Human Research Subjects Core

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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.