TABLE 1.
Characteristics of Consent Forms Presenting Barriers to Withdrawal*
| Notify the PI‡ | Return for Another Visit | Return for Further Testing | All Stipulations Combined | No Barriers | Total Sample | |
|---|---|---|---|---|---|---|
| (n = 21) | (n = 8) | (n = 6) | (n = 30) | (n = 84) | (n = 114) | |
| N(%) | N (%) | N (%) | N (%) | N (%) | N (%) | |
| Phase of clinical Trial† | ||||||
| Phase I | 11 (55)|| | 7 (88) | 4 (67) | 19 (63)° | 77 (92) | 96 (85) |
| Phase II | 3 (15) | 0 | 1 (17) | 3 (10) | 1 (1) | 4 (4) |
| Phase III | 6 (30) | 1 (12) | 1 (17) | 7 (23) | 6 (7) | 13 (11) |
| Therapeutic research | ||||||
| Yes | 16 (76)§ | 6 (75) | 5 (83) | 23 (77)° | 34 (40) | 57 (50) |
| No | 5 (24) | 2 (25) | 1 (17) | 7 (23) | 50 (60) | 57 (50) |
| Study Sponsorship | ||||||
| In house (no sponsor) | 3 (14)|| | 0 | 1 (17) | 3 (10)|| | 54 (64) | 57 (50) |
| Company | 5 (24) | 7 (88) | 3 (50) | 13 (43) | 13 (16) | 26 (23) |
| Federal funding | 13 (62) | 1 (12) | 2 (33) | 14 (47) | 17 (20) | 31 (27) |
| IRB Review Level | ||||||
| Full Board | 20 (95) | 7 (88) | 6 (100) | 28 (93) | 69 (82) | 97 (85) |
| Expedited | 1 (5) | 1 (12) | 0 | 2 (7) | 15 (18) | 17 (15) |
Notes:
*
Some PIs sponsored more than one protocol.
†
Since 1 protocol was not a clinical trial, total for analysis was one less than N for notify the PI and further testing.
‡
Chi-Square analyses were only performed on Notify the PI and the set of All Withdrawal Stipulations Combined, and not performed on ‘Return for another visit’ or ‘Return for further testing’ because of small numbers.
§
P < 0.05,
°
P < 0.005,
||
P < 0.0005.