Background The use of tissue collected at a forensic post-mortem for forensic genetics research purposes remains of ethical concern as the process involves obtaining informed consent from grieving family members. Two forensic genetics research studies using tissue collected from a forensic post-mortem were recently initiated at our institution and were the first of their kind to be conducted in Cape Town, South Africa. Main body This article discusses some of the ethical challenges that were encountered in these research projects. Among (...) these challenges was the adaptation of research workflows to fit in with an exceptionally busy service delivery that is operating with limited resources. Whilst seeking guidance from the literature regarding research on deceased populations, it was noted that next of kin of decedents are not formally recognised as a vulnerable group in the existing ethical and legal frameworks in South Africa. The authors recommend that research in the forensic mortuary setting is approached using guidance for vulnerable groups, and the benefit to risk standard needs to be strongly justified. Lastly, when planning forensic genetics research, consideration must be given to the potential of uncovering incidental findings, funding to validate these findings and the feedback of results to family members; the latter of which is recommended to occur through a genetic counsellor. Conclusion It is hoped that these experiences will contribute towards a formal framework for conducting forensic genetic research in medico-legal mortuaries in South Africa. (shrink)

Africa has a colonial past that renders it a linguistic melting pot, where language is not only important for communication but is inextricably related to cultural identity. In Africa, there are over 2000 languages that are still being used and spoken. Language diversity coupled with cultural diversity may affect the process of obtaining informed consent in data-intensive research. We explore some of the challenges and opportunities of multilingualism in handling informed consent in the context of data-intensive research. In multilingual contexts, (...) as in most African countries, language is exceptionally central, and translation has potential cultural, social, historical, functional and scientific importance. However, it is recognised that terminological and translation activities may not always be cost-effective or feasible. We consider alternative mechanisms of harmonisation of data-related terminology and concepts in multilingual contexts, such as iconography, graphic elicitation and other multimedia formats of information sharing. The inclusion of visual or multimedia explanations in informed consent forms can improve comprehension, enhance information transfer and learning, reduce potential vulnerabilities associated with low literacy levels or the inability to interpret technical language associated with data-intensive research, build trust with participants and their communities, and promote autonomy of potential participants. We recognise that the inclusion of visual or multimedia content to facilitate information transfer is only one component of the informed consent process for data-intensive research. Research ethics committees (RECs) should be mindful of other key considerations and challenges of informed consent for data-intensive research in sub-Saharan Africa (SSA), and to explore whether these alternative forms of consent are ethical and effective in multilingual contexts. (shrink)

Despite its invasive nature, specific consent for general anaesthesia is rarely sought—rather consent processes for associated procedures include explanation of risk/benefits. In adult intensive care, because no one can consent to treatments provided to incapacitated adults, standardised consent processes have not developed. In paediatric intensive care, despite the ready availability of those who can provide consent, no tradition of seeking it exists, arguably due to the specialty’s evolution from anaesthesia and adult intensive care. With the current Montgomery-related focus on consent, (...) this seems untenable. We undertook a qualitative study in a specialist children’s hospital colocated paediatric/neonatal intensive care (same medical team) in which parental acceptance of admission and entailed procedures is considered implied by virtue of that admission. Semistructured interviews were carried out with both staff and parents to investigate their views about consent, the current system and a proposedblanket consent system, in which parents actively consent at admission to routine procedures. Divergent views emerged: staff were worried that requiring consent at admission might prove a further emotional burden, whereas parents found providing consent a way of coping, feeling empowered and maintaining control. Inconsistencies were found in the way consent is obtained for your routine procedures. Practice does seem inconsistent with contemporary consent standards for medical intervention. Our findings support the introduction of a blanket consent system at admission together with ongoing bedside dialogue to ensure continuing consent. Both parents and staff expressed concern about avoiding possible harmful delays to children due to parental emotional overload and language difficulties. (shrink)

Background. Over the past decades there have been tremendous efforts to improve the ethical conduct of research involving humans throughout the world. As a one-size-fits-all philosophy can no longer work, most countries have developed specific legal and ethical guidelines for research, tailored to their own context. We reviewed South African ethical guidelines and Health Research Acts as they pertain to the role of caregivers in consent practices for minors’ participation in HIV/AIDS-related research. Methods. An argument-driven review was conducted on two (...) SA Acts and Guidelines respectively: the SA National Health Act of 2003; the Children’s Act No. 38 of 2005 and the Department of Health Ethics in Health Research Guidelines 2nd edition of 2015 and the Good Clinical Practice Guidelines of 2006, with a particular focus on minors as research participants. We also examined the relevant ethical and legal guidance using an exemplar of paediatric HIV testing within research conducted in SA. Results. Available ethical guidelines for caregivers’ consent in research involving minors are still not comprehensive or aligned with SA regulations governing research with minors. The recent revision and development of the National Health Research Ethics Guidelines, regarding the role of caregivers in consent practice for minors’ participation in health research, may be a positive move in clarifying the proper role for caregivers when enrolling minors in research. Conclusion. Caregivers are deemed to have a role to play in research involving minors. Therefore, the inconsistencies in existing ethical guidelines and governing regulations regarding the role of caregivers in paediatric HIV research, need to be addressed following the recent ethical paradigm change. (shrink)