Human research Subject Core

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The extent to which research programs involving human subjects are productive depends, in large part, on the ability to efficiently recruit subjects to participate in studies. In general, the widest impact of research involving humans is achieved when participants represent both genders and majority and minority populations. Individual research programs in communication sciences and disorders may have specialized subject needs, including subjects with hearing loss, infants, children, users of either hearing aids or cochlear implants, or children with normal speech and language. Independent efforts by individual research programs to recruit subjects meeting both general and specific needs would be time-consuming, inefficient, and less successful relative to what can be achieved with a more centralized recruitment function. As in the previous cycle, the goals for the continuation of the Human Research Subjects Core (HRSC) are to support the research process by providing access to a large pool of individuals who are interested in participating in research. Through concerted and broadly based recruitment efforts, the HRSC provides access to subjects meeting both general and specific requirements, and, thus, provides benefit to virtually every research program at BTNRH that involves humans as subjects. It will continue and expand minority-recruitment efforts that would be difficult, if not impossible, for individual programs. It will continue to provide additional services related to the preparation of IRB and NIH grant applications, and IRB annual reports and NIH progress reports. It will continue to provide additional layers of security for patient/subject confidentiality and evaluations of the subjectconsent process. It will expand the clinical information contained in the HRSC database by including speech, language, and vocabulary scores from standardized clinical tests. Most importantly, the HRSC is expected to have a positive impact on both the quality and quantity of the human-research studies at BTNRH.