'Some parts of the consent form are written using complex scientific language’: community perspectives on informed consent for research with pregnant and lactating mothers in Uganda

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Background

It is increasingly recognized that the language used by clinicians and researchers, rather than being inclusive to diverse populations, can become a barrier. The Human Immunodeficiency Virus (HIV) scientific research community, in particular, has issued guidance on the use of destigmatizing, ‘person-first’ language [1], Getting the language right, and constantly reviewing the language used as acceptable terminology, is critical to addressing stigma. Using the wrong words can inadvertently undermine people, perpetuate disparities, confer judgment, and create barriers to accessing care or sharing relevant information. Conversely, the right words can empower people, encourage them to access care, and improve the care itself [1]. In some situations, the desire to be as inclusive as possible in the choice of terminology may inadvertently introduce or perpetuate barriers within some communities.

Language barriers such as illiteracy [2] or limited language fluency can obstruct the informed consent process, making it challenging for participants to grasp research information fully. Barriers to communication arising from lack of access to education resulting in lower literacy and low understanding of scientific processes may prevent complete understanding of procedures. This places participants at risk of giving uninformed consent without comprehension, increasing medical errors, and deprives patients of their constitutional rights to information in a language of their own choice [3, 4]. When language difficulties, cultural differences, and bias are present, the exchange of information can be greatly distorted. This means that communication may not be as clear or accurate as intended, leading to potential misunderstandings or misinterpretations. It is important to be aware of these factors and strive to overcome them to facilitate effective communication.

Obtaining genuine consent through verbal or written informed methods during research can be challenging, especially if inappropriate language is used. It is important to communicate clearly and respectfully to ensure that participants fully understand the research process and give their informed consent willingly. Using appropriate language and providing all necessary information can help facilitate this process effectively. The presence of multiple languages poses a communication challenge for healthcare workers. Uganda is a multilingual country [5, 6] with over 70 estimated languages spoken. Among these languages, 43 belong to four primary language families: Bantu, Nilotic, Central Sudanic, and Kuliak. Of these, 41 are indigenous to Uganda, and two are not.

In south-central Uganda, the most spoken Bantu language is Luganda. Bantu-speaking areas often have dialect continua [5] where different dialects blend. For instance, “Runyankore” is spoken in Mbarara, while “Rutooro” in Fort Portal, and in between, there are villages where a combination of both of both dialects is spoken. Before 1952, these dialects shared a literature called Runyoro, as they were mutually intelligible. Separate writing systems were later developed for Runyoro, Rutooro, Runyankore and Rukiga. The term “Runyakitara” was introduced around 1990 to refer to this language cluster, not tied to a specific ethnic group but to the cultural legacy of the Kitara Empire, aiding in work with these languages. Acholi is a Southern Luo dialect spoken by the Acholi people in the districts of Gulu, Kitgum, Amuru, Lamwo, Agago, Nwoya, Omoro and Pader in northern Uganda. It is also spoken in South Sudan in Magwi County, Eastern Equatoria [7]. Lugbara, or Lugbarati, is the language of the Lugbara people. It is spoken in the West Nile region in north western Uganda, as well as the Democratic Republic of the Congo’s Orientale Province with a little extension to the South Sudan as the Zande or Azande people. For some of these languages such as Acholi and Lango, there are no concepts related to kinship [8] that have been reported or documented. These languages probably contain unique terms for expressing familial relationships that reflect their cultural context.

This diversity in languages reflects the rich cultural tapestry of Uganda. English has been the official language since independence was declared in 1962 [6]. English is widely used in schools throughout Uganda due to its introduction in 1894–1962 when the country became a protectorate of the British Empire. All university education is in English therefore it is the language in which most of the researchers are familiar with for expressing scientific ideas. For some individuals, particularly in urban areas, English may be the stated first language for written material [9].

By improving communication and comprehension, research into the consenting process can contribute to ensuring that participants are fully informed and empowered to make decisions regarding their participation in research. This is relevant to all individuals in all societies, but may have particular relevance for groups where there lack of empowerment, lack of access to education and patriarchal cultural systems may perpetuate inequity. For the past decade, our team has focused on promoting equitable access to research, particularly for pregnant and lactating women and their infants [10]. Through several community events and research prioritization exercises it has become clear that the informed consent process may need to be tailored to the specific needs of these women. Whilst it is easy to agree that language issues emerging whilst gaining informed consent could be resolved when health care workers share information clearly, without excessive technical language [11], it is necessary to understand specifically how this should be done within a particular context. It is important to create systems that aid in comprehension and understanding of information shared with patients.

This project aimed to describe community members’ perspectives regarding terminologies used during the informed consent process for pregnant and lactating mothers in Uganda. What is considered inclusive and respectful may vary between settings and it is the responsibility of researchers to work with communities to explore what works appropriately. Along similar lines, whilst the Academy of Breastfeeding Medicine [2] calls for increasing use of gender-neutral or ‘desexed’ language, it is acknowledged that this recommendation may not apply globally. Some terms may be distracting or difficult to understand for readers who come from cultures where there are no apparent non-female lactating people, as well as for people with low literacy, or who cannot read in their primary spoken language. There is a need to determine accurate, respectful, relevant and preferred language, particularly for use in our research programme which focuses on complex and understudied populations [3].

Methods

Study design

A cross-sectional qualitative study among community members, research participants and members of our community advisory board (CAB) was conducted in August and September 2023. The Maternal and Infant Lactation pharmacoKinetics (MILK) study CAB was established in 2021 with members including religious leaders (Muslim, Anglican, and Catholic), persons with disabilities, local political leaders, and cultural leaders. Focus group discussions (FGDs) among community members were segregated by age and sex. Focus group discussions were chosen for their effectiveness in capturing information on social and cultural norms and a wide range of opinions. The diversity within the groups was chosen to allow for a broad range of views to be explored. The study focused on focused on terminologies used in the informed consent process involving research related to pregnant and lactating mothers.

Validation workshops were planned in various study locations across the country to confirm findings and reach a final agreement on the terminology to be used for pregnant and lactating women in participant-facing materials including those used during the informed consent process. The team for the validation workshop comprised a diverse group of stakeholders, each playing a crucial role in the process. Researchers were primarily responsible for facilitating and guiding the workshop, ensuring that discussions stayed focused and productive. Study participants contributed valuable insights regarding the study findings, enriching the dialogue. Local council leaders played a key role in ensuring that participants were included and helped identify potential issues. This diverse composition of stakeholders fostered a collaborative environment, allowing the team to comprehensively address the overall validation of key findings.

Study setting

Infectious diseases institute

The Infectious Diseases Institute (IDI) currently provides care and treatment services to more than 220,000 people living with HIV in urban and rural settings in Uganda directly through our large clinic, and in partnership with government and non-government health facilities. The institute is also committed to major long-term outreach programs to build capacity across Uganda.

Choice of study sites

We chose locations where we had previously conducted studies and therefore had existing relationships with community leaders and had established trust. From these formal introductions, we then purposively sampled the five communities based on a selected mixture of both semi-urban and rural communities in Kampala, Mbarara, Hoima, Amuru, and Arua, as displayed in (Fig. 1), choosing subdistricts that had not been strongly involved in prior research. CAB members that currently or had recently advised on specific studies relating to pregnant and lactating mothers were approached, as were former research participants from IDI irrespective of their tribe, provided they were fluent in Luganda.

Fig. 1

Map showing geographical location of FGDs, together with total number of participants in each region

Participant selection and sampling

We identified community members with the help of local community leaders and via contacts made through the research portfolio led by IDI, and associated sites were approached individually through their respective institutions’ administrators. CAB members associated with the MILK study and former research participants from IDI who had previously given permission to be contacted for future related studies were identified by the study team. Individuals were then contacted, briefed about the study and invited to participate in FGDs. Physical meetings were held at participants’ community locations. The FGDs were preceded by participants providing consent for participation and recording of this conversation.

A purposive sample were invited to take part in 19 FGDs, with men and women aged 18 years and above being included in the study. Participants represented at least six different mother tongues (Luganda, Acholi, Runyankole, Runyoro, English and Lugbara). A total 3 FGDs each comprising of 6–9 participants with similar characteristics was held per study site. Participants were grouped according to age and sex, with males and females from age 26 and above in separate FGDs, but youth (aged 18–25) being in a mixed sex group. This was on the basis of maximum variation (we held a single FGD for youth with varying characteristics per region irrespective of gender, socioeconomic status, or cultural background). From our previous community engagements, we observed that youth tend to participate less actively when grouped with older adults. It was also noted, and confirmed during pilot FGDs in Hoima district and discussions with the CAB, that it is culturally more accepted for males and females of this age to interact together in group settings than it is for older adults who have established more distinct societal roles. Therefore, for this study, we conducted FGDs specifically within the mentioned age group to encourage active participation and facilitate open sharing of ideas.

CAB members formed a separate FGD as did individuals who had previously participated in research [12]. The sample size of 19 FGDs was based on the need to explore research questions thoroughly and achieve thematic saturation. The participant selection process was iterative, involving multiple rounds of FGDs. Throughout the period of data collection, the team engaged in ongoing analysis of detailed notes and debrief notes on the themes and patterns that arose during discussions. As discussions progressed, the team coded the data for recurring themes. This coding process helped in identifying which themes were prevalent and which were emerging across FGDs. The team identified redundancy when repeated ideas or themes had already been discussed in previous FGDs. At this point it was determined that additional FGDs would not add significant value or insight.

Data collection

Three separate FGDs were conducted in each region, for older men, older women and youth. Focus group discussions were held in community locations in the local language. Research assistants provided information on the study before each FGD, ensuring participants understood the purpose, topics, confidentiality, and consent. The FGDs were led by at least two researchers, with one as a moderator and the other as a note-taker. Discussions in the topic guide focused on language used during informed consent, whether the participants found the informed consent form easy or not to understand and consideration of the appropriateness of the terminologies for pregnant and lactating mothers during in Uganda. Each FGD lasted 60–90 min, and all were audio-recorded. Translation and transcription were done concurrently: the transcriptionists, fluent in both the local language and English, listened to the language and translated as they typed in English. Once the transcription was completed, the transcriptionists read through the transcription against the audio file to check for accuracy and completeness. The study did not employ formal back-translation to verify accuracy because the focus was on community involvement and their understanding. It had been noted during previous translation exercises that the official use of language in Kampala can differ from how the language is actually used out in the communities; indeed this was one motivation for undertaking this current study. We did not consider that back-translation would provide greater accuracy in our thematic analysis. However, the transcript was then given to another member of the field team fluent in both languages for checking and verification of any unclear words or terminology. Quality assurance was also done to ensure accuracy of translation, Participants’ identities were kept anonymous. Demographic information was collected through a questionnaire administered before the FGDs were conducted. The period for data collection and interpretation was two months.

Data analysis

Based on the information provided, an inductive approach [13, 14] was utilized for data analysis based on data and responses from the topic guide. This enabled meaningful interpretations of qualitative data, fostering a deeper understanding of patterns (themes) of language matters phenomena in rich detail. Transcribed FGDs were thoroughly reviewed multiple times for data familiarization. One joint codebook coding framework (a reference tool for directed coding) was used to enhance consistency and transparency to the coding process. This was developed based on four transcripts that were manually reviewed and coded to create the initial set of codes. These were merged after consensus and consultation with the Principal Investigator as a tie breaker. These codes were cross-checked iteratively among four coders trained in qualitative data analysis to enhance reliability. All transcripts were imported into NVivo version 12 for data organization and to perform open coding (naming identified sections of text (descriptive labels) relevant to a research question or analytic goal. Subsequently, codes were grouped into categories and themes were identified. A final merged code book was developed from different categories and the main findings from data and responses from the uniform topic guide were synthesized. Illustrative quotations for each emergent theme were chosen for results narration.

Results

This section presents the findings from a comprehensive study involving 146 participants across 19 FGDs. The primary focus is on the characteristics of the participants and the various factors influencing the informed consent process. The demographic analysis indicated that a significant portion of the participants were from Kampala, with a median age of 31 years. The majority of participants were married, had at least one child, and resided in urban areas. The results indicate that individual, health facility, and community-level factors significantly shape the informed consent experience. Detailed demographic data and the distribution of participants across different regions are provided in Tables 1 and 2. The findings underscore the critical role of language and comprehension in the informed consent process, highlighting the need for tailored strategies to enhance understanding and engagement among participants.

Table 1 Demographic characteristics of all participants in different regions

Table 2 Region, number and composition of FGDs

Characteristics of participants

Details of the sites and the 19 FGDs details are reported in Tables 1 and 2. Among the 146 participants, Kampala had the highest number of participants at (54, 37.0%). This is because Kampala included two participant categories (research participants and CAB members segregated by gender and age). The median age of our participants was 31 (with an interquartile range of 24–41). The majority were married (91, 62.3%), 116 (79.4%) had at least one child, and 99 (67.8%) were living in urban areas of Uganda as reflected in Table 1. Figure 1 shows the distribution of FDG participants across different regions of Uganda.

Language factors influencing the informed consent process

Figure 2 shows the various individual, health system and community factors relating to language which were shown to generally influence informed consent.

Fig. 2

Recommendations from participants to address language challenges to informed consent

Individual-level factors for informed consent

Language barriers and low comprehension compounded by high rates of illiteracy affected participants’ comprehension and hindered their ability to give informed consent. Having a participant information leaflet (PIL) and informed consent form (ICF) in the appropriate language for each participant enhanced reading and signing of the informed consent.

Based on our experience in this stage of the study, we have observed from those consent forms that the copy which I was given was printed in English which may be difficult to interpret for some people. In addition, one is required to sign somewhere but they may not know how to write. Besides that, there is no problem with that except for the issue of signing.

-- FGD_10_Men_Mbarara district.

Illiteracy (never having had the opportunity to learn to read and write, often also associated with a lack of elementary education in the basic principles of science) leading to low comprehension among some study participants hindered the process of obtaining informed consent, making it challenging for participants to retain and understand research information fully. However, a participant from one FGD said, she did not want her mother labelled as ‘’illiterate’’ during consent process.

“Then, there also other research programs that are introduced in the community, they are brought by researchers but they tend to use words like ‘omuntu atasomire’ [illiterate person]. Much as she doesn’t have education background, she is my parent, and it would be offensive to call her illiterate.”

-- FGD_14_Young Adults_Hoima district.

Young adults in one FGD liked the choice offered by the researcher regarding specific language to use during consent. Participants from most FGDs were fluent in both English and their local language, which made it easy for them to decide in which language they preferred to consent. However, one participant said was only fluent in her local language of Luganda.

“Luganda is my language, am a muganda [from South central Uganda] and I have grown up in Buganda and it pleased me that when I came, I was given a form in Luganda so I read and understood everything well”.

-- FGD_01_Young Adults 18–24_ Mulago.

There was concern that the in Luganda, description of pregnancy relied on limited words compared to English.

“What I’ve seen is disturbing us it the fact that Luganda as a language is summarized compared to English, so considering that English is wide let us go with owolubuto or olubuto lwomwana [pregnancy] and an English person would still interpret it as pregnancy. Luganda words have a limit when it comes to English but to get the meaning of pregnancy it should be olubuto lwomwana”

--FGD_01_Young Adults 18-24_IDI Mulago.

Health facility- level factors for informed consent

Using inappropriate and unclear language

Participants reported that there was use of inappropriate and unclear language introduced by inaccurate translations in the consent forms. Participants suggested the use of more appropriate language during informed consent. Words with long noun phrases were not understood by many Ugandans whose mother tongue was not English, sometimes due to the choice of words. This presented a major barrier to effective consenting.

“This is what I have observed about these forms[consent]; uh the language that was used is Runyoro, and we can understand it since it is our mother tongue. For example, when you say ‘olusa olwabeigaisire’ [permission from study participants, to be changed to consent statement from study participants], it may not bring sound proper in Runyoro considering that we should use the language appropriately. So, I suggest that we amend that without depleting the meaning”

--FGD_15_Men_Kahooro, Hoima district.

Poor and complicated grammar or errors in the informed consent form

Participants across most FGDs reported poor and complicated grammar in some consent forms. Some words in the previous consent forms were described by several participants as incorrect. In addition, the style of writing or grammar of translations in the consent form did not make sense, and in some situations there were spelling errors. This is because researchers do not conduct translations and back translations as rigorously as should be prior to data collection, but also because these forms were not checked by community members using the language colloquially. They suggested consent forms must contain correct spelling according to the right linguistic language dialect.

“There is a word on page 7. The phrase reads, ‘Nyinekushalaho hati?’ [should I decide now?] I think it should be written as “Nyinekusharamu hati [do I need to decide now?] “There is a word on the front page which is ‘okuhandika’[write]. It should be rectified to ‘okuhandiika’ with double i. Another word is written as ‘Handihachye[later],’ here, we use k instead of ‘c’; “handihakye”. That is why it was a bit difficult for us to read”.

--FGD_12_Women_Mbarara City.

“When I read the consent forms, I came across a statement; “Ebigendenda okukubaganya ebiloswoozo [purpose of the FGD] which has a wrong spelling, it should state ebigendelerwa”

--FGD_17_Young Adults_Research Participants_IDI-Mulago.

Complex terminologies in the individual informed consent forms

Complex medical terminologies are difficult to translate into most local languages. The consent form was found challenging for some participants as they commonly stated they did not understand the scientific words.

“I read the consent document and understood some of it some parts in the consent form are written using complex scientific language then the next page had pockets I didn't understand”

--FGD_06_Youth_Amuru district.

Community facility- level factors for informed consent

A participant in one FGD highlighted that social and cultural norms influence language use in informed consent. He suggested that researchers should consider the social context of language, including the use of respectful, trending terms when addressing women during the consent process. For instance, he suggested referring to women as “lady” or “madam” when greeting them. He emphasized the importance of engaging with community representatives to identify the preferred respectful language within the specific study context.

“Our culture is slowly fading away. We have adopted new linguistic behaviors where the term ‘a lady’ sounds more appealing. Yet, traditionally, the term lady is perceived negatively as a mere visitor in a home because a woman is believed to stay home and look after the homestead. …I think the two titles; ‘lady’ and ‘woman’ are distinctively used in the community. You cannot address a respectable female adult by saying, “Woman, I greet you.” For example, when the researchers come to the community, it would not sound appropriate to address a female adult as, “That woman.” Or say “Woman, I greet you.” We usually use words like; “Greetings Madam. How has been your day Ma’am. Lady…how has been your day?” In most cases, we simply use the term lady as a title of respect. So, you could call her ‘Madam’; “Greetings madam.”

-- FGD_03_Men_IDI Mulago.

Strategies to address language-related challenges to informed consent

This section highlights multifaceted interventions to address language-related challenges to informed consent. This includes individual-based strategies such as providing translated (ICFs) in both English and relevant local languages, which participants have indicated enhances their understanding of the study information. Feedback from FGDs highlights the importance of using language that participants comprehend, as well as the necessity for detailed explanations from researchers. Health system approaches emphasize the need for improved communication skills among researchers, ensuring that they convey information in participants’ preferred languages. Simplifying terminologies and conducting linguistic research to align consent documents with local contexts are also critical recommendations. Furthermore, community involvement in the development of study tools is vital to ensure the use of accurate and respectful language. By implementing these strategies, researchers can significantly improve the informed consent process, fostering better comprehension and engagement among participants.

Individual- based approaches

Availing translated ICFS for both English and appropriate local language

Participants suggested several recommendations to resolve language barriers that would lead to improved informed consent (Fig. 2) including the use of appropriate language that participants understood as it enhanced easy comprehension of information shared about the study during informed consent.

I read the “Luganda” [language] words as they were written and you explained to me everything that I failed to understand—and I was able to understand it”.

-- FGD_02_Women_IDI Mulago.

“Since they [consent forms] are in English, I have understood them. However, it is important to have someone explain the information to you in detail”

--FGD_19_CAB Members Mulago.

Participants preferred informed consent forms translated in their respective local languages while others recommended consent forms in local language and English for easy communication during informed consent.

“…I prefer English as it’s the language I understand better; We can read and understand English faster than Lugbara [language]” -- FGD_09_Young Adults 18–24_Mvara sub county Arua.

All participants were able to read and comprehend most of the terminologies in the consent document they signed. The consenting process in the current FGDs was more authentic and the participants appreciated the whole process as it was explained.

“I have read the consent form and they have explained the information to me, which I have accepted and consented to participate in this study.”-- FGD_10_Men_Mbarara district.

Health system approaches

Improved communication skills among researchers

The study found that participants easily understood research information communicated through researchers in their preferred local languages as in many cases, English was a secondary preference.

I suggest that these documents should be in all languages basing on the community where they go to do the research. When we go to Ankole, you should make sure that the consent forms are in Runyankole [language] so that as a participant, you are able to reply to the exact questions that the research participants ask you. Or if you go to the north, you should make sure that you get an interpreter who can communicated to them in a language they understand such that the communication is complete—because most people understand English but they cannot effectively translate it to another person—and that may cause the interpreter to guess what the person is referring to yet if you read for that person in a language they understand, it would be easier for them to understand it very well.

-- FGD_18_Women _Mulago.

Simplify terminologies in the consent form and adopt applicable language

Participants urged researchers to simplify terminologies and accommodate the diverse languages in a multicultural society. In addition, researchers should use appropriate language with good grammar that is understood by the target population or community.

“I find it reasonable to us that it should be “Acholi” [language] because we are going to be answering and keeping the document but you can determine what language is best depending on which community you are in. Though to me, the Luo language is the best because I am a Luo[tribe]”-- FGD_04_Men_Lamogi, Amuru District.

Conduct linguistic research among eligible populations

Participants urged researchers to conduct linguistic research among eligible populations. They drew specific emphasis to the current study attesting that the terminologies in question were applicable to the western world did not resonate with their community, with some words appearing overly simplistic or inappropriate.

“There is a word on the first page of the consent form.... “Pregnant and Lactating” Is it lactating? So, that terminology—but when I read there, I know that it means breastfeeding but others may not understand it [Lactating]”

--FGD_19_CAB Members, Mulago.

“There are certain words which are not appropriate for use in the community such as the pre-current; ‘a person with a uterus’, feeding parent’. Those are the first words which are abominable in our community and not desirable to listen to in public especially in the presence of children. They should keep them to themselves. They can use them at the airports however they like but they should not input their mindset in this community. Here, we are male or female, full stop”

-- FGD_15_Men_Kahooro, Hoima district.

Community approaches

Involvement of community members in developing study tools in appropriate languages

Despite using translators, researchers should involve community members in developing study tools in appropriate languages right from study inception stage. During informed consent design, targeted communities should contribute to development of study tools to reach alignment on the accurate and respectful language to be used in consent forms.

“I am suggesting that when you are including those words in the documents, please ensure that there is a ‘munyoro’ tribe or a ‘mutooro’ tribe to be able to confirm the words, this will prevent you from using words that are not suitable to be included”.

--FGD_15_Men_Kahooro, Hoima district.

Summary of Results

This section outlines key recommendations aimed at enhancing the informed consent process by addressing language challenges faced by participants. Recognizing the importance of clear communication, the recommendations emphasize the necessity for researchers to provide translated informed consent documents in local languages to improve comprehension. Additionally, the suggestions advocate for the simplification of terminology, the avoidance of complex jargon, and the use of culturally appropriate language. By focusing on clarity and respect, researchers are encouraged to engage with community members during the development of consent materials, ensuring that the language used is both accessible and contextually relevant. These strategies aim to foster a more inclusive and effective informed consent process, ultimately promoting participant understanding and trust .

The study reveals that individual, health facility and community-level factors significantly affect the informed consent process. The demographic profile indicates a mainly urban, married population with a median age of 31, highlighting the need for tailored communication strategies. Language barriers, including low comprehension and illiteracy, hinder the informed consent experience, with participants preferring forms in their local languages for better clarity and respect. Challenges at health facilities, such as inappropriate language and complex medical terms, further complicate the process. Community social and cultural norms also influence consent language, necessitating engagement with community representatives for culturally appropriate communication. The study recommends providing translated consent documents, simplifying terminology, and involving community members in developing study tools to improve understanding and trust. Overall, the findings emphasize the importance of clear communication and cultural sensitivity in research, especially in diverse and multilingual settings.

Discussion

Introduction

The study identifies significant language barriers at the individual, health facility, and community levels that hinder the informed consent process in Uganda. These barriers highlight the need to simplify terminology to accommodate the country’s diverse linguistic landscape, thereby improving participation in health research. Language not only facilitates communication but also reflects cultural values and norms, making cultural sensitivity crucial in the informed consent process. Effective communication fosters trust and understanding between healthcare providers, researchers, and participants. Despite regulations requiring informed consent, multilingual settings present challenges, such as misunderstandings due to language proficiency issues and the complexity of translating medical information accurately. Low literacy rates further complicate comprehension, particularly among populations with limited language skills. These challenges are not exclusive to developing countries; they also occur in developed nations, emphasizing the need for effective communication strategies among healthcare workers [15]. To address these issues, it is essential to simplify medical terminology, adapt consent forms to local contexts, and involve community members in the design process. Recommendations include using direct address, active voice, and clear language. Researchers should also be mindful of evolving social and cultural norms in language use to avoid assumptions that may lead to disrespect. Implementing interventions such as translating documents, utilizing interpreters, and employing visual aids is vital for effective informed consent. This may be particularly useful when a language does not have specific words for the medical and scientific concepts being communicated. Future research should explore language-related obstacles, particularly among vulnerable populations, to ensure culturally sensitive and comprehensible consent procedures. The languages chosen in our study all had written forms, but it would be important to explore the informed consent process for individuals fluent in languages which have never been written. Engaging communities in developing these processes is essential for identifying barriers and fostering trust, ultimately leading to more ethical and effective health research practices.

Our findings suggest that language barriers at individual, health facility and community levels could hinder informed the consent process within communities in Uganda. We suggest simplifying terminologies to accommodate the diverse languages in a multicultural society during informed consent for health research that will enhance research participation. Language is not only a means of communication but also a reflection of cultural values, beliefs, and norms [16]. It shapes the way individuals perceive the world around them and influences their behaviour and interactions with others. Culture, on the other hand, influences the development and evolution of language, as it provides the context and meaning behind the words and expressions used by a particular group of people. Cultural sensitivity [17] plays a crucial role in the informed consent process as it ensures that individuals from diverse cultural backgrounds are respected, understood, and appropriately informed about their participation in research or medical procedures. By being culturally sensitive, healthcare providers and researchers can effectively communicate with individuals, considering their cultural beliefs, values, and practices [17]. This helps in building trust and rapport with participants, leading to better comprehension of the information provided and increased willingness to participate.

Regulations and guidelines governing the conduct of clinical research require informed consent to be obtained from each human subject before research initiation, and all researchers are bound to follow these regulations [18]. Despite the research regulations, achieving the goal of informed consent in multi-lingual settings poses several challenges. Research participants may not be proficient in the language used for obtaining informed consent, leading to misunderstandings or misinterpretations of the information provided. Translating complex medical information accurately into multiple languages can be challenging [19] as nuances and cultural differences may be lost in translation. Healthcare facilities may not always have access to qualified interpreters or translated materials, making it difficult to ensure that patients fully comprehend the information provided. In multi-lingual settings, obtaining informed consent may take longer due to the need for translation and clarification, potentially delaying research procedures. One of the main challenges is the diversity of languages and cultural norms present in a country such as Uganda [9, 20]. Addressing these challenges requires researchers to prioritize effective communication strategies, such as using qualified interpreters, providing translated materials, and taking cultural differences into account when obtaining informed consent in multi-lingual settings.

The fundamental ethical principle of informed consent law [21] is to safeguard the independence of human participants, emphasizing that the well-being and interests of a subject involved in clinical research take precedence over those of society. Addressing a range of issues including language considerations for informed consent enhances participation of both individuals and communities in health research.

At the individual level, language barriers, compounded by low literacy may lead to poor comprehension of research information and hinder obtaining informed consent. This finding is supported by studies that show mothers may have difficulty during the informed consent process due to language barriers with limited English proficiency and suggested verbal and written translations for informed consent [3, 22]. Language barriers can negatively impact the rights of the participant to informed consent and confidentiality [3, 23] When individuals are unable to effectively communicate in a language that they understand, it can lead to misunderstandings or misinterpretations of important information related to their consent for research participation. There is a need to address language barriers to ensure that individuals can fully understand and participate in decisions regarding their research participation and understand their rights regarding the revealing of personal information.

Language barriers [23, 24] make informed consent complex and have been reported during documentation and obtaining informed consent in developed countries [24]. Insufficient language competence among healthcare workers leads to a considerable impairment of informed consent [25]. Language and communication skills are essential for healthcare workers when it comes to informed consent practice as these enhance proper understanding of research processes including related risks, and benefits among individual research participants. By being able to communicate clearly and effectively with or without interpreters during informed consent [26] with individual study participants in their preferred language, researchers can ensure that study participants are fully informed and can make informed decisions about their study participation. This can lead to better research outcomes and increased research participation. Additionally, language skills for healthcare workers can help build trust and rapport between researchers and participants, leading to a more positive and collaborative relationship. Health care workers can adopt language skills [27] by engaging in language training programs that focus on medical terminology and patient interaction to enhance proficiency in commonly spoken languages within the community. They can also utilize translation apps and telehealth services that provide real-time translation to assist in communication with patients who speak different languages. They can engage with the local community to practice language skills and understand the specific needs of diverse populations or recruit healthcare professionals who are already proficient in multiple languages to bridge communication gaps.

At the health facility level, participants commonly reported that there was use of inappropriate, unclear language use described by inaccurate translations, and poor and complicated grammar in some consent forms. Instructions or standard operating procedures for preparing research consent forms in an appropriate manner have been developed [28]. An individual sufficiently fluent in the language needs to check the accuracy of the forward and back translation of consent documents for efficiency. Participants reported that complex terminologies are difficult to translate to some local languages. This remains a challenge reported by several researchers conducting research in Uganda [29]. Simplifying medical terminology in the consent form and adaption to local context with involvement of community members from study design stage is key. When creating a consent form for individuals without a scientific background, researchers should make sure to use language that is easy to understand. Specific suggestions that came through the FDGs included: Address the reader directly using “you” instead of using terms like “subjects.” Use active voice to clearly state who will do what, and use simple words with fewer syllables. Researchers should keep sentences short and focused on one main idea, and break up long paragraphs into shorter ones. They should also avoid using complex or unfamiliar words, explain technical terms in simple language, and define any abbreviations the first time they appear in the text.

Our study showed that appropriate adoption of social/cultural norms in language use is necessary to ensure participants continue to feel respected. The linguistic landscape continues to evolve and adapt to current social/cultural norms [30] and this may influence the way information is communicated in informed consent documents. The incorporation of certain phrases or terminology that are popular may make informed consent forms easier to understand for individuals, but conversely, incorrect assumptions about preferred language within a community may lead to a feeling of disrespect. There is a need to identify social/cultural norms in communication styles for health research, such as the use of infographics, informal language, and preferred terminologies that may also influence how informed consent information is communicated. Communities with deep cultural beliefs desire respect for their traditional or cultural beliefs. Voices of women and men representing different communities highlight practical recommendations to address language-related challenges (Fig. 2) to informed consent.

Implementing interventions for language-related issues may support an effective informed consent process. This can be done by breaking down complex terms into more easily understandable language, and translating informed consent documents in respective appropriate local language was suggested. Obtaining the services of an interpreter or an intermediary such as a patient advocate or other healthcare worker may assist in putting the information in the participants’ native language ‘in language understandable to the study participant’, to fulfil the obligation for understanding before informed consent [20]. In Uganda, the availability of formally employed healthcare interpreters can vary by institution and region. While some healthcare facilities may have designated interpreters, many rely on informal or ad hoc arrangements, where bilingual staff or family members assist with interpretation. Regarding clinical studies, the presence of formal positions for interpreters can also differ. Some studies may include interpreters as part of their research design, while others might not have dedicated interpreters and instead depend on informal support. It is essential to review specific studies or healthcare facilities for precise information on their interpreter services. Bilingual dictionaries that render the terms from the source language in a manner that is as accurate and as clear as possible have been reported [31] and could be adopted for use in research. The use of plain language, visual aids, community-based participatory approaches, and training for researchers in cultural competency could be adopted to simplify terminologies.

Future studies should further investigate obstacles related to language during the informed consent procedure in Uganda to gain a deeper insight into the significance of language in informed consent for expectant and lactating mothers and healthcare studies in general. These language-related challenges should also be explored and resolved in other environments where issues with obtaining sufficient informed consent arise, such as with hard-to-reach populations, underserved research communities, and in various settings where research protocols are in place. By actively engaging the community in these processes, researchers can ensure that the consent procedures are culturally sensitive, relevant, and easily understood by all stakeholders. Community involvement helps in building trust and rapport between researchers, healthcare providers, and community members, leading to increased transparency and accountability in the consent process. Furthermore, involving the community in the development of informed consent processes helps in identifying potential barriers or challenges that may hinder the effective communication of information.

Strengths

This study in Uganda was one of the first to examine language-related obstacles to obtaining informed consent through FGDs in selected districts in Uganda. The FGDs provided a robust and participatory approach to identifying and addressing language-related obstacles. Validation workshops were conducted in various study locations to confirm findings and reach a final agreement on the terminology to be used for pregnant and lactating women during the informed consent process. The results highlight the importance of translating informed consent documents, simplifying language in consent forms, avoiding complex medical terminology or unfamiliar words, improving communication skills for informed consent, and engaging the community to provide input on language used in study protocols. By considering these barriers from the perspectives of multiple respondents, the study further validated the common language challenges faced by pregnant and lactating individuals during the informed consent process. Although the study focused on Uganda, the study’s insights and recommendations are applicable to other multilingual and multicultural settings. Our findings offer insights that could inform the development of more effective informed consent processes in other multilingual, low-resource settings, although further research is required to adapt and test this model in different cultural and linguistic contexts Table 3.

Table 3 Major themes and sub-themes factors influencing the informed consent process

Limitations

Participants for the study were selected from five different areas in Uganda, and diverse results could have been obtained from various tribal and linguistic groups across the nation. Underrepresented language groups led to a lack of diverse perspectives in study samples, which skewed results and limited the applicability of findings to broader populations. There was a possibility of social desirability bias and potential underreporting of language-related barriers by participants who may have been hesitant to share detailed experiences about the informed consent process. Social desirability bias causes participants to respond in ways they believed were more acceptable or favourable, rather than providing honest answers. This can distort the data and further compromise the generalizability of the study findings, as the results may not accurately reflect the true behaviours or opinions of the entire population which hinders the reliability and applicability of research conclusions. All participants were adults over 18 years old, with the majority being 25 years and older and residing in the Kampala region. Future research could intentionally include emancipated minors (defined in Uganda as those between the ages of 14 and 17 years who have become parents) to gain more perspectives from this age bracket. Furthermore, only six languages were represented, excluding the voices of other diverse language communities, decision-makers, and cultural or religious leaders. As this study is qualitative, the findings may not be generalizable, but they do provide guidance on improving language matters during informed consent in Uganda. There are potential inaccuracies in translating and interpreting participants’ responses during FGDs however validation workshops were conducted to affirm the findings. Future research could incorporate a broader range of languages to ensure findings are more representative of the entire population. The study does not include quantitative measures of the impact of simplified language or community involvement on actual research participation rates, future studies could incorporate quantitative measures to enhance the credibility of findings and provide a more nuanced understanding of the language matter.

Conclusions

Language barriers influence the informed consent process within communities studied in Uganda with a need to resolve language barriers at the individual, health system, and community levels. Integrating language matters and the development of appropriate language terminologies in the informed consent process as well as long-term planning of research communication is likely to enhance understanding and could improve research participation, although further studies are needed to assess the impact of these changes among pregnant and lactating mothers in Uganda. The use of appropriate language enhances informed consent in keeping with principles of Good Clinical Practice.