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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