volume 35 issue 2/3 scaw newsletter · 2014-09-19 · randall j. nelson, phd president ......

SCAW's, USDA/AC, NIH/OLAW, CITI Program at the University of Miami and others present an IACUC training workshop on May 15, 2014 Topics for presentation and discussion will in-clude: ♦ Keynote: Science, Ethics and the IACUC: A

Research Love Triangle ♦Creating a Proactive and Engaged IACUC: A

Proposal ♦Officially Responsible Research Conduct In-

volves Training: Are you on the Right Track? ♦Just in Cases: Protocol Review Scenarios with

PHS and USDA ♦To Hot to Handle: The Care and Feeding of

“Problem” Investigators (PIs) ♦Using PAM to Make Animal Research a

Non-Stick Experience ♦ Hot Topics with AAALAC International

Representatives from federal regulators agencies and accrediting organizations will participate and be available to answer ques-tions.

For program and registration go to page 14-

Doing More With Less: Running A Fit Animal Research Program

Sponsors: SCAW, UTHSC-SA, OLAW/NIH/DHHS, USDA/APHIS/AC Menger Hotel, San Antonio, TX

December 8-9, 2014

SCAW’s Winter Conference will again be held in beautiful downtown San Antonio on December 8-9, 2014. The historic Menger Hotel will house this educational two-day event and is only min-utes from the Riverwalk. All of SCAW’s Workshops and Conference will help meet the requirement stated in the Guide for the Care and Use of Laboratory Animals 8th edition, 2011 that states “All personnel in-volved with the care and use of animals must be adequately educated, trained, and/or quali-fied in basic principles of laboratory animal science to help ensure high-quality science and animal well-being”. It will also address USDA/APHIS/AC Policy 15.

CEU Credits: SCAW conferences and work-shops will be reviewed and approved by the American Association of Veterinary State Boards (AAVSB) RACE program and will meet the requirements for continuing education credit for Veterinarians and Veterinary Tech-nicians. Please contact the AAVSB RACE program at [email protected] should you have any comments/concerns regarding SCAW's program’s validity or relevancy to the veterinary profession.

S C I E N T I S T S C E N T E R F O R A N I M A L W E L F A R E

Fall/Winter 2013/2014

Volume 35 Issue 2/3

SCAW Newsletter

Inside this issue:

News from OLAW, USDA and AAALAC International

3-4

News from Around 5-7

End Points and the IACUC

8-13

SCAW’s IACUC Training Program and Registration

15-16

Save the Date

IACUC Training Workshop

May 15, 2014

NIH Campus

Natcher Conference Center

More information on 4-15

SCAW’s Annual

Winter Conference December 8-9,

2014 San Antonio, TX

IACUC Training Workshop May 15, 2014 NIH Campus

The Scientists Center for Animal Welfare (SCAW) is composed of research professionals dedicated to balancing animal welfare and excellence in basic and applied scientific inquiry. SCAW recognizes that some research areas present challenges regarding animal use. SCAW affirms that the potential benefit to humans and animals from research and the cost to the animal subject(s) must both be considered. By addressing animal research challenges directly through education and training, SCAW serves to facilitate open discussion and helps craft solutions as well as promote best practices. Through its outreach to the broader research community, SCAW demonstrates its commitment to excellence in animal care and science.

Mission

Randall J. Nelson, PhD President University of Tennessee Health Science Center Paul G. Braunschweiger, PhD Vice President University of Miami Miller School of Medicine Gregory R. Reinhard, DVM, MBA, DACLAM Treasurer Merck & Company A. Wallace Hayes, PhD, DABT, FATS, FIBiol, FACFE Secretary Harvard School of Public Health Ernest D. Prentice, PhD Past President University of Nebraska Medical Center B. Taylor Bennett, DVM, PhD, DACLAM Management Consultant Anthony Comuzzie Texas Biomedical Research Institute Margaret S. Landi, VMD GlaxoSmithKline Pharmaceu- ticals William J. White, VMD,MS, DACLAM, Dipl.ECLAM Charles River Joanne Zurlo, PhD The Center for Alternatives to Animal Testing Linda Tockey Managing Director SCAW

The SCAW newsletter is pub-lished by the Scientists Center for Animal Welfare. Submis-sions to the newsletter are en-couraged and need to be in electronic format. Please send to [email protected]. SCAW has made every effort to ensure the accuracy of materi-als in the newsletter, but SCAW is not responsible for loss or damages caused by errors, omissions, misprints or misin-terpretations of the newsletter contents. Information con-tained in this newsletter should not be used as the basis of decisions by any reader without referring to applicable laws, regulations and/or professional advice. No part of the SCAW newsletter may be reproduced without prior written permission from SCAW. Some photos in the SCAW newsletter and website have been used from “On Screen Image Collection” from digires.co.uk. When was the last time you visited WWW.SCAW.COM? SCAW has a new website to make it more user friendly and informative. There is a wealth of information and resources on research animal welfare as well as general information about SCAW, see below:

Board of Trustees

Volume 35 Issue 2/3

SCAW Information

•Special secured infor-mation section for SCAW Institutional Members

•Membership

•Upcoming meetings, workshops and Confer-ences

•Current publications and older ones in pdf format

•IACUC Training Work-shops and Conferences

•Resources and links

•Mission Statement

•IACUC Talk

•SCAW Newsletters

•History of meetings, workshops and confer-ences

•Rowsell Award

•Resources for K-12 students and teachers Editorial Board: Chair, A. Wallace Hayes, PhD, DABT, FATS, FIBiol, FACFE, Margaret Landi, DVM, Gregory R. Reinhard, DVM, MBA, DACLAM Please send any sugges-tions to Linda Tockey at [email protected]

Mission Statement

Position statements Be sure to go to AAALAC’s position statement page to view the revised and new position statements.

• Definition of "Laboratory Animals"

• The Attending Veterinarian and Veterinary Care

• Cage or Pen Space

• Social Housing

• Selecting the Appropriate Standard(s) for the Care and Use of Agricultural Animals

• Safety Requirements for Walk-In Cage/Rack Washers and Bulk Sterilizers

News from OLAW, USDA and AAALAC International

Invitation to Comment on Proposed Guidance Regarding Significant Changes to Ongoing Animal Activities Request for Information: Invitation to Comment on Proposed Guidance Regarding Significant Changes to Ongoing Animal Activities was pub-lished in the NIH Guide for Grants and Con-tracts on March 11, 2014, NOT-OD-14-063. This Notice is to inform PHS awardee institu-tions that OLAW is seeking input on proposed guidance regarding what is considered a sig-nificant change to an ongoing animal activity that requires IACUC review. The PHS Policy requires that IACUCs “review and approve, re-quire modifications in (to secure approval) or withhold approval of proposed significant changes regarding use of animals in ongoing activities.” (IV.B.7.).

Comments and suggestions must be submitted electronically at http://grants.nih.gov/grants/rfi/rfi.cfm?ID=36. Comments must be received on or before May 15, 2014.

Implementation of the Revised International Guiding Principles

for Biomedical Research Involving Animals

Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals has been published in the NIH Guide for Grants and Contracts on Au-gust 2, 2013, NOT-OD-13-096. The PHS Pol-icy requires that institutions have an ap-proved Animal Welfare Assurance before con-ducting activities involving live vertebrate animals. Institutions outside the U.S. that receive PHS funding are required to have a Foreign Assurance that commits the institu-tion to follow the Guiding Principles.

Full implementation is expected after October 1, 2013. OLAW will confirm an institution's adoption of the Guiding Principles at the next renewal of the Foreign Assurance.

Volume 35 Issue 2/3

Continue on next page

NEW VIDEO: Stop Hiding and Change

the World!

Those of you who work with research animals are heroes of love and compas-sion, says Cindy Buckmaster, Chair of AMP's Board of Di-rectors. Watch this new video by Cindy and the AMP team for inspiration on how you - Yes, YOU - can help family, friends and ac-quaintances under-stand the care and concern you have for the animals in your charge, and your dedication to improv-ing the quality of life for all.

SCAW Newsletter

Animal Welfare Act Contin-gency Regulation: APHIS published a final rule requiring all dealers, exhibitors, inter-mediate handlers, carriers, research facili-ties and other entities regulated by the Agency under the Animal Welfare Act (AWA) to take additional steps to be better pre-pared for potential disaster situations. They are required to develop a plan for how they are going to respond to and recover from emergencies most likely to happen to their facility, as well as train their employees on those plans. These emergency plans are also referred to as “contingency plans.” The goal of this rule is to increase the regulated community’s awareness and understanding about their responsibilities to protect their animals in emergency situations. Develop-ing contingency plans could potentially save the lives of their animals – and their employ-ees – during an emergency or natural disas-ter. It will also allow each USDA licensee and registrant to evaluate their prepared-ness and to more fully understand how they can better survive a disaster or emergency situation. For more information go to USDA/APHIS/AC

USDA National Animal Health Emergency Response Corps-NAHERC When an animal health emergency occurs, an immediate response is necessary to pro-tect both animals and people. The United States Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) will look to many sources to obtain the veterinary personnel needed to help meet the critical staffing needs of such an emergency. In 2001, APHIS established the NAHERC to respond to exotic disease out-breaks and other disasters which affect live-stock, poultry, companion animals, and wild-life. More volunteers are urgently needed to assure a decisive response to any potential animal health crises. For more information from USDA NAHERC send email to: [email protected] and place NAHERC INFO in title block.

Now Available

SCAW’s

Educational

Tool

“Policies,

Regulations,

Guidelines and

More…”

For more

information go

to WWW.SCAW.COM

USDA Animal Care Creates Online Process for Submitting Animal Welfare Concerns USDA Animal Care has created a new, online form for members of the public to submit their concerns about animals that are covered under the Animal Welfare Act and the Horse Protection Act. The form is on our website: http://www.aphis.usda.gov/animal_welfare/aw_complaint_form.shtml. It is a quick and efficient method to notify us of animal wel-fare concerns so we can look into those con-cerns. Complaints can be made anony-mously; however, providing your contact information will allow us to contact you if we need additional information.

USDA Animal Care Provides Its Inspectors With New Guidance for Conducting Inspections At USDA Animal Care, we are continually looking to improve the way we administer the Animal Welfare Act and help ensure that all of our methods and processes uphold the intent of the federal regulations. The information that follows is intended to in-form you of some changes we are making that will affect certain inspections and our publically-available inspection reports. We have provided our inspectors updated procedural guidance on the following topics: documenting attempted inspections; taking photographs during pre-license inspections; conducting inspections inside a residence; and documenting citations on inspection reports. More specific information can be found in the updated Inspection Guide, posted on our website: http://www.aphis.usda.gov/animal_welfare/downloads/Inspection%20Guide%20-%20November%202013.pdf.

Animal Welfare Act Contingency Plan Final Rule

Volume 35 Issue 2/3

News from Around

Primates in Medical Research

Moshe Bushmitz and Understanding Animal Research have developed a new educational ebook.

The book has been developed to help explain the vital role played by non-human primates in medical research programs to students, facility employees, stakeholders and others.

Electronic books are an exciting new platform. They allow images, sound and video to create an interactive display that complements the text. The user ex-perience is more immediately engaging and personal than either a website or text book, providing an immersive educa-tional tool which brings the subject to life. The book has been used here to provide a new type of text on primates. The book has several advantages over traditional textbooks: a large amount of information can be made available in an easily port-able format, they can be updated and revised easily.

The iBook can be downloaded at iTunes for free at https://itunes.apple.com/us/book/primates-in-medical-research/id676974662?mt=11 There is also a PDF option http://www.understandinganimalresearch.org.uk/news/2013/08/free-ibook-primates-in-medical-research-now-available/

curiousYOUNGwriters

curiousYOUNGwriters (cYw) is a platform for publishing student writing. Each story is au-thored by a pre-collegiate student, who re-searches and writes about an uncommon ani-mal helping researchers find better answers to some age-old health questions. cYw is hosted by States United for Biomedical Research (SUBR) and is endorsed by The Biology Teach-ers Association of New Jersey (BTANJ).

Some topics include;

Chickens Tackle Hashimoto’s Thyroiditis

Counting on Sheep to Save Children with Tay-Sachs

Doberman Pinschers Asleep on the Job: Uncovering the Mysteries of Narcolepsy

Click here for more information on Curious Young Writers.

Prized Science is the American Chemical Society

Video series

Prized Science is a video series featuring the work and contributions of recipients who won ACS awards. Watch, listen, and dis-cover how the chemistry behind ACS’ awards transforms our lives. ACS encourages educators, schools, muse-ums, science centers, news organizations and others to embed links to Prized Science on their websites. The videos discuss scien-tific research in non-technical language for general audiences. New episodes in the series, which focuses on ACS’ 2013 national award recipients, will be issued periodically.

Videos are suitable for classroom use and other audiences of students and non-scientists. ACS encourages educators, schools, museums, science centers, news organizations, and others to embed links to Prized Science on their websites.

ICCVAM Mission and Vision A New Vision and Direction for ICCVAM

SCAW Newsletter

Be sure to go to AAALAC’s Frequently

Asked Questions.

Please note that this newly restructured FAQ page (January 2013)

includes new and revised questions related to the 8th

edition of the Guide for the Care and Use of

Laboratory Animals (NRC 2011). If you have a question not addressed in our FAQs,

please email; [email protected]. For further guidance,

please refer to AAALAC International's Position

Statements. AAALAC’s Frequently

Asked Questions can be found at http://www.aaalac.org/

accreditation/faq_landing.cfm

In early 2013, NIEHS and NTP announced a plan to make significant changes to the focus and priorities of both NICEATM and ICCVAM (see editorial by NIEHS and NTP Director Linda Birnbaum, Environmental Health Perspectives, February 2013). These changes will better align ICCVAM and NICEATM with the vision laid out by the National Academy of Sciences in the 2007 National Research Council report Toxicity Testing in the 21st Century: A Vision and a Strategy. ICCVAM welcomed the opportunity to work with NICEATM to forge a new direction forward, and developed a document describing the initial steps towards this goal. The document dis-cussed:

• ICCVAM priority setting and scientific areas for immediate resource investment

• Plans to improve communications with stakeholders and the public

• Exploration of new paradigms for validation and utilization of alternative toxicological methods In addition, ICCVAM stated the intent of member agencies to take a more active role in prior-ity setting and operations of the Committee and to devote more effort to fewer focus areas. ICCVAM made “A New Vision and Direction for ICCVAM” available in draft form for comment in September 2013. Attendees at that month’s meeting of the Scientific Advisory Committee on Alternative Toxicological Methods discussed the document and proposed initial steps. Mission ICCVAM's mission is to facilitate development, validation, and regulatory acceptance of new and revised regulatory test methods that reduce, refine, and replace the use of animals in testing while maintaining and promoting scientific quality and the protection of human health, animal health, and the environment. For more information on ICCVAM vision click here.

28th Annual Charles River Short Course on Laboratory Animal Science June 16-19, 2014

Marriott Hotel, Newton, MA

Over 5,000 lab animal professionals have participated in the Charles River Short Course on Laboratory Animal Science since its inception in 1986. Whether you are an experienced animal researcher seeking continuing education credits, a veterinarian studying for ACLAM boards or just starting your career, the short course offers lectures and workshops to put you on the path to success. This year, the course offers 18 brand new topics, 21 CE hours, optional workshops, a tour of Charles River and an opportunity to see the sights in Boston, MA or Maine. Register at www.criver.com/shortcourse14 Contact: [email protected]

The Humane Society of the United States is seeking nominations for its 2014 Russell and Burch Award. The Russell and Burch Award is presented to scientists who have made out-standing contributions to the advancement of alternative methods in the areas of research (including biomedical), testing, or higher edu-cation. Alternative methods—also known as the Three Rs—are methods that can replace or reduce the use of animals, or refine proce-dures so that animals experience less pain or suffering.

The Humane Society of the United States Solicits Nominations for the 2014 Russell and Burch Award

Volume 35 Issue 2/3

OLAW encourages PHS-Assured institutions to

begin using the Updated AVMA

Guidelines for the Euthanasia of Animals:

2013 Edition when reviewing research projects as soon as

possible, and expects full implementation after September 1, 2013. Previously approved projects

undergoing continuing review according to PHS

Policy, IV.C.5., which requires a complete de

novo review at least once every 3 years,

must be reviewed using the 2013 Guidelines after September 1,

2013..

The award is named in honor of William Rus-sell and Rex Burch, the scientists who formu-lated the Three Rs approach of replacement, reduction, and refinement. The Award is a means of recognizing the important role that scientists play in limiting the use and suffer-ing of animals in laboratories. Please visit: http://www.humanesociety.org/issues/biomedical_research/facts/russell-burch-award.html for more information about the nominations process and timeline.

The AVMF has partnered with the AVMA, Zoetis, and the Smithsonian Institution Traveling Exhi-bition Service (SITES) to create “Animal Connections: Our Journey Together,” a custom-built traveling exhibit on an 18-wheel truck that expands into 1,000 square foot interactive science experience.

The exciting exhibit introduces visitors of all ages to the complex bond between humans and animals, by using a dynamic combination of interactive learning stations, films and touch screen videos, and three-dimensional settings to explore topics about animals in the home, on the farm, in the wild, at the zoo and in the veterinary clinic.

The AVMF is seeking volunteer veterinarians, technicians, students, and AVMF supporters in each city on the exhibit’s tour to help us:

• Inform the public about our Ambassador for Animals Program and encourage member-ship.

• Educate the public about the exhibit and the veterinary field.

• Promote the exhibit to family, friends, and colleagues and encourage attendance.

This is a fun and exciting opportunity for you to share your passion for veterinary medicine with the community! Volunteers will be scheduled for two-hour shifts at the exhibit. All vol-unteers will be provided with t-shirts and we ask that veterinarian volunteers wear their lab

coats.

Anyone interested in volunteering, a complete list of tour dates or additional information should contact Laura Roth at AVMF (847) 285-6689 or [email protected].

Join The AVMF For “Animal Connections: Our Journey Together”

A Mobile Exhibit That Explores the Human–Animal Bond

Parameters to consider when formulating humane endpoints 1. Changes in external physical ap-pearance or other clinical signs Examples of clinical signs include changes in the condition of the fur/coat, posture, gait, or body condition, and the presence of swellings or masses, prolapse, sunken eyes, and head tilt. Animals should be examined regularly by appropriately trained staff. The fre-quency of such examinations will de-pend on the species, whether any previ-ous abnormalities have been observed, timing and nature of the anticipated ef-fects, and the objectives of the study. Frequency of examinations should in-crease as animals approach the antici-pated humane endpoint. Once an end-point is reached the pre-planned action should occur. A chart of commonly ob-served clinical signs and conditions per species is provided below. 2. Physiological changes Examples of physiological parameters include body temperature, weight loss, appetite, examination of stool produc-tion and/or changes in color and consis-tency, heart rate, respiratory rate, EKG, and EEG. Physiological changes should

be monitored to assist in the de-termination of endpoints, and the relevance of these parame-ters established. Two common physiological changes that are used are body weight and body temperature, or a combination of the two. Significant body weight loss may be one of the most sen-sitive indicators that an animal’s

condition is deteriorating, particularly if it occurs over a short period of time. Body weight loss is usually secondary to a change in feed and water consumption, which should also be closely monitored by animal care staff. It may be due to metabolism changes for subchronic or chronic studies. Body weight loss should be compared to age/sex matched con-trols. In young animals that have not reached their adult body weight, an abnormal con-dition may be indicated by a reduced rate of weight gain when compared to the ap-propriately matched control animal, rather than an actual weight loss. If body weight is used as an endpoint, the proto-col should define the frequency of weigh-ing, the individuals responsible for per-forming weighing, and analysis of the weighing. For most protocols, an acute weight loss of 10% of body weight is con-sidered an endpoint. For studies where weight loss greater than 10% is expected and is still consistent with good animal welfare, justification for the necessity to allow this must be included in the proto-col and approved by the IACUC. Body condition scoring can be used instead of weighing, especially if there are con-founding factors such as tumor models, pregnancy, ascites production or young growing animals. There are body condi-tion scoring examples in the literature for mice10, dogs, and farm animals. Changes in body temperature for certain types of studies may be an endpoint de-terminant. Hyperthermia or hypothermia has been successfully used in infectious

ENDPOINTS AND THE IACUC

(part two)

By: Elizabeth M. Dodemaide, BVSc, MA, MACV Sc and

Gregory R. Reinhard, DVM, MBA, DACLAM

SCAW Newsletter


OLAW has posted a flow chart as an added tool for

Assured institutions in meeting the

reporting requirements for

departures from the Guide. The chart is

available for download on the Departures from

the Guide webpage. Here you will also

find detailed guidance on the

reporting requirements plus useful examples.

Flow Chart for Guid-ance on Departures

from the Guide

studies. A number of studies have shown that in mouse models of infectious dis-ease, the animals whose body tempera-ture dropped more than 6°C went on to die14. 3. Diagnostic laboratory testing Examples of biochemical parameters that may change in response to disease con-ditions, and can potentially serve as markers of disease status, include blood, urine, tissues, and cerebral spinal fluid. Various hematological, clinical chemistry and urinary parameters can provide an indication of an animal’s condition. Con-sideration should be given to collecting and monitoring parameters that may be useful in assessing an animal’s well-being. In determining toxicity to certain organs such as liver and kidneys, serum chemistry has been a valuable tool. The Food and Drug Administration (FDA) defines a biomarker as “a characteristic that is objectively measured and evalu-ated as an indicator of normal biologic processes, pathologic processes, or phar-macologic responses to a therapeutic intervention." 4. Behavioral signs Observing changes in behavior can be used to assess changes in the well-being of an animal. Behavioral changes that contribute to analysis for endpoints can be considered in four general categories: 1. Response to external stimuli e.g. response to touch 2. Occurrence or changes in the fre-

quency of behaviors that might occur as a result of pain or discomfort e.g. vocalization, licking, biting, or guard-ing.

3. Adverse behaviors relevant to the

model e.g. lameness for arthritis stud-ies.

4. Non-specific behaviors e.g. sleeping

patterns, eating and drinking patterns, and grooming

For effective behavior analysis it is critical that the monitoring personnel are trained to recognize normal and abnormal behav-ior for the species and even individual strains. Pain and distress monitoring of-ten involves behavior observation and/or scoring. Pain and distress scoring is a method to convert subjective animal ob-servations into an objective scoring sys-tem which can be helpful in assessing animal behavior. (see Table 1 at end of document) Moribund A moribund animal is one that is near death and may be comatose or unrespon-sive to stimuli, exhibit dyspnea, hypother-mia, prostration, etc. Although the goal of a sensitive humane endpoint is to inter-cede before a moribund state occurs, euthanasia should always be indicated if it does occur. Death as the endpoint There are several types of studies where death of the animal may historically have been the experimental endpoint. This re-quirement is now questioned. These areas include regulatory toxicology, diagnostic toxicology, acute toxicity studies in re-search, infectious disease studies, micro-organism virulence challenge studies, vac-cine efficacy trials, cancer research, and cancer treatment evaluation. In short, death may be a possible endpoint but not the only endpoint. Death as an endpoint should be avoided, the goal is to beat death to the point!

Continued from page 8

Volume 35 Issue 2/3

OLAW Statement on Recent Media

Coverage Related to Animals in

Research

OLAW issues

statement clarifying events concerning

the welfare of laboratory animals that were shared recently with the media by SAEN.

Read the full statement.

To learn more about OLAW’s

compliance oversight activities, visit the Reporting

Noncompliance webpage..


For novel studies - identifying endpoints After completing the study for the first time examine the data, compare animals that had “good” and “bad” outcomes, look for variables that are differentially associated with these outcomes: It may be possible to refine the endpoint crite-ria, with earlier experimental endpoints to avoid or reduce potential pain and distress. Score sheets An assessment system may be used for scoring clinical signs to indicate serious-ness of ill health and well-being, and is particularly useful when a single pa-rameter does not have significant predic-tive value for determining humane end-points. Multiple parameters may have an additive value in assessing overall health and well-being. Endpoints are sometimes determined by using a list of key signs and behavioral observations to evaluate the extent of deviation from normal. The key signs and observations are listed on score sheets or checklists. These are helpful in ensuring that appropriate observa-tions are made, consistently interpreted, and properly documented. Signs and observations are to be recorded as pre-sent (+) or absent (-) or a degree (0 – 3) representing normal to severe. By con-vention, negative signs indicate normal-ity. A cumulative rating may be obtained by adding the score for each category. An increase may indicate deviation from normal. This can be interpreted as an indication of increasing pain and dis-tress. A threshold should be identified which would indicate an intervention or endpoint. Score sheets may need to be specific for each experimental proce-dure, each species and even each strain.

Establishing a Plan It is good practice to write a plan to fol-low animal care and monitoring proce-dures, to identify personnel responsible for evaluation, record keeping, notifica-tion of the investigator and/or veterinar-ian and intervention. The plan may in-clude score sheets or checklists and in-tervention as designated in the protocol. Record Keeping A laboratory notebook, animal medical records or another officially designated record system is advisable to document the monitoring events, monitoring data and actions taken when the endpoint point is reached. Records should be readily available for veterinary staff or IACUC members to review. “Other” Advantages of Good Endpoints New and better endpoints may have other non humane benefits,- less per di-ems, shorter testing time, enhanced re-search data, and publishable information on refinements. There is also the human factor – animal care staff and investiga-tors are able to see that animals suffer less. Unexpected Complications How is this handled? Unexpected out-comes or complications should be com-municated to the veterinary staff. If IA-CUC procedures ask for all reports of ad-verse events, then the IACUC must be informed as well. Role of the IACUC IACUCs need to carefully consider all pro-tocols where there is potential for animal pain and distress, particularly in studies involving diseases where clinical signs are expected e.g. infectious diseases, tumor studies. Establishing clear, con-cise guidelines for humane endpoints, expectations for animal treatment, obser-vation and euthanasia can assist investi-


SCAW and CITI Program at the

University of Miami has partnered to

develop a Student Scholarship Fund.

If you are a full time student and

would like to attend any one of

SCAW’s Workshops or Conferences

please click here to find out on how

to apply for the SCAW/CITI Student

Scholarship to have your

registration fee waived.

SCAW Newsletter


gators in preparing protocols. In addi-tion, IACUCs may write Standard Operat-ing Procedures which can be referenced by the investigator, or use templates to aid in protocol preparation. When faced with a novel model, IACUCs may choose to request increased over-sight of the animals by the veterinary staff, they may ask the PI to send regular reports to the IACUC or ask for a pilot study using a small number of animals to be performed first to validate the model and establish appropriate humane end-points. Where no committee member has knowledge or experience with a model, they may ask an outside expert in the field to serve as a consultant and advise the IACUC. A strategy that many IACUCs use is to write a set of humane endpoint guide-lines for investigators to follow when planning and conducting studies with the potential for pain and/or distress. These guidelines need to be clear, concise, de-scribe the expectations of the IACUC, and the responsibilities of the investigator and all staff who will perform the experi-ment. In some instances it is possible to also have a score sheet template which can be customized for individual studies. When approving a protocol, the IACUC may set conditions for that approval. These may include: a. asking the PI to conduct a small pilot study first and then report back to the IACUC at the conclusion with the results. The IACUC can then determine whether the humane endpoints were or were not, appropriate, and whether the PI can go ahead with a larger study; b. notifying the veterinary staff before starting the study so that they can do regular observations of the animals; or c. reporting periodically to the IACUC on


Volume 35 Issue 2/3

progress of the study. Conclusion Establishing humane endpoints in all studies where there is potential for pain and distress is establishing responsible endpoints. The IACUC needs to work with the PI, the veterinarian and the ani-mal care staff to initiate and follow through on appropriate oversight for all studies. The intensity of the oversight should be commensurate with the po-tential for pain and distress. All animals deserve the right to always be treated humanely and with compassion.


SCAW’s 2013

IACUC Training

May SCAW IACUC

Training Workshop Bethesda, MD Mary 15 2014

Program and

registration is on page

14-15 or available online

at www.scaw.com

SCAW Newsletter

Table 1

Guidelines for Potential Signs Associated with Pain or Distress in

Rodents and Rabbits+

Clinical Signs Mice Rats Guinea pig

Hamsters, Gerbils

Rabbits

Decreased Food and/or Water Consumption X X X X X

Weight loss X X X X X

Self-imposed isolation/hiding X X X X X

Self-mutilation, gnawing at limbs X X X X X

Abnormal Breathing (rapid or labored ) X X X X X

Grinding Teeth X X X X

Biting /Aggression (strain variation) X X X

Unkempt Appearance (Erected, Matted, or Dull Haircoat)

X X X X X

Abnormal Posture/Positioning/movements (e.g., head-pressing, Hunched Back, Stagger-ing )

X X X X X

Tearing (including Porphyria+), Lack of Blinking Reflex, palpebral ptosis

X X+ X X X

Dilated Pupils X X

Prolapse of third eyelid X

Muscle Rigidity, Lack of Muscle Tone X X X X X

Dehydration/Skin Tenting/Sunken Eyes X X X X X

Twitching, trembling, tremor X X X X X

Abnormal Vocalization (Rare) X X X X X

Back-arching (cat stretch), writhing X

Tumor Growth and Ulceration X X


Volume 35 Issue 2/3

References: 1. Animal Welfare Act and Animal Welfare Regu-

lations, 9CFR part 1, Section 2.31, 2002.

2. Public Health Service Policy on Humane Care and Use of Laboratory Animals. OLAW, NIH, 2002.

3. Institute for Laboratory Animal Research Guide for the Care and Use of Laboratory Animals, 8th Ed. 2011. National Academies Press, Washington DC.

4. CCAC Guidelines on: choosing an appropriate endpoint in experiments using animals for re-search, teaching and testing, 1998.

5. DB Morton and PH Griffiths. Guidelines on the recognition of pain, distress and discomfort in experimental animals and an hypothesis for as-sessment, The Veterinary Record, Vol. 116 (16), 431, 1985.

6. W. S. Stokes. Humane Endpoints for Laboratory Animals Used in Regulatory Training, in ILAR Jour-nal, Vol. 43 Supplement pp S31, 2002.

7. P. Hawkins, Recognizing and assessing pain suffering and distress in laboratory animals: a survey of current practice in the UK with recom-mendations, in Laboratory Animals Ltd, 36, 378, 2002.

8. N. Sass. Humane Endpoints and Acute

Toxicity Testing, in ILAR Journal, Vol. 41(2), 2000

9. L. Medina. How to Balance Humane End- points, Scientific Data Collection and Appropriate Veterinary Interventions in Animal Studies, in Contemporary Topics, 43 (5), 2004.

10. Guidance document on the recognition, as-sessment, and use of clinical signs as humane endpoints for experimental animals used in safety evaluation. November 2000. Organisation for Economic Co-operation and Development (OECD), Environmental Health and Safety Publi-cations, Series on Testing and Assessment, No. 1

11. UKCCCR Guidelines for the Welfare Animals in Experimental Neoplasia (2nd Edition). United Kingdom Coordinating Committee on Can-cer Research, London 1997.

12. Institutional Animal Care and Use Committee Guidebook, 2nd ed., 2002, ARENA, Office of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD.

13. C. Foltz; M. Ullman-Cullere; Guidelines for Assessing the Health and Condition of Mice, Lab Animal, V0l 28(4) 1999

14. RA Trammell, LA Toth, Markers for Predicting Death as an Outcome for Mice Used in Infectious Disease Research - Comparative Medicine, 61(6): 492–498, 2011

Table 2 A variety of clinical signs can be used for assessing morbidity in non-rodent

(NHPs, dogs, pigs, ferrets) species:

(1) Decreased Appetite

(2) Rapid Weight Loss >20% (e.g. failure to gain weight compared to aged matched con-trols) (3) Abnormal Heart Rate (increased/decreased)

(4) Changes to peripheral pulses (bounding or weak, thready), or blood pressure

(5) Abnormal Breathing (rapid, shallow or labored slow)

(6) Dehydration (skin turgor, mucous membranes, urinary output)

(7) Body Temperature (increased, decreased)

(8) Changes in musculoskeletal/neurologic Function (twitching, tremors, seizures, convul-sions, paresis, hyperesthesia, decreased reflexes, lameness) (9) Vocalization at handling

(10) Mucous Membrane Discoloration

(11) Self-mutilation, i.e. autotomy

(12) Depression

About the authors Elizabeth M. Dodemaide, BVSc, MA, MACVSc, is the Associate Director, Laboratory Animal Services at Rutgers, the State University of New Jersey Gregory R. Reinhard, DVM, MBA, DACLAM is on the SCAW Board Trustee and is the Managing Direc-tor of Reinhard & Associates, a compli-ance management firm.

IACUC Training Workshop Sponsors: SCAW, OLAW/NIH/DHHS, USDA/APHIS/AC and

CITI Program at the University of Miami May 15, 2014

Natcher Conference Center Wisconsin Avenue

Bethesda MD

SCAW Newsletter

Mark your Calender for

SCAW’s Annual Winter

Conference again at the

Menger Hotel

“Doing More With Less: Running A Fit Animal Research Program”

San Antonio, TX

December 8– 9, 2014

PROGRAM 8:00 Registration Coffee and muffins 8:30 Introduction and Welcome to IACUC Training Introduction of Speakers Gregory R. Reinhard, DVM, MBA, DACLAM 8:45 Keynote: Science, Ethics and the IACUC: A Research Love Triangle Ernest D. Prentice, PhD 9:30 Creating a Proactive and Engaged IACUC: A Proposal Randall J. Nelson, PhD 10:00 Break 10:30 Officially Responsible Research Conduct Involves Training: Are you on the Right Track? Paul G. Braunschweiger, PhD 11:00 Are You Up To Date with APHIS, OLAW and AAALAC Interna- tional: Q & A for You and Me Introduction and Moderator: Gregory R. Reinhard, DVM, MBA, DACLAM Carol Clarke, DVM, DACLAM USDA/APHIS/AC Representative Eileen Morgan, OLAW Representative John F. Bradfield, DVM, PhD, DACLAM, AAALAC Interna- tional Representative 12:00 Lunch

1:00 Just in Cases: Protocol Review Scenarios with PHS and USDA Ernest D. Prentice, PhD Randall J. Nelson, PhD Carol Clarke, DVM, DACLAM USDA/APHIS/AC Representative Eileen Morgan, OLAW Representative 2:00 To Hot to Handle: The Care and Feeding of “Problem” Investiga- tors (PIs) J. G. Collins, PhD 2:30 Break 3:00 Using PAM to Make Animal Research a Non-Stick Experience Gregory R. Reinhard, DVM, MBA, DACLAM 3:30 Hot Topics John F. Bradfield, DVM, PhD, DACLAM, AAALAC International Representative 4:00 When the Relatives Come to Visit: Site Visits/Inspections John F. Bradfield, DVM, PhD, DACLAM, AAALAC International Representative Carol Clarke, DVM, DACLAM USDA/APHIS/AC Representative Eileen Morgan, OLAW Representative Randall J. Nelson, PhD Ernest D. Prentice, PhD 5:00 End of Workshop

Volume 35 Issue 2/3

Program and

registration is now up

on SCAW’s website:

www.scaw.com

Scientists Center for Animal Welfare 2660 NE Hwy 20,

Suite 610-115 Bend OR 97701

Tel: 301.345.3500 Fax: 301.345.3503

Email: [email protected] Website:

May 15, 2014, Bethesda, MD

___ $350 General Registration Fee

___ $300 SCAW Institutional Member Fee

___ $150 Student (Contact SCAW about CITI student sponsorship)

Name: __________________________________________ Job Title: __________________________________________ Company Name: __________________________________________ Street Address, City, State, Zip: __________________________________________ __________________________________________ __________________________________________ Telephone and Fax: __________________________________________ E-mail: [Please print clearly] __________________________________________ I will pay for my registration with: ____ Check or Money Order enclosed ____ MasterCard ___Visa American Express is accepted online only. Card Number: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ Expiration Date: __ __/ __ __ Security Code # __ __ __ Billing Zip code __ __ __ __ __ Name of cardholder and e-mail of cardholder (please print): _______________________________________________ Authorized signature: _______________________________

It is expected that this course will be ap-proved for hours of continuing education credit in jurisdictions which recognize AAVSB RACE approval; however partici-pants should be aware that some boards have limitations on the number of hours accepted in certain categories and/or restrictions on certain methods of deliv-ery of continued education. Call the SCAW office at 301 345-3500 for further information.

This workshop will help meet the require-ment stated in the Guide for the Care and Use of Laboratory Animals 8th edi-tion, 2011 that states“All personnel in-volved with the care and use of animals must be adequately educated, trained, and/or qualified in basic principles of laboratory animal science to help ensure high-quality science and animal well-being”. It will also address USDA/APHIS/AC Policy 15.

REGSTRATION

2660 NE Hwy 20, Suite 610-115 Bend, OR 97701 Phone: 301.345.3500 Fax: 541.383.4655 E-mail: [email protected] Website: www.scaw.com

May SCAW IAUCU Training Workshop Natcher Conference Center/NIH Campus Bethesda, MD May 15, 2014 June Publication of SCAW Newsletter October AALAS National Meeting San Antonio, TX October 19-23, 2014 (SCAW Exhibiting) November Publication of SCAW Newsletter

January SCAW IAUCU Training Workshop Westin Diplomat Resort & Spa Hollywood FL January 8, 2014 March Publication of SCAW Newsletter SCAW IAUCU Training Workshop The Graduate School and University Center New York, NY March 19, 2014

December SCAW Board Meeting San Antonio, TX December 9th, 2014 SCAW Winter Conference Menger Hotel San Antonio, TX December 8-9-, 2014

Schedule of Activities 2014

"...promoting best practices in animal research and testing"

We’re on facebook

volume 35 issue 2/3 scaw newsletter · 2014-09-19 · randall j. nelson, phd president ......

Documents