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 |