NON-THERAPEUTIC RESEARCH
Only if risk is minimal or a “minor increase over minimal risk”; defined by IRB
- nature of study and exposures commensurate with those in the patients’ actual or expected medical, psychological, social, or education situations
- a single needle stick (or placement of an IV catheter)
- within experience of most children “going to the doctor”
- a bone marrow aspirate may be acceptable as part of a study in children with cancer being evaluated with a new chemotherapy agent