The CHRISTUS Health Research Compliance Program is committed to advancing the highest standards of ethics, integrity, and honesty. We comply with all applicable laws, regulations, and policies governing research, privacy, and conflict of interest. The Program strives to promote best practices and ethical behavior and to deter activity contrary to these standards by (a) anticipating risk, and (b) encouraging strong stewardship and management accountability at all levels. Our team collaborates with institutional colleagues responsible for compliance implementation.
Auditing & Monitoring
Routine: Routine audits involves randomly selecting studies from any of our ministries and reviewing them for compliance. This audit is Non-punitive, rather, it creates an interactive forum to help refine our processes.
For Cause: For-cause audits are not a routine compliance review and are usually triggered by the following events:Participant ComplaintWhistleblowerIRB request due to new information that might affect the rights and welfare of research subjects
Directives: This is when the IRB or Institutional Official feels that there is a need to probe further to determine if a particular trend found at a site or with a specific study necessitates an audit.
- Send out the Intent to Audit Letter
- Collect documents from the site
- Conduct Audit
- Review Initial Audit findings with the site (This step is to give sites an opportunity to clarify any issue and ask questions)
- Conduct final audit review with the site
- Send post audit letter to the site
- Follow-up with corrective action, if necessary