The rise of genomic studies in Africa – not least due to projects funded under H3Africa – is associated with the development of a small number of biorepositories across Africa. For the ultimate success of these biorepositories, the creation of cell lines including those from selected H3Africa samples would be beneficial. In this paper, we map ethical challenges in the creation of cell lines.

Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups.

BackgroundThe issue of stigma is very important in the battle against HIV/aids in Africa since it may affect patient attendance at healthcare centres for obtaining antiretroviral medications and regular medical check-ups. Stigmatization creates an unnecessary culture of secrecy and silence based on ignorance and fear of victimization. This study was designed to determine if there is external stigmatization of people living with HIV and AIDS by health care workers at a tertiary hospital in KwaZulu-Natal province, South Africa. The study investigated (...) the impact of knowledge of HIV/aids by HCWs on treatment of patients, as well as the comfort level and attitude of HCWs when rendering care to PLWHA.MethodsA descriptive cross sectional study was designed to collect data using an anonymous self-administered structured questionnaire from 334 HCWs. The study was conducted in clinical departments of a large multidisciplinary 922-bed tertiary care teaching hospital in Durban, KZN.ResultsOverall HCWs had an above average knowledge about HIV/aids although some gaps in knowledge were identified. Tests of statistical significance showed that there was association between level of education and knowledge of HIV/aids ; occupation and knowledge of HIV/aids ; and gender and knowledge of HIV/aids. Test for comfort level was only significant for gender, with males showing more comfort and empathy when dealing with PLWHA. The study also revealed that patients were sometimes tested for HIV without informed consent before surgery, due to fear of being infected, and there was some gossiping about patients' HIV status by HCWs, thereby compromising patient confidentiality. The majority of HCWs showed a willingness to report incidents of stigmatization and discrimination to higher authorities, for better monitoring and control.ConclusionsAlthough knowledge, attitude and comfort level of HCWs taking care of PLWHA was above average, enforcement of existing antidiscrimination laws and continuing education in medical ethics and healthcare law, would greatly improve the performance of HCWs taking care of PLWHAs. More psychological support and counselling should be provided to HCWs, to further reduce the impact of stigmatization and discrimination against PLWHA. (shrink)

ObjectiveInformed consent is a prerequisite for caesarean section, the commonest surgical procedure in low- and middle-income settings, but not always acquired to an appropriate extent. Exploring perceptions of health care workers may aid in improving clinical practice around informed consent. We aim to explore health workers’ beliefs and experiences related to principles and practice of informed consent.MethodsQualitative study conducted between January and June 2018 in a rural 150-bed mission hospital in Southern Malawi. Clinical observations, semi-structured interviews and a focus group (...) discussion were used to collect data. Participants were 22 clinical officers, nurse-midwives and midwifery students involved in maternity care. Data were analysed to identify themes and construct an analytical framework.ResultsDefinition and purpose of informed consent revolved around providing information, respecting women’s autonomy and achieving legal protection. Due to fear of blame and litigation, health workers preferred written consent. Written consent requires active participation by the consenting individual and was perceived to transfer liability to that person. A woman’s refusal to provide written informed consent may pose a dilemma for the health worker between doing good and respecting autonomy. To prevent such refusal, health workers said to only partially disclose surgical risks in order to minimize women's anxiety. Commonly perceived barriers to obtain a fully informed consent were labour pains, language barriers, women’s lack of education and their dependency on others to make decisions.ConclusionsHealth workers are familiar with the principles around informed consent and aware of its advantages, but fear of blame and litigation, partial disclosure of risks and barriers to communication hamper the process of obtaining informed consent. Findings can be used to develop interventions to improve the informed consent process. (shrink)

Background: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values (...) underlying informed consent. Methods: Over a 2-week period in April 2014 we conducted semistructured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute’s requirements for consent, and the researchers’ strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Results: Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors’ accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. Conclusions: We argue that while building and maintaining trusting relationships in research is important—not least in developing countries—strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out. (shrink)

ObjectiveTo evaluate the knowledge and performance of surgical residents regarding the person from whom informed consent should be taken for surgery and from whom the consent is taken in practice.Materials and methodsThis study was done in 2013. The population of this study was all residents of urology, surgery, orthopaedic surgery and gynaecology of Tehran and Iran University of Medical Sciences. The study tool was a self-administered questionnaire, containing questions on their knowledge and performance regarding informed consent acquisition from patients with (...) different conditions in terms of age, sex, marital status and their capacity to make treatment decisions.ResultsA total of 213 residents participated in the study. The mean score of the participants’ knowledge was 72.95 out of 100. There was no significant correlation between the residents’ knowledge and performance. Regarding a competent married male patient, 98.2% of the residents knew that the person’s consent was enough, but only 63.6% obtained informed consent only from the patient. These percentages were 69% and 19.7% for a competent married female patient, respectively. For a competent single male patient, 90.9% of the residents were aware that the patient’s consent was enough, while only 40% of the residents obtained informed consent only from the patient. These percentages were 65.3% and 16% for a competent single female patient, respectively.ConclusionDespite the residents’ average knowledge of patient autonomy, this right is not observed for female patients, and their treatment is subject to consent acquisition from other family members. (shrink)

Treatment informed consent aims to preserve the autonomy of patients in the clinician – patient relationship so as to ensure valid consent. An acceptable method of evaluating understanding of consent information is by assessing the extent of recall by patients of the pieces information believed to have been passed across. When concerns are not satisfactorily addressed from the patients’ perspective, recall of consent information may be low. This study is a questionnaire – based cross – sectional interview of consecutive adult (...) surgical patients who could give their respective medical histories and who were booked for elective major surgical procedures over a period of 7 months in a tertiary health institution in southeastern Nigeria. Four to five days after a formal consent session, during ward admission, extent of recall of information on the nature of the disease condition or diagnosis, the nature of the planned procedure and the risks involved in the planned procedure were assessed and analyzed on the background of how satisfying the consent sessions were from individual patient’s perspective. Generally, the recall of nature of disease condition and nature of planned procedure is better than recall of risks involved in the planned procedure. More specifically however, recall in these 3 domains is significantly better among the patients that affirmed that their concerns were satisfactorily addressed. The findings from this study support that no effort should be spared in ensuring that the consent information are satisfying to the patients from the patients’ viewpoint. (shrink)

This paper explores the role of ‘community’ in the context of global bioethics. With the present globalization of bioethics, new and interesting references are made to this concept. Some are familiar, for example, community consent. This article argues that the principle of informed consent is too individual-oriented and that in other cultures, consent can be community-based. Other references to ‘community’ are related to the novel principle of benefit sharing in the context of bioprospecting. The application of this principle necessarily requires (...) the identification and construction of communities. On the global level there are also new uses of the concept of community as ‘global community.’ Three uses are distinguished: (1) a diachronic use, including past, present, and future generations, (2) a synchronic ecological use, including nonhuman species, and (3) a synchronic planetary use, including all human beings worldwide. Although there is a tension between the communitarian perspective and the idea of global community, this article argues that the third use can broaden communitarianism. The current development towards cosmopolitanism is creating a new global community that represents humanity as a whole, enabling identification of world citizens and evoking a sense of global solidarity and responsibility. The emergence of global bioethics today demonstrates this development. (shrink)