The Assurance between Michigan Tech and the Public Health Services for the IACUC allows administrative approval, by the IACUC chair, for protocol amendments that are solely to:
- Add, delete, or change a title of a study;
- Add, delete, or change personnel other than the Principal Investigator;
- Add or delete location(s);
- Add laboratory animals (rats and mice only) to an approved protocol when the increase is no greater than 10% of the original number of animals;
- Add, delete, or change a funding source.
The Principal Investigator (PI) is responsible for the submission of the completed and signed amendment form to the IACUC staff. Final approval of an amendment for addition of personnel will not be given until all personnel have received appropriate training and have enrolled in the Occupational Health Program (OHP).
The above reviews will be designated as “Administrative Reviews” in the on-line submission management system. “Approval” may be listed as either “approved” or “acknowledged” in the system.
Addition of Personnel (other than PI)
When the IACUC receives an amendment that includes addition of new personnel:
- Personnel shall not work with animals until they have completed the required on-line training course(s) at citiprogram.org and this has been verified by the IACUC Chair. Required training includes completing the Investigators, Staff and Students courses and the appropriate species-specific modules (dependent upon each individual protocol).
- Personnel also shall not work with animals until they have enrolled in Occupational Health Program.
Addition of Location
Addition of new location(s) for the use of animals may be administratively approved after the PI has submitted an amendment indicating a request for location change. This location shall be approved in writing by the Attending Veterinarian or designee as allowable before the site may be used to conduct animal work. All locations where animals are housed, or procedures take place, are subject to IACUC approval and must be inspected by the IACUC before animal work may commence. The Attending Veterinarian (or designee) shall have 24/7 access to all locations where animal work is carried out.
Addition of Animal Numbers
An increase of up to 10% in the number of laboratory rats and/or mice (but not other species) approved in the original protocol may be approved administratively after the PI has submitted an amendment indicating a request for additional animals. This number must be verified by the IACUC chair, or designee, as allowable before additional animals may be put on the protocol by purchase or transfer.
Addition of Funding Source
Addition of a new or different funding source may be administratively approved. However, if the funding source requires a grant/protocol comparison, then the change may be administratively approved only after the assigned reviewer provides written verification that the comparison is satisfactory.
Reporting to IACUC
All administratively approved amendments will be placed on the agenda for the next scheduled meeting of the IACUC for informational purposes. All administrative approvals take effect when verification of all requirements is completed and written notification from the IACUC or their designee is sent to the PI.