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91. Additional EPA Requirements for IRB Review and Approval

In addition to the Common Rule, University IRBs will comply with the following additional requirements before approving research invoking EPA regulations.

  • The IRB will not approve research involving intentional exposure of pregnant women or children to any substance. This includes research not yet submitted to the EPA.
  • The IRB will review and approve observational research involving pregnant women and fetuses only if the IRB finds and documents that the research is consistent with 45 CFR 46 Subpart B (for details, see IRB policy for research involving pregnant women and fetuses).
  • The IRB will review and approve observational EPA research involving children that does not involve greater than minimal risk only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians (for details, see IRB policy for consent and assent requirements for research involving children).
  • The IRB will review and approve observational EPA research involving children that poses greater than minimal risk only if the IRB finds and documents that

o   the intervention or procedure holds out the prospect of direct benefit to the individual subject or is likely to contribute to the subject's well-being,

o   the risk is justified by the anticipated benefit to the subjects,

o   risk-to-benefit ratio of the research is at least as favorable to the subjects as that of available alternative approaches, and

o   adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.

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