1. Additional Protections for Children Involved as Subjects in Research
Mary Prather, RN MPH
June 6, 2014

2. Background 21 CFR Part 50, Subpart D 45 CFR Part 46, Subpart D AAHRPP
Standard II-4
Standard II-5
FDA & OHRP
not greater than minimal risk
greater than minimal risk but present the prospect of direct benefit
greater than minimal risk and not prospect of direct benefit to individual subjects but likely to yield generalizable knowledge about the subjects disorder/condition
Not otherwise approvable
Wards
In each category the regulations describe approval criteria and prescribe the assent and permission requirements
Both require the IRB “FINDS”, FDA requires “and DOCUMENT”
Standard II-3: The IRB or EC approves each research protocol or plan according to criteria based on applicable laws, regulations, codes, and guidance
Standard II-4: The IRB or EC provides additional protections for individuals who are vulnerable to coercion or undue influence and participate in research
Standard II-5: The IRB or EC maintains documentation of its activities