Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

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Since February 2024, an approximately 20-minute video has been used to explain the common content of Informed Consent Forms (ICF) in order to obtain consent to participate in clinical trials at SOUSEIKAI. We believe that the use of the video has many advantages over following a verbal paper-based explanation, such as being easier to understand, while enabling the same comprehensive explanation. However, it is important to check the participants' understanding of the video. Therefore, we conducted a questionnaire survey of 103 healthy Japanese participants aged 18 to 54 who watched the video for the first time. Almost all of the participants（101; 98％）responded that they “fully understood.” Regarding the speed of the explanations, 77（75％）responded “just right”, and 24（23％）responded “somewhat slow.” Regarding the duration of the video, about half of the participants chose “just right” and half chose “somewhat long.” Most participants felt that the opportunity to ask questions was sufficient. Fifty-two（50％）participants preferred the video to a verbal explanation, and only 6（6％）preferred a verbal explanation. Those who had received clinical trial explanations at least once in the past tended to prefer the video explanation. Overall, the video was well-accepted and the content was well-understood. However, it takes a certain amount of time to properly explain the common content of ICFs, and approximately half of the participants felt that the video was long. Therefore, the development of an even easier to understand and more concise version of the video in the future would be advantageous.

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