Purpose
The mission of the HSPP Quality Assurance Program is to support the University’s research enterprise by ensuring the protection of research participants; monitoring compliance with all applicable federal, state, and local laws and regulations; fostering the ethical conduct of human subject’s research; and providing education and guidance to the University’s researchers regarding regulatory requirements. One way in which these goals are met is by conducting ongoing oversight activities of human research activities.
The program aims to ensure research staff have the educational resources and guidance necessary to successfully conduct research; and provide the research community with the study support, tools, and other resources needed to perform compliant research.
Investigator-Initiated Audit
Researchers may request to schedule an audit to ensure compliance with research regulations and local policies. This is helpful in preparation for inspections or monitoring by federal agencies or sponsors, when a study reaches the point when data collection is complete, or just to ensure the project stays on track for large or multi-year studies.
Several tools exist to help researchers prepare for any audit or inspections and to ensure ongoing compliance with regulations and policies.
Routine Audit
Routine audits are compliance reviews of the conduct of IRB approved studies that are meant to be educational to help improve research practices. An HSPP staff member, who is internal to the IRB office, performs the audit. Routine audits typically consist of an in-person review of adherence to the IRB approved protocol, assessment of study records and participant files, and evaluation of other research activities. All active studies are subject to routine audits. Studies may be selected for review based on the following criteria:
- Principal Investigators (PI) with a high volume of studies
- Active studies
- Studies with minimal or no external oversight
- Inclusion of vulnerable populations
- Subject safety or noncompliance issues
- Involvement of investigational drugs or devices
- Collection of sensitive data
- Risk level of studies
- Externally-funded studies, including DoD-funded, and FDA-regulated research
- Studies transferred to a new PI
- PI serves as Sponsor Investigator for Investigational New Drug (IND) or Investigational Device Exemption (IDE) studies
For-Cause Audit
For-cause audits are conducted upon request of the IRB Committee, IRB Chair, HSPP Director, or Institutional Official. For-cause audits may be conducted as a result of reported concerns about the conduct of research activities or subject safety, concerns about the conduct of the study as a result of Reportable New Information (RNIs), at the request of the Institutional Review Board or Institutional Official, or in collaboration with other administrative offices, a partner institution or a reviewing IRB. Notification of a for-cause audit may result in temporary suspension of IRB approval until all concerns are resolved.
How to Prepare for Your Audit
- Allocate enough time to prepare for the audit
- Prepare all study documents for review for the day of the audit
- Ensure all study documents are available and easily accessible on the day of the audit
- Review our Audit Preparation Guidance
- Ask questions!
Audit Process
All audits will follow a standardized process outlined below:
1. Initial Contact – You will be sent an Audit Notification via email. This will serve as formal notification of an audit as well as a request for availability. The notification will list the study selected for review. NOTE: For-cause audits may require an immediate or short turn-around with little notification depending on the level of concern for subject safety.
2. In-Person Audit – During the audit, the reviewer will briefly meet with the PI to discuss the study and the PI will provide the study files for review. The PI or designee who is familiar with the study will be available during the audit in case the reviewer has questions. After the audit, the reviewer will provide recommendations for improvement and educational support to the research team. The following records may be reviewed:
- IRB Correspondence
- Informed Consent Forms
- Data Collection Tools
- Recruitment Materials
- Study Logs and Forms
- Study Staff Qualifications
3. Audit Report and Responses – After the in-person audit, you will be sent a finalized Audit Report. The report will include a summary of the findings. You may be instructed to submit a Reportable New Information (RNI) and/or Corrective Action and Preventative Action (CAPA) plan, if requested.