Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...) healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government. (shrink)

Ethics in scientific research has never been more important. Recent controversies over the integrity of data in federally funded science, the manipulation and distortion of privately sponsored research, cloning, stem cell research, and the patenting of DNA and cell lines, illustrate the need for a more thorough education in ethics for researchers at all levels. Now in its second edition, Responsible Conduct of Research provides an introduction to many of the social, ethical, and legal issues facing scientists today. The fully (...) updated volume includes three brand new chapters and additional cases for discussion, as well as analysis of the latest issues and problems in research ethics. Featuring chapters that treat such topics as ethical decision-making, research misconduct, and intellectual property, this new edition will be an indispensable resource for students and teachers, academics and industry professionals alike. (shrink)

A broad consensus affirms the concept that all human beings have equal moral worth (Beauchamp and Childress 1994; Rawls 1971). Translating this ethical norm into practice requires careful attention...

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each school (...) in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

A broad consensus affirms the concept that all human beings have equal moral worth (Beauchamp and Childress 1994; Rawls 1971). Translating this ethical norm into practice requires careful attention...