Table 5.
Satisfaction with the Consent Process at Final Visit
| Form A (n=46) |
Form B (n=53) |
Comparison P value |
||
|---|---|---|---|---|
| Survey Item # | Answer | percentage | ||
| Item #1 | >0.99 | |||
| How satisfied were you with the consent process that occurred before you enrolled in the study? | 1-Very satisfied | 84.8 | 86.8 | 0.78 |
| 2-Satisfied | 15.2 | 13.2 | ||
| 3-Somewhat unsatisfied | 0 | 0 | ||
| 4-It could have been much better | 0 | 0 | ||
| Item #2 | 0.94 | |||
| Was there anything you experienced that you now feel should have been explained better before you enrolled in the study? | 1-No | 100 | 98.1 | >0.99 |
| 2-Yes | 0 | 1.8 | ||
| Item #4 | 0.37 | |||
| Do you think the consent form you were given for this research study was… | 1-Much too detailed | 4.3 | 3.8 | |
| 2-Too detailed | 15.2 | 7.5 | ||
| 3-About right | 78.3 | 88.7 | 0.18 | |
| 4-Too simple | 0 | 0 | ||
| 5-Much too simple | 0 | 0 | ||
| 6-I didn’t read it | 2.2 | 0 | ||
Note: 46 of 55 (83.6%) in the Form A group and 53 of 56 (94.6%) in the Form B group completed the final visit questionnaire. The final visit occurred at study week 24 or 48, depending upon the vaccine study in which the subject was participating.