Table 2

 Comparison of mean number (SD) of stipulations given in each category by IRB submission study type (pharmacological v non-pharmacological)

Stipulation categoryPharmacological (n = 60)Non-pharmacological (n = 62)F Value
All F values are statistically significant at p<0.003.
Consent form25.07 (20.21)8.40 (13.54)27.52
Spelling0.57 (1.65)0.07 (0.43)9.50
Grammar3.55 (4.31)1.03 (3.99)10.81
Format3.27 (4.40)1.05 (1.54)13.15
Phrasing6.50 (6.19)2.72 (4.94)13.34
Clarify risks and benefits3.80 (3.56)1.16 (2.32)22.55
Clarify protocol/procedures3.33 (2.77)0.88 (1.46)35.80
Study protocol0.07 (0.31)0.61 (1.08)14.28