Report of Findings
A Summary Report will be drafted by the IRB Monitor and sent to the PI for his/her review and responses. The report will provide a detailed summary of the audit identifying areas of improvement and recommendations for improvement. The PI and the IRB Monitor will sign the report. A copy of the signed report will be provided to the Director of Research Compliance, the PI, and the IRB Chair. When indicated, the PI will be invited to respond to each indication of non-compliance listed in the summary with a plan of corrective action for each item. This plan will be submitted to the IRB within 2 weeks of the date of the summary.
- It is anticipated that in most cases serious violations involving risk of injury to participants will have already been reported to the IRB. However, if an audit demonstrates that a serious violation involving risk of injury to participants has not been reported, it will be reported immediately to the IRB Chair, Director of Research Compliance, and to the Vice President of Research (or his/her designee).
Audit of Informed Consent/Assent Process
Investigators can request an overview of the consent process at any time before or during initiation of a study. During an audit of consent, the IRB Monitor will review:
- The timing of recruitment and screening in relation to informed consent.
- The appropriateness of the person obtaining consent.
- The consent process to meet the needs of vulnerable populations.
- Steps to aid participants with barriers to understanding or lack of capacity to consent (language, reading level, etc.)
- Steps to see if the participant understands the research purpose, risks, benefits, voluntary participation, withdrawal, confidentiality, costs/compensation, and contacts for questions or injuries.
If you have questions regarding the auditing process or would like to schedule a time to meet with the Post Approval Monitor for an individual or group education session please contact:
Joan Levine, MPH Post Approval Monitor
University of Connecticut
Research Compliance Services
438 Whitney Road Extension, Unit 1246
Storrs, CT 06269-1246