The Regulatory Environment for Use of Animals in Research

Balancing Compliance and FlexibilityDr. Nancy Marks

Director of the IACUC Office

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

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)

IACUC review/approval of animal protocols Self-monitoring – Post Approval Monitoring

& IACUC semi-annual facility inspectionsand program review

Self-correcting – Identification/Education Self-reporting – OLAW & AAALAC

Elements of Self-regulation

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 OLAW◦ Any serious deviation from the Guide for the

Care and Use of Laboratory Animals◦ Any suspension of an activity by the IACUC

Reporting Requirement: PHS Policy IV.F.3.

The Guide for the Care and Use of Laboratory Animals -8th Edition – 2011

AVMA Guidelines for the Euthanasia of Animals -2013 Edition

Animal Rights Activism – new approach: Using political/public pressure on agencies to increase oversight & regulatory burden

Helpful- OLAW Regulatory Flexibility

What has changed?

Disasters or accidents = harm or death to animals‣Conduct of research without IACUC approval‣Significant change to procedure without approval of

IACUC‣Use of expired protocol‣Failure to:

adhere to IACUC approved protocol monitor animals post-procedurally maintain appropriate records carry out veterinary care instructions properly conduct IACUC business provide adequate training

‣ IACUC suspension of research

Examples of reportable Events

OLAW will:◦ Provide assistance and guidance

Institution must demonstrate that corrective actions are being implemented

◦ Evaluate appropriateness of the actions OLAW views self reporting:

◦ Positively◦ Indication of self-regulation◦ Appropriate oversight◦ Demonstrates compliance

Reporting is viewed as a Cooperative Process

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 grant Pre-award entities are not informed unless incident is

egregious (may invoke media attention) or research has been suspended repeatedly

A Conversation with OLAW

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.

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. 

Retrain personnel Modify institutional policies Repair or modify facility Return funds to your grant, data

not useable Enhance PI and study oversight Modify, suspend, or terminate

animal study protocol

Examples of Institutional Corrective Actions

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 sections NIH- Office of Laboratory Animal Welfare (OLAW)

◦ Now permits administrative handling or some significant changes: Less time & burden

Increased use of performance standards Use regulatory flexibility where possible

Reducing the Tension: Compliance vs. Regulatory Burden