Improvement of Phase I Clinical Trial Informed Consent Document Readability
Dean, Stephanie M.
MetadataShow full item record
When seeking the consent of a patient to participate in a clinical trial, the Informed Consent Document (ICD) is a substantial part of the informed consent process to review and discuss significant aspects of research with the prospective study participant. This document and process must ensure that the prospective participant is fully aware of the objectives of the research, its risks and benefits, requirements for study eligibility and activities, and other study-specific information. The informed consent process is used to convey clinical trial information to the prospective participant and to document that the participant has formally agreed to participate in the clinical trial. A component of a study participant’s comprehension of the ICD is the document’s readability. For this capstone project, the author examined the readability levels of both study-specific ICDs and the ICD template utilized in a Phase I Clinical Research Unit (CRU) (“Institution”) in 2017. It was found that the average readability levels exceeded the 8th grade threshold, a threshold generally accepted by most Institutional Review Boards (IRBs) for the Protection of Human Subjects. In order to better understand the Institution’s participant population, the author conducted a survey to obtain data regarding the participants’ educational background. Data gathered from this survey were used to support the project’s objectives. The project objectives were to (1) provide recommendations to improve the readability of the Institution’s ICD template for the purpose of increasing participant comprehension of consent documents, (2) to reduce the readability level of the Institution’s ICD template to an 8th grade level or lower, (3) to review and lower the readability level of both the ICD document as a whole, as well as the specific sections of the ICD which comprise the document, and (4) to determine the appropriate readability level for the Institution’s volunteer population. By adhering to recommendations provided by both Federal and private bodies to improve document readability, it was found that achieving a readability level of 8th grade or lower was feasible. Additionally, it was found that such a level is suitable for the Institution’s participant population, as evidenced by the education and background information gathered in the participant survey. Recommendations provided by the author to improve the Institution’s ICD template to a readability level less than 8th grade have been derived. Furthermore, the author recommends additional research to better understand and possibly improve participant overall comprehension of Institutional ICDs.