Goldstein A O, Frasier P, Curtis P, Reid A, Kreher N E
Department of Family Medicine, University of North Carolina, Institute for the Generalist Physician, Chapel Hill, USA.
J Fam Pract. 1996 Jun;42(6):606-11.
Consent forms are required in most biomedical research involving human subjects. In recent years, a number of studies from different disciplines have reported problems related to consent form readability.
We analyzed 284 consent forms submitted to and approved by five institutional review boards (IRBs) (schools of Medicine, Nursing, Academic Affairs, Dentistry, and Public Health) at one university and one IRB at another. We examined consent form readability scores and factors that might relate to readability.
The average reading level of all consent forms was high: 12.2, which corresponds roughly to a 12th-grade reading level. Less than 10% of all consent forms were written at a 10th grade reading level or below. Thirty-two percent of all consent forms had no evidence of revisions, and less than 2% of consent forms were revised more than once. Readability scores were not related to consent form revisions, the type of IRB, the year of study, or the university where the research was conducted.
Poor readability of consent forms probably occurs in all university-related research. We recommend that IRBs require readability checks for research consent forms before researchers submit their proposals to an IRB.
在大多数涉及人类受试者的生物医学研究中都需要使用知情同意书。近年来，来自不同学科的多项研究报告了与知情同意书可读性相关的问题。
我们分析了提交给一所大学的五个机构审查委员会（医学院、护理学院、学术事务部、牙科学院和公共卫生学院）以及另一所大学的一个机构审查委员会并获得批准的284份知情同意书。我们检查了知情同意书的可读性得分以及可能与可读性相关的因素。
所有知情同意书的平均阅读水平较高：为12.2，大致相当于十二年级的阅读水平。所有知情同意书中不到10%是按照十年级或更低的阅读水平撰写的。所有知情同意书中32%没有修订的迹象，不到2%的知情同意书被修订过不止一次。可读性得分与知情同意书的修订、机构审查委员会的类型、研究年份或开展研究的大学无关。
知情同意书可读性差的情况可能在所有与大学相关的研究中都会出现。我们建议机构审查委员会在研究人员向其提交研究方案之前，要求对研究知情同意书进行可读性检查。
