Skip to main content

Table 2 Quantitative data from study information sheets

From: Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

  Total no. of documents
n = 42 (%)
Unit size by no. words
range (median)
Total length of document 42 217–3997 (1665)
 CTIMP 14 217–2676 (2067)
 Non-CTIMP 28 230–3997 (1602)
Total area of interest 42 79–926 (344)
 Proportion of total length of document (area of interest/total length of document)   79/1197–641/953
7–68%
 CTIMP 14 79–371 (232)
 Non-CTIMP 28 155–926 (422)
Why the proxy is being approached 42 (100%) 22–494 (104)
 CTIMP 14 22–217 (122)
 Non-CTIMP 28 27–494 (98)
Basis for the decision 38 (90%) 8–267 (83)
 CTIMP 10 14–123 (51)
 Non-CTIMP 28 8–267 (107)
How the proxy might approach deciding 13 (31%) 18–185 (67)
 CTIMP 1 76
 Non-CTIMP 12 18–185 (66)
Practical instructions for the proxy 38 (90%) 18–309 (80)
 CTIMP 10 18–151 (75)
 Non-CTIMP 28 28–309 (83)
Withdrawal from the study (including proxy’s role) 34 (81%) 19–168 (44)
 CTIMP 11 25–87 (49)
 Non-CTIMP 23 19–168 (43)
  1. CTIMP Clinical trial of an investigational medicinal product, governed by CTR
  2. Non-CTIMP Research other than a clinical trial of an investigational medicinal product, governed by MCA