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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%)
  1. CTIMP Clinical Trial of Investigational Medicinal Products, RIP participants(s) had died; REC Research Ethics Committee, Nov November
  2. *p < 0.01; **p < 0.05 [chi-squared test]; *** ‘Strict definition’ of consent, as described by Yank and Rennie[22]