Liability in Clinical Research

Clinical Effectiveness UnitDivision, PS & MD

2005

Liability in Clinical Research

Clinical Effectiveness UnitDivision, PS & MD

2005

Clinical research is a high-risk activity

Liability cannot be waived

Control Risk & LiabilityControl Risk & LiabilityControl Risk & LiabilityControl Risk & LiabilityLiability can not be waived but risk can be controlled.Liability can not be waived but risk can be controlled. This This ethical responsibility should be shared byethical responsibility should be shared by

– Investigators (& HC profession)Investigators (& HC profession)– Sponsors (& Industry)Sponsors (& Industry)– Study sites administrationStudy sites administration– RECsRECs

Basic considerationsBasic considerations– What is the risk?What is the risk?– Is it fair to expose human subjects to such risk?Is it fair to expose human subjects to such risk?– Is it worthy to take the risk?Is it worthy to take the risk?– Can myself, the organization bear the risk?Can myself, the organization bear the risk?

Liability can not be waived but risk can be controlled.Liability can not be waived but risk can be controlled. This This ethical responsibility should be shared byethical responsibility should be shared by

– Investigators (& HC profession)Investigators (& HC profession)– Sponsors (& Industry)Sponsors (& Industry)– Study sites administrationStudy sites administration– RECsRECs

Basic considerationsBasic considerations– What is the risk?What is the risk?– Is it fair to expose human subjects to such risk?Is it fair to expose human subjects to such risk?– Is it worthy to take the risk?Is it worthy to take the risk?– Can myself, the organization bear the risk?Can myself, the organization bear the risk?

Indemnity & insurance are last resorts for transferring / financing risk, one must aim at prevention

Research-related LiabilityResearch-related LiabilityInvolves MalpracticeInvolves Malpractice No MalpracticeNo Malpractice

SponsorSponsor usu. not liable (indemnity usu. not liable (indemnity is often conditional)is often conditional)

Compensation according to Compensation according to indemnity agreementindemnity agreement

Research Research organization organization (RO)(RO)

Vicarious liability (Vicarious liability ( direct liability if allowed direct liability if allowed unqualified persons to unqualified persons to conduct research)conduct research)Damage to credibilityDamage to credibilityRegulatory enforcementRegulatory enforcementShould be covered by Should be covered by malpractice insurancemalpractice insurance

When there is no external When there is no external sponsor, the RO is deem to be sponsor, the RO is deem to be the sponsorthe sponsorIf the financial risk is not If the financial risk is not transferred to a third-party transferred to a third-party through an indemnity or through an indemnity or insurance arrangement (minsurance arrangement (may not ay not be covered by malpractice be covered by malpractice insuranceinsurance), the ), the research instituteresearch institute

InvestigatorInvestigator Disciplinary & legal Disciplinary & legal proceedingsproceedings

& investigators are liable to bear & investigators are liable to bear the financial consequencethe financial consequence

Indemnity by SponsorIndemnity by Sponsor usually excludes usually excludes malpractice, negligence, error, omission, malpractice, negligence, error, omission, or protocol violation, etc.or protocol violation, etc.

Indemnity by SponsorIndemnity by Sponsor usually excludes usually excludes malpractice, negligence, error, omission, malpractice, negligence, error, omission, or protocol violation, etc.or protocol violation, etc.

Insurancecompany Sponsor

Study sitesInvestigators

Indemnifier Indemnitee

IndemnifierIndemnitee

Research subjects

Indemnity & InsuranceIndemnity & Insurance

An insurance backed indemnity is most preferableIt is desirable for a research institute to acquire additional insurance for research activities

Vicarious LiabilityVicarious LiabilityAn employer is vicariously liable for negligent acts or An employer is vicariously liable for negligent acts or omissions by her employee in the course of omissions by her employee in the course of employment. Vicarious liability does not apply if:employment. Vicarious liability does not apply if:– employee was not negligentemployee was not negligent– employee is acting in his/her own right rather than employee is acting in his/her own right rather than

on the employer's businesson the employer's business– investigator is not an employeeinvestigator is not an employee

Is a trial without ethical approval part of the RO’s business?Is research part of the terms of appointment of an honorary staff?Case: a Govt driver used a Govt vehicle for his own purpose & the Court ruled that Govt (employer) was not liable

Special ConsiderationsSpecial ConsiderationsInvestigator is not an employeeInvestigator is not an employee

– Vicarious liability does not apply, insurance does not coverVicarious liability does not apply, insurance does not cover– RO may be charged direct liability of granting patient RO may be charged direct liability of granting patient

access / research rights to an unsuitable personaccess / research rights to an unsuitable person– RO bears OS&H liability to investigatorRO bears OS&H liability to investigator

Study site is not affiliated to ROStudy site is not affiliated to RO– REC has no jurisdiction over non-affiliated sitesREC has no jurisdiction over non-affiliated sites– RO has no control over non-affiliated sitesRO has no control over non-affiliated sites– Investigator has duty of care to research subjects & RO by Investigator has duty of care to research subjects & RO by

endorsing the research may be vicariously liable for endorsing the research may be vicariously liable for negligent acts or omissions by her employeenegligent acts or omissions by her employee

Adopt a cautious approach & a more stringent standard in Adopt a cautious approach & a more stringent standard in planning, review & study oversightplanning, review & study oversight

REMINDERREMINDER

1.1. Liability should be managed proactivelyLiability should be managed proactively

2.2. Indemnity & insurance are last resorts Indemnity & insurance are last resorts for transferring / financing riskfor transferring / financing risk