Ethics and Consent Language that Satisfies Editors
Reading time ~6 minutes · Published September 23, 2025
Keywords: ethics statement example, IRB consent language.
Human subjects (IRB/REC)
Ethics approval was obtained from the [Institutional Review Board/Research Ethics Committee] at [Institution], protocol [ID], approval date [YYYY-MM-DD]. All procedures conformed to the Declaration of Helsinki and relevant national regulations.
Informed consent obtained
Written informed consent was obtained from all participants prior to enrollment after provision of a plain-language information sheet and an opportunity to ask questions.
Waiver/alteration of consent
The [IRB/REC] approved a waiver of informed consent (protocol [ID]) because the study posed no more than minimal risk and could not practicably be carried out without the waiver. Only de-identified data were analyzed.
De-identified data / secondary use
We analyzed a de-identified dataset provided under a data use agreement with [Source]. The [IRB/REC] determined the analysis to be non-human subjects research under [regulation/reference].
Retrospective chart review
This retrospective review was approved by the [IRB/REC] (protocol [ID]). The requirement for consent was waived due to minimal risk and the use of de-identified records.
Animal research
All procedures were approved by the Institutional Animal Care and Use Committee at [Institution] (protocol [ID]) and complied with [national directive/guideline]. Anesthesia, analgesia, and humane endpoints were implemented as specified in the protocol.
Multi-site or international studies
Ethics approvals were obtained at all participating sites (protocol IDs listed in Supplementary Table S1). Procedures were harmonized through a common operating protocol and local regulatory requirements.
Trial registration
The trial was prospectively registered at [registry] (identifier [ID]) on [date]. The protocol and statistical analysis plan are available at [URL/DOI].
Data availability
De-identified participant data, the data dictionary, and analysis code are available at [repository/DOI] under [license] upon publication. Requests for additional materials will be considered by the corresponding author and the [IRB/REC] as required.
Consent for publication
Participants provided specific consent for publication of non-identifiable quotes and aggregated results. Images or case details that could permit identification are not included without explicit written permission.
Competing interests
Authors declare the following competing interests: [if any]. Where no competing interests exist, we state: The authors declare no competing interests.
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