Simonds Vanessa Watts, Garroutte Eva Marie, Buchwald Dedra
a Department of Health and Human Development , Montana State University , Bozeman , Montana , USA.
b Department of Sociology , Boston College , Boston , Massachusetts , USA.
J Health Commun. 2017 Aug;22(8):682-691. doi: 10.1080/10810730.2017.1341565. Epub 2017 Jul 31.
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.
在旨在解决健康差异问题的研究中，存在健康差异的少数族裔群体代表性不足。提高少数族裔代表性的一种方法是采用基于社区的参与式方法来克服研究参与的障碍，从知情同意过程开始。参与的相关障碍包括个人或社区对研究过程和目的缺乏认识或接受。这些障碍与有限的健康素养相关。为了为改进同意过程提供建议，我们审查了97份同意文件和10个相关的机构审查委员会网站，以确定它们对健康素养的要求以及对基于社区研究原则的遵守程度。我们使用材料适用性和可理解性评估工具评估了同意文件的阅读水平，并获得了它们对健康素养要求的总体衡量指标。尽管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，并且不适合向潜在参与者介绍研究目的。我们还评估了同意书和机构审查委员会政策对基于社区的参与式原则的认可情况，发现很少有政策承认或遵守这些原则。为了提高对同意文件的理解，我们建议将其重新构建为符合当前健康素养指南的教育材料。
