The Union Health Ministry has released new guidelines for the ethical use of “leftover, de-identified, and anonymous” samples from diagnostic or surgical procedures on patients for commercial purposes. These specimens include organs, tissues, cells, body fluids, and other biological materials sourced from patients, autopsies, tissue banks, IVF clinics, and organ donation centers.
After clinical and laboratory testing, hospitals often have leftover samples, which are typically considered biomedical waste and disposed of accordingly. However, the guidelines highlight that these de-identified samples can be valuable for research and development, aiding in the creation of diagnostic tools, innovations, and health markers.
The guidelines emphasize the necessity of ensuring that these samples are completely anonymized and de-identified to prevent any traceability back to the patients. Robust data security measures must be implemented to protect any residual information associated with the samples. Additionally, companies should maintain transparent communication with hospitals and relevant institutions.
Commercial entities have shown significant interest in utilizing these samples to develop kits and technologies that could improve diagnostic accuracy, therapeutic advancements, and overall patient outcomes. The guidelines stress that these commercial products should be affordable to ensure widespread accessibility for patients and healthcare providers in the country.
According to the guidelines, patients own their biological samples and data, while institutions act as custodians. Per the ICMR National Ethical Guidelines, 2017, informed consent is required for any secondary use of samples for research. However, if the samples are irreversibly de-identified or leftover after clinical care, they lose their identity, making it impractical to obtain informed consent for secondary use. Therefore, the guidelines allow for a “waiver of informed consent” in such cases, ensuring no loss of patient rights or autonomy.
The guidelines caution that de-identified samples with clinical information could still potentially become identifiable, risking patient confidentiality. Samples that can be re-identified, contain clinical or personal information, or are specifically intended for research do not fall under these guidelines.
As reported by Medical Buyer, companies must adhere to all relevant local, national, and international regulations governing the collection, storage, and use of biological samples. This includes obtaining necessary ethical clearances and formal agreements such as MoUs or MTAs. Any deviations, regulatory violations, or disputes will be addressed by government regulatory agencies through appellate bodies like the High Court or the Supreme Court.