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45CFR46

Code of Federal Regulations

(Common Rule)

(Pregnant, Fetuses, Neonates)

(Prisoners)

(Children)

(IRB Registration)

Standard Operating Procedures

Moral

Decision-Making

1. DR.ETHICS™

Informed  Consent

2. RED BOOK

IRB: Exempt From CFR Purview?

IRB:Human Subject Research?

IRB: Need Informed  Consent?

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