Table 2.
Proportion of correct responses on the Participant Comprehension Survey by assigned study arm (N=50).
| Number | Question | Participants with correct answers, n (%) | VICa vs paper, risk ratio (95% CI) | |
|
|
|
VIC arm (n=25) | Paper arm (n=25) |
|
| 1 | Why did we ask you to participate in this study? | 18 (72) | 20 (80) | 0.90 (0.66-1.23) |
| 2 | Which of the following are benefits of this study? | 18 (72) | 17 (68) | 1.06 (0.74-1.52) |
| 3 | Which of the following procedures is part of the study? | 25 (100) | 24 (96) | 1.04 (0.96-1.13) |
| 4 | Which of the following is true if you choose to participate? | 23 (92) | 24 (96) | 0.96 (0.83-1.10) |
| 5 | Which of the following is an expected risk from participating in the study? | 22 (88) | 20 (80) | 1.10 (0.86-1.40) |
| 6 | While you are in this research study, what will happen to your personal health information? | 24 (96) | 19 (76) | 1.26 (1.00-1.60) |
| 7 | Which of the following statement is true about your participation in the study? | 20 (80) | 18 (72) | 1.11 (0.81-1.52) |
| 8 | How can you withdraw from this study? | 24 (96) | 20 (80) | 1.20 (0.97-1.48) |
| 9 | Who can you call if you have questions about your rights as a participant in this study? | 18 (72) | 16 (64) | 1.13 (0.77-1.65) |
| 10 | Your driver’s license number will be collected for purposes of this study | 25 (100) | 25 (100) | 1.00 (1.00-1.00) |
| 11 | To participate in this study, you need to provide blood sample | 24 (96) | 25 (100) | 0.96 (0.89-1.04) |
| 12 | If you are injured while participating in this study, you or your insurance carrier will be expected to pay the costs of this treatment | 9 (36) | 12 (48) | 1.23 (0.76-1.99) |
| 13 | If you participate in the procedures for this study, you will be paid for your time | 25 (100) | 25 (100) | 1.00 (1.00-1.00) |
aVIC: Virtual Multimedia Interactive Informed Consent.