Protocol Noncompliance: Questions

Protocol Noncompliance: Questions
Protocol Noncompliance   Institutional Animal Care and Use Committees

  • Is it a requirement to report serious adverse events and all incidents of protocol noncompliance to USDA, APHIS?
    • No. Only the following are required by the Animal Welfare Act regulations to be reported:

• Change of operations: 9 CFR §2.30 (c) (1)  

• Protocol suspension: 9 CFR §2.31 (d) (7)

• Uncorrected significant deficiencies from a semi-annual inspection: 9 CFR §2.31 (c) (3)

• The Annual Report: 9 CFR §2.36

  • Is it a requirement to report all serious adverse events and serious or continuing incidents of protocol noncompliance to NIH, OLAW?
    • Yes. According to NIH Notice NOT-OD-05-034(link is external), PHS Policy, IV.F.3, requires that: "The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: (a) any serious or continuing noncompliance with this Policy; (b) any serious deviation from the provisions of the Guide [for the Care and Use of Laboratory Animals]; or (c) any suspension of an activity by the IACUC." 
  • Does OLAW expect the IACUC to report incidents of noncompliance even if no animals were harmed and the incident wasn’t intentional? 
  • May an IACUC suspend (stop) animal activities that it did not initially approve?
    • Yes. The PHS Policy, Guide, and the USDA Animal Welfare Regulations presume that all ongoing animal activities have received the required prospective review and approval. An activity that has been undertaken without prior approval should be halted and subsequently reported to OLAW because it constitutes serious noncompliance.