Disclosure And Ethical Conduct Of Clinical Research

摘要

Recent national efforts to promote and enhance clinical research by the National Institutes of Health (NIH), including the Clinical and Translational Science Awards (CTSA) and Roadmap Initiative, present new and challenging opportunities for pharmacists who require an advanced knowledge of clinical research, regulatory affairs, and ethics. Lack of awareness and negligence may result in serious ethical controversies and scientific misconduct that receive substantial attention. The central source for most education and training related to ethical conduct and the safety of research involving human subjects in academic health centers is the institutional review board (IRB). The IRB is a committee mandated by the National Research Act, Public Law 93-348, and established within a university or other institution that conducts biomedical or behavioral research involving human subjects.