An Effort Towards Achieving Watertight Compensation System for Clinical Trial Injuries in India

Clinical trial of any drug, device or vaccine whether new or already marketed, is associated with risks and burdens. There is need to protect participants who volunteer in trials, by way of medical treatment and compensation for trial related injuries.

Clinical trial participants help advance medical science knowledge, but face the risk discomforts and risks for which there should be regulatory provisions by which they are reimbursed for expenses and compensated.

In this era of ethical medicine, India has taken an aggressive and responsible step towards clinical trial participants’ protection by introducing Rule 122DAB, D and C Rule 1945 and its amendments. Schedule Y which still has some loopholes, needs to be tweaked further to make it fool proof. An attempt is made to develop more logical and rational regulations, considering all stakeholders and the negative public perception towards clinical research.

Some of the readily modifiable factors are regulatory procedures, medical reimbursement and compensation rules. This paper analyses the rationale behind compensation guidelines for clinical research from the country's leading in clinical trials such as USA and European countries like Germany Taking into consideration the views of all stakeholders in clinical research, (i.e. sponsors, investigators, government, patients, ethics committees, lawyers and ethicists) uniform, harmonious, highly ethical yet robust compensation guidelines are proposed. The present study addresses the critical issue of compensation to clinical trial participants’ injuries more logically and aptly by adhering to the very basic principles of ethics namely respect, beneficence and justice.

The above study hopes to propose a watertight, ethical, uniform, harmonious yet robust compensation system for clinical research participants