Informed consent practices in research involving people living with schizophrenia and bipolar affective disorders at a national mental health referral hospital in Uganda: a qualitative study

Obtaining informed consent from research participants is an ethical imperative. Disclosure of research information to potential participants to enable them to make a decision is usually done by providing information sheets. Concerns have been raised about the length and complexity of the participant information sheets. This study sought to explore the practices of key research team members in obtaining informed consent for research involving participants with schizophrenia and bipolar affective disorder at the national referral mental health hospital in Uganda. The study was conducted at Butabika National Referral Mental Hospital, Makerere University, Mbarara Universit,y and Gulu University. In-depth interviews were conducted with 21 participants who were selected through purposive and snowball sampling procedures. Audio recordings were transcribed, and transcripts were managed using Nvivo 14. Data were analyzed using inductive thematic analysis. Two themes emerged from the findings including key considerations during the Informed consent process and (2) enhancing participants' understanding of the research and medical terms. Participant autonomy was maintained through follow-up to see if they still had capacity in the course of participation. Researchers kept the participants interested in the consent discussion through building rapport and having their attention to listen to the study information, and dedicated more time to ensure an effective interaction to provide research information. Caregivers were involved in the consent process to support the participants by acting as either witnesses or surrogates. Participants' understanding of consent information was enhanced through reading the research information to them, using iterative learning, and consulting the research community and health professionals who interact with the participants in the course of care. It was important for participants to be aware of their participation in research throughout the study period, in line with the principle of autonomy. Participant attention during the consent discussion ensured effective disclosure of study information. Iterative learning and use of appropriate words improved their understanding of consent information.