These FAQs provide guidance that represents OHRP's current thinking on these topics 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. 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.