Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change [0.03%]
医生对将孕妇纳入COVID-19临床试验的态度：是时候改变理念了
Marie-Julie Trahan,Annabelle Cumyn,Matthew P Cheng et al.
Marie-Julie Trahan et al.
Excluding pregnant people from Covid-19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate...
Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use [0.03%]
迈向IRB先例体系的步骤：试点总结IRB决策的方法以供将来使用
Andrea Seykora,Carl Coleman,Stephen J Rosenfeld et al.
Andrea Seykora et al.
Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect for their decision...
A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era [0.03%]
新冠疫情时期的伦理审查：质量而非速度
Leonardo Tamariz,Fred J Hendler,John M Wells et al.
Leonardo Tamariz et al.
With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through ...
Opt-Out Design for an Observational Toxicology Study Involving Intoxicated Patients at a Dance Music Event [0.03%]
音乐节醉酒患者参与的观察性毒理学研究退出设计
Paul Calle,Peter Blanckaert,Sabine Lemoyne et al.
Paul Calle et al.
At electronic dance music events in Belgium in 2013 to 2015, seemingly intoxicated patients were included without their informed consent in an observational toxicology study when the attending physicians determined that they needed treatmen...
IRB Decision-Making about Minimal Risk Research with Pregnant Participants [0.03%]
涉及孕妇受试者的最小风险研究的伦理审查决策问题
Amina White,Christine Grady,Margaret Little et al.
Amina White et al.
Pregnant individuals are often excluded from research without clear justification, even when the research poses minimal risk of harm to the fetus. Little is known about institutional review board (IRB) decision-making practices when reviewi...
Making Metrics Meaningful: How Human Research Protection Programs Can Efficiently and Effectively Use Their Data [0.03%]
质量指标：如何高效利用数据保护人类研究项目
Kimberley Serpico
Kimberley Serpico
Human research protection programs (HRPP) generate an abundance of data on performance, capacity, and compliance. When used effectively, this information can be instrumental in helping HRPPs meet programmatic and institutional goals, demons...
Holly A Taylor,Kathryn M Porter,Erin Talati Paquette et al.
Holly A Taylor et al.
This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues...
Luke Gelinas,Walker Morrell,Sarah A White et al.
Luke Gelinas et al.
Online communication has emerged as an important vehicle for participant interaction during the course of clinical research. At the same time, such communication has been identified as a source of risks both for participants and the scienti...
Ian Tully
Ian Tully
Recent changes to the Common Rule have helped reduce regulatory burden on researchers conducting minimal risk research. However, in this paper, I propose a way of minimizing burden further within the existing confines of the current regulat...
Developing Biopsychosocial Research on Maternal Mental Health in Malawi: Community Perspectives and Concerns [0.03%]
马拉维母婴精神健康生物心理社会学研究：社区视角与关注点
Lucinda Manda-Taylor,Eric Umar,Robert C Stewart et al.
Lucinda Manda-Taylor et al.
Interest in maternal mental health research is growing around the world. Maternal mental health research studies in Malawi have, for instance, sought to determine and establish the incidence and prevalence of depression and anxiety in pregn...