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Table 4 Assent processes used to enroll children into clinical studies (n = 79)

From: Operationalization of assent for research participation in pre-adolescent children: a scoping review

Method for obtaining assenta

 

 Not specified

33 (41.8)

 Written

31 (39.2)

 Verbal

18 (22.8)

 Otherb

4 (5.1)

Minimal age for assent specified

 

 Yes

28 (35.4)

  Min (years)

5

  Max (years)

13

 No

51 (64.6)

Exclusion criteria other than age specified

 

 Yesc

6 (7.6)

 No

73 (92.4)

Format assent information providedd

 

 Not specified

45 (57.0)

 Verbal

20 (25.3)

 Written in person

14 (17.7)

 Written by mail

3 (3.8)

 Written (not further specified)

4 (5.1)

 Unclear

3 (3.8)

 Comic book

1 (1.3)

 Otherd

3 (3.8)

Information provided to patient specified

 

 Yes

13 (16.5)

 No

66 (83.5)

Assent rate reported or able to be calculated

 

 Yes

14 (17.7)

 No

57 (72.2)

 Not applicable (e.g. study protocol)

8 (10.1)

Assent rate (reported or calculated)

 

 Median (range)

89.0 (32.0-100.0)

  1. aSome studies obtained assent in more than manner
  2. bOther ways to obtain assent were via a form (but unclear if form used to get signature), nonverbal, use of an online form and formal acceptance
  3. cSpecific exclusion criteria were developmental disabilities or extreme difficulties in understanding simple instructions for assent procedure and baseline questionnaire, being an adolescent (not age-specified), being too unwell to participate, being in school grade less than 5 (not age-specified), failing comprehension assessment because of substance use and moderate or severe learning difficulties
  4. dSome studies provided the information in more than one format
  5. eOther formats used included cartoons/play, online written form and pictures that children were invited to color