2019
Question
[CLICK ON ANY CHOICE TO KNOW THE RIGHT ANSWER]
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Drugs and Clinical Trials Rules 2019
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New Drugs and Clinical Trials Rules 2018
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Drugs and Clinical Trials Rules 2019
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New Drugs and Clinical Trials Rules 2019
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Detailed explanation-1: -It contains 32 principles, which stress on informed consent, confidentiality of data, vulnerable population and requirement of a protocol, including the scientific reasons of the study, to be reviewed by the ethics committee.
Detailed explanation-2: -ICMR has always been on the forefront to set the standards for ethics in biomedical and health research. The Council brought out a policy document in 1980, which was revised in 2000 and further revised in 2006.
Detailed explanation-3: -While conducting biomedical and health research, the four basic principles namely; respect for persons (autonomy), beneficence, non-maleficence and justice must guide research in order to protect the dignity, rights, safety and well-being of research participants.