Clarity, consent and coverage for
research-related injuries
6th Annual Columbia University IRB Conference
Boston, MA
Patrick Taylor
Children’s Hospital Boston, Harvard Medical School,
Petrie-Flom Center, Harvard Law School
Background – Default rules
• Legal rules and litigation procedures 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: 13 states; Medicaid: 7
– 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 determine 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:
• Participant coverage
promise to pay certain
without suing
damages in the event • Direct commitment to
of a lawsuit, including
provide care, with or
a lawsuit by
without right to bill
participants. Sponsor:
insurer
test articles, protocol
• Administrative
design Institution:
process, no fault,
protocol
capped –funded by
noncompliance,
sponsor, insurer, or
medical negligence
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, analogous 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 patient protection.
Thanks