Table 1.
Relative Frequency of Respondents Who Mentioned a Theme by Respondent Type
| Theme | Respondents, n (%)* | ||
|---|---|---|---|
| Circumstances in which conflicts of interest should be disclosed | Investigators N=8 | IRB Chairs N=23 | COIC Chairs N=14 |
| In all circumstances | 6 (75) | 14 (61) | 8 (57) |
| Degree of financial relationship involvement | 4 (50) | 10 (43) | 7 (50) |
| Risk to subjects | 0 (0) | 2 (9) | 0 (0) |
| Never | 0 (0) | 0 (0) | 0 (0) |
| Other | 0 (0) | 5 (22) | 0 (0) |
| Rationale for or benefits of disclosure | |||
| Right to know | 5 (63) | 3 (13) | 3 (21) |
| More informed decision | 7 (88) | 17 (74) | 10 (71) |
| Liability | 3 (38) | 8 (35) | 2 (14) |
| Regulations | 0 (0) | 3 (13) | 0 (0) |
| General warning to participants | 1 (13) | 8 (35) | 3 (21) |
| Building trust | 3 (38) | 7 (30) | 9 (64) |
| Transparency/honesty | 6 (75) | 12 (52) | 4 (29) |
| Public perception | 1 (13) | 4 (17) | 3 (21) |
| Other | 3 (37) | 4 (17) | 2 (14) |
| Information to be disclosed (level of detail) | |||
| Funding source (i.e., sponsor) | 7 (88) | 17 (74) | 10 (71) |
| Amount of funding | 7 (63) | 17 (78) | 10 (93) |
| Ties between investigator and sponsor | 6 (75) | 21 (91) | 13 (93) |
| Potential consequences of ties between investigator and sponsor | 5 (63) | 9 (39) | 7 (50) |
| Patient can ask questions | 3 (38) | 9 (39) | 6 (43) |
| Other | 7 (87) | 14 (61) | 9 (64) |
| Negative effects or barriers to disclosure (risks) | |||
| Enrollment | 5 (63) | 18 (78) | 11 (79) |
| Breaks down trust | 5 (63) | 6 (26) | 3 (21) |
| Lengthen informed consent document | 3 (38) | 6 (26) | 4 (29) |
| Lengthen informed consent process | 3 (38) | 2 (9) | 0 (0) |
| Investigators think unnecessary | 2 (25) | 0 (0) | 1 (7) |
| Investigator privacy | 2 (25) | 5 (22) | 4 (29) |
| Conflicts of interest difficult to understand | 2 (25) | 10 (43) | 10 (71) |
| None | 1 (13) | 1 (4) | 4 (29) |
| Other | 5 (62) | 8 (35) | 2 (14) |
| Timing of disclosure | |||
| Timing of disclosure | 6 (75) | 7 (30) | 6 (43) |
| Informed consent document | 7 (88) | 12 (52) | 4 (29) |
| Educational brochure | 2 (25) | 1 (4) | 0 (0) |
| Informed consent process | 2 (25) | 10 (43) | 6 (43) |
*
Respondents could provide more than one coded response for any category