Investigators who propose research with these groups must provide information about their involvement, including special protections that will be afforded to these participants. The IRB must be able to determine that the protections will satisfy the applicable federal regulations (i.e., 45 CFR 46 Subpart B). Investigators use the Special Population Review Form—Pregnant Women, Fetuses, Neonates/Nonviable Neonates to provide protocol-specific information that is sufficient for the IRB to confirm that the applicable requirements are met.
A neonate, after delivery, or a fetus that has been determined to be viable may be included in research only if the provisions of Subpart D of 45 CFR 46 are met. Therefore, the investigator must assign a Children's Risk Level and submit the Special Population Review Form: Children, Minors. Please contact the OIRB on a protocol-by-protocol basis for guidance.​