Table 2.
Comparison between current (line 1 in each row) and previous (line 2 in each row) cohorts 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. | 52 (100%) 915 (99.1%) |
0 (0%) 0 (0%) |
0 (0%) 8 (0.9%) |
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. | 52 (100%) 904 (98%) |
0 (0%) 2 (0.2%) |
0 (0%) 16 (1.7%) |
1.000 |
| 3. I have been informed how long my participation in the Personalized Medicine Research Project is likely to last. | 34 (68.0%) 532 (57.8%) |
0 (0%) 21 (2.3%) |
16 (32.0%) 367 (39.9%) |
0.328 |
| 4. All the procedures in the research project are standard for any routine genetic testing. | 44 (84.6%) 604 (65.9%) |
0 (0%) 7 (0.8%) |
8 (15.4%) 306 (33.4%) |
0.018 |
| 5. In this research project, one of the major goals is to understand how genes contribute to the development of disease. | 48 (94.1%) 850 (92.6%) |
0 (0%) 2 (0.2%) |
3 (5.9%) 66 (7.2%) |
1.000 |
| 6. In this research project one of the major goals is to explore the genetic basis for reactions to prescription drugs. | 33 (63.5%) 487 (53.0%) |
4 (7.7%) 61 (6.6%) |
15 (28.8%) 371 (40.4%) |
0.227 |
| 7. In the research project, one of the major goals is to establish a DNA database for researchers to use. | 41 (80.4%) 679 (74.3%) |
0 (0%) 21 (2.3%) |
10 (19.6%) 214 (23.4%) |
0.648 |
| 8. In the research project, one of the researchers’ major purposes is to look for genes associated with higher and lower rates of disease. | 43 (82.7%) 775 (84.7%) |
0 (0%) 6 (0.7%) |
9 (17.3%) 134 (14.6%) |
0.679 |
| 9. The genetic testing in this study will result in my learning which conditions/diseases I will develop. | 16 (30.8%) 254 (27.7%) |
19 (36.5%) 358 (39.0%) |
17 (32.7%) 306 (33.3%) |
0.875 |
| 10. My DNA will not be stored as part of this research study. | 19 (36.5%) 277 (30.2%) |
13 (25.0%) 165 (18.0%) |
20 (38.5%) 476 (51.9%) |
0.141 |
| 11. As part of this study, researchers will have access to my medical records. | 40 (80.0%) 490 (53.7%) |
4 (8.0%) 187 (20.5%) |
6 (12.0%) 236 (25.8%) |
0.001 |
| 12. After I choose to participate in this research study, my sample will be labeled with my name in order to identify it. | 14 (26.9%) 219 (23.9%) |
30 (57.7%) 505 (55.1%) |
8 (15.4%) 192 (21.0%) |
0.604 |
| 13. This research project does not carry any risks or discomforts. | 39 (75.0%) 675 (73.5%) |
2 (3.8%) 125 (13.6%) |
11 (21.2%) 118 (12.9%) |
0.036 |
| 14. There may not be direct medical benefit to me from my participation in this research study. | 49 (94.2%) 762 (83.5%) |
0 (0%) 37 (4.1%) |
3 (5.8%) 114 (12.5%) |
0.133 |
| 15. By participating in this research study, I am helping the researchers learn information that may benefit future patients. | 51 (100%) 902 (98.4%) |
0 (0%) 1 (0.1%) |
0 (0%) 14 (1.5%) |
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. | 20 (39.2%) 221 (24.0%) |
20 (39.2%) 421 (45.8%) |
11 (21.6%) 278 (30.2%) |
0.057 |
| 17. The researchers did not offer me any alternative besides involvement in this research study. | 18 (36.0%) 271 (29.6%) |
24 (48.0%) 454 (49.7%) |
8 (16.0%) 189 (20.7%) |
0.575 |
| 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. | 21 (40.4%) 297 (32.6%) |
11 (21.2%) 150 (16.5%) |
20 (38.5%) 464 (50.9%) |
0.195 |
| 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. | 40 (78.4%) 605 (66.0%) |
5 (9.8%) 29 (3.2%) |
6 (11.8%) 283 (30.9%) |
0.001 |
| 20. If I had not wanted to participate in this study, I could have declined to sign the consent form. | 51 (98.1%) 893 (97.1%) |
1 (1.9%) 4 (0.4%) |
0 (0%) 23 (2.5%) |
0.184 |
| 21. I will have to remain in this research study even if I decide someday that I want to withdraw. | 2 (4.2%) 108 (11.7%) |
39 (81.3%) 573 (62.3%) |
7 (14.6%) 239 (26.0%) |
0.027 |
| 22. I felt pressured by study personnel to participate in the Personalized Medicine Research Project. | 1 (2.1%) 18 (2.0%) |
46 (95.8%) 875 (95.9%) |
1 (2.1%) 19 (2.1%) |
1.000 |
| 23. I felt pressured by someone other than the study personnel to participate in the Personalized Medicine Research Project. | 0 (0%) 19 (2.1%) |
49 (94.2%) 873 (95.8%) |
3 (5.8%) 19 (2.1%) |
0.149 |
| 24. The $20 greatly influenced my decision to participate in the Personalized Medicine Research Project. | 2 (3.8%) 311 (34.3%) |
47 (90.4%) 545 (60.0%) |
3 (5.8%) 52 (5.7%) |
<0.001 |