C&G PROCEDURES FOR PROJECTS INVOLVING ANIMALS

(sent to C&G Reps 8/16/02)

The National Institutes of Health have announced “just-in-time” procedures for certification of review and approval of animal usage by the Committee on Animal Research (CAR). The “just-in-time” procedures are applicable for all proposals submitted to the NIH for receipt dates that will result in those applications being reviewed for May/June 2003 Councils. The NIH application deadlines are September 10, 2002 and later. “Just-in-time” is not applicable for the September 1 deadline. Principal Investigators submitting proposals to the NIH no longer need to submit animal protocols to the CAR before proposal submission but now may wait until they are alerted by the funding institute that the proposal will be funded.

If CAR review will occur “just-in-time” as announced in the NIH Guide for Grants and Contracts dated August 8, 2002 check “yes” for Vertebrate Animals on the PHS 398 application face page and write “JIT” in the space where one would otherwise insert either the CAR Approval Date or “pending”. Pending for the NIH signifies that a CAR application is under review and therefore should not be listed on a “just-in-time” application.

At this time “just-in-time” procedures for CAR review have only been announced by the National Institutes of Health. For other Public Health Service and federal agencies it is still required that the animal use application either be under review by the CAR at the time of proposal submission (“pending”) or that the CAR review and approval date is noted on the grant application face page. Non-competing continuation applications are not under “just-in-time” and must have CAR approval when the application (progress report) is submitted.

(posted to web 10/20/2000)

In order to insure compliance with US Public Health Service (PHS) regulations this notice is being sent in advance of a forthcoming memo to faculty and campus administrators from the Vice Chancellor for Research. Effective immediately the Contracts and Grants Office (C&G) review of all proposals being submitted to any PHS agency, will include review to assure that: 1) Committee on Animal Research (CAR) approval is currently in place at the time of proposal submission, 2) the CAR approval date is correctly noted on the grant application face page, and 3) an application has been submitted to the CAR for any grant proposal that cites the animal approval as "pending".

In recognition that proposals are being prepared for the upcoming November 1 deadline investigators and fellows may need to submit applications to the CAR immediately. It is critical for the upcoming deadline that investigators be informed that "pending" CAR approval means that an application is on file with the CAR for review. Proposals to PHS agencies without either a current CAR approval or a CAR Application in process will not be submitted. In order to perform this compliance review it is required that the following be submitted as attachments to the Contracts and Grants Approval Form, the revised version of which is now available on the Contracts and Grants website. This new version of the C&G Approval Form should be used effective immediately when submitting proposals to C&G. Required attachments to this form when animal subjects are involved are:

1. One copy of the relevant CAR Approval Letter that corresponds to activities fully described in the Research Plan section of the PHS proposal.



2. One copy of the Personnel Chart of the CAR application if the CAR Approval Letter is issued to someone other than the Principal Investigator of the PHS proposal. If the Principal Investigator needs to be added to the Personnel Chart that must be done prior to proposal submission. Sponsors of post-doctoral scholars applying for fellowships must add the post-doc to the Personnel Chart and submit for CAR review any modifications to the protocol as needed for performance of the work described in the PHS fellowship application. This must be done in advance of the submission of the fellowship application.



3. One copy of the CAR Application Cover Page showing the date of submission to the CAR if the PHS proposal face page is marked "pending" for CAR approval. No PHS proposal marked "pending" for CAR Approval will be submitted by Contracts and Grants unless the CAR has received the application for the work described in the PHS proposal. For proposals where animal use approval is marked as "pending" Principal Investigators should be reminded that institutional certification of CAR approval to the PHS funding agency is required within 60 days of the proposal submission date, and this material must be forwarded to PHS via C&G. If CAR review and approval and the certification to the PHS agency is not made within the 60-day period the PHS proposal may be withdrawn.

No proposal for a non-competing continuation application will be submitted on to the awarding agency without a current CAR approval in place, in accordance with the PHS 2590 continuation application guidelines. Principal investigators should be reminded of the requirement to renew animal care and use protocols annually without any lapse in approved status.

The major Public Health Service funding components are:

• Assistant Secretary for Health



• Agency for HealthCare Research and Quality (AHRQ)



• Centers for Disease Control and Prevention (CDC)



• Food and Drug Administration (FDA)



• Health Care Financing Administration (HCFA)



• Health Resources and Services Administration (HRSA)



• Bureau of Health Professions
  • Bureau of Health Resources Development
  
  
  • Maternal and Child Health Bureau
  
  
  • National Institutes of Health (NIH)
    Note: See JIT instructions for NIH


• Substance Abuse and Mental Health Services Administration (SAMHSA)