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% |