Human Research Subjects Core

人类研究课题的核心 受试者招募会影响研究效率和研究进度。然而，高效的学科招聘存在障碍。总体而言，很少有联系的个人参与研究，少数族裔社区的参与率更低。法规的变化导致了学科招聘的额外障碍。确保遵守与人类研究相关的法规有损于时间 从事研究工作。人类研究对象核心(HRSC)的总体目标是提高涉及人类对象的项目的生产率和研究速度，通过三种机制实现：(1)提高对象招募效率，特别关注少数人对象的招募；(2)协助调查人员进行质量保证评估，确保符合规定，并提供安全的环境来存储同意/同意/HlPAA表格；以及(3)协助调查人员准备IRB和NIH进度报告、IRB申请和NIH申请的登记表格。这些服务旨在通过允许PI更多地专注于研究来提高生产率，同时确保他们遵守有关人类受试者使用的规定。 在人权委员会的帮助下，70%的被联系个人现在作为研究对象参与。 少数族裔在研究研究中的代表性现在接近他们在我们的集水区的代表性。 已经建立了许多机制，以减轻行政负担并确保遵守。 作为下一个周期的新成员，HRSC工作人员将(1)为数据库中无法获得信息的个人提供听力、鼓室和语言测试，(2)向没有工作人员有资格执行这些评估的研究项目提供这些服务，以及(3)通过让HRSC协调员观察受试者对IRB批准的方案的同意来提供协商一致的过程评估。HRSC服务的结合将提高NIDCD资助的以人类为研究对象的项目的生产率和研究速度。

HUMAN RESEARCH SUBJECTS CORE Subject recruitment influences research productivity and the pace of research. There are, however, barriers to efficient subject recruitment. In general, few contacted individuals participate in research, with even lower participation among minority communities. Regulatory changes result in additional barriers to subject recruitment. Ensuring compliance with regulations related to human research detracts from time engaged in research. The overarching goal of the Human Research Subjects Core (HRSC), to increase productivity and the pace of research for programs that involve human subjects, is achieved through three mechanisms: (1) increase subject-recruitment efficiency, with special attention to minority-subject recruitment, (2) assist investigators with quality-assurance evaluations, ensure compliance with regulations, and provide a secure environment in which consent/assent/HlPAA forms are stored, and (3) assist investigators in the preparation of IRB and NIH progress reports, IRB applications, and enrollment forms for NIH applications. These services are designed to increase productivity by allowing PIs to focus more on research while assuring that they are in compliance with regulations governing the use of human subjects. With the assistance of the HRSC, 70% of contacted individuals now participate as research subjects. Minority representation in research studies now approximates their representation in our catchment area. Many mechanisms have been put into place that alleviate administrative burdens and ensure compliance. New to the coming cycle, HRSC staff will (1) provide audiometric, tympanometric, and speech-language testing for individuals in the database for whom information is not available, (2) provide these services to research programs that do not have staff qualified to perform these evaluations, and (3) provide consentprocess evaluations by having the HRSC Coordinator observe the consenting of subjects for IRB-approved protocols. The combination of HRSC services will increase both productivity and the pace of research for NIDCD-funded programs that involve humans as subjects.