Study on ‘Compensation for Clinical Trial Injuries: A comparative analysis of seven countries’

Sama conducted an exploratory research focusing on compensation mechanisms in clinical trials. A systematic review of the compensation mechanism in seven countries including India was undertaken. Policy documents, legislations, published papers and studies, clinical trial registries, websites of the country regulatory bodies and case laws related to clinical trial injury related compensation were looked at as a part of this research. All the countries included in the study adhere to the international guidelines on clinical trials and most have compensation policies on paper; albeit with vague direction for implementation and loopholes for open interpretation of critical aspects. In absence of concrete mechanisms to ensure accountability and operationalisation, these guidelines are often rendered toothless.

The issues of reporting and compensation for adverse events including death in clinical trials have emerged in the recent past. Ethics, medical ethics and human rights mandate that medical management and compensation ought to be provided in case of harm during or after clinical trial participation. While ethics and human rights frameworks are universal across most of the countries who are involved majorly in the conduct of clinical trials, the operationalisation and underlying policies guiding the compensatory mechanism differ among different countries. A comparative analysis across countries will inform the debate, and policy making processes pertaining to clinical trial compensations.

Bookmark the permalink.

Comments are closed.