Table 5 Difficulties reported by research staff with the informed consent process, the level of difficulty of PILs/ICFs and factors which would deter research staff from approaching a participant
From: An evaluation of the process of informed consent: views from research participants and staff
What do you find difficult about facilitating informed consent discussions? | Number of respondents (%), n = 115* |
PIL/ICF too long and/or too complicated | 72 (63%) |
Difficult for patients to understand complex information (disease related or study methodology related) | 64 (56%) |
Not enough time; time pressures in clinic | 46 (40%) |
Difficult to explain complex information | 44 (38%) |
Patient is anxious or upset | 32 (28%) |
Have dual role of healthcare professional and researcher | 26 (23%) |
Other: | |
Language barrier | 2 (1.7%) |
Lack of private & quiet space | 3 (2.6%) |
Participants wanting to please researcher by consenting | 2 (1.7%) |
GDPR has made PIL/ICF too long and too complex | 2 (1.7%) |
Other reasons | 2 (1.7%) |
Not applicable; no difficulties | 4 (3.5%) |
Do you think participant information leaflets and consent forms are in general: | Number of respondents (%), n = 115 |
Easy for participants to understand | 13 (11%) |
Fairly easy for participants to understand | 43 (37%) |
Fairly hard for participants to understand | 44 (39%) |
Very hard for participants to understand | 9 (8%) |
Didn’t reply | 6 (5%) |
What situations make you less likely to offer a study/trial to a participant? | Number of respondents (%), n = 115* |
Patient is too anxious or upset | 55 (48%) |
Patient doesn’t have enough time | 52 (45%) |
Patient has already received too much information at this visit | 44 (38%) |
Don’t think patient will understand the study/trial | 32 (28%) |
Don’t have enough time in clinic | 31 (27%) |
Other | 24 (21%) |
Didn’t reply | 8 (7%) |
Not applicable – all eligible patients approached | 3 (2.6%) |