The world of clinical trials research is highly regulated, with an array of documents guiding the conduct of clinical trials research. Policy documents and procedural guidelines, such as Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP), cover most aspects of clinical research but none of these documents discuss standards for engaging community in the research process.
Community representatives working with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) increasingly felt that this type of guidance was needed and in 2009 sought to develop recommendations as a way to address good community practice. These recommendations are intended as a tool to help research staff and community representatives expand and deepen existing partnerships, and forge new ones, with the ultimate goal of facilitating effective community engagement in all aspects of clinical trials research.
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