ArticleBMC medical ethics2026
Ethical challenges researchers encounter during the informed consent processes for research involving people with schizophrenia and bipolar affective disorder: a qualitative assessment.
Article in BMC medical ethics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundInformed consent is an important safeguard for participants enrolled in mental health research. However, several factors affect the informed consent process. This study explored the ethical challenges encountered by research team members during the informed consent process when enrolling participants with schizophrenia and bipolar affective disorder into research.
methodsA qualitative study was conducted with key research team members at three mental health referral hospitals in Uganda. Twenty-one people were purposively selected to participate in semi-structured interviews. Data were analyzed using inductive thematic analysis and managed using NVivo 14 software.
resultsTwo themes were generated from the interpretation of the data: (1) understanding, family involvement, and decision-making in the consent process, and (2) negotiating vulnerability, decision-making power, and meaning in the informed consent process. Research team members reported that some of their potential participants appeared to be stable but did not fully understand the information provided. and failed capacity assessments even after receiving multiple explanations. Cases of decisional conflicts between participants and family members concerning participation were also reported, whereas some participants easily exhibited restlessness, short attention span and fatigue during lengthy consenting processes, others were hesitant to consent without consulting their family members. Additionally, research team members observed that participants sometimes prolonged the consent discussions by talking about their life stories. The use of psychiatric terms in consent forms inadvertently stigmatized participants, making them uncomfortable.
conclusionInformed consent is an important safeguard for participants enrolled in mental health research. However, multi-faceted ethical challenges affect the informed consent process for patients living with schizophrenia and bipolar affective disorders in Uganda, including cognitive limitations and social factors such as emotional needs, family dynamics and stigma. There is a need to understand the perspectives and experiences of family members who consent on behalf of an individual with limited capacity to consent for research.
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