Animals in Research: Navigating the Animal Protocol Approval Process

1. Animals in Research: Navigating the Animal Protocol Approval Process Summer Seminar Series Susan Warren IACUC Chair

2. So… • You have written a grant application which includes experiments that require the use of live animals, OR • You are a new faculty member at UMMC, and have designed your first series of animals studies • How do you go about obtaining IACUC approval for the proposed animal experiments? • Why do you need an Approved Animal Activity Form (aka Animal Protocol)?

3. How to Obtain IACUC Approval for the Proposed Animal Studies

4. Rule #1 • ALWAYS obtain IACUC approval PRIOR to beginning any animal work – regardless of the funding source (intramural/departmental or extra-mural)

5. http://www.umc.edu http://research.umc.edu Office of Research Compliance IACUC Contact – list individuals Compliance: training requirements registration form; IACUC Policy Statements Forms: animal activity form (protocol) Animal Activity Protocol Paperwork

6. When in doubt, Ask for help!! Sources of Assistance Laboratory Animal Facility (LAF) • http://lab-animal-facility.umc.edu IACUC Members • http://research.umc.edu

7. What Happens in the Protocol Approval Process? After submitting the completed protocol form: • Protocol is assigned to two IACUC reviewers • They review and present the document to the entire Committee • The Committee discusses then votes on the protocol • Generally, your protocol will be approved in approximately 2 months from time of submission

8. How Long Is My Protocol Approval Good For? • Animal Protocols are approved for a three year cycle – (Federal mandate) • On the anniversary date of the protocol approval, you receive a protocol continuation form • On the third anniversary of the protocol, it is necessary to submit a complete 3 year resubmission – BE certain to Include Appendix K – progress report

9. Things to Keep in Mind • Any modifications to your approved Animal Protocol require approval by the IACUC • A change (amendment) can take the form of a memo (if the change is minor) OR • If the scope of the change is broad, the committee may be require additional information in the form of a protocol re-write • Contact an IACUC member should you need to modify your approved protocol. The amendment needs to be approved prior to beginning the modified studies

10. Why Do I Need Approval for My Animal Experiments?

11. IACUC Certification and Animal Welfare Assurance NIH policy requires the submission of Institutional Animal Care and Use Committee (IACUC) approval when animal studies are involved.

12. The Link Between the Grant Application and the Animal Protocol

13. Vertebrate AnimalsSection of An NIH PHS 398 Application • detailed description of the proposed use of the animals Identify the species, strains, ages, sex, and numbers of animals • Justify the use of animals. • Provide information on the veterinary care of the animals involved. (AAALAC Accreditation 11-06-2003) • Describe the procedures for ensuring that discomfort, pain, and injury will be limited. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury. • Describe any method of euthanasia to be used and the reasons for its selection.

14. Reconciling the Grant Animal Methods and the Approved Animal Protocol After the grant application reaches the Office of Research Animal Methods in the Grant Application are checked against the details in the submitted animal activity form Personnel listed in the Grant Application are checked against the individuals detailed in the approved animal activity form Both documents should agree • A Letter indicating IACUC approval of the animal methods in the grant application is issued and will accompany the application • HOWEVER, …

15. Reconciling the Grant Animal Methods and the Approved Animal Protocol Some differences in methods, as well as personnel, may be noted in the two documents. These differences need to be reconciled. • A Letter indicating IACUC approval is “Pending” is issued and will accompany the grant application. • How does the “Pending” status of the animal protocol affect your grant submission?

16. “Just-In-Time” Protocol Approval • Effective in 2002 (and updated October 31, 2003), the NIH announced …a change in the PHS Policy on Humane Care and Use of Laboratory Animals to allow institutions to provide IACUC approval in a "just-in-time" fashion prior to award • What is this?

17. “Just-In-Time” Protocol Approval • If you enter "Pending" in the box requesting IACUC approval date, then ….. • You will receive a communication from the funding agency. The name and address of the Scientific Review Administrator of the SRG will be sent to the principal investigator/program director and applicant organization as soon as possible after the receipt date, usually within 6 weeks. • A follow-up certification of IACUC approval must then be sent to and received by the Scientific Review Administrator of the scientific review group (SRG).

18. DEA and Controlled Substances • If your animal experiments require the use of controlled substances, for example • Ketamine hydrochloride: Schedule III • Sodium pentobarbital: Schedule II • Morphine: Schedule II • Buprenorphine: Schedule III • You need to apply for a DEA License in order to purchase and utilize specific drugs

19. How DO I Find the DEA? • http://www.deadiversion.usdoj.gov/ • UMMC Office of Compliance • Ms Donna Fairchild, 5-3944

20. Summary • Always receive IACUC approval prior to beginning animal work • When in doubt, ask for assistance • Consider “Just-in-time” animal protocol submission • Obtain DEA License