1. Liability in Clinical Research Clinical Effectiveness Unit Division, PS & MD 2005 Liability in Clinical Research Clinical Effectiveness Unit Division, PS & MD 2005

2. Clinical research is a high-risk activity Liability cannot be waived

3. Control Risk & Liability Liability can not be waived but risk can be controlled. This ethical responsibility should be shared by – Investigators (& HC profession) – Sponsors (& Industry) – Study sites administration – RECs Basic considerations – What is the risk? – Is it fair to expose human subjects to such risk? – Is it worthy to take the risk? – Can myself, the organization bear the risk? Liability can not be waived but risk can be controlled. This ethical responsibility should be shared by – Investigators (& HC profession) – Sponsors (& Industry) – Study sites administration – RECs Basic considerations – What is the risk? – Is it fair to expose human subjects to such risk? – Is it worthy to take the risk? – Can myself, the organization bear the risk? Indemnity & insurance are last resorts for transferring / financing risk, one must aim at prevention

4. Research-related Liability Involves Malpractice No Malpractice Sponsor usu. not liable (indemnity is often conditional) Compensation according to indemnity agreement Research organization (RO) Vicarious liability (  direct liability if allowed unqualified persons to conduct research) Damage to credibility Regulatory enforcement Should be covered by malpractice insurance When there is no external sponsor, the RO is deem to be the sponsor If the financial risk is not transferred to a third-party through an indemnity or insurance arrangement (may not be covered by malpractice insurance), the research institute Investigator Disciplinary & legal proceedings & investigators are liable to bear the financial consequence & investigators are liable to bear the financial consequence

5. Indemnity by Sponsor usually excludes malpractice, negligence, error, omission, or protocol violation, etc. Insurance company Sponsor Study sites Investigators Indemnifier Indemnitee Indemnifier Indemnitee Research subjects Indemnity & Insurance An insurance backed indemnity is most preferable It is desirable for a research institute to acquire additional insurance for research activities

6. Vicarious Liability An employer is vicariously liable for negligent acts or omissions by her employee in the course of employment. Vicarious liability does not apply if: – employee was not negligent – employee is acting in his/her own right rather than on the employer's business – investigator 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

7. Special Considerations Investigator is not an employee – Vicarious liability does not apply, insurance does not cover – RO may be charged direct liability of granting patient access / research rights to an unsuitable person – RO bears OS&H liability to investigator Study site is not affiliated to RO – REC has no jurisdiction over non-affiliated sites – RO has no control over non-affiliated sites – Investigator has duty of care to research subjects & RO by endorsing the research may be vicariously liable for negligent acts or omissions by her employee Adopt a cautious approach & a more stringent standard in planning, review & study oversight

8. REMINDER 1.Liability should be managed proactively 2.Indemnity & insurance are last resorts for transferring / financing risk