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Human Subjects

Policies & Guidance

Additional Review by Non-IRB Committees

Some human subjects research studies may require review by and approval from regulatory offices or committees other than the IRB. According to both regulatory requirements and “ best practices” (for example, AAHRPP accreditation standards), IRB approval must be withheld until all other such approvals have been obtained. Such other offices/committees may be either internal or external to IU.

  • For committees internal to IU (for example, Radiation Safety Committee):
    • Documentation of submission to such a committee must be included in your submission to the IU HSO;
    • Any such submission to the HSO without documentation will be determined to be incomplete until documentation is submitted; and
    • Except in extraordinary circumstances, a ny such incomplete submission will not be forwarded to a convened IRB or expedited reviewer until documentation is obtained.
  • For committees external to IU (for example, other IRBs or Ethics Committees such as at Moi University or other institutions with which IU has subcontracted for human subjects research):
    • Approval from such a committee should be obtained prior to submission to the IU HSO;
    • Any such submission to the HSO without approval will be determined to be incomplete until approval is obtained; and
    • Except in extraordinary circumstances, any such incomplete submission will not, be forwarded to a convened IRB or expedited reviewer until approval is obtained.
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