Table 2 ICP elements raised by FTM-EC by different study types
Concerns about informed consent process | All studies | Use of new or linked specimens | Involvement of vulnerable population | Final review outcome | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Â | Â | Yes | No | Yes | No | Approved | Deferred | |||||||
n = 63 | n = 54 | n = 9 | n = 41 | n = 22 | n = 57 | n = 6 | ||||||||
n | % | n | % | n | % | n | % | n | % | n | % | n | % | |
Purpose of the study | 10 | 15.9 | 8 | 14.8 | 2 | 22.2 | 8 | 19.5 | 2 | 9.1 | 9 | 15.8 | 1 | 16.7 |
Duration of the study | 2 | 3.2 | 2 | 3.7 | 0 | 0.0 | 0 | 0 | 2 | 9.1 | 2 | 3.5 | 0 | 0.0 |
Procedure for study activities | 42 | 66.7 | 39 | 72.2 | 3 | 33.3 | 30 | 73.2 | 12 | 54.6 | 36 | 63.2 | 6 | 100.0 |
Potential risk/discomfort | 26 | 41.3 | 22 | 40.7 | 4 | 44.4 | 19 | 46.3 | 7 | 31.8 | 23 | 40.6 | 3 | 50.0 |
Method for minimizing risk | 4 | 6.4 | 3 | 5.6 | 1 | 11.1 | 3 | 7.3 | 1 | 4.6 | 4 | 7.0 | 0 | 0.0 |
Potential benefit | 7 | 11.1 | 6 | 11.1 | 1 | 11.1 | 6 | 14.6 | 1 | 4.6 | 6 | 10.5 | 1 | 16.7 |
Concern about vulnerable status | 25 | 39.7 | 23 | 42.6 | 2 | 22.2 | 23 | 56.1 | 2 | 9.1 | 22 | 38.6 | 3 | 50.0 |
Voluntary participation | 13 | 20.6 | 11 | 20.4 | 2 | 22.2 | 7 | 17.1 | 6 | 27.3 | 13 | 22.8 | 0 | 0.0 |
Right to withdraw from study | 13 | 20.6 | 10 | 18.5 | 3 | 33.3 | 8 | 19.5 | 5 | 22.7 | 12 | 21.1 | 1 | 16.7 |
Concern about confidentiality | 13 | 20.6 | 12 | 22.2 | 1 | 11.1 | 9 | 22 | 4 | 18.2 | 13 | 22.8 | 0 | 0.0 |
Coverage of cost (if any) | 10 | 15.7 | 10 | 18.5 | 0 | 0.0 | 8 | 19.5 | 2 | 9.1 | 9 | 15.8 | 1 | 16.7 |
Justification for compensation | 26 | 41.3 | 25 | 46.3 | 1 | 11.1 | 21 | 51.2 | 5 | 22.7 | 22 | 38.6 | 4 | 66.7 |
Contact name/telephone for emergency | 16 | 25.4 | 14 | 25.9 | 2 | 22.2 | 13 | 31.7 | 3 | 13.6 | 13 | 22.8 | 3 | 50.0 |
Notifiable body for protocol non-compliance | 4 | 6.5 | 3 | 5.7 | 1 | 11.1 | 4 | 9.8 | 0 | 0 | 4 | 7.1 | 0 | 0.0 |