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Article History

Received: 1 April 2025

Accepted: 4 July 2025

First Online: 15 July 2025

Declarations

:

: As UK-based PPIE and intervention development activity, ethical approval was not required and since PPIE contributors are not research participants they are not required to give formal written consent for their involvement. The PPIE activities in the creation and evaluation of the PAW Toolkit (Phases 1–3) did not require research ethics approval as they were classified as public consultation and educational development by the University of Nottingham Faculty of Medicine and Health Sciences Research Ethics Committee (Ref: FMHS 358–0921; 08 Jan 2020 and 27 September 2021). The same committee subsequently granted research ethics approval for the PAW Toolkit feasibility trial (Ref: FMHS 237–0323; 31 March 2023) – although ethical approval is not required for PPIE activity, this trial approval does include our Phase 4 PPIE plans. As good practice, across Phases 1–4, our PPIE-partner and public contributors were made aware of the nature of their involvement, their right to withdraw when they wish, any implications and risks of being involved. For synchronous PPIE activity, including the Phase 1 stakeholder consultation event and the Phase 3 concept mapping exercise, two researchers (HB, SS) documented ‘informed verbal consent’ for synchronous activity in the presence of the group. For asynchronous PPIE activity ‘informed assumed consent’ was taken, including Phase 1 anonymous online PPIE surveys with public contributors (employees/employers) and expert peer review (public contributors/stakeholders), Phase 2 expert peer review, and anonymous PPIE evaluation feedback surveys with PAW Toolkit users, and Phase 3 expert peer review. For Phase 2, our PPIE-partner (SG) gathered ‘informed written consent’ from public contributors sharing their views in interviews. In Phase 4, while our PPIE-partner provided verbal consent, written consent is not required as she is considered an equal member of the research team.

: Not applicable.

: The authors declare no competing interests.