Bio banking poised to be the next major health enterprise

Most patients may not know what happens to their biopsy sample or surgically excised tissues once the pathology report is issued. It is presumed that such biomaterial will be disposed of or stored in a regulated manner and that, as it happens, is largely the case. In fact, pathologists may retain a sample for a variable period depending on the type of illness and treatment plan. Biochemical laboratories may hold tested material for even shorter time periods.

Aided by technological advancements in tissue storage and research techniques, scientists are taking a second look at tissue and other biological samples that can be re-used as research material for better understanding of disease and therapeutics, even at a genetic level. On occasion, consent may be sought from patients for research use of their tissue samples after routine testing. In the last decade, governments, biotech industry and medical scientists have recognized the advantages of tissue research on stored biological samples and the concept of ‘bio banking’ emerged.

A bio-bank is a stored collection of human biological material, like excised tissues, blood or tumors. They also store medical data linked to the bio-samples. Bio-bank may vary in size from large bio-repositories at a national level to very small storage units attached to research laboratories. The purpose of a bio-bank is medical research for new cures, better understanding of disease at a molecular level and more recently, genetic research. Bio-banks have received attention only recently, as the scientific community began to debate the social, ethical and legal implications of storage, ownership and sharing of bio-samples and benefits derived from research.

The ethical issues revolve around questions of tissue ownership, consent for use of biomaterial and confidentiality of human data, among others. Although human tissue has long been stored, distributed and used in education, forensics, therapeutics and research, it is only in the last decade or so, that concerns about commercialization of research, human rights in medicine, and confidentiality of genetic information have led to debate and a need for consensus on protocol and practices in bio-banking.

The potential for the advancement of medical knowledge from such research is obvious and patients therefore give consent for their tissue samples to be used, even when there is no direct tangible health benefit for themselves. It is often when the general benefit of such research is tinged with commercial gain by sponsors of research that it could lead to some confusion in the minds of these donors.

Pharmaceutical and research companies plead, in their defence, that they have to meet the high costs of research and storage infrastructure. Should any benefits accrued be shared with the stakeholders, including the bio-bank itself? There is debate on whether the tissue is owned by the bio-bank, the researcher, the sponsor, the donor or the institution. The answer to this will determine who can have access to these samples and the protocol and clearance needed for such use.

Medical solution

Taking consent from patients for use of their samples is complicated, as the primary research plan may change and it may be difficult to track patients down for further consent, if the research objective is altered. Many patients may not want to know the details of research use as long as their personal data is protected or the samples anonymised. In the case of genetic research, is there a responsibility to divulge information to tissue donors regarding predilection for disease if it is detected? Would patients always want to know? What would they do with this information if a medical solution for the disorder does not exist?

There is keen interest evinced in genetic data by private industry experts such as forensics, employers, lawyers and insurance companies who can use this information, not always to the advantage of the individual. It could lead to discrimination and stigmatization of already marginalized vulnerable groups. It is possible for confidentiality to be compromised in genetic research and the basic human right to privacy could be a casualty unless ethical review and specific guidelines for use of tissue samples and medical data in Bio-banks are framed.

In line with the amended Helsinki Declaration by the World Medical Association and the Unesco International Declaration on Human Genetic Data 2003, the Indian Council of Medical Research has scripted guidelines relating to DNA/Cell line banking within its Ethical Guidelines for Biomedical Research on Human Participants. Although there are references to benefit sharing, rights of the researcher and ‘donor’ and ethical oversight of bio-repositories, it is still unclear how these guidelines can be implemented in practice.

Bio banking could well be the next major health enterprise to impact our country after health tourism and clinical trials. While we cannot allow narrow interests to impede the pace of medical research and scientific discoveries, ethical guidelines need to ensure social equity, distributive justice and public participation with informed consent. If the general public can be motivated to contribute to health research, it would be expected that other stakeholders including investors, inspire trust and work with an altruistic spirit for the larger good.  

(The writers are with the department of health and humanities, St Johns Research Institute, Bangalore)