The Regulatory Environment for Use of Animals in - PowerPoint Presentation

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The Regulatory Environment for Use of Animals in Research

Balancing Compliance and

Flexibility

Dr. Nancy Marks

Director of the IACUC OfficeSlide2

All vertebrate animals Animal

Welfare Assurance

Institutional program of animal care and use Institutional Animal Care and Use Committee (IACUC)Self-regulation by institution Required record keeping – program and IACUC records Reporting – annual and non-compliance

What Guides Us? PHS Policy Slide3

OLAW Philosophy“

It

is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act PHS/NIH Oversight - Office of Laboratory Animal Welfare (OLAW)Slide4

IACUC review/approval of animal protocolsSelf-monitoring – Post Approval Monitoring & IACUC semi-annual facility

inspections

and program review Self-correcting – Identification/EducationSelf-reporting – OLAW & AAALACElements of Self-regulation Slide5

The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

Any serious or continuing noncompliance with PHS

Policy as defined by OLAWAny serious deviation from the Guide for the Care and Use of Laboratory AnimalsAny suspension of an activity by the IACUCReporting Requirement: PHS Policy IV.F.3. Slide6

The Guide for the Care and Use of Laboratory Animals -8th Edition – 2011AVMA Guidelines for the Euthanasia of Animals -2013 EditionAnimal Rights Activism – new approach: Using political/public pressure on agencies to increase oversight & regulatory burden

Helpful-

OLAW Regulatory FlexibilityWhat has changed?Slide7

Disasters or accidents = harm or death to animals

Conduct of research without IACUC approval

Significant change to procedure without approval of IACUCUse of expired protocolFailure to:adhere to IACUC approved protocolmonitor animals post-procedurallymaintain appropriate records

carry out veterinary care instructions

properly conduct IACUC business

provide adequate training

IACUC suspension of research

Examples of reportable EventsSlide8

OLAW will:Provide assistance and guidance

Institution

must demonstrate that corrective actions are being implemented Evaluate appropriateness of the actionsOLAW views self reporting:PositivelyIndication of self-regulationAppropriate oversightDemonstrates complianceReporting is viewed as a Cooperative Process Slide9
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Is the issue reportable? Better to ask or report than not.

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 U of Iowa is reporting as expected by enforced self –reporting (7 reports 2013, 8 reports 2014)Post–award financial entities are informed only if grant funds need to be repaid to your grantPre-award entities are not informed unless incident is egregious (may invoke media attention) or research has been suspended repeatedlyA Conversation with OLAWSlide11

Dear Dr. Wolff :This letter is to report an incident involving mice. Though the Principal Investigator was not found to be out of compliance, the incident is being reported due to the resulting death of two mice. The University of Iowa PHS Assurance Number is A3021-01. The Grant number affected is

XXXXXXXXXXXXXXXXXX.

 June 18, 2013: A lab member placed two cages of mice into the Thoren cage rack backwards which allowed water from the watering system to flow resulting in water overflowing into 11nearby cages. Ultimately two animals died. The lab member has been retrained on proper placement of cages into the rack system thereby preventing inadvertent water flow. As the Institutional Official, I was promptly notified. July 10, 2013: The IACUC members discussed the incident at a convened meeting. I have reviewed this event and believe this incident has been fully addressed. I am confident the retraining will minimize the chance of a repeat of this event. 

If you have any questions pertaining to this report, please contact me.Slide12

Dear Dr. Walker, The Office of Laboratory Animal Welfare (OLAW) acknowledges receipt of your July 17, 2013 letter reporting a serious deviation from the provisions of the

Guide for

the Care and Use of Laboratory Animals at the University of Iowa. According to the information provided, OLAW understands that two mice drowned and several other cages filled with water after two cages were inadvertently placed on the rack backwards and activated the water valves. The corrective action consisted of retraining the laboratory staffer responsible. Based on its assessment of this explanation, OLAW understands that measures have been implemented to correct and prevent recurrence of this problem. OLAW concurs with the actions taken by the institution to comply with the PHS Policy on Humane Care and Use of Laboratory Animals. Slide13

Retrain personnel Modify institutional policies

Repair

or modify facility Return funds to your grant, data not useableEnhance PI and study oversightModify, suspend, or terminate animal study protocol Examples of Institutional Corrective Actions Slide14
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New Electronic Form - “eIACUC”Increase use of template text, drop-down menus, & yes/no answers

Promoting less prescription, use of “ranges”, general & flexible answers

eIACUC includes copy functionality & pre-filled personnel sectionsNIH- Office of Laboratory Animal Welfare (OLAW)Now permits administrative handling or some significant changes: Less time & burdenIncreased use of performance standards Use regulatory flexibility where possibleReducing the Tension: Compliance vs. Regulatory Burden