1. ICRIN, 23 rd April 2009 Indemnity and Insurance Cover for Clinical Research and CRFs Kieran Ryan, Surgical R&D Manager “ Building on our heritage in surgery, we will enhance human health through endeavour, innovation and collaboration in education, research and service”.

2. Insurance and Indemnity for Clinical Research Meeting the Challenge of Change

3. Definition SI 190 of 2004  “insurance or indemnity” includes a contract of insurance, a contract of indemnity, a guarantee, a surety, a warrant and a bond and which in any case shall be available to cover the liability of the sponsor and the investigator to provide for compensation in the event of any injury, loss or damage to, or the death, of any subject arising out of the arrangement for, or conduct of, the clinical trial and which the sponsor, or investigator, shall become liable to pay to such subject, or in respect of such subject, by way of damages or costs; NOTE : You also need to be insured/indemnified for all other clinical research!!!!!!!

4. 4 Insurance & Indemnity Indemnity is the provision of a written assurance or contract confirming that liabilities will be provided for  Purpose is to ensure that in the event of injury there is a facility that compensation (financial) can be paid to reinstate the claimant to the same financial position that they were in prior to the incident. Insurance is a contract or policy which requires premium to be paid into a fund from which compensation payments can be made in the event of a claim.

5. 5 Indemnity Characteristics Written undertaking  Specifies responsibilities of parties  A Legally binding Contract  Signed by legally appointed officers of the sponsor and investigator site  Must be governed in accordance with Irish Law  Usually in accordance with the ABPI guidelines for compensation in clincial trials

6. 6 Indemnity Characteristics No Fault Compensation / Non-negligent harm  Prove causation without need for admission of legal liability Sponsor Indemnity  Product Liabilities  Protocol Liabilities  Applicable legal and regulatory liabilities Investigator and Trial Site Indemnity  Medical Negligence Liabilities  Mismanagement of the trial Liabilities  Public Liability

7. 7 Insurance Characteristics Transference of financial risk to insurers (Policies)  Public Liability and Clinical Trials Insurance  Professional Liability (negligence / malpractice)  Levels carried by sponsors €5M to €20M (each and every)  Right to Compensation not solely governed by level of insurance policy limits Variables considered  Number of countries and number of patients  Phase of trial and clinical risk issues  National Requirements (no levels defined in Ireland)  Increased claims = increased insurance cost

8. 8 Insurance Options Determine scope of Liability Cover (CIS + PL + EL + ??) OPTIONS  Transfer Liability to “off the shelf” insurance products  Group Purchase Scheme Risk Sharing (Good Risk not subsidising Bad Risk)  Liability can be retained but must be financed!!! Self Insurance Large Retentions / Excesses / Deductibles Layers of Insurance Covers and Re-insurance  Common among large multinational pharma companies. Insurance is an operational matter – best deal lowers costs and pass through to researchers!

9. Dealing with the Practical Issues Meeting the Challenge of Change

10. Perspectives on Clinical Research Insurance As Research Programme Manager? As Member of Ethics Committee? As a Professional Training Body?

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12. 12 Clinical Research – Main Risks Injury (physical and psychological) to participants from poorly designed or executed research Breach of privacy and confidentiality in relation to inappropriate research methodologies and publication practices Breach of rights and dignity of participants in relation to consent Lack of compliance with legislation and regulations Damage to good-name and reputation Inappropriate usage or wastage of resources Financial impropriety and inequity in support and funding Variance in the standards of the conduct of research Breach of indemnity or insurance requirements Absence of a learning and research culture

13. As Research Programmes Manager? What Cover do I need for my research?  Sponsored Clinical Trials ? Sponsor covers it in respect of Product Liability and Protocol Liability  Investigator Led Clinical Trials? CIS covers clinical malpractice (if in public hospitals) Product Liability? Protocol Liability?  Clinical Trials Cover (how much?), (Public Liability, Employers Liability, Directors and Officers Liability) Verification of cover from all engaged  Investigators, Nurses, Data Co-ordinators, Labs, CRCs, Statisticians, (manufacturer) Costs (direct and passed-on)

14. As a REC member? Legally required to check for adequate compensation cover  SI 190 of 2004, Part 3, Section 13(6)(k) “the provision made for indemnity or compensation in the event of injury or death attributable to the clinical trial” How do we do this?  Submission of insurance certs Sponsor Third Parties (CRO, University Staff, non-hospital employees Clinical Research Centre  Historical experience  Approvals from authorised officers of the various parties  Indemnity Forms or Clinical Trial Agreements in place

15. As a Professional Training Body? Research / Scholarship = Professional Development Research Programmes provide opportunities for Trainees Insurance/Indemnity as a Barrier  Research activity to be part of normal clinical practice  No ambiguity of cover  Insurance adding to overhead costs  Insurance and contractual Matters leading to delays

16. 16 Discussion Points Governance Arrangements for CRCs will determine the structure of insurance requirements  Convergence of CIS cover and cover by standard insurance policies (no gaps) Can we ensure that insurance costs are minimised with appropriate levels of cover?  Collaboration on a Group scheme may offer best value Single Indemnity Form within HSE – Great Progress  Can we have standard indemnity forms between Sponsor/Research collaborative and the CRCs? National guidance desirable  Standard wording for CTAs and Contracts  Standard Verification process for RECs  Conducting a risk assessment Allowance in Grants to cover such costs which are essential for the protection of clinical research patients/participants.