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LETTER TO EDITOR
Year : 2016  |  Volume : 7  |  Issue : 1  |  Page : 54

“Settlement Agreement” a new controversial agreement


Scientia Clinical Services, Pune, Maharashtra, India

Date of Web Publication12-Jan-2016

Correspondence Address:
Ravindra Bhaskar Ghooi
Scientia Clinical Services, G 801, Rohan Nilay, Aundh, Pune - 411 007, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.173772

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How to cite this article:
Ghooi RB. “Settlement Agreement” a new controversial agreement. Perspect Clin Res 2016;7:54

How to cite this URL:
Ghooi RB. “Settlement Agreement” a new controversial agreement. Perspect Clin Res [serial online] 2016 [cited 2019 Oct 17];7:54. Available from: http://www.picronline.org/text.asp?2016/7/1/54/173772



Sir,

A sponsor has introduced a new document called the “Settlement Agreement.” This agreement is to be signed by the subject/nominee after the DCGI orders the payment of medical reimbursement/compensation. As per the proposed agreement, the subjects/nominees agree to waive their right to legal recourse against the sponsor, investigator, or site, in case they are dissatisfied. To the best of my knowledge, such an agreement has not been used in the past and is a precedent.

National and International Guidelines suggest that trial documents should be written in simple language that would be understandable to a common individual; however, the agreement is made out in legalese. They also require that documents should not contain any language that waives or appears to waive the responsibility of the sponsors, which the agreement does. Agreements signed in India come under the Indian Contract Act of 1872, specifically under its section 28. The said section holds that any agreement that restricts the rights or puts a time limit on either party to legal remedies is void. Such agreements therefore violate the National and International Ethical Guidelines as well as the national law.

Many subjects taking part in clinical trials have a lower economic and social standing compared to that of sponsors who are often large corporate entities. If the sponsor asks the subject/nominee to sign a document to receive the amount ordered by DCGI, the subject/nominee is put under undue pressure. Such agreements can also lead to a lot of unnecessary litigation which is harmful to the interests of the subjects. The Ethics Committee (EC) is duty bound to intervene to protect the rights and wellbeing of the subjects.

The sponsor has a right to introduce any document that adds value to the trial process; however, we believe that this agreement does not. It is not clear if the sponsor will pay the subject/nominee even if they refuse to sign the agreement. If the sponsor fails to pay the ordered sum, this will come under Rule 122 DAB (7). This section gives the regulator the power to stop the clinical trial and even prevent the sponsors from conducting trials in the country, after giving them an opportunity to show cause.

Active ECs usually meet every month, and the documents that are reviewed during every meeting run into 1000 pages. Most EC members are professionals who are pressed for time to read these voluminous submissions. In such a situation, it requires great diligence spot a 2 or 3 page agreement which is submitted along with trial documents. Not all members are trained to appreciate the legality of such agreements; hence, sponsors should specifically request EC to consider any new document rather than introduce it in a surreptitious manner.

Through this letter, we would like to warn all investigators/EC

members to carefully read submissions to ensure that such controversial agreements are not introduced. They are unethical, illegal and could cause needless burden to subjects and their nominees.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.




 

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