Post Approval Administration

One major investigator responsibility is to be compliant all IACUC policies, decisions, conditions, and requirements. This means ensuring that the research is implemented as specified in the approved IACUC protocol. Review the below topics to view what is required after the IACUC provides approval.

Modifications and Ammendments

Modifications to approved protocols must be documented appropriately, reviewed, and approved.

Minor modifications may entail such things as increasing by small numbers additional animal subjects, addition of new personnel (i.e. assignment of a new technician), or perhaps changing the route of administration of drug.  Minor modifications may be approved administratively by the IACUC Chair and the University Veterinarian without full review.  Minor changes can be proposed through submission of a Request for Minor Change/Amendment to an Animal Use Protocol form.

Click to download the Request for Minor Change/Amendment to an Animal Use Protocol  

Major modifications may entail a large change in numbers of animals being used or requested, an increase in invasiveness, a change in species, an increase in pain or discomfort, or a change in the method of euthanasia. Significant changes in protocols for ongoing use of vertebrate animals in research, testing, and education will be submitted using a Request for Significant Change to Animal Use Protocol form for review at a regularly scheduled meeting of the full IACUC committee.  Investigators must await approval by the IACUC before implementing the revised protocol procedures. Revised protocols must also meet the standards of the “Animal Welfare Act”, the Guide, and State and local regulations.

Click to download the Request for Significant Change to an Animal Use Protocol

Annual Review / 3 Year Renewals 

The Human and Animal Research Protections Office (HARPO) will monitor the cycle and forward notification to investigators of the requirements for continuing review at least thirty (30) days before the scheduled end date.

An administrative review of vertebrate protocols is required prior to the end of the protocol period. The investigator will submit to HARPO, at least thirty (30) days before the first day of the anniversary month, a report of any changes or departures from the originally submitted protocol and a narrative explanation for such changes. If no changes have been made, a statement to that effect must be submitted.

Click to download the Protocol Annual Review Report

PHS Policy (IV.C.5.) states "the IACUC shall conduct continuing review of activities covered by this policy at appropriate intervals as determined by the IACUC but not less than once every three (3) years".  UMBC animal research protocols are approved for a three-year term. The investigator or instructor must resubmit, at least ninety (90)  days before the next regularly scheduled IACUC meeting, a new application for Committee review in order to continue research activities.

It is the responsibility of the principal investigator (PI) to maintain the “approval” status of his or her protocol(s). HARPO will generally give advanced notice when protocols need three-year renewals and will provide help when requested.

Per PHS Policy, the IACUC may not extend the three-year approval by any means other than IACUC review and approval using the procedures of IV.C.2. When IACUC approval expires, it is no longer valid - there are no exceptions and no extensions of approval granted by the IACUC.

No experimental use or observation of animals may take place during a protocol lapse period. Continuation of animal activities beyond the expiration is a serious and reportable violation of PHS Policy.

Reports of adverse events, which are events that occur consistent with routine care or expected outcomes that results in an unexpected morbidity or mortality in animals that was not described in the animal use protocol, should be reported at the time of the problem or event and summarized in the Annual Report, including an explanation of how these events/problems were resolved.

A new Animal Research Protocol Form must be submitted; this form undergoes the same review process as any new protocol. The renewal should include all previous modifications or amendments made to the protocol since its original approval.

Click to download a Animal Research Protocol Form

Protocol Monitoring           

info to come

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