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Table 3 Ranking of essential elements of consent

From: Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam

 Research Stakeholders
N = 27
Study Participants
(N = 14)
Total
(N = 41)
Inclusion of the word research
 Essential19 (70.4)10 (71.4)29 (70.7)
 Neutral6 (22.2)2 (14.3)8 (19.5)
 Non-essential2 (7.4)2 (14.3)4 (9.8)
Study purpose
 Essential24 (88.9)13 (92.9)37 (90.2)
 Neutral3 (11.1)1 (7.1)4 (9.8)
 Non-essential0 (0.0)0 (0.0)0 (0.0)
Use of randomization
 Missing022
 Essential8 (33.3)5 (41.7)13 (33.3)
 Neutral8 (29.6)3 (25.0)11 (28.2)
 Non-essential11 (37.0)4 (33.3)15 (38.5)
Study procedures
 Essential19 (70.4)10 (71.4)29 (70.7)
 Neutral7 (25.9)3 (21.4)10 (24.4)
 Non-essential1 (3.7)1 (7.1)2 (4.9)
Participant responsibilities
 Essential18 (66.7)12 (85.7)30 (73.2)
 Neutral8 (29.6)0 (0.0)8 (19.5)
 Non-essential1 (3.7)2 (14.3)3 (7.3)
Study risks
 Essential18 (66.7)7 (50.0)25 (61.0)
 Neutral8 (29.6)5 (35.7)13 (31.7)
 Non-essential1 (3.7)2 (14.3)3 (7.3)
Study benefits
 Missing011
 Essential19 (70.4)10 (76.9)29 (72.5)
 Neutral6 (22.2)2 (15.4)8 (20.0)
 Non-essential2 (7.4)1 (7.7)3 (7.5)
Alternative treatments
 Missing011
 Essential13 (48.1)10 (76.9)23 (57.5)
 Neutral8 (29.6)3 (23.1)11 (27.5)
 Non-essential6 (22.2)0 (0.0)6 (15.0)
Insurance
 Missing101
 Essential10 (38.5)10 (71.4)20 (50.0)
 Neutral10 (38.5)2 (14.3)12 (30.0)
 Non-essential6 (23.1)2 (14.3)8 (20.0)
Payments
 Essential16 (59.3)8 (57.1)24 (58.5)
 Neutral8 (29.6)2 (14.3)10 (24.4)
 Non-essential3 (11.1)4 (28.6)7 (17.1)
Study costs
 Missing011
 Essential16 (59.3)11 (84.6)27 (67.5)
 Neutral7 (25.9)1 (7.7)8 (20.0)
 Non-essential4 (14.8)1 (7.7)5 (12.5)
Voluntary nature of study
 Missing011
 Essential23 (85.2)10 (76.9)33 (82.5)
 Neutral4 (14.8)1 (7.7)5 (12.5)
 Non-essential0 (0.0)2 (15.4)2 (5.0)
Data access by monitors
 Missing011
 Essential5 (18.5)3 (23.1)8 (20.0)
 Neutral2 (7.4)2 (15.4)4 (10.0)
 Non-essential20 (74.1)8 (61.5)28 (70.0)
Confidentiality
 Missing011
 Essential15 (55.6)6 (46.2)21 (52.5)
 Neutral9 (33.3)2 (15.4)11 (27.5)
 Non-essential3 (11.1)5 (38.5)8 (20.0)
Inform when changes to protocol
 Missing011
 Essential6 (22.2)11 (84.6)17 (42.5)
 Neutral10 (37.0)2 (15.4)12 (30.0)
 Non-essential11 (40.7)0 (0.0)11 (27.5)
Contact information of investigators
 Missing011
 Essential19 (63.0)11 (84.6)30 (75.0)
 Neutral6 (22.2)0 (0.0)6 (15.0)
 Non-essential2 (14.8)2 (15.4)4 (10.0)
Study termination
 Missing022
 Essential6 (22.2)3 (25.0)9 (23.1)
 Neutral6 (22.2)1 (8.3)7 (17.9)
 Non-essential15 (55.6)8 (66.7)23 (59.0)
Study duration
 Essential16 (59.3)9 (64.3)25 (61.0)
 Neutral3 (11.1)2 (14.3)5 (12.2)
 Non-essential8 (29.6)3 (21.4)11 (26.8)