With biobank research on the increase and the history of exploitation in Africa, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of Material Transfer Agreements that currently exist internationally. However, these templates do not address the specific concerns of South Africa and even of Africa as a continent. This article will examine three significantly important ethico-legal concepts that were deliberated and carefully adapted by a South African Institution to suit (...) the transfer of Human Biological Materials and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico-legal challenges in the South African/African context; the decisions made with regard to how the related ethico-legal challenges were addressed in the MTA; and justifications for implementing these decisions. The processes considered could be of benefit to other developing world countries who consider it necessary to manage the transfer of HBMs across national boundaries. (shrink)

Glucocorticoids are understood to represent useful biomarkers of stress and can be measured in saliva, hair, and breastmilk. The collection of such biosamples is increasingly included in biobank and cohort studies. While collection is considered “non-invasive” by biomedical researchers (compared to sampling blood), community perspectives may differ. This cross-sectional, qualitative study utilising eight focus groups aimed to determine the feasibility and acceptability of collecting ostensibly “non-invasive” biological samples in Malawi. Breastfeeding women, couples, field workers, and healthcare providers were purposively sampled. (...) Data about prior understandings of, barriers to, and feasibility of “non-invasive” biosampling were analysed. Participants described biomaterials intended for “non-invasive” collection as sometimes highly sensitive, with sampling procedures raising community concerns. Sampling methods framed as physically “non-invasive” within biomedicine can consequently be considered socially “invasive” by prospective sample donors. Biomedical and community framings of “invasiveness’ can therefore diverge, and the former must respond to and be informed by the perspectives of the latter. Further, considerations of collection procedures are shaped by therapeutic misconceptions about the immediate health-related utility of biomedical and public health research. When researchers engage with communities about biosampling, they must ensure they are not furthering therapeutic misconceptions and actively seek to dispel these. (shrink)

Scientific interest in genomics in Africa is on the rise with a number of funding initiatives aimed specifically at supporting research in this area. Genomics research on material of African origin raises a number of important ethical issues. A prominent concern relates to sample export, which is increasingly seen by researchers and ethics committees across the continent as being problematic. The concept of genomic sovereignty proposes that unique patterns of genomic variation can be found in human populations, and that these (...) are commercially, scientifically or symbolically valuable and in need of protection against exploitation. Although it is appealing as a response to increasing concerns regarding sample export, there are a number of important conceptual problems relating to the term. It is not clear, for instance, whether it is appropriate that ownership over human genomic samples should rest with national governments. Furthermore, ethnic groups in Africa are frequently spread across multiple nation states, and protection offered in one state may not prevent researchers from accessing the same group elsewhere. Lastly, scientific evidence suggests that the assumption that genomic data is unique for population groups is false. Although the frequency with which particular variants are found can differ between groups, such genes or variants per se are not unique to any population group. In this paper, the authors describe these concerns in detail and argue that the concept of genomic sovereignty alone may not be adequate to protect the genetic resources of people of African descent. (shrink)

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not (...) allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi. (shrink)

BackgroundGenome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.DiscussionWe explore ethical (...) issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. With regard to participants, important challenges are raised about community consultation and consent. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. In the context of protecting the interests of researchers in low income countries, we discuss aspects of data sharing and capacity building that need to be considered for sustainable and mutually beneficial collaborations.SummaryMany ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the (...) REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

BackgroundEthical and regulatory guidance on the collection and use of human biospecimens for research forms an essential component of national health systems in Sub-Saharan Africa, where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks.MethodsAn extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which (...) HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens.ResultsOf the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent, ownership, reuse, storage, and export/import/transfer. Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS.ConclusionsDespite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise. (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed the REC (...) of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)