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A phenomenological study of the participant experience in clinical trials and the potential for subject care through open dialog.
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.
Funding
The Nakanishi Mutsuko Nursing Practice Research Fund
Scholarship Society of the Japan Society of Nursing Research
History
Declaration of conflicts of interest
The author declare no conflicts of interest.Corresponding author email
rkitao1@gmail.comLead 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, JapanHuman 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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