Table 3 Ranking of essential elements of consent
Research Stakeholders N = 27 | Study Participants (N = 14) | Total (N = 41) | |
|---|---|---|---|
Inclusion of the word research | |||
Essential | 19 (70.4) | 10 (71.4) | 29 (70.7) |
Neutral | 6 (22.2) | 2 (14.3) | 8 (19.5) |
Non-essential | 2 (7.4) | 2 (14.3) | 4 (9.8) |
Study purpose | |||
Essential | 24 (88.9) | 13 (92.9) | 37 (90.2) |
Neutral | 3 (11.1) | 1 (7.1) | 4 (9.8) |
Non-essential | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Use of randomization | |||
Missing | 0 | 2 | 2 |
Essential | 8 (33.3) | 5 (41.7) | 13 (33.3) |
Neutral | 8 (29.6) | 3 (25.0) | 11 (28.2) |
Non-essential | 11 (37.0) | 4 (33.3) | 15 (38.5) |
Study procedures | |||
Essential | 19 (70.4) | 10 (71.4) | 29 (70.7) |
Neutral | 7 (25.9) | 3 (21.4) | 10 (24.4) |
Non-essential | 1 (3.7) | 1 (7.1) | 2 (4.9) |
Participant responsibilities | |||
Essential | 18 (66.7) | 12 (85.7) | 30 (73.2) |
Neutral | 8 (29.6) | 0 (0.0) | 8 (19.5) |
Non-essential | 1 (3.7) | 2 (14.3) | 3 (7.3) |
Study risks | |||
Essential | 18 (66.7) | 7 (50.0) | 25 (61.0) |
Neutral | 8 (29.6) | 5 (35.7) | 13 (31.7) |
Non-essential | 1 (3.7) | 2 (14.3) | 3 (7.3) |
Study benefits | |||
Missing | 0 | 1 | 1 |
Essential | 19 (70.4) | 10 (76.9) | 29 (72.5) |
Neutral | 6 (22.2) | 2 (15.4) | 8 (20.0) |
Non-essential | 2 (7.4) | 1 (7.7) | 3 (7.5) |
Alternative treatments | |||
Missing | 0 | 1 | 1 |
Essential | 13 (48.1) | 10 (76.9) | 23 (57.5) |
Neutral | 8 (29.6) | 3 (23.1) | 11 (27.5) |
Non-essential | 6 (22.2) | 0 (0.0) | 6 (15.0) |
Insurance | |||
Missing | 1 | 0 | 1 |
Essential | 10 (38.5) | 10 (71.4) | 20 (50.0) |
Neutral | 10 (38.5) | 2 (14.3) | 12 (30.0) |
Non-essential | 6 (23.1) | 2 (14.3) | 8 (20.0) |
Payments | |||
Essential | 16 (59.3) | 8 (57.1) | 24 (58.5) |
Neutral | 8 (29.6) | 2 (14.3) | 10 (24.4) |
Non-essential | 3 (11.1) | 4 (28.6) | 7 (17.1) |
Study costs | |||
Missing | 0 | 1 | 1 |
Essential | 16 (59.3) | 11 (84.6) | 27 (67.5) |
Neutral | 7 (25.9) | 1 (7.7) | 8 (20.0) |
Non-essential | 4 (14.8) | 1 (7.7) | 5 (12.5) |
Voluntary nature of study | |||
Missing | 0 | 1 | 1 |
Essential | 23 (85.2) | 10 (76.9) | 33 (82.5) |
Neutral | 4 (14.8) | 1 (7.7) | 5 (12.5) |
Non-essential | 0 (0.0) | 2 (15.4) | 2 (5.0) |
Data access by monitors | |||
Missing | 0 | 1 | 1 |
Essential | 5 (18.5) | 3 (23.1) | 8 (20.0) |
Neutral | 2 (7.4) | 2 (15.4) | 4 (10.0) |
Non-essential | 20 (74.1) | 8 (61.5) | 28 (70.0) |
Confidentiality | |||
Missing | 0 | 1 | 1 |
Essential | 15 (55.6) | 6 (46.2) | 21 (52.5) |
Neutral | 9 (33.3) | 2 (15.4) | 11 (27.5) |
Non-essential | 3 (11.1) | 5 (38.5) | 8 (20.0) |
Inform when changes to protocol | |||
Missing | 0 | 1 | 1 |
Essential | 6 (22.2) | 11 (84.6) | 17 (42.5) |
Neutral | 10 (37.0) | 2 (15.4) | 12 (30.0) |
Non-essential | 11 (40.7) | 0 (0.0) | 11 (27.5) |
Contact information of investigators | |||
Missing | 0 | 1 | 1 |
Essential | 19 (63.0) | 11 (84.6) | 30 (75.0) |
Neutral | 6 (22.2) | 0 (0.0) | 6 (15.0) |
Non-essential | 2 (14.8) | 2 (15.4) | 4 (10.0) |
Study termination | |||
Missing | 0 | 2 | 2 |
Essential | 6 (22.2) | 3 (25.0) | 9 (23.1) |
Neutral | 6 (22.2) | 1 (8.3) | 7 (17.9) |
Non-essential | 15 (55.6) | 8 (66.7) | 23 (59.0) |
Study duration | |||
Essential | 16 (59.3) | 9 (64.3) | 25 (61.0) |
Neutral | 3 (11.1) | 2 (14.3) | 5 (12.2) |
Non-essential | 8 (29.6) | 3 (21.4) | 11 (26.8) |