Читать книгу The SAGE Encyclopedia of Stem Cell Research - Группа авторов - Страница 352

Clinical trials are of the utmost importance in the development and continued monitoring of new drugs entering the market, to ensure their safety and efficacy in improving human health. Although extensive experimentation in the lab and in animal models of human disease takes place prior to clinical trials, trials on human patients are a necessity to determine whether the new approach will work well in humans, and often in what group of people and in what combination with other drugs (if any). Because the treatments being administered to volunteer patients are for the first time being tested in humans, various mechanisms must be in place to protect those volunteers as much as possible. Failure to do so can lead to abuse and unfair maltreatment of patients, which is why strict regulations are in place for clinical trials to ensure ethical treatment of volunteer patients.

For clinical trials to be ethical, there must be informed consent, internal review board (IRB) review, and compliance with regulations based on influential historical events that are now used as guidelines, having been developed in response to problems or concerns in practice. An example of these regulations is the Code of Federal Regulations, Title 45 Volume 46 (45 C.F.R. 46, issued by the U.S. Department of Health and Human Services, which governs federally funded research in the United States). The historical events that led to the original establishment of ethical regulations in clinical trials are in part documented and based upon well-respected, influential documents known as the Nuremberg Code, the Helsinki Report, and the Belmont Report. The seven main principles of ethical clinical research that today guide the conduct of ethical clinical research and trials are based on these documents.