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Drawing at left of Louis Pasteur, colleague, and patient, courtesy of the New York Academy of Medicine. |
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The Standards for Clinical Research set forth some essential principles and processes for the conduct of clinical research in the intramural research programs of the National Institutes of Health. To achieve patient safety, efficient protocol implementation, and effective quality assurance requires adequate training of clinical investigators and sufficient infrastructure to support their endeavors. Consequently, the Standards should assist both new and experienced investigators as they apply good clinical practice in their research to achieve high-quality results. The Standards were developed by the Clinical Center Medical Executive Committee, on which all the NIH institutes are represented by their clinical directors. They have been endorsed by the Clinical Center's Board of Governors and Advisory Council as well as by the scientific directors of the intramural research programs and the institute directors. The NIH community is committed to implementation of the Standards and evaluation of their application. It is important that every investigator involved in clinical research at NIH read, understand, and incorporate the Standards into everyday practice, undertaking training, as appropriate, to enable her or him to do so. It is equally important that the institutes, individually and collaboratively, assure the availability of all resources essential to the conduct of good clinical research. The Standards for Clinical Research Within the NIH Intramural Research Program complements Guidelines for the Conduct of Research in the Intramural Research Program at NIH [http://www.nih.gov/news/irnews/guidelines.htm] and A Guide to Training and Mentoring in the Intramural Research Program at NIH [http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/mentor-guide.htm]. These statements encompass the NIH standards of training, ethics, and conduct for scientists. John I. Gallin,
M.D. Michael M. Gottesman,
M.D. |
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