Procedure for Not Human Subjects Research Designation
This procedure describes how human materials or data not involving human subjects under the definition of 45 CFR Part 46 and 21 CRF Part 56 may receive a designation of "Not Human Subjects Research." Use of the Not Human Subjects Research designation is applicable to research activities that involve cadaver materials, use of outdated blood products (from the Red Cross or other blood banks), commercially available cell lines, or coded private information (OHRP, Guidance on Research Involving Coded Private Information or Biological Specimens) unless the sponsoring agency determines otherwise.
Chair or designee:
Approved on November 2, 2009, by:
Ferdinand Urthaler, MD
Sheila Deters Moore, CIP