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Appendix A-8 Additional Requirements for Environmental Protection Agency (USEPA) Research

  1. Research conducted, supported, or intended to be submitted to USEPA is subject to Environmental Protection Agency Regulations.
  2. Intentional exposure of pregnant women or children to any substance is prohibited.
  3. Observational research involving pregnant women and fetuses are subject to additional DHHS requirements for research involving pregnant women (45 CFR §46 Subpart B) and additional DHHS requirements for research involving children (45 CFR §46 Subpart D.)
  4. Research involving children must meet category #1 or #2.
  5. Other specific requirements of the US Environmental Protection Agency (USEPA) Research can be found in the “Additional Requirements for Environmental Protection Agency (USEPA) Research and Research Intended to be Submitted to the Environmental Protection Agency” section in the IRB’s “WORKSHEET: Additional Federal Agency Criteria (HRP-318).”