POLICY STATEMENT

It is UAB policy that research will include additional safeguards to protect the rights and welfare of subjects when some or all of the subjects involved in the research are children.

When reviewing research involving children, the convened IRB or reviewer for expedited procedure will determine and document that the regulatory criteria allowing approval under 45 CFR Part 46 Subpart D, and if applicable 21 CFR Part 50 Subpart D and/or 34 CFR Part 97 Subpart D, have been met. Investigators are responsible for providing information for the IRB to make this determination.