Table 2.
Opinions of researchers from various Ethiopian institutions on the consent processes and development of REA, September, 2012 (n = 241)
| Variables | Frequency | % |
|---|---|---|
|
How is consent form developed in your experience? (multiple responses) |
|
|
| By the investigator |
142 |
58.9 |
| With prior ethical assessment |
70 |
29.0 |
| With stakeholder participation/consultation |
41 |
17.0 |
| By the sponsor |
17 |
7.1 |
| Others (research advisors, collaborators, students) |
13 |
5.2 |
|
Opinions on consent process |
|
|
| Do you think all participants understand consent forms well? |
|
|
| Yes |
97 |
40.2 |
| No |
144 |
59.8 |
| Based on your experiences, are you satisfied with the way the consent process was designed and conducted? (Y/N) |
|
|
| Yes |
37 |
15.4 |
| No |
204 |
84.6 |
| Do you think that the best interest of study participants is taken in to consideration and adequately addressed through the current ethical appraisal and consent processes? |
|
|
| Yes |
35 |
14.5 |
| No |
206 |
85.5 |
| Based on your experiences, what do you think are the most common problems in the current consent process? |
|
|
| Lack of clarity |
116 |
48.1 |
| Inadequate information |
82 |
34 |
| Language |
68 |
28.2 |
| Cultural difference |
66 |
27.4 |
| Undue expectations |
64 |
26.6 |
| Power imbalance |
50 |
20.7 |
| Coercion |
19 |
7.9 |
| Others |
11 |
4.6 |
|
Ethical Pre–assessment for Consent Process |
|
|
| Do you think it is important to contextualize consent forms and consent processes to local settings? |
|
|
| Yes |
230 |
95.4 |
| No |
11 |
4.6 |
| Do you agree with the idea of the study participant be approached in advance before the start of the study to get input for the development of the consent form and to find out how it should be administered? |
|
|
| Yes |
196 |
81.3 |
| No |
45 |
18.7 |
| Do you think that study participants should be involved, in the development of consent forms and designing of the consent process so as to make it culture and setting sensitive? |
|
|
| Yes |
171 |
71 |
| No |
70 |
29 |
| In your opinion, would REA serve adequately addressing the consent process issues and in making sure that ethical issues are very well addressed in a research process? |
|
|
| Yes |
95 |
39.4 |
| No |
146 |
60.6 |
| From your experiences, is there any initiative so far; is there any initiative that involves the study participants in the development and design of consent information sheet and consent process? |
|
|
| Yes |
29 |
12 |
| No | 212 | 88 |