Creation of Japanese versions of the Ethics Checklist for Digital Health Research in Psychiatry (ECDHRP) and Transparent Reporting of Ethics for Generative AI (TREGAI) Checklist and examination of content validity

Translation and content validation of the Ethics Checklist for Digital Health Research in Psychiatry (ECDHRP) and the Transparent Reporting of Ethics for Generative AI (TREGAI) Checklist for the Japanese version Review of content and validity

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030250255

Enrollment

Registered

2025-07-28

Start date

2025-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ethical and Psychosocial Issues in Digital Health and Generative AI Research in Medicine

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Applicants must meet all of the following criteria (i) Applicants who meet either (A) or (B) below. (A) Researcher group: Those who have been involved in the design and implementation of research related to digital health, including GenAI, and have research experience, as well as those who may apply or use the checklist of this study to their own research. (B) Expert Group: Persons with professional backgrounds and practical experience in areas related to this study (e.g., research ethics, digital technology, AI research, clinical psychology, law). (ii) Those who are at least 20 years old. (iii) Native speakers of Japanese.

Exclusion criteria

Exclusion criteria: Persons whose consent was not obtained at the time of explanation via web or video call

Design outcomes

Primary

Measure	Time frame
Cognitive interviews will be conducted based on semi-structured interviews for each participant after the forward and backward translation of the Japanese versions of the ECDHRP and TREGAI checklists, in order to evaluate the content validity of each item along the following four dimensions: (1) Relevance (e.g., Do you think this item is relevant to ethics in digital health research?) (2) Comprehensiveness (e.g., Do you think there are any missing or additional aspects that should be included in this checklist regarding ethics in digital health research?) (3) Clarity (e.g., Is this item easy to understand and clear in meaning?) (4) If the participant responds negatively to any item: Reasons for the response	—

Measure

Time frame

Cognitive interviews will be conducted based on semi-structured interviews for each participant after the forward and backward translation of the Japanese versions of the ECDHRP and TREGAI checklists, in order to evaluate the content validity of each item along the following four dimensions: (1) Relevance (e.g., Do you think this item is relevant to ethics in digital health research?) (2) Comprehensiveness (e.g., Do you think there are any missing or additional aspects that should be included in this checklist regarding ethics in digital health research?) (3) Clarity (e.g., Is this item easy to understand and clear in meaning?) (4) If the participant responds negatively to any item: Reasons for the response

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Contacts

Public ContactShio Maeda

University of Tsukuba

maeda.shio.gn@u.tsukuba.ac.jp+81-29-859-1858

Outcome results