Mandating Evidence-Based Informed Consent Practices: A Critical Engagement with IRB Leader Focus Group Findings [0.03%]
有关IRB领导者焦点小组发现的基于证据的知情同意实践的批判性参与强制性研究
Meredith V Parsons,Erin D Solomon,Kari Baldwin et al.
Meredith V Parsons et al.
Evidence-based informed consent practices-such as writing in plain language, formatting for readability, and assessing understanding using validated instruments-are underutilized in research practice. Yet the Common Rule does not specifical...
Exception from Informed Consent and Waiver of Informed Consent for Comparative Effectiveness Trials in Emergency Care Research [0.03%]
急诊护理研究中的知情同意豁免和比较有效性试验的知情同意放弃政策
Jonathan D Casey,Matthew W Semler,Jeremy Brown et al.
Jonathan D Casey et al.
For many of the decisions made in the clinical care setting, clinicians lack evidence to inform which treatment would result in the best patient outcomes. This problem is particularly common in emergency care, a field in which the condition...
Exception from Informed Consent in Emergency Care Research: Reports from a Workshop Addressing "Edge Cases" [0.03%]
紧急情况下进行临床试验免除知情同意的报告——关于“边缘状态”的研讨会报告
Jeremy Brown,Neal W Dickert,Robert Silbergleit
Jeremy Brown
The ethical challenges of enrolling critically ill patients into emergency care clinical trials without their consent remain, despite a 30-year regulatory framework for conducting research in the emergency setting. In this series introducti...
Pain Management Research in Prehospital Settings: The Pain of Exception from Informed Consent [0.03%]
院前疼痛管理研究：知情同意例外带来的痛苦
Michael Linke,Francis X Guyette,Jason McMullan
Michael Linke
Effective pain management in prehospital settings remains a significant challenge, particularly for patients with acute trauma. This report examines the complexities of conducting prehospital pain studies, focusing on two clinical trials as...
Policies for the Inclusion of Pregnant Women in Research: Results from an International and a US Study [0.03%]
来自国际和美国的研究纳入孕妇的政策结果
Anne Drapkin Lyerly,Renee Muthakana,Aliyah Webster et al.
Anne Drapkin Lyerly et al.
Leading medical organizations have called for advancement of pregnancy-specific research to reduce harmful evidence gaps. However, meeting this objective poses ethical, legal, and policy dilemmas for investigators, oversight committees, aca...
Navigating Challenges with IRB Review for Community-Engaged Research with Transgender Youth in the United States [0.03%]
美国社区参与的关于变性青年的研究中的伦理挑战及对策
Alic G Shook,Ruby Lucas,Calvin Liang et al.
Alic G Shook et al.
Navigating the complexities of institutional review board (IRB) determinations in participatory research with transgender youth is essential for prioritizing youth voices and establishing equitable opportunities for research participation. ...
Human Research Protection Training Requirements: Alternatives for Community Researchers at CTSA-Funded Research Institutions [0.03%]
临床和转化科学奖资助机构中社区研究人员的人类研究保护培训要求替代方法
Emily E Anderson,Alison Santiago
Emily E Anderson
Enhanced protection for research participants is often stated as a goal and potential benefit of engaging community partners in research. However, many community-engaged research teams report challenges in completing human research protecti...
Challenges of Conducting Risk-Benefit Analysis of Early Phase Clinical Trials: Results of a National Survey of IRB Chairs [0.03%]
我国IRB主席开展一期临床试验风险效益分析挑战的全国调查结果
Christine M Baugh,Dragana Bolcic-Jankovic,Mark Fedyk et al.
Christine M Baugh et al.
Institutional review boards (IRBs) are charged with conducting risk-benefit analysis for early phase clinical trials that often involve high levels of uncertainty regarding a trial's potential risks and benefits. Our study used a survey of ...
Troubling Hope: Religious Faith and False Hope in Clinical Research Participants [0.03%]
困扰的希望——临床试验受试者中的宗教信仰与虚假希望
Andrea Thornton
Andrea Thornton
Much of the discussion of hope in oncology research ethics literature raises concern that hope is problematic because it indicates irrationality or misunderstanding, which makes potential research participants vulnerable to exploitation. If...
Broadening Core Research Ethics Principles: Insights from Research Conducted with Black Communities [0.03%]
扩大核心研究伦理原则的适用范围：基于黑人社区的研究见解
Johanne Jean-Pierre,Tya Collins,Khandys Agnant et al.
Johanne Jean-Pierre et al.
Drawing from a 2023 symposium panel that focused on conducting health equity research with Black communities, we propose to expand our interpretation of core research ethics principles. In light of a surge of research conducted in Black dia...