Table 2 Main issues for which clarification/revision were requested
Main issues | Studies involving minority group | All studies | ||
|---|---|---|---|---|
N = 44 | N = 291 | |||
n | (%) | n | (%) | |
Participant information sheet | 38 | 86.4 | 181 | 62.2 |
Informed consent/assent form | 38 | 86.4 | 149 | 51.2 |
Research methodology | 37 | 84.1 | 235 | 80.7 |
Recruitment (inclusion–exclusion criteria) | 32 | 72.7 | 175 | 60.1 |
Procedures for treatment and care | 29 | 65.9 | 103 | 35.4 |
Risk-benefit considerations | 27 | 61.4 | 108 | 37.1 |
Compensation | 26 | 59.1 | 76 | 26.1 |
Sample size | 21 | 47.7 | 122 | 41.9 |
Minor typographic errors | 13 | 29.5 | 70 | 24.0 |
CRF/Questionnaire/MTA | 8 | 18.2 | 128 | 43.9 |