Page 46 - Insurance Times June 2021

How to limit exposure to liability suit? h. Ethics Committee - The clinical trial must pass through
the ethics committee which examines it on various
It is possible ensuring & resorting to the following aspects -
a. Parties to the clinical trial must sign clinical trial parameters, e.g. trial design, clinical protocol, etc.
agreement to ensure the investigators' commitments i. Placebo - A pill / medicine prescribed for psychological
to conduct the trial in accordance with the protocol, reasons but having no physiological effect.
relevant rules and regulation and to take care of other j. P.I. - Principle Investigator.
concerns.
b. Company must establish and maintain a policy of Clinical trials liability insurance:
adherence to the required clinical trials protocol. Now let us discuss about the Clinical Trials Liability Insurance
c. Company must do everything to minimize the risk of law for those organizations those who conduct the Clinical Trial
suit. Processes.
d. The company must not stray from safety norms.
What does clinical trials insurance
e. The company must ensure fulfillment of informed
consent rules cover?
Basically Clinical Trials Liability Insurance is simply a kind of
f. The sponsoring company obviously needs Clinical Trial
legal liability insurance covering -
Liability Insurance in addition to General Liability &
1. Liabilities may arise from death / injury (This is called
Product Liability
Personal Damage) to the subject arising out of
g. Clinician needs Professional Indemnity Insurance allegation of -
h. Clinical research organization needs Error & Omission 1. Lack of care
Policies 2. Insufficient / improper disclosures
i. Financial Conflict of interest between the sponsor and 3. Conflict of interest
investigator (Equity Stake / Propriety interest). 2. Claimants may include:
1) Research subject (volunteers)
Terms used in clinical trials: 2) Dependents of research subject in case of death
a. Clinical trial - Test carried out on human subjects to
3) Guardians of child subjects
verify safety, efficacy of a therapeutic product.
1. The policy generally covers legal expenses also.
b. Trial subject - Patients or healthy person taking part in
2. Some policies also provide coverage for material
a clinical trial
damage suffered by trial subjects in relation to the
c. Clinical test protocol - detailed rules, formalities and clinical trial
procedures to be followed for a particular trial. This is
3. Insurance coverage exists for damages suffered from
required to be submitted to FDA (Food & Drug
breaches of data protection in relation to the insured
Administration) before any clinical trial is started in USA
clinical trial.
d. Informed consent document - This is required to be
4. The territorial limit for the policy is India but can be
signed by every human subject in a clinical trial. It
extended beyond India on request.
details all the known or reasonably foreseeable risk of
5. The territory is specified in the policy
the study and other relevant factors.
6. Coverage may be extended for post trial liabilities (for
e. Institutional Review Board (IRB) each clinical trial is also
60 months)
reviewed by IRB of the hospital, clinic where trial is
conducted. 7. These Policies are issued on claims made basis.
f. External IRB's also utilized to bring more transparency 8. Policy may be issued as -
i. Single trial policy, &
g. The Board reviews the protocol and consent document
to ensure the participant's rights are protected and ii. Multi trial policy - one policy covers several trials
such other considerations are taken care of. of the policyholders.

46 The Insurance Times, June 2021