Table 2.
Type | Subtype | n | Frequency (%) |
---|---|---|---|
Protocol violations (50%) |
Inclusion or exclusion | 60 | 45.0 |
Noncompliance | 45 | 33.8 | |
Patient safety issues | 31 | 23.3 | |
Lack of principal investigator oversight |
12 | 09.0 | |
Consent violations (26.6%) |
Not fully informed | 34 | 47.8 |
Documentation issues | 17 | 23.9 | |
No IRB approval | 12 | 16.9 | |
Coercive consent | 11 | 15.4 | |
Fabrication (13.9%) | Creation of data | 19 | 51.4 |
Fabrication of documentation | 12 | 32.4 | |
Financial conflict of interest (5.2%) |
Failing to disclose | 3 | 18.1 |
Double-billing | 9 | 63.6 | |
Enrollment incentives | 3 | 18.1 | |
Falsification (5%) | Documentation | 12 | 91.6 |
Investigator credentials | 1 | 0.8 |