ICRIN, 23rd 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”

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Insurance and Indemnity for Clinical Research

Meeting the Challenge of Change

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!!!!!!!

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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.

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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

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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

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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

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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!

Dealing with the Practical Issues

Meeting the Challenge of Change

Perspectives on Clinical Research Insurance

As Research Programme Manager?

As Member of Ethics Committee?

As a Professional Training Body?

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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

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)

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

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

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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.