Through strengthened biobank governance, broad consent has been widely accepted as a means to replace donors' discretion based on the information of individual research protocols. Trust and other ethical and social notions, such as reciprocity and solidarity, are key concepts that support biobank governance. The types of allowed broad consent are several; however, they remain unclear, and whether these ethical and social notions are associated with public attitudes toward the consent model is not fully understood. This quantitative study examined two hypotheses: narrower and limited broad consent are more accepted by the public, and acceptance rates for broad consent increase with established measures related to biobank governance. This analysis supported both hypotheses, implying that the limited type of broad consent should be considered an important option, and that a specific type of governance is critical in promoting trust, reciprocity, and solidarity between biobanks and the public.

The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.

Historically, some of the worst abuses of human research participants have involved populations which are vulnerable to coercion, harm, or exploitation, such as prisoners, children, and people with compromised decision-making abilities. Although there has been considerable philosophical and ethical debate about how to protect vulnerable populations, there have been only a handful of empirical studies on vulnerable population policies. We conducted a cross-sectional study on vulnerable population policies from the 105 top funded U.S. academic research institutions. We used deductive and inductive methods to develop our framework for coding the policies. We tested for associations between policies and research and development expenditure rank, public vs. private status, geographic region, and Association for Accreditation of Human Research Protection Programs accreditation (AAHRRP). U.S. academic institutions have a variety of policies for research with vulnerable populations. Every institution in our sample had at least 2 policies for research with vulnerable populations (including a general policy) and most had 8 or more. As expected, the most highly prevalent policies pertained to populations covered in subparts B, C, and D of the Common Rule (pregnant women, fetuses, neonates, prisoners, and children) but other groups were well-represented, including people with disabilities; people with impaired decision-making capacity; students/trainees; and people with limited English proficiency including illiteracy. AAHRRP accreditation was positively associated with eight different types of policies. U.S. academic institutions have a variety of policies for research with vulnerable populations. Additional research is needed to better understand the types of safeguards that institutions have adopted to protect vulnerable populations and the factors that influence policy development.

To attain effective community engagement (CE) for genetics and genomics research (GGR) is a challenge. This study aimed to analyzed participants' perspectives on how to attain effective CE for GGR in Uganda. A cross-sectional qualitative study involving in-depth interviews with twenty research ethics committee members and three national research regulators was conducted. GGR is faced with; low genetic literacy among stakeholders, social implications, cultural attitudes towards GGR, and lack of specific guidelines for CE in GGR. Attaining effective CE in GGR should involve; development of guidelines for GGR streamlining CE; boosting stakeholders' Knowledge in GGR and CE; engagement beyond sensitization; and consensus decision-making. Overall, attaining effective CE in GGR requires addressing the key aspects unique to GGR.

Journal editors instruct authors to describe human participant protections in original research reports. However, little is known about African biomedical journal authors' adherence to such journal editors' instructions. This study investigated changes in editors' instructions to authors and authors' reporting of research ethics information in selected African biomedical journals between 2008 and 2017. Twelve selected journal websites and online articles were reviewed in Eastern, Southern, and Western African [ESWA] countries. A pre-tested schema and a checklist were used to collect data from journal websites and articles published in 2008 and 2017, and the data were analysed using descriptive and inferential statistics. Half of the journals requested prospective authors to disclose ethics approval and related issues in their manuscripts between 2008 and 2017. There was a significant increase in instructions to authors regarding information on the protection of research participants within this period; more authors complied with these requirements in 2017 than in 2007.

Investigations regarding perceptions of the institutional research integrity climate in the Arab Middle East remain underexplored. We surveyed faculty from three Egyptian universities. We utilized the Survey of Organizational Research Climate (SOuRCe) tool, which incorporates seven subscales that measure different aspects of the research integrity climate. Responses were obtained from a 5-point Likert scale. Of the 228 participants, the subscales 'Regulatory Quality' and '[Lack of] Integrity Inhibitors' received the highest mean scores, whereas the lowest scores pertained to 'Departmental Expectations,' 'Integrity Socialization,' and 'Responsible Conduct of Research´ indicating areas in need of improvement. Academic leaders should set fairer expectations for research and funding for their researchers, ensure junior researchers are socialized into research integrity practices, and promote effective RCR training and availability of RCR policies. We identify specific targeted interventions to enhance the research integrity climate within these institutions.

We demonstrate the fruitfulness of using card sort activities as an engagement method by detailing community consultation for ethical, legal, and social implications of sociogenomics. Readers are provided with a user-guide for card sort engagement through: (1) an overview of the card sort activity and its merits for engagement, (2) detailed methods of sorting for values-elicitation and prioritization goals, and (3) strategies to design this approach for other participatory research designs. Our intent is to add to meaningful exchanges between community engaged researchers and empirical bioethicists.

Clinical studies are reviewed by clinical research ethics committees (CRECs) in order to ensure that they are conducted within the framework of good clinical practice and that the rights of volunteers are respected. Research type, department, status, scope, principal investigator's characteristics and CREC decisions were all evaluated. A total of 1044 research applications were found to have been submitted. In addition, 14.6% of the applications were clinical trials and 48.8% were retrospective studies. Of all the researchers, 50.4% of them were found to have indicated an incorrect type of research. The very low number of interventional clinical trials suggests that researchers tended to be hesitant about conducting such trials or did not have the means to do so. The fact that the applications were often submitted by indicating a wrong type of research method also signifies the investigators' lack of knowledge in this regard.

Prospective research participants do not always retain information provided during consent procedures. This may be relatively common in online research and is considered particularly problematic when the research carries risks. Clinical psychology studies using the trauma film paradigm, which aims to elicit an emotional response, provide an example. In the two studies presented here, 112-126 participants were informed they would be taking part in an online study using a variant of this paradigm. The information was provided across five digital pages using either a standard or an interactive format. In both studies, compared to the control condition, participants in the interactive condition showed more retention of information. However, this was only found for information about which they had been previously asked via the interactive format. Therefore, the impact of adding interactivity to digital study information was limited. True informed consent for an online study may require additional measures.

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.

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.

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. 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. 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. 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.

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.

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 ( = 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.

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. 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. 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. AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.

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 ( = 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.

This is a correspondence letter in response to an article published in the journal: Flaherman VJ, Nankabirwa V, Ginsburg AS. Promoting Transparent and Equitable Discussion of Controversial Research. Journal of Empirical Research on Human Research Ethics 2023; 18(4): 248-9.

For research purposes, it is generally accepted that experimental ostracism manipulations can lead to a reduction of participants' well-being. To eventually restore participants' well-being, researchers rely on post-experimental debriefings that discredit prior deception. However, evidence suggests that discredited beliefs can persevere. The present research investigates whether a potent debriefing procedure restores participants' well-being after an experimentally induced ostracism experience. In two studies, participants were either excluded or included in a Cyberball game, indicated their well-being, and were debriefed. In two additional conditions, participants were debriefed before indicating their well-being. Ostracism compared to inclusion led to decreased positive and increased negative mood. The debriefing did not counteract this effect (Studies 1 & 2). Unwanted aftereffects of the manipulation persevered for more than one day after the experimental session (Study 2). These findings question the effectiveness of debriefings and raise issues about research ethics.

The main purpose of this study was to translate the Plagiarism Attitude Scale into Turkish and validate it for use in Turkish settings, in order to better understand research integrity attitudes and awareness of the Turkish academic and student community, while also contributing an instrument for research in this area. The research was designed and conducted with 483 participants. In the process of adapting the scale to Turkish, language, content, and construct validity analyses were performed. Following the completion of the validity phase, the reliability of the scale was examined using Cronbach's alpha coefficient and the split-half method. The results indicate that the scale's language and content validity are deemed sufficient. According to the findings of the research, the Plagiarism Attitude Scale, in its adapted Turkish version, is considered a valid and reliable tool. The use of this Turkish scale will assist local researchers in sharing their unique perspectives and help the international community better understand research ethics concerns in Türkiye. Additionally, this scale will serve as a valuable resource for planning educational programs.