Indemnify Compensation for damage, loss, or injury suffered. Insure someone against legal responsibility for their actions.

IndemnifyCompensation for damage, loss, or

injury suffered. Insure someone against legal responsibility for their actions.

InsureTo make sure, certain, or secure.

Pay money in order to receive financial compensation if something is lost or damaged or someone is hurt or killed

Indemnity is giving an undertaking that compensation will be paid

whereas

insurance is paying a premium for an insurance policy, so that the insurer will pay compensation in the event of a claim for injury or bodily harm being made.

Liability

Definition:

The state of being legally obliged & responsible to pay money to

another– as insurer.

.

Objectives

Understand the concept of Indemnity & Insurance.

Study the elements of an Indemnity Agreement.

Exception of Indemnity Agreement.Terms of Indemnity Agreement.Elements of Subject Injury Reimbursements

Insurance or indemnity

Vital to communicate topotential researchparticipants during informed consent process

included in the subjectinformation sheet.

See Central Office for Research Ethics Committees COREC website.

Assumption of trial risk is part of the cost of business.

If indemnification is not provided, academic Institution is shouldering the

risk of running Sponsor’s trial”

the Sponsor as the individual or institution that takes overall responsibility for the initiation, management and financing of the study or for the arrangement of these activities.

CRO Involvement

The CRO doesn’t provide indemnification for subject injury, it is provided by the sponsor

- Separate Letter of Indemnification (LOI) signed by Sponsor

- Provisions incorporated in the agreement with CRO

Indemnification-Investigator

Sponsor should indemnify for any

injuries, illness or damages arising from trial activities, basically investigator for the study

Standard Indemnification4 points needed

1. Any Services provided related to the Study

2. Institution’s Participation in the Study

3. Sponsor’s Manufacturing Defect of the Study Drug/Device

4. Negligent use of data

Indemnification: Institution PositionInstitution wants broad indemnification rights:

1. Covering the Institution, its officers, directors, trustees, employees, representatives, research and professional staff and agents

2. Applying - claims, damages, liabilities, costs, losses

and expenses (including attorneys’ fees) - Side effects, injury and illness to a person - negligent use of the data, results or inventions - Product infringement

Indemnification: Industry PositionIndustry wants to limit indemnification:By not offering it

Limiting to Product Liability (defect or malfunction)

Applying injury and not illness or use of the data, results or inventions or product infringement

Limiting coverage to insurance policies

Conditional on notice

Elements of IndemnificationIdentify the proper parties/entities to be

indemnified (e.g. Trustees/ Directors, officers, employees, agents, affiliates, students)

Cover

liability losses - e.g. claims, demands, costs, judgments

potential damages- any injury, death, illness, property damage

all activities that may lead to claim – - administration of study drug or comparator - implantation/use of device and accessories - procedures required by the protocol

Indemnity Elements

Sponsor will indemnify…

Institution and all agents, employees, (etc.) under the supervision of investigator

for any judgment dues/ damages awarded

for any bodily injury

for any injury not related to a claim of indemnitee’s negligence

for any claim-directly caused by administration of the drug/ device

Terms of IndemnificationFollowing receipt of notification of claim

Notify in writing to the other party sponsor/Institution) about any claims.

Sponsor - full control of the claim or proceeding & use legal representation

Sponsor – to inform Institution of the progress of any proceedings.

Both parties to provide help as required for efficient conduct and prompt handling of any claim or proceeding.

Terms of Indemnification …contd.

Sponsor will indemnify…provided that: -Institution strictly follows the Protocol-Study conducted in accordance with the

Protocol (all written instructions delivered by Sponsor, all laws and regulations, accepted standards of medical and clinical practice and GCP Guideline.)

-Sponsor has the right to select defense counsel, (direct the defense, settlement, or other disposition of any Claims, and witnesses for purposes of discovery, pre-trial preparation, and/or trial.)

Exceptions to IndemnificationAny claim demand, cause of action,

expense, loss to the extent caused by Indemnitee’s - negligence - willful malfeasance, or - failure to follow Protocol or written instructions,

unless deviation to protect safety of subject.- any claim, etc. to the extent caused by

Institution’s failure to obtain proper informed consent

Elements of Subject Injury

Covers subjects’ broad potential

- injuries (injury, illness)- expenses (diagnosis, medical care,

hospitalization) -all research components (i.e. administration

of drug or comparator, implantation/devices, procedures)

required by the protocol

Subject Injury

In the event of injury:Institution: Industry pays for diagnosis, injury &

illnesscaused by research.

Industry:Industry reimburses costs of care & treatment

except that not caused by Institution’s negligence,willful malfeasance, failure to follow Protocol and/or covered by subject’s insurance.

http://research.bidmc.harvard.edu

Subject Injury at IssueSponsor will pay - subject for the costs… - Institution for reasonable expenses for

treating subject - unforeseen injuries caused by the Study - emergency treatment to stabilize

subject… - If subject suffers - illness or injury due

to study drug - Illness/ injury - by unanticipated serious problems associated with the Device

InsuranceFor Sponsor initiated studies, request that

sponsor insurance be primary coverage. 

The sponsor is responsible - primary burden of risk,

set by the Risk Management Office REQUIRES RISK ASSESSMENT*

Non-negligent harm insurance

called "no-fault" insurance – it is insuring against something happening that

could not have been foreseen.

Certificates of InsuranceWhy obtain certificate of insurance?

Verify coverage Malpractice policies are not covered Use in case sponsor goes out of business so

you can file claim against insurance carrier

Insurance-SubjectContract where one party will indemnify

another or agree to pay a specified amount upon determinable contingencies

First party - the insurerSecond party – the insuredThe contract – the insurance policyThe consideration – the premiumThe contingency – the hazard or perilThe exclusions – no coverage for specific actions / occurrences

Disagreements Over Indemnity and Subject Injury Language Cause Prolonged Negotiations

Unable to reach resolution - Both industry and academia suffer the consequences of contentious negotiations:

Expenditures of timeExpenditures of resourcesTrial delays, patient recruitment delaysOther sites enroll and recruitment closes

before your site has reached agreement

HREC. FORM OF INDEMNITY FOR CLINICAL TRIALS (AUSTRALIA )STANDARD

Developed by Medicines Australia - used by The Association of the British Pharmaceutical Industry (ABPI), for use in Australia. It is the basis for agreements between pharmaceutical companies sponsoring clinical studies and the institution that hosts the study to be conducted. To: [Name and address of the legal entity (hospital, institution or authority) in which the Study is to be conducted ("the demnified Party") Only a single legal entity should be named. Where more than one legal entity is to be indemnified, separate Forms of Indemnity should be used for each legal entity to be indemnified. From: [Name, registered address and Australian Business Number of sponsoring company] ("the Sponsor")Re: Clinical Study No. [ ], [protocol title including name of product]The Indemnified Party agrees to participate in the above sponsored study ("the Study") involving [{patients of the Indemnified Party} {non-patient volunteers}] ("the Subjects") to be conducted by [name of investigator's)] ("the Investigator") in accordance with the protocol annexed, as amended in writing from time to time with the agreement of the Sponsor and the Indemnified Party ("the Protocol"). The Sponsor confirms that it is a term of its agreement with the Investigator that the Investigator shall obtain all necessary approvals from the applicable Human Research Ethics Committee (“HREC”) and the Indemnified Party, where appropriate. The Indemnified Party agrees to participate by allowing the Study to be undertaken on its premises or as otherwise agreed, utilizing such facilities, personnel and equipment as may reasonably be required for the Study.

In consideration of such participation by the Indemnified Party, subject to paragraph 4 below, the Sponsor indemnifies and holds harmless the Indemnified Party and its employees, agents, and members of and advisors to its HREC in respect of and against all claims and proceedings (including any settlements or ex gratia payments made with the consent of the parties hereto and reasonable legal and expert costs and expenses) made or brought (whether successfully or otherwise) by or on behalf of Subjects (including their dependants and children injured in utero through the participation of the child’s mother in the Study) against the Indemnified Party or any of its employees, agents or members of and advisors to its HREC for personal injury (including death) to Subjects (and children injured in utero through the participation of the child's mother in the Study) arising out of or relating to the administration and/or use of the product's) under investigation or any clinical intervention or procedure provided for or required by the Protocol to which the Subjects would not have been exposed but for the participation of the Subjects in the Study.

The above indemnity by the Sponsor will not apply to any such claim or proceeding referred to in paragraph 3 above:(1) to the extent that such personal injury (including death) is caused by the negligent or wrongful acts or omissions or breach of statutory duty of the Indemnified Party or any of its employees, agents or members of and advisors to its 2) to the extent that such personal injury (including death) is caused by the failure of the Indemnified Party, its employees, or agents to conduct the Study strictly in accordance with the Protocol. (3) unless as soon as reasonably practicable following receipt of notice of such claim or proceeding, the Indemnified Party notifies it to the Sponsor in writing and at the Sponsor's request, and cost, has permitted the Sponsor to have full care and control of the claim or proceeding using legal representation of its own choosing.(4) if the Indemnified Party, its employees, agents, or members of and advisors to its HREC have made any admission in respect of any such claim or proceeding or taken any action relating to any such claim or proceeding prejudicial to the defence of any such claim or proceeding without the written consent of the Sponsor. Such consent will not be unreasonably withheld. This condition will not be treated as breached by any statement properly made by the Indemnified Party, its employees, agents, or members of and advisors to the HREC in connection with the operation of the Indemnified Party's internal complaint procedures, accident reporting and quality assurance procedures or disciplinary procedures or where such statement is required by law.The Sponsor will keep the Indemnified Party and its legal advisers fully informed of the progress of any such claim or proceeding, consult fully with the Indemnified Party on the nature of any defence to be advanced and not settle any such claim or proceeding without the written approval of the Indemnified Party which approval is not to be unreasonably withheld.Without prejudice to the provisions of paragraph 4(3) and 4(4) above, the Indemnified Party will use reasonable endeavors to inform the Sponsor promptly of any circumstances of which it has knowledge

and which may reasonably be thought likely to give rise to any such claim or proceeding and will keep the Sponsor informed of developments in relation to any such circumstances even where the Indemnified Party decides not to claim indemnity from the Sponsor. Likewise, the Sponsor will use reasonable endeavors to inform the Indemnified Party of any such circumstances and will keep the Indemnified Party informed of developments in relation to any such claim or proceeding made or brought against the Sponsor alone.The Sponsor and the Indemnified Party will each give to the other such help as may reasonably be required for the efficient conduct and prompt handling of any claim or proceeding by or on behalf of Subjects (including their dependants and children injured in utero through the participation of the child’s mother in the Study).Without prejudice to the foregoing, if injury is suffered by a Subject while participating in the Study, the Sponsor agrees to adhere to the “Guidelines for Compensation for Injury Resulting From Participation in a

the Sponsor agrees to adhere to the “Guidelines for Compensation for Injury Resulting From Participation in a Company-sponsored Clinical Trial” published by Medicines Australia and will request the Investigator to make clear to the Subjects that the Study is being conducted subject to those Guidelines.(Signature) (Position)SIGNED by the Chief Executive or a duly authorised representative of the Indemnified Party...................................................................(Signature) (Position)

http://www.medicinesaustralia.com.au/pages/images/Form%20of%20Indemnity.doc For the purpose of this indemnity, the expression "agents" is deemed to include, but is not limited to:(1) any person carrying out activities for the Indemnified Party under a contract connected with such of the Indemnified Party's facilities and equipment as are made available for the Study under paragraph 2 above; and(2) any health professional providing services to the Indemnified Party under a contract for services or otherwise.This indemnity will be governed by and construed in accordance with the laws applicable in the State or Territory in which the Indemnified Party is established.DATED the day of in the year .SIGNED by a duly authorised representative of the Sponsor.....................................................................(Signature) (Position)SIGNED by the Chief Executive or a duly authorised representative of the Indemnified Party...................................................................(Signature) (Position)

http://www.medicinesaustralia.com.au/pages/images/Form%20of%20Indemnity.doc

CLINICAL TRIAL INSURANCE

Indemnity provided by the University

The University carries out clinical trials in two ways:-

a).Academic research

on volunteers -patients/students/public

administration of novel drugs or treatments to patients/volunteers

not sponsored by pharmaceutical companies

b).Medical research

carried out on volunteers or patients.

for new drugs or treatments

sponsored by pharmaceutical companies

The policy provides cover for legal liability incurred, and an automatic compensation award, where negligence cannot be

proved.

POLICY DEFINITION OF A CLINICAL TRIAL

Clinical Trial shall mean an investigation or series of investigations conducted on any person for a Medicinal Purpose

a) treating or preventing disease

b) diagnosing disease

c) assisting with or alternating in any way the process of conception or investigating or participating in methods of contraception

d) inducing anesthesia

e) otherwise preventing or interfering with the normal operation of a physiological function

PERSONS ENTITLED TO INDEMNITY UNDER THE POLICY

The University, and at the University’s request

A. director/ member of the University Council or Senate

B. any Person Employed

C. member of the University’s Ethics Committee

D. Principal

E. any PG/UG student engaged solely in Non-Hazardous

Clinical Trials while under the direct control

and supervision of a Medical or Dental Practitioner

F. any Medical or Dental Practitioner not otherwise

insured, engaged solely in Non- Hazardous Clinical Trials

POLICY EXCLUSIONSBodily injury/ death/ disease or illness of any Person

Employed by the Insured

Any claim what so ever directly/ indirectly caused/ contributed to by or arising from

ionising radiations/ radioactivity /nuclear waste/toxins from the combustion of nuclear fuel

Any claim from any consequence of war invasion

act/foreign enemy hostilities

Any Clinical Trial where the substance under investigation has been designed and manufactured by the Insured

If the Research Subject is entitled to compensation from another party

Policy exclusive cont……

Injury to any Research Subject who is pregnant at the time of the Clinical Trial

Injury to any Research Subject who is under age of 5 years during Clinical Trial

Any Clinical Trial in which the Medicinal Purpose is related to contraception

Involving genetic engineering

when number of Research Subjects exceeds the Maximum as stated in the Schedule - 500

CLINICAL TRIAL REGISTER

All sponsored trials should be declared to ERI (European Regulatory Intelligence)

All non-sponsored trials should be declared to the Director of Health & Safety.

ERI and the Health & Safety Department will maintain a register of all Clinical Trials declared in any one insurance year (the insurance year runs from 1st August to 31st July).

These registers are submitted to insurers each year (or upon request) to enable the policy premium to be calculated. For cover to be granted, the trial must appear on the registers.

Questions??