Biobanks and human health research: Balancing progress and protections

Abstract

The advent of biobanks in the field of science and technology has seen scientists entering a new age in biotechnology research. General ethical considerations, which apply to health research involving human participants, will apply equally to biobank research. However, in addition, there are unique ethical issues specific to biobank research. This is because of the nature of biobank research which has evolved to include an intersection of disciplines and networks. While the unique considerations pertaining to genetic research also apply in this context, with biobanks, international collaborations have emerged on a scale not previously seen. Without doubt this type of collaborative research is pivotal to advancing science, health and well-being. Nevertheless, multifaceted ethico-regulatory and social complexities have surfaced, including concerns around individual and group autonomy, informed consent, privacy, confidentiality, secondary use of samples and data over long periods, data sharing, benefit sharing and differing legal requirements across national boundaries.[1] Because biobanks are essential for major advances in health research, a balance is required between the tensions arising from the need for progress towards human health and well-being and ethico-regulatory and social concerns.In this paper we briefly describe biobanks and the advancement from biobanks to networking and sample and data-sharing. We discuss how the supremacy of informed consent is challenged by this new age research and some of the risks that could occur in the context of biobank research. We highlight the importance of safeguards like specimen and data access agreements and the pivotal role of public trust for the success of this type of research enterprise. The need for ethics in the governance of biobanks is underscored. Pertinent international and local ethics and governance documents are referred to. The legal void in South Africa (SA) with regard to biobank research is also discussed. While the ethico-regulatory issues relating to biobank research in this paper are not exhaustive, we raise what we consider to be the relevant ones. Biobanks -a brief descriptionBiobanks are repositories that store animal, plant and human specimens. This paper focuses on biobanks that store human bio logical materials (HBMs) specifically for research purposes. Biological materials, as defined in the Regulations to the South African National Health Act (NHA) [2] are: 'material from a human being including DNA, RNA, blastomeres, polar bodies, cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors from the same' .[3] Biobanks are repositories that store not only organised collections of HBMs usually from a large number of donors but also their associated data, including individual health records and information derived from their analysis. [1,4] A well-functioning up-to-date biobank serves to accelerate important advances in health research as it exploits 'state-of-the-art genetics together with big data se...

Considerations for an integrated population health databank in Africa: lessons from global best practices

“…Others include the Australian Guidelines on Human Biobanks and Genetic Research Databases 103 ; The OECD Principles and Guidelines for Access to Research Data from Public Funding 104 ; the Bermuda Principles 105 ; and the Expert Advisory Group on Access (EAGDA) report on Data Access 106 , 107 . Similar tools have been developed in parts of Africa 108 .…”

Biobanks in South Africa: A global perspective on privacy and confidentiality

“…that an 'ethico-regulatory framework' that is exclusively focused on biobanks [16] and in concurrence with all the principles of the UDBHR and international guidelines for biobanks should be developed and implemented in SA in the near future. [7][8][9] …”

“…informed consent, privacy and confidentiality, sharing of benefits, and many other ethical challenges. It is surmised that there are >12 biobanks of different sizes in SA, [7][8][9] but there is currently no national instrument that focuses exclusively on the ethics of biobanks. The National Health Act No.…”

Challenges and Opportunities in Ensuring Ethical Research in Africa

“…They further note that although some of the stakeholders have suggested that there should be host institution research capacity building in order to enable much of the research processes to be conducted locally, there is an acknowledgement that no level of local capacity can completely eliminate sample export. Dhai, Mahomed and Sanne (2015) argue that these challenges should not impede on human health research because networking and sharing of data maximise research potential through desired statistical power attainment, addressing resource constraint and some of the financial issues as well as being for the common good. It is for this reason that a mechanism for monitoring of the fate of exported samples is required.…”