Significant Changes to Approved Research Protocols
Overview/Policy Statement
Animal Welfare Regulations require that investigators receive IACUC approval for all significant changes to approved animal research protocols. However, federal regulations provide little guidance with respect to actual criteria to be used in determining what constitutes a significant change to an approved research protocol.
Policy Statement: The IACUC has defined a Significant Change as any deviation from the protocol that substantially alters or affects the overall study objectives/rationale, specific approved procedures, or the potential for pain, distress and discomfort in the animals. The following guidelines have been developed to help investigators determine what qualifies as a significant change to an approved protocol for animal use, and has set forth procedures to assist in the timely review and approval of such changes.
In general, the addition of a new procedure that increases the invasiveness or the amount of pain or distress an animal experiences requires a full committee review. Additionally, if the study objective changes significantly, a new protocol may be required. Consultation with a ULAR Veterinarian or the IACUC Administrator is recommended for assistance in determining appropriate levels of review.
Levels of Review
Full committee review — the modification request must be presented for discussion and vote at a convened meeting of the full IACUC. Examples of modifications that require full committee review:
- An increase in the number of animals in excess of 10% over the originally-approved allocation
- Addition of a more invasive procedure
- Addition of a survival surgical procedure.
- Addition of a new species
- Change in Lead Researcher
Designated Review — the modification may be reviewed by a subcommittee consisting of at least two voting members of the IACUC, provided that no member of the IACUC calls for an elevation of the modification request to full committee following review of a written description of the request by all committee members. Examples of modifications that may be considered for Designated Review:
- Addition of a non-invasive procedure, such as a behavior test.
- Addition of or minor changes to experimental or therapeutic agents
- A small number of additional animals (less than 10% increase over previously-approved allocation).
Administrative/Chair Review — the modification will be reviewed by the IACUC Administrator and presented, if appropriate, to the IACUC Chair for administrative approval. Examples of modifications appropriate for administrative review:
- Addition or deletion of non-essential personnel (graduate student researchers, undergraduates.)
- Change of animals between approved categories, such as from “Pregnant” to “Dam with Litter” or between “Adult” and “Adult-s”, provided that the pain/distress category is either lowered or does not change.
Procedure for Submitting Modification Requests
PROCEDURE FOR SUBMITTING MODIFICATION REQUESTS:
Download the Modification Request Form and review the Instructions.
NEW: Revised Version of the Protocol: Each modification to an approved protocol must be incorporated into the approved protocol narrative and highlighted to ensure that the additions and/or changes are clear to IACUC reviewers. Lead Researchers are responsible for maintaining the current approved version of all animal protocols.
NOTE: Requests to modify approved IACUC protocols cannot be submitted via the web portal at this time. Modification requests may be submitted via email attachment by sending them directly to the IACUC administrative mailbox at IACUC@rgs.uci.edu, or they can be delivered via campus mail to the Office of Research Administration.
-- IMPLEMENTATION OF NEW PROCEDURE --
Beginning June 1, 2007, the IACUC will implement a new requirement for submission of revised versions of the entire protocol with each approved modification incorporated into the narrative and highlighted. In order to minimize the burden on researchers with existing protocols, this requirement will be phased in according to the following schedule:
- All new and three-year renewal protocols approved on or after June 1, 2007 – revised versions of the entire protocol are required with each modification request.
- Protocols in year 1 of the approved three-year cycle as of June 1, 2007: All previously-approved modifications (i.e., any modifications that were submitted and approved during the first year after full committee review and approval) must be incorporated into the narrative, and a fully revised version of the protocol must accompany the Annual Continuation Application submitted at the end of year 1. All subsequent modification requests must be accompanied by a revised version of the protocol.
- Protocols in year 2 of the approved three-year cycle as of June 1, 2007: All previously-approved modifications (i.e., any modifications that were submitted and approved during the first and second year after full committee review and approval) must be incorporated into the narrative, and a fully revised version of the protocol must accompany the Annual Continuation Application submitted at the end of year 2. All subsequent modification requests must be accompanied by a revised version of the protocol.
- Protocols in year 3 of the approved three-year cycle as of June 1, 2007: Since these protocols will be due for de novo review by the full committee at a convened meeting, Lead Researchers are not required to incorporate all previously-approved modifications into the approved narrative. However, those researchers whose protocols have few approved modifications may elect to incorporate them into the narrative at any time, and those that have already begun to follow the new procedure should feel free to continue to do so.
