Frequently Asked Questions (FAQs) & Other Guidance

OHRP’s Division of Policy and Assurances offers a list of frequently asked questions and other guidance documents about the HHS regulations for the protection of human subjects in research. FAQs are organized by topic. Select the link below to go to the respective FAQs page in Regulations & Guidance.

• 45 CFR 46 (the Human Research Regulations) FAQs 
• Assurance Process FAQs 
• Children: Research with Children FAQs 
• Exempt Research Determination FAQs 
• Informed Consent FAQs 
• Investigator Responsibilities FAQs 
• IRB Registration Process FAQs 
• Prisoner Research FAQs 
• Quality Improvement Activities FAQs 
• Other Guidance