Biobanks, defined by the World Medical Association (WMA) as collections of biomaterials (interchangeably referred to as samples) and associated data, [1] have evolved in response to advances in sample preservation infrastructure and data storage technologies. [2] This in turn has enabled the use of biobanking as a resource for supporting scientific research and development through readily available materials (including samples and data). The laws pertaining to biobanks and biobank research should reflect and be consistent with protection of materials as a means of preventing inappropriate sharing and access, thereby causing an infringement of ethical principles. Unlike morality, laws are enforceable. Health research in South Africa (SA) is regulated by a number of instruments, including: the Bill of Rights of the Constitution, 1996 (hereinafter referred to as the Constitution), [3] which is supreme law; the National Health Act No. 61 of 2003 (NHA) [4] and its relevant research-related regulations; the Health Professions Council of SA (HPCSA)'s policies and professional codes of ethics (general and research-related); [5] and the National Department of Health's Ethics in Health Research: Principles, Processes and Structures. [6] Legislation differs between countries in as much as standards applicable in one society may not necessarily apply in another, hence the need for a specific and adequate national regulatory framework. In this article, the current ethicolegal framework for biobank research in SA is discussed, as well as material transfer agreements (MTAs) and regulations pertaining to the export of materials. The most relevant international regulations pertaining to the sharing of materials are highlighted as reference for development of a framework specific to SA, and specific recommendations that address the current inadequacies are offered. This ope-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

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Research involving humans often generates considerable data irrespective of the context in which the research is being conducted. This data must be protected from unauthorized access, use, and sharing as a means of safe-guarding research participants’ rights. Notwithstanding the fact that several jurisdictions globally have promulgated laws and regulations aimed at protecting individual citizens’ personal information, violation of privacy and related rights occurs in some instances. This could partly relate to a general lack of health research sector specific data governance policies and laws, which include data transfer agreements prevalent in most countries. The chapter therefore aims to cover the ethical aspects of health research data access, use, and sharing as a means of enabling health research institutions and policymakers to develop robust data governance structures and procedures. The scope of the chapter covers health research data generated in empirical research as well as that which is produced within a medical laboratory research context, i.e., human sample associated data.

The main ethical issues specific to the African continent research agenda relate to the vulnerability of African researchers, particularly as a result of inadequate resources, inadequate or lack of applicable legislation, and genetic variability of African populations that make samples from such populations most sought-after by researchers from other continents. This paper explores some of the ethical research challenges in Africa through an ethico-legal assessment of the literature and offers opportunities for addressing these challenges. The literature review findings revealed ethical dilemmas that include consent issues, cross-border transfer of samples and material transfer agreements, commodification of human material as well as benefit sharing. Based on these findings, opportunities for ethical research arise and these include benefit sharing such as researcher recognition and participating community study-related health benefits and well-defined agreements that consider appropriate specimen access and use. Significant changes in African research status quo are required to counter the effects of ethical research challenges, thereby ensuring sound ethical conduct and integrity in research. In addition to the noted opportunities, this paper also recommends monitoring of the fate of exported samples and proposes an ethical matrix that can be used by governments and institutions in addressing the highlighted research challenges in ethical decision making and policy intervention.