RKS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Regulatory Knowledge and Support (RKS): There are many regulatory challenges facing clinical and translational research efforts. To be clinically proven, treatment innovations will require "phase 1" testing of novel "high risk" interventions in human subjects. Some study designs will be associated with ethical controversy (e.g. sham procedures, gene transfer, and xenotransplantation). It is critical that patients who participate in high-risk translational research are fully informed, understand, and voluntarily agree to participate through the informed consent process and that investigators comply with both the letter and the spirit of the human subject protection regulations. Regulatory compliance will help foster public support and trust in the clinical and translational research enterprise. The overall goal of the Regulatory Knowledge and Support key function is to assure that all research activities are in compliance with federal policies, rules, and guidelines for research involving animals and/or human subjects. The goal of the key function is to enhance the model support services already in place at collaborating institutions by providing "research-focused" and "translational research specific" support for regulatory compliance and management.