The Ministry of Health & Family Welfare (MoHFW) on October 2024, issued the Guidelines for ethical use of leftover De-identified/Anonymous Samples for Commercial Purpose.
The present guidance ONLY addresses the Ethical Use of leftover, irreversibly deidentified samples, or pooled samples, that are non-identifiable and collected for clinical care (non-research) for development of future product/ technology and or commercial purposes.
This guideline is NOT applicable for use of leftover ‘research’ samples, since their secondary use must be aligned with the original informed consent given by the research participant.
The following are the Ethical considerations for leftover samples in commercial use:
• The hospitals must ensure that the samples are completely anonymous/ de-identified irreversibly/ non-identifiable material/ leftover biological samples/ not specifically intended for research purposes/ are going to be discarded after clinical diagnostics/ care.
• These could be pooled samples/or samples without any traceable link/ or without any identifiers that could potentially lead back to the patient. Robust data security measures must be in place to protect any residual information associated with the samples.
• Companies should maintain transparent and open communication with the relevant institutions/ hospitals
• Commercial kits and technologies that are prepared should be affordable, ensuring broader accessibility for patients and healthcare providers in the country.
For more details, please refer to the document provided below.
