1. Subject Injury at OHSU Darlene Kitterman, Director, Investigator Support, OCTRI Kathryn Schuff, MD, MCR, Chair, OHSU IRB Melanie Hawkins, RN, Director, Clinical Research Billing Compliance

2. OHSU Subject Injury Definition Adverse reactions: – Arising directly from or contributed to by the research – That are not due to the subject’s primary disease – That would not have been expected from the standard treatment using currently approved therapies for the subject’s condition

3. OHSU Subject Injury Policy Industry sponsors must pay any costs resulting from injuries incurred by study subjects – The sponsor is benefitting from the study and the subjects should not be harmed financially for participating in the study – The sponsor must pay for the entire injury, not just if insurance doesn’t cover Covered services still involves co-pays/deductibles and affects subject insurance maximums Billing issues with submitting injuries to insurers – Exceptions: Marketed drugs/devices for their approved purposes Category B devices OHSU personnel caused the injury (then OHSU pays for the injury) Investigator initiated studies: – Coverage of injury by OHSU dependent upon various factors, including the Oregon Tort Claims Act – Federal grants do not cover subject injuries

4. Subject Injury Consent Form Language Need to specify what injuries the subject is not responsible for (drug, drug and procedures, just procedures, etc.) The entire injury needs to be paid for (no billing to insurance first) Do not discuss who will pay for what injuries in what circumstances (OHSU for certain circumstances and sponsor in others) Cannot predicate payment for injury upon following instructions (exculpatory) Template language required – For study interventions that are not required to cover injury, know what the sponsor will cover so that the consent matches the contract – Be clear with sponsors that the template language is required

5. Subject Injury Issues in Contracts Consent issues: – No billing injuries to insurance – Failure to follow instructions Injuries at other facilities: Can’t limit reimbursement for injuries only to injuries treated by OHSU Reimbursement rates: Sometimes identified in the contract, OHSU bills the sponsor for injuries treated at OHSU at the DHHS negotiated rate Attribution: The sponsor cannot be the entity to make the determination of whether an adverse event is an injury (conflict of interest) Timelines for reporting sometimes included in contracts and begin upon OHSU becoming aware of the injury

6. Identifying A Subject Injury When the study team is notified of adverse experiences, they need to be evaluated to determine if they are considered injuries The principal investigator is responsible for making the determination of whether an injury has occurred

7. Reporting a Subject Injury Industry sponsored – Sponsor Contact the sponsor immediately upon the PI determining an injury has occurred May not have all the information but tell the sponsor an injury is suspected and complete information will be provided as it is available Document that notification in writing (email or note to file) – CRBO: Contact immediately to assist with directing charges appropriately and collecting cost information for the sponsor – CTO-Contracting: Contact if the sponsor refuses to pay for the injury (will involve Legal as appropriate) Investigator initiated: Contact Risk Management

8. Subject Injury Reimbursement Processes Charges for the injury are directed to the study account If the subject’s insurance has been billed to their insurance, the charges will be reversed and directed to the study account. If charges were incurred at another healthcare facility, CRBO will assist with directing those charges to the study Once available, the study team provides itemized bill for the injury to the sponsor for payment The study team should report to CRBO if any issues arise with obtaining reimbursement

9. MMSEA Issues Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) Added mandatory reporting requirements to sponsors when they pay for the injury of a medicare beneficiary CRBO informs the sponsor if a subject who has been compensated for an injury is a medicare beneficiary and provides the information needed by the sponsor for reporting Sponsor inquiries related to MMSEA: – Do not release lists of the SSNs of all subjects on the study to the sponsor – Refer the sponsor to CRBO