IACUC Policy 017: Administrative Review Eligibility

1. Purpose: The purpose of this policy is to define the process and criteria under which the OHIO IACUC staff may conduct administrative reviews of proposed changes to previously approved animal research protocols. This policy ensures that such reviews are consistent with federal regulations, including the PHS, NIH-OLAW, and USDA-APHIS.
2. Scope: This policy applies to all animal research activities conducted under the oversight of the OHIO IACUC. It specifically addresses the review and approval of non-significant changes and certain significant changes to animal protocols that may be handled administratively. 

3. Policy: Protocol changes that may be reviewed and approved administratively (i.e. non-significant changes) include:

   a.	correction of typographical errors;
   b.	correction of grammar;
   c.	contact information updates; and
   d.	change in personnel, other than the Principal Investigator (PI).    NOTE: There must be an administrative review to ensure that all such personnel are appropriately identified, adequately trained and qualified, enrolled in occupational health and safety programs, and meet other criteria as required by the IACUC.)
   e.	Change in funding status.

4. Process:

4.1 Amendment Submission- PI or PI Group Member submits an amendment to an approved protocol. 

4.2 Screening by IACUC Staff- Staff determines if the amendment qualifies for administrative review based on criteria a–e. (e.g., personnel changes, contact information updates, typographical corrections). 

4.3 Assignment to IACUC EHS Representative- If new personnel are added, the amendment is routed to the Environmental Health & Safety (EHS) representative to verify Occupational Health enrollment. 

4.4 Training Verification- If new personnel are added, IACUC staff verifies the following: 

• One, all personnel listed in the amendment have completed the CITI Program Course titled “Investigators, Staff, and Students (IACUC) (i.e. Working with the IACUC).
• The IACUC staff member verifies that the Principal Investigator (PI) or designated PI Group Member has provided information about the relevant training and experience for all personnel listed in the amendment. This information is located in each team member’s Training Profile If any individual lacks the necessary training, a statement that the individual(s) will be trained must be documented in that individual’s Training Profile. 

5. Definitions & Acronyms: 

• Significant Change – A modification to an approved animal activity that may: 1) Have a negative impact on animal welfare, or 2) Involve administrative or procedural changes that require IACUC oversight.
• NIH- National Institutes of Health
• PHS – Public Health Service
• OLAW – Office of Laboratory Animal Welfare
• USDA – United States Department of Agriculture
• APHIS – Animal and Plant Health Inspection Service 

6. References & Resources: 

• 6.1 NIH-OLAW Significant Changes- https://olaw.nih.gov/guidance/significant-changes.htm 

7. Change History: