Biomedical Research Involving Human Participants in India - Some Observations
Abstract
Biomedical research involving human participants is an area of concern world over and once in a while catches media attention when some sensational exigencies related to research occur. These issues could be either adverse events following research or violation of ethical principles. This may either follow “whistle blowing” from some quarters or when instances of exploitation of underprivileged are brought to light by activist groups or watchdogs.
Under this principle it is mandated that “ due care and caution must be exercised at all stages of research and experiments to ensure that the research participant and those affected by it including community are put to the minimum risk, suffer from no known adverse effects, and generally, benefit from and by the research or experiment and that requisite steps are taken to ensure that both professional and ethical reviews of the research are undertaken at appropriate stages so that further and specific guidelines are laid down, and necessary directions given, in respect of the conduct of the research or experiment”. This has led to the constitution of Institutional Ethical Committees.
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