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107. FDA Requirements for IRB Review

IRB Review (§56.109)

DHHS criteria for IRB review and approval of research apply to FDA research (for details, refer to the DHHS policy section) with the following FDA exceptions for IRB approval of the informed consent process:

  • Under specific conditions as required by the FDA (§50.23), the University Biomedical IRB allows exceptions to DHHS requirements for informed consent for emergency use of a test article for an individual as described previously.
  • Although FDA allows an exception from informed consent requirements for planned emergency research (§50.24), the University Biomedical IRB does not currently review or approve planned emergency research. Consequently the requirements to notify Sponsor of exceptions to informed consent under §50.24 do not apply.

FDA Requirements for IRB Review by Expedited Procedures (§56.110)

Use of expedited procedures for IRB Review of FDA research is consistent with DHHS requirements (i.e., the Common Rule) with the following addition:

  • Category 3: FDA (with agreement from DHHS) also considers the following procedures to be noninvasive:

o   Vaginal swabs that do not go beyond the cervical os;

o   Rectal swabs that do not go beyond the rectum; and

o   Nasal swabs that do not go beyond the nares.

Review by the University or Affiliate Institution (§56.113)

As is consistent with the Common Rule, FDA research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the University or affiliate institutions. However, institutional officials may not approve research that has not been approved by an IRB.

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