Designated Review
UCI's IACUC utilizes a Designated Review procedure in certain specific circumstances:
- Certain modifications to existing approved protocols that do not significantly alter the approved design. Some examples of modifications appropriate for Designated Review are small numbers of additional animals (i.e., less than 10% of the originally approved allocation), addition of an experimental or therapeutic agent, or a refinement or minor change in procedure or euthanasia method.
- Non-invasive field studies, defined in the Animal Welfare Regulations as a "study conducted on free-living wild animals in their natural habitat. However, this term excludes any study that involves an invasive procedure, harms, or materially alters the behavior of an animal under study." (These are fairly rare at UCI.)
How Designated Review Works
Lead Researcher requests for Designated Review of modifications are screened by the IACUC Administrator and then sent out via email to all members of the IACUC. Since Designated Review by subcommittee typically takes place on Fridays, the email poling takes place on the Friday preceding the scheduled subcommittee review. Non-invasive field studies are sent out shortly after receipt in the IACUC office.
Each IACUC member should review the Designated Review request and let the Administrator know if he or she has any concerns. Specifically, each member must inform the Administrator if the modification or field study warrants full committee review. To encourage exchange of ideas, members should use "Reply to All" when commenting on a Designated Review request, so that all members may be informed of their concerns. But - it only takes one member of the IACUC to bring a modification request or field study to the full committee from Designated Review.
Remember to speak up if you have any concerns about the modification request or field study - if no one responds at all, the Administrator will assume that everyone concurs with the appropriateness of subcommittee review. Feel free to request additional information by contacting the Administrator - be specific about the questions to be asked, and be sure to indicate whether a little clarification or full committee review is needed.
If no one objects to Designated Review, then a subcommittee consisting of one scientific member of the committee and one veterinarian will meet in the IACUC Administrative Office to review the modification request and the approved protocol. The IACUC Administrator will periodically call for volunteers from the committee to take part in this procedure.
Once both members of the subcommittee sign the modification request, it is processed as an approved modification. A list of all modifications approved by subcommittee is appended to each month's IACUC minutes and becomes part of the committee's official record.
