# Presentation: 541756

## National Institutes of HealthOffice of Extramural ResearchOffice of Laboratory Animal Welfare

- Denis Doyle
- Director, Division of Assurances
- (301)594-2289
- dd14y@nih.gov

## OLAW Electronic Access

**E-mail**:  olaw@od.nih.gov
**Web Site**: http://grants.nih.gov/grants/olaw/olaw.htm

## OLAW Responsibilities

- Administration and implementation of  PHS Policy on Humane Care and Use of Laboratory Animals
- Educational programs
- Negotiation of assurances
- Evaluation of compliance

## Authorizing Legislation and  Implementing Policy

**Health Research Extension Act of 1985, ****Public Law 99-158 "Animals In Research****”**November 20, 1985
**Public Health Service Policy on Humane Care ****and Use of Laboratory Animals**** **Revised September, 1986 Reprinted March, 1996

**Institute of Laboratory Animal Resources****Commission on Life Sciences****National Research Council****1996**
**The PHS Policy requires institutions to use the Guide as a basis for developing and implementing an institutional program for activities involving vertebrate animals**

## http://grants.nih.gov/grants/olaw/tutorial/index.htm

## Key Elements of PHS Policy

- Enforced self-regulation
- Animal welfare assurance
- Oversight by IACUC
- Recordkeeping requirements
- Reporting requirements

## Enforced Self-Regulation

- Performance standards
- Flexible
- Self-monitoring
- Self-correcting
- Self-reporting

## Assurances

- What is an Animal Welfare Assurance?
- Documentation of institutional commitment
- Description of institutional programs and procedures
- Principal method of compliance oversight

## Assurances

- Types of Assurances
- Full
- Interinstitutional
- International

## Assurances

- Information to be included in the assurance:
**Applicability**
**Lines of authority and responsibility**
**IACUC membership**
**Procedures used to implement the Policy**
**Veterinary care program**
**Personnel qualifications**
**Occupational health program**
**Training**
**Facilities and species**
**Institutional accreditation status**

## IACUC Membership Requirements

- At least five members
- Veterinarian with program authority
- Scientist experienced in animal research
- Non-scientist
- Individual unaffiliated with the institution

## Responsibility of the IACUC

- Review applications and proposals
- Semiannual program and facility evaluation with report to IO
- Review concerns
- Advise IO
- Suspend PHS-supported activities if necessary

## Important Considerations in IACUC Review

- Procedures
- Analgesia and anesthesia
- Euthanasia
- Environmental conditions
- Veterinary medical care
- Personnel qualifications
- Alternatives

## Recordkeeping Requirements

- Animal welfare assurance
- Minutes of IACUC meetings
- Records of IACUC review of protocols
- Semiannual IACUC reports, including minority views
- Annual IACUC report, including minority views
- Accrediting body determinations

## Semiannual IACUC Reports

- Describe adherence to the Guide
- Identify departure from Guide and provide reasons
- Develop plan and schedule for correcting deficiencies
- Submit report recommendations to IO

## Annual Reporting Requirements

- Program or facility changes
- IACUC membership changes
- Dates of semiannual IACUC evaluations
- Dissenting views
- Gain or loss of AAALAC accreditation

## Responsibilities of the Principal Investigator

- Correct completion of the PHS 6246-1 or 6246-3 form
- Have the animal work reviewed by the IACUC
- Address the five points in the vertebrate animal section
- Comply with institutional policies and procedures

## Vertebrate Animal Section

- Description of proposed use of animals
- Justification of use, species and numbers
- Veterinary care
- Procedures to minimize pain and distress
- Method of euthanasia

## Form PHS 6246-1

- Department of Health and Human Services
- Public Health Service
**Small Business Innovation Research** **Program**
**Phase I Grant Application**
*Follow instructions carefully*

## 5.Vertebrate Animals

- No
- Yes
- 5a.  If “yes” IACUC approval date
- 5b.  Animal Welfare Assurance no.

## OLAW Site Visits

- Division of Assurances
-   random, routine, use private peer          consultants
-   examine adequacy and accuracy of Assurance document as actually applied
-   confirm that self regulating system is working based on personal visit

## Site Visit Emphasis

- Institutional support for entire program
- Functioning of IACUC
- Lines of authority
- lines of communication from vet and IACUC chair to Institutional Official
- Documentation
- minutes, SOP’s, health records, semiannual reports, protocols

## Site Visit

- Animal facilities, procedure areas, support space
- Meet with IACUC, Veterinarian, Institutional Official
- Review training, occupational health, USDA reports