title: Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.
abstract: OBJECTIVE
  To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs.
  
  
  METHODS
  The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared.
  
  
  RESULTS
  Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05).
  
  
  CONCLUSIONS
  The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.
authors.affiliation: The Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.|Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Gaiyan
authors.initials: G
authors.lastname: Wen
authors.affiliation: Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Xinchun
authors.initials: X
authors.lastname: Liu
authors.affiliation: Center for Medical Experiments, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Lihua
authors.initials: L
authors.lastname: Huang
authors.affiliation: The Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.|Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Jingxian
authors.initials: J
authors.lastname: Shu
authors.affiliation: The Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.|Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Nana
authors.initials: N
authors.lastname: Xu
authors.affiliation: Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Ruifang
authors.initials: R
authors.lastname: Chen
authors.affiliation: The Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.|Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Zhijun
authors.initials: Z
authors.lastname: Huang
authors.affiliation: The Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Guoping
authors.initials: G
authors.lastname: Yang
authors.affiliation: The Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Xiaomin
authors.initials: X
authors.lastname: Wang
authors.affiliation: Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Yuxia
authors.initials: Y
authors.lastname: Xiang
authors.affiliation: The Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.|Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Lu
authors.affiliation: The Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.|Clinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Yuan
mesh_terms: D002681:China; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D032882:Comprehension; D032962:Consent Forms; D006801:Humans; D011932:Reading