caption: Defining the Universe Bottom line:
exif: {"Image DocumentName": "Defining the Universe Bottom line:", "Image ImageDescription": "Inclusion of women and minorities in all NIH funded or supported clinical research is mandated by law. What is subject to the statute/policies? All studies (intramural, extramural, contracts) that meet the NIH definition of clinical research. NIH definition of clinical research: (1) Patient-Oriented Research: Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual (e.g., IRB Exemption 4). Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical studies, or (d) development of new technologies; (2) Epidemiologic and Behavioral Studies; and (3) Outcomes Research and Health Services Research. Additional requirements for NIH-defined Phase III clinical trials related to unbiased design and assessment of potential differences. Bottom line: If you answer yes to human subjects and not E4, you should address inclusion because there are very few studies that will not be considered NIH-defined clinical research.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}