Humans as Model Organisms [0.03%]
人类作为模式生物
Carolyn P Neuhaus
Carolyn P Neuhaus
Tom Tomlinson,Raymond G De Vries
Tom Tomlinson
Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collec...
Cleaning Up the Lab Cages: Healthy Human Phase I Trials and Animal Welfare Requirements [0.03%]
清理实验室笼子：健康的人体I期试验与动物福利要求
Carl Elliott
Carl Elliott
Michael Householder,Ana Laura Solano-López,Derby Muñóz-Rojas et al.
Michael Householder et al.
Costa Rica is a small developing nation in Central America with a well-regarded universal health care system and a strong human rights tradition. In the latter part of the twentieth century, it became a popular site for clinical trials fund...
Widening the Lens [0.03%]
拓宽视野
Karen J Maschke
Karen J Maschke
Advancing Ethics and Policy for Healthy-Volunteer Research through a Model-Organism Framework [0.03%]
借鉴模型生物体框架推动健康志愿者研究中的伦理与政策发展
Jill A Fisher,Rebecca L Walker
Jill A Fisher
Nonhuman animal research and phase I healthy-volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share...
Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research [0.03%]
关于多中心研究单一机构审查委员会审核的《共同规则》提案的意见征求
Holly A Taylor,Stephan Ehrhardt,Ann-Margret Ervin
Holly A Taylor
We reviewed the public comments submitted in response to the Department of Health and Human Services' (DHHS's) original and revised proposal for mandated single-IRB review of federally funded multisite research to see who responded to the p...
Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions [0.03%]
本土知识和单一机构审查委员会在多中心研究中的挑战与解决方案
Robert Klitzman,Ekaterina Pivovarova,Alexandra Murray et al.
Robert Klitzman et al.
New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowle...