Protocol Noncompliance: Resources
| Protocol Noncompliance | Institutional Animal Care and Use Committees |
- Legal
- Animal Welfare Act and Regulations USDA Animal Care Blue Book
- 9CFR Chapter 1 Subchapter A—Animal Welfare 2.30 (c) 6 and (c) 7 IACUC Functions
- 9CFR Chapter 1 Subchapter A—Animal Welfare 2.30 (d) IACUC review of activities involving animals
- Health Research Extension Act of 1985 Public Law 99-158
- Public Health Service Policy on the Humane Care and Use of Laboratory Animals for institutions receiving funding from U.S. Public Health Service agencies
- Guide for the Care and Use of Laboratory Animals, 8th edition
- USDA
- Animal Welfare Inspection Guide See chapter on “Protocol Review Information for the Inspector--Inspection Protocol Review Guidance”
- Compliance Inspections
- The Reporting of Adverse Events at Research Facilities on USDA Inspection Reports
- Animal Care Creates New Process for Appealing Animal Welfare Act Inspection Report
- RM 001-00 IACUC Non-Compliance Policy.pdf The USDA National Wildlife Research Center IACUC is responsible for reviewing and, if warranted, fully investigating allegations of animal mistreatment or protocol noncompliance. This policy provides a mechanism to respond to such allegations.
- OLAW
- NOT-OD-05-034--Guidance on Prompt Reporting to OLAW under the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
- NOT-OD-10-081--Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals
- Reporting Noncompliance--Resources provided to assist Public Health Service (PHS) awardee institutions in meeting reporting requirements.
- What Investigators Need to Know About the Use of Animals
- What is Protocol for Reporting an Animal-Research Project Exceeding Its Expiration Date?
- Terms of suspension—A discussion of research continuing following suspension of the Principal Investigator
- Reactivation of a suspended protocol
- Quick action for an injured mouse An investigator takes care of an emergency but does it cause non-compliance with the approved protocol?
- Citation for a discussion of noncompliance
- Refusal to renew an expiring protocol
- Noncompliance in survival surgery technique
- Reportability of protocol suspensions An investigator voluntarily suspends a protocol to avoid an IACUC suspension.
- Getting around late protocol renewals Can an investigator transfer animals from an expired protocol to an active protocol after the expiration date?
- Tackling investigator noncompliance
- A Mouse Isn't a Rat, But What's the Big Deal? An investigator uses mice instead of rats, which were approved in his protocol, and proceeds with the work despite a suspension.
- To Report or Not to Report? Rats are used in an unapproved study.
- International Perspective
- Quick start guide - Gov.uk A Guide for license holders on the operation of the United Kingdom Animals (Scientific Procedures) Act 1986
- Australian code for the care and use of animals for scientific purposes 8th edition (2013)See Section 5 Complaints and non-compliance
- Thailand Animals for Scientific Purposes Act 2015 Chapter II Ethics In Procedures On Animals For Scientific Purposes
- Directive, Commission Implementing Decision and Commission RecommendationGuidance from the European Commission on implementing Directive 2010/63/EU On Protection Of Animals Used For Scientific Purposes. See Section 3 Requirements for projects
- Inspections & Enforcement—see European Commission Guidance Note 1 Inspecting Compliance with Project Authorizations