Step 4: Responsibilities after Initial Approval
Requesting Amendments or continuing reviews
- Requesting an amendment for any significant changes to your proposed study procedures, funding, personnel, substances administration or any other changes PRIOR to conducting the new procedures.
- Minor administrative changes can also be submitted through the Amendment process.
- A protocol is approved for a three year approval period. The expiration date is 3 years from the date of approval and that cannot be extended. Funded work must be renewed prior to expiration to avoid non compliance or issues with funding or publication.
- The RED system allows the PI to copy their existing protocol to create their 3 year rewrite. The information must be fully updated prior to resubmission per this guidance.
Documentation and Records Requirements
- Maintaining accurate records for animal use, census
- Maintain Surgery records
- Maintain Training records for all staff and submit amendments for personnel changes
Laboratory/ Unit/ Facility Inspection requirements
NC State’s Institutional Animal Care and Use Committee (IACUC) is responsible for the inspection of all NC State owned sites where vertebrate animals are housed or used for purposes of research, teaching and testing. The frequency and specific methodology of these inspections vary with the type of activity conducted, discussed further below. In general, all housing sites and all areas where survival surgery is conducted are inspected at least once every six months.