Some parts in the consent form are written using complex scientific language: Community members’ perspectives regarding terminologies used during informed consent process for research involving pregnant and lactating mothers in Uganda

Some parts in the consent form are written using complex scientific language: Community members’ perspectives regarding terminologies used during informed consent process for research involving pregnant and lactating mothers in Uganda | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Some parts in the consent form are written using complex scientific language: Community members’ perspectives regarding terminologies used during informed consent process for research involving pregnant and lactating mothers in Uganda Adelline Twimukye, Sylvia Nabukenya, Aida Kawuma, Josephine Bayigga, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4788238/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 21 Dec, 2024 Read the published version in BMC Medical Ethics → Version 1 posted 11 You are reading this latest preprint version 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 and suggest interventions to enhance goal of the informed consent processes. Methods A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board (CAB) members. 19 FGD comprised individuals aged 18 years and over. Participants represented 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. Terminologies were discussed in a community validation workshop. Results At the individual level, language barriers, and low understanding of written information due to illiteracy contribute to community members’ poor comprehension, thus hindering their ability to achieve informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, and 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 trends in language use affected cultural perceptions of informed consent. They emphasized the need for respectful communication, particularly towards women. Participants suggested use of appropriate language, availing translated informed consent document in respective appropriate local languages, simplifying terminologies in the consent forms, adapting to the local context and involvement of community members in language matters of study protocols from design stage. Conclusion Language barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Integrating considerations of language and development of appropriate language terminologies in informed consent process as well as long-term planning of research communication could improve research participation among pregnant and lactating mothers in Uganda. The use of appropriate language enhances informed consent in keeping with principles of Good Clinical Practice. language-related barriers Informed consent Participatory Research communication language matters pregnant and lactating mothers Uganda Figures Figure 1 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. What is considered inclusive and respectful may vary between settings and it is the responsibility of the researchers to work with communities to explore what works appropriately. Along similar lines, whilst the Academy of Breastfeeding Medicine 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, and for people who are not reading in their native 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. Language barriers such as illiteracy ( 2 ) or using a language in which an individual is not fluent can hinder the informed consent process, making it challenging for participants to grasp research information fully. Barriers to communication arising from illiteracy and language could prevent complete understanding of procedures. This puts patients at risk of providing informed consent (IC) without comprehension, increases 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 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 during the informed consent process. Uganda is a multilingual country ( 5 , 6 ) with over 70 estimated languages spoken. Among these languages, 43 fall into four main language families: Bantu, Nilotic, Central Sudanic, and Kuliak. Out of these 43 languages, 41 are indigenous to Uganda, while two are non-indigenous. 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 mix 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 likely have specific terms or ways of expressing familial relationships that are unique to 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 it became a protectorate of the British Empire. All university education is in English therefore it is the language in which most of the team will be most familiar with expressing scientific ideas. 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 studies. Language issues during informed consent of pregnant and lactating mothers could be resolved when health care workers share information needed in a clear manner, and free from technical language ( 9 ). It is important to create systems that aid in language comprehension and understanding of information shared with patients. Utilizing trained interpreters ( 3 ) can enhance patient communication and strengthen the relationship between healthcare workers and patients. This project aimed to describe community members’ perspectives regarding terminologies used during the informed consent process for pregnant and lactating mothers in Uganda. METHODS Study design A cross-sectional qualitative study among community members, research participants and members of the community advisory board (CAB) was conducted in August and September 2023. Focus group discussions (FGDs) were segregated by age and sex. Focus group discussion was chosen for its 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. The CAB members comprised of religious leaders (Muslim, Anglican, and Catholics), persons with disabilities, local political leaders, and cultural leaders. Validation workshops were planned 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. 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 areas 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 were recruited irrespective of their tribe as long as they were fluent in Luganda. Figure I: Map showing study regions and total number of FGD participants 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. 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. Community locations were selected based on previous studies, with participants representing 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 for youth (aged 18–25) being in a mixed sex group; this was on the basis of societal norms. CAB members formed a separate FGD as did individuals who had previously participated in research. ( 10 ) Appointments were scheduled with potential participants for a specific time, place, and duration of the FGDs. The sample size of 19 FGDs was determined based on the need to explore research questions thoroughly and achieve thematic saturation. The participant selection process was iterative, involving multiple rounds of selection and focus group discussions to achieve thematic saturation. 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 and appropriateness of the terminologies for pregnant and lactating mothers during in Uganda. FGDs lasted 60–90 minutes, and were audio-recorded. Translation and transcription were done concurrently (the transcriptionists listened to the language and translated as typed in English by people knowledgeable in the local language and English. Once the transcription was completed, the transcriptionists read through the transcription against the audio file to check for accuracy and completeness. The transcript was also passed onto another member of the field team fluent in local language and English 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 was utilized for data analysis based on data and responses from the topic guide Initially, transcribed FGDs were thoroughly reviewed multiple times for data familiarization. One joint codebook coding framework (a reference tool for directed coding) was to enhance consistency and transparency to the coding process was then developed based on four transcripts (25% of the total) that were manually reviewed and coded to create the initial set of codes 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 then grouped into categories and themes were identified. A final merged code book was developed from different categories and main findings from data and responses from uniform topic guide synthesized. Illustrative quotations for each emergent theme were chosen for results narration. RESULTS 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 . Table 2 shows the distribution of FDG participants across different regions of Uganda. Table 1 Demographic characteristics of all participants in different regions Characteristic Frequency (%), n = 146 District/ Region Amuru (Northern) 23 (15.8) Arua (West Nile) 20 (13.7) Hoima (Western) 25 (17.1) Kampala (Central) 54 (37.0) Mbarara (Western) 24 (16.4) Area of residence Urban (Kampala) 47 (32.2) Urban (Other) 57 (39.0) Rural 42 (28.8) Age Median (IQR) 31 (24–41) years Age categories ≤ 24 years 39 (26.7) 25–35 years 52 (35.6) ≥ 36 years 55 (37.7) Number of children None 23 (15.8) 1–3 71 (48.6) 4–5 25 (17.1) Not answered 24 (16.4) Education level Primary 36 (24.7) Secondary 66 (45.2) Tertiary/University 44 (30.1) Marital status Single 50 (34.3) Married 91 (62.3) Divorced 1 (0.7) Widow/widower 4 (2.7) Religion Catholic 55 (37.7) Protestant 63 (43.2) Islam 15 (10.3) Other 13 (8.9) Sex Male 69 (47.3) Female 77 (52.7) Table 2 Region, number and composition of FGDs REGION FGD Number and Composition Number of Participants Kampala • FGD 1 Youth • FGD 2 Women • FGD 3 Men • 8 • 8 • 8 Amuru • FGD 4 Men • FGD 5 Women • FGD 6 Youth • 7 • 8 • 8 Arua • FGD 7 Men • FGD 8 Women • FGD 9 Youth • 6 • 6 • 8 Mbarara • FGD 10 Men • FGD 11 Youth • FGD 12 Women • 8 • 8 • 8 Hoima • FGD 13 Men • FGD 14 Youth • FGD 15 Women • 8 • 9 • 8 Research Participants IDI-Mulago • FGD 16 Men • FGD 17 Youth • FGD 18 Women • 8 • 7 • 8 CAB Members IDI-Mulago • FGD 19 CAB • 7 TOTAL 19 FGDS 146 Participants Language factors influencing the informed consent process Various individual, health system and community language matters were shown to generally influence 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 patient 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 had the opportunity to learn to read and write) 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 option 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 described by inaccurate translations in the consent forms. Participants suggested the use of 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, style of writing or spelling errors, grammar of translations in the consent form did not make sense. This is because researchers do not conduct translations and back translations as rigorously as it should be at the prior to data collection. They suggested consent forms to be spelled correctly 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 stated that trends affected language culture in informed consent. He suggested consideration of social context of language including use of trending respectable words for women during consent. For example, when greeting women during consent they should be referred to as lady or madam. Researchers should engage with community representatives to find out what their preferred respectful language is in that specific study context. “Our culture is slowly fading away. We have adopted new linguistic trends 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 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 (Box 1) 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 script study tools to agree 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. Box 1. Recommendations from participants to address language challenges to informed consent. • Researchers should avail translated informed consent document in the appropriate local language for individual participants to enhance comprehension during informed consent. • Researchers should simplify terminologies in the consent form and adapt them to local context. • Researchers should avoid long nouns, keep sentences short and focused on one main idea, and break up long paragraphs into shorter ones for better comprehension. • Researchers should also avoid using complex terminologies like medical “jargon” or unfamiliar words, and they should explain technical terms in simple language. • Researchers should adopt the use of phrases or terminology that are locally considered to be clear, respectful and appropriate and incorporate them into informed consent forms. • Researchers should communicate to participants individually or through interpreters in the preferred local language of the participant. • Researchers should consider the social context of language including use of respectful words while designing informed consent forms. • Researchers should involve community members in developing study tools in appropriate languages from the study design stage to agree on clear, appropriate and respectful language to be used in consent forms. DISCUSSION 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. 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 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. 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 prior to research initiation, and all researchers are bound to follow these regulations ( 11 ). 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, 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. 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 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 matters 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 , 12 ). Language barriers can negatively impact on the rights of the participant to informed consent and confidentiality ( 3 ), ( 13 ) 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 need to address language barriers in order to ensure that individuals are able to fully understand and participate in decisions regarding their research participation and understand about their rights regarding revealing of personal information. Language barriers ( 13 ) ( 14 ) make informed consent complex and have been reported during documentation and obtaining Informed consent in developed countries ( 14 ). Insufficient language competence among health care workers leads to a considerable impairment of informed consent ( 15 ). Language and communication skills are essential for health care 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 ( 16 ) 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 health care workers can help build trust and rapport between researcher and participants, leading to a more positive and collaborative relationship. At the health facility level, participants commonly mentioned reported that there was use of inappropriate, unclear language use described by inaccurate translations, poor and complicated grammar in some consent forms. Instructions or standard operating procedures for preparing research consent forms in an appropriate manner have been reported ( 17 ). Somebody fluent enough 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 ( 18 ). 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, and explain technical terms in simple language and define any abbreviations the first time you use them. Our study showed that appropriate adoption of trends in language use is necessary to ensure participants continue to feel respected. Language landscape continues to evolve and adapt to current trends, 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 need to identify trends in communication styles for health research, such as the use of infographics, informal language, 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 (Box 1) to informed consent. Implementing interventions for language-related matters may support an effective informed consent process. This can be done through breaking down complex terms into more easily understandable language, translating informed consent document in respective appropriate local language was suggested. Obtaining the services of an interpreter or an intermediary such a patient advocate or other healthcare worker to assist in putting the information in the participants native language ‘in language understandable to the study participant’, in order to fulfil the obligation for understanding prior to informed consent ( 19 ). 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 ( 20 ) and could be adopted for use in research. 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. 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 the 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 focus group discussions 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, providing a model that can be adapted globally to improve informed consent processes. 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. 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 informed consent process. 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 age 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 in nature, 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. CONCLUSIONS Language barriers influence the informed consent process within communities in Uganda with a need to need to resolve language barriers at individual, health system and community levels. Integrating language matters and development of appropriate language terminologies in informed consent process as well as long-term planning of research communication could improve research participation among pregnant and lactating mothers in Uganda. The use of appropriate language enhances informed consent in keeping with principles of Good Clinical Practice. Declarations ETHICS APPROVAL AND CONSENT TO PARTICIPATE We obtained expedited ethical clearance for this study from the institutional review board (IRB) of Infectious Diseases Institute (IDI- REC- 2023- 37) Uganda National Council of Science and technology (HS2890ES). Also, approval was sought from the district health team and study participants. Written informed consent was sought, and only those who consented participated in the study. The research team ensured the utmost confidentiality during the entire process of the study. CONSENT FOR PUBLICATION Not applicable. ACKNOWLEDGEMENTS We wish to thank the MILK Study team members and study participants. In addition, special thanks go to members of the MILK Community advisory board and members of the IDI research office for their insightful feedback during the development of this protocol. We are also grateful to research assistants: Jovia Tabwenda (JT), Jaqueline Kyeyune (JK), Christine Turyahabwe (CT), William Baluku (WB), Kalisa Patricia Kelly (KPK), Immaculate Muloni (IM), for their contribution in collecting data. FUNDING The study was funded by a Participatory Research Grant from the Faculty of Health and Life Sciences at the University of Liverpool. CW, RN, ANK, FWO and SPA are supported by Wellcome Clinical Research Career Development Fellowship 222075/Z/20/Z, awarded to CW. AUTHORS’ CONTRIBUTIONS AT and JB performed analysis of the data, CW, RN, AT, SPA, ANK and SN were involved in writing the protocol. AT, RN, SPA, JB and FB were involved in collecting the data. CW was responsible for the overall concept and design of the study protocol. FWO, RN, AT, JB, CW and SPA participated in data visualization and validation. All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors and have contributed to, seen, and approved the final submitted version of the manuscript. COMPETING INTERESTS The authors have no competing interests to declare. AVAILABILITY OF DATA AND MATERIALS The datasets used and/ or analysed during the current study are available from the corresponding author on reasonable request. References Waters L, Hodson M, Josh J. Language matters: The importance of person-first language and an introduction to the People First Charter. HIV Med. 2023;24(1):3-5. Chima SC, editor Language as a barrier to informed consent and patient communications in South African hospitals-a working paper. The Asian Conference on Ethics, Religion & Philosophy 2018 Official Conference Proceedings; 2018. Australian lawyers Alliance. Opinion 2024 [Available from: https://www.lawyersalliance.com.au/opinion/language-barriers-informed-consent-and-interpreters-in-medical-care.%20Accessed%2022-5-2024. Schlemmer A, Mash B. The effects of a language barrier in a South African district hospital. South African medical journal. 2006;96(10):1084-7. Wikipedia. Languages of Uganda 2024 [Available from: https://en.wikipedia.org/wiki/Languages_of_Uganda. Bhan A, Majd M, Adejumo A. Informed consent in international research: perspectives from India, Iran and Nigeria. 2006. Wikipedia. Acholi dialect 2024 [Available from: https://en.wikipedia.org/wiki/Acholi_dialect. Onyango-Ouma W, Aagaard-Hansen J. Dholuo Kincepts in Western Kenya. Studies in African Linguistics. 2020;49(2):305-21. Ssali A, Poland F, Seeley J. Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda. BMC medical ethics. 2015;16:1-14. Waitt C, Orrell C, Walimbwa S, Singh Y, Kintu K, Simmons B, et al. Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: a randomised trial (DolPHIN-1 study). 2019;16(9):e1002895. Gupta UC. Informed consent in clinical research: Revisiting few concepts and areas. Perspectives in clinical research. 2013;4(1):26-32. Clark S, Mangram A, Ernest D, Lebron R, Peralta L. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers. Journal of Surgical Education. 2011;68(2):143-7. Haricharan HJ, Heap M, Coomans F, London L. Can we talk about the right to healthcare without language? A critique of key international human rights law, drawing on the experiences of a Deaf woman in Cape Town, South Africa. Disability & Society. 2013;28(1):54-66. Schenker Y, Wang F, Selig SJ, Ng R, Fernandez A. The impact of language barriers on documentation of informed consent at a hospital with on-site interpreter services. Journal of General Internal Medicine. 2007;22:294-9. Borowski D, Koreik U, Ohm U, Riemer C, Rahe-Meyer N. Informed consent at stake? Language barriers in medical interactions with immigrant anaesthetists: a conversation analytical study. BMC health services research. 2019;19:1-10. Crawford A. " We can't all understand the whites' language": an analysis of monolingual health Services in a multilingual society. 1999. partners human research committee instructions for preparing research consent forms. Partners human research committee instructions for preparing research consent forms n. d. [Available from: https://nsmcwebcontent.blob.core.windows.net/cmslibrary/nsmc/irb/Research_Consent_Form_Instructions.06.07.pdf. Nabukenya S, Ochieng J, Kaawa-Mafigiri D, Munabi I, Nakigudde J, Nakwagala Frederick N, et al. Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study. 2022;18(3):193-209. Deumert A. ‘It would be nice if they could give us more language’–Serving South Africa’s multilingual patient base. Social Science & Medicine. 2010;71(1):53-61. Wangia JI, Ayieko G. Translation of Kinship Terminology in Selected Bilingual Dictionaries in Kenya and Its Implication for Cross-Cultural Communication. Chemchemi International Journal of Humanities and Social Sciences. 2016;10(2). Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 21 Dec, 2024 Read the published version in BMC Medical Ethics → Version 1 posted Editorial decision: Revision requested 21 Oct, 2024 Reviews received at journal 21 Oct, 2024 Reviewers agreed at journal 02 Oct, 2024 Reviews received at journal 02 Sep, 2024 Reviewers agreed at journal 06 Aug, 2024 Reviewers agreed at journal 05 Aug, 2024 Reviewers invited by journal 31 Jul, 2024 Editor invited by journal 24 Jul, 2024 Editor assigned by journal 24 Jul, 2024 Submission checks completed at journal 24 Jul, 2024 First submitted to journal 23 Jul, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4788238","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":341313432,"identity":"a20e5aa6-74b2-4fc8-81b1-14de08ee6a63","order_by":0,"name":"Adelline Twimukye","email":"","orcid":"","institution":"Infectious Diseases Institute, Makerere University","correspondingAuthor":false,"prefix":"","firstName":"Adelline","middleName":"","lastName":"Twimukye","suffix":""},{"id":341313433,"identity":"62f9d54d-73d1-412f-979f-abddc3339e83","order_by":1,"name":"Sylvia Nabukenya","email":"","orcid":"","institution":"Infectious Diseases 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11:12:27","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4788238/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4788238/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12910-024-01147-4","type":"published","date":"2024-12-21T15:58:20+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":63297879,"identity":"f2cc3f99-cb93-40ed-9d3e-e2d7f57f890c","added_by":"auto","created_at":"2024-08-26 15:41:58","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":603389,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eMap showing study regions and total number of FGD participants\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Figure1Ugandamap.png","url":"https://assets-eu.researchsquare.com/files/rs-4788238/v1/51d6ce1de47d28fb26f3f718.png"},{"id":72201940,"identity":"08730710-c1d8-4342-a05c-666db0d9379e","added_by":"auto","created_at":"2024-12-23 16:12:31","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1551241,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4788238/v1/d009ddea-82b1-4908-b1d5-9387227520d6.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Some parts in the consent form are written using complex scientific language: Community members’ perspectives regarding terminologies used during informed consent process for research involving pregnant and lactating mothers in Uganda","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eIt 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, \u0026lsquo;person-first\u0026rsquo; language (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e), 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. (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). 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. What is considered inclusive and respectful may vary between settings and it is the responsibility of the researchers to work with communities to explore what works appropriately. Along similar lines, whilst the Academy of Breastfeeding Medicine calls for increasing use of gender-neutral or \u0026lsquo;desexed\u0026rsquo; 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, and for people who are not reading in their native 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.\u003c/p\u003e \u003cp\u003eLanguage barriers such as illiteracy (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) or using a language in which an individual is not fluent can hinder the informed consent process, making it challenging for participants to grasp research information fully. Barriers to communication arising from illiteracy and language could prevent complete understanding of procedures. This puts patients at risk of providing informed consent (IC) without comprehension, increases medical errors, and deprives patients of their constitutional rights to information in a language of their own choice (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). 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.\u003c/p\u003e \u003cp\u003e Obtaining 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 during the informed consent process. Uganda is a multilingual country (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) with over 70 estimated languages spoken. Among these languages, 43 fall into four main language families: Bantu, Nilotic, Central Sudanic, and Kuliak. Out of these 43 languages, 41 are indigenous to Uganda, while two are non-indigenous.\u003c/p\u003e \u003cp\u003eIn south-central Uganda, the most spoken Bantu language is Luganda. Bantu-speaking areas often have dialect continua (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) where different dialects blend. For instance, Runyankore is spoken in Mbarara, while Rutooro in Fort portal, and in between, there are villages where a mix 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 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). 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 (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) that have been reported or documented. These languages likely have specific terms or ways of expressing familial relationships that are unique to their cultural context.\u003c/p\u003e \u003cp\u003eThis 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\u0026ndash;1962 when it became a protectorate of the British Empire. All university education is in English therefore it is the language in which most of the team will be most familiar with expressing scientific ideas.\u003c/p\u003e \u003cp\u003eBy 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 studies. Language issues during informed consent of pregnant and lactating mothers could be resolved when health care workers share information needed in a clear manner, and free from technical language (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). It is important to create systems that aid in language comprehension and understanding of information shared with patients. Utilizing trained interpreters (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) can enhance patient communication and strengthen the relationship between healthcare workers and patients. This project aimed to describe community members\u0026rsquo; perspectives regarding terminologies used during the informed consent process for pregnant and lactating mothers in Uganda.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003e A cross-sectional qualitative study among community members, research participants and members of the community advisory board (CAB) was conducted in August and September 2023. Focus group discussions (FGDs) were segregated by age and sex. Focus group discussion was chosen for its 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.\u003c/p\u003e \u003cp\u003eThe CAB members comprised of religious leaders (Muslim, Anglican, and Catholics), persons with disabilities, local political leaders, and cultural leaders. Validation workshops were planned 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.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy setting\u003c/h2\u003e \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e \u003ch2\u003eInfectious Diseases Institute\u003c/h2\u003e \u003cp\u003eThe 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.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eChoice of Study Sites\u003c/h2\u003e \u003cp\u003eWe 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.\u0026nbsp;1), choosing areas 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 were recruited irrespective of their tribe as long as they were fluent in Luganda.\u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure I: Map showing study regions and total number of FGD participants\u003c/b\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eParticipant selection and sampling\u003c/h2\u003e \u003cp\u003e We identified community members with the help of local community leaders and via contacts made through the research portfolio led by IDI. 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. Community locations were selected based on previous studies, with participants representing at least six different mother tongues (Luganda, Acholi, Runyankole, Runyoro, English and Lugbara). A total 3 FGDs each comprising of 6\u0026ndash;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 for youth (aged 18\u0026ndash;25) being in a mixed sex group; this was on the basis of societal norms. CAB members formed a separate FGD as did individuals who had previously participated in research. (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) Appointments were scheduled with potential participants for a specific time, place, and duration of the FGDs. The sample size of 19 FGDs was determined based on the need to explore research questions thoroughly and achieve thematic saturation. The participant selection process was iterative, involving multiple rounds of selection and focus group discussions to achieve thematic saturation.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eThree 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 and appropriateness of the terminologies for pregnant and lactating mothers during in Uganda. FGDs lasted 60\u0026ndash;90 minutes, and were audio-recorded. Translation and transcription were done concurrently (the transcriptionists listened to the language and translated as typed in English by people knowledgeable in the local language and English. Once the transcription was completed, the transcriptionists read through the transcription against the audio file to check for accuracy and completeness. The transcript was also passed onto another member of the field team fluent in local language and English 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.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eBased on the information provided, an inductive approach was utilized for data analysis based on data and responses from the topic guide Initially, transcribed FGDs were thoroughly reviewed multiple times for data familiarization. One joint codebook coding framework (a reference tool for directed coding) was to enhance consistency and transparency to the coding process was then developed based on four transcripts (25% of the total) that were manually reviewed and coded to create the initial set of codes 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 then grouped into categories and themes were identified. A final merged code book was developed from different categories and main findings from data and responses from uniform topic guide synthesized. Illustrative quotations for each emergent theme were chosen for results narration.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eCharacteristics of participants\u003c/h2\u003e \u003cp\u003eDetails of the sites and the 19 FGDs details are reported in Tables\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e and \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. 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\u0026ndash;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\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e shows the distribution of FDG participants across different regions of Uganda.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic characteristics of all participants in different regions\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eCharacteristic Frequency (%), n\u0026thinsp;=\u0026thinsp;146\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eDistrict/ Region\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAmuru (Northern)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23 (15.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eArua (West Nile)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20 (13.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHoima (Western)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25 (17.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKampala (Central)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e54 (37.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMbarara (Western)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24 (16.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eArea of residence\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUrban (Kampala)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e47 (32.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUrban (Other)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e57 (39.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRural\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e42 (28.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eAge Median (IQR) 31 (24\u0026ndash;41) years\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eAge categories\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026le;\u0026thinsp;24 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e39 (26.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e25\u0026ndash;35 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e52 (35.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;36 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e55 (37.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eNumber of children\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23 (15.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u0026ndash;3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e71 (48.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u0026ndash;5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25 (17.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNot answered\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24 (16.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eEducation level\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36 (24.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSecondary\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e66 (45.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTertiary/University\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e44 (30.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eMarital status\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSingle\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e50 (34.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMarried\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e91 (62.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDivorced\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (0.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWidow/widower\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (2.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eReligion\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCatholic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e55 (37.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProtestant\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e63 (43.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIslam\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15 (10.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (8.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e69 (47.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (52.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eRegion, number and composition of FGDs\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eREGION\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFGD Number and Composition\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNumber of Participants\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKampala\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; FGD 1 Youth\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 2 Women\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 3 Men\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAmuru\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; FGD 4 Men\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 5 Women\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 6 Youth\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; 7\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eArua\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; FGD 7 Men\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 8 Women\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 9 Youth\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; 6\u003c/p\u003e \u003cp\u003e\u0026bull; 6\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMbarara\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; FGD 10 Men\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 11 Youth\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 12 Women\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHoima\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; FGD 13 Men\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 14 Youth\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 15 Women\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003cp\u003e\u0026bull; 9\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResearch Participants\u003c/p\u003e \u003cp\u003eIDI-Mulago\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; FGD 16 Men\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 17 Youth\u003c/p\u003e \u003cp\u003e\u0026bull; FGD 18 Women\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003cp\u003e\u0026bull; 7\u003c/p\u003e \u003cp\u003e\u0026bull; 8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCAB Members\u003c/p\u003e \u003cp\u003eIDI-Mulago\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; FGD 19 CAB\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026bull; 7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTOTAL\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19 FGDS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e146 Participants\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eLanguage factors influencing the informed consent process\u003c/h2\u003e \u003cp\u003eVarious individual, health system and community language matters were shown to generally influence informed consent.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eIndividual-level factors for informed consent\u003c/h2\u003e \u003cp\u003eLanguage barriers and low comprehension compounded by high rates of illiteracy affected participants\u0026rsquo; comprehension and hindered their ability to give informed consent. Having a patient information leaflet (PIL) and informed consent form (ICF) in the appropriate language for each participant enhanced reading and signing of the informed consent.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e 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\u003c/em\u003e\u003c/p\u003e\u003cp\u003e\u003cem\u003e--\u003c/em\u003e FGD_10_Men_Mbarara district.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003e Illiteracy (never had the opportunity to learn to read and write) 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.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThen, there also other research programs that are introduced in the community, they are brought by researchers but they tend to use words like \u0026lsquo;omuntu atasomire\u0026rsquo; [illiterate person]. Much as she doesn\u0026rsquo;t have education background, she is my parent, and it would be offensive to call her illiterate.\u003c/p\u003e\u003cp\u003e-- FGD_14_Young Adults_Hoima district.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003e Young adults in one FGD liked the choice option 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.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;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\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003cp\u003e-- FGD_01_Young Adults 18\u0026ndash;24_ Mulago.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThere was concern that the in Luganda, description of pregnancy relied on limited words compared to English.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eWhat I\u0026rsquo;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\u003c/p\u003e\u003cp\u003e--FGD_01_Young Adults 18\u0026ndash;24_IDI Mulago.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eHealth facility- level factors for informed consent\u003c/h2\u003e \u003cdiv id=\"Sec15\" class=\"Section3\"\u003e \u003ch2\u003eUsing inappropriate and unclear language\u003c/h2\u003e \u003cp\u003e Participants reported that there was use of inappropriate and unclear language described by inaccurate translations in the consent forms. Participants suggested the use of 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.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e 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 \u0026lsquo;olusa olwabeigaisire\u0026rsquo; [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\u003c/em\u003e\u003c/p\u003e\u003cp\u003e--FGD_15_Men_Kahooro, Hoima district.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003ePoor and complicated grammar or errors in the informed consent form\u003c/h2\u003e \u003cp\u003e 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, style of writing or spelling errors, grammar of translations in the consent form did not make sense. This is because researchers do not conduct translations and back translations as rigorously as it should be at the prior to data collection. They suggested consent forms to be spelled correctly according to the right linguistic language dialect.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;There is a word on page 7. The phrase reads, \u0026lsquo;Nyinekushalaho hati?\u0026rsquo; [should I decide now?] I think it should be written as \u0026ldquo;Nyinekusharamu hati [do I need to decide now?] \u0026ldquo;There is a word on the front page which is \u0026lsquo;okuhandika\u0026rsquo;[write]. It should be rectified to \u0026lsquo;okuhandiika\u0026rsquo; with double i. Another word is written as \u0026lsquo;Handihachye[later],\u0026rsquo; here, we use k instead of \u0026lsquo;c\u0026rsquo;; \u0026ldquo;handihakye\u0026rdquo;. That is why it was a bit difficult for us to read\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003cp\u003e--FGD_12_Women_Mbarara City.\u003c/p\u003e\u003cp\u003eWhen I read the consent forms, I came across a statement; \u0026ldquo;Ebigendenda okukubaganya ebiloswoozo [purpose of the FGD] which has a wrong spelling, it should state ebigendelerwa\u003c/p\u003e\u003cp\u003e--FGD_17_Young Adults_Research Participants_IDI-Mulago.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eComplex terminologies in the individual informed consent forms\u003c/h2\u003e \u003cp\u003eComplex 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.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eI 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\u003c/p\u003e\u003cp\u003e--FGD_06_Youth_Amuru district.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eCommunity facility- level factors for informed consent\u003c/h2\u003e \u003cp\u003e A participant in one FGD stated that trends affected language culture in informed consent. He suggested consideration of social context of language including use of trending respectable words for women during consent. For example, when greeting women during consent they should be referred to as lady or madam. Researchers should engage with community representatives to find out what their preferred respectful language is in that specific study context.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Our culture is slowly fading away. We have adopted new linguistic trends where the term \u0026lsquo;a lady\u0026rsquo; 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. \u0026hellip;I think the two titles; \u0026lsquo;lady\u0026rsquo; and \u0026lsquo;woman\u0026rsquo; are distinctively used in the community. You cannot address a respectable female adult by saying, \u0026ldquo;Woman, I greet you.\u0026rdquo; For example, when the researchers come to the community, it would not sound appropriate to address a female adult as, \u0026ldquo;That woman.\u0026rdquo; Or say \u0026ldquo;Woman, I greet you.\u0026rdquo; We usually use words like; \u0026ldquo;Greetings Madam. How has been your day Ma\u0026rsquo;am. Lady\u0026hellip;how has been your day?\u0026rdquo; In most cases, we simply use the term lady as a title of respect. So, you could call her \u0026lsquo;Madam\u0026rsquo;; \u0026ldquo;Greetings madam.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\u003cp\u003e-- FGD_03_Men_IDI Mulago.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eStrategies to address language-related challenges to informed consent\u003c/h2\u003e \u003cdiv id=\"Sec20\" class=\"Section3\"\u003e \u003ch2\u003eIndividual- based approaches\u003c/h2\u003e \u003cdiv id=\"Sec21\" class=\"Section4\"\u003e \u003ch2\u003eAvailing translated ICFS for both English and appropriate local language\u003c/h2\u003e \u003cp\u003eParticipants suggested several recommendations to resolve language barriers that would lead to improved informed consent (Box 1) including the use of appropriate language that participants understood as it enhanced easy comprehension of information shared about the study during informed consent.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eI read the \u0026ldquo;Luganda\u0026rdquo; [language] words as they were written and you explained to me everything that I failed to understand\u0026mdash;and I was able to understand it\u003c/p\u003e\u003cp\u003e\u003cem\u003e--\u003c/em\u003e FGD_02_Women_IDI Mulago.\u003c/p\u003e\u003cp\u003eSince they [consent forms] are in English, I have understood them. However, it is important to have someone explain the information to you in detail\u003c/p\u003e\u003cp\u003e--FGD_19_CAB Members Mulago.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eParticipants 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.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026hellip;\u003cem\u003eI prefer English as it\u0026rsquo;s the language I understand better\u003c/em\u003e; \u003cem\u003eWe can read and understand English faster than Lugbara [language]\u003c/em\u003e\u003c/p\u003e\u003cp\u003e-- FGD_09_Young Adults 18\u0026ndash;24_Mvara sub county Arua.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003e 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.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eI have read the consent form and they have explained the information to me, which I have accepted and consented to participate in this study.\u003c/p\u003e\u003cp\u003e\u003cem\u003e--\u003c/em\u003e FGD_10_Men_Mbarara district.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eHealth system approaches\u003c/h2\u003e \u003cp\u003e \u003cb\u003eImproved communication skills among researchers.\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThe 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.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003eI 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\u0026mdash;because most people understand English but they cannot effectively translate it to another person\u0026mdash;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.\u003c/em\u003e \u003c/p\u003e\u003cp\u003e-- FGD_18_Women _Mulago.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eSimplify terminologies in the consent form and adopt applicable language\u003c/h2\u003e \u003cp\u003e 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\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003eI find it reasonable to us that it should be \u0026ldquo;Acholi\u0026rdquo; [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]\u003c/em\u003e\u003c/p\u003e\u003cp\u003e-- FGD_04_Men_Lamogi, Amuru District.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003e \u003cb\u003eConduct linguistic research among eligible populations.\u003c/b\u003e \u003c/p\u003e \u003cp\u003e 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.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThere is a word on the first page of the consent form.... \u0026ldquo;Pregnant and Lactating\u0026rdquo; Is it lactating? So, that terminology\u0026mdash;but when I read there, I know that it means breastfeeding but others may not understand it [Lactating]\u003c/p\u003e\u003cp\u003e--FGD_19_CAB Members, Mulago.\u003c/p\u003e\u003cp\u003e\u003cem\u003eThere are certain words which are not appropriate for use in the community such as the pre-current; \u0026lsquo;a person with a uterus\u0026rsquo;, feeding parent\u0026rsquo;. 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\u003c/em\u003e\u003c/p\u003e\u003cp\u003e\u003cem\u003e--\u003c/em\u003e FGD_15_Men_Kahooro, Hoima district.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003eCommunity approaches\u003c/h2\u003e \u003cp\u003e \u003cb\u003eInvolvement of community members in developing study tools in appropriate languages.\u003c/b\u003e \u003c/p\u003e \u003cp\u003eDespite 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 script study tools to agree on the accurate and respectful language to be used in consent forms.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I am suggesting that when you are including those words in the documents, please ensure that there is a \u0026lsquo;munyoro\u0026rsquo; tribe or a \u0026lsquo;mutooro\u0026rsquo; tribe to be able to confirm the words, this will prevent you from using words that are not suitable to be included\u003c/em\u003e\u0026rdquo;.\u003c/p\u003e \u003cp\u003e--FGD_15_Men_Kahooro, Hoima district.\u003c/p\u003e \u003cp\u003e\u003cb\u003eBox 1. Recommendations from participants to address language challenges to informed consent.\u003c/b\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e \u003ccolgroup cols=\"1\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Researchers should avail translated informed consent document in the appropriate local language for individual participants to enhance comprehension during informed consent.\u003c/p\u003e \u003cp\u003e\u0026bull; Researchers should simplify terminologies in the consent form and adapt them to local context.\u003c/p\u003e \u003cp\u003e\u0026bull; Researchers should avoid long nouns, keep sentences short and focused on one main idea, and break up long paragraphs into shorter ones for better comprehension.\u003c/p\u003e \u003cp\u003e\u0026bull; Researchers should also avoid using complex terminologies like medical \u0026ldquo;jargon\u0026rdquo; or unfamiliar words, and they should explain technical terms in simple language.\u003c/p\u003e \u003cp\u003e\u0026bull; Researchers should adopt the use of phrases or terminology that are locally considered to be clear, respectful and appropriate and incorporate them into informed consent forms.\u003c/p\u003e \u003cp\u003e\u0026bull; Researchers should communicate to participants individually or through interpreters in the preferred local language of the participant.\u003c/p\u003e \u003cp\u003e\u0026bull; Researchers should consider the social context of language including use of respectful words while designing informed consent forms.\u003c/p\u003e \u003cp\u003e\u0026bull; Researchers should involve community members in developing study tools in appropriate languages from the study design stage to agree on clear, appropriate and respectful language to be used in consent forms.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eOur 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. 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 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. This helps in building trust and rapport with participants, leading to better comprehension of the information provided and increased willingness to participate.\u003c/p\u003e \u003cp\u003eRegulations and guidelines governing the conduct of clinical research require informed consent to be obtained from each human subject prior to research initiation, and all researchers are bound to follow these regulations (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). 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, 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. 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.\u003c/p\u003e \u003cp\u003e The fundamental ethical principle of informed consent law 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 matters for informed consent enhances participation of both individuals and communities in health research.\u003c/p\u003e \u003cp\u003eAt 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 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Language barriers can negatively impact on the rights of the participant to informed consent and confidentiality (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e), (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) 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 need to address language barriers in order to ensure that individuals are able to fully understand and participate in decisions regarding their research participation and understand about their rights regarding revealing of personal information.\u003c/p\u003e \u003cp\u003eLanguage barriers (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) make informed consent complex and have been reported during documentation and obtaining Informed consent in developed countries (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Insufficient language competence among health care workers leads to a considerable impairment of informed consent (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Language and communication skills are essential for health care 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 (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) 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 health care workers can help build trust and rapport between researcher and participants, leading to a more positive and collaborative relationship.\u003c/p\u003e \u003cp\u003eAt the health facility level, participants commonly mentioned reported that there was use of inappropriate, unclear language use described by inaccurate translations, poor and complicated grammar in some consent forms. Instructions or standard operating procedures for preparing research consent forms in an appropriate manner have been reported (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Somebody fluent enough 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 (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). 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, and explain technical terms in simple language and define any abbreviations the first time you use them.\u003c/p\u003e \u003cp\u003e Our study showed that appropriate adoption of trends in language use is necessary to ensure participants continue to feel respected. Language landscape continues to evolve and adapt to current trends, 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 need to identify trends in communication styles for health research, such as the use of infographics, informal language, 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 (Box 1) to informed consent.\u003c/p\u003e \u003cp\u003eImplementing interventions for language-related matters may support an effective informed consent process. This can be done through breaking down complex terms into more easily understandable language, translating informed consent document in respective appropriate local language was suggested. Obtaining the services of an interpreter or an intermediary such a patient advocate or other healthcare worker to assist in putting the information in the participants native language \u0026lsquo;in language understandable to the study participant\u0026rsquo;, in order to fulfil the obligation for understanding prior to informed consent (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). 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 (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) and could be adopted for use in research. Use of plain language, visual aids, community-based participatory approaches, and training for researchers in cultural competency could be adopted to simplify terminologies.\u003c/p\u003e \u003cp\u003eFuture 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. 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 the 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.\u003c/p\u003e \u003cdiv id=\"Sec26\" class=\"Section2\"\u003e \u003ch2\u003eSTRENGTHS\u003c/h2\u003e \u003cp\u003eThis study in Uganda was one of the first to examine language-related obstacles to obtaining informed consent through focus group discussions 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, providing a model that can be adapted globally to improve informed consent processes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section2\"\u003e \u003ch2\u003eLIMITATIONS\u003c/h2\u003e \u003cp\u003eParticipants 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. 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 informed consent process. 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 age 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 in nature, 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\u0026rsquo; responses during FGDs however validation workshops were conducted to affirm the findings.\u003c/p\u003e \u003c/div\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eLanguage barriers influence the informed consent process within communities in Uganda with a need to need to resolve language barriers at individual, health system and community levels. Integrating language matters and development of appropriate language terminologies in informed consent process as well as long-term planning of research communication could improve research participation among pregnant and lactating mothers in Uganda. The use of appropriate language enhances informed consent in keeping with principles of Good Clinical Practice.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eETHICS APPROVAL AND CONSENT TO PARTICIPATE\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe obtained expedited ethical clearance for this study from the institutional review board (IRB) of Infectious Diseases Institute (IDI- REC- 2023- 37) Uganda National Council of Science and technology (HS2890ES). Also, approval was sought from the district health team and study participants. Written informed consent was sought, and only those who consented participated in the study. The research team ensured the utmost confidentiality during the entire process of the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSENT FOR PUBLICATION\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eACKNOWLEDGEMENTS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe wish to thank the MILK\u0026nbsp;Study team members\u0026nbsp;and study participants. In addition, special thanks go to members of the MILK Community advisory board and members of the IDI research office for their insightful feedback during the development of this protocol.\u0026nbsp;We are also grateful to research assistants: \u0026nbsp;Jovia Tabwenda (JT), Jaqueline Kyeyune (JK), Christine Turyahabwe (CT), William Baluku (WB), Kalisa Patricia Kelly (KPK), Immaculate Muloni (IM), for their contribution in collecting data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFUNDING\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was funded by a Participatory Research Grant from the Faculty of Health and Life Sciences at the University of Liverpool. CW, RN, ANK, FWO and SPA are supported by Wellcome Clinical Research Career Development Fellowship 222075/Z/20/Z, awarded to CW.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAUTHORS’ CONTRIBUTIONS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAT and JB performed analysis of the data, CW, RN, AT, SPA, ANK and SN were involved in writing the protocol. AT, RN, SPA, JB and FB\u0026nbsp;were involved in collecting the data. CW\u0026nbsp;was responsible for the overall concept and design of the study protocol. FWO, RN, AT, JB, CW and SPA participated in data visualization and validation. All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors and have contributed to, seen, and approved the final submitted version of the manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCOMPETING INTERESTS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no competing interests to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAVAILABILITY OF DATA AND MATERIALS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/ or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWaters L, Hodson M, Josh J. Language matters: The importance of person-first language and an introduction to the People First Charter. HIV Med. 2023;24(1):3-5.\u003c/li\u003e\n\u003cli\u003eChima SC, editor Language as a barrier to informed consent and patient communications in South African hospitals-a working paper. The Asian Conference on Ethics, Religion \u0026amp; Philosophy 2018 Official Conference Proceedings; 2018.\u003c/li\u003e\n\u003cli\u003eAustralian lawyers Alliance. Opinion 2024 [Available from: https://www.lawyersalliance.com.au/opinion/language-barriers-informed-consent-and-interpreters-in-medical-care.%20Accessed%2022-5-2024.\u003c/li\u003e\n\u003cli\u003eSchlemmer A, Mash B. The effects of a language barrier in a South African district hospital. South African medical journal. 2006;96(10):1084-7.\u003c/li\u003e\n\u003cli\u003eWikipedia. Languages of Uganda 2024 [Available from: https://en.wikipedia.org/wiki/Languages_of_Uganda.\u003c/li\u003e\n\u003cli\u003eBhan A, Majd M, Adejumo A. Informed consent in international research: perspectives from India, Iran and Nigeria. 2006.\u003c/li\u003e\n\u003cli\u003eWikipedia. Acholi dialect 2024 [Available from: https://en.wikipedia.org/wiki/Acholi_dialect.\u003c/li\u003e\n\u003cli\u003eOnyango-Ouma W, Aagaard-Hansen J. Dholuo Kincepts in Western Kenya. Studies in African Linguistics. 2020;49(2):305-21.\u003c/li\u003e\n\u003cli\u003eSsali A, Poland F, Seeley J. Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda. BMC medical ethics. 2015;16:1-14.\u003c/li\u003e\n\u003cli\u003eWaitt C, Orrell C, Walimbwa S, Singh Y, Kintu K, Simmons B, et al. Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: a randomised trial (DolPHIN-1 study). 2019;16(9):e1002895.\u003c/li\u003e\n\u003cli\u003eGupta UC. Informed consent in clinical research: Revisiting few concepts and areas. Perspectives in clinical research. 2013;4(1):26-32.\u003c/li\u003e\n\u003cli\u003eClark S, Mangram A, Ernest D, Lebron R, Peralta L. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers. Journal of Surgical Education. 2011;68(2):143-7.\u003c/li\u003e\n\u003cli\u003eHaricharan HJ, Heap M, Coomans F, London L. Can we talk about the right to healthcare without language? A critique of key international human rights law, drawing on the experiences of a Deaf woman in Cape Town, South Africa. Disability \u0026amp; Society. 2013;28(1):54-66.\u003c/li\u003e\n\u003cli\u003eSchenker Y, Wang F, Selig SJ, Ng R, Fernandez A. The impact of language barriers on documentation of informed consent at a hospital with on-site interpreter services. Journal of General Internal Medicine. 2007;22:294-9.\u003c/li\u003e\n\u003cli\u003eBorowski D, Koreik U, Ohm U, Riemer C, Rahe-Meyer N. Informed consent at stake? Language barriers in medical interactions with immigrant anaesthetists: a conversation analytical study. BMC health services research. 2019;19:1-10.\u003c/li\u003e\n\u003cli\u003eCrawford A. \u0026quot; We can\u0026apos;t all understand the whites\u0026apos; language\u0026quot;: an analysis of monolingual health Services in a multilingual society. 1999.\u003c/li\u003e\n\u003cli\u003epartners human research committee instructions for preparing research consent forms. Partners human research committee instructions for preparing research consent forms n. d. [Available from: https://nsmcwebcontent.blob.core.windows.net/cmslibrary/nsmc/irb/Research_Consent_Form_Instructions.06.07.pdf.\u003c/li\u003e\n\u003cli\u003eNabukenya S, Ochieng J, Kaawa-Mafigiri D, Munabi I, Nakigudde J, Nakwagala Frederick N, et al. Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study. 2022;18(3):193-209.\u003c/li\u003e\n\u003cli\u003eDeumert A. \u0026lsquo;It would be nice if they could give us more language\u0026rsquo;\u0026ndash;Serving South Africa\u0026rsquo;s multilingual patient base. Social Science \u0026amp; Medicine. 2010;71(1):53-61.\u003c/li\u003e\n\u003cli\u003eWangia JI, Ayieko G. Translation of Kinship Terminology in Selected Bilingual Dictionaries in Kenya and Its Implication for Cross-Cultural Communication. Chemchemi International Journal of Humanities and Social Sciences. 2016;10(2).\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-ethics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meth","sideBox":"Learn more about [BMC Medical Ethics](http://bmcmedethics.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meth/default.aspx","title":"BMC Medical Ethics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"language-related barriers, Informed consent, Participatory Research, communication, language matters, pregnant and lactating mothers, Uganda","lastPublishedDoi":"10.21203/rs.3.rs-4788238/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4788238/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eAppropriate language use is essential to ensure inclusion of diverse populations in research. We aimed to identify possible language-related barriers regarding the informed consent and suggest interventions to enhance goal of the informed consent processes.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board (CAB) members. 19 FGD comprised individuals aged 18 years and over. Participants represented 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. Terminologies were discussed in a community validation workshop.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAt the individual level, language barriers, and low understanding of written information due to illiteracy contribute to community members\u0026rsquo; poor comprehension, thus hindering their ability to achieve informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, and 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 trends in language use affected cultural perceptions of informed consent. They emphasized the need for respectful communication, particularly towards women. Participants suggested use of appropriate language, availing translated informed consent document in respective appropriate local languages, simplifying terminologies in the consent forms, adapting to the local context and involvement of community members in language matters of study protocols from design stage.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eLanguage barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Integrating considerations of language and development of appropriate language terminologies in informed consent process as well as long-term planning of research communication could improve research participation among pregnant and lactating mothers in Uganda. The use of appropriate language enhances informed consent in keeping with principles of Good Clinical Practice.\u003c/p\u003e","manuscriptTitle":"Some parts in the consent form are written using complex scientific language: Community members’ perspectives regarding terminologies used during informed consent process for research involving pregnant and lactating mothers in Uganda","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-26 15:41:53","doi":"10.21203/rs.3.rs-4788238/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-10-22T03:54:27+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-10-21T14:12:28+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"177694201327989721313961029048633818447","date":"2024-10-02T07:51:55+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-09-02T09:48:32+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"135145100784832437796398211697064938911","date":"2024-08-06T12:35:02+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"115322229672149088273621632150426836788","date":"2024-08-05T08:17:12+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-07-31T13:22:58+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2024-07-24T15:15:41+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-07-24T15:10:44+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-07-24T15:10:16+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Medical Ethics","date":"2024-07-23T11:11:02+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-ethics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meth","sideBox":"Learn more about [BMC Medical Ethics](http://bmcmedethics.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meth/default.aspx","title":"BMC Medical Ethics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"b19eabc9-def3-4f37-8b80-8d3a9228f81c","owner":[],"postedDate":"August 26th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-12-23T16:05:00+00:00","versionOfRecord":{"articleIdentity":"rs-4788238","link":"https://doi.org/10.1186/s12910-024-01147-4","journal":{"identity":"bmc-medical-ethics","isVorOnly":false,"title":"BMC Medical Ethics"},"publishedOn":"2024-12-21 15:58:20","publishedOnDateReadable":"December 21st, 2024"},"versionCreatedAt":"2024-08-26 15:41:53","video":"","vorDoi":"10.1186/s12910-024-01147-4","vorDoiUrl":"https://doi.org/10.1186/s12910-024-01147-4","workflowStages":[]},"version":"v1","identity":"rs-4788238","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4788238","identity":"rs-4788238","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}