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Considering the far reaching implications of AI based technologies in healthcare, the Indian Council of Medical Research (ICMR) has formulated and released ‘Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare’ towards reviewing research proposals in AI.
“These guidelines will provide the ethical framework for development of AI based tools which will benefit all stakeholders, including innovators, developers, patients, technologists, researchers, healthcare professionals, ethics committees (ECs), sponsors and funding agencies involved in research related to AI in biomedical research and healthcare. I hope that this document will contribute to the adoption of ethical standards during development of AI based tools in India,” according to Dr. Rajiv Bahl, Secretary, Department of Health Research and Director General, ICMR.
Both healthcare and AI technologies are rapidly advancing and so shall the associated ethical dimensions. The document therefore shall remain a living document and undergo refinement periodically. The purpose of these guidelines is not to limit innovation or recommend any disease-specific diagnostic or therapeutic approach but to guide effective yet safe development, deployment and adoption of AI based technologies in biomedical research and healthcare delivery.
India has given these guidelines legal status under the new drugs and clinical trials rules. In developing AI technology for application in healthcare, broadly the same ethical principles can be followed. However, since AI technology has several unique methodological and interpretation challenges and in the context of a rapidly evolving healthcare scenario, the guidelines have been formulated in consultation with experts from these two fields.
“ICMR “Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare, 2023” has been formulated to guide the stakeholders in ethical conduct of research that provides AI solutions in healthcare and will help in identifying and negotiating emerging ethical challenges and concerns. Similar to the basic field, ethics for AI/ML is also a rapidly evolving area and therefore the document is a live document and will be updated as and when the need arises,” said Prof (Dr) Narendra Kumar Arora, executive director, The INCLEN Trust International.
The document includes separate sections addressing ethical principles for AI in health, guiding principles for stakeholders, ethics review process, governance of AI use for healthcare and research, and informed consent process involving human participants and their data. The guideline has been formulated after extensive discussions with subject experts, researchers and ethicists.
“This document entitled ‘Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare’ is the result of continuous efforts of the member of the Drafting Committee of ethical guidelines of AI in biomedical research and healthcare,” said M. Vishnu Vardhana Rao, Director, ICMR-National Institute of Medical Statistics, New Delhi.
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