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. (shrink)

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. (shrink)

The scarcity of resources during the COVID‐19 pandemic caused ethical dilemmas in prioritizing patients for treatment. Medical and ethical guidance only emphasizes clinical procedures but does not consider the sociocultural aspect. This study explored the perception of former COVID‐19 patients and their families on the decision‐making process of the patient's selection at a time of scarcity of resources. The result will inform the development of an ethical guide for allocating scarce resources that aligns with Indonesian culture. We conducted qualitative research (...) with in‐depth interviews between May ‐ December 2022 involving sixteen participants from various cities in Indonesia. We transcribed the interviews and analyzed the results using thematic analysis. This study found that doctor's decisions often differed from patient's expectations in allocating scarce resources, and therefore, it should be communicated appropriately. Medical decisions were not sufficiently made ethically, but must also be made communicatively. In Indonesia's strong communal culture, community involvement was essential to distributing limited resources. A better approach to ethical education, including adequate communication skills, is necessary to prepare health professionals for facing unpredictable future pandemics. (shrink)

We aimed to conduct a scoping review to assess the profile of retracted health sciences articles authored by individuals affiliated with academic institutions in Latin America and the Caribbean (LAC). We systematically searched seven databases (PubMed, Scopus, Web of Science, Embase, Medline/Ovid, Scielo, and LILACS). We included articles published in peer‐reviewed journals between 2003 and 2022 that had at least one author with an institutional affiliation in LAC. Data were collected on the year of publication, study design, authors' countries of (...) origin, number of authors, subject matter of the manuscript, scientific journals of publication, retraction characteristics, and reasons for retraction. We included 147 articles, the majority being observational studies (41.5%). The LAC countries with the highest number of retractions were Brazil (n = 69), Colombia (n = 16), and Mexico (n = 15). The areas of study with the highest number of retractions were infectology (n = 21) and basic sciences (n = 15). A retraction label was applied to 89.1% of the articles, 70.7% were retracted by journal editors, and 89.1% followed international retraction guidelines. The primary reasons for retraction included errors in procedures or data collection (n = 39), inconsistency in results or conclusions (n = 37), plagiarism (n = 21), and suspected scientific fraud (n = 19). In conclusion, most retractions of scientific publications in health sciences in LAC adhered to international guidelines and were linked to methodological issues in execution and scientific misconduct. Efforts should be directed toward ensuring the integrity of scientific research in the field of health. (shrink)

Gene‐editing research is a complex science and foreign in most communities including Botswana. Adopting a qualitative deliberative framework with 109 participants from 7 selected ethnic communities in Botswana, we explored the perceptions of local communities on cultural values, norms, and beliefs that may motivate or deter likely participation in the use of gene‐editing related research. What emerged as the ethnic community's motivators for research participation include the potential for gene‐editing technologies to promote access to individualized medications, and the possibility of (...) protecting family members from genetic related diseases. Deterrents for research participation include cultural values such as implications of lineage for chieftainship, trust, fear or anxiety, uncertainty, and sensitivity on the use of gene‐editing. Findings of our study have implications for continuous engagement with local communities to explore potential ways of addressing cultural sensitivities that can further deter their participation in future gene‐editing related research. (shrink)

Artificial intelligence (AI) will drastically change the healthcare system. Radiology is one speciality that is most affected as AI algorithms are increasingly used in diagnostic imaging. AI‐enhanced health technologies will, inter alia, increase workflow efficiency, improve diagnostic accuracy, reduce healthcare‐related costs, and help alleviate medical personnel shortages in under‐resourced settings. However, the development of AI‐enhanced technologies in healthcare is fraught with legal, ethical, and human rights concerns. Currently, the use of AI in South African healthcare is not governed by sui (...) generis legislation or ethical guidance focused exclusively and specifically on AI, although various provisions and principles from law and ethics find application. This article outlines these normative principles and explains their relationship with the extant legal obligations and regulatory framework as applied to the use of AI in radiology services in South Africa. The article concludes with three key recommendations for radiology practitioners using AI in South Africa. These are the need for: vigilant monitoring of AI use in practice, reforms to the liability framework, and appropriate guidance from local regulators and the Health Professions Council of South Africa on the ethical use of AI. (shrink)

This article considers the practical question of how research institutions should best structure their legal relationship with the human genomic data that they generate. The analysis, based on South African law, is framed by the legal position that although a research institution that generates human genomic data is not automatically the owner thereof, it is well positioned to claim ownership of newly generated data instances. Given that the research institution exerts effort to generate the data, it can be argued that (...) it has a moral right to claim ownership of such data. Combined with the fact that it has an interest in having comprehensive rights in such data, it appears that the prudent policy for research institutions is to claim ownership of the human genomic data instances that they generate. This policy is tested against two opposing policy positions. The first opposing policy position is that research participants should own the data that relate to them. However, in light of data protection legislation that already provides extensive protections to research participants, bestowing data ownership on research participants would offer little benefit to such individuals, while leading to significant practical problems for research institutions. The second opposing policy position is that the concept of ownership should be abandoned in favour of data custodianship. This opposing position is problematic, as avoiding reference to ownership is a denial of legal reality and hence not a useful policy. Also, avoiding reference to ownership will leave research institutions with limited legal remedies in the event of appropriation of data by third parties. Accordingly, it is concluded that the wisest policy for research institutions is indeed to explicitly claim ownership of the human genomic data instances that they generate. (shrink)

The escalating integration of Artificial Intelligence (AI) in clinical settings carries profound implications for the doctrine of informed consent, presenting challenges that necessitate immediate attention. China, in its advancement in the deployment of medical AI, is proactively engaging in the formulation of legal and ethical regulations. This paper takes China as an example to undertake a theoretical examination rooted in the principles of medical ethics and legal norms, analyzing informed consent and medical AI through relevant literature data. The study reveals (...) that medical AI poses fundamental challenges to the accuracy, adequacy, and objectivity of information disclosed by doctors, alongside impacting patient competency and willingness to give consent. To enhance adherence to informed consent rules in the context of medical AI, this paper advocates for a shift towards a patient‐centric information disclosure standard, the restructuring of medical liability rules, the augmentation of professional training, and the advancement of public understanding through educational initiatives. (shrink)