These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.
The purpose of such research should be:
- directed towards enhancing knowledge about the human condition while maintaining sensitivity to the Indian cultural, social and natural environment;
- conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/ or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and
- subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.
- All research involving human participants should be conducted in accordance with the basic and general ethical principles as outlined in section 1. The researcher and the team are responsible for protecting the dignity, rights, safety and well-being of the participants enrolled in the study. They should have the appropriate qualifications and competence in research methodology and should be aware of and comply with the scientific, medical, ethical, legal and social requirements of the research proposal. The ECs are responsible for ensuring that the research is conducted in accordance with the aforementioned principles.