Federal regulations consider pregnant women, human fetuses, *neonates of uncertain viability, and *nonviable neonates (hereafter referenced as PG Women/Fetuses) to be vulnerable populations. For research conducted or supported by DHHS or other federal agencies, under Subpart B (45CFR46.201-206) the regulations require additional safeguards for their protection in human research. Show
Through its IRB-Flex policy, the University opts to suspend Subpart B and apply equivalent protections for minimal risk research involving PG Women/Fetuses that is neither conducted nor supported by a federal agency. Specifically, for non-federally funded minimal risk research involving PG Women/Fetuses, the IRB may suspend the requirements for preclinical studies, least possible risk to fetus, and both mother's and father's consent for research that holds out the prospect of direct benefit solely for the fetus, while ensuring protections are adequate. Research involving PG Women/Fetuses requires the researcher form Population: Pregnant Women and Fetuses. NOTE: Biomedical research involving investigational drugs or devices may have implications for women of childbearing potential. These implications are addressed in subsequent policy sections. For Research Subject to Subpart B: Requirements for IRB Review and ApprovalAs noted above, the University applies Subpart B to all federally funded research, and to all greater than minimal research. Additionally, for federally-funded, minimal risk research, the IRB may determine that existing protections are sufficient and no additional protections are warranted. The IRB's determination that existing protections are sufficient, or the IRB's findings related to the requirements for Subpart B will be documented in IRB minutes for projects reviewed at convened IRB meetings, or in project records for projects reviewed by expedited procedures. IRB Approval for Research Involving PG Women/Fetuses (§46.204)When Subpart B applies to projects involving PG Women/Fetuses, the IRB will confirm and document all of the following requirements are met:
IRB Approval for Research Involving Neonates of Uncertain Viability or Nonviable Neonates (§46.205)The IRB requires University and affiliate researchers planning to involve neonates of uncertain viability or nonviable neonates in research to meet all of the following conditions:
Additional Requirements Specific to Research Involving Neonates of Uncertain Viability
Additional Requirements Specific to Research Involving Nonviable NeonatesAfter delivery, a nonviable neonate may not be involved in research unless all of the following additional conditions are met:
Research Involving Viable Neonates.After delivery, the additional requirements for research involving children (i.e., Subpart D) apply to research involving viable neonates. IRB Approval for Research Involving the Placenta, the Dead Fetus or Fetal Material (§46.206)The IRB is must review and approve research involving the placenta, dead fetus or macerated fetal material, or cells, tissue, or organs excised from a dead fetus only if information associated with this material is recorded for research purposes in a manner that living individuals (e.g., parents, siblings) can be identified, directly or through identifiers linked to those individuals. If such identification is possible, then the individuals who may be identified are research participants and federal regulations for the protection of human participants apply. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates (§46.207)Federal regulations include a risk-benefit category for IRB review of research projects involving PG Women/Fetuses that are not approvable under one of the three previously identified types of research (i.e., §46.204, §46.205, or §46.206). If a University or Affiliate Investigator proposes to engage in research that is not otherwise approvable and therefore requires review under §46.207, the Director of Research Integrity and/or the Chair of the IRB will meet with the PI. The purpose of the meeting will be to explore options for review by another IRB in the Western states that regularly reviews pediatric research (e.g., UCSF Benioff Children's Hospitals in San Francisco or Oakland). The PI will be encouraged and offered guidance to establish an agreement with the external IRB for regulatory review. Research Involving Transplantation of Fetal Tissue or Non-embryonic Stem CellsOther federal laws apply to research involving fetal tissue and non-embryonic stem cells. The University will not engage in either of these research activities. Is this research permitted under subpart B quizlet?Is this research permitted under Subpart B? Yes - this research is permitted.
Can research subject to subpart b and that includes pregnant?Federal Research Regulations
These special protections are found in Subpart B. The IRB may approve research involving pregnant women or fetuses only if all conditions for research are met (see description of conditions below) provided that the research also meets the general criteria for approval.
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