The Quality Assurance (QA) Program was established to promote and maintain ethical research conduct. The primary mission of the QA Program is to evaluate and improve human research protections through education, training, and monitoring. Quality Assurance staff work with investigators, research staff, and the IRB to ensure research is compliant with regulations, guidance, institutional policies, and best practices for human research protections.
The QA Program is responsible for reviewing activities associated with human research protections. These responsibilities include:
- Routine, on-site QA audits.
- Assistance with IRB submissions, reporting, and recordkeeping.
- Random, internal reviews of approved IRB protocols.
- IRB member evaluations.
- Development of QA tools and training.
- Random reviews of IRB Meeting Minutes.
- Overseeing the IRB Liaison Program.
- What types of QA audits could occur?
- How are IRB protocols selected for routine QA audits?
- How are individuals notified when their IRB protocol is selected for a routine QA audit?
- What do the QA audits entail?
- What will be reviewed during the QA audit?
- What will the QA auditors ask during the interview?
- How long do the on-site, QA Audits typically take to complete?
- How are findings communicated upon completion of the QA audit?
- Who will receive the results of the QA audit?
- What can an investigator do to prepare for a QA audit?
- What if problems are identified when preparing for a QA audit?
A routine (not-for-case) QA audit is an assessment or examination of a research-related practice or procedure with the possibility (or intention) of instituting change if necessary. Routine QI reviews of study activities and study documentation are performed on-site as a service to investigators, with feedback provided regarding practices associated with the conduct of the study.
A for-cause (directed) QA audit is an audit of research or investigators that is initiated at the request of the IRB or the Institutional Official to obtain (or verify) information necessary to ensure compliance with regulations and institutional requirements. A for-cause audit is generally based on a concern, complaint, or an allegation that was brought to the attention of the IRB and is used to inform decisions about the conduct of human subjects research and/or human subjects protection.
Studies are randomly identified for routine on-site QA audits from the list of all open protocols in the IRB database. Any study involving human subjects, including those that have received exempt determinations, may be selected for routine QA audit. Exceptions to random selection include studies that have received QA audits or for-cause audits within the same calendar year as well as studies closing prior to scheduled review.
The research team (Principal Investigator, Co-investigators, and/or individuals listed in IRBNet) will receive an email notification from the IRB Office indicating that a particular IRB protocol has been selected for a QA audit. The QA staff will arrange a mutually agreeable appointment for on-site review, typically within 2-4 weeks of notification.
The QA audit will involve an internal records review as well as an on-site visit. The on-site visit will involve two parts: (1) An on-site records review of all protocol documentation and (2) a tour of the research facility and a brief interview with a few members of the research team.
- IRB-approved documents, including initial, continuing, and amendment reviews.
- IRB-related correspondence, including IRB approval letters.
- Informed consent documents.
- Screening/enrollment lists used to identify potential participants.
- Sponsor correspondence.
- Reports of unanticipated problems and adverse events.
- Drug and device accountability records.
The QA staff may ask questions regarding the research team, protocol procedures, recruitment, the consent process, record keeping, adverse events, or other questions specific to the protocol.
The on-site portion of the QA audit should last no more than two hours. If additional time is required, the IRB office will notify the investigators as soon as possible.
QA staff will provide the research team with a written report via email, no later than one week following the audit. The Principal Investigator is expected to review this report and return a signed copy to the IRB Office within 10 business days.
The results of routine QA audits will be shared with all members of the research team. The results may also be reviewed by the IRB Chair and/or the IRB Committee if deemed necessary.
To prepare for a QA audit, ensure that all IRB-related materials are well-organized and readily available for the QA staff. You can use the Audit Checklist for Investigators as a guide. Also, please be sure to check the CITI Human Subject Research records for all team members to ensure that all training records are up-to-date.
If problems are identified, please contact the IRB Office immediately.
Depending on the severity of the issue, a deviation report and/or problem report may be required.