Research can be conducted on persons with mental illness in the form of psychological, physical, chemical or medicinal intervention. However, this can be done only when the person’s free and informed consent has been obtained(( Section 99(1), the Mental Healthcare Act, 2017.)). Research can be conducted based on a person’s case study notes even without his consent, as long as his identity is not revealed(( Section 99(4), the Mental Healthcare Act, 2017.)).
In case the person is unable to give consent but does not resist participation, the professional conducting the research can take permission from the State Mental Health Authority(( Section 99(2), the Mental Healthcare Act, 2017.)). The Authority can give permission only after getting the consent from the person’s nominated representative and after ensuring the following(( Section 99(3), the Mental Healthcare Act, 2017.)):
- The research cannot be conducted on any other person, such as a person capable of giving consent. For example, Ram is suffering from a very rare form of a mental illness, and the proposed research must be conducted on a person suffering from that mental illness only.
- The research is necessary to promote the mental health of the population represented by that person.
- The knowledge that will be gained from the research is relevant to the health needs of the person
- There is no conflict of interest in any kind.
- The research is in line with national and international guidelines and regulations, and ethical approval has been obtained from the relevant institutions.
Please note that any consent given by the person with mental illness or his nominated representative can be withdrawn at any time(( Section 99(5), the Mental Healthcare Act, 2017.))