1. Patricia Brown, VMD, MS, DACLAM Director, OLAW, NIH April 14, 2016 ORI Workshop Research with… Animals

2. Federally supported scientists are accountable from the time they first plan their research to the time the research is completed to protect the welfare of the animals used in the research. 2 NIH Core Message http://grants.nih.gov/grants/policy/air/NIH_ensure_welfare.htm

3. Authorizing Legislation - Public Law 99-158 Health Research Extension Act of 1985 NIH Director to establish guidelines for research funded by PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies 3

4. PHS Policy Applicability PHS-conducted or supported activities involving animals CDC, FDA, and NIH MOUs with Dept. of Veterans Affairs and NSF for oversight of animal research 4

5. PHS Policy Definition of Animal “any live vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes” 5

6. Key Elements of the PHS Policy All vertebrate animals Animal Welfare Assurance Institutional Animal Care and Use Committee (IACUC) Self-regulation by institution Requirements for: Record keeping Reporting 6

7. 7 PHS Policy Standards for Animal Care and Use AVMA Guidelines for the Euthanasia of Animals: 2013 Edition

8. U.S. Gov’t Principle II “Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society." 8

9. U.S. Gov’t Principle III “The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered." 9

10. U.S. Gov’t Principle IX “Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made…by an appropriate review group such as an IACUC. Such exceptions should not be made solely for the purpose of teaching or demonstration.” 10

11. Post-Award Responsibilities Obtain IACUC approval prior to using animals or making significant changes. Ensure research is conducted according to the approved protocol. Comply with institutional policies and procedures. 11

12. Post-Award Responsibilities, cont. Address significant changes to the use of animals in progress reports to NIH. Obtain prior permission from NIH for the use of animals involving a change in scope, including changes in performance site. 12

13. Post-Award Miss-steps Conducting research in the absence of IACUC approval Implementing a significant change without IACUC approval 13

14. Institutional Reporting Conducting research without IACUC approval must be reported by the IACUC through the Institutional Official to: OLAW the funding component(s) supporting the award Where charges have been made for unauthorized animal activities, appropriate adjustments must be made to remove those charges 14

15. Additional Reporting Requirements Reporting required by PHS Policy IV.F.3 Any serious deviation from the provisions of the Guide Any suspension of an activity by the IACUC 15

16. PHS-supported research is a partnershi p Collaborative relationship between the NIH and awardee institution Mutual need to assure compliance As stewards of public funds, partners are responsible and obligated Institutional self-governance is the foundation of the partnership 16

17. Thank You 17 Thank you