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Table 6 Approach taken by research staff in the informed consent process and confirming participants’ understanding

From: An evaluation of the process of informed consent: views from research participants and staff

Approach taken during informed consent process

Number of respondents, n = 115 (%)*

Explain verbally

105 (91%)

Give PIL & ask participant to read it

97 (84%)

Read PIL to participant

55 (48%)

Show participant video or website

7 (6%)

Other

12 (10%)

Follow a structured approach (follow a checklist or the layout of the PIL)

Number of respondents, n = 115 (%)

All the time

40 (35%)

Often

36 (31%)

Occasionally

16 (14%)

Never

17 (15%)

Didn’t reply

6 (5%)

Check participant’s understanding

Yes

No

Didn’t reply

 

101 (88%)

7 (6%)

7 (6%)

If understanding is checked

Number of respondents (%), n = 101*

 Ask participant if they have understood

89 (88%)

 Ask participant to ‘teach back’ or ‘talk back’

35 (35%)

 Encourage participant to ask questions

93 (81%)

 Other

6 (6%)

 Didn’t reply

2 (2%)

Continue to monitor consent

 All the time

30 (26%)

 Often

30 (26%)

 Occasionally

33 (29%)

 Never

16 (14%)

 Didn’t reply

6 (5%)

  1. *Question had multiple response options
  2. PIL Participant Information Leaflet