Larson Elaine, Foe Gabriella, Lally Rachel
School of Nursing, Mailman School of Public Health, Columbia University, New York, New York, USA.
School of Continuing Studies, Columbia University, New York, New York, USA.
Clin Transl Sci. 2015 Aug;8(4):355-6. doi: 10.1111/cts.12253. Epub 2015 Jan 8.
In 100 Institutional Review Board approved consent forms (CFs), we assessed pages, reading levels, and whether they included essential elements. CF page numbers ranged from 3 to 28 (mean, 10.3) and readability ranged from grades 5.6 to 28.9 (mean, 11.6). The CF mean score for including essential elements was 90.8% (range: 63.5-100%). There were no significant differences by specialty in number of pages (p = 0.053), but surgical specialties had the highest readability (mean, 13.1), and pediatrics the lowest (10.5), p = 0.008. While approved CFs generally included the Office for Human Research Protections recommended essential elements, they were very long, and even pediatric forms, which had the lowest reading levels, were written on average at a tenth grade level. Researchers need guidance to resolve pressure between regulatory mandates and guidelines and "keeping it simple and clear."
在100份经机构审查委员会批准的同意书（CFs）中，我们评估了页数、阅读水平以及它们是否包含基本要素。CF的页码范围为3至28页（平均10.3页），可读性范围为5.6年级至28.9年级（平均11.6年级）。包含基本要素的CF平均得分率为90.8%（范围：63.5%-100%）。各专业在页数上无显著差异（p = 0.053），但外科专业的可读性最高（平均13.1年级），儿科专业最低（10.5年级），p = 0.008。虽然获批的CF通常包含人类研究保护办公室推荐的基本要素，但它们篇幅很长，即便阅读水平最低的儿科表格，平均也是按照十年级的水平撰写的。研究人员需要指导，以解决监管要求和指南之间的压力以及“保持简单明了”的问题。
