Views of clinical trial participants on the readability and their understanding of informed consent documents

ABSTRACT

Background: One of the ethical imperatives for a valid consent process in clinical medication trials is that the process be guided by and recorded in an informed consent document (ICD). Concerns have been expressed, however, about readability and participant understanding of ICDs, which are often 10–20 pages long. Objective measures of readability and understanding have been used to support these concerns in several articles, but surprisingly the voice of trial participants on ICDs has not been heard in previous studies. Hence, this study compares participants' subjective views on readability and their understanding of ICDs with those ICDs' objective readability scores. It also evaluates whether family, friends, and additional aids would foster better understanding of the ICD. Methods: Sixty current trial participants rated the readability and their understanding of deidentified standard ICDs. These had been sourced from two multicenter international Phase III trials on medication for diabetes mellitus and cancer. Results: Less than 10% of participants considered the ICDs difficult to read or difficult to understand in spite of objective readability scores at levels of about 12th grade education, but about a quarter considered the ICDs to be too technical. Participants gave mixed responses about friends or family members helping or the need for videos, pictures, additional reading material, and frequently answered questions (FAQ) sheets as an aid to their understanding. Conclusions: These findings suggest individual clinical trial participants should be engaged on their views of an ICD, for doing so is part of informed consent as a process rather than consent being merely focused on written information. Such participant-specific engagement should guide whether family and friends, videos, pictures, additional reading material, and FAQ sheets would be of assistance in improving understanding.

KEYWORDS:

• research ethics
• clinical trials
• person
• consent
• information requirements
• subjective standard

Acknowledgments

We thank Joyce Jordaan, who assisted with the statistical processing of the data.

Author contributions

All authors made substantive intellectual contributions to this study and participated in conceptualizing and designing the study. Data were collected by RS, and all authors had an indispensable role in the analysis and interpretation of data, with FS providing specifically statistical guidance. All authors were involved in drafting the article and/or revising it critically for important intellectual content, and gave final approval of the version to be published.

Funding

No funding was received for this study.

Conflicts of interest

The authors have no competing or conflicting interest to report pertaining to this study.

Ethics approval

Written informed consent for participation in this study was obtained from all participants, and the study was approved by the legally accredited IRB at the University of Pretoria.

Availability of data and material

We included the basic frequencies of responses in the tables of this article. The raw data are not made publicly available at this time in protection of intellectual property rights by which the initially intended analyses need to be completed and published before data may be made publicly available.