The role of consultation services for clinical study participants: A survey of progress on the five year activation plan for clinical study/Trial 2012

Background: Participants in clinical studies in Japan may receive less support than participants in Chiken (clinical trials for marketing approval). In the Five Year Activation Plan for Clinical Study/Trial 2012, the government requested medical institutions to consider a consultation service for all clinical study participants, in addition to the existing consultation services provided by Chiken. The service was firstly intended to be created at 15 model institutions. The plan, however, did not specify any requirements for the service. Objective: To investigate how the consultation service is currently being provided and utilized at institutions throughout Japan in support of clinical study participants, and to consider how to better support and protect research participants. Methods: In 2016, we conducted a questionnaire survey of 15 model institutions designated in the Action Plan for the Five Year Plan. We additionally interviewed individuals in charge of the consultation services at those institutions to obtain in-depth information. Results: Ten institutions responded to the survey. Nine of them had established the service. Four institutions provided us with detailed responses through interviews and e-mail. The majority of consultations reported were inquiries for research participation addressed by ill patients and their relatives, instead of questions or concerns made by actual clinical study participants. Limitations: Since most of the institutions that responded to the survey already had consultation services prior to our survey, the situation at the institutions that did not respond to the survey is still unclear. Conclusions: The majority of consultation services are currently being used to provide information to patients and their family members regarding research participation, rather than as consultations for study participants. The primary role of the consultation service as a protection for research participants needs to be reconsidered.