Safia Mahomed and Ames Dhai
Research involving human genetic or genomic information analysed together with other personal or health data for the understanding of multi-factorial diseases has increased significantly over the past few decades. This has necessitated the establishment of biobanks where organised collections of human biological materials and associated data from large numbers of individuals are collected, stored and distributed for the purpose of health research.
These biobanks, also known as repositories, range from large national biobanks catering for research into a range of conditions to smaller ones within institutions and could either be public or private in nature. The notion of biobanking is not new but the open and evolving nature of biobanks has profound ethical, legal and social implications. In addition, complexities arise with premature or unplanned closure, which, in the context of biobanks is fraught with challenges. Increasing international collaborations and differing national positions create added concerns.
Biobank research – risks and harms
Risks of physical harms are rare. Common risks are usually social and dignitary and extend beyond the individual participant to population groups that the participant is associated with as well as the public at large. Stigmatization and discrimination may implicate both research participants and non-participants and are frequently group-based, with genetic discrimination being extensively feared. Violating religious or personal values could result in dignitary risks, e.g., unidentifiable samples could lead to research that the donor may not approve of, e.g., use of samples for research on termination of pregnancy to which the donor could have strong religious objections. Weighing the potential benefits of knowledge to be gained for society at large against potential harms for participants in biobank research would be important considerations in the risk/benefit analysis.
Autonomy and biobank research
Biobanks introduce a new paradigm in the context of autonomy and informed consent. It frequently separates the sample collection process, i.e., the informed consent process, from the actual research on the sample with the real possibility that the research could be conducted many years later and may involve research questions and methods that could not have been contemplated at the time of sample collection. Samples that are exchanged may undergo transformation into specific cell lines that can themselves be duplicated and exchanged. Data may be extensively exchanged across many national boundaries. These considerations challenge the supremacy of consent as rights in the world of networks and extensive computerised processing of personal and health data over prolonged periods cannot be protected now. In addition, because of the risks of individual and group identifiability, the potential for infringing privacy and confidentiality rights is a real threat.
Property rights of tissues in biobanks
While entrenched moral significance is attached to the donation of body parts, tissues and organs, biobanks evoke the notion that property that is shared by all humanity must take into account population and individual considerations. The traditional role of informed consent does not include that of soliciting and obtaining gifts of HBMs. Specimens may become the source of immortalised cell lines and other valuable products. History shows that disputes have arisen because researchers used samples without necessary permissions or when donors were exploited for financial and scientific gain. Property and contract laws do not adequately categorise the knowledge generated by the donated specimen and data, hence it is difficult to apply traditional principles of delict, contract and property law to biobanks.
Obtaining trust through public engagement
Public consultation and involvement are vital to the success of biobanking. Public and community participation is recognised as a crucial component of some clinical trial research and hence it is not a new concern. In addition, patient support groups are also being increasingly recognised as active participants in the research process. Ongoing dialogue between the public, researchers and biobank managers is essential and if Africa is to play a pivotal role in biobank research, the consultation process must start.
Biobanks – closure
The reality remains that biobank closure may occur prematurely due to bankruptcy or finite terms of funding. Biobanks may be sold. Transfer of materials to other entities has not been explored adequately as yet. Different cultural and religious groups may have different attitudes to biological material, and these could change over time. HBMs and medical records may be the only substantial assets when a biobank files for bankruptcy. In line with the laws of insolvency, the creditors would require that the sale and distribution of the assets are maximised – a situation that could be perceived as morally repugnant. Perhaps laws will have to be passed that limit the ability of the biobank to accept donations only where the donor retains certain non-waivable property rights, which would bind transferees of the information. While this will restrict the donor’s ability to make unconditional gifts, there does not seem to be any other alternative.
It is important to pursue scientific knowledge. This is essential to human progress, human wellbeing and the relief of suffering. However, this can be done only if human dignity is respected and upheld. Africa must be aware of both the benefits and potential harms associated with biobanks. This does not mean that Africa should shy away from opportunities of being involved in biobank research. Rather, to keep abreast of and be involved in new scientific developments, Africa must appraise the ethical, social and legal issues and develop policies and guidelines in response.
Safia Mahomed – Attorney - PhD candidate (UNISA)
Ames Dhai* – Adjunct Professor and Director Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg.
*Corresponding AuthorSafia Mahomed and Ames Dhai