900: Post-approval review
The policy describes procedures to assist Office of Research Assurances (ORA) personnel in maintaining and ensuring continuing quality and standards for all IRB procedures.
The quality assurance and improvement program exists to heighten awareness of regulatory requirements and improve the ethical conduct of research in the Institutional Review Board’s approved research. Therefore, the post-approval review program consists of four areas of focus:
- Evaluation of the effectiveness of the human subject research protection program (HRPP).
- Evaluation of how investigators implement protocols as approved by the IRB.
- Identification of issues to be addressed in HRPP education and training.
- Evaluation of the informed consent process to determine if it meets standards or can be improved.
3. Specific policies
3.1 Site visits and third-party verification
The IRB has the authority to observe, or have a third party observe, the informed consent process of research it has approved, and to verify that the study is being conducted as required by the ORA and within the institutional policies and procedures and site-specific procedures, as appropriate. The post-approval reviewer, a representative of the IRB, will conduct site visits, inspect records, observe consents and interview principal investigators and study staff as described in the post-approval review guidance.
The criteria for selecting studies to be audited may include:
- Studies that involve more than minimal risk to subjects.
- Studies that involve vulnerable populations.
- Studies that involve large numbers of subjects.
Sponsors may be asked to submit copies of monitoring reports.
The post-approval reviewer will conduct a minimum of 1 not-for-cause audit per month. For-cause investigations will be conducted by the ORA director, the IRB chair, and the institutional official.
4. Applicable regulations and guidelines
6. Procedures employed to implement this policy & assignment of responsibility
|Post-approval reviewer||Call investigator or contact key site personnel to set up a day and time to conduct a site visit.
Review and bring to site visit complete IRB file.
Confirm that the study is being conducted in compliance with the information provided on these documents by observation if possible.
Complete the site visit report and send to the ORA director and IRB coordinator.
|IRB coordinator||Communicate with the principal investigator to follow up on action items.|
|ORA director||Develop and implement quality improvements as indicated by audits.|