There are complex unresolved ethical, legal and social issues related to the use of human tissues obtained in the course of research or diagnostic procedures and retained for further use in research. The question of intellectual property rights over commercially viable products or procedures that are derived from these samples and the suitability or otherwise of participants relinquishing their rights to the samples needs urgent attention. The complexity of these matters lies in the fact that the relationship between intellectual property (...) rights and ownership or rights pertaining to the samples on which the intellectual property right is based may either be overlooked or taken for granted. What equally makes the matter complex is that samples may be obtained from participants in developing countries and exported to developed countries for analysis and research. It is important for research ethics committees to tread carefully when reviewing research protocols that raise such issues for purposes of ensuring that appropriate benefit sharing agreements, particularly with developing countries, are in place.This paper attempts to analyse the key questions related to ownership and intellectual property rights in commercially viable products derived from human tissue samples. Patent law is used as a point of reference as opposed to other forms of intellectual property rights such as industrial designs because it is the right that most inventors apply for in respect of human tissue-related inventions. The key questions are formulated following a systematic analysis of peer reviewed journal articles that have reported original investigations into relevant issues in this field. Most of the cases and reported studies that are referred to in this paper do not directly deal with HIV/AIDS research but the underlying principles are helpful in HIV/AIDS research as well. Pertinent questions, which members of ethics review committees should focus on in this regard are discussed and suggestions on appropriate approaches to the issues are proposed in the form of specific questions that an ethics review committee should consider. Specific recommendations regarding areas for further research and action are equally proposed. (shrink)

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...) Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)

Thaddeus Metz, in his book “A Relational Moral Theory” compares the relational African view to Western theories of right action with a focus on Kant (respective contemporary Kantianism) and Utilitarianism. In focussing on the opposition between a relational and an individualistic view, Metz questions the interpretation of basic normative assumptions that are guiding central Western moral and political institutions. He particularly focusses on Kantian and Utilitarian approaches to which he ascribes substantive moral assumptions in terms of utility respective autonomy. In (...) this paper, we reconstruct Metz’s position on the opposition between a relational and an individualistic view on ethics. We then investigate whether his relational conceptualisation is a convincing reconstruction of African views and question his take on Western positions, focussing in particular on views around individual rights and communality as presented in the Kantian tradition. We highlight the value of ubuntu in intercultural discourse to foster ethical and moral reasoning in a holistic way and conclude that any reflection on ethics necessarily involves an understanding of our common human nature, which is at the core of philosophical anthropology. (shrink)

The ongoing efforts to establish biobanks in Africa envisage the availability of biological samples and data in accordance with relevant national legislation and ethical principles. Current literature has established that many African countries “do not have national legislation or guidelines on the use of stored biological samples” or if such guidelines are in place, then “disparities exist in relation to informed consent and export and import requirements.” In this regard, this article considers the extent to which the available legal and (...) ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors. (shrink)

ABSTRACTThe objective of this module is to familiarise you with the concept of informed consent, its ethical basis, its elements, and typical problems that are encountered even by the most well intentioned researchers when trying to achieve genuine informed consent.

This piece outlines concrete cases of benefit sharing that occur in relation to the sharing of human (biological) samples. For example, it surveys Indonesia’s decision, in 2006, to stop sharing virus samples of H5N1 (avian influenza) with the WHO Global Influenza Surveillance Network (GISN). It also outlines some of the ethical issues that arise in these cases.

Responses to the COVID-19 pandemic globally disrupted lives and contributed to the exacerbation of pre-existing inequalities. Women in research were also affected. The prominent role that women played in professional and personal care duties had a detrimental effect on their research outputs, potentially hindering their career progression. Moreover, the challenges faced by women academics during the pandemic, including job loss, increased mental health issues, and the intersection of gender with other socio-demographic traits exacerbated existing gender disparities within academia. By systematically (...) scoping the qualitative literature on the experiences of women researchers during the pandemic, this study sought to explore how women experienced and reacted to the challenges generated by the COVID-19 pandemic. A qualitative meta synthesis of the included studies revealed three themes: gendered professional expectations, colliding identities and coping strategies. These themes show how gendered roles such as teaching and professional care work, associated with the hierarchical and gendered division of tasks both at home and in the workplace, made women feel unsupported and alienated as relevant agents in the academic context. The study reveals the importance of pastoral care, teaching and service work as the essential backbone of the academic infrastructure, especially in times of crises. It also exposes how productivity-focused researcher assessment criteria, rewarding mainly individual results and unrewarding of care and service work, can be viewed as perpetuating structural inequalities based on gender, parenting situations, contractual situations and background. In conclusion, this study exposes the need to proactively address the gendered practices and implicit biases which reproduce inequalities within academia and highlights how paying attention to the experiences and needs of women researchers is essential for improving the resilience and crises preparedness of academic the system. (shrink)

Researchers from the Universities of Oxford, Nairobi, and Manitoba are collaborating on a project to develop an HIV vaccine based on the immunological protection mechanisms found in commercial sex workers from the Majengo slum in Nairobi. This group consists of educationally and economically disadvantaged women who resort to commercial sex work for a living. A clinic was established in the slum to study sexually transmitted diseases, which now includes HIV/AIDS. The clinic serves as a research facility for the collaborating researchers (...) who have been using the women's blood, cervical, vaginal, and saliva samples for the ongoing studies. The clinic runs two HIV-integrated activities: HIV research and HIV care and treatment. For HIV negative participants, samples are collected and used for research and care after they give informed consent. (shrink)