Biomedical research on autism in low- and middle-income countries: Considerations from the South African context
Siobhan de Lange, Dee Muller, Chloe Dafkin
Developing World Bioethics, 26 February 2024
Abstract
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by social/communicative difficulties and perseverative behaviours. While research on autism has flourished recently, few studies have been conducted on the disorder in non-Western contexts. In low- and middle-income countries (LMICs), biomedical research on autism is required to better understand the needs of the population and to develop contextually appropriate interventions. However, autistic individuals are a vulnerable study population and LMICs present with various considerations. While the presentation of autism is heterogeneous, stigma is a common social consequence affecting research. Drawing specifically on the South African context, the ethical intersections of these issues are discussed, along with the limitations of the current informed consent process. Community engagement is recommended as an adjunct to informed consent to ensure that biomedical research is conducted in a more inclusive way. Practical pointers are provided for implementing systematic support for conducting community engagement alongside biomedical research.

Informed consent-patients’ understanding of risk
Wijohn TR, Newcombe RM, Reynolds J, El-Jack S, Armstrong GP
The New Zealand Medical Journal, 23 February 2024; 137(1590) pp 14-21
Abstract
Aims
The central concept of informed consent is communication of the chance of a successful outcome. The risks and benefits are probabilistic concepts derived from populations; they do not map with any certainty to the individual. We tested patients’ comprehension of basic probability concepts that are needed for informed consent.
Methods
Patients (n=478) completed five questions designed to test risk estimates that are relevant to informed consent. The questions posed non-medical scenarios to avoid patients associating them with their clinical care. The questionnaire was in English and was only offered to patients whose nurse felt that they had sufficient English literacy to understand the questions.
Results
Out of a possible total of five correct answers, Asian patients scored lowest, and significantly less than Pākehā/Europeans (average total score 2.6±1.7 vs 3.6±1.4, p<0.001, 95% confidence interval 0.5 to 1.38). The total score for Māori/Pasifika was intermediate (3.2±1.4), yet they had the lowest deprivation index. This discordant finding may be due to poorer English literacy among Asian participants. On multiple linear regression, Asian ethnicity and advancing age were the independent predictors of a low score. Socio-economic deprivation decile and sex were not.
Conclusions
When answering questions constructed according to best practice, many (but not all) patients have reasonable risk comprehension. Further improvement could target older patients, those of Asian ethnicity and probably all patients where English is a second language. Liberal use of interpreters is suggested.

Macro and micro ethics in fetal and embryological collections: Exploring the paradigms of informed consent among Australian education-focused stakeholders
Joyce El-Haddad, Nalini Pather
Anatomical Sciences Education, 12 February 2024
Abstract
The management of human fetal and embryological collections presents an ethical challenge that can be explored from different perspectives, particularly when considering informed consent. The “micro ethics” level focuses on parties engaged in giving and receiving human tissue while the “macro ethics” level focusses on the collective responsibility of the discipline and society. Additionally, adopting a framework, where ways of working are designed with relevant communities, requires understanding the perspectives of individuals, communities, and organizations. The aim of this study therefore was to assess the perceptions of education-focused Australian stakeholders. A survey collected the perspectives of 198 participants. The majority of participants (61.6%; n = 122/198) indicated that human fetal and embryological remains obtained prior to era of informed consent should be retained for use in education/research. It is likely that their perspective is based on the notion that if human fetal and embryological collections are used for good, then disposing of them would deny this benefit. Women (p < 0.001) indicated a preference for obtaining fetuses and embryos with informed consent for education and research (38.4%; n = 76/198). Majority were in favor of recording both maternal (MI) (59.6%; n = 118/198) and paternal information (PI) (58.1%; n = 115/198) with each donation. Majority (56.1%; n = 111/198) expressed that donations should be accepted from both parental sources. Consideration of stakeholder perspectives is important in developing guidelines regarding these collections. The results from this study demonstrate a level of discomfort with respect to collections without informed consent, which should be considered at the macro ethical and micro ethical level.

Consented maternal care and associated factors among mothers who gave birth at public health institutions in South Wollo Zone, Amhara region, Ethiopia 2022
Research Article
SAGE Open Medicine, 12 February 2024
Open Access
Wassie Yazie Ferede, Besfat Berihun Erega, Fillorenes Ayalew Sisay, Abeba Belay Ayalew, Yismaw Yimam Belachew, Tigist Seid Yimer
Abstract
Introduction
Informed consent in healthcare services is a legal, ethical, and professional requirement on the part of all treating health providers and providing person-centered care. The methods of requesting consent during childbirth have not been extensively studied. In Ethiopia, there is not at all a single study done.
Objective
The purpose of this study is to determine associated factors among mothers who gave birth at health institutions in the South Wollo Zone, Amhara region, Ethiopia in 2022.
Methods
Mothers who gave birth at South Wollo Zone public health institutions, from 01 March to 30 April 2022 participated in a multi-center institutional-based cross-sectional study design. Systematic random sampling was used to select 423 study participants. A validated questionnaire was used for data collection, and the data were collected through face-to-face interviews. Data were entered into Epi-Data version 4.6 and exported to SPSS version 23 for analysis. A multivariable logistic regression analysis was performed to identify factors associated with the outcome variable. The level of significance was determined using an adjusted odds ratio with a 95% confidence interval.
Result
The study had 416 participants in total, with a response rate of 98.3%. Out of the 416 respondents interviewed, 67.1% of the women received consented care. The age group of 30–34, complications during childbirth, intended pregnancy, merchant, and primary and referral hospital were significantly associated with consented care.
Conclusion
The level of non-consented care during delivery was high compared with other literature reflecting substantial mistreatment. Therefore, stakeholders should strengthen monitoring and assessment systems to prevent abuse, and further study is required to look for practical ways to make improvements. Key elements of consented care have also been included in Basic and Emergency Obstetric Care training sessions and given to health providers.

The role of self-efficacy in women’s autonomy for health and nutrition decision-making in rural Bangladesh
Research
Allison P. Salinger, Ellen Vermes, Jillian L. Waid, Amanda S. Wendt, Sarah J. N. Dupuis, Md Abul Kalam, Abdul Kader, Sheela S. Sinharoy
BMC Public Health, 1 February 2024
Open Access
Abstract
Background
Agency – including the sub-domains of intrinsic agency, instrumental agency, and collective agency – is a critical component of the women’s empowerment process. Self-efficacy (a component of intrinsic agency) may operate as a motivational influence for women to make choices according to their own preferences or goals, such that higher self-efficacy would be associated with more autonomous decision-making (a key component of instrumental agency).
Methods
We examine these relationships using mixed methods. We developed a series of decision-making autonomy indices, which captured alignment between the woman’s reported and preferred roles in health and nutrition decisions. Using ordinal logistic regression, we assessed the relationship between generalized self-efficacy and decision-making autonomy.
Results
There was a consistently positive association across all categories of decision-making, controlling for a number of individual and household-level covariates. In a sub-sample of joint decision-makers (i.e., women who reported making decisions with at least one other household member), we compared the association between generalized self-efficacy (i.e., one’s overall belief in their ability to succeed) and decision-making autonomy to that of domain-specific self-efficacy (i.e., one’s belief in their ability to achieve a specific goal) and decision-making autonomy. Across all decision-making categories, domain-specific self-efficacy was more strongly associated with decision-making autonomy than generalized self-efficacy. In-depth interviews provided additional context for interpretation of the regression analyses.
Conclusions
The results indicate the importance of the role of self-efficacy in the women’s empowerment process, even in the traditionally female-controlled areas of health and nutrition decision-making. The development of the decision-making autonomy index is an important contribution to the literature in that it directly recognizes and captures the role of women’s preferences regarding participation in decision-making.

Informed consent practice and associated factors among healthcare professionals in public hospitals of Southern Ethiopia, 2023: a mixed-method study
Research
Getachew Nigussie Bolado, Bizuayehu Atnafu Ataro, Mulualem Gete Feleke, Christian Kebede Gadabo, Tamirat Ersino Kebamo, Worku Mimani Minuta
BMC Nursing volume, 30 January 2024; 23(77)
Open Access
Abstract
Background
Patients may sign a consent form before the specific treatment is offered for a variety of reasons, including during an outpatient appointment. Healthcare professionals must obtain consent from patients or other legal persons before providing any treatment or performing any procedures. But, little attention has been given to the informed consent process in Ethiopia.
Objective
To assess informed consent practice and associated factors among healthcare professionals in Wolaita Zone, Southern Ethiopia public hospitals from January, 2023.
Methods
An institutional-based cross-sectional mixed-method study was conducted among 399 healthcare professionals. Simple random sampling and purposive sampling techniques were used to select healthcare professionals for quantitative and qualitative studies respectively. Data for both studies were collected using self-administered questionnaire and key informant interview respectively. EpiDataV4.6 and the Statistical Package for the Social Science was used for entry and analysis of quantitative data. OpenCode software was used for thematic analysis for qualitative data.
Results
339 respondents were included in the study, with a response rate of 94.3%. The good practice of informed consent among the healthcare professionals is 53.1%. There was a significant association between the good practice of informed consent and being male [AOR: 0.003 (95% CI: 0.000–0.017)], working in a comprehensive specialized hospital [AOR: 4.775 (95% CI: 1.45–15.74)] and in-service training [AOR: 0.038 (95% CI: 0.013–0.114)].
Conclusion and recommendations
More than half of healthcare professionals had good practices for informed consent. However, it is critical to plan and intervene various strategies with the goal of improving knowledge and attitude toward informed consent.

Study on the Reasons of Discharge with the Personal Consent of Patients Admitted to the Emergency Ward of Kowsar Hospital of Semnan, Iran
Mehdi Yarahmadi, Mehri Ayati, Mohammad Taghi Ghorbanian
Journal of Guilan University of Medical Sciences, 20 January 2024
Abstract
Background
Discharge against Medical Advice (DAMA) indicates the dissatisfaction of patients with the care services of the health system. Additionally, it threatens the patient’s life and causes negative financial outcomes for hospitals.
Objective
This study aimed to identify the causes of self-discharge decisions in the emergency department at Kowsar Hospital, Semnan, Iran.
Methods
This was a descriptive-analytical study conducted between August 2021 to March 2022. The data were collected by a researcher-made questionnaire containing demographic characteristics and reasons for self-discharge, including three main concepts: personal, staff-related factors, and environmental factors with sub-concepts. Data were analyzed using SPSS.
Results
Of 140 patients with a mean age of 33.52 ± 16.17 years, 58.6% were men and 41.4% were women. Moreover, 63.6% of patients were married, 42.1% had a diploma education, and 11.4% had a history of taking neuropsychiatric drugs. Also, 42.9% of patients were covered by social security insurance. The highest rate of self-discharge was in the evening (42.1%) and night (37.9%) shifts. The most important reasons for self-discharge decision were problems related to insurance (30%), COVID-19 infection (26.4%), poor communication (17.1%), dissatisfaction with care (15.7 %), disrespectful behavior of staff (12.9%), and inappropriate emergency ward facilities (12.1%).
Conclusion
Make appropriate decisions to improve the quality of medical services and increase cooperation in health insurance, separating the departments of infectious diseases away from other departments, holding briefing sessions for physicians and medical staff, increasing awareness of patients about possible complications of self-discharge, and expanding the amenities of emergency ward can reduce the rate of self-discharge decision.

Editor’s note: The Guilan University of Medical Sciences is located in Rasht, Iran.

Compliance with research ethics in epidemiological studies targeted to conflict-affected areas in Western Ethiopia: validity of informed consent (VIC) by information comprehension and voluntariness (ICV)
Research
Gemechu Tiruneh, Mekdes Yilma, Bizuneh Wakuma, Eba Abdisa, Lami Bayisa, Michelle Nichols, Anja Bedeker, Nicki Tiffin
BMC Medical Ethics, 18 January 2024
Open Access
Abstract
Background
The conduct of research is critical to advancing human health. However, there are issues of ethical concern specific to the design and conduct of research in conflict settings. Conflict-affected countries often lack strong platform to support technical guidance and monitoring of research ethics, which may lead to the use of divergent ethical standards some of which are poorly elaborated and loosely enforced. Despite the growing concern about ethical issues in research, there is a dearth of information about ethical compliance in conflict areas. Valid and ethically informed decision-making is a premier pact with research participants in settling possible ethical issues before commencing the research, which is ensured by gaining informed consent from prospective participants of the research.
Aims
This research aimed to explore compliance with research ethics and consent validity in community-based epidemiological research conducted previously.
Methods
Research participants were recruited in the western part of Ethiopia in three districts subjected to conflicts. A community-based cross-sectional study design was utilized, and 338 residents were enrolled as study participants. All participants had previously been enrolled as research participants in epidemiological studies. Data was collected using a questionnaire that was pilot-tested before the commencement of the main data collection. The questionnaire focused on participants’ experiences of the informed consent process followed when they were recruited for an epidemiological study and covered themes such as essential information provided, level of comprehension, and voluntarism of consent.
Results
Over half of the study participants, 176 (52%), were not provided with essential information before consenting. And 135 (40%) of them did not comprehend the information provided to them. One hundred and ninety (56%) participants freely and voluntarily agreed to partake in one of these epidemiological studies, with over a quarter (97; 28.7%) of them reporting they were subjected to undue influence. Written consent was obtained from only 32 (9.4%) of the participants.

The Role of Male Consent in Assisted Reproductive Technology Procedures: an Examination of Japanese Court Cases
Original Paper
Yuko Muraoka, Minori Kokado, Kazuto Kato
Asian Bioethics Review, 18 January 2024
Open Access
Abstract
With the development of assisted reproductive technologies, medical, ethical, legal, and social issues have arisen that did not exist when natural conception was the only means of childbirth. In Japan, men tend to believe that assisted reproductive technologies are not directly related to them, with the literature showing that men are often reluctant to be involved in fertility treatment processes. To better understand this situation, this study analyzes the role of male consent during assisted reproductive technology procedures in Japan. First, we examined Japanese court cases that dealt with issues related to male consent during assisted reproductive technology procedures and identified three situations in which problems related to male consent during such procedures may arise. Next, we analyzed the background of such issues and the implications of the lack of consent regarding men’s reproductive rights. Finally, we explored the need for legislation on assisted reproductive technologies. The study concludes that discussions on the scope of male partner rights in assisted reproductive technology procedures are key for minimizing unnecessary conflict between partners, thus ensuring both the rights of women who wish to have children and the welfare of their children.

Culturally appropriate consent processes for community-driven indigenous child health research: a scoping review
Research
Cindy Peltier, Sarah Dickson, Viviane Grandpierre, Irina Oltean, Lorrilee McGregor, Emilie Hageltorn, Nancy L. Young
BMC Medical Ethics, 3 January 2024; 25(3)
Open Access
Abstract
Background
Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols.
Methods
We followed PRISMA guidelines and Arksey and O’Malley’s approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically.
Results
We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community.
Conclusions
Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children.