S. Taplin, J. Chalmers, Judith Brown, Tim Moore, Anne Graham, M. McArthur
{"title":"How do Research Ethics Committee Members Respond to Hypothetical Studies with Children? Results from the MESSI Study","authors":"S. Taplin, J. Chalmers, Judith Brown, Tim Moore, Anne Graham, M. McArthur","doi":"10.1177/15562646221087530","DOIUrl":"https://doi.org/10.1177/15562646221087530","url":null,"abstract":"Hypothetical scenarios were used to assess the influence of the sensitivity of the study topic, payments, and study methods on research ethics committee (HREC) members’ approval of social research studies involving children. A total of 183 Australian HREC members completed an online survey. The higher the perceived sensitivity of the study topic, the less likely the study would be approved by an HREC member. HREC members were most likely to approve each of the hypothetical studies if no payment was offered. Payment was the most common reason for not approving the low risk studies, while risks were the most common reasons for not approving the more sensitive studies. Face-to-face interviews conducted at home with children elicited substantially higher rates of approval from HREC members with more sensitive study topics. Both HRECs and researchers may benefit from additional guidance on managing risks and payments for children and young people in research.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49643363","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":"Preliminary Evidence for an Association between Journal Submission Requirements and Reproducibility of Published Findings: A Pilot Study","authors":"Mitch Brown, R. McGrath, D. Sacco","doi":"10.1177/15562646221083384","DOIUrl":"https://doi.org/10.1177/15562646221083384","url":null,"abstract":"Systemic efforts have been employed to improve the reproducibility of published findings in psychology. To date, little research has been conducted evaluating how well these efforts work. In an effort to bridge this gap, the current study looked at journal submission requirements intended to encourage authors to engage in best practices for facilitating reproducible science and offers preliminary evidence for their potential efficacy. We calculated reproducibility indices (p-curves) for three randomly selected empirical studies published in each of 23 psychology journals in 2019 and correlated quantitative results from those analyzes with the number of submission requirements for each journal that intended to ensure compliance with best reporting practices. Results indicated a greater number of submission requirements at a given outlet was associated with indices indicating greater likelihood of reproducibility of findings. We frame findings as impetus for future, more extensive, research to identify causal links between submission requirements and reproducibility.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47877317","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":"Research Ethics Consultation in Nursing Studies.","authors":"Chikako Kane, Satoshi Sakaguchi, Masayuki Chuma, Kenta Yagi, Kenshi Takechi, Yuki Aoe, Tomoko Takagai, Hiroaki Yanagawa","doi":"10.1177/15562646211036577","DOIUrl":"https://doi.org/10.1177/15562646211036577","url":null,"abstract":"<p><p>Despite the importance and acceptance of research ethics consultation as an entity in many medical research areas, little is known about its status in nursing research. Focusing on inquiries from nurse researchers, we retrospectively analyzed records of integrated clinical research consultation, provided by members of the Clinical Research Center independently of the research ethics committee, at a Japanese university hospital during 2018-2019. Among various consultations in nursing studies (<i>n</i> = 101), 43 were related to research ethics. The main issues in research ethics consultation were compatibility with guidelines (<i>n</i> = 28; 65%) and application of ethics review (<i>n</i> = 12; 28%). Future studies should investigate international settings and address the relevance of research ethics consultation to promote proper nursing studies.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39297431","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":"The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss Study.","authors":"Agata Ferretti, Marcello Ienca, Minerva Rivas Velarde, Samia Hurst, Effy Vayena","doi":"10.1177/15562646211053538","DOIUrl":"https://doi.org/10.1177/15562646211053538","url":null,"abstract":"<p><p>Big data trends in health research challenge the oversight mechanism of the Research Ethics Committees (RECs). The traditional standards of research quality and the mandate of RECs illuminate deficits in facing the computational complexity, methodological novelty, and limited auditability of these approaches. To better understand the challenges facing RECs, we explored the perspectives and attitudes of the members of the seven Swiss Cantonal RECs via semi-structured qualitative interviews. Our interviews reveal limited experience among REC members with the review of big data research, insufficient expertise in data science, and uncertainty about how to mitigate big data research risks. Nonetheless, RECs could strengthen their oversight by training in data science and big data ethics, complementing their role with external experts and ad hoc boards, and introducing precise shared practices.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3b/ab/10.1177_15562646211053538.PMC8721531.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39625154","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}
Steven R Lawyer, Kathleen Smith, Beena Thomas, Shelby Pemberton
{"title":"Reactions to Laboratory-Based Trauma Research in a Sample of Incarcerated Women.","authors":"Steven R Lawyer, Kathleen Smith, Beena Thomas, Shelby Pemberton","doi":"10.1177/15562646211043632","DOIUrl":"https://doi.org/10.1177/15562646211043632","url":null,"abstract":"<p><p>An evidence-based approach to research ethics is critical to ethical research but little is known about how trauma survivors-especially those from vulnerable populations-respond to laboratory-based trauma research. One hundred four incarcerated women (<i>N</i> = 64 rape survivors) reported their traumatic life experiences, listened to and responded to an audio recording of a dating interaction that culminates in a completed rape, and then reported their responses to their participation. Compared to the control group (<i>N</i> = 40), rape survivors (<i>N</i> = 64) had more posttraumatic stress disorder symptoms and these symptoms were associated with more emotional responding. Both groups showed a positive benefit-cost ratio with regard to their participation did not differ on their overall reactions to research participation. These findings suggest that laboratory-based trauma research methods are associated with consistently positive experiences, which can help inform researchers and institutional review boards about the risks and benefits of such research.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39431561","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}
Kathleen M West, Kerri L Cavanaugh, Erika Blacksher, Stephanie M Fullerton, Ebele M Umeukeje, Bessie Young, Wylie Burke
{"title":"Stakeholder Perspectives on Returning Nonactionable Apolipoprotein L1 (APOL1) Genetic Results to African American Research Participants.","authors":"Kathleen M West, Kerri L Cavanaugh, Erika Blacksher, Stephanie M Fullerton, Ebele M Umeukeje, Bessie Young, Wylie Burke","doi":"10.1177/15562646211063267","DOIUrl":"https://doi.org/10.1177/15562646211063267","url":null,"abstract":"<p><p>The ethics of returning nonactionable genetic research results to individuals are unclear. Apolipoprotein L1 (<i>APOL1</i>) genetic variants are nonactionable, predominantly found in people of West African ancestry, and contribute to kidney disease disparities. To inform ethical research practice, we interviewed researchers, clinicians, and African American community members (<i>n</i> = 76) about the potential risks and benefits of returning <i>APOL1</i> research results. Stakeholders strongly supported returning <i>APOL1</i> results. Benefits include reciprocity for participants, community education and rebuilding trust in research, and expectation of future actionability. Risks include analytic validity, misunderstanding, psychological burdens, stigma and discrimination, and questionable resource tradeoffs.</p><p><p><b>Conclusions:</b><i>APOL1</i> results should be offered to participants. Responsibly fulfilling this offer requires careful identification of best communication practices, broader education about the topic, and ongoing community engagement.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9053332/pdf/nihms-1756502.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39696991","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}
Mutshidzi A Mulondo, Joyce M Tsoka-Gwegweni, Puleng LenkaBula, Perpetual Chikobvu
{"title":"A Survey to Determine the Capacity Development Needs of Research Ethics Committee Administrators in South Africa.","authors":"Mutshidzi A Mulondo, Joyce M Tsoka-Gwegweni, Puleng LenkaBula, Perpetual Chikobvu","doi":"10.1177/15562646211056762","DOIUrl":"https://doi.org/10.1177/15562646211056762","url":null,"abstract":"<p><p>Most capacity development efforts for research ethics committees focus on committee members and little on ethics administrators. Increasing studies mandate the focus on administrators' capacity development needs to enable adequate and effective committee support. This study investigated current responsibilities, training requirements, and administrator role needs. An online cross-sectional survey was conducted among administrators from 62 National Health Research Ethics Council-registered research ethics committees in South Africa. In total, 36 administrators completed the questionnaire. Results show that, in addition to administration, they perform managerial, review process and guidance-advisory tasks. Nearly 49% indicated only having received informal research ethics-related training, not targeted formal training, with 81% of the informal training being through workshops. Research ethics administrators' responsibilities have evolved to complex tasks requiring targeted capacity development efforts.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39646036","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}
Anna M Scott, E Ann Bryant, Jennifer A Byrne, Natalie Taylor, Adrian G Barnett
{"title":"\"No Country Bureaucratised its way to Excellence\": A Content Analysis of Comments on a Petition to Streamline Australian Research Ethics and Governance Processes.","authors":"Anna M Scott, E Ann Bryant, Jennifer A Byrne, Natalie Taylor, Adrian G Barnett","doi":"10.1177/15562646211048268","DOIUrl":"https://doi.org/10.1177/15562646211048268","url":null,"abstract":"<p><p>We created a petition for a national inquiry into the Australian system of research ethics and governance, to inform the politicians about the problems with the existing system. We analyzed the reasons that signatories offered for why signing the petition was important to them. A total of 409 comments (by 805 signatories) focused on five major themes: (1) views on previous changes to the system of research ethics and governance; (2) drawbacks of the existing system; (3) suggested changes to the system; (4) anticipated impacts of changing the system; and (5) miscellaneous/other comments. Comments ranged from several words to over 400 words in length, and most often focused on the procedural aspects, and commented on theme 2: drawbacks of the existing system.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39510075","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}
Minna Stolt, Emilia Kielo-Viljamaa, Anne-Marie Laitinen, Riitta Suhonen, Helena Leino-Kilpi
{"title":"Reporting of Research Ethics in Studies Focusing on Foot Health in Patients with Rheumatoid Arthritis - A Systematic Review.","authors":"Minna Stolt, Emilia Kielo-Viljamaa, Anne-Marie Laitinen, Riitta Suhonen, Helena Leino-Kilpi","doi":"10.1177/15562646211047654","DOIUrl":"https://doi.org/10.1177/15562646211047654","url":null,"abstract":"<p><p>Research ethics is a fundamental part of the entire research. Patients with rheumatoid arthritis are sensitive group of research participants because their long-term health problems cause significant changes in their foot health. In foot health research, data are usually collected through a clinical assessment of the foot or questionnaires. However, there is limited evidence of the reported research ethics of empirical studies on foot health in patients with rheumatoid arthritis. Therefore this review aimed to analyze the reported research ethics of peer-reviewed empirical studies focusing on foot health in patients with rheumatoid arthritis as research participants. This systematic review used the Medline/PubMed, CINAHL, and Embase databases. A total of 1,653 records were identified, and 32 articles were included in the final analysis. Reporting research ethics in studies of patients with rheumatoid arthritis is fragmented, focusing predominantly on ethical approval and informed consent and lacking a broader discussion about research ethics.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8721538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39516556","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}
Samuel Asiedu Owusu, Grace Addison, Barbara Redman, Lisa Kearns, Paul Amuna, Amos Laar
{"title":"Assessment of the Operational Characteristics of Research Ethics Committees in Ghana.","authors":"Samuel Asiedu Owusu, Grace Addison, Barbara Redman, Lisa Kearns, Paul Amuna, Amos Laar","doi":"10.1177/15562646211051189","DOIUrl":"https://doi.org/10.1177/15562646211051189","url":null,"abstract":"<p><p>There were eighteen Research Ethics Committees (RECs) operating in Ghana as of December 2019 but no empirical assessment of their operational characteristics had been conducted. We assessed the characteristics of Ghanaian RECs using an existing Self-Assessment Tool for RECs in Developing Countries. We present results from nine RECs that participated in this nation-wide assessment. Our results indicate that the RECs are generally adherent to the recommendations in the Tool including being composed of members with diverse expertise. They also reviewed and approved research protocols as well as had access to some limited funding for their activities. There is no national policy on research human protections or an ethics authority to regulate the activities of the RECs. We recommend the establishment of this authority in Ghana while encouraging institutions to sustain efforts aimed at making their RECs operate independently.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8712386/pdf/nihms-1741794.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39532251","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}