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

3. Insure To 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

4. 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.

5. Liability Definition: The state of being legally obliged & responsible to pay money to another– as insurer..

6. 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

7. Insurance or indemnity Vital to communicate to potential research participants during informed consent process included in the subject information sheet. See Central Office for Research Ethics Committees COREC website.

8. 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”

9. 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.

10. 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

11. Indemnification-Investigator Sponsor should indemnify for any injuries, illness or damages arising from trial activities, basically investigator for the study

12. Standard Indemnification 4 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

13. Indemnification: Institution Position Institution 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

14. Indemnification: Industry Position Industry 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

15. Elements of Indemnification Identify 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

16. 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

17. Terms of Indemnification Following 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.

18. 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.)

19. Exceptions to Indemnification Any 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

20. 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

21. Subject Injury In the event of injury: Institution: Industry pays for diagnosis, injury & illness caused 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

22. Subject Injury at Issue Sponsor 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

23. Insurance For 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*

24. Non-negligent harm insurance called "no-fault" insurance – it is insuring against something happening that could not have been foreseen.

25. Certificates of Insurance Why 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

26. Insurance-Subject Contract where one party will indemnify another or agree to pay a specified amount upon determinable contingencies First party - the insurer Second party – the insured The contract – the insurance policy The consideration – the premium The contingency – the hazard or peril The exclusions – no coverage for specific actions / occurrences

27. 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 time Expenditures of resources Trial delays, patient recruitment delays Other sites enroll and recruitment closes before your site has reached agreement

28. 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.

29. 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

30. 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

31. 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.

32. 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

33. 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

34. POLICY EXCLUSIONS Bodily 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

35. 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

36. 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.

37. Questions??