IRB Audit Procedures

In an effort to fulfill its mandate of protecting human subjects, the Mount Carmel IRB will perform both routine and for-cause audits. The Human Subject Protection Research Study Coordinator, on behalf of the IRB, will randomly choose protocols of a certain category on which to perform a routine audit. A for-cause audit will be performed if a concern has been brought to the attention of the IRB. The audit will be performed within a timely fashion following the receipt of the concern.

Once it has been decided that an audit will be performed, the Investigator will be notified in writing. If this is a routine audit, the Investigator will be given a two-week notice. If this is a for-cause audit, no pre-notification is required, although an attempt will be made to give the Investigator some prior notice, when there is no cause for doing otherwise.

Four Audited Categories

1. Regulatory and protocol compliance
   • 1572 (PI's contract with federal government)
   • Protocol (amendments)
   • Informed consent
   • Other IRB forms
   • Communication (IRB, sponsor, etc.)
   • Other (training, etc.)
2. Subject (may be all subjects or a representative sample)
   • Consent
   • Eligibility
   • Adverse events/complications
   • Other
3. Adverse events or complications
   • Recorded vs. reported
   • SAEs
   • Other
4. Data management
   • Source documents
   • Case report forms

Following completion of the on-site audit, a summary will be compiled by the Research Study Coordinator and reviewed by the IRB. The Investigator will be sent a letter from the IRB indicating the findings, along with an outline of any remedies required and a date by which such remedies must be completed.

If after reviewing the audit findings, the IRB feels that the research is not being conducted in accordance with the IRB's requirements, or according to good clinical practice standards, the IRB has the authority to suspend or terminate approval of the research. Any suspension or termination of approval will include a statement of the reasons for the IRB's action and will be reported promptly to the investigator (in writing). The suspension or termination will also be reported to the institutional officials, the sponsor and the Food and Drug Administration (FDA). The report to the FDA is required if:

• The protocol is suspended for more than 30 days
• The protocol is terminated
• The investigator is given remedies to be fulfilled in order to lift the suspension and these remedies are not accomplished by the deadline indicated by the IRB

Note: The sponsor, upon receipt of the IRB's notice of suspension, may also impose additional sanctions upon the investigator. These sanctions must be reported to the IRB by the investigator when they are received and when the sanctions have been lifted.

Research Audit/Self-Assessment

The Research Audit/Self-Assessment was designed as an educational tool to:

1. Help the researcher assess and/or audit his/her research for compliance
2. Assist the Human Subject Protection Office in assessing the educational needs of researchers and/or the research staff.

Click here for the Research Audit/Self-Assessment form. Take your time and answer each question. Once you have completed the form, return it to the Human Subject Protection Office. The staff will review your audit, and, if necessary, contact you to assist you in bringing your research study into compliance.