Ethical Guidelines for Biomedical Research on Human Subjects (2000)

'The document titled "Ethical Guidelines for Biomedical Research on Human Subjects" by the Indian Council of Medical Research (ICMR) provides a framework for conducting biomedical research involving human subjects. The guidelines were released in 2000 and are intended to promote ethical considerations in medical research.

The document emphasizes the importance of informed consent, voluntariness, non-exploitation, privacy, confidentiality, precaution, risk minimization, professional competence, accountability, transparency, maximization of public interest, distributive justice, institutional arrangements, public domain, totality of responsibility, and compliance.

The guidelines also outline the process for ethical review procedures, including the role of Institutional Ethics Committees (IECs) in reviewing research proposals. The IECs are responsible for ensuring that research protocols meet ethical standards, and they have a continuing responsibility to monitor compliance with ethics requirements during and after the completion of projects.

The document highlights the need for ongoing evaluation and re-evaluation of research proposals, citing examples such as human cloning and stem cell research. It emphasizes that biomedical research has acquired dimensions that are both exciting and awesome, raising delicate and difficult issues of ethics that require careful consideration to ensure that risks do not outweigh benefits.

Overall, the guidelines aim to provide a comprehensive framework for conducting biomedical research involving human subjects in an ethical manner.'