The Inevitability and Ethics of Inaccurate Screening in Clinical Trials: A Call for Research and Guidance [0.03%]
临床试验中不准确筛查的不可避免性与伦理问题：研究与指导的呼吁
David Wendler
David Wendler
Accurate screening of potential research participants is vital to ensuring the scientific, regulatory, and ethical appropriateness of clinical trials. Yet there are no definitive screening tests for many conditions, and many screening tests...
Enrolling Children in Clinical Trials for Genetic Neurodevelopmental Conditions: Ethics, Parental Decisions, and Children's Identities [0.03%]
遗传神经发育障碍儿童临床试验的伦理、家长决策及儿童身份问题分析
Erin Turbitt,Ainsley J Newson,Barbara B Biesecker et al.
Erin Turbitt et al.
Knowledge of genetic mechanisms contributing to neurodevelopmental conditions is advancing. This is informing development of new drugs to treat or ameliorate these conditions, through targeting underlying genetic pathways. Drugs are tested ...
Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance [0.03%]
利益相关者对单一IRB审查流程的体验及对美国食品药品监督管理局指南的建议
Amy Corneli,Carrie B Dombeck,Kevin McKenna et al.
Amy Corneli et al.
The revised Common Rule requires using a single institutional review board (sIRB) for U.S.-based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of ...
Advance Research Directives: Dementia Researchers' Views on a Prototype Directive and Implementation Strategies [0.03%]
痴呆症研究人员对一种新型指令和实施策略的观点
Nola Ries,Elise Mansfield
Nola Ries
Advance research directives (ARDs) enable people to document preferences for future research participation in the event of incapacity. This article reports on interviews with 11 dementia researchers in Australia that focused on the content ...
American Indian and Alaska Native Enrollment in Clinical Studies in the National Institutes of Health's Intramural Research Program [0.03%]
美国国家卫生研究院 intramural 研究项目中美洲土著居民和阿拉斯加本地居民的临床研究注册情况
Deionna Vigil,Ninet Sinaii,Barbara Karp
Deionna Vigil
Clinical studies conducted by the National Institutes of Health's Intramural Research Program (NIH-IRP) provide eligible individuals with access to innovative research treatments that may not otherwise be available. The NIH-IRP's mission is...
SARS-CoV-2 Human Challenge Trials: Rethinking the Recruitment of Healthy Young Adults First [0.03%]
新冠肺炎人体挑战试验：重新考虑首先招募健康年轻人
Kenji Matsui,Yusuke Inoue,Keiichiro Yamamoto
Kenji Matsui
In the midst of the ongoing Covid-19 pandemic, researchers across the globe are still working to develop effective vaccines. To expedite this process even further, human challenge trials have been proposed by the World Health Organization (...
Franklin G Miller,Jonathan D Moreno
Franklin G Miller
In the midst of the Covid-19 pandemic, ethicists, researchers, and journalists have recommended studies that deliberately infect healthy volunteers with the coronavirus as a scientific means of expediting vaccine development. In this essay,...
Balancing External Validity and Concern for Psychosocial Harms in Translational Genetic Research [0.03%]
遗传转化研究中平衡外部有效性与心理社会危害的关系
Jessica Mozersky,Michelle N Meyer,Alanna Kulchak Rahm et al.
Jessica Mozersky et al.
Ayesha Bhatia,Paul S Appelbaum,Katherine L Wisner
Ayesha Bhatia
A pregnant woman was enrolled in a double-blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research par...
Case Reports
Ethics & human research. 2021 Mar;43(2):28-34. DOI:10.1002/eahr.500084 2021
Phoebe Friesen,Rachel Douglas-Jones,Mason Marks et al.
Phoebe Friesen et al.
Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IR...