International ethical guidelines for medical research

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Dear Members,

Research involving individuals who by reason of mental or behavioural disorders are not capable of giving adequately informed consent

Before undertaking research involving individuals who by reason of mental or behavioural disorders are not capable of giving adequately informed consent, the investigator must ensure that:

such persons will not be subjects of research that might equally well be carried out on persons whose capacity to give adequately informed consent is not impaired;

the purpose of the research is to obtain knowledge relevant to the particular health needs of persons with mental or behavioural disorders;

the consent of each subject has been obtained to the extent of that person's capabilities, and a prospective subject's refusal to participate in research is always respected, unless, in exceptional circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,

in cases where prospective subjects lack capacity to consent, permission is obtained from a responsible family member or a legally authorized representative in accordance with applicable law.

Regards,

Dr. Vijaya Chaudhari.

JR-1 Dept. Of Pharmacology,

GMC, Nagpur.

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