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.
Amendments
Animal welfare regulations require that investigators obtain IACUC approval for all significant changes to approved animal research protocols. The IACUC has developed guidelines and procedures to help investigators determine what qualifies as a significant change amendment to an approved protocol for animal use as well as a process to follow for procedures that may be handled administratively.
Using Office of Laboratory Animal Welfare guidance on Significant Changes to Animal Activities, the IACUC defines amendments as:
Significant Changes requiring full committee or designated member review
A significant change requiring full committee or designated member review are those that are an amendment of or deviation from previously approved protocol procedures that have, or have the potential to have, a negative impact on animal welfare.
Examples include:
- changes from nonsurvival to survival surgery;
- changes resulting in greater pain, distress, or degree of invasiveness;
- changes in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;
- changes in species;
- changes in study objectives;
- changes in Principal Investigator (PI); and
- changes that impact personnel safety.
Significant Changes requiring attending veterinarian authorization
A significant change requiring attending veterinarian authorization are those that are a modification to or amendment of previously approved protocol procedures may not have a direct impact on animal welfare, but are considered significant. This process is incorporated into UMBC animal care and use program and follows the August 2014 NIH Guidance on Significant Changes to Animal Activities Notice (NOT-OD-14-126).
Examples include:
- changes in anesthesia, analgesia, sedation, or experimental substances;
- changes in euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals;
- changes in duration, frequency, type, or number of procedures performed on an animal; and
- an increase in previously approved animal numbers
Changes that may be handled administratively
OLAW’s guidance allows for some proposed changes to protocols to be reviewed by an IACUC administration office (e.g. the ORPC) and presented, where appropriate, to the IACUC Chair and/or attending veterinarian for administrative approval.
Examples include:
- correction of typographical errors;
- correction of grammar;
- contact information updates;
- change in personnel, other than the PI (including documenting training), and
- investigators using fewer animals than approved.
All amendments are now submitted KUALI protocols. Go into your KUALI protocol and click on the Amend tab on the right hand side. From there you can select the type of modification you are requesting. You will also update your protocol with your new modification and then click on the submit button. The OPRC staff will review the requests and provide documentation of the receipt of such changes and indicating these modifications have been added to the approved protocol.
Annual Review
Kuali Protocols will forward a courtesy email notification to investigators of the requirements for annual review at least thirty (30) days before the protocol’s anniversary date and send a reminder at least fifteen (15) days prior. The ultimate responsibility for submitting the annual review report on time lies with the researchers. This report requests information about the activity of the protocol, whether any complications have been observed and if there any proposed changes for the upcoming year. Delinquency is submitting an annual report will result in an administrative hold being placed on the protocol.
Use the “Renew” section in your approved protocol to begin the process of submitting an annual renewal.
Annual renewals are reviewed by the ORPC and forwarded to the next committee meeting for informational purposes only. If complications or modifications are identified in the report, the IACUC Chair and/or other members will, as needed, review the annual report. Annual renewals that require changes may be submitted using the “Renew/Amend” section in your approved protocol. Annual renewal requesting significant changes will undergo DMR or full committee review.
Third Year Renewal
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). ORPC 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.
Using the “Submitting an IACUC Protocol” section in Kuali Protocols for submitting a new protocol.