Institutional Review Board (IRB) approval will be required for (final approval of) Supplemental Methodological Studies (SMS) that interact directly with National Children’s Study participants and/or use participants’ identifiable data, biospecimens, and/or environmental samples. The reviewing IRB will determine whether samples are identifiable and whether a proposed SMS should be considered human subjects research. SMS will require local (and perhaps NICHD) IRB review and approval or a determination by the relevant IRB that the study is not considered human subjects research. Note: IRB approval is not required prior to provisional approval, but is required prior to final approval to implement the SMS.
NICHD IRB: The National Children’s Study Program Office staff (Human Subject Protections/IRB Team) will determine whether a given application requires NICHD IRB review. If it does, the IRB Team will initiate the process at NICHD. If NICHD IRB approval is required, this approval should, whenever possible, precede local IRB approval and must be obtained prior to final approval to implement the SMS.