Table 2 Summary of statements regarding consent and compliance with ethical guidelines
From: Adherence with reporting of ethical standards in COVID-19 human studies: a rapid review
Case study n = (%) | Case series n = (%) | Observational study n = (%) | CTIMPs n = (%) | Studies/trials (non-CTIMPs) n = (%) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
April search n = 68 | Nov search n = 71 | April search n = 120 | Nov search n = 240 | April search n = 55 | Nov search n = 385 | April search n = 2 | Nov search n = 3 | April search n = 0 | Nov search n = 18 | |
No consent specified in article | 48 (70.6%)* | 27 (38%)* | 86 (71.7%) | 179 (75%) | 23 (92%) | 139 (36%) | 2 (50%) | 0 (0%) | - | 2 (11%) |
Written consent | 11 (16.2%) | 14 (20%) | 17 (14.2%) | 32 (13%) | 14 (25.5%) | 80 (21%) | 2 (50%) | 3 (100%) | – | 8 (45%) |
Article does not specify if verbal or written | 6 (8.8%) | 17 (24%) | 10 (8.3%) | 17 (7%) | 3 (5.5%) | 41 (11%) | 0 (0%) | 0 (0%) | – | 6 (33%) |
Verbal consent | 2 (2.9%) | 1 (1%) | 2 (1.6%) | 7 (3%) | 2 (3.6%) | 32 (8%) | 0 (0%) | 0 (0%) | – | 2 (11%) |
Electronic | 0 (0%) | 0 (0%) | 0 (0%) | 2 (0.8%) | 3 (5.5%) | 57 (15%) | 0 (0%) | 0 (0%) | – | 0 (0%) |
Not applicable—RIP | 1 (1.5%) | 11 (16%) | 4 (3.3%) | 3 (1.2%) | 0 (0%) | 0 (0%) | N/A | 0 (0%) | – | 0 (0%) |
Assent | 0 (0%) | 1 (1%) | 1 (0.8%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 0 (0%) |
Consent implied (completion of a survey) | – | – | – | – | 0 (0%) | 36 (9%) | – | – | – | – |
Consent waived | 3 (4.4%) | 0 (0%) | 25 (20.8%) | 67 (28%) | 10 (18.2%) | 0 (0%) | – | – | – | – |
Waived by Unknown | 2 (2.9%) | 0 (0%) | 1 (0.8%) | 9 (13%) | 2 (3.6%) | – | – | – | – | – |
Waived by REC | 1 (1.5%) | 0 (0%) | 24 (20%) | 54 (81%) | 0 (0%) | – | – | – | – | – |
Waived by other (local committee or law) | 0 (0%) | 0 (0%) | 0 (0%) | 4 (6%) | 2 (3.6%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 0 (0%) |
Wording of consent, if provided | n = 11 | n = 31 | n = 17 | n = 57 | n = 14 | n = 234 | n = 2 | n = 3 | n = 0 | n = 16 |
‘Written Informed Consent’/Strict definition *** | 5 (45.5%) | 13 (42%) | 13 (76.5%)** | 28 (49%)** | 6 (43%) | 123 (53%) | 2 (50%) | 3 (100%) | – | 5 (31%) |
Journal editor has copy of written consent form | 0 (0%) | 6 (8.5%) | 0 (0%) | 0 (0%) | – | – | – | – | – | – |