.
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
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SI 190 of 2004
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“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

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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

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Transfer Liability to “off the shelf” insurance products
Group Purchase Scheme

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Risk Sharing (Good Risk not subsidising Bad Risk)
Liability can be retained but must be financed!!!

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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

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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 ?


Investigator Led Clinical Trials?
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Sponsor covers it in respect of Product Liability and Protocol
Liability
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

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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
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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?
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Research / Scholarship = Professional Development
Research Programmes provide opportunities for
Trainees
Insurance/Indemnity as a Barrier
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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
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Governance Arrangements for CRCs will determine the structure
of insurance requirements

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Can we ensure that insurance costs are minimised with
appropriate levels of cover?

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Collaboration on a Group scheme may offer best value
Single Indemnity Form within HSE – Great Progress

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Convergence of CIS cover and cover by standard insurance policies (no gaps)
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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