Journal of empirical research on human research ethics : JERHRE最新文献

{"title":"Facilitating Timely Institutional Review Board Review: Common Issues and Recommendations.","authors":"Emily Rodriguez,&nbsp;Challace Pahlevan-Lbrekic,&nbsp;Elaine L Larson","doi":"10.1177/15562646211009680","DOIUrl":"https://doi.org/10.1177/15562646211009680","url":null,"abstract":"<p><p>Review of clinical research by institutional review boards (IRBs) is integral to the protection of human subjects and necessary for the conduct of legal and ethical research. Because such review is time and resource intensive, it is critical to identify common issues that contribute to delayed review and approval of research. Hence, the aim of this quality improvement project was to identify factors associated with long delays in IRB approval and identify potential strategies to streamline the review process. In collaboration with the human subjects research protection program at a large academic health center in the northeastern United States, we conducted a content analysis of minutes of convened IRB meetings for every new protocol (initial submission) approved between January and September 2019 that required greater than or equal to two full board reviews prior to approval (<i>n</i> = 33). We also examined characteristics of new protocols that were reviewed less than twice at convened meetings during the same time frame (<i>n</i> = 244). Using χ² or Fisher's exact tests, the characteristics of protocols with multiple reviews by the convened IRBs were compared with those protocol submissions reviewed by the convened IRBs only once. Three factors significantly associated with increased delays were researcher conflict of interest (30% vs. 12%, respectively, <i>p</i> < .01), need for radiation safety evaluation (36% vs. 20%, respectively, <i>p</i> = .03), and protocols that were clinical trials (73% vs. 60%, respectively, <i>p</i> < .01). Other factors associated with delayed IRB approval were excessive technical jargon (93.94%, <i>n</i> = 31), inadequate description of data security or inability to meet data security requirements of the institution (75.76%, <i>n</i> = 25), protocol design affecting patient safety (57.58%, <i>n</i> = 19), and lack of clarity regarding compensation and payment or study duration (<i>n</i> = 18, 54.54% each). Approaches to mitigate delays in approval and increase the efficiency and efficacy of the IRB process are recommended.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"255-262"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211009680","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38880159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing Quality and Efficiency of Institutional Review Board Review Under a Human Research Protection Program at a Leading Hospital in Central Southern China: A Descriptive Analysis of the First Three Years.","authors":"Xiaomin Wang,&nbsp;Jessica Hahne,&nbsp;Lun Li,&nbsp;Kaveh Khoshnood,&nbsp;Guoping Yang,&nbsp;Hong Yuan,&nbsp;Xing Liu","doi":"10.1177/1556264621995656","DOIUrl":"https://doi.org/10.1177/1556264621995656","url":null,"abstract":"<p><p>This study analyzes the Institutional Review Board (IRB) quality and efficiency at a leading hospital in Central Southern China, under the first three years of a Human Research Protection Program (HRPP). We conducted a descriptive, retrospective analysis from 2015 through 2017. We extracted characteristics from the protocol archive in duplicate. Of 396 protocols submitted, 98% were approved. Mean protocol review time decreased from 23 to 15 calendar days, 344 serious adverse events SAEs were reviewed, and 93 conflicts of interest (COIs) were disclosed. IRB quality and efficiency mechanisms improved. Remaining needs include increased monitoring of COIs and unanticipated problem involving risks to subjects or others, distinctions between research types, and cooperation with specialized committees.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"280-289"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1556264621995656","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25487131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Citizens, Research Ethics Committee Members and Researchers' Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems.","authors":"Annabelle Cumyn,&nbsp;Roxanne Dault,&nbsp;Adrien Barton,&nbsp;Anne-Marie Cloutier,&nbsp;Jean-François Ethier","doi":"10.1177/1556264621992214","DOIUrl":"https://doi.org/10.1177/1556264621992214","url":null,"abstract":"<p><p>A survey was conducted to assess citizens, research ethics committee members, and researchers' attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"165-178"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1556264621992214","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25470964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What are Important Ways of Sharing Power in Health Research Priority Setting? Perspectives From People With Lived Experience and Members of the Public.","authors":"Bridget Pratt","doi":"10.1177/15562646211013294","DOIUrl":"https://doi.org/10.1177/15562646211013294","url":null,"abstract":"<p><p>Community engagement (patient and public involvement) is gaining prominence in health research worldwide. But there remains limited ethical guidance on how to share power with communities in health research priority setting, particularly that which has been informed by the perspectives of those being engaged. This article provides initial evidence about what they think are important ways to share power when setting health research projects' topics and questions. Twenty-two people with lived experience, engagement practitioners, and members of the public who have been engaged in health research in the United Kingdom and Australia were interviewed. Thematic analysis identified 15 key ways to share power, many of which are <i>relational</i>. This study further demonstrates that tensions exist between certain ways of sharing power in health research priority setting. More research is needed to determine how to navigate those tensions.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"200-211"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211013294","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38950986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Process, Power, and Impact of the Institutional Review Board in Criminology and Criminal Justice Research.","authors":"Elaine Gunnison,&nbsp;Jacqueline B Helfgott","doi":"10.1177/1556264621992240","DOIUrl":"https://doi.org/10.1177/1556264621992240","url":null,"abstract":"<p><p>While research on Institutional Review Boards (IRBs) has been conducted on issues ranging from quality, process, and effectiveness, gaps remain. Social science researchers have raised issues regarding decisions by IRBs applied to the social sciences based on biomedical research. To date, little is known about the experience of social scientists in criminology and criminal justice with IRBs and this research seeks to fill this gap. An online survey, including open- and closed-ended questions drawn from the validated IRB-Researcher Assessment Tool, was administered to members of the <i>Academy of Criminal Justice Sciences</i> and the <i>American Society of Criminology</i> about their experiences with IRBs. Results revealed that researchers report experiencing challenges with their IRBs including timeline delays of their research, bias against their research, and decisions that protect legal liability rather than human subjects ethics. Recommendations for improving IRB reviews of protocols and challenges unique to criminology and criminal justice are discussed.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"263-279"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1556264621992240","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25452403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Abstracts From the PRIM&R 2020 Advancing Ethical Research Conference.","authors":"","doi":"10.1177/1556264621996909","DOIUrl":"https://doi.org/10.1177/1556264621996909","url":null,"abstract":"s From the PRIM&R 2020 Advancing Ethical Research Conference Continuing the collaboration between JERHRE and Public Responsibility in Medicine and Research (PRIM&R), we are once again pleased to publish empirical research poster abstracts from the 2020 PRIM&R Annual Conference, Advancing Ethical Research, held virtually in December. Variation in Interpretation of Subpart B Conditions by Stakeholders in the Institutional Review Board Review Process of Abortion Research, United States, 2019 Jessica Blackburn, Roger Rochat, Lisa B. Haddad, and Sarah Cordes Emory University, Atlanta, USA","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"NP1-NP7"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1556264621996909","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25524722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"\"Like a Sheriff in a Small Town\": Status, Roles, and Challenges of Ethics Committees in Academic Colleges of Education.","authors":"Daniel Sperling","doi":"10.1177/15562646211005253","DOIUrl":"https://doi.org/10.1177/15562646211005253","url":null,"abstract":"<p><p>In recent years, Research Ethics Committees in academic colleges of education have constituted to review research proposals in the field of education. Yet, little is known about their work, composition, challenges, and relationships with external partners. This study explores the views and attitudes of 13 members and chairpersons of Research Ethics Committees in colleges of education in Israel, and two policy makers at the Ministry of Education about their roles, responsibilities, challenges, and limitations. Findings revealed an instrumental attitude towards the ethics committee. Committees are perceived as supportive rather than enforcing. Interviews shed light on the complex relationships between committee members, college lecturers/researchers, ethics regulators, and academic management. Moreover, the findings emphasized the lack of formal training and broad discussion on ethics. The study calls for strengthening committees' raison d'être and the internalization of ethics among committee members, researchers, and lecturers in the field of education.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"290-303"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211005253","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25531221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Informed Consent for Online Research-Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms.","authors":"Caitlin Geier,&nbsp;Robyn B Adams,&nbsp;Katharine M Mitchell,&nbsp;Bree E Holtz","doi":"10.1177/15562646211020160","DOIUrl":"https://doi.org/10.1177/15562646211020160","url":null,"abstract":"<p><p>Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants (<i>n</i> = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"154-164"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211020160","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38943386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementing a Review Process to Facilitate and Prioritize COVID-19 Research: Staying One Step Ahead of the Pandemic.","authors":"Elli Gourna Paleoudis,&nbsp;Laurie G Jacobs,&nbsp;Tamara Friedman,&nbsp;Cheryl Fittizzi,&nbsp;Ihor Sawczuk,&nbsp;Judy Aschner","doi":"10.1177/15562646211017042","DOIUrl":"https://doi.org/10.1177/15562646211017042","url":null,"abstract":"<p><p>The first coronavirus disease 2019 (COVID-19) patient in the state of New Jersey (NJ) was admitted on March 2, 2020. With the number of hospitalized patients increasing exponentially in the following days and no established treatment approaches, research was to play a significant role in this fight. To facilitate review of all COVID-19 research proposals in a large health care network in NJ, we established the COVID-19 Research Review Committee (RRC) and implemented a peer-review process prior to the Institutional Review Board submission. The RRC was tasked with processing, soliciting, reviewing, and prioritizing research proposals and was comprised of a multidisciplinary group of reviewers. Within a 9-week period, three network-wide requests for proposals were released with 238 proposals submitted and 93 approved, an approval rate of 39%. The establishment of the RRC helped ensure scientific merit, better utilization of resources, collaborations across disciplines and network hospitals, and compliance with applicable regulatory and ethical standard.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"188-192"},"PeriodicalIF":1.3,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211017042","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38969689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perceived Social Influences on Women's Decisions to use Medications not Studied in Pregnancy. A Qualitative Ethical Analysis of Preexposure Prophylaxis Implementation Research in Kenya.","authors":"Kenneth Ngure, Susan B Trinidad, Kristin Beima-Sofie, John Kinuthia, Daniel Matemo, Grace Kimemia, Anne Njoroge, Lillian Achiro, Jillian Pintye, Nelly R Mugo, Elizabeth A Bukusi, Jared M Baeten, Renee Heffron, Grace John-Stewart, Maureen C Kelley","doi":"10.1177/15562646211012296","DOIUrl":"10.1177/15562646211012296","url":null,"abstract":"<p><p>Implementation research ethics can be particularly challenging when pregnant women have been excluded from earlier clinical stages of research given greater uncertainty about safety and efficacy in pregnancy. The evaluation of human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) during pregnancy offered an opportunity to understand important ethical considerations and social influences shaping women's decisions to participate in the evaluation of PrEP and investigational drugs during pregnancy. We conducted interviews with women (<i>n</i> = 51), focus groups with male partners (five focus group discussions [FGDs]), interviews with health providers (<i>n</i> = 45), four FGDs with pregnant/postpartum adolescents and four FGDs with young women. Data were analyzed using thematic content analysis, including ethical aspects of the data. Our study reveals that women navigate a complex network of social influences, expectations, support, and gender roles, not only with male partners, but also with clinicians, family, and friends when making decisions about PrEP or other drugs that lack complete safety data during pregnancy.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"225-237"},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39237703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}