1. Protocol Violations and Protecting Animal Subjects Patricia Brown, VMD, MS, DACLAM Director, Office of Laboratory Animal Welfare National Institutes of Health April 14, 2016 1

2. PHS Policy Applicable to all PHS- conducted or supported activities involving animals IACUC through IO must report: noncompliance with the Policy Deviation from the Guide IACUC suspensions 2

3. IACUCs Must Ensure that Research Conforms to Federal Standards AVMA Guidelines for the Euthanasia of Animals 4

4. Institutional Reporting Assistance Guidance on Prompt Reporting to OLAW under the PHS Policy NOT-OD-05-034, Feb 24, 2005 OLAW Webpage: Reporting Noncompliance http://grants.nih.gov/grants/olaw/reporting_noncompliance.htm OLAW Online Seminar Reporting Noncompliant Events to OLAW https://webmeeting.nih.gov/p31061868/ 4

5. Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask: Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media 5

6. Reportable Issues Data Analysis OLAW opened 5,115 cases from 2010 – 2015 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, annual report Reports from funding components Allegations from other sources OLAW opened 809 cases in 2015 6

7. Reportable Issues by Institution Type Other 16% Institution of Higher Learning 68% Government 12% Commercial 4% 7

8. Types of Reportable Issues Animal Study Protocol Issues 31% Animal Husbandry 13% Clinical Issues 13% Other Issues 18% Failure to Follow Institutional Policies 15% Investigator & Research Team 5% Institutional Responsibility 1% No Violation Found 1% Physical Plant 2% IACUC Responsibility 2% 8

9. Types of Reportable Issues cont. Animal Study Protocol Issues 45% Failure to follow protocol 38% Unapproved significant change 9% Inadequate oversight 3% Work before protocol approval 3% Work under expired protocol 31% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 5% 9

10. Types of Reportable Issues cont. 15% Other Human error, accident Neglect, abuse, crime Training failure Equipment failure Natural disaster Failure to Follow Institutional Policies 18% 10

11. Types of Reportable Issues cont. Clinical Issues Animal Husbandry Issues 42% Food and water issues 23% Other husbandry 18% Inadequate records or ID 7% Escaped animal(s) 6% Space issue 2% Sanitation failure 2% Enrichment/exercise Animal Husbandry Issues 42% Food and water issues 23% Other husbandry 18% Inadequate records or ID 7% Escaped animal(s) 6% Space issue 2% Sanitation failure 2% Enrichment/exercise 13% 11

12. Types of Reportable Issues cont. Institutional Issues 1% Physical Plant 2% 50% HVAC 41% Other 9% Construction & maintenance No Violation Found 1% 12 IACUC Issues 2%

13. Types of Animals Involved Rodents 77% NHPs 7% Fish 3% All Other Species 5% Ungulates 3% Not Specified by Institution 3% Carnivores 2% 13

14. Individual Responsible for Reportable Issue Investigator & Research Team 73% None 7% Vet Staff 3% Animal Care Staff 12% IACUC 4% Other 1% Institution 1% 14

15. Institutional Corrective Actions Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol 15

16. Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation 16

17. Implications of Reportable Issues Corrective actions and improved systems Special terms and conditions of awards Enhanced reporting requirements Cost disallowance Suspension or termination of award Restriction or withdrawal of Assurance Criminal prosecution 17

18. Other Possible Ramifications Negative publicity for the institution Damage to reputation, assessment by peers Retract or withdraw scientific publication Institutional standing with alumni Institutional loss of personnel, inability to attract new staff Inquiries from Congress, other Federal regulators 18

19. Contact OLAW OLAW: 301-496-7163 E-mail: olaw@od.nih.gov OLAW Website: http://olaw.nih.gov 12