Navigating Informed Consent Requirements and Expectations in Cluster Randomized Trials: Research Ethics Board Members' and Researchers' Views [0.03%]
集群随机试验中的知情同意要求和期望：研究伦理委员会成员与研究人员的看法
Anita Ho,Soodabeh Joolaee,Michael McDonald et al.
Anita Ho et al.
Informed consent is a cornerstone of ethical human research. However, as cluster randomized trials (CRTs) are increasingly popular to evaluate health service interventions, especially as health systems aspire toward the learning health syst...
Barbara E Bierer,Deborah A Zarin,Luke Gelinas
Barbara E Bierer
To be ethical, clinical trials must exhibit a favorable risk-benefit balance at the time of their initiation. However, in some cases, the expected value of a study decreases while the study is ongoing, due to developments outside of the stu...
Editors' Statement on the Responsible Use of Generative AI Technologies in Scholarly Journal Publishing [0.03%]
关于在学术期刊出版中负责任地使用生成型人工智能技术的编辑声明
Gregory E Kaebnick,David Christopher Magnus,Audiey Kao et al.
Gregory E Kaebnick et al.
Generative artificial intelligence (AI) has the potential to transform many aspects of scholarly publishing. Authors, peer reviewers, and editors might use AI in a variety of ways, and those uses might augment their existing work or might i...
Megan Doerr,Joon-Ho Yu
Megan Doerr
Impactful translational research requires new approaches to computational analysis and bioethics, both of which have been advanced by adoption of community-engagement strategies. Community knowledge and experience will hone data collection,...
Stakeholder Reflections on Implementing the National Institutes of Health's Policy on Single Institutional Review Boards [0.03%]
美国国立卫生研究院单一机构审查委员会政策的实施情况及各利益相关者观点
Amy Corneli,Kevin McKenna,Emily Hanlen-Rosado et al.
Amy Corneli et al.
The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH-funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in-dept...
Gershom Chongwe,Joseph Ali,Dan Kabonge Kaye et al.
Gershom Chongwe et al.
Over recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such tria...
Jon F Merz
Jon F Merz
Amy Karle
Amy Karle
Factors Associated with IRB Review Time in a Non-Federally Funded Study Using an sIRB of Record [0.03%]
非联邦资助研究中使用记录sIRB的因素与IRB审查时间的相关性分析
Erin Lamers-Johnson,Vanessa K Will,Julie M Long et al.
Erin Lamers-Johnson et al.
From 2018 to 2020, U.S. federal mandates began requiring the use of a single institutional review board (sIRB) of record for federally funded, multisite studies. With an interest in the efficiency of site activation, we compared the frequen...
Multicenter Study
Ethics & human research. 2023 Jul-Aug;45(4):16-29. DOI:10.1002/eahr.500173 2023