An active study of 30 pts w/spinal deformity underwent 3 column osteotomy procedures for deformity correction is evaluating the following outcomes at 3,6,12 months. Research proposal was approved by IRB but on week 2, health-related quality-of-life questionnaire which serves to evaluate additional study outcomes is added to the protocol. What's true regarding the need to resubmit the study protocol to IRB?
A) No need to resubmit since the original study was approved
B) Resubmission is required since the new measure affects participant safety
C) Resubmission is optional, depending on the significance of the new measure
D) Resubmission is required, as any protocol change must be approved