Many believe that informed consent makes clinical research ethical.
However, informed consent is neither necessary nor sufficient for ethical
clinical research. Drawing on the basic philosophies underlying major codes,
declarations, and other documents relevant to research with human subjects,
we propose 7 requirements that systematically elucidate a coherent framework
for evaluating the ethics of clinical research studies: (1) value—enhancements
of health or knowledge must be derived from the research; (2) scientific validity—the
research must be methodologically rigorous; (3) fair subject selection—scientific
objectives, not vulnerability or privilege, and the potential for and distribution
of risks and benefits, should determine communities selected as study sites
and the inclusion criteria for individual subjects; (4) favorable risk-benefit
ratio—within the context of standard clinical practice and the research
protocol, risks must be minimized, potential benefits enhanced, and the potential
benefits to individuals and knowledge gained for society must outweigh the
risks; (5) independent review—unaffiliated individuals must review the
research and approve, amend, or terminate it; (6) informed consent—individuals
should be informed about the research and provide their voluntary consent;
and (7) respect for enrolled subjects—subjects should have their privacy
protected, the opportunity to withdraw, and their well-being monitored. Fulfilling
all 7 requirements is necessary and sufficient to make clinical research ethical.
These requirements are universal, although they must be adapted to the health,
economic, cultural, and technological conditions in which clinical research
Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more
Subscribe for full-text access to content from 1998 forward and a host of useful features
Activate your current subscription (AMA members and current subscribers)
Purchase Online Access to this article for 24 hours
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 636
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
and access these and other features:
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.