The Ministry of Health and Family Welfare (MoHFW) has published Indian Council of Medical Research’s (ICMR) Guidelines for Ethical use of Leftover De-identified/ Anonymous Samples for Commercial Purpose. These guidelines were issued through an Office Memorandum dated December 15, 2023 and published on June 19, 2024.
Human biological samples, often collected during diagnosis or treatment, can be a valuable resource for therapeutic advancements and improving patient outcomes and diagnostic accuracy. These guidelines aim to ensure this process is conducted ethically and transparently.
Applicability and Scope
The guidelines apply only to leftover samples that are irreversibly anonymized and not intended for further research. Samples must be completely anonymous, with no link back to the original patient. Hospitals are responsible for ensuring robust data security.
Companies involved in using these samples must maintain open communication with hospitals and ensure the resulting technologies are affordable for patients in India.
Additionally, informed consent is not required for anonymized leftover samples, as patients cannot be identified.
Benefits of the Guidelines
The Ministry’s guidelines aim to promote research and development of new diagnostic tools and treatments. They also ensure leftover samples are not discarded but used for potential benefit to future patients. Moreover, the guidelines also protect patient privacy by mandating complete anonymization of samples.
