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.