In Conversation with Dr. Jugnu Jain, Founder & CEO of Sapien Biosciences 

Q: How do you maintain Patient Privacy and Confidentiality in Sapien? 

A: As a biobank, Sapien is engaged in biomedical non-clinical research. The formations and operations of a biobank  including the procedures to deal with biological material and data relating to it, fall under Indian Council of Medical  Research (ICMR)’s ‘National Ethical Guidelines for Biomedical and Health Research Involving Human  Participants’. Sapien adheres to such guidelines by obtaining relevant Ethics Committees’ approvals as well as  protecting patients’ identity and privacy by appropriately coding the samples and data.

Q: What are the steps taken for anonymisation and pseudonymisation of data as means of privacy protection  at Sapien?  

A: Sapien follows pseudonymization or coding of patient data which means that the user of samples or data cannot  know the identity of the patient. All patient identifiers such as hospital number (MRN, UHID, UID), lab sample  or report number (LRN, LID), date of procedure, date of sample collection, name, address, contact information  of patient, etc., are all removed and coded carefully to safeguard identity and privacy.  

Q: What are the Legal & Ethical standards applied to Procurement, Storage, and Transfer of Tissues and  Cells for Non-Clinical Research Purposes? 

A: Samples and data at Sapien have been procured after building a solid foundation of ethical and legal compliance  since Sapien is a pioneer in private biobank-ing in India. The following procedure is undertaken for the same: 

➢ Significant deliberation and consensus-building were done at the start with the members of Institutional Ethics  Committees (IECs), lawyers familiar with ethical and legal guidelines, scientists involved in drafting ICMR  guidelines, studying international biobanking norms, and clinicians, pathologists, hospital management, etc.  ➢ A 2-step process has been implemented whereby; 

• First, procurement of remnant samples from pathology and other labs is done in bulk for biobanking with  the review and approval from each participating hospital’s IEC.  
• Second, the use of specific samples and/or data maintained in the biobank at Sapien is then again reviewed  by another DHR-registered IEC (of the biobank) using a project and user-specific protocol. The probability  of harm or discomfort anticipated in the research is nil or not expected for research on anonymous or non identified data/samples, as per ICMR.  

➢ A Material Transfer Agreement (MTA) and /or Data Sharing Agreement (DSA) is entered into, defining the  terms of the project between the biobank and the user of the samples and/or data prior to submitting a protocol  to the IEC and sharing any material /data with the user. The end-user covenants that the samples and data will  be used only for the specified purpose for which the IEC approval is taken.  

Q: What are the Rights and Entitlements in Human Tissue and Cells?

A: Usually, human tissue removed as part of standard medical procedures such as blood for diagnosis or tissue during  surgery as part of treatment, belongs to the patient and the hospital acts as the custodian of the sample. As per  National Accreditation Board for Testing and Calibration Laboratories (‘NABL’) guidelines, the pathology blocks  from which diagnosis is made in NABL-accredited pathology labs are to be stored for a minimum of 5 years, prior  to 2019. Post-2019 revision of NABL guidelines, diagnostic blocks made from 2019 onwards need to be stored  for 10 years. After the term is over, many hospitals do not keep the blocks due to lack of space and manpower to  maintain them. The samples can be used for research purposes after completion of NABL-mandated storage  period and after fulfilling the conditions as defined in ICMR guidelines for biobanking and relevant IEC approval.  

Another type of sample is where researchers collect fresh tissue from routine surgeries or additional blood samples  with the patient’s or caregiver’s consent. The purpose of collection, terms of use, safeguards to protect patient  identity and privacy, etc., are spelt out in the informed consent including that in the event that their donated  samples are used for projects that lead to a commercial output the donor does not have a right to commercial  benefit. If the patient /caregiver consents, then that sample is taken and biobank-ed for R&D projects. These  additional, non-diagnostic samples do not fall under the 5 or 10-year NABL storage limit.  

Q: What are the challenges faced in the legal framework in your sphere of activity, especially from the point  of view of technology and law? 

A: The revised ICMR guidelines of 2017 went a long way towards defining the different risk categories of obtaining and using human samples and data and also on how the ethics committees should review the different categories  of protocols to safeguard the interests of all involved. Additional safeguards have been added in the ICMR  guidelines for protecting vulnerable populations such as minors, tribals, physically or mentally disadvantaged  patients. Hence, we remain optimistic about the future. 

Q: What is your Opinion on the future of Biobanking? 

A: Time magazine featured biobanks among “10 Ideas Changing the World Right Now” back in 2009, highlighting  biobanks as an enabler of innovation in pharma and biotech industry. The Medicines Development Catapult  (MDC), a UK government-funded non-profit, reported in 2019 that 85% of UK pharma companies cited the lack  of access to patient samples and data as one out of the five top hurdles in bringing new medicines to market faster  and cheaper. So, biobanks like Sapien are crucial in R&D for new medicines and diagnostics. Sapien is now among  the top 10 biobanks in the world. Over the coming years, it will be expanding its curation of non-cancer NCDs  including IBD, CKD, NASH where the understanding of risk factors and gut microbiome are needed.