Health Ministry issues guidelines for ethical use of 'leftover, de-identified and anonymous samples' for commercial use

New Delhi: The Union Health Ministry has issued guidelines for the ethical use of “leftover, de-identified and anonymous” samples generated from a diagnostic or surgical procedure on patients for commercial use.

These specimens include organs, parts of organs, cells, tissues, cell products such as blood, blood products (even positive for eHBsAG/HCV/HIV/Syphilis and expired blood), urine, saliva, DNA/RNA, hair, nail clippings, or any other cells, body fluids etc.

The source for these specimens may be patients, autopsy specimens, abandoned wastes, tissue banks, IVF clinics and organ donation centres among others, the health ministry said recently.

After these samples have undergone the required clinical and laboratory testing for the patient, there are large quantities of leftover samples that may remain available in the hospitals.

These samples may be referred to as biomedical waste, sometimes maybe a biohazard, and require appropriate disposal methods, the ministry said.

The hospital itself may have no added value for these samples, nor the capacity to store these samples after the provision of patient care. Such samples are usually discarded as hospital waste, it stated.

According to the ‘Guidelines for Ethical use of Leftover de-identified/ Anonymous Samples for Commercial Purpose’, these leftover samples if de-identified or anonymous can serve as a precious resource for research and development activities to develop diagnostics, advance innovations, or for the development of kits, identify specific disease markers, or determine relevant health parameters and other such purposes and may have huge value.

“There has been keen interest from commercial companies in procuring and using the leftover and de-identified samples for the development of commercial kits/products or technologies that have the potential to improve future patient outcomes, provide diagnostic accuracy, or offer therapeutic advancements ultimately benefiting society,” the guidelines said.

It, however, underlined that the hospitals must ensure the samples are completely anonymous and de-identified irreversibly or non-identifiable materials or leftover biological samples which are not specifically intended for research purposes and are going to be discarded after clinical diagnostics or care.

These could be pooled samples or samples without any traceable/ 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 and hospitals, the guidelines stated.

“Commercial kits and technologies that are prepared should be affordable, ensuring broader accessibility for patients and healthcare providers in the country,” it stressed.

The patients own the biological samples and data collected and the institutions are the custodians acting on their behalf and as per ICMR National Ethical Guidelines, 2017, informed consent is required from the patients for any secondary use of samples for ‘research’.

However, if the clinical samples are anonymous or de-identified irreversibly or left over after clinical care, they lose identity and there is no way for the institutions to go back to patients to obtain informed consent for any secondary use, the guidelines said.

“Therefore, for the use of deidentified/ anonymous leftover samples, use may be permitted with a ‘waiver of informed consent’.” the guidelines said.

There would be no loss to the patient’s rights or autonomy in such cases as the left-over samples are de-identified and cannot be traced to the patient.

The guidelines emphasized that de-identified samples that contain clinical information could still become identifiable and, therefore, could lead to a breach in the confidentiality of the patient.

“If the samples are identified/coded/ can be reversible to identify the patient, and samples are not leftover, samples contain clinical/personal information or they are research samples this guideline will not be applicable,” it stressed.

Companies must adhere to local, national, and international regulations governing the collection, storage, and secondary use of biological samples.

This includes obtaining necessary approvals such as ethical clearance as well as establishing formal agreements such as MoUs or MoA and MTAS.

In case of deviation, violation of regulations and disputes between parties, government regulatory agencies take action through appellate bodies like the High Court or the Supreme Court.