Takshashila Discussion Document - Ethical Guidelines for Clinical Trials and Research in India

This discussion document proposes a modified set of 8 ethical principles and a guidance questionnaire that researchers and ethics committees can refer to, to ensure that the research is within the ethical boundaries. ICMR’s ethical guidelines of 2017 need to be revised, with more focus on the fundamental ethical principles that govern the moral decisions and on ethical dilemmas that arise while conducting clinical trials/biomedical and health research. This document recommends revising the section on categorisation of risk  to reflect the fact that the definition of risk may differ from one study to another. Additionally, various  aspects of ethical principles should be explained with relevant examples for the researchers to understand the ethical dilemmas in research.

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