Abstract
Biobanks have come to be essential apparatuses of genetic and genomic research as they are seen as essential tools for translational medicine in particular. Various unique ethical and legal challenges arise in the course of biobanking as biobanks generate a range of ethical and legal challenges related to privacy, informed consent, control and ownership, withdrawal of samples, commercialization, genomic sovereignty, return of results, incidental findings, and research governance. These issues have generated much policy debate within the international world, and yet in South Africa, debates on the ethical and legal challenges posed by biobanks and biobank networks still remain alienated. According to Wolf, biobanks are the dominant part of a “biobank research system,” consisting of primary research also known as collection sites, the biobank, and secondary research sites that access biobank data or samples for further research. Therefore, incidental findings could arise at several points in a biobank-research system, that is, in primary research, biobank research, and secondary research. Within the South African context literature and guidance are sparse on the handling of significant incidental findings which are identified in biobank systems. How incidental findings should be handled as well as the role of biobanks in enabling this process, are well-founded concerns. Unresolved in South Africa, is how to manage incidental findings of potential health, reproductive, environmental and medicinal risk that are of particular importance to individual contributors. With a proposal for a national biobank in South Africa, it is apparent that researchers as well as clinicians are anticipated to access data from biobanks and to this end, laws, clear public guidance and regulations on the handling of incidental findings are indispensable.
Highlights
Within the South African context literature and guidance are sparse on the handling of significant incidental findings which are identified in biobank systems
This article has shown that research participants need to be protected from research-related harm which may emerge as a result of an omission to disclose incidental findings
Actionable and verified incidental findings should be revealed to participants since incomplete understanding and under-researched findings of incidental findings can lead to unnecessary worry, upset and confusion
Summary
Biobanks have come to be essential apparatuses of genetic and genomic research as they are seen as essential tools for translational medicine in particular (Wolf et al “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets” 2012 14(4) Genetics in Medicine 361; and see Zawati and Knoppers “International Normative Perspectives on the Return of Individual Research Results and Incidental Findings in Genomic Biobanks” 2012 14(4) Genetics in Medicine 484). Various unique ethical and legal challenges arise in the course of biobanking as biobanks generate a range of ethical and legal challenges related to privacy, informed consent, control and ownership, withdrawal of samples, commercialization, genomic sovereignty, return of results, incidental findings, and research governance. These issues have generated much policy debate within the international world, and yet in South Africa, debates on the ethical and legal challenges posed by biobanks and biobank networks still remain alienated. Framework” 2013 6(2) South African Journal of Bioethics and Law 38–39 DOI:10.7196/sajbl.296 published 2013-10-24), it is apparent that researchers as well as clinicians are anticipated to access data from biobanks and to this end, laws, clear public guidance and regulations on the handling of incidental findings are indispensable
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