IRB submissions (n = 124) given at least one stipulation, and descriptive statistics for number of stipulations given per submission by category
| Stipulation category | Number (%) of submissions with at least one stipulation | Number of stipulations | |
|---|---|---|---|
| Mean (SD) | Range | ||
| Consent form | 96 (74.2%) | 17.22 (19.48) | 0–109 |
| Grammar | 58 (48.3%) | 2.33 (4.29) | 0–29 |
| Format | 72 (60.0%) | 2.35 (3.99) | 0–24 |
| Phrasing | 74 (61.7%) | 4.73 (5.90) | 0–30 |
| Jargon | 51 (42.5%) | 1.65 (2.92) | 0–14 |
| Clarify risks and benefits | 68 (56.7%) | 2.53 (3.29) | 0–14 |
| Clarify protocol/procedures | 72 (60.0%) | 2.51 (2.56) | 0–10 |
| Study protocol | 23 (18.5%) | 0.34 (0.84) | 0–4 |
| Research/measure/forms/surveys | 5 (4.0%) | 0.05 (0.25) | 0–2 |
| Application to the IRB | 4 (3.2%) | 0.03 (0.18) | 0–1 |
| Site participation letter | 10 (8.1%) | 0.10 (0.37) | 0–3 |
| Other | 9 (7.3%) | 0.10 (0.37) | 0–2 |