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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”
Meeting the Challenge of Change

Insurance and Indemnity

for Clinical Research
 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!!!!!!!
 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!

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Meeting the Challenge of Change

Dealing with the

Practical Issues
 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

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 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
 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.

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