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A phenomenological study of the participant experience in clinical trials and the potential for subject care through open dialog.

posted on 2023-07-26, 13:45 authored by Ryota KitaoRyota Kitao

Using a phenomenological approach, this study aimed to understand how individuals experience participation in clinical trials from the perspective of participants by interviewing 11 experienced research participants. 

Analysts provided interpretive descriptions to share the narrative meaning of the participants’ experiences as participants of intervention trials. 

The results were organized into four categories: 1) decision to participate, 2) understanding the trial, 3) being marginalized, and 4) talking about meaning. The participants attach personal meaning to their participation experience. Their personal perspective of their willingness to participate and their unpleasant experiences may change through interactions with the researcher. Thus, the qualitative outcome reports will serve as a guide for ethical actions to be taken by researchers for the benefit of future participants.


The Nakanishi Mutsuko Nursing Practice Research Fund

Scholarship Society of the Japan Society of Nursing Research


Declaration of conflicts of interest

The author declare no conflicts of interest.

Corresponding author email

Lead author country

  • Japan

Lead author job role

  • Other

Lead author institution

1_Ethics Support Unit, Kyoto University Hospital, Kyoto, Japan 2_Faculty of Health Sciences, Tokyo Metropolitan University, Tokyo, Japan

Human Participants

  • Yes

Ethics statement

The study participants gave written and verbal informed consent (IC) to the researcher prior to their voluntary participation. The research protocol and explanatory consent documents were reviewed and were approved by the X Ethics Review Committee (September 19, 2018; blinded for review) and the Ethics Review Committee at the cooperating medical institution (January 9, 2020; blinded for review), and permissions were obtained from the head of each institution. In the description, publication of results and information and document management ensured anonymization.

Terms agreed

  • Yes, I agree to Advance terms


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