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Protocol Violations and Protecting Animal Subjects

Learn about PHS Policy violations and reporting procedures for animal research. Understand the consequences of noncompliance and the importance of self-reporting. Discover corrective actions and potential repercussions for violations. Ensure that your institution follows federal standards and safeguards animal welfare.

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Protocol Violations and Protecting Animal Subjects

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  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 PolicyNOT-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/

  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

  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

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

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

  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 5% 31% • Investigator & Research Team Issues • Unauthorized laboratory or animal housing • Unauthorized or unqualified personnel • Food and water restriction issues

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

  11. Types of Reportable Issues cont. Clinical Issues 13% • 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%

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

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

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

  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

  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

  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

  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

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

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