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HHS SBIR/STTR Conference

Research Involving Animals;The PHS Policy and Animal Welfare Requirements

Eileen MorganDirector, Division of AssurancesOffice of Laboratory Animal WelfareNational Institutes of Health

November 7-9, 2017Milwaukee, Wisconsin

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Define live vertebrate animals for PHS award purposes Identify the three types of Animal Welfare

Assurances Identify the criteria for an Interinstitutional Assurance Identify the PHS Policy requirements for an institution

receiving funding involving the use of live vertebrate animals

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Learning Objectives forVertebrate Animal Use

PHS Policy DefinitionAnimal defined as:

“any live vertebrate animal used or intended

for use in research, research training,

experimentation, or biological testing or for

related purposes”.

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Key Elements of the PHS Policy• Applies to all vertebrate animal

use

• Animal Welfare Assurance

• Institutional program of animal care and use

• Institutional Animal Care and Use Committee (IACUC)

• Self-regulation by institution

• Requirements

• Record keeping – Program and IACUC records

• Reporting – Annual and non-compliance

PHS Policy Standards for Animal Care and Use

AVMA Guidelines for the Euthanasia of Animals

(2013 Edition)

http://grants.nih.gov/grants/olaw/request_publications.htm

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PHS Policy and NIH Grants Policy Requirements – TRUE OR FALSE?

a. A completed Vertebrate Animal Section, VAS in the grant application

b. Animal Welfare Assurance for the applicant organization and all performance sites.

c. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals.

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PHS Policy and NIH Grants Policy Requirements – TRUE OR FALSE?

a. A completed Vertebrate Animal Section, VAS in the grant application

b. Animal Welfare Assurance for the applicant organization and all performance sites.

c. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals.

ALL ARE TRUE

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Animal Welfare Assurance

• Contract with Federal Government• Description of the institutional program of

animal care and use• Documents institutional commitment• Principal method for compliance oversight

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Types of Animal Welfare Assurances

• Domestic Assurance• Interinstitutional Assurance• Foreign Assurance

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Domestic Animal Welfare Assurance

• Institution controls their own animal facilities • Has a complete animal care and use program

• Institutional Official (IO) • IACUC• Veterinarian

• Remains in effect for up to 4 years • Assurance signed by IO• Can be renewed• Requires PHS funding • Requested by grant management personnel

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What is needed for an SBIR award? Beaker Scientific, Inc. is submitting an application for an

NIH SBIR grant for research involving animals. The animal activity will be conducted at Expert Bio., a

CRO. Expert Bio has an Assurance on file with OLAW. The PI, Dr. Beaker says Beaker Scientific has an MOU

with Expert Bio in place so he’s ready to conduct the research when he receives the award.

A. Dr. Beaker is correct because he has an MOUB. Dr. Beaker will need IACUC approval with the MOUC. Dr. Beaker will need an Interinstitutional Assurance

through OLAW D. Dr. Beaker will need an Interinstitutional Assurance

through OLAW and IACUC approval13

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Anyone want to squeak up?

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What is needed for an SBIR award? Beaker Scientific, Inc. is submitting an application for an

NIH SBIR grant for research involving animals. The animal activity will be conducted at Expert Bio., a

CRO. Expert Bio has an Assurance on file with OLAW. The PI, Dr. Beaker says Beaker Scientific has an MOU

with Expert Bio in place so he’s ready to conduct the research when he receives the award.

A. Dr. Beaker is correct because he has an MOUB. Dr. Beaker will need IACUC approval with the MOUC. Dr. Beaker will need an Interinstitutional Assurance

through OLAW D. Dr. Beaker will need an Interinstitutional Assurance

through OLAW and IACUC approval15

Is Dr. Beaker Correct?

A. Dr. Beaker is correct because he has an MOUB. Dr. Beaker will need IACUC approval with the

MOUC. Dr. Beaker will need an Interinstitutional

Assurance through OLAW D. Dr. Beaker will need an Interinstitutional

Assurance through OLAW and IACUC approval

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Interinstitutional Assurance (IA)

Grantee organization does not have animal care and use program

Animal research will be conducted at an Assured Institution

Approved for life of grant (up to five years -project specific)

Requested of OLAW by grants management personnel

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Prime awardee is accountable and must confirm: Assurance

IACUC approval (dated within 3 years)

Approval only required from one Assured entity

Animal welfare requirements apply to all consortium participants and sub-projects

For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements

Consortium Agreements: Sub-awards

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Which Study Should Be Checked “Yes” for Vertebrate Animals?

Embryonated egg

Tadpole

Zebrafish

Cow spleen from slaughterhouse

Antibodies from goat

Chimpanzee behavior study

Octopus nerve study

Mosquito malaria study (host vertebrate?)

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Grant Applicant to Address Vertebrate Animal Use (electronic submission)

SF 424 ~ Research & Related Application Project / Performance Site Location(s)Other Project Information (Section 2 & 2a)

PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (5.

Vertebrate Animals) PDF format Vertebrate Animal Section (VAS) criteria

addressed23

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Reflects grantee information

SF424

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Vertebrate Animal Section Criteria

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1. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

2. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

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Vertebrate Animal Section Criteria

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html

3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

4. Euthanasia. (Cover Page Supplement, Forms E) State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

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1. Vertebrate Animals SectionAre vertebrate animals euthanized?You must answer this question if you answered “Yes” to the question “Are Vertebrate Animals Used?” on the R.220 – R&R Other Project Information Form.Check "Yes" or "No" to indicate whether vertebrate animals in the project are euthanized.If “Yes” to euthanasia: Is method consistent with American Veterinary Medical Association (AVMA) guidelines?You must answer this question if you answered “Yes” to the “Are vertebrate animals euthanized?” question above. Check “Yes” or “No” to indicate whether the method of euthanasia is consistent with the AVMA Guidelines for the Euthanasia of Animals. For more information: See AVMA Guidelines for the Euthanasia of Animals.If “No” to AVMA guidelines, describe method and provide scientific justification:If you answered “No” to the “Is method consistent with AVMA guidelines?” question, you must describe (in 1000 characters or fewer) the method of euthanasia and provide a scientific justification for its use. This justification will be reviewed by Office of Laboratory Animal Welfare (OLAW).If you answered “Yes” to the “Is method consistent with AVMA guidelines” question, skip this question.

New FAQ on Review

• If an applicant fails to address one of the criteria in the VAS, will the application be reviewed? (06/16/2017)

• Each of the criteria must be addressed in the VAS. Failure to adequately address the criteria may negatively affect the application’s impact/priority score. If none of the criteria are addressed, the application will be designated incomplete and it will not be reviewed. The VAS must not be used to circumvent page limits. The applicant should only address the required criteria and include descriptions of the proposed use of animals.

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VAS Review by OLAW

• Assurance Officer reviews VAS for grants (and contracts) submitted to OLAW with request for:

• Assurance• or resolution of animal welfare concerns.

• Assurance Officer reviews and accepts VAS or requests additional information be provided.

• OLAW administrative personnel send grants specialist questions to provide to PI for response.

• Grants specialist gets Grants Officer approval for updated VAS and sends to OLAW Division of Assurance email box for review and acceptance.

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Funding Component (IC) and Peer Review Responsibilities

• Consideration of animal welfare in the grant proposal should be evaluated (Review of VAS)

• If evaluation identifies concerns with animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns)

• Ensure that institution has an Assurance

• If no Assurance, grants management requests that OLAW negotiate Assurance

• Verify IACUC approval – valid date for 3 yrs.

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• Institutions are not permitted to charge for animal activities when terms and conditions are not upheld

• Absence of a valid Assurance on file with OLAW

• Absence of valid IACUC approval

• Failure to obtain IACUC approval for animal activity

• Failure to obtain IACUC approval for significant changes prior to implementing

• Continuing animal activities after IACUC approval has expired

• Continuing animal activities after suspension of IACUC approval

Policy on Allowable Costs for Grants Activity Involving Animals

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• Institutions are required to report noncompliant situations• OLAW (olawdco@mail.nih.gov or 301-594-2061)• Institute/Center (IC) supporting the award

• NIH expects grantees to continue to maintain and care for animals during periods of noncompliance

• Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis

• NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html

Policy on Allowable Costs for Grants Activity Involving Animals

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NIH-supported research is a partnership

Collaborative relationship exists between NIH and awardee institutionThe partners share a mutual need to

assure complianceEach partner has responsibilities and

obligations as stewards of public funds Institutional self-governanceis the foundation of PHS Policy

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Educational Resources

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OLAW Online SeminarsOnline seminars quarterly at 1pm ET

About the program:http://grants.nih.gov/grants/olaw/e-seminars.htm

Recordings and transcripts of previous online seminars:http://grants.nih.gov/grants/olaw/educational_resources.htm

March 10, 2016 – The 2016 Vertebrate Animal Section, Grants Policy, and Congruence

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Workshops and Conferences 2017- 2018

http://grants.nih.gov/grants/olaw/workshop.htm

IACUC 101/201/301 Series Workshops June 13-14, 2018 – IACUC 101/301, Portland, OR

August 1-2, 2018 – IACUC 101/201, Portland, ME

November 7-9, 2018 IACUC 101/201/301, Delray Beach, FL

SCAW Workshops and Conferences December 4-5, 2017 – Winter Conference, San Antonio, TX

PRIMR 2018 IACUC Conference March 19-21, 2018 – Columbus, Ohio

USDA AWIC Workshops – Beltsville, MD March 13-14, 2018 – Beltsville, MD

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Resources from OLAW

http://grants.nih.gov/grants/olaw/request_publications.htm

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Learning Objectives forVertebrate Animal Use

Define live vertebrate animals for PHS award purposesIdentify the three types of Animal Welfare

AssurancesIdentify the criteria for an Interinstitutional Assurance Identify the PHS Policy requirements for an

institution receiving funding involving the use of live vertebrate animals

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SCENARIO 1: What Would You Do ?

• Bob’s Biotech (BB) will be the grantee for an award involving animal research.

• BB does not have their own animal facility but has made preliminary plans with Lark University to conduct the animal studies in Lark University’s facility.

What are the requirements for the grant to allow the animal activities to proceed?

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SCENARIO 1: What Would You Do ?

• What needs to be included in the grant?

• What is needed from OLAW?

• What else does the PI need to provide?

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SCENARIO 1: OutcomesWhat are the requirements for the grant to allow

the animal activities to proceed?

A. Completed VAS for animal work to be conducted at Lark University

B. List Lark University as a performance siteC. Both sites need an Assurance (Lark

University needs a Domestic Assurance, Bob’s need an IA with Lark University)

D. IACUC approval from Lark University E. All of the above

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SCENARIO 2: What Would You Do ?

The PI at Research Inc. indicates that he will not be performing any animal activities but in the application he indicates he will be obtaining custom rabbit antibodies from Alpha Omega Enterprises.

What are the requirements for the grant to allow the animal activities to proceed?

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SCENARIO 2: What Would You Do ?

• What needs to be included in the grant?

• What is needed from OLAW?

• What else does the PI need to provide?

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SCENARIO 2: OutcomesWhat are the requirements for the grant to allow

the animal activities to proceed?

A. Complete VAS for Research Inc. animal activity

B. List Alpha Omega as a performance siteC. Both sites need an Assurance (Domestic for

Alpha Omega and IA for Research Inc.) D. IACUC approval from Alpha Omega E. All of the above

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Contacting OLAW

OLAW: 301-496-7163olaw@od.nih.gov

Division of Policy and Educationolawdpe@mail.nih.gov

Division of Assurancesassurances.olaw@od.nih.gov

Division of Compliance Oversightolawdco@mail.nih.gov

OLAW Website: http://olaw.nih.gov

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Questions? Please Ask!

• ListServ or RSS Feed: Subscribe through OLAW webpage for current announcements, notices, policy interpretations.

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Thank you for your Participation!

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