Understanding the language barriers to translating informed consent documents for maternal health trials in Zambia: a qualitative study
Original Research
Alice Beardmore-Gray, Musonda Simwinga, Bellington Vwalika, Sebastian Chinkoyo, Lucy Chappell, Jane Sandall, Andrew Shennan
BMJ Open, 5 April 2024
Abstract
Objective
Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or ‘lost in translation’. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages.
Design
We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data.
Setting
The study was based in Lusaka, Zambia.
Results
The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood.
Conclusion
Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.

Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda
Research Article
Rebecca Kampi, Clement Okello, Joseph Ochieng, Erisa Sabakaki Mwaka
PLOS One, 4 April 2024
Open Access
Abstract
Introduction
While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners’ experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals’ perspectives on information disclosure during the consenting process in cancer care.
Methods
A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results.
Results
There were five key themes, and these included information disclosure to patients; assessment of patients’ cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process.
Conclusion
Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Obligation, Informed Consent, and Health-Care Reforms in China
Jia Liu
Asian Journal of Law and Society, 1 April 2024
Abstract
Drawing on recent jurisprudential literature that emphasizes the role and function performed by obligation, this article examines how the ethical doctrine of informed consent has been implemented in the context of health-care reforms in China. It argues that, while the Chinese incorporation of informed consent has sought to empower patients, the major medical laws and social policies fail to instantiate the obligations. Along with this failure, the Chinese medical laws have also failed to secure the bond of trust between them. This article also points out that a rounded analysis of the implementation of informed consent in China must take into account the obligation and function of the major components of the health-care delivery system other than physicians and hospitals, such as health-care insurance schemes.

Patients’ comprehension and satisfaction with informed consent at day surgery unit at King Khalid University Hospital, Riyadh, Saudi Arabia
Original Article
Sulaiman A Alshammari, Suliman Ahmed Aldhalaan, Abdulaziz Mohammed Alqahtani, Ahmed Tawfik Khoja, Ghaith Uthman Alkhulayfi, Meshal Abdulaziz Aljudai
International Journal of Medicine in Developing Countries, 12 February 2024
Open Access
Abstract
Background
Informed Consent (IC) is a crucial element in medical practice and research. However, additional research is needed to assess the quality of IC in Middle Eastern regions, including Saudi Arabia. This study aimed to measure surgical patients’ comprehension and satisfaction with IC and related factors at King Khalid University Hospital (KKUH).
Methods
This cross-sectional study investigated postsurgical patients’ satisfaction and comprehension of IC at the day surgery unit at KKUH from August to December 2022. Data collection was done through an online questionnaire.
Results
A total of 387 patients participated in this study, with over half (56.1%) being women (mean age = 41.4 ± 13.4). More than 88% of the patients were satisfied with all IC components. Patients aged 26-45 reported the highest levels of IC understanding (54.9%, p < 0.05), and female patients demonstrated higher overall comprehension compared to male patients (p = 0.088). Those with higher education and income had the highest comprehension scores (61.2%, p < 0.05) and (28.4%, p < 0.05), respectively. Only 54% of patients read the IC form and were aware of who provided them with the forms. Approximately 92% of the patients signed the IC form themselves, and 72% required less than an hour to consent.
Conclusion
Middle-aged patients, women, and those with a high level of education exhibited the highest overall IC comprehension and satisfaction. The findings underscore the importance of personnel delivering therapy introducing themselves and indicating their involvement in the team. The future of the IC process lies in electronic standardization through the use of “Esihi,” KKUH’s current electronic record system.

A Survey Of Awareness And Practices Of Informed Consent Among Dentists In Rawalpindi And Islamabad, Pakistan
Shaista Rafi, Hina Khan, Muhammad Hamza Hussain, Hira Aslam, Yousra Khan, Hala Hidayat
Pakistan Oral & Dental Journal, 29 March 2024
Abstract
Objective
The aim was to determine the awareness and practices of dental professionals about informed consent among various levels of qualification. A total of 129 dentists from Rawalpindi and Islamabad were included by convenience sampling technique.
Methodology
Dentists practicing clinically in Rawalpindi and Islamabad were included. Undergraduate dental students, dental technicians and dental assistants were excluded.
Results
Data was collected using an especially developed questionnaire, and analyzed using SPPS through chi-square tests. The mean age was 33.89±7.57 years. A total of 126 dentists (96.67%), including 45 females (34.88%) and 84 males (65.12%), were familiar with informed consent. The most frequently reported “basic element of Informed Consent” was confidentiality (n=50, 38.76%), followed by treatment alternatives (n=33, 25.58%), and all of these (n=29, 22.48%). The most frequently reported “main purpose of Informed Consent” was legal (n=128, 18.12%), followed by ethical (n=45, 35.16%), and all of these (n=51, 39.72%). Most of the participants said they take Informed Consent prior to treatment (n=103, 79.84%), stating that it is not a waste of time (n=69, 53.49), that they take it verbally (n=107, 82.95%), and that the minimum age to sign Informed Consent by oneself is above 18 years (n=109, 84.5%). Only 6 (4.65%) said they provide a copy of Informed Consent to patients.
Conclusion
There was lack of awareness and good practices among dental professionals regarding the process of taking informed consent. More qualified dentists reported better awareness and practices compared to less qualified dentists. Only few dental professionals have the habit of obtaining written Informed Consent.

Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study
Research
Masunga K. Iseselo, Edith A. M. Tarimo
BMC Medical Ethics, 13 March 2024; 25(29)
Open Access
Abstract
Background
Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.
Methods
We conducted a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.
Results
Volunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.
Conclusion
Engagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials.

The informed consent process: An evaluation of the challenges and adherence of Ghanaian researchers
Paa-Kwesi Blankson, Florence Akumiah, Amos Laar, Lisa Kearns, Samuel Asiedu Owusu
Developing World Bioethics, 13 March 2024
Abstract
This study assessed challenges faced by researchers with the informed consent process (ICP). In-depth interviews were used to explore challenges encountered by Investigators, Research assistants, Institutional Review Board members and other stakeholders. An electronic questionnaire was also distributed, consisting of Likert-scale responses to questions on adherence to the ICP, which were derived from the Helsinki Declaration and an informed consent checklist of the US Department of Health and Human Research (HSS). Responses were weighted numerically and scores calculated for each participant. The median score of the level of adherence to the informed consent process was 93%. Most of the respondents (60%) cited the lack of time for the ICP to be a challenge, with 65% indicating a lengthy consent document to be the main challenge with the informed consent document. Challenges with language and communication were the dominant theme among informants. Despite the high adherence of Ghanaian researchers and research assistants to the ICP, challenges are still prevalent, requiring diligent and continuous efforts in research implementation.

Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda
Original Research
Shafic Makumbi, Francis Bajunirwe, Deborah Ford, Anna Turkova, Annabelle South, Abbas Lugemwa, Victor Musiime, Diana Gibb, Imelda K Tamwesigire
BMJ Open, 1 March 2024
Open Access
Abstract
Objectives
To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.
Design
Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with in-depth interviews.
Setting and participants
From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda.
Outcome measures
The outcome measures were the proportion of parents with voluntary consent, factors affecting voluntariness and the sources of external influence. Parents rated the voluntariness of their consent on a voluntariness ladder. Indepth interviews described participants’ lived experiences and were aimed at adding context.
Results
All 151 parents randomly sampled for the survey participated (84% female, median age 40 years). Most (67%) gave a fully voluntary decision, with a score of 10 on the voluntariness ladder, whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 2.7% scored 4. Trust in medical researchers (adjusted OR 9.90, 95% CI 1.01 to 97.20, p=0.049) and male sex of the parent (adjusted OR 3.66, 95% CI 1.00 to 13.38, p=0.05) were positively associated with voluntariness of consent. Prior research experience (adjusted OR 0.31, 95% CI 0.12 to 0.78, p=0.014) and consulting (adjusted OR 0.25. 95% CI 0.10 to 0.60, p=0.002) were negatively associated with voluntariness. Consultation and advice came from referring health workers (36%), spouses (29%), other family members (27%), friends (15%) and researchers (7%). The indepth interviews (n=14) identified the health condition of the child, advice from referring health workers and the opportunity to access better care as factors affecting the voluntariness of consent.
Conclusions
This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents’ trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents’ consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.