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Table 2 Top themes defined as those identified by more than half the committees in the ShED19, ShED20 and WHEAT exercises

From: Measuring inconsistency in research ethics committee review

Theme Number of RECs % of RECs
ShED 19
Query or statement regarding overall objectives & outcomes 14 93%
Comment over worsening of UTI and/or detecting side effects 10 67%
PIS: Explanation of placebo and/or randomisation 10 67%
Clarity over insurance & indemnity information 9 60%
Methodological comment over controls, placebo &/or randomisation 8 53%
Methodological comment over design of arms in trial 8 53%
Query regarding collection of human tissue 8 53%
PIS: Further advice if symptoms persist 8 53%
ShED 20
Comments on use of Safer Sleep Box 19 95%
Limits of confidentiality being clear to participants 16 80%
Inclusion criteria of trial 15 75%
Inclusion of vouchers as incentive 13 65%
Data protection concerns 13 65%
PIS: Typos, grammar, formatting and re-titling 12 60%
Recruitment method 12 60%
Positioning of box during use 11 55%
Comments on size of participant group 11 55%
Independent Review 11 55%
Comments on questionnaires 10 50%
Training and information on safer sleep box for participants 10 50%
Methodology and basic nature of study 10 50%
Scientific justification of the study 10 50%
WHEAT
Opt Out Consent: any mention 12 100%
PIS: comments on potentially coercive wording 9 92%
Opt Out Consent: Comments on the ethics of the basic principle 8 67%
PIS: Suitable description of risks and benefits 7 58%
Opt-Out Consent: how this is to be recorded 7 58%
Opt-Out Consent: Hard copy for patients/clinicians 7 58%
Patient Public Involvement 6 50%
  1. A complete list of themes is contained in the Additional file 1