For clinical trials administrators and investigators who desire best practices in human subjects protection, there can be no better place to start than with research staff education. Education and training of research staff and investigators traditionally was provided in the form of a mentoring program in which a junior person learned from a senior person, says Ruth Fischbach, PhD, MPE, director of the Center for Bioethics at Columbia University in New York City.
The Genetic Modification Clinical Research Information System (GeMCRIS), a web-based data system designed to assist researchers and others involved in human gene therapy studies, manages information about science and safety of clinical trials in this field. Three years in development, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) jointly launched GeMCRIS at the end of March.
When should placebos be used in clinical research? Can subjects with a medical condition be asked to consent to withdraw from their current medications and take an experimental medication with the 50/50 chance that what they actually receive will be no medication at all?
Nearly half of all American adults 90 million people have difficulty understanding and using health information, and there is a higher rate of hospitalization and use of emergency services among patients with such limited health literacy, states a report released April 8 by the Institute of Medicine (IOM).
Documentation is becoming a routine part of patient education in inpatient settings. However, many health care providers have not yet formed this good habit in outpatient areas. Proper documentation establishes a paper trail showing that education took place. This is important for the legal department should litigation occur.
Terry Chase, ND, RN, patient and family education program coordinator at Craig Hospital in Englewood, CO, received her nursing degree in 1996. She had been teaching in public schools for ten years, but her experience as a patient following a spinal cord injury prompted her to change careers.
