Health Literacy and Informed Consent Materials: Designed for Documentation, Not Comprehension of Health Research.
Health Literacy and Informed Consent Materials: Designed for Documentation, Not Comprehension of Health Research.
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DOI：
10.1080/10810730.2017.1341565
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发表时间：
2017-08
影响因子：
4.4
通讯作者：
Buchwald D
中科院分区：
文献类型：
--
作者：
Simonds VW;Garroutte EM;Buchwald D
在旨在解决这些差异的研究中，存在健康差异的少数民族人口的代表性不足。改善少数群体代表性的一种方法是从知情同意程序开始，使用基于社区的参与性方法来克服参与研究的障碍。相关的参与障碍包括个人或社区缺乏对研究过程和目的的认识或接受。这些障碍与卫生知识普及程度有限有关。为了提供改进同意过程的建议，我们检查了97份同意文件和10个相关的机构审查委员会网站，以确定他们的健康素养需求和对社区研究原则的遵守程度。我们评估了同意文件的阅读水平，并通过使用材料的适用性和可理解性评估工具获得了他们健康素养需求的全球措施。虽然这些文件被认为适合作为医疗表格，但它们的可读性水平不合适，也不适合教育潜在的参与者了解研究目的。我们还评估了同意表格和机构审查委员会的政策，以支持基于社区的参与性原则，发现很少有人承认或遵守这些原则。为了提高对同意文件的理解，我们建议将其重组为符合现行卫生知识普及指南的教育材料。
Minority populations with health disparities are underrepresented in research designed to address those disparities. One way to improve minority representation is to use community-based participatory methods to overcome barriers to research participation, beginning with the informed consent process. Relevant barriers to participation include lack of individual or community awareness or acceptance of research processes and purposes. These barriers are associated with limited health literacy. To inform recommendations for an improved consent process, we examined 97 consent documents and 10 associated Institutional Review Board websites to determine their health literacy demands and degree of adherence to principles of community-based research. We assessed the reading level of consent documents and obtained global measures of their health literacy demand by using the Suitability and Comprehensibility Assessment of Materials instrument. Although these documents were deemed suitable as medical forms, their readability levels were inappropriate, and they were unsuitable for educating potential participants about research purposes. We also assessed consent forms and Institutional Review Board policies for endorsement of community-based participatory principles, finding that very few acknowledged or adhered to such principles. To improve comprehension of consent documents, we recommend restructuring them as educational materials that adhere to current health literacy guidelines.
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