Regulatory Landscape of International Direct-to-Participant (DTP) Genomic Research: Time to Untie the Gordian Knot? [0.03%]
国际直接面向参与者的组学研究监管现状：是时候解开 Gordian 紧局了吗？
Mark A Rothstein,Ma&#x;n H Zawati,Bartha Maria Knoppers
Mark A Rothstein
Carl H Coleman
Carl H Coleman
Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are "designed to develop or contribute to generalizable knowledge." However, the "gen...
Leila Barraza,James G Hodge Jr,Chelsea L Gulinson et al.
Leila Barraza et al.
Vexed Again: Social Scientists and the Revision of the Common Rule, 2011-2018 [0.03%]
再添烦恼：社会科学家与《共同准则》修订（2011—2018）
Zachary M Schrag
Zachary M Schrag
In revising the Federal Policy for the Protection of Human Subjects (Common Rule) between 2009 and 2018, regulators devoted the vast bulk of their attention to debates over biomedical research. They lacked both expertise in and concern abou...
Phebe Hong,Ameet Sarpatwari,Aaron S Kesselheim
Phebe Hong
Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere? [0.03%]
借鉴英国和国际经验改革美国人类受试者保护制度的启示——兼论国内多中心临床研究伦理审查模式的选择问题
Edward S Dove
Edward S Dove
This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weakne...
Local All-Age Bicycle Helmet Ordinances in the United States: A Review and Analysis [0.03%]
美国地方全民自行车头盔条例的回顾与分析
Molly Merrill-Francis,Jon S Vernick,Keshia M Pollack Porter
Molly Merrill-Francis
Bicycle helmets protect against head injury. Mandatory helmet laws likely increase their use. Although 21 states and Washington, DC have mandatory helmet laws for youth (variously defined) bicyclists, no U.S. state has a mandatory helmet la...
Lainie Friedman Ross,J Richard Thistlethwaite
Lainie Friedman Ross
The traditional living donor was very healthy. However, as the supply-demand gap continues to expand, transplant programs have become more accepting of less healthy donors. This paper focuses on the other extreme, asking whether and when in...
The Ethics of Breastfeeding by Women Living with HIV/AIDS: A Concrete Proposal for Reforming Department of Health and Human Services Recommendations [0.03%]
艾滋病妇女母乳喂养伦理：卫生与人群服务部建议改革的一个具体提议
Lawrence O Gostin,Matthew M Kavanagh
Lawrence O Gostin
Amy L McGuire,Jessica Roberts,Sean Aas et al.
Amy L McGuire et al.
In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons (MIC) and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then exa...