BIOBANKING – ETHICS AND CHALLENGES
Maharashtra National Law University, Mumbai
With the technological revolution, the world has witnessed unforeseen amounts of progress in all avenues. Science has seen a special degree of change with newer facets being discovered every second. We have discovered a lot about our environment, and even more so about ourselves. As for the latter, biology has made unforeseen developments. Today we know almost everything about our own bodies, their physical structure and anatomical functions. But, there has always been a very core level subject that still has significant relevance and ever-present importance in all of science. Genetic studies have been a field of fascination for one and all. Be it meta-human hypotheses or the theory of immortality, genetic study is the potential key to every fictitious thought anyone might have.
But, with advancements, come more complex challenges. Due to the increased demand arising from developments in the area of genomics, metagenomics, proteomics, personalized medicine, disease biology, bioenergy, environmental remediation and allied fields, the concept of ‘biobanking’ has been gaining massive momentum and demand. Biobanking, or the creation of biorepositories – biobanks – can be broadly described as “an organized collection of human biological material and associated information stored for one or more research purposes”. A biobank is thus a repository that accepts, processes, stores and distributes such biospecimens and related data for academic and clinical uses.
For a broad classification, presently, there are only two types of biobanks in operation. These are:
- POPULATION BASED BIOBANKS
These biobanks store biomaterial and related characteristics data viz. lifestyle, clinical and environmental data. Organisation for Economic Cooperation and Development (OECD) defined population biobanks as “collections of biological material and the associated data and information stored in an organized system for a population or a large subset of a population”.
2. DISEASE ORIENTED BIOBANKS OR CLINICAL BIOBANKS
These biobanks are the interface between clinical practice and research and are usually affiliated to hospitals and research institutes. Objectives of these biobanks are to collect samples representing a variety of diseases and to identify biomarkers associated with the disease. These biobanks are further divided into two major types:
- Tissue banks – Tissue banking is an active tool for translational research. Here human tissues are harvested, processed, stored and finally distributed for transplantation. Heart valves, tendons, bones, joints, cartilage, cornea, fascia and Dura matter from the human cadaver are the most common tissues harvested by the biobanks.
- Rare (Orphan) Disease biobanks or Genetic biobanks – Rare (Orphan) diseases are those diseases whose prevalence is as low as less than one in 2000. In India, more than 72 million people are suffering from more than 7000 rare diseases. The exclusive nature of the samples plays an important role in the translational research. Here, small samples may have great importance for research as they could have direct relevance for patients’ health. These biobanks work through full time participation of patients and share benefits with donors.
The latter of the two broad categories is gaining popularity in India and is also revolutionizing research in the country. Indian Council for Medical Research(ICMR),Council for Scientific and Industrial Research (CSIR) and Department of Biotechnology (DBT) are the major agencies supporting research in India. The ICMR is the national organization and also the apex body for developing ethical frameworks and guidelines and also enforcing them. Due to such rapid advancement in biomedical sciences, new ethical dimensions have emerged. The concerns that are often raised in connection to creating a repository of biological data are manifold. The foremost and most widely discussed one among these is the issue of privacy and data subject anonymity.
Privacy is a fundamental right in India. But, in cases of medical privacy, there is a constant tension between competing rights and the reasoning by the courts in addressing the tension. In all such cases, the right to privacy is circumscribed by another right or in the public interest or in the best interests of the relevant party. Moreover, although courts have recognized the right to privacy as a fundamental right, they have also noted the limits of applying this right as an absolute, fundamental right. The courts have also taken the position that in many instances besides the right of privacy, the duty of not disclosing information to a third party, based on a code of ethics or ethical guidelines, cannot be invoked as a defense that should always be accepted by the court. These reveal serious lacunae in the jurisprudence over the right to privacy in India. The lacunae arises from the fact that although the right to privacy is considered a fundamental right that flows from Article 21, which is the right to life, courts have been reluctant to stretch its limits and have rather circumscribed its reach by invoking different reasons.
As such, there are very few laws on ethics like data privacy of patients or protection against misuse of samples or protection against liability for test subjects etc. there is minimal oversight by the government and even lesser supervision. There are also no relevant de-identification or security policies for anyone who chooses to participate in the research. But, recently, in 2017, the ICMR revised its own guidelines, including primary versions of a lot of these required policy reforms. The revision has introduced many new sections and also revamped the existing sections in the older guidelines. A new Section 11 was dedicated to biological materials, biobanks and datasets. This section vividly covered issues like Informed Consent Form (ICF), storage of biospecimens and data with their personal identifiers, ethical issues related to donors, ethical issues related to research, biological material/data in forensic departments of laboratories, governance of biobank/biorepository, Special issues related to datasets and Contingency planning. The new guidelines also protect the research participants from exploitation, harm and injustice by theoretically elaborating upon the principles .of essentiality, voluntariness, non-exploitation, social responsibility etc. However, there is a gross mismatch when it comes to the practical applications of these guidelines in a culturally and ethically diverse country like ours.
Even so, one cannot deny that these guidelines serve as a starting point for grounding discourse on a range of important issues. It is not too great a claim to say that biobanks require a rethinking of our ethical assumptions and frameworks which we have applied generally to other issues in ethics. New ethical structures are required. The foremost need of the hour is to develop a document that not only protects the research participants but also promotes research in the true spirit of altruism.
Thus, through relevant debate and discussion, in time, we are certainly bound to get where we are supposed to be.
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