Research Guidelines for Vulnerable Subjects
	§ DHHS regulations allow IRBs to approve research for children and vulnerable populations which is categorized as: – Minimal risk – Having a direct benefit to subjects § Investigations that involve more than minimal risk without direct benefit may require: – Approval of DHHS – Greater scrutiny by panel of experts § Exemptions from review of research involving adults (45 CFR 46.406) may not apply to research involving children or “vulnerable subjects”