# Presentation: 544544

## July 13, 20068th Annual NIH SBIR / STTR Conference  ~ Cleveland, OhioPublic Health Service Policy on Humane Care and Use ofLaboratory Animals

**Venita B. Thornton, DVM, MPH **
**Senior Assurance Officer**
**Office of Laboratory Animal Welfare**
**Office of Extramural Research**

## Office of the NIH DirectorOffice of Extramural Research

**Notes:**
OLAW has the responsibility for the general administration & coordination of the PHS Policy. Our Office provides specific guidance, instruction and materials to institutions that must comply with the PHS Policy. 

## OLAW Educational Program

- Partnerships with organizations & institutions
- Workshops, meetings, conferences
- IACUC 101 training program
- IACUC Guidebook, 2nd edition
- Web-based tutorial, resources
- Published articles, FAQs, commentary
- Policy interpretations published in NIH Guide for Grants and Contracts

## Health Research Extension ActPublic Law 99-158, 11/20/85

- NIH Director to establish guidelines
- Applicable to PHS funded research
- Institutional Animal Welfare Assurance certifications of compliance
- Institutional Animal Care and Use Committee (IACUC) to oversee research
- Institutional opportunity to correct deficiencies

**Notes:**
The HREA provides the statutory mandate for the PHS Policy. 

## PHS Policy

- Animal Welfare Assurances
- Establish institutional program of animal care and use
- CEO appointment of IACUC
- Designation of Institutional Official
- Institutions self monitor and self report

## Public Health Service Agencies:

- National Institutes of Health
- Food and Drug Administration
- Centers for Disease Control and Prevention
- Substance Abuse and Mental Health Services Administration
- Health Resources and Services Administration
- Indian Health Service

## PHS Policy:  Standards for Animal Care and Use

- Guide for the Care and Use of   	Laboratory Animals
- U.S. Government Principles
- AVMA Panel on Euthanasia
- USDA Animal Welfare Regulations

## Guide for the Care and Use of Laboratory Animals

- National Academy of Sciences’ Institute for Laboratory Animal Research
- Performance Standards
- Published data
- Expert opinion and experience
- Scientific principles

## U.S. Government Principlesfor the Utilization & Care of Vertebrate Animals Used in Testing, Research, and Training  (page 4 ~ PHS Policy)

- Basic tenets of animal care and use
- Implemented by all U.S. Federal agencies that perform or sponsor research
- Similar to the CIOMS (international) principles
- (Council for International Organizations of Medical Sciences)
- Used by IACUCs in their review of proposals

**Notes:**
Principles were adopted by US Gov’t agencies that either develop requirements for or that sponsor procedures involving the use of vertebrate animals. 
Incorporated into the PHS Policy in 1986, and continue to provide a framework for conducting research in accordance with the Policy. 

Transportation
Relevance to health, advance of knowledge
Appropriate species, quality and numbers, alternatives considered
Minimization of discomfort, distress and pain
Appropriate sedation, analgesia or anesthesia
Humane endpoints and euthanasia
Appropriate living conditions and provision of veterinary care
Trained personnel
Exceptions reviewed by IACUC

## 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 (11. Vertebrate Animals)
- PDF Format
- (5) Points of Vertebrate Animal Section (VAS) addressed

## Slide 11

## Slide 12

## Grant Applicant to Address Five Points (Vertebrate Animal Section ~SF424 ~ PHS398 attachment)

- Description of the use of animals
- species, strains, ages, sex, and numbers of animals
- Justify the use, species and numbers of animals
- Veterinary care – performance site
- Procedures to minimize pain and distress
- Pain and distress will be limited to *that which is unavoidable *
*D*escribe use of analgesics, anesthetics, etc.
- Describe method of euthanasia
- Reasons for selection of method
- If not consistent with AVMA Panel - provide justification.

## Funding Component (IC) and Review Responsibilities

- Consideration of animal welfare during peer review (may affect score of application)
- If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding
- Ensure that institution has an Assurance
- If no Assurance, the IC request OLAW to negotiate Assurance
- Assurances are unsolicited
- Verify IACUC approval

**Notes:**
Applications from organizations with approved Animal Welfare Assurances will be considered INCOMPLETE, if they do not contain the information concerning the use of vertebrate animals required as part of the application’s research plan (see instructions for completing the PHS 398 & PHS 416-1 for the 5-points ~VAS).  In the case of apparent or potential violation of the Policy, NIH may refer an appliation back to the applicant for further IACUC review. 

## OLAW Responsibilities

- Oversee implementation of PHS Policy
- Provide interpretation and guidance
- Negotiate Animal Welfare Assurances
- Evaluate compliance
- Institutional self reporting
- Third party allegations
- Educational activities
- Workshops
- Resources
- Training sessions

## Animal Welfare Assurance

- Description of animal care and use program
- Lines of authority and responsibility
- Institutional Animal Care and Use Committee
- Procedures to implement the PHS Policy
- Program of veterinary care
- Occupational safety and health program for employees
- Training of personnel (investigators, technicians, IACUC)
- Facilities
- Species

## IACUC Responsibilities

- Review animal use protocols (including significant changes to ongoing protocols)
- Inspect facilities every six months
- Review program of animal care and use every six months
- Report to Institutional Official for Animal Welfare every six months
- Review concerns about animal care and use
- Advise Institutional Official
- Authority to suspend PHS-supported activity in noncompliant

## Criteria for Protocol Review(IV.C.1.  of Policy, p 13-14)

- US Govt Principles
- Standards of the Guide
- Minimization of pain and distress consistent with sound research design
- Appropriate use of anesthesia and analgesia
- Humane endpoints

## Criteria for Protocol Review(Continued)

- Living conditions and husbandry of animals appropriate for species ( husbandry)
- Medical care available and provided by Veterinarian
- Qualifications and training of personnel conducting procedures on animals
- Method of euthanasia appropriate and consistent with AVMA Panel on Euthanasia unless scientific justification provided in writing and approved by IACUC

## Institutional Official “prompt” reports to OLAW

- Serious or continuing noncompliance with the PHS Policy
- Serious deviations from the *Guide*
- Any suspension of an activity by the IACUC

## What happens when institutions report noncompliance / suspensions?

- Evidence that oversight is effective
- OLAW provides assistance / advice
- Institution take corrective actions
- Institutional program is improved   
- Research goes forward
- Rare cases:  institution is unable to take corrective actions and NIH applies sanctions (withdraw or restrict funding)

## Compliance Data Analysis 

- All cases opened from 2000 through 2005
- “case” = institutional self-reports,     			complaints, allegations, etc.
- 1659 total cases

## Source of Concern

**Notes:**
Other category includes whistle blowers, animal rights allegations, other agency findings (e.g., USDA), etc.

## Types of Organizations Reporting

**Notes:**
Academic includes colleges and universities, medical schools, veterinary schools, and Regional Primate Centers

Commercial includes animal producers and suppliers, small business, pharmaceutical and other commercial.

Government includes government agencies and VA medical centers

Other includes hospitals and nonprofit research organizations

## Type of Noncompliance

**Notes:**
Notice that the first four items together (36%) involve a PI operating outside the parameters of an approved protocol.

Work before approval:  includes failure to submit ASP for review
Failure to follow asp:  includes failure to have required veterinary participation

Failure to follow policies includes failures to adhere to institutional policies and procedures, e.g., tumor size guidelines, inst determined end-points, procurement procedures, animal housing, restraint, numbers, theft of animals, releasing animals into the wild, etc.

Surgical post-op failure includes lack of aseptic surgery.

Unauthorized personnel self explanatory.

Inadequate records animal ID records, study records.

Failed euthanasia includesCO2 issues, botched decapitation.

Other: includes items below a certain thresh-hold (>4.3%?), e.g., husbandry, vet care, enrichment, outdated drugs, facility issues, equip failures, human errors (cagewashing live animals), accidents (animal escapes, loss of air to isolator), dysfunctional program.

## Types of Animals Involved

**Notes:**
Note that one case can involve more than one species.

Unspecified mammals – includes marine mammals, bats

## Responsible Individual(s)

**Notes:**
Responsible individual  - the person who is culpable.

Student includes medical & veterinary students, Grads/ Post docs

IACUC  includes improper actions (e.g., granting “admin” extension of expired protocol, waiver of Guide or euthanasia guidelines without scientific justification).

## Institutional Corrective Action

**Notes:**
How situations are dealt with.

Retraining includes requirement for PI to submit corrective action plan to IACUC

Inst Policy Modification refers to creation of a policy where one was lacking or inadequate.

Counseling refers to something short of an official reprimand.

Enhanced ASP PI Oversight:  closer monitoring by the IACUC, reporting to the IACUC, etc.

Other:  probation, reprimand, fine, termination of employment

##  Data Acknowledgment

Steve Potkay, DVM
 OLAW Veterinary Consultant

- Steve Potkay, DVM
-  OLAW Veterinary Consultant

## How To Contact OLAW

- _[http://grants.nih.gov/grants/olaw/olaw.htm](http://grants.nih.gov/grants/olaw/olaw.htm)_
- Office of Laboratory Animal Welfare
- National Institutes of Health
- RKL-1, Suite 360, MSC 7982
- 6705 Rockledge Drive
- Bethesda, Maryland 20892-7982