Clarity, consent and coverage for research-related injuries 6 th Annual Columbia University IRB Conference Boston, MA Patrick Taylor Children’s Hospital.
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Presentation on theme: "Clarity, consent and coverage for research-related injuries 6 th Annual Columbia University IRB Conference Boston, MA Patrick Taylor Children’s Hospital."— Presentation transcript:
Clarity, consent and coverage for research-related injuries 6 th Annual Columbia University IRB Conference Boston, MA Patrick Taylor Children’s Hospital Boston, Harvard Medical School, Petrie-Flom Center, Harvard Law School
Background Rules and litigation procedures to allocate joint liability between provider/institution and industry sponsor, subject to contract. Participants: –Health insurers often exclude experimental treatment, and may exclude coverage for treatment of research consequences. –Medicare cancer trial coverage: routine care costs included injuries arising from research –Private payers and Medicaid: states –New federal mandate – delayed effect
Research-related Injuries: Human subject regulations: research consent must inform subjects whether or not care and compensation will be provided in the event of an injury, and additional costs (e.g.,care costs for SAEs) (Common Rule: 45 C.F.R. 46.116; FDA regs: 21 C.F.R. 50.25) Institutional policy and practice, and informed consent promise determines whether care and care costs will in fact be provided, and what for.
Accreditation standards (AAHRPP) Element I.8.A. The Organization has a written agreement with the Sponsor that addresses medical care for research participants with a research-related injury, when appropriate. Other elements I.8.B-D: By agreement, Sponsor must: – promptly report to the Organization findings that could affect the safety of participants or influence the conduct of the study. –Disseminate findings generally –Notify the Organization, after the study has ended, of later findings that could affect participant safety, so Organization may consider whether to inform participants.
Coordination Informed consent should reflect institutional policy decision and provide clarity to subjects about provision of care and coverage of costs. Clinical trial agreement should support institution’s ability to honor commitments made in informed consent and reflect business decisions by institution and company about appropriate allocation of financial risk and responsibility. Operations at institution should support policy decision and allocation structure that have been worked out
Contracts with industry - Distinguish: Indemnification: promise to pay certain damages in the event of a lawsuit, including a lawsuit by participants. Sponsor: test articles, protocol design Institution: protocol noncompliance, medical negligence Participant coverage without suing Direct commitment to provide care, with or without right to bill insurer Administrative process, no fault, capped –funded by sponsor, insurer, or provider
Special cases Department or self-funded studies. Institution chooses to commit for free care for adverse events. Adverse events may require care by departments other than that interested in the research. Need to coordinate fee waivers by doctors in different departments with waiver agreement by hospital, and effective administration of billing – identifying patients and events particular to trial.
Special cases NIH funded international interventional trial. Institution owns unlicensed invention, or company will make test drug available for a novel population or indication but their policy does not include it and the insurer premium is unacceptable and uncertain. Special academic policy, like nalogous to industry policy, providing both for indemnification coverage – and a no-fault direct pay, easy process for patients in up to $10K at no additional premium cost. Premium is lower than industries because insurer credits academic HRPP with better patie43nt pr5otection..
Special cases Department or self-funded studies – care commitment, with professional fee waivers, may require organized cross-practice discussion to coordinate hospital and professional fee waivers. Consent offers free care for research- relqFederally funded studies with an industry partner (incremental coverage). Federally funded studies without an industry policy (institution policy). International trials – regulatory coverage variations and restrictions.