APPROVED
EXECUTIVE COMMITTEE
MINUTES
Monday, October 22, 2012
VOTING MEMBERS:
Bates, Black, Johnson, Klingelhutz, Rosenstein, Rubenstein,
Segaloff and Shields
VOTING MEMBERS ABSENT:
Anderson, Atkins, Lawrence, Leslie and Menda
EX-OFFICIO MEMBERS PRESENT:
Geist and Parker
EX-OFFICIO MEMBERS ABSENT:
Adams, Apicella, Asprey, Brennan, Cooper, Hammond,
Henderson, Hingtgen, Kates, Knosp, Robillard, Rosenthal,
Sharp, Tracy, Wilson and Winokur
GUEST:
Dr. James Walker
1. Minutes
The October 8, 2012 minutes, and the October 12, 2012 appointments were approved.
2. Report from the Dean’s Office (Geist)
None.
3. New Business
3.1 Office of Institutional Animal Care & Use Committee, and Office of Animal Care (Walker)
Dr. Walker oversees the units responsible for NIH regulations, and related UI policies and
procedures. Those units are: (1) Office of Animal Resources, (2) Office of the Institutional Animal
Care and Use Committee (IACUC), (3) Conflict of Interest in Research Office, (4) Environmental
Health and Safety Office, (5) Human Subjects Office and (6) Research Administration Services.
His hand-out is attached to the minutes.
Background
Dr. Walker explained that all institutions follow the same regulations as defined by NIH. The way in
which an institution implements and operationalizes NIH regulations is influenced by the
environment and culture of that institution.
The CCOM is awarded $210 million dollars annually for research. $65 million involves human
subject research, $55 million involves animal research and $40 million involves both human and
animal subjects.
Enhancements
For the last 1.5 years, the Offices of Animal Care and the IACUC have initiated numerous changes
that are detailed in the attachment. A few noteworthy changes are listed below.
 An internal and external review of OAR and IACUC were completed May 2012. Three areas (3)
reviewed included (1) the IACUC Office and OAR, their operations, funding models, staffing,
and areas amendable for quality improvement,(2) Financial & Business Operations, and (3)
Animal Facilities.
 Improved financial transparency between OAR and the research labs through the development of
an improved financial accounting system.
 Construction of new animal facilities: PBDB (projected completion mid-2014), Underground
Central Vivarium located in the MERF-CBRB-PBDB courtyard (projected completion
mid-2016), and the Oakdale Vivarium (projected completion fall 2015)
 Three full-time IT programmers have been hired and are working full time on IT improvements in
OAR and IACUC operations.
 Additional animal husbandry staff will be hired. Institutional benchmarking data show UI staffing is
about one-third below the average for the same size institutions. Staffing is anticipated to be
below average.
Many of the recommendations have already been implemented, but some are ongoing such as
development of an electronic animal research protocol, development of clinical and veterinary
templates for use in the electronic application, improved coordination between OAR and IACUC
veterinarians, and removal of OAR clinical veterinarians from the IACUC review process creating a
single review system located in the IACUC Office itself.
Continued Challenges
 Animal housing space continues to be extremely limited and will remain that way until mid-late
2014. The limited space is more critical for the large animals.
Role for Executive Committee
 Advise on the representation of a University Research Advisory Committee.
 Provide a perspective relative to OAR/IACUC policies and procedures.
The Executive Committee appreciates the initiatives and enhancements implemented by Dr. Walker
and his staff.
4. Old Business
None
5. New Business
5.1 Preparation for the meeting with Drs. Densen and Cooper to discuss Curriculum Review
Drs. Densen and Cooper will present to the Executive Committee November 12, 2012. Please
forward questions to Jane Holland at jane-holland@uiowa.edu.
Questions identified by the Executive Committee include
 What is the status of the Curriculum Renewal Project?
5.2 After hearing that Dean Schwinn broke her leg, the Executive Committee asked Debbie
Segaloff to send her a get well card.
5.3 Raphael Hirsch will be invited to present to the Executive Committee February or March 2013.
Meeting ended 1: 21 pm.
Respectfully submitted,
Al Klingelhutz
Secretary
Presentation by Dr. James Walker,
UI’s Animal Research Program- Governing Policies and Procedures
October 22, 2012
What policy or procedural changes would you like to see regarding the IACUC & OAR?
OAR and the IACUC have been undergoing comprehensive changes over the last year and a half to
improve IACUC policies and procedures along with day-to-day operational changes. New regulatory
agency guidelines, coupled with changes in regulatory agency interpretation of existing laws continue to
add burden and impact business processes. Additional recommendations for improvement from an
internal and external review of the OAR and IACUC in May 2012 are being considered or already
instituted. Completed and pending improvements are outlined below:
Office of the Institutional Animal Care and Use Committee (IACUC)
 Staffing
o Added IACUC Veterinarian/Director position
 Nancy Figler, DVM started July 2012; reports directly to Institutional Official
 Has assumed all IACUC responsibilities and leadership
o Assistant IACUC Administrator - being recruited
o Added temporary junior veterinarian to conduct administrative/ veterinary reviews
 Dr. Brianne Ball hired in June 2012
o Recruited new IACUC Training & Compliance Coordinator
 Mike Andrews (23 years research lab experience) started April 2012
 Conducts required Post Approval Monitoring and educational visits to
laboratories
o Increased IACUC office staffing now permits expanded focus on programmatic/policy
issues and process improvements
 Animal Protocol Review Improvements
o Replaced hardcopy with electronic protocol submission
o DEO signature requirement eliminated
o Administrative pre-review and veterinary reviews combined in IACUC office to minimize
PI to IACUC office back and forth communications.
o Email communication increasingly being replaced between PI’s or senior technicians and
IACUC office staff with telephone calls or face to face meetings to address protocol
reviews questions
o Mandatory Full IACUC reviews no longer required; Designated (committee) Member
Review (DMR) conducts protocol review; IACUC meetings focus more on policy,
procedures, education and referred animal protocol reviews
o Amendments now incorporated into original protocol document- reducing paperwork,
clarifying context of approved animal procedures
o Animal Protocol review times reduced from 6-8 weeks to 2-3 weeks in most cases
(IACUC review and PI responses); amendments 5-7 days (includes IACUC review and
PI response time)
o Changed SOP for Post Approval Monitoring of animal research labs
 One comprehensive laboratory visit every 12 months
 One mid-cycle laboratory visit for short overview of surgery areas only
o Electronic Animal Protocol (eIACUC) under development; completion date December
2013; additional functionality: workflow, e-committee review, document management,
etc., Dec 2014
o Protocol – Grant congruency now performed for NIH funded studies only as required.
 Improved Communication
o Weekly meetings of the Attending Veterinarian (AV), IACUC Office staff and IACUC Chair
to discuss current business; harmonize communications with research community;
standardize procedures.
o Weekly meetings of OAR and IACUC vets to assess and harmonize current
practices/policies.
o Researcher listserv developed for enhanced/improved communication.
 New IACUC website launch March 2012 (http://animal.research.uiowa.edu/)

IT Infrastructure Improvement
o Sustained funding provided by the OVPR and University Financial Services for two full
time programmers to improve IT infrastructure for IACUC;
 New electronic application (eIACUC) scheduled for completion in Dec 2013;
functionality includes standardized demographic information and veterinary
procedure templates.
 Full system functionality: e-committee review, workflow, document management,
amendments, continuing reviews, etc., completed by Dec 2014.
Office of Animal Resources
 OAR Director/AV no longer IACUC Vice Chair
 IACUC (regulatory activities) separated from OAR Office (veterinary care, animal husbandry)
 Staffing
o Associate Director (Open)- first recruitment failed, re-initiate early 2013
o Two clinical veterinarians (Maria Martino-Cardona and Helen Valentine)
o Added temporary junior clinical veterinarian (Dr. Kathleen Donovan started June 2012)
o Vet tech and husbandry staffing levels under review
 New OAR website launched March 2012 http://animal.research.uiowa.edu/
 Animal Per Diem rates – see IT Infrastructure Improvements & benchmarking sections below.
 Animal Housing - Facilities Status and Challenges
o Med Labs and BSB - currently at operating capacity; inadequate ABSL2 space for nonrodents
o MERF/CBRB limited growth for barrier housing
o Oakdale facilities: Most require replacement to meet current standards; (see below
under “New Facility Plans”)
o Current new faculty hires:
 Will fill about 50% of remaining barrier rodent housing
 Transferring 80+ new transgenic lines of mice to UI in calendar year 2012
 Require specialized housing/use space (extremely limited availability)
o New and existing faculty
 Several needs OAR unable to accommodate (Examples: ABSL2; high or low
ambient temperature housing; altered light cycle)
 New Facility Plans
o PBDB: (Completion mid-2014)
 New accessible office complex for OAR and IACUC
 12 Barrier rodent rooms;
 Small animal (rodent) Imaging Core
 Large animal Imaging Core
 Large species (USDA) Aseptic Surgery Suite
 NOTE: No housing for non-rodent species
o Central Vivarium: Underground in courtyard of PBDB (Completion mid-2016)
 Funding from CCOM and Central Administration; use of GEF funding rescinded
 Flexible and diverse facility for small and large species;
 Centralized cage washing operation for entire medical campus vivaria
o Oakdale Vivarium: (Design underway; completion: fall 2015)
 Funding from CCOM and Central Administration
 Primarily large species
 Aseptic surgery suite for non-rodents (USDA);
 Non-rodent ABSL2 housing (pigs, sheep, rabbits, ferrets, chickens, etc.)
 Rodent ABSL2 housing for Oakdale researchers
 Rodent ABLS1 housing for Oakdale researchers
 Transgenic and Genome Manipulation Core moved from MTF to OV
 IT Infrastructure Improvements
o Enhancing ARIS (OAR’s business, operational and financial software)
 Third programmer hired; charter created; stakeholder’s group being formed;
 Goals include: improve financial statements, standardize annual cost analysis
and improve transparency for per diem rates; per diem rate projections; improve
purchasing & inventory capability, enhance billing system, automate account
reconciliation; expand internal controls, develop/implement audit program;
automate forms, provide improved account access by PIs/delegates.
Internal and External Review of OAR and the IACUC: (Completed May 2012)
 Reviews included four areas: 1.)IACUC, 2.) OAR, 3.) Financial and Business Operations, 4.)
Facilities
o Recommendations:

- Increase staff (in progress)
 Restructure protocol review (done)
 Develop electronic application (in progress)
 Standardize & publish clinical and veterinary procedure templates for eIACUC (in
progress)
 Improve communication/coordination between OAR & IACUC (done)
 Remove OAR clinical veterinarians from IACUC pre-review (done)
 Improve educational offerings for faculty/staff (in progress)
 Collaborate with other CIC institutions to develop best practices (in progress)
 Increase visibility of veterinary staff in facilities (in progress)
 Increase/improve oversight of animal health of all animals at the cage level by
veterinary staff (in progress with daily rounds, including Saturday/Sunday on site
hours)
 Improve animal health monitoring at the cage level (in progress by use of
Illness/Injury Card [So-called “Orange Card”])

Benchmarking Data (Northwestern Study – Dec 2011;Yale 2011 Cost Survey of U.S. Research
Institutions; CIC
o UI staffing levels(compared to surveys): by # of animals:50%; by # of cages:70%; by # of
protocols:50%
o IACUC review times: CIC average 5+weeks (UI currently 2-3 weeks)
o Per diems: for 2011- mice UI $0.47/$0.55; Midwest average $0.86/$0/96 (Yale 2011 Study)
o Total facility space (square feet) by animals/cages for 2011: UI 66K, benchmarking 125K
Advisory and Stakeholders’ Groups
 Faculty Advisors for the eIACUC programming project: D. Hammond, C. Sigmund, P. Schlievert,
K. Campbell, J. Engelhardt, B. Fritzsch, J. Freeman
 Stakeholders’ Advisors - senior research staff advise on IT improvements and standardizing
Animal Protocol questions and answers; collaborate with AV, IACUC director, IACUC staff and IT
personnel; current senior staff include D. Fredericks(J. Buckwalter), B. Luczak (M. Anderson), S.
White (D. Hammond), W. Zhou (J. Engelhardt), D. Davis (C. Sigmund), R. Crawford (Campbell)]
What new opportunities/challenges do you see the new centralized animal facility bringing?
 Facility improvements when new OD Vivarium completed in fall 2015
o Proper ABSL2 housing for non-rodent species
o Proper ABSL2 housing for rodents being utilized on the OD campus
o Aseptic surgery suite and housing for large animal species (USDA) for Orthopedic
research in proximity to laboratory use areas
o ABSL1 housing for rodent and non-rodent species utilized on OD campus
 Facility improvements when new Central Vivarium completed in mid-2016
o Adequate/complying ABSL1 housing for non-rodent species
o Suite design to accommodate flexible housing of various species and various animal
health status levels
o Numerous small procedure rooms available within Central Vivarium to solve specialized
housing needs
o Housing rooms capable of maintaining higher or lower ambient temperatures when
required for specific research procedures.



Inadequate facilities (space and capabilities) until new construction completed in fall 2015
Unable to approve recent research projects due to housing limitations
Continuing need to engage OAR Director in faculty recruitments to address research needs
What can be/is the role of the Executive Committee relative to the IACUC & OAR?
 Advise on appropriate representation for a permanent “Research (Compliance) Advisory
Committee” that will include animal research;
 Identify new IACUC members when needed
 Support strategic QA/QI initiatives with faculty (policy) and senior research staff
(procedures)
 Provide ongoing feedback on OAR/IACUC operations; specific details regarding system
weaknesses, process bottlenecks, suggestions for improvement.
 Support implementation of new processes with the research community.
 Support necessary improvement of animal facilities
How do NIH and UI regulations mirror each other and differ regarding the protection of subjects &
animals?
 The UI policies take into consideration consistency with the following regulations and
guidance documents which reflect federal law or voluntary accreditation standards. UI’s
animal research enterprise is structured to comply with the following regulations,
regardless of research funding source:
o Animal Welfare Act (1966, P.L. 99-1998); USDA-APHIS administers and
enforces the AWA, its standards and regulations;
o Public Law 99-158, “Health Research Extension Act of 1985” provides a
statutory mandate for PHS Policy; Office of Laboratory Animal Welfare (OLAW)
under the Office of Extramural Research interprets, coordinates and administers
policy
o PHS Policy on Humane Care and Use of Laboratory Animals
o U.S. Government Principles for the Utilization and Care of Vertebrate Animals
Used in Testing, Research and Training
o Guide for the Laboratory Care and Use of Laboratory Animals, 8th Edition (NRC)
o AVMA Guidelines on Euthanasia, 2007
o International Guiding Principles for Biomedical Research Involving Animals
(1985) developed by the Council for International Organizations of Medical
Sciences (CIOMS)
o NIH Regulatory Guidance – Notices, FAQs, VAS, OLAW Online Seminars
 To receive NIH funding, UI is required to submit for approval, and operate under an
Animal Welfare Assurance in accordance with the PHS Policy for Humane Care and Use
of Laboratory Animals (PHS Assurance No. A3021-01)
 Accreditation standards are established by the American Association for the Accreditation
of Laboratory Animal Care International (AAALACi): AAALACi serves as the independent
review body in lieu of NIH in conducting inspections; ensures regulations and NIH
guidelines are fully addressed by accredited institution; UI has maintained Full
Accreditation since 1994.
How do NIH and UI regulations impact workload and productivity of your staff re: IACUC & OAR?
 Staff workload is totally driven by the need to meet regulatory requirements for the care
and use of the research animals. Regulatory obligations are the same for all animal
research institutions; business processes are institution-dependent. Adequate facilities,
staffing and core infrastructure intended to facilitate research largely drive business
processes. Partnering with the research community with ongoing review and quality
improvement initiatives is key to facilitating animal research.
What are the unique differences between the various Institutions regarding the use of animals in
research
 There should be no differences between institutions with regard that all are regulated in
the same manner. That said, following are reasons of perceived differences between any
two research institutions:
 Facility capabilities/limitations
 Staffing levels/type
 Professional interpretation/judgment
 Research needs/requirements
 Agricultural vs. biomedical research
 Animal health status requirements/capabilities for various facilities
 Institutional subsidy level of animal program (OAR & IACUC)