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Table 4 A list of the themes and subthemes that were developed from the data and used to code the free-text responses in researchers’ response to question QA14-1 of the IRAS form

From: Public involvement could usefully inform ethical review, but rarely does: what are the implications?

Theme Sub-theme
Involvement in design Public were consulted
Public member of planning team
Review of plans by committee/ steering group
Participants gave feedback at early stage
Protocol was reviewed
Patient information sheet was reviewed
Topic confirmed as important
Impact on conceptual design
Impact on practical design
Impact on ethical design
Impact on recruitment strategy
Impact on design of intervention
Simple statement reporting involvement at this stage
No involvement matching INVOLVE’s definition
Involvement in management Consultation of pre-existing patient group
Project advisory group
Project management group
Steering Group/ Committee
Trial management group
Simple statement reporting involvement at this stage
No involvement matching INVOLVE’s definition
Involvement in undertaking Participation in research
Participants giving feedback to researchers during project
Giving feedback to participants/ the public on progress
Involved in delivering training as the intervention
Involved as interviewers
Involved in recruitment
Involved as service user researchers
Members of Steering Group with oversight
Simple statement reporting involvement at this stage
No involvement matching INVOLVE’s definition
Involvement in analysis Focus group to discuss findings
Public to comment on implications for practice
Involvement in analysing data
Findings shared with Steering Group
Simple statement reporting involvement at this stage
No involvement matching INVOLVE’s definition
Involvement in dissemination Dissemination to clinicians
Dissemination to patients
Dissemination to the participants
Working with a patient organisation to disseminate findings
Taking part in public engagement events
Public give talks/ presentations
Public write or co-author reports and publications
Public comment on researchers’ final reports
Steering Group comment on researchers’ final report
Simple statement reporting involvement at this stage
No involvement matching INVOLVE’s definition
Timing of involvement Planned for the future after ethical review
Good practice Good practice [consistent with INVOLVE’s values and principles] described
Reasons for no involvement Benefits of research are evident
A clinician already gave advice on the project
Commercial trial
Confidentiality concerns
Participants are healthy volunteers
Project highly technical
Job of sponsor to comment on project
No resources for involvement
Project has minimal patient participation
No patients available
No room for influence
This is a pilot study
Study involved routine clinical practice
Project is the same design as previous project
Simple statement = not required or appropriate