DMC Research Compliance Our mission is to assure that all research at the DMC is ethical, safe and compliant with regulatory standards; and to support clinical researchers across the Detroit Medical Center hospitals by providing comprehensive legal, regulatory and billing consultation.

DMC Research Review Process Protocol Submission Review - DMC Clinical Research Office Protocol/Consent/ WSU-IRB PSF/HIPAA/CTA/Budget Billing Coverage Analysis Facility Research Committee (FRC) - DMC Market Level The FRC shall review each proposed study in order to determine whether individual research studies are appropriate for the Tenet Facility. The FRC evaluates each study’s impact on the organization, including staffing, patient safety, supplies and reimbursement. Tenet Policy COMP RCC 4.47 eCATS - Tenet Corporate Compliance/Legal Review Monitoring/Auditing: Research Patient Accounts - DMC Market Level

Concurrent Submission WSU IRB Billing Coverage Analysis, CTA DMC CRO DMC/ FRC Approval Final Approval Pending DMC Approval Final IRB Approval Legal Approval Conduct Research Collaborative Approval Process

Why a WSU IRB Review and a DMC CRO/FRC Review? Tenet Policy: Institutional Review Boards Each Tenet Facility must identify, and engage by written agreement, at least one Institutional Review Board (IRB) to review the clinical research studies to be conducted at the Facility. Tenet Policy COMP RCC 4.47 DMC relies exclusively on the WSU IRB to assure that the ethical standards around human investigation, privacy, and consent are met. DMC CRO/FRC has an entirely different purpose, addressing: » the impact of research on each hospital facility » billing and coding compliance, » use of Tenet-owned patient records or other datasets.

What is the Stark Law in Regards to Research? Non-payment for research services and sponsor overpayments to the investigator for clinical research services constitute a violation. What is Research Billing Fraud and Abuse? Direct or indirect funds passed along to a physician investigator as a result of participating in a study that exceed fair market value; For example: A sponsoring company is knowingly making a payment to the physician in return for prescribing their FDA-approved medication or medical device which may be reimbursed by Medicare or Medicaid (Anti-Kickback Statute) The hospital bills CMS for a clinical research service and the investigator or hospital is being paid for the same service by the sponsor (False Claims Act)

Monica Malian Director DMC Clinical Research Office Orchestra Place Phone: (313) THANK YOU