The Department of Health and Human Services Office for Human Research Protections has announced the availability of a new set of Frequently Asked Questions and Answers on Informed Consent. These FAQs provide guidance on OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited.

The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required.