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B203 Organization Policy on Research Involving Pregnant Women, Fetuses, Neonates

August 2008

The Organization requires adherence to DHHS regulations regarding additional protections required for research involving pregnant women, fetuses, and neonates.  In addition to the other responsibilities assigned to the JHM IRBs under 45 CFR Part 46 Subpart A, the Organization requires the IRBs to make determinations on whether pregnant women may or may not be included in research (45 CFR 46  Subpart B, 46.203).  For research that requires convened review and the IRB determines that the research procedures are more than minimal risk, the required regulatory findings must be documented on a review sheet.  For research that will involve neonates, the IRB must make required regulatory findings and document the determinations on a separate review sheet.

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