Research Compliance Services (RCS) is committed to ensuring that all approved research is conducted in accordance with the IRB approved protocol, federal and state regulations, UConn’s institutional policies, and the ethical principles outlined in the Belmont Report. The primary goal of the Monitoring Program is to provide the most current information to investigators and students through education, training, and monitoring. RCS believes that by working together with Principal Investigators and student researchers, we can assist with identifying needed areas of education and minimize risks to human subjects. Additionally, monitoring visits help foster communication between researchers and the IRB and provides targeted education for faculty, staff, and students conducting human subjects research. All studies, including those approved under the Exempt Category are subject to audit.
For-cause audits will be a priority for the Monitoring Program. However, special emphasis is placed on studies that include vulnerable populations or have activities that may place participants at greater risk than what may be anticipated in ordinary circumstances. Monitoring takes place with an emphasis on quality improvement and providing support for researchers.
Categories of Audits
- Routine: The Post Approval Monitor collaborates with the IRB Program Director and IRB Chair to select studies to audit. Selection may include monitoring only certain elements of the research, such as observation of the informed consent process, study procedures, or study records.
- Informed consent: This audit is intended to support researchers in conducting the informed consent process. It may include observation of the consent process and/or a thorough review of the process. Monitoring also includes reviewing the process of how Principal Investigators train study personnel on administering consent to participants.
- For-cause: Under 45 CFR 46.113 requirements, this review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or the IRB Monitor. This includes a review of all or any related study activities.
- Investigator Initiated: A PI may request an on-site review to help keep records and procedures in compliance with federal regulations and institutional policies or to prepare for an external audit by a sponsor or federal agency.
Except in cases where the safety of subjects is a concern, or where the IRB specifically requests an unannounced audit, written notification of an audit will be sent from RCS. Depending on the nature of the research study, an IRB member who has experience in the study topic may also be present at the audit. The Investigator will contact the Post Approval Monitor to arrange a visit within the following estimated timeframes:
- Routine: At least two weeks’ notice in advance of the initial meeting of the audit.
- Informed Consent: At least one week notice in advance of the monitoring.
- For-cause: At least twenty-four (24) hours’ notice by a telephone call and email to the PI from the Institutional Official or his/her designee.
- Investigator Initiated: A time will be arranged by mutual convenience.
Elements of Audit Review
Before Audit: Investigators will receive a letter informing them that their study has been chosen for an audit. The investigator will then contact the Monitor and a time will be scheduled for the audit.
Prior to the audit, the Monitor will review the Study Protocol and all documentation related to the study in the IRB submission including:
- Grant Application, if applicable; the grant application may be compared to the IRB approved protocol.
- The IRB submission. IRB Meeting issues (quorum, diversity, expertise, conflict of interest); adequacy of review.
- IRB submission to determine whether it contains all correspondence/amendments, adverse events, and protocol deviations the investigator submitted.
- Whether annual continuing review was completed.
- Elements of Informed Consent/Assent documents, as well as review of the required elements of informed consent according to the federal regulations and IRB requirements.
- Subsequent publications resulting from IRB approved protocols may also be reviewed.
Investigators can prepare for the audit by reviewing the checklist of questions below. (Please note that not all items on the checklist apply to all research studies)
Preparing for an audit
- Does the researcher have available the most recently approved protocol, consent form, and study documents for review?
- How many participants are currently enrolled? How many have been approved by the IRB?
- Are all key personnel listed on the Appendix A Personnel Form? Are personnel conducting procedures according to their role in the study?
- Have any participants withdrawn/dropped from study? If so, is reason documented?
- Have any adverse events occurred? Were all reported to the IRB?
- Are participants consented with the most recently IRB approved and validated version of the consent form? Have all the consent forms been signed and dated by the participant and the person obtaining consent?
- Have all study measures and procedures been approved by the IRB before implementing?
- Are all advertisements and methods of recruitment IRB approved?
- Are study documents maintained as outlined in the protocol? Are participant ID numbers generated per protocol?
- Have all enrolled participants met eligibility criteria? Is there documentation of eligibility?
- Have there been any protocol deviations? Have they been reported to the IRB?
- Have there been any unanticipated problems with protocol implementation?
- Has participant compensation been documented?
- Have there been any participant complaints?
- Are raw data files organized, complete, and legible?
During the audit, the Monitor will briefly meet with the PI to discuss the study. The PI will provide the Monitor with the study files. The PI must make available the use of a quiet space for the Monitor to review the study files. The PI or designee who is familiar with the study will be available during the audit in case the Monitor has questions. As needed, during the audit, the Monitor will provide recommendations and educational support on record retention and documentation, and other compliance related issues. Documents pertaining to research will be held strictly confidential.
Review of Regulatory Compliance may include review of the following:
- Roles and responsibilities of investigators and key personnel
- Protocol file/regulatory documentation
- IRB Documentation
- Consent/Assent Forms
- Individual participant records to determine if :
- The participants met the inclusion/exclusion criteria for the study
- Study related procedures are performed according to the protocol
- Study related procedures are scheduled and performed per the study time line
- Data are recorded and stored securely as described in the Consent Form
- Adverse events and/or protocol deviations have been reported according to institutional policy
- Payments were made to participants as described in the protocol
- Participant ID numbers are assigned according to the protocol
After the audit is complete, the Monitor will meet with the PI (and/or student investigator) and provide a brief summary of findings.
Report of Findings
A report that includes a detailed summary of the audit findings and recommendations for improvement will be sent to the PI within 10 days after the audit has been completed. 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. Findings of non-compliance will be reported to the IRB at its next fully convened meeting.
- 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 Services, and to the Vice President for 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, CIP
Post Approval Monitor