Ian Stevens,Frederic Gilbert
Ian Stevens
Closed-loop deep brain stimulation (DBS) devices hold great promise for treating various neurological and psychiatric conditions. Yet while these algorithmic-based devices provide personalized treatment to each patient, they also present un...
David Wendler
David Wendler
The use of deception is typically prohibited in studies that pose greater than minimal risk overall. This approach prevents researchers from using deception to conceal significant risks or to deceive participants about the purpose, potentia...
Julian J Koplin,Martin R Turner,Julian Savulescu
Julian J Koplin
Imaging research regularly yields incidental findings that may have personal medical or reproductive decision-making significance to study participants. It is widely assumed that researchers have a moral obligation to disclose at least some...
Jon Lasser,Gail Ryser,Dora Borrego et al.
Jon Lasser et al.
Given the widespread use of deception in psychological experiments and the frequent recruitment of college students as participants, scholars have taken an interest in the ways college students assess the potential costs and benefits of dec...
Adrian Kwek
Adrian Kwek
The use of crowd workers as research participants is fast becoming commonplace in social, behavioral, and educational research, and institutional review boards are encountering more and more research protocols concerning these workers. In w...
Oversight of Right-to-Try and Expanded Access Requests for Off-Trial Access to Investigational Drugs [0.03%]
有关获准使用试验性药物的“权益试行规定”及扩大准入请求的监管问题
Carolyn Riley Chapman,Jared Eckman,Alison S Bateman-House
Carolyn Riley Chapman
For decades, the U.S. Food and Drug Administration (FDA) has provided an "expanded access" pathway that allows patients who meet qualifying conditions to gain access outside a clinical trial to an investigational medical product being teste...
Robert Klitzman,Paul S Appelbaum,Alexandra Murray et al.
Robert Klitzman et al.
In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study s...
Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards [0.03%]
在临床研究中包括孕妇：为伦理审查委员会提供的实用指南
Pamela Payne
Pamela Payne
Scanty evidence exists about the safety and effectiveness of drugs-and of their efficacious dosing-that women may need to treat acute and chronic health issues during their pregnancies. This lack of evidence puts pregnant women and their fe...
Reprioritizing Risk and Benefit: The Future of Study Design in Early-Phase Cancer Research [0.03%]
重新评估风险和效益：早期癌症研究设计的未来方向
Bryan Anthony Sisk,James Dubois,Brian P Hobbs et al.
Bryan Anthony Sisk et al.
The scientific purpose of phase I trials is to determine the maximum tolerated dose and/or optimal biological dose of experimental agents. Yet most participants in phase I oncology trials enroll hoping for direct medical benefit. The most c...
Safeguarding Participants in Psychiatric Genetic Research: Perspectives of Key Stakeholder Groups [0.03%]
精神疾病遗传研究中的参与者保护：关键相关方的观点
Maryam Rostami,Laura B Dunn,Jane Paik Kim et al.
Maryam Rostami et al.
Public trust in research depends on implementation of research protections. Genetic and psychiatric research may elicit "exceptionalism," the belief that these types of research deserve special protections. Genetic information has been view...