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Auditing human subjects research
The primary goal of an audit is to evaluate a research project to ensure the rights and welfare of human research participants are protected and that the research complies with federal regulations, state laws, and institutional policies. Indiana University maintains a comprehensive internal audit program and also provides support when an external entity conducts an audit of an IU research study.
Learn more about how internal audits of human subjects research are conducted at IU. Quick Guide: Internal audits at Indiana University
Different entities may audit research studies, including external sponsors and federal agencies such as the Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP). If you are notified about an upcoming external inspection, IU policy requires that you notify the Quality Improvement Office by email at firstname.lastname@example.org. Office staff will assist you during the inspection process. Staff will attend the introductory and closeout meetings and review the study team's responses to an external audit prior to submission.
Most audits, regardless of type, generally follow a similar set of steps:
- Site notification: notification that an audit will be conducted, with details of when, where, who, and what.
- Site and auditor preparation: The time between notification and the auditor's visit should be used to prepare by ensuring all records are available and organized for the auditor. The auditor will review available study information (protocol, amendments, etc).
- Site visit: The auditor meets with appropriate research team members for orientation to the records and processes; reviews the specified research records; interviews involved staff; and asks questions. A closeout meeting with appropriate study staff is conducted during which findings are discussed and the research team is encouraged to ask questions.
- Audit report: A report containing any findings is sent later, at which time a response is usually required. As a result of an audit, most studies will have at least a few items requiring some amount of attention. Any issues related to protocol deviations or noncompliance should be handled according to institutional policies and procedures. Quality Improvement Office staff can guide you in reporting these issues if they arise.
The best way to prepare for an audit is to ensure compliance from the beginning of the study and then perform periodic self-audits. Principal investigators must verify that all members of the research team are appropriately educated in research compliance initially and on an ongoing basis (maintaining all training documentation, either general or study specific). All documentation related to the research should be organized and easy to follow. All records relating to a particular research subject must have documentation that allows reconstruction of the course of events relating to creation, modification, and deletion of data.
Upon notification of the audit, as much as possible, ensure the intent and expectations of the audit are known so that preparation can be done accordingly. Make sure to inform all applicable involved parties of the details of the upcoming audit (i.e., research team, IU Human Subjects Office and Quality Improvement Office, investigational pharmacy, laboratory, etc.). If time permits, complete a self-audit of the records to identify any potential issues that can be corrected prior to the audit.
Tools and resources
The FDA provides extensive online reference materials that help you understand what to expect in an FDA inspection, as well as information about their inspections of other investigators and sites:
- FDA Information Sheet Guidance: Inspections of Clinical Investigators
- FDA Bioresearch Monitoring Program (BIMO) Guidance Manual for Clinical Investigator Inspections
- FDA Clinical Investigator Inspection List (CLIIL)
- FDA Inspections, Compliance, Enforcement, and Criminal Investigations: Posted Warning Letters
Here are a few tools to help you prepare for an audit, whether internal or external. Self-audit templates can be modified for use in a particular study. Quality Improvement Office staff can also present educational sessions to large or small groups related to IU audits, FDA audits, or other research compliance topics.
- Informed Consent/Assent/Authorization Internal Audit Template (Accessible 8/11/22)
- Regulatory Binder Self-Audit Template (Accessible 8/11/22)
- Subject Chart Self-Audit Template (Accessible 8/11/22)
- Investigational Product Self-Audit Template (Accessible 8/11/22)
Need to know more?
Contact an IU human subjects research compliance specialist at email@example.com.