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Table 2 Main reasons for the revisions

From: Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees

Main issues for the revisions Revised protocols Ratio (%)
Legal and administrative issues 112 30
Information to the patient and consent 105 28
Privacy 52 14
Sample size 34 9
Protocol 22 6
Treatment or clinical issues 19 5
Inclusion criteria 4 1
Others 26 7
Total 374 100