Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell research -- International research.

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)

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)

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...

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...

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...

It is universally accepted that informed consent to participate in medical research should be given by subjects. People have the fundamental human right to freely choose, without coercion or withholding of information necessary to make a reasonable choice, whether they will undergo any risks associated with a research project. United States researchers have known for some time that they have the duty to inform potential subjects of the nature of proposed research and the risks and possible benefits, and to seek (...) consent. Investigators also have the duty to design the research so that it will be scientifically valid while minimizing foreseeable and avoidable harms. (shrink)

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 and is embodied in various federal human research protection regulations. In a program named "SATURN", 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)

This book posits three ethical principles by which the concept of equal worth can be used in a practical manner to resolve conflicts and wars. Shamoo argues that once the principle of equal worth is adopted in foreign policy, humanity will be able to achieve peace.

A literature search was conducted on studies of new drugs used with patients with schizophrenia reported by U.S. and non-U.S. researchers from 1966–1993, yielding 41 U.S., and a total of 24 other non-U.S. studies, among them 11 British studies. Results of the U.S. and non-U.S. studies were pooled separately and compared. Among several comparable conditions discussed, the lack of any data on suicides in the U.S. studies was observed. For a second statistical analysis of suicide rates ‘person-years’ were calculated to (...) adjust for differing washout durations. The results obtained include findings that the percentage of patients relapsing in U.S. studies was slightly lower than in non-U.S. studies ; the percentage of patients dropping out in U.S. studies was higher than in non-U.S. studies ; known location of dropout patients in U.S. studies was 1.7%, compared to 2.6% in non-U.S. studies. The most interesting finding was that no suicides were reported in U.S. studies, compared to 0.6% of patients reported in British studies. Some U.S. studies used ‘challenge doses’, such as amphetamines or L-dopa; no non-U.S. studies reported their use. Compared to U.S. studies, those by non-U.S., and particularly British, researchers appeared to report adverse events in their studies. ‘Challenge’ drugs were not used; suicides were reported. It is estimated that the probability that no patients suicided who participated in the U.S. is small—one in 500. (shrink)