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Animals in Research: Navigating the Animal Protocol Approval Process

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Animals in Research: Navigating the Animal Protocol Approval Process Summer Seminar Series Susan Warren IACUC Chair So You have written a grant application which ... – PowerPoint PPT presentation

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Title: 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
Animal Activity Protocol Paperwork
  • 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)

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 Animals Section 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
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