Appropriate language use is essential to ensure inclusion of diverse populations in research. We aimed to identify possible language-related barriers regarding the informed consent process and propose interventions to improve clarity and understanding of pregnant and breastfeeding women participating in research. A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August 2023 to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board members. 19 FGD (...) comprised adult participants representing at least six different mother tongues (Luganda, Acholi, Runyankole, Runyoro, Lugbara and English). An inductive thematic approach was utilized for data analysis using NVivo version 12 software to identify language factors that influence informed consent. A series of community validation workshops ensured concurrence. At the individual level, language barriers, and low levels of literacy contributed to poor comprehension, thus hindering ability to achieve genuine informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, with poor and complicated grammar in some consent forms. Participants reported that complex medical terminologies are difficult to translate to local languages. Community members highlighted that social/cultural norms in language use affected cultural perceptions of informed consent. To enhance understanding for individuals without education in science, participants suggested simplification of terminologies and avoidance of complex medical jargon. Researchers should identify participants’ preferred languages and communicate in those languages whenever possible. If researchers are not fluent, trained interpreters should be identified. Informed consent documents must be translated into local languages to ensure participants comprehend the study’s purpose, procedures, risks, and benefits. Involving community members during development and translation of these documents can provide valuable insights into local dialects and culturally specific concepts, ensuring that study tools like surveys and consent forms are accurate and respectful. Language barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Consideration of locally understandable terms in community-facing study documentation is likely to enhance understanding and could improve research participation, although further studies are needed to assess these. The use of appropriate language ensures that informed consent is genuine in keeping with principles of Good Clinical Practice, and developing a research communication strategy should be part of inclusive research design. (shrink)

Little is known about how people living with HIV should be engaged in the decision-making process for returning individual pharmacogenomic research results. This study explored the role people living with HIV want to play in making decisions about whether and how individual results of pharmacogenomic research should be presented to them. A convergent parallel mixed methods study was conducted, comprising a survey of 221 research participants and five deliberative focus group discussions with 30 purposively selected research participants. Most participants (122, (...) 55.2%) preferred the collaborative role, 67 (30.3%) preferred the active role and 32 (14.5%) preferred the passive role. Factors that significantly influenced preference for an active role compared with a collaborative role were marital status (OR: 0.282, p = 0.013), research experience (OR: 4.37, p = 0.028), and religion (OR: 2.346, p = 0.041). The reasons proffered for the active role included prior experience with antiretroviral treatment and increased exposure to research activities. The reasons given for preferring the passive role included limited level of awareness about the interaction between patients’ genes and drugs, trust in researchers to make the right decision, and fear of making decisions with harmful implications. Overall, findings from our study show that participants want to be engaged in the decision-making process. Research teams ought to provide adequate and simple information about the pharmacogenomic research and implications of the results to support participants’ informed decisions. (shrink)

This study aimed to explore stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV. A qualitative approach to investigation involved five focus group discussions with 30 Community representatives, 12 key informant interviews with researchers, and 12 in-depth interviews with research ethics committee members. In total, 54 stakeholders who were involved in pharmacogenomics research and HIV treatment and care contributed to the data collection between September 2021 and February 2022. The study explored five (...) prominent themes: (i) defining the nature of research results to return to participants; (ii) preparing research participants to receive their results; (iii) obtaining informed consent for the return of results; (iv) opinions on health personnel to return the results to participants; and (v) opinions on how research results should be communicated to participants. Respondents identified various strategies for the return of individual results with minimal ethical risks including the setting up of a diverse and independent committee to undertake a risk-benefit assessment based on local context; ongoing discussions about the possible kinds of results and their implications throughout the study; and employing genetic counsellors to communicate results to participants. The strategies identified in this study should be further studied and independently verified. (shrink)

Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were conducted. (...) The data were analyzed thematically using NVivo version 12 software. Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics were less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine. This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists’ practices and attitudes toward informed consent. (shrink)