Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

Abstract

PurposeTo 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.MethodsThe 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.ResultsAmong 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).ConclusionThe 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.

What information and the extent of information research participants need in informed consent forms: a multi-country survey

“…An informed consent form (ICF) is mandatory and essential in most studies involving human subjects as it is a primary vehicle for disclosure of information and documentation of consent [ 1 , 2 ]. An observation of the current research practice reveals that ICFs continue to increase in length and complexity in an attempt to comply with regulatory requirements [ 3 – 6 ], which increasingly require more and more elements to address past and present unethical practice [ 7 , 8 ]. Lengthy and complex ICFs decrease the ability of potential participants to comprehend the ICF content and exercise their autonomy in decision making to participate in a study [ 9 ].…”

Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections

“…However, clearly explaining all relevant information for IC has proven to be a major challenge [ 7 ]. Challenges include the complexity and amount of information [ 8 ] and the readability and understandability of IC documents [ 7 , 9 , 10 ].…”

Quality of informed consent in clinical trials

“…A study by G. Wen on Chinese and international ICFs revealed a difference between national and international forms in terms of readability and content integrity, with a benefit towards the latter. The Chinese forms were evaluated as difficult to read, with poor descriptions of alternatives, a low degree of information on future data/sample processing, inclusion criteria or unpredictable risks [15] Interestingly, the growing number of pages does not result in the patient's better understanding. Out of 90 patients taking part in the perception questionnaire conducted by A. S. Meza-Lopez et al, 84 stated that they understood the ICFs; however, a closer analysis revealed that 2% -57% misunderstood the basic concepts of the research, including the name of the study drug, randomization and placebo [11].…”