Consenting practices to enhance comprehension in research involving individuals with schizophrenia and bipolar affective disorder in Uganda: a qualitative inquiry

Abstract

BACKGROUND: Obtaining informed consent from research participants is an ethical imperative. In mental health research, cognitive deficits can impair the ability to provide individual consent. This study explored the consenting practices of key research team members to enhance comprehension in research involving individuals with schizophrenia and bipolar affective disorder at the national referral mental health hospital in Uganda. METHODS: The study was conducted at a national referral mental hospital in Uganda. In-depth interviews were conducted with 21purposively selected participants. Audio recordings were transcribed, and transcripts were managed using NVivo 14. Data were analyzed using inductive thematic analysis. RESULTS: Two themes emerged from the findings: (1) key considerations during the informed consent process, and (2) reported practices for enhancing participants' understanding of the research and medical terms. Researchers reported that participants' capacity to consent was maintained through follow-up to see if they still had capacity in the course of participation. They kept participants interested in consent discussions through building rapport, listening to them attentively, and dedicating more time to ensure effective interaction. Caregivers played an important role in consenting. Researchers perceived that comprehension of consent was supported through reading the consent information to participants verbatim, using iterative learning, and consultation with the community and health professionals who routinely interact with participants. CONCLUSION: Researchers reported using ongoing consent discussions, rapport building, caregiver involvement, iterative learning, and adaptation of study information to local contexts. These findings suggest the perceived value of contextual and relational factors in supporting autonomy during the consent process for persons with schizophrenia and bipolar affective disorder.