Licensing biospecimens for cancer research

Prof. Juergen Scheele, Chief Medical Officer, Innoplexus highlights that healthcare professionals must come together to ensure that licensing of biospecimens for cancer research follows the highest ethical standards and is used for drug discovery and exploring new avenues in cancer prevention, treatment and control

Advances in biomedical research have now made it possible to collect biospecimens or natural materials from the human body like tissue, blood, and urine and DNA samples and store it for the purposes of research so as to gain insights into the nature of a particular disease and how it affects different people in different ways. It can also provide an in-depth perspective on regional variations in the onset of a disease in a large, vastly populated country like India and whether social or cultural factors have any role to play in the onset or progression of a particular disease!

India, like the rest of the world, is in the grip of an epidemiological transition. Non-communicable diseases like cancer are exponentially on the rise in urban as well as rural areas of the country. According to a recent Indian Council for Medical Research (ICMR) report entitled “Burden of cancers in India”, the number of people in India projected to be suffering from cancer is projected to increase to 29.8 million in 2025 from 26.7 million in 2021.[1]

The cancer burden varies within the regions of India with the ICMR study pointing to a higher cancer burden in North India followed by the North-East. It also affects men and women differently throwing up the need for gender-specific cancer research. While the rising cancer incidence is partly attributed to the improvement in diagnostics, a disproportional increase in cases in less affluent and most populous states is also a cause for concern. This is where the need for bio-specimens-led cancer research comes in. Large-scale collection and storage of bio-specimens make it possible to carry out cross-sectional longitudinal studies and focused clinical trials that can give us rich insights into the regional and gender-specific variations in the rising incidence of cancer and why it is prevalent more in certain regions. It can also help understand the inter-linkages between poverty and cancer and advance health equity in cancer research.

Personalised and precision medicine can help optimise treatment plans for different people and this too is facilitated by having access to biospecimens. It can also provide us a fresh understanding of how different drugs work for groups of people and so help in new drug discoveries. What’s more, new ways to prevent and treat cancer can be devised through licensing bio-specimens for research purposes.

All countries including India have guidelines pertaining to the use of biospecimens in medical research. The US based National Cancer Institute (NCI) has developed best practice guidelines on the licensing of biospecimens for cancer research. [2] This covers three broad areas of technical best practices on infrastructure and specimen handling, recommendations on informatics and data management and recommendations on ethical, legal and social issues. In India, the ICMR has published the National Ethical Guidelines for Biomedical and Health Research involving human participants.[3] There is also a guidance document on transfer of human biological material for research/commercial purposes and detailed guidelines for international collaboration.[4]

Current regulations governing research with human subjects place a lot of emphasis on informed consent. In a country like India, socio-economic barriers to informed consent have always been a challenge to biomedical research. Besides religious, linguistic and cultural barriers, levels of literacy also pose a further risk. In rural India, individual decisions are often overlooked as people abide by collective decision making and this too poses a challenge.

Obtaining informed consent on the collection, storage and future research use of biospecimens can be further challenging as the specifics of future research are often not known. Additional considerations arise when consent is sought for research involving the use of generation of genomic data. The practice of taking informed consent has to go beyond forms and signatures.[5] Outlining the benefits of this kind of research in a language people can understand along with adherence to strict social and ethical guidelines can go a long way indeed!

Other pressing issues arising from the collection, storage and use of bio-specimens in cancer research may be due to an inadequate understanding of current regulations governing research in human subjects, misuse of genetic information, economic factors and public knowledge. Understanding the context is key to interpreting regulations in the right manner and complying with regulatory requirements. Ultimately, the spirit of good science must prevail!

Awareness plays a key role in advancing research involving human subjects and there is a need to enhance biospecimen knowledge among healthcare providers and representatives of community organisations. Apart from knowing the pros and cons of licensing bio-specimens for cancer research, healthcare professionals should also know that the information gathered should be used only for research purposes and guard against its misuse.

Healthcare professionals must come together to ensure that licensing of biospecimens for cancer research follows the highest ethical standards and is used for drug discovery and exploring new avenues in cancer prevention, treatment and control. Timely sharing of electronic health records across providers, while ensuring data security and privacy, is essential for prompt care of cancer patients as well as the enhancement of medical research and precision medicine.

Intelligent data management and AI-led data sharing practices are being touted as possible solutions to some of these challenges. Use of blockchain technology has been recently advocated by research communities and is gaining momentum from the industry perspective. Hopefully, advancements in data sharing processes can put an end to long-standing ethical issues and create a protection framework for research with human subjects!

References

[1] https://bmccancer.biomedcentral.com/articles/10.1186/s12885-022-09578-1

[2] https://www.federalregister.gov/documents/2010/08/23/2010-20872/national-cancer-institutes-best-practices-for-biospecimen-resources

[3] https://ethics.ncdirindia.org/asset/pdf/ICMR_National_Ethical_Guidelines.pdf

[4] https://main.icmr.nic.in/content/transfer-biological-material

[5] https://indiabioscience.org/columns/indian-scenario/informed-consent-beyond-forms-and-signatures

 

biospecimensblockchain technologyCancer researchPrecision Medicine
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