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.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1186/s40359-026-05168-z.

Introduction

Obtaining informed consent from research participants is an ethical imperative [1, 2]. Research participants should be informed about the nature, purpose, benefits, risks, and alternatives to participation, as well as confidentiality. Most importantly, they should know that participation is voluntary [3–6].

Conducting research among patients with mental illness is crucial for improving their care [7–9]. But, this can only be realized if patients are willing to voluntarily participate in research [7, 10–12]. However, concerns have been raised about the ability of individuals with mental illness to participate in research [9, 13, 14]. Individuals with schizophrenia are at a higher risk of reduced decision-making capacity due to cognitive deficits and impaired insight, which can hinder their ability to make informed choices [15]. Similarly, individuals with bipolar affective disorder may experience inattention and distractibility, leading to a compromised ability to process and retain study information [16].

A study conducted in the United States found that clinically stable outpatients with schizophrenia struggled with recalling study information due to fatigue and poor attention [15]. Similarly, a related study noted that individuals with schizophrenia or bipolar disorder experienced fluctuations in their decisional capacity over time [17]. Furthermore, a study in South Africa revealed that participants with schizophrenia initially had a poor understanding of study information, and they required more time to comprehend the information fully [18]. These findings emphasize the need for assessing an individual’s capacity to give consent before participating in research [10, 19], as well as conducting periodic assessments after enrollment [17], since consent is an ongoing process [20].

Researchers can evaluate a participant’s ability to give meaningful informed consent through screening [21]. There are primarily two methods for assessing this capacity [14]: evaluating overall cognitive abilities with tests like mental status examinations [14, 22] and conducting specific capacity assessments that focus on the participant’s understanding of the particular research study [14]. Combining these approaches increases confidence in assessing capacity [10]. Several validated tools are available for evaluating capacity to consent among individuals with mental health conditions [23], including the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) [24, 25] and the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) [18, 26].

The requirement to inform participants typically involves providing information sheets before they decide to participate in research [2, 3, 27, 28]. However, there are global concerns about whether potential participants, especially in low- and middle-income countries (LMICs), can understand this information [13, 15–17, 29–31]. In LMICs, participants are often laypersons [32] with limited formal education, low mental health literacy, and high levels of stigma [9, 33–40]. Lay persons may find it challenging to differentiate between distinct psychiatric conditions due to limited exposure to mental health education [41]. Moreover, cultural beliefs contribute to the stigma and misconceptions surrounding mental illness [9, 13, 42].

A study conducted in South Africa, aimed to evaluate whether individuals with schizophrenia improved their understanding of a research study through iterative learning, found that the quality of informed consent was strongly linked to the recruiter’s grasp of the study information, as well as their ability to choose appropriate language and simplify explanations for the study participants [18]. For research involving people with mental illnesses, informed consent procedures should be flexible to accommodate varying levels of understanding and education [43–45]. All study information must be translated appropriately and presented in a way that enhances participants’ comprehension, taking into account the community’s understanding of the mental disorders being studied [43]. However, language differences can complicate the communication of medical concepts [9]. Studies in low-resource settings have reported challenges in finding suitable local terminology for schizophrenia when translating consent documents [37, 46, 47].

In Uganda, mental, neurological, and substance use disorders significantly contribute to the overall public health burden [48]. Mental health services are part of the minimum healthcare package, which encompasses various levels of care, ranging from primary healthcare to district hospitals, regional referral hospitals, and tertiary care at Mulago National Referral Hospital and Butabika National Referral Mental Hospital [48, 49]. These facilities provide curative, preventive, and rehabilitative psychiatric services. All public psychiatric services and basic medications are free [48]. Private health facilities and non-governmental organizations also offer mental health services, including psychotherapy and counselling [48].

Informed consent is a legal and ethical requirement in Uganda, which can be given in written or verbal form [50, 51]. Patients or their next of kin can make decisions, although family members may be consulted [52]. According to the 2019 Patients’ Rights and Responsibilities Charter, every patient has the right to receive adequate and accurate information about their illness and proposed treatments to make informed decisions [53]. This information should be provided at the earliest possible stage and in an understandable way, enabling patients to make a free, informed, and independent choice [53]. Consent must be obtained by the clinician directly involved in the patient’s care.

The 2018 Uganda Mental Health Act states that individuals who are 18 years or older and voluntarily seek help from a health or mental health unit are entitled to receive voluntary treatment, provided they give their consent. If an individual is brought by a relative or concerned person, they will only receive treatment if the relative or concerned person gives written consent [54].

The 2014 Uganda National Guidelines for the Conduct of Research Involving Human Participants require researchers to obtain informed consent from individuals or their authorized representatives before participation [55]. The consent form must clearly state that the activity is a study and not a health service [55]. Additionally, the 2019 Patients’ Rights and Responsibilities Charter stipulates that a patient who is a potential research participant must provide informed consent and has the right to decline participation at any stage of the research [53].

Schizophrenia and bipolar disorder are among the common mental illnesses in Uganda [56–59], and research is conducted among individuals with these conditions. Previous studies on informed consent have primarily focused on assessing decisional capacity for research among individuals with schizophrenia and bipolar affective disorders [18, 60, 61]. However, there has been limited research on other aspects of the consent process, such as methods of information disclosure, researcher-participant interaction, and various practices or considerations that enhance participants’ understanding of research information.

This study explored the consenting practices for ensuring comprehension of research information in research involving individuals with schizophrenia and bipolar affective disorder in Uganda. The findings may contribute to the improvement of guidelines for obtaining informed consent from individuals with mental illness conditions to ensure ethical and respectful treatment of individuals in research.

Methods

The study employed a cross-sectional qualitative study design to explore the informed consent practices at a national mental health referral hospital in Uganda. The study was conducted among key research team members (both clinical researchers and non-clinical study staff) who had conducted research involving persons with schizophrenia and bipolar affective disorders for more than two years. In-depth interviews were conducted with 21 key research team members selected through purposive and snowball sampling. With snowball sampling, the recruited research participants were asked to recommend other individuals who met the study’s inclusion criteria for participation.

Respondents included nine principal investigators, one project leader, four study coordinators and seven research assistants involved in research involving participants with schizophrenia and bipolar affective disorder. Respondents were either approached physically or contacted through phone calls and emails to explain the study to them and request an appointment. In-depth interviews were conducted by GB, physically or virtually via Zoom, depending on one’s availability and were audio recorded. The interviews were guided by a semi-structured interview guide that was informed by the literature and developed by GB and ESM (Supplementary File 1). The interview guide had three sections. The first section gathered data on demographic characteristics. The second section had questions on the processes and procedures of obtaining consent, while the third section captured information on the roles played by key research members during the consent process.

Interviews were transcribed verbatim, and data were managed using NVivo 12 software. Data analysis was conducted continuously using an inductive thematic approach [62, 63]. Two researchers, GB and RB, independently coded the transcripts line-by-line to generate an initial coding framework. The two researchers involved in coding subsequently met to compare codes, discuss differences in interpretation, and reach consensus through discussion. Themes and patterns in the data were identified inductively until consensus was reached on the final themes after several iterative discussions. Thematic saturation was achieved when no substantially new themes were emerging from the interview data. The researchers read through the transcripts several times and cross-checked with the audio files to ensure that the data was accurately captured. Quotes in the respondents’ transcripts that were congruent with the overarching themes were also identified. Findings have been presented based on the consolidated criteria for reporting qualitative research (COREQ) checklist for qualitative studies [64].

In terms of reflexivity, the lead researcher (GB) has research interests in Bioethics, particularly in informed consent. He conducted all interviews but did not transcribe the interview recordings. To minimize influence on data interpretation, coding was conducted by more than one researcher, coding decisions were discussed and reviewed collaboratively, and interpretations were continually checked against participants’ accounts to ensure that the findings remained grounded in the data. We acknowledged that the lead researcher’s (GB) background in bioethics and his status as a PhD fellow within the same academic community as the respondents shaped the research encounter. This shared professional identity likely facilitated rapport but also risked social desirability bias, in which respondents may have highlighted ideal practices such as iterative learning. Throughout the inductive thematic analysis, the research team (GB and RB) held reflexive debriefings to challenge the lead researcher’s potential bias, ensuring that themes remained grounded in participants’ accounts of navigating low-resource constraints related to informed consent.

This study was reviewed and approved by the Makerere University School of Biomedical Sciences Research and Ethics Committee (SBS-2023-375) and the Uganda National Council for Science and Technology (HS3175ES). Administrative clearance was sought from Butabika National Mental Referral Hospital. Informed consent was obtained from each participant. Participation was voluntary, and each participant was free to withdraw at any time without facing any consequences. To maintain confidentiality, each participant was assigned a unique identification number that was attached to the information they provided during the study. Each participant received UGX 50,000 (USD 13.61) as a token of appreciation for their time.

Results

Participant socio-demographics

Twenty-one key research team members participated in the study; 12 were male and nine were female. Most participants were principal investigators and at least had master’s level training as shown in Table 1. The majority had five or more years of experience in mental health research.

Table 1.

Respondent socio-demographics

Characteristic	No of Participants
Sex
Male	12
Female	9
Highest level of education attained
Diploma	1
Bachelors	5
Masters	5
PhD	8
Post Doc	2
Position
Principal Investigator	9
Project Leader	1
Project Coordinator	4
Research Assistant	7
Experience with mental illness related research
1–4 years	1
5–10	11
11–14	3
15–20	5
21–25	1

The participants were engaged in different kinds of research among persons with schizophrenia and bipolar affective disorder. These included genetic studies investigating the linkage between DNA and schizophrenia or bipolar affective disorder, observational and interventional studies, and adherence to anti-psychotic medication.

Two themes emerged from the data (Table 2).

Table 2.

Themes and subthemes

Themes	Subthemes
1. Key considerations during the Informed consent process	• Ensuring participants continue to have the ability to consent throughout the study • Patience, rapport building, and keeping participants engaged during consent • Involvement of caregivers in the consent process
2. Reported practices for enhancing participants’ understanding of the research and medical terms	• Reading consent information to participants • Using iterative learning • Conducting formative evaluation to understand the context of the community • Working with psychiatry health professionals

Key considerations during the informed consent process

Ensuring participants continue to have the ability to consent throughout the study

The findings show that researchers do not view informed consent among people with severe mental illness as a one-time event. Researchers understood that a participant’s decisional capacity can change over time depending on their mental condition, treatment, or recovery. This means that a person who is unable to make decisions at one point may later regain that ability, while someone who initially gave consent may later lose the ability to fully understand the study. Because of this, respondents saw consent as a continuous process that needed regular review.

We are also cognizant of the fact that along the treatment journey, they [patients] might develop the capacity to consent and therefore consent to participate or actually not [retain capacity] to participate in the study. So those are considerations we have with respect to consent (R001, Principal Investigator).

The practice of checking participants’ understanding at every interaction shows that researchers were concerned about protecting participants’ rights throughout the study, not just at the beginning. Simply signing a consent form was not enough. Participants needed to continue understanding why they were in the study and what their participation involved. This shows that researchers placed great importance on respecting participant autonomy and making sure consent remained meaningful over time.

You follow them to see if they [still] understand what your study is about, and you find that on the second visit, the person is saying I don’t understand all these things. So, you end up having to do this consenting as a continuous process to ensure that the person understands what you’re doing (R003, Study Coordinator).

Informed consent should be continuous, reminding the person if possible, at every interaction. Otherwise, the person may end up leaving whatever you have told them there and then, and maybe when someone else asks them what the study is all about, they cannot tell (R015, Study Coordinator).

These findings also suggest that maintaining ethical consent requires extra time and effort from research teams. However, researchers appeared willing to make this effort because participant protection was considered more important than convenience.

Patience, rapport building, and keeping participants engaged during consent

The findings show that informed consent is not only about giving information but also about building trust with participants. Researchers explained that many participants with severe mental illness may feel misunderstood, stigmatized, or treated unfairly in society. Because of this, participants may be hesitant to trust researchers immediately. Building rapport, therefore, becomes an important part of helping participants feel safe enough to listen, ask questions, and make their own decisions.

It is more to do with feeling appreciated and understood because out there, they feel that they are not understood. In front of a researcher, they expect that you should treat them better than the general population treats them (R020, Principal Investigator).

If a patient with schizophrenia or bipolar feels that you’ve understood their concern, [or] if they feel that you’re empathetic, then they’re going to understand that you’re the right person to talk to (R013, Research Coordinator).

It [consent process] may take sometime, to understand [them], they will have to trust you first, to see that you do not stigmatize them, the way you handle them (R013, Coordinator).

It [time] is absolutely crucial to earn their trust, make them feel safe, and create a clear line of communication in the initial stage of interaction, and this makes having additional time quite essential (R017, Research Assistant).

The findings also show that patience is very important during the consent process. Some participants may take longer to understand information because of their illness, medication side effects, or communication difficulties. However, researchers did not attribute participants’ lack of decision making to this slackened pace. Instead, they believed participants simply needed more time and clearer explanations.

Also, by nature of their illness, some speak relatively more slowly, which calls for patience (R017, Research Assistant).

[For]some of them, the side effects of the drugs just make them a bit slow, but someone being slow does not mean that someone cannot make a decision (R05, Research Assistant).

It may take longer. They may seem a bit uncomfortable and fidgety, but they get through the consenting process, they get through it up to the end (R005, Research Assistant).

Keeping participants interested and focused was also seen as an important aspect of the consenting process. Researchers recognized that if participants lost attention or became distracted, they might not fully understand the study information. This means that good consent depends not only on what information is shared, but also on how it is shared.

I must create rapport. It makes it easier for the person to listen. The consent form is very long but very informative. You have to read it in a way that keeps the person engaged and interested in what they are going to participate in (R008, Research Assistant).

You have to give them an opportunity to ask questions but [this] will [also] depend on the rapport you’ve created. If they feel with you, they will ask you many questions. But also sometimes they ask you questions that divert you off the study, but you have to give them an opportunity to ask questions (R013, Study Coordinator).

Overall, the findings suggest that informed consent works best when researchers use empathy, patience, and clear communication.

Involvement of caregivers in the consent process

The findings show that caregivers often play an important role in the consent process, especially because many participants come to health facilities with family members or caregivers. Caregivers can help participants feel supported and may help researchers communicate important information.

In some instances, we used to involve the caretakers … and tell them how we are going to involve their patients in the research (R014, Research Assistant).

While family members act as ethical safeguards, their presence or involvement introduces the risk of family pressure. However, the findings show that researchers were careful to protect the participants’ right to decide for themselves whenever possible. If a participant was able to understand the study and make a decision, researchers ensured that the participant, not the caregiver, gave the consent. This shows that participant independence and voluntary decision-making were highly valued. The researchers’ practice of insisting that the final decision rests with the participant represents a delicate navigation of relational autonomy within a communal cultural context.

You have to make sure that it is the participant or patient and not the caregiver accepting or declining the study (R019, Principal Investigator).

I always like the patient to accept or refuse [to participate] unless if the next of kin has a part to fill (R014, Research Assistant).

When participants could not make decisions on their own because of limited understanding or mental health challenges, caregivers or next of kin were allowed to provide consent on their behalf. This helped ensure that vulnerable individuals were not excluded from research that could benefit them.

With regards to informed consent, we need to determine the capacity, and so as we determine the capacity, we are also cognizant of the fact that some might not have the capacity to consent and therefore, we require a surrogate to consent (R001, Principal Investigator).

There would still be patients who would not have capacity to make a valid decision, and in that case, we needed to move to the next of kin to consent on behalf of the patient (R002, Principal Investigator).

Respondents pointed out that if a participant cannot read or write, an independent witness observes the consent process to ensure that it is fair. This witness will confirm that the information presented by the researcher is consistent with the details provided in the informed consent document.

You end up having a family member being an impartial witness to the consenting process. You don’t want to be in a situation where the person says, no I didn’t agree to [taking] part in the study, I think I was just forced (R003, Study Coordinator).

The use of independent witnesses for participants who could not read or write also shows that researchers wanted to protect participants from coercion or unfair treatment. Overall, these findings suggest that caregiver involvement was used as a supportive ethical safeguard while still trying to protect participant autonomy.

The informed consent considerations reflect researchers’ efforts to navigate the ethical challenges associated with fluctuating decisional capacity and participant vulnerability in mental health research. Follow-up assessments, rapport building, patience, and caregiver involvement were described as mechanisms for supporting participants’ ability to exercise autonomy while recognizing that decision-making capacity may change over time. The findings suggest that consent was viewed by respondents as an ongoing relational process rather than a single administrative event.

Reported practices for enhancing participants’ understanding of the research and medical terms

The findings show that helping participants understand research information was a major concern for researchers. They understood that written consent forms alone were often not enough, especially for participants who had difficulty reading, concentrating, or understanding medical terms.

Reading consent information to participants

Researchers describe reading the consent information aloud as a primary strategy for supporting understanding because it allowed participants to listen, ask questions, and receive explanations immediately. This made the consent process more interactive and helped researchers check whether participants were following the discussion.

In most cases, when you give someone something to read, they do not have that discipline [to read] and understand word by word. So, when you’re reading to them, it’s easier. (R011, Research Assistant).

Somebody may look at it [consent form]and only reads maybe the first two lines (R04, Research Assistant).

We actually read out the consent information to our participants, mostly because we found that it was more convenient and a participant could ask a question directly (R020, Principal Investigator).

So, it is [reading] sentence by sentence, reading through with the person page by page and seeking questions [at] every end of a section (R021, Study Coordinator).

Using iterative learning to improve their understanding of the consent information

The use of repeated explanations and iterative learning shows that researchers understood that some participants needed more than one explanation before they could fully understand the study. Instead of assuming that participants could not consent, researchers gave them extra support to improve their understanding. This suggests that decision-making ability was seen as something that could be strengthened with proper communication.

If in the first trial my participant gets 5 or even zero, you have to read those particular points for my participant to understand that question. You look for the page, the paragraph, you read it again, and then you ask the question afresh, such that you’re aiming for my participant to [get] 15 as the pass mark (R008, Research Assistant).

This approach implies that researchers take on the task or aim to facilitate decisional capacity through acknowledging that participants can provide meaningful consent given adequate time and provided with simplified explanations.

Conducting formative evaluation to understand the context of the community where the research is conducted

The difficulty of translating medical terms like schizophrenia and bipolar disorder affective disorder into local languages also showed that language can be a major barrier to informed consent. Researchers addressed this by learning how communities describe these conditions and by adapting their language to fit local understanding. This suggests that effective consent depends not only on simple language but also on culturally meaningful communication.

So we don’t have [the term] schizophrenia in Runyankole language, I don’t even know whether [there is a] Luganda [term for it ](R013, Study Coordinator).

In the local language, you are never going to get a word like schizophrenia or bipolar. We mostly use a word that is understandable in that culture, in that context (R001, Principal Investigator).

We were not sure of how the community understood schizophrenia or bipolar. We started with a qualitative study to explore their understanding of these disorders. So, then the consent forms included [information to help them understand these conditions] (R002, Principal Investigator).

Working with health professionals

Working with health professionals such as psychiatrists and nurses also helped researchers explain difficult concepts more clearly. Overall, the findings show that informed consent requires researchers to actively make information understandable, relevant, and culturally appropriate for participants.

You work with someone at the ward so that you can get the best word that they use. Because even if you break the word down into a simple [form] that is not understood by them [participants], it becomes difficult (R003, Study Coordinator).

They don’t know what schizophrenia is or what bipolar is. Especially in the morning, we have a lady here who normally tries to explain how to call these people [patients] (R016, Research Assistant).

These approaches illustrate how researchers attempted to support understanding within contexts characterized by linguistic, educational, and cultural barriers. Beyond information disclosure, the practices described by respondents were aimed at promoting meaningful participation in decision-making through communication strategies that acknowledged differences in literacy, mental health literacy, and local understandings of mental illness. The findings, therefore, highlight the relational dimensions of autonomy, whereby understanding is supported through interactions among participants, caregivers, researchers, communities, and healthcare professionals.

Discussion

This study explored researchers’ reported consenting practices for enhancing comprehension in research involving individuals with schizophrenia and bipolar affective disorder. Participant follow-up ensured their capacity to consent was maintained throughout the study. Building rapport with participants was crucial, and this often required additional time to facilitate effective communication and provide necessary research information. Researchers involved caregivers to support participants, acting as witnesses or surrogates during the consent process. The researchers reported reading information aloud, using iterative learning, and consulting with the research community and health professionals as strategies to enhance participants’ understanding.

Our findings suggest that research participants with schizophrenia and bipolar affective disorder are routinely followed up to ensure they are clinically stable and understand their study involvement. This practice, which aligns with previous findings [65], helps to assess their ongoing interest and understanding of what participation entails. Protecting their autonomy is important, as participants’ decision-making capacity may fluctuate throughout the course of a study [9]. This consideration is particularly important for longitudinal studies. If a participant loses their decision-making capability, the researcher can withdraw them from the study or involve a surrogate decision-maker [21].

The findings from this study revealed that time was considered an important resource during consenting. Previous research indicates that the duration and quality of interaction between the researchers and the prospective participants enhance their understanding [66]. For individuals with mental illness, the consent process may require additional time [67], highlighting the need for a personalized approach to effectively inform potential participants [68]. Researchers viewed additional time as a means of supporting understanding and participation. Patience enabled participants to process information, ask questions, and engage meaningfully in decision-making. However, the way this process is conducted is also crucial [9]. Information should be tailored to each participant’s cognitive abilities, including memory, language and attention span [69].

Respondents emphasized the importance of building trust before discussing consent, aiming to create a safe environment in which participants felt comfortable engaging in the consent process. This may be particularly important for individuals with mental health conditions like schizophrenia, who often experience stigma that can influence their willingness to participate in research [20, 70]. In many sub-Saharan African settings, mental illness is often understood through spiritual or supernatural explanations, with conditions such as schizophrenia sometimes attributed to evil spirits [40, 71]. These beliefs may contribute to stigma and make potential participants hesitant to engage in research [20]. Consequently, the way researchers interact with participants is crucial. Respectful engagement, rapport building, and reassurance about privacy and confidentiality can foster trust, encourage open communication, and support participants’ understanding of the study [20, 39, 72–74].

Respondents reported involving family members in the consent process. A related study conducted in India found that caregivers helped facilitate this process by acting as impartial witnesses and simplifying complex terms for participants [39]. Involving family members allows them to better understand the study and, when necessary, act as surrogates for individuals who may have difficulty comprehending the study information. In the African context, illness is often regarded as a shared responsibility given the communal way of life [75]. Family members play a crucial role in patient care and in providing social support. Involving family in the consent process can foster trust and respect for cultural norms [76]. However, when prospective participants are supported by relatives, family pressure may compromise their autonomy to decline participation [39, 40, 44]. Therefore, researchers must emphasize that the final decision should rest with the participants, regardless of caregiver opinions.

Additionally, cognitive impairment may make participants with schizophrenia more vulnerable to confusion between research and clinical care [30]. Many participants enrol in research when they are desperate to improve their health or functioning [20]. Researchers must clarify the difference between research and treatment during the consent process [43]. It is also essential to assess how well participants understand the information provided. This is particularly important when health professionals are involved in research. To improve voluntariness, physicians in leading roles, such as principal investigators, should not be directly involved in enrolling or consenting participants [42].

Respondents indicated that they primarily read consent information aloud because it allowed participants to receive explanations and ask questions. A study in another LMIC found that the study information was read and explained to participants in their preferred language [18, 47]. Some individuals may pretend to read out of fear of being judged [77]. In related findings, it was observed that many participants sign consent forms without fully understanding them [3, 78], which limits their grasp of important elements of the study [79]. Respondents reported reading consent information aloud, even when translated forms were available. This ensured participants were engaged and attentive regardless of their literacy levels. This aligns with evidence from previous findings that attention difficulties may affect the ability of individuals with schizophrenia to absorb study information [15].

The large amount of information provided during consent procedures, combined with patients’ impaired memory, makes it challenging for them to learn and remember the key points [15, 18]. Moreover, low health literacy among prospective participants increases the burden on the researchers, who must not only explain the research project but also the mental condition being studied [40]. This underscores the need for effective ways to engage participants and facilitate understanding. To assist those who cannot read, multimedia tools can enhance communication alongside traditional paper consent forms.

The common practice for informed consent in research is the use of paper-based consent forms [80]. In Uganda, this method remains prevalent in mental illness related studies, despite multimedia innovations [61, 81]. When conducting research involving individuals with mental illness in LMICs, many participants encounter cognitive challenges and have limited education [74]. Therefore, oral communication is essential for improving understanding. The consent process should be viewed as a conversation [30], rather than simply reading and signing a consent form by prospective participants. For instance, in a study conducted among Xhosa-speaking participants living with schizophrenia in South Africa, the issue of low literacy levels was addressed by orally presenting study information, enabling participants to ask questions and receive answers from research assistants [47].

In low-resource settings, visual aids have shown promise in improving participants’ understanding of key elements in the consent forms [74]. For instance, a study conducted in India among individuals with schizophrenia found that using a flip chart was more practical, easier to utilize, and more effective for communicating study information in an engaging and interactive way [39]. However, these multimedia tools have not yet been adopted or tested in Uganda. Therefore, further research is necessary to evaluate the effectiveness and applicability of these methods in improving understanding during the consent process.

The reported use of iterative learning was aimed at facilitating participants’ understanding of the consent information. Similar approaches have been reported in research conducted among individuals living with schizophrenia in South Africa, where iterative learning improved participants’ understanding of study information and enhanced performance on capacity assessment tools [18]. Capacity assessments may help identify aspects of study information that participants find difficult to understand, thereby enabling investigators to revisit and clarify those elements [67] and improve participants’ understanding [72]. The researchers viewed understanding as a dynamic process that can be improved through ongoing dialogue and repeated explanations. They did not assume that initial comprehension difficulties indicated an inability to consent and used clarification to support understanding, reflecting a supported decision-making approach.

Researchers reported enhancing participants’ understanding of the research and medical terms by exploring how mental illnesses are understood in the community and involving healthcare personnel. Previous studies have also shown that this approach fosters respect and communication of research information during the consent process [82]. The need to empower individuals with mental illness to participate in research is now greatly acknowledged [67]. Participants should be supported to make informed decisions [83]. Our findings highlight the different avenues used to ensure participant understanding while respecting cultural diversity.

Psychiatric terminology is often unknown or poorly understood in communities within LMICs [35]. This is further complicated by publicly available information, such as online sources, pamphlets, or books that contain terminology that is too complex for the general public [84]. This challenge remains unresolved, but efforts to improve understanding of mental health conditions through culturally appropriate terminology continue. In Many African contexts, local languages lack specific words or phrases to describe schizophrenia or bipolar affective disorder (and other conditions for that matter). This makes it hard to translate the psychiatric terms accurately without losing meaning. These challenges affect global research, as language differences and varying concepts for mental illnesses, alongside stigma, hinder the provision of research information [9].

Previous research in South Africa has emphasized the importance of integrating community-based participatory approaches into the research process. A Community Advisory Board (CAB) was formed, including patient advocacy groups, hospital board members, and representatives from local Xhosa communities. The CAB served to represent community interests, such as reviewing informed consent forms and addressing stigma related to mental health [47]. The CAB members were particularly concerned about ensuring that the translation of the word “schizophrenia” in the Xhosa language was not offensive [37]. In many communities, a single word describes all mental health disorders. Engaging with the community allows researchers to use language that potential participants can easily understand [85]. Given Africa’s cultural, literacy, and language diversity [86], involving research communities can facilitate the development of culturally relevant consent forms.

Study strengths and weaknesses

In this study, in-depth interviews were conducted with various cadres of key research team members who were directly or indirectly involved in consenting, to gain an overall insight into the practices of obtaining consent.

This study has some limitations. First, the findings are based on researchers’ self-reported accounts of consent practices rather than on direct observation of consent encounters. No observations were made to determine how consent information was delivered or to assess researcher-participant interactions and actual practices. Without observing consent encounters or interviewing participants, the effectiveness of these reported practices cannot be confirmed and remains an area for future research. Second, most participants were highly educated researchers from a single institutional setting. The study did not include the perspectives of research participants, caregivers, or research ethics committee members, whose experiences may have provided important complementary insights into the consent process.

Conclusion

This study provides insight into researchers’ descriptions of their approaches to supporting comprehension during informed consent among individuals with schizophrenia and bipolar affective disorder. The findings suggest that researchers view consent as an ongoing and context-sensitive process that may involve repeated discussions, caregiver involvement, rapport building, and adaptation of study information to local contexts. Further research involving observation of consent encounters and the perspectives of participants themselves is needed to evaluate the effectiveness of these practices.

Implications for practice

This study highlights key considerations for obtaining informed consent among individuals with schizophrenia and bipolar affective disorder through the use of more interactive forms of information disclosure and simplifying the study information and slower administration of the consent process to support those who have challenges in understanding research information easily.

Implications for policy

The study provides evidence to inform policy on the aspect of supporting individuals with schizophrenia and bipolar affective disorder to comprehend research information. The UNCST guidelines require that the information given to the research participant or the representative, whether it is conveyed orally or in writing, shall be in a language and form understandable to the participant or relative. However, for those with challenges in understanding study information, a longer consent process is required to accommodate contextual and individual factors of the potential participants.

Implications for education

Participants with schizophrenia and bipolar affective disorder may have a limited understanding of the conditions they have, which are being studied due to low mental health literacy. In addition, there are no equivalent local terms for these conditions. Educational programs could focus on simplifying consent forms and explaining research participation in a clear, culturally appropriate, and easily understandable way.

Implications for future research

Future research should explore other innovative interventions in the consent processes that can support participants when faced with challenges related to the understanding of research information. Furthermore, future studies should consider an observational component and, if possible, ethically include the voices of participants to reflect on what they understood, what confused them or what helped.

Abbreviation

UBACC

University of California, San Diego Brief Assessment of Capacity to Consent

Biographies

Godfrey Bagenda

is a PhD Fellow at Makerere University under the mentorship and supervision of AD, EK and ESM.

Robert Bakanoma

is a Qualitative research expert and research scientist at the Medical Research Council / Uganda Virus Research Institute, and the London School of Hygiene and Tropical Medicine Uganda Research Unit.

Dickens Akena

is a Senior Lecturer in the Department of Psychiatry at Makerere University.

Eunice Kamaara

is a Professor of African Christian Ethics at Moi University, Kenya.

Erisa Sabakaki Mwaka

is a Bioethicist and Associate Professor of Human Anatomy at Makerere University.

Authors’ contributions

GB, DA, EK and ESM contributed to the conception of the study and study design. GB collected the data, GB and RB analyzed the data. GB drafted the manuscript, DA, EK, and ESM provided comments and made suggestions to the manuscript, which were addressed by GB. All authors approved the final manuscript.

Funding

This work is part of the PhD Fellowship and was supported by the Fogarty International Center of the National Institutes of Health, through the Makerere University International Bioethics Research Training Program (NIH grant Number D43TW010892).

Data availability

Data to this work is readily available as a supplementary file 2.

Declarations

Ethics approval and consent to participate

This study was approved by the Makerere University School of Biomedical Sciences Research and Ethics Committee (Ref No: SBS-2023-375) and the Uganda National Council for Science and Technology (Ref No: HS3175ES). Administrative clearance will also be sought from Butabika National Mental Referral Hospital. Written Informed consent was obtained from each participant. This study was conducted according to the ethical standards stipulated in the Uganda National Council for Science and Technology guidelines.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.