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...
Allison Kratka,Peter A Ubel,Karen Scherr et al.
Allison Kratka et al.
Despite doing well on antiretroviral therapy, many people living with HIV have expressed a willingness to accept substantial risks for an HIV cure. To date, few studies have assessed the specific quantitative maximal risk that future partic...
Reported Participation Benefits in International HIV Prevention Research with People Who Inject Drugs [0.03%]
注射吸毒者参与国际艾滋病预防研究的获益报告
Jeremy Sugarman,Ilana Trumble,Erica Hamilton et al.
Jeremy Sugarman et al.
Given ethical concerns about research involving people who inject drugs and those affected by HIV, identifying potential participation benefits is important. We evaluated participant-reported benefits in a trial conducted in Indonesia, Ukra...
Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks [0.03%]
改进生物银行西班牙语知情同意文件的翻译和文化适宜性
Kathleen M Brelsford,Ernesto Ruiz,Catherine M Hammack et al.
Kathleen M Brelsford et al.
A growing proportion of prospective research participants in the United States speak limited or no English. We conducted cognitive interviews with native Spanish speakers to test Spanish-language translations of simplified and traditional b...
Deborah R Barnbaum
Deborah R Barnbaum
A valid informed consent process for a randomized controlled trial requires the disclosure to potential participants that they will be randomized to receive the study intervention or a control intervention. This is a case of randomization w...
Participant Engagement in Translational Genomics Research: Respect for Persons-and Then Some [0.03%]
论参与性：跨学科转化基因组研究中的尊重个体原则及其他
Janet E Childerhose,Candice R Finnila,Joon-Ho Yu et al.
Janet E Childerhose et al.
The expansion of both formal and informal frameworks of "engaged" research in translational research settings raises emerging and substantial normative concerns. In this article, we draw on findings from a focus group study with members of ...
How Do We Really Communicate? Challenging the Assumptions behind Informed Consent Interventions [0.03%]
知情同意干预措施背后的假设及其挑战：我们真正如何沟通？
Stephanie Solomon Cargill
Stephanie Solomon Cargill
It is generally accepted that ethical research requires valid informed consent and that current informed consent practice frequently fails to attain it. Interventions concerning the content and methods of communication in informed consent h...