Directed Reviews (For-Cause Audits)
The Compliance Unit performs various directed review (for-cause audit) activities to ensure the rights and welfare of research participants are protected. The IRB, the Vice President for Research, Institutional Official or designee may direct the Compliance Unit to conduct directed reviews. The Principal Investigator (PI) and their research personnel must fully cooperate with all directed reviews conducted by the IRB and external inspections conducted by regulatory agencies, funding agencies, or study sponsors. In addition, the PI must implement the appropriate corrective and preventative actions to resolve any observations and ensure that their research aligns with applicable federal regulations, state laws, and institutional policies.
Directed reviews are not routine post-approval monitoring. The following may trigger a directed review:
- Reportable new information that might affect the rights and welfare of research participants
- Any review of materials submitted via eIRB+
- An allegation of non-compliance (perceived or confirmed)
- A suspension or termination of IRB approval
- Participant or employee complaint
Preparing For a Directed Review Visit
A senior IRB compliance analyst will ask the PI and their study contact to provide the following information when scheduling the activity:
- PI and study staff availability
- Access to study files and regulatory documentation
- Access to participant records
- Space in which to review study documents
- Time to discuss with the PI or designated study team member
The senior IRB compliance analyst will make every attempt to accommodate study staff schedules. Once scheduled, the compliance analyst will provide the PI and study contact with a link to the assessment checklists to complete the forms and assess their study in advance of the visit, as applicable. On very rare occasions, the compliance analyst may not be able to schedule the visit before arriving on site.
The review activity evaluates areas such as, but not limited to, the following:
- Regulatory and IRB documentation
- Protocol adherence
- Participant recruitment, selection, and payment procedures
- Participant enrollment and corresponding records
- Informed consent procedures
- Participant payment
- Document and data retention and storage practices
- Confidentiality and privacy practices and processes
- Clinical trial requirements
- CAPA plan implementation and adherence
From the time of initial correspondence to the date of the visit, the research team is encouraged to contact the Compliance Unit with any questions or concerns related to the activity.
Closeout and Follow-Up Actions
Upon completing an in-person directed review, the compliance analyst may discuss the observations with the PI and their designee(s) while on-site or schedule a follow-up meeting after the visit. The PI will receive a written report detailing the observations made during the directed review. The report may include recommended or required actions. The compliance analyst will bring to the IRB compliance manager and/or executive director any issues that may pose an immediate threat to research participants or constitute serious non-compliance.
Following a directed review, the compliance analyst will request the PI submit their responses via a Reportable New Information item in eIRB+. The compliance analyst will route the report and responses to the convened IRB for their review and deliberation. The Board will review the observations and the responses, make their determination, and inform the investigator if additional actions are required. An IRB analyst will route additional actions to the research team following the convened review.
Required Corrective Actions vs. Recommended Corrective Actions
The Investigator must promptly address all actions to comply with federal regulations, state laws, and institutional policies and guidelines.
If the required action is not feasible, then the Investigator must provide justification.
Consider all recommended actions as they are strongly encouraged.
Decide the following that is best for you:
Required vs Recommended Corrective Actions
For additional guidance please reference our SOP, available on the SOPs webpage:
- HRP-025 – SOP Directed Review Audits
You may also contact the Northwestern IRB Compliance Unit at firstname.lastname@example.org.