information about the PIs or protocols.
  • Findings reportable to OHRP will include identifying information about the PI and protocol. In such cases, the IRB and the vice chancellor of DORED will determine how to proceed.

The committee also will issue quarterly reports with recommendations on education and process improvement.

PREP Committee Members

PREP committee members 2016-2017

PREP forms