Table 3 ICP elements raised by FTM-EC by different study types
Concerns about informed consent process | Clinical (IND) study | Other clinical study | Laboratory (Basic Science) study | Social/Behavioral/Epidemiology study | ||||
|---|---|---|---|---|---|---|---|---|
NÂ =Â 11 | NÂ =Â 17 | NÂ =Â 22 | NÂ =Â 13 | |||||
n | % | n | % | N | % | n | % | |
Purpose of the study | 1 | 9.1 | 1 | 5.9 | 4 | 18.2 | 4 | 30.8 |
Duration of the study | 0 | 0.0 | 2 | 11.8 | 0 | 0.0 | 0 | 0.0 |
Procedure for study activities | 10 | 90.9 | 12 | 70.6 | 12 | 54.5 | 8 | 61.6 |
Potential risk/discomfort | 6 | 54.6 | 7 | 41.2 | 7 | 31.8 | 6 | 46.2 |
Method for minimizing risk | 2 | 18.2 | 0 | 0.0 | 0 | 0.0 | 2 | 15.4 |
Potential benefit | 0 | 0.0 | 0 | 0.0 | 4 | 18.2 | 3 | 23.1 |
Concern about vulnerable status | 5 | 45.5 | 5 | 29.4 | 10 | 45.5 | 5 | 38.5 |
Voluntary participation | 1 | 9.1 | 2 | 11.8 | 6 | 27.3 | 4 | 30.8 |
Right to withdraw from study | 3 | 27.3 | 1 | 5.9 | 6 | 27.3 | 3 | 23.1 |
Concern about confidentiality | 5 | 45.5 | 2 | 11.8 | 4 | 18.2 | 2 | 15.4 |
Coverage of cost (if any) | 1 | 9.1 | 3 | 17.7 | 6 | 27.3 | 0 | 0.0 |
Justification for compensation | 7 | 63.6 | 5 | 29.4 | 8 | 36.4 | 6 | 46.2 |
Contact name/telephone for emergency | 4 | 36.4 | 7 | 41.2 | 3 | 13.6 | 2 | 15.4 |
Notifiable body for protocol non-compliance | 1 | 9.1 | 1 | 6.3 | 1 | 4.6 | 1 | 7.7 |