Human research Subject Core

涉及人类受试者的研究项目在多大程度上是富有成效的， 很大程度上取决于有效招募受试者参与研究的能力。一般来说，最宽的 涉及人类的研究的影响是在参与者代表两性和 多数人和少数民族。在通信科学的个人研究计划， 疾病可能具有特殊的受试者需要，包括听力损失的受试者，婴儿， 儿童、助听器或人工耳蜗使用者，或言语正常的儿童， 语言个别研究计划独立努力招募符合以下两个条件的受试者： 一般和具体的需求将是耗时的，效率低下的，相对于 通过更加集中的征聘职能可以实现什么。与上一个周期一样， 继续人类研究主题核心（HRSC）的目标是支持 研究过程中，通过提供访问的个人谁是感兴趣的大池 参与研究。通过协调一致和基础广泛的招聘工作， 提供符合一般和具体要求的科目，因此， 这对BTNRH的几乎每一个涉及人类作为受试者的研究项目都有好处。它将 继续并扩大招募少数族裔的努力，这将是困难的，如果不是不可能的， 个别方案。它将继续提供与IRB准备有关的额外服务 和NIH拨款申请，以及IRB年度报告和NIH进展报告。它将继续 为患者/受试者保密性和受试者知情同意评价提供额外的安全层 过程它将通过以下方式扩大HRSC数据库中包含的临床信息： 包括来自标准化临床测试的言语、语言和词汇分数。最 重要的是，HRSC预计将对项目的质量和数量产生积极影响 在BTNRH进行的人类研究。

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.