SPONSORED PROGRAMS AND

ANIMAL USE

WITH FAQS

Presented by: Office of Sponsored Programs (OSP) and Office of Animal Welfare (OAW)

OSP All-Staff Meeting

October 2014

ANIMAL USE – WHAT IS IT?Vertebrate Animal use includes (not exhaustive list):• Use of animal tissue• Breeding animals at another facility• Ordering customized antibodies• Having studies outsourced• Working with a collaborator who is

doing animal work at another institution• Collecting animal data in a field study

EGC1 ANIMAL COMPLIANCE (AC-1)-QUESTIONS

AC-1. Does this application involve the use of vertebrate animals?

AC-1-A. Does the application involve the use of live vertebrate animals, at any location, by UW faculty, staff or students, or non-UW personnel visiting the UW and working under a UW IACUC protocol?

ANIMAL COMPLIANCE (AC-1) QUESTIONS ON EGC1, CONT’D. AC-1-B. Does the application involve use of live

vertebrate animals at any domestic (US) location other than the UW (e.g. custom antibodies, contracts, subcontracts or any collaborative work in support of the specific aims of the grant)?

At time of OAW review (after proposal submission), OAW will require a letter from the other institution’s IACUC representative that assures grant-protocol concurrence. Note that work being done at FHCRC, the VA, and SBRI don’t require a letter since OAW has their protocols and can do those reviews in-house.

AC-1-C. Are you citing any foreign sites for performance of live vertebrate animal work?

Any foreign site must have a PHS Assurance # and they must provide an English-language copy of their protocol. This is verified by OAW after proposal submission as part of its review.

LEVEL OF INFORMATION OAW NEEDS ON EGC1, FOR EACH FACILITY:

o Name of Facility (e.g., "UW main campus", "field location", "San Diego Zoo")

o Facility Location (e.g., "Seattle, WA", "Marrowstone Island, WA", "San Diego, CA")

o IACUC Protocol Number(s)

o IACUC Approval 3-year date range for each protocol number listed. Contact OAWsend@uw.edu if you need this information.

THE GOOD, THE BAD AND THE UGLY

Ugly:

• Protocol listed with incorrect approval date range• Not listing all protocols that are relevant

Good

Not so good

WHAT ELSE IS NEEDED ATCOMPETING PROPOSAL STAGE, OTHER THAN THIS EGC1 INFO?

Most sponsors do not require protocol approval at the proposal stage. Check sponsor requirements.

What is typically required:

o Indication that animal use approval is pending and the UW Assurance # (see SF424 Other Project Info for example):

o A description of the Vertebrate Animal Use anticipated

Remember: All references to an IACUC protocol # in the proposal should indicate review is “pending”.

POST PROPOSAL SUBMISSION: THE OAW SIDE-BY-SIDE REVIEW(CONGRUENT REVIEW OF PROTOCOL TO PROPOSED WORK IN GRANT)

The proposal is submitted to sponsor. Now what?o STEP 1 – PI e-mails proposal and eGC1 copies to

OAWsend@uw.edu (pdf is fine)o STEP 2 – OAW performs Administrative Reviewo STEP 3 – OAW performs Scientific Reviewo STEP 4 – PI Responds to OAW Review (if

applicable)o STEP 5 – OAW issues Letter of Approval*

*This Approval letter is issued to the PI via e-mail (soft copy), and OSP is copied. OSP adds to eGC1 attachments, upon receipt.

WHEN SHOULD A COPY OF THE EGC1 AND SUBMITTED PROPOSAL BE PROVIDED TO OAW FOR THIS SIDE-BY-SIDE REVIEW?

Type of Funding When to submit materials to OAW

Do I get a prompt from the sponsor or OSP?

New/supplemental funding and Sponsor has a formal “Just In Time” notification process (e.g. NIH)

Upon receipt of “JIT” notice (approx. 6-8 weeks prior to requested start date)

PI gets a “JIT” notification from the sponsor. OSP creates a “Pre-Award Notification” (PAN) in SPAERC.

New/supplemental funding and Sponsor does NOT have a formal “Just in Time” notification process

Approximately 6-8 weeks prior to anticipated start date.

No; plan a tickler reminder for those eGC1s that have a “yes” to animal use compliance questions!!

Avoid delays in getting funding processed!

JIT: WHAT DOES JIT MATERIAL SUBMITTED TO SPONSOR CONSIST OF WHEN ANIMAL USE IS PROPOSED?

To Sponsor: Animal Use Protocol # Protocol Approval date range

UW Requirement: Letter of Approval on record

The eGC1 alone is not enough: The protocol approval letter is not useful:

CONTINUATION FUNDING OR AFTER THE FACT EGC1S IN WHICH RESEARCH INVOLVES ANIMAL USE OAW is automatically added as an approver ahead of OSP on the following eGC1 types:

o Non-competing renewalo Non-competing revisiono Non-competing supplemento Supplement/extensiono Transfero When the eGC1 is marked After-the-Fact (ATF)

OSP cross-checks that the protocol # listed on any materials to sponsor, when applicable, are the same protocol numbers listed in eGC1 that is approved by OAW.

FAQ #1: ONLY OUR INTENDED SUBRECIPIENT WILL CARRY OUT ANIMAL USE ACTIVITY. OSP CAN PROCESS MY AWARD WITHOUT A LETTER OF APPROVAL FROM UW OAW, RIGHT? SUBRECIPIENT WILL TAKE CARE OF THEIR OWN ANIMAL USE COMPLIANCE.

Answer: No

OAW requires a letter from the subrecipient’s IACUC representative, confirming its own side-by-side review. Letter needs to contain:

o Protocol #o Approval Dateo Statement that grant (grant # or title) has been reviewed

alongside protocol

This letter, once obtained by PI/dept, should be sent to oawsend@uw.edu.

OAW will then issue a Letter of Approval once this information is on file.

FAQ #2: I HAVE THE OPTION OF PUTTING “JIT” IN THE EGC1. OSP DOESN’T NEED TO PROVIDE PROTOCOL INFORMATION TO THE SPONSOR AT PROPOSAL SUBMISSION, SO WHY ARE YOU ASKING ME TO PUT IN PROTOCOL DETAILS?

Answer: Continue to choose “JIT” when appropriate. But also list the site, protocol number(s) and approval date range as this will save time in processing the grant once it goes to OAW.

OAW refers to the eGC1 information once it carries out the side-by-side review. If not in the eGC1, it increases the time needed to carry out this review.

FAQ #3: I THOUGHT OAW WAS ADDED AS AN APPROVER TO THE APPROVAL GRAPH ON THE EGC1. WHY THIS SEPARATE “LETTER OF APPROVAL”?

Answer:

OAW is NOT added as an approver to eGC1s for competing funding. OAW only knows about your submitted competing proposal when you send in your paperwork to OAW:

E-mailed copy of eGC1 E-mailed copy of proposal Reference to protocol #(s) (in eGC1, ideally) If a new IACUC protocol, or a change to an existing IACUC

protocol is necessary to cover all the work described in the proposal, the New protocol and/or Significant Change form.

Please send all documents to oawsend@uw.edu

FAQ #4: WHEN SHOULD A PI SUBMIT HIS/HER PROPOSAL TO OAW FOR REVIEW? THE PROPOSAL HAS BEEN SUBMITTED TO THE SPONSOR AND THE ANTICIPATED START DATE IS THREE MONTHS OUT.

For NIH grants, submit a copy of your grant and eGC1 to

OAW as soon as you receive notice of a fundable score from NIH (JIT notification from NIH are sent 6-8 weeks prior to anticipated start date).

For sponsors that do not issue a JIT notification, it is the PI/dept’s responsibility to manage timelines according to anticipated start date*. There is no REMINDER!

*OAW recommends submission of required documents to OAW 6-8 weeks prior to anticipated start date.

FAQ 5: WHAT HAPPENS WHEN THERE IS A CHANGE IN THE SCOPE OF THE RESEARCH AFTER THE PROPOSAL HAS BEEN FUNDED AND ANIMAL WORK IS ADDED ONCE THE GRANT IS ALREADY IN PROGRESS?

Anytime there is a change involving animal work on a grant, it needs to be reviewed by OAW. This could include adding a new performance site or changing the procedures or species. At the very least, it will likely require submitting a Significant Change and it may also require submitting a concurrence letter to the sponsor.

FAQ 6: I WANT TO CONTRACT WORK TO CREATE CUSTOM ANTIBODIES/HAVE TRANSGENIC MICE BRED/ORDER CANNULATED RATS/TEST MY COMPOUND IN VIVO. WHAT SHOULD I DO?

Types of Work: While the majority of research utilizing animals is performed on campus, it is not uncommon for University Researchers to initiate animal work at other institutions.  Examples include:

creation of genetically modified animals the production of surgically modified animals the production of custom antibodies entire studies utilizing animals  Expectations and Regulatory Requirements:  The University of Washington

has an expectation that the animal work will be performed in a manner comparable to the work performed at the UW.  In addition to this general requirement, there are a number of factors that will drive the requirements for outsourced work. 

The three biggest considerations are: funding source species used    foreign institution  All animal work, regardless of funding source (e.g., departmental, private trust,

federal grant) must be reviewed by the Office of Animal Welfare to determine the regulatory requirements for your work.

FAQ 7: MY PI WILL BE RECEIVING A TRAINING GRANT. WE DO NOT HAVE ALL TRAINEES IDENTIFIED. SOME MAY USE ANIMALS. HOW IS THIS IACUC REVIEW HANDLED?

eGC1: Answer “yes” to animal use

Within Proposal: OAW finds it helpful if the known current or new trainees and their mentors and related protocol #(s) are listed either within the grant or separately.

If the trainees are TBD, just say that.

In some cases, trainees will not be performing animal work. It is helpful to indicate this too.

The OAW letter of approval will need to provide this information to the sponsor so the more organized it is, the faster the review.

FAQ 8: MY PI COMMUNICATED THERE WILL NOT BE ANIMAL USE UNTIL YEAR 2 OF A MULTI-YEAR PROJECT. I REALLY DON’T WANT THE FIRST YEAR FUNDING HELD UP IN OSP. WHAT SHOULD I DO?

Answer: Most sponsors, including NIH, require IACUC approval for all proposed animal work that will occur at any time during any year of the proposal. The PI must obtain approval from the IACUC for the animal work that is proposed to the sponsor. The PI can submit Significant Changes to the IACUC protocol as work progresses and it is determined changes are needed.

If it is impossible to write a protocol at this juncture, please provide this information to OSP in writing (e-mail), when OSP is requiring your Letter of Approval.

RESOURCESOAW instructions specific to grant and contracts: http://depts.washington.edu/oawhome/grants-contracts/

OSP Time of Award page:

http://www.washington.edu/research/index.php?page=timeOfAward