Knowledge about clinical trial agreement and clinical trial related insurance among Ethics Committee members: A cross-sectional survey.

Sir,

In the current regulatory, clinical trials scenario, it is essential for the Ethics Committee members to be aware of clinical trial related insurance and clinical trial agreement (CTA). A recent study assessed the quality of insurance document submitted to an Ethics Committee and found major deficiencies in terms of not covering the entire duration of clinical trials or presence of certain clauses that make compensation to be paid to study participants difficult.[1] We conducted a study to explore the awareness among Ethics Committee members of insurance and CTA after obtaining approval from the Institutional Ethics Committee. A validated questionnaire was electronically mailed to members of 160 Ethics Committee in India of which only 16 (10%) responded. The median (range) duration of functioning of the Ethics Committee was 8 (0.5–28) years, and their annual load for review of projects ranged between 8 and 350. A majority (12/16) of the study participants opined that mention of just the name of concerned clinical trial in the insurance policy indicates that the study has been insured. A little over a third (6/16) said (wrongly) that the clinical trial indemnity policy covers professional negligence on the part of investigator, and two-third (10/16) felt that it is either the institute or investigator who has to obtain the indemnity policy. Only 10/16 rightly said that the clause on premature termination of clinical trials and the responsibilities of the study participants thereafter should be included in a CTA irrespective of its mention in the protocol. One-fourth (4/16) of the study participants said that the Ethics Committee can act as an arbitrator in case of any disputes between the investigator and sponsor. Three respondents named the stakeholders of a tripartite CTA incorrectly. A total of 9/16 opined that the CTA should be between the investigators and institution in case of investigator-initiated study.

We found a poor knowledge of the Ethics Committee members regarding CTA and clinical trial related insurance in the present study. Even the ethical guidelines have started featuring the same only in recent years.[2] The role of the International Electrotechnical Commission (IEC), among others, is to review if appropriate provisions have been made to protect the rights of the subject participants in case of any trial related injury or death or in the event of premature termination of the clinical trial. Therefore, the knowledge of CTA and clinical trial related insurance document is important for members of the IEC. An earlier study conducted in India showed that 30% of the institutions had policies for the management of compensation of research related injuries, and 83% of the Ethics Committee members were unaware of the details of insurance contract.[3] In the present regulatory scenario, in India, it is necessary for IEC members to be aware of both the insurance and CTA. The present study indicates the need for training of Ethics Committee members regarding CTA and clinical trial related insurance.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.