Journal of Empirical Research on Human Research Ethics最新文献

This scoping review explores current practices for obtaining consent in research on risky behaviours among adolescents in Canada. The JBI methodology for scoping reviews was used. The database search was conducted in August 2021 and updated in November 2022. Papers published in 2010 or later were included. Extracted data included study characteristics, sample characteristics, and consent procedures. The review included 83 reports covering 57 studies. Nearly 60% of studies relied on adolescent self-consent for participation. Adolescent self-consent was more common than parental/guardian consent for studies using in-person research methods, older adolescent groups, and particularly vulnerable populations. Parental/guardian consent was more common for studies using younger age groups and general population samples. Adolescent self-consent was more common than parental/guardian consent for most risky behaviours covered by this review. These results provide insight into current consent practices in this area and offer guidance to researchers and institutional review boards in Canada.

This research identifies the circumstances in which Human Research Ethics Committees (HRECs) are trusted by Australians to approve the use of genomic data - without express consent - and considers the impact of genomic data sharing settings, and respondent attributes, on public trust. Survey results (N = 3013) show some circumstances are more conducive to public trust than others, with waivers endorsed when future research is beneficial and when privacy is protected, but receiving less support in other instances. Still, results imply attitudes are influenced by more than these specific circumstances, with different data sharing settings, and participant attributes, affecting views. Ultimately, this research raises questions and concerns in relation to the criteria HRECs use when authorising waivers of consent in Australia.

Background: Institutional review boards (IRBs) face delays in reviewing research proposals, underscoring the need for optimized standard operating procedures (SOPs). This study assesses the abilities of three artificial intelligence (AI) platforms to address IRB challenges and draft essential SOPs. Methods: An observational study was conducted using three AI platforms in 10 case studies reflecting IRB functions, focusing on creating SOPs. The accuracy of the AI outputs was assessed against good clinical practice (GCP) guidelines. Results: The AI tools identified GCP issues, offered guidance on GCP violations, detected conflicts of interest and SOP deficiencies, recognized vulnerable populations, and suggested expedited review criteria. They also drafted SOPs with some differences. Conclusion: AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.

Health research must be of high ethical and scientific quality and consider the needs and experiences of women, men, and nonbinary individuals. National Research Ethics Committees (RECs) are in a strategic position to impede sex- and gender-blind research. In 2020 and 2021, training programs on gender mainstreaming and sex and gender approaches in research evaluation were launched in Senegal. They were evaluated through a mixture of qualitative and quantitative methods. Knowledge acquisition was 16.67%, 8.54%, and 28.42% for the trainees of 2021, 2020, and those who attended the training in both years, respectively. Gender mainstreaming was reported as pertinent in research ethics by 74% of participants. This training is expected to catalyze gender-transformative research ethics in West Africa.

Objective: This review explores the ethico-cultural and implementation challenges associated with the individual-based informed consent (IC) model in the relatively collectivistic African context and examines suggested approaches to manage them. Methods: We searched four databases for peer-reviewed studies published in English between 2000 to 2023 that examined the ethico-cultural and implementation challenges associated with the IC model in Africa. Results: Findings suggest that the individual-based IC model largely misaligns with certain African social values and ethos and subverts the authority and functions of community gatekeepers. Three recommendations were proffered to manage these challenges, that researchers should: adopt a multi-step approach to IC, conduct a rapid ethical assessment, and generate an African-centered IC model. Conclusions: A pluriversal, context-specific, multi-step IC model that critically harmonizes the cultural values of the local population and the general principles of IC can minimize ethics dumping, safeguard the integrity of the research process, and promote respectful engagement.

Artificial Intelligence (AI) and other large language models are rapidly infiltrating the world of education and educational research. These new technological developments raise questions about use and ethics throughout the world of educational research, particularly for qualitative methods given the philosophical and structural foundations of its associated designs. This paper seeks to interrogate the perceived ethics around the use of AI in qualitative research and draws on survey data from qualitative researchers (n = 101) collected from April-May 2023. Findings indicate that researchers were more apt to embrace the use of AI for transcription purposes, and to a lesser extent for preliminary coding. Researchers from high research productivity (R1) universities were generally less accepting of AI's use in the research process than other researchers.

Gender-diverse individuals are underserved in clinical research settings. Reliance on gendered language throughout the consent process for clinical research contributes to the marginalization of these populations. The research objective was to assess use of gender-inclusive language used to describe the contraception requirement in consent forms. We categorized and analyzed contraception language in 289 clinical trial consent forms using a deductive and summative content analysis approach. We found that 79% (n = 227) of consent forms contained gender-inclusive language, 80% (n = 231) used terms that fell under the biological sex language, and 91% (n = 264) used gendered language. No consent forms used exclusively gender-inclusive language and the majority 63% (n = 182) featuring a combination of all three language types. There were many consent forms which would have been entirely gender-inclusive language if section headings with references to biological-sex-specific contraceptives were excluded, suggesting that gender-inclusive language may be attainable with minor revisions.

This study aimed to evaluate children's capacity for informed consent. We translated into Azerbaijani language and adapted the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). We enrolled four healthy groups: children aged 11, 12, and 13 years and adults. We provided the participants with information about the simulated research proposal and a related informed consent form. Subsequently, they were administered the UBACC. The mean total UBACC scores were 11.9 (11-year-olds), 12.7 (12-year-olds), 14.0 (13-year-olds), and 16.0 (adults). The gradual increase in the mean UBACC scores with age suggests the continuous maturation of the capacity to comprehend the informed consent process. There was no specific cutoff age to decide whether the children were competent enough to provide informed consent.

Events such as the Tuskegee syphilis study shaped how the public perceives and trusts medical research globally. However, few studies have examined trust in medical research in developing countries. We tested the hypothesis that levels of trust may be lower among community members compared to hospitalized persons in Uganda. We enrolled 296 participants in rural northern Uganda, and 148(50%) were from the community, 192(65%) were female. Mean level of trust for medical research was higher among hospitalized persons compared to community members (p = 0.0001). Previous research participation (p = 0.03), and willingness to participate in future research (p = 0.001) were positively associated with trust. Medical personnel should engage more with the communities in which they practice fostering trust in medical research.