Doesn adding personnel take a long time for the IACUC to approve?
No, it is accomplished by filling out the short Protocol Personnel Modification Form (PPMF)5. NOTE: for eProtocol REVISIONS, the process may be delayed if there is a pending action (e.g., REVISION or RENEWAL). In order to help make this as simple as possible, the OLAW guidance was revised in 2003 to allow changes in personnel (other than the PI) to be considered a “minor” change which can be approved administratively rather than requiring a full IACUC protocol review. The IACUC is still required to assure that all such personnel are a) appropriately identified, b) adequately trained and qualified, and c) enrolled in applicable occupational health and safety programs6. The basic training requirements for being added to a protocol can be fulfilled by turning in a short occupational health questionnaire form and completing a few online training modules. A complete description of how to fulfill training requirements can be found on the IACUC website7.
Related Questions
- You said the SMProcess can be completed within 2 months. How many of our personnel are needed, and must they be dedicated to this for the entire time?
- How will the IRB approve all of these submissions in time to ensure that everyone is compliant with the new HIPAA regulations before April 14th?
- How does the TPS licensing work with administrative and personnel that we track time for?
