Research Compliance Program
The CHRISTUS Health Research Compliance Program within the Office of Research Finance & Administration, is dedicated to ensuring the ethical, responsible, and compliant conduct of research across our institution. We are committed to upholding the highest standards of integrity, transparency, and accountability in all research activities.
Our program is designed to support researchers and institutional leadership in navigating the complex regulatory landscape that governs human subjects research, privacy and data protection, conflict of interest, and research integrity. We align our practices with federal and state regulations, institutional policies, and industry best practices to promote a culture of compliance and continuous improvement.
Key Functions of the Program Include:
- Oversight and Monitoring: Proactive identification and mitigation of compliance risks through internal audits, monitoring activities, and collaboration with oversight committees.
- Education and Training: Comprehensive training programs for investigators, research staff, and administrators to ensure awareness of regulatory requirements and ethical standards.
- Policy Development and Implementation: Establishing and maintaining clear, accessible policies that guide research conduct and support institutional goals.
- Collaboration and Integration: Working closely with institutional partners—including the Office of Compliance and Privacy, legal counsel, and research administration—to ensure seamless integration of compliance into the research lifecycle.
- Reporting and Response: Providing confidential mechanisms for reporting concerns and ensuring timely, fair, and thorough investigations of potential noncompliance.
Auditing & Monitoring
- Routine Audits: Routine audits are conducted periodically and involve the random selection of studies across our ministries. These reviews are non-punitive and serve as an opportunity to engage with research teams, identify areas for improvement, and reinforce best practices.
- For-Cause Audits: These audits are initiated in response to specific concerns or events, such as:
- Participant complaints
- Whistleblower reports
- Requests from the Institutional Review Board (IRB) based on new information that may impact participant rights or safety
- Directive Audits: Directive audits are initiated by the IRB, Institutional Official, or the Research Compliance team when patterns or trends suggest the need for a deeper review of a particular study or site.
- Notification: An Intent to Audit letter is sent to the research site outlining the scope and purpose of the audit.
- Document Collection: The site is asked to submit relevant study documentation for preliminary review.
- Audit Execution: The audit is conducted, either remotely or on-site, by the Research Compliance team.
- Preliminary Review Meeting: Initial findings are shared with the site to clarify any issues and provide an opportunity for discussion and feedback.
- Final Review Meeting: A comprehensive review of the audit findings is conducted with the site.
- Post-Audit Letter: A formal summary of the audit findings and any required actions is sent to the site.
- Corrective Action Follow-Up: If necessary, the site is supported in implementing corrective and preventive actions.
