Can records or databases be reviewed to identify potential subjects without obtaining informed consent or parental permission?

Yes, under certain circumstances. Although the HHS regulations do not specifically reference this type of activity, sometimes referred to as “preparatory to research,” such an activity must be reviewed and approved by an IRB in accordance with HHS regulations at 45 CFR 46.109(a) when: • The activity involves human subjects research, as defined by the regulations at 45 CFR 46.102(f); • The research does not meet the criteria for exemption under HHS regulations at 45 CFR 46.101(b). In general, informed consent of the subjects, or parental permission for children involved in research, must be sought and documented in accordance with, and to the extent required by, HHS regulations at hhs.gov/ohrp/humansubjects/guidance/45cf...">45 CFR 46.116 and 45 CFR 46.117 respectively.

However, an IRB may approve a consent or parental permission procedure that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirements to ...

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