1. OVPR Services and Responsibilities
  2. Research Integrity & Compliance
  3. Human Subjects Research
  4. Compliance Monitoring
  • uconn
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Compliance Monitoring

*New* PI Self-Assessment

The Education & Outreach unit is introducing a new PI Self-Assessment process this fall, as a voluntary component of the post-approval monitoring program. The new PI Self-Assessment serves as an alternative approach for certain studies, offering a more flexible and educational approach to research oversight. This option will be available for studies that are classified as minimal risk by the IRB, excluding studies subject to FDA regulations. Completing a self-assessment removes you from the routine monitoring process for minimal risk research for a period of 2 years.

 

If your study is selected for a self-assessment, you will receive a PI Self-Assessment Form and Record Review Form from the Education & Outreach (E&O) team. If you agree to participate, complete and return the form within 30 days of notification. After submission, the E&O team may follow up with questions, request a brief meeting for clarification, or review applicable documents. As a final step, an audit summary report will be sent to you for your records.

 

Studies not eligible for this process will continue to receive traditional routine post-approval monitoring.

Human Research Protection Compliance Monitoring Program

Human subjects research at UConn and UConn Health is monitored by the HRP Education & Outreach program. The goal of the monitoring program is to assess compliance of human subjects research with federal, state, local law, and UConn policies, identifying areas for improvement, and providing recommendations and support based on best practices, current policies and the principles set forth in the Belmont Report.

Studies may be randomly selected for a compliance review or chosen for other reasons as described in the applicable policies and procedures. Categories of compliance reviews include routine, self-assessment, informed consent, for-cause, IRB-directed, and investigator-initiated. All active studies are subject to such reviews, including exempt research or studies where a reliance agreement is in place with another institution.

A detailed report summarizing the review findings, required actions, and recommendations will be sent to the researcher. Additionally, findings from the review may be shared with individuals responsible for research oversight to reinforce compliance with policies and regulatory requirements. Findings from these reviews help inform and shape future educational offerings. More information about the monitoring program can be found in our policies and standard operating procedures.

Related Policies & Procedures: