RKS

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 监管知识和支持（RKS）： 临床和转化研究工作面临许多监管挑战。为了得到临床证明，治疗创新将需要在人类受试者中对新型“高风险”干预措施进行“1期”测试。一些研究设计将与伦理争议相关（例如假手术、基因转移和异种移植）。参与高风险转化研究的患者必须充分知情、理解并自愿同意通过知情同意程序参与，研究者必须遵守人类受试者保护法规的文字和精神。合规性将有助于促进公众对临床和转化研究企业的支持和信任。 监管知识和支持关键职能部门的总体目标是确保所有研究活动符合涉及动物和/或人类受试者的联邦政策、规则和指导原则。该关键职能的目标是通过为法规遵从和管理提供“以研究为重点”和“具体转化研究”的支持，加强合作机构已经到位的模型支持服务。

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.