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LETTER TO EDITOR
Year : 2016  |  Volume : 7  |  Issue : 4  |  Page : 191-192

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


1 Department of Clinical Pharmacology, Seth GS Medical College and Hospital, Mumbai, Maharashtra, India
2 Legal Expert, Institutional Ethics Committee, Seth GS Medical College and Hospital, Mumbai, Maharashtra, India

Date of Web Publication12-Oct-2016

Correspondence Address:
Urmila M Thatte
Department of Clinical Pharmacology, Seth GS Medical College and Hospital, Acharya Donde Marg, Parel, Mumbai - 400 020, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.192048

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How to cite this article:
Sridharan K, Deshpande S, Sirur S, Gogtay NJ, Thatte UM. Knowledge about clinical trial agreement and clinical trial related insurance among Ethics Committee members: A cross-sectional survey. Perspect Clin Res 2016;7:191-2

How to cite this URL:
Sridharan K, Deshpande S, Sirur S, Gogtay NJ, Thatte UM. Knowledge about clinical trial agreement and clinical trial related insurance among Ethics Committee members: A cross-sectional survey. Perspect Clin Res [serial online] 2016 [cited 2019 Sep 19];7:191-2. Available from: http://www.picronline.org/text.asp?2016/7/4/191/192048

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.

 
   References Top

1.
Ghooi RB, Divekar D. Insurance in clinical research. Perspect Clin Res 2014;5:145-50.  Back to cited text no. 1
[PUBMED]  Medknow Journal  
2.
Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Participants. Available from: http://www.icmr.nic.in/ethical_guidelines.pdf. [Last accessed on 2014 Dec 16].  Back to cited text no. 2
    
3.
Thatte UM, Kulkarni-Munshi R, Kalekar SA. Review of policies for injuries to research participants in India. J Med Ethics 2009;35:133-9.  Back to cited text no. 3
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