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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