Table 3 Patients Subjective Understanding
From: Patients acceptance and comprehension to written and verbal consent (PAC–VC)
Items examined | Consent type | |||
|---|---|---|---|---|
Verbal assent | Written consent | |||
Count | N % | Count | N % | |
You understand the purpose of study | ||||
Agree | 1 | 8.3 | 0 | 0.0 |
Cannot decide | 2 | 16.7 | 0 | 0.0 |
Disagree | 9 | 75.0 | 6 | 100.0 |
You know how long you will be enrolled in this study | ||||
Agree | 3 | 25.0 | 3 | 50.0 |
Cannot decide | 4 | 33.3 | 0 | 0.0 |
Disagree | 5 | 41.7 | 3 | 50.0 |
You understand what will be done in this study and what you are being asked to do | ||||
Agree | 1 | 8.3 | 1 | 20.0 |
Cannot decide | 3 | 25.0 | 0 | 0.0 |
Disagree | 8 | 66.7 | 4 | 80.0 |
You recognize the experimental part that may be used in your treatment. (Study intervention) | ||||
Agree | 1 | 8.3 | 0 | 0.0 |
Cannot decide | 2 | 16.7 | 0 | 0.0 |
Disagree | 9 | 75.0 | 6 | 100.0 |
You recognize the possible risks or discomforts that may result due to participation in this study | ||||
Agree | 0 | 0.0 | 0 | 0.0 |
Cannot decide | 2 | 16.7 | 1 | 16.7 |
Disagree | 10 | 83.3 | 5 | 83.3 |
You recognize the possible benefits you may gain from participation | ||||
Agree | 0 | 0.0 | 0 | 0.0 |
Cannot decide | 2 | 16.7 | 0 | 0.0 |
Disagree | 10 | 83.3 | 6 | 100.0 |
You recognize the possible benefits that may help future patients | ||||
Agree | 0 | 0.0 | 0 | 0.0 |
Cannot decide | 0 | 0.0 | 0 | 0.0 |
Disagree | 12 | 100.0 | 6 | 100.0 |
You know alternative options/treatments you may have if you had chosen to NOT participate | ||||
Agree | 2 | 16.7 | 1 | 16.7 |
Cannot decide | 1 | 8.3 | 1 | 16.7 |
Disagree | 9 | 75.0 | 4 | 66.7 |
You understand that your information is being kept confidential and disclosed only to authorized personnel | ||||
Agree | 0 | 0.0 | 0 | 0.0 |
Cannot decide | 0 | 0.0 | 0 | 0.0 |
Disagree | 12 | 100.0 | 6 | 100.0 |
You know whom you should contact in case of side effects or injuries that may result due to participation in the study | ||||
Agree | 1 | 8.3 | 2 | 33.3 |
Cannot decide | 2 | 16.7 | 0 | 0.0 |
Disagree | 9 | 75.0 | 4 | 66.7 |
You know what compensation or treatment is available for you in case of side effects or injury | ||||
Agree | 3 | 25.0 | 3 | 50.0 |
Cannot decide | 3 | 25.0 | 0 | 0.0 |
Disagree | 6 | 50.0 | 3 | 50.0 |
You understand that your participation is completely voluntary and it is not going to affect your treatment if you choose to withdraw | ||||
Agree | 0 | 0.0 | 0 | 0.0 |
Cannot decide | 0 | 0.0 | 0 | 0.0 |
Disagree | 12 | 100.0 | 6 | 100.0 |
You understand that you can withdraw from this study at any time you wish to do so | ||||
Agree | 0 | 0.0 | 0 | 0.0 |
Cannot decide | 0 | 0.0 | 0 | 0.0 |
Disagree | 12 | 100.0 | 6 | 100.0 |
You know whom you should contact in case you have questions, comments, concerns or complaints about the study | ||||
Agree | 2 | 16.7 | 2 | 33.3 |
Cannot decide | 2 | 16.7 | 0 | 0.0 |
Disagree | 8 | 66.7 | 4 | 66.7 |