IRB Interim Audits of Approved Protocols: The policy for audits of ongoing research protocols by the IRB is delineated on the following page:
IRB Research Protocol Audit Procedures
The Institutional Review Board, under the direction of the Chair, shall have the right to conduct audits at research sites, which are conducting protocol(s) approved by the Committee for Human Research Protections of Cone Health. The purpose of conducting these audits is to verify that sites are maintaining records on each study subject and that patient informed consent procedures are being followed.
Identify sites for audit.
- Sites shall be determined by an audit subcommittee.
- Sites conducting multiple protocols would be prioritized.
- No site would be audited more than once a year, unless deficiencies were found at a previous audit.
- The IRB will notify the site at least 2 weeks in advance of the audit visit.
- The IRB auditors should review the following:
- Notification will involve date and time of visit and protocol(s) to be reviewed.
- Log of patients enrolled in the study.
- View original consent form to document signatures of patient, person reviewing the consent form and family member or witness (when applicable).
- Document the recording and reporting of adverse events, especially serious adverse events.
- Telephone patients selected at random from the enrollment log by the IRB auditors to verify that correct procedures were followed during the informed consent process.
- Verify that patients were given complete information and voluntarily signed the consent form.
- Verify that study records are being stored properly to protect privacy and confidentiality of participants in accordance with good standards and HIPAA requirements and guidelines.
- Assess how participants were recruited for the study; i.e., to safeguard against potential discrimination and exploitation.
- At least one member of the IRB subcommittee conducting on-site audits must be a physician, pharmacist or nurse familiar with research procedures and data collection.
- The number of IRB members conducting each on-site audit will be determined by the IRB chairman.
- IRB members conducting site audits will be reimbursed for time and travel expenses.
Results of Findings
- The audit team shall report back the findings of the site audit to the full IRB committee.
- Findings of significant deviation from informed consent procedures, protocol conduct or data collection and reporting may be reported to the appropriate committee or agency.
- Reports may be filed with Moses Cone Health System Risk Management Team, company sponsor and/or the FDA.
- Level of reporting will be at the discretion of the IRB and its Chair.
- For any and all violations in protocol discovered during an audit, or an any other time, the IRB reserves the right to require correction of such violations within a reasonable time period, to the satisfaction of the IRB. Failure to correct violations may result in an order to terminate the research study.