Frequently Asked Questions

These FAQs provide guidance that represents OHRP's current thinking ont hese topics and should be viewed as recommendations, unless specific regulatory requiremtns are cited. The use of the word "must" in OHRP guidance means that something is requried 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. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.