{"title":"Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members: Comment.","authors":"Hinpetch Daungsupawong, Viroj Wiwanitkit","doi":"10.1177/15562646241273804","DOIUrl":"10.1177/15562646241273804","url":null,"abstract":"","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"236-237"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elsayed Abdelkreem, Maha Emad Ibrahim, Sawsan Elateek, Fatma Abdelgawad, Henry J Silverman
{"title":"Perceptions of the Research Integrity Climate in Egyptian Universities: A Survey Among Academic Researchers.","authors":"Elsayed Abdelkreem, Maha Emad Ibrahim, Sawsan Elateek, Fatma Abdelgawad, Henry J Silverman","doi":"10.1177/15562646241273097","DOIUrl":"10.1177/15562646241273097","url":null,"abstract":"<p><p><b>Problem:</b> Investigations regarding perceptions of the institutional research integrity climate in the Arab Middle East remain underexplored. <b>Subjects:</b> We surveyed faculty from three Egyptian universities. <b>Method:</b> 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. <b>Findings:</b> 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. <b>Conclusions:</b> 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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"250-262"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Harriet Nankya, Vincent Pius Alibu, Edward Wamala, Enock Matovu, John Barugahare
{"title":"Understanding of Key Considerations for Effective Community Engagement in Genetics and Genomics Research: A Qualitative Study of the Perspectives of Research Ethics Committee Members and National Research Regulators in a low Resource Setting.","authors":"Harriet Nankya, Vincent Pius Alibu, Edward Wamala, Enock Matovu, John Barugahare","doi":"10.1177/15562646241289015","DOIUrl":"10.1177/15562646241289015","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"197-207"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Karen M Meagher, Sara Watson, Lia Kaz, Shawneequa Callier, Anya E R Prince, R Jean Cadigan
{"title":"Ready, Set, Sort! A User-Guide to Card Sorts for Community-Engaged Empirical Bioethics.","authors":"Karen M Meagher, Sara Watson, Lia Kaz, Shawneequa Callier, Anya E R Prince, R Jean Cadigan","doi":"10.1177/15562646241281802","DOIUrl":"10.1177/15562646241281802","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"186-196"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11630629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142631904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"How Making Consent Procedures More Interactive can Improve Informed Consent: An Experimental Study and Replication.","authors":"Marije Aan Het Rot, Ineke Wessel","doi":"10.1177/15562646241280208","DOIUrl":"https://doi.org/10.1177/15562646241280208","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646241280208"},"PeriodicalIF":1.7,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142082433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lillian MacNeill, A Luke MacNeill, Shelley Doucet, Alison Luke, Alex Goudreau
{"title":"Obtaining Consent for Research on Risky Behaviours Among Adolescents in Canada: A Scoping Review.","authors":"Lillian MacNeill, A Luke MacNeill, Shelley Doucet, Alison Luke, Alex Goudreau","doi":"10.1177/15562646241253953","DOIUrl":"10.1177/15562646241253953","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"124-134"},"PeriodicalIF":1.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11298111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140946444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lyndsay Newett, Rebekah McWhirter, Lisa Eckstein, Vanessa Warren, Dianne Nicol
{"title":"Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing.","authors":"Lyndsay Newett, Rebekah McWhirter, Lisa Eckstein, Vanessa Warren, Dianne Nicol","doi":"10.1177/15562646241261848","DOIUrl":"10.1177/15562646241261848","url":null,"abstract":"<p><p>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 (<i>N</i> = 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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"19 3","pages":"113-123"},"PeriodicalIF":1.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11298119/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Assessing the Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members.","authors":"Kannan Sridharan, Gowri Sivaramakrishnan","doi":"10.1177/15562646241263200","DOIUrl":"10.1177/15562646241263200","url":null,"abstract":"<p><p><b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"83-91"},"PeriodicalIF":1.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Guillermo Z Martínez-Pérez, Carme Campoy Guerrero, Brigitte Bagnol, Samba Cor Sarr, El Hadji Mamadou Mbaye, Ousmane Diouf, El Hadji Ibrahima Touré, Viviane Mbengue, Oumy Ndiaye, Farah Nabil
{"title":"Evaluation of a Training Program on Gender Mainstreaming in Health Research Evaluation at the Senegalese National Research Ethics Committee.","authors":"Guillermo Z Martínez-Pérez, Carme Campoy Guerrero, Brigitte Bagnol, Samba Cor Sarr, El Hadji Mamadou Mbaye, Ousmane Diouf, El Hadji Ibrahima Touré, Viviane Mbengue, Oumy Ndiaye, Farah Nabil","doi":"10.1177/15562646241238816","DOIUrl":"10.1177/15562646241238816","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"103-112"},"PeriodicalIF":1.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Richard Appiah, Giuseppe Raviola, Benedict Weobong
{"title":"Balancing Ethics and Culture: A Scoping Review of Ethico-Cultural and Implementation Challenges of the Individual-Based Consent Model in African Research.","authors":"Richard Appiah, Giuseppe Raviola, Benedict Weobong","doi":"10.1177/15562646241237669","DOIUrl":"10.1177/15562646241237669","url":null,"abstract":"<p><p><b>Objective:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"143-172"},"PeriodicalIF":1.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11298123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}