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":"https://doi.org/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":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-10-21","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}
Irene Jonathan, Eliza Akers, Min Shi, David B Resnik
{"title":"Vulnerable Research Participant Policies at U.S. Academic Institutions.","authors":"Irene Jonathan, Eliza Akers, Min Shi, David B Resnik","doi":"10.1177/15562646241290093","DOIUrl":"https://doi.org/10.1177/15562646241290093","url":null,"abstract":"<p><p><b>Background:</b> 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. <b>Methods:</b> 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). <b>Results:</b> 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. <b>Conclusion:</b> 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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479536","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}
Brian J McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker
{"title":"Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives.","authors":"Brian J McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker","doi":"10.1177/15562646241290078","DOIUrl":"https://doi.org/10.1177/15562646241290078","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479534","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}
{"title":"Public Perspectives on Consent for and Governance of Biobanking in Japan.","authors":"Masanori Oikawa, Yoshiyuki Takimoto","doi":"10.1177/15562646241286143","DOIUrl":"https://doi.org/10.1177/15562646241286143","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142331536","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}
{"title":"Comparison of Instructions to Authors and Reporting of Ethics Components in Selected African Biomedical Journals: 2008 and 2017.","authors":"Isaac O Dipeolu, Douglas R Wassenaar","doi":"10.1177/15562646241276237","DOIUrl":"https://doi.org/10.1177/15562646241276237","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142114330","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}
{"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":null,"pages":null},"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}
{"title":"An Example of a Clinical Research Ethics Committee in Türkiye: Types of Studies Analysed, Their Phases and Investigators.","authors":"Gungor Buket","doi":"10.1177/15562646241273162","DOIUrl":"https://doi.org/10.1177/15562646241273162","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908198","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}
{"title":"Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members: Comment.","authors":"Hinpetch Daungsupawong, Viroj Wiwanitkit","doi":"10.1177/15562646241273804","DOIUrl":"https://doi.org/10.1177/15562646241273804","url":null,"abstract":"","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-08-09","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":"https://doi.org/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":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","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":null,"pages":null},"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}