Table 4.
Comparison between computer-based consenting (line 1 in each row) and traditional (line 2 in each row) groups about factual statements related to informed consent. Expected responses are highlighted in bold.
| Statement | Agree | Disagree | Unsure | p-value |
|---|---|---|---|---|
| 1. When I signed the consent form to have my blood drawn, I knew that I was agreeing to participate in a research project. | 25 (100%) 27 (100%) |
0 (0%) 0 (0%) |
0 (0%) 0 (0%) |
1.000 |
| 2. The main goal of genetic research studies, such as the Personalized Medicine Research Project, is to improve scientific knowledge for future patients. | 25 (100%) 27 (100%) |
0 (0%) 0 (0%) |
0 (0%) 0 (0%) |
1.000 |
| 3. I have been informed how long my participation in the Personalized Medicine Research Project is likely to last. | 17 (68.0%) 17 (68.0%) |
0 (0%) 0 (0%) |
8 (32.0%) 8 (32.0%) |
1.000 |
| 4. All the procedures in the research project are standard for any routine genetic testing. | 22 (88.0%) 22 (81.5%) |
0 (0%) 0 (0%) |
3 (12.0%) 5 (18.5%) |
0.705 |
| 5. In this research project, one of the major goals is to understand how genes contribute to the development of disease. | 24 (96.0%) 24 (92.3%) |
0 (0%) 0 (0%) |
1 (4.0%) 2 (7.7%) |
1.000 |
| 6. In this research project one of the major goals is to explore the genetic basis for reactions to prescription drugs. | 15 (60.0%) 18 (66.7%) |
3 (12.0%) 1 (3.7%) |
7 (28.0%) 8 (29.6%) |
0.623 |
| 7. In the research project, one of the major goals is to establish a DNA database for researchers to use. | 20 (80.0%) 21 (80.8%) |
0 (0%) 0 (0%) |
5 (20.0%) 5 (19.2%) |
1.000 |
| 8. In the research project, one of the researchers’ major purposes is to look for genes associated with higher and lower rates of disease. | 21 (84.0%) 22 (81.5%) |
0 (0%) 0 (0%) |
4 (16.0%) 5 (18.5%) |
1.000 |
| 9. The genetic testing in this study will result in my learning which conditions/diseases I will develop. | 9 (36.0%) 7 (25.9%) |
12 (48.0%) 7 (25.9%) |
4 (16.0%) 13 (48.1%) |
0.045 |
| 10. My DNA will not be stored as part of this research study. | 11 (44.0%) 8 (29.6%) |
8 (32.0%) 5 (18.5%) |
6 (24.0%) 14 (15.9%) |
0.137 |
| 11. As part of this study, researchers will have access to my medical records. | 18 (72.0%) 22 (88.0%) |
3 (12.0%) 1 (4.0%) |
4 (16.0%) 13 (48.1%) |
0.385 |
| 12. After I choose to participate in this research study, my sample will be labeled with my name in order to identify it. | 5 (20.0%) 9 (33.3%) |
16 (64.0%) 14 (51.9%) |
4 (16.0%) 4 (14.8%) |
0.542 |
| 13. This research project does not carry any risks or discomforts. | 20 (80.0%) 19 (70.4%) |
0 (0%) 2 (7.4%) |
5 (20.0%) 6 (22.2%) |
0.580 |
| 14. There may not be direct medical benefit to me from my participation in this research study. | 25 (100%) 24 (88.9%) |
0 (0%) 0 (0%) |
0 (0%) 3 (11.1%) |
0.236 |
| 15. By participating in this research study, I am helping the researchers learn information that may benefit future patients. | 25 (100%) 26 (100.0%) |
0 (0%) 0 (0%) |
0 (0%) 0 (0%) |
1.000 |
| 16. Because I am participating in a genetics research study, it is possible that the study sponsor, various government agencies, or others who are not directly involved in my care could view my medical records. | 10 (40.0%) 10 (38.5%) |
9 (36.0%) 11 (42.3%) |
6 (24.0%) 14 (15.9%) |
0.936 |
| 17. The researchers did not offer me any alternative besides involvement in this research study. | 4 (16.0%) 14 (56.0%) |
16 (64.0%) 8 (32.0%) |
5 (20.0%) 3 (12.0%) |
0.013 |
| 18. The consent form that I signed describes who will pay for my treatment if I am injured or become ill as a result of participation in this research study. | 14 (56.0%) 7 (25.9%) |
5 (20.0%) 6 (22.2%) |
6 (24.0%) 14 (41.9%) |
0.065 |
| 19. The consent form I signed lists the name of person (or persons) whom I should contact if I have any questions or concerns about this research study. | 20 (83.3%) 20 (74.1%) |
2 (8.3%) 3 (11.1%) |
2 (8.3%) 4 (14.8%) |
0.787 |
| 20. If I had not wanted to participate in this study, I could have declined to sign the consent form. | 24 (96.0%) 27 (100.0%) |
1 (4.0%) 0 (0%) |
0 (0%) 0 (0%) |
0.481 |
| 21. I will have to remain in this research study even if I decide someday that I want to withdraw. | 1 (4.2%) 1 (4.2%) |
21 (87.5%) 18 (75.0%) |
2 (8.3%) 5 (20.8%) |
0.701 |
| 22. I felt pressured by study personnel to participate in the Personalized Medicine Research Project. | 0 (0%) 1 (4.2%) |
24 (100%) 22 (91.7%) |
0 (0%) 1 (4.2%) |
0.489 |
| 23. I felt pressured by someone other than the study personnel to participate in the Personalized Medicine Research Project. | 0 (0%) 0 (0%) |
23 (92.0%) 26 (96.3%) |
2 (8.0%) 1 (3.7%) |
0.603 |
| 24. The $20 greatly influenced my decision to participate in the Personalized Medicine Research Project. | 1 (4.0%) 1 (3.7%) |
24 (96.0%) 23 (85.2% |
0 (0%) 3 (11.1%) |
0.236 |