Promoting Integrity in Your Laboratory
Animal Welfare Research Program
The CITI Program
Paul Braunschweiger PhD
Chair, University of Miami IACUC
CITI Program Co-Founder
University of Miami Miller School of Medicine
Foundations for the Ethical Treatment of
Animals in research
• Aristotle
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Student of Plato, Teacher to Alexander the Great.
Research - Empirical observation and experience.
Scientific method.
Animals:
• Sensation, Passion, memory, understand
relationships.
• NOT Capable of Thought or reasoning
– Aristotle believed that creatures were arranged in a
graded scale of perfection.
Plato and Aristotle –
“The Athens School” by Raphael
– Man at a higher state of perfection because
Man can reason and reflect.
– Animals and plants exist for man’s use, but
not abuse.
Foundations for the Ethical Treatment
of Animals in Research
• Ethical basis for animal welfare
– 18th Century - Jeremy Bentham 1748 - 1832
• Utilitarianism, The moral status of animals
• Animals had moral status and rights to be treated
humanely.
• “Cruelty towards animals is an incentive to cruelty
towards men.”
• In response to Descartes:
“The question is not, Can they reason?
nor, Can they talk? but, Can they suffer?”
1748 - 1832
Foundations for the Ethical Treatment
of Animals in Research
• Marshall Hall (1790–1857), a physician and
noted physiologist, supported animal research
but stated:
• ‘Unhappily… the subjects of animal physiology
are sentient, and every experiment is attended
by pain and suffering.’
• 5 guiding principles of animal research:
1790–1857
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i) the lack of an alternative
ii) a clear objective
iii) the avoidance of repetition of work
iv) the need to minimize suffering
v) full and detailed publication of the results.
In 1831, he outlined five principles to govern animal experimentation. Of the Principles of Investigation in
Physiology. Lancet 1 (1856), pp. 393–394.
The Principles of Humane Experimental
Technique
Russell WMS and Burch RL (1959)
"The Principles of Humane Experimental Technique"
– 3Rs
– Reduction
– Replacement
– Refinement
Foundations for the Ethical Treatment of
Animals in Resarch
• The Regulatory Requirements
– 20th Century – Organizations, Codes and
Legislation
• Nuremburg Code – Point 3
• AALAS -1963
• The Guide to the Care and Use of Laboratory Animals
(NRC)
– 1963, 1996, 2010
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Betrayal of the Public Trust Brings
Regulation
• 1984 Univ. Penn. Head Trauma Study.
– PETA and ALF alleges inhumane research practices.
– Videos
– NIH investigated. Research activities not conducted
according the existing policies.
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Lack of adequate anesthesia and analgesia.
Lack of sterile technique.
Lack of supervision by PI.
Lack of training of laboratory personnel.
– NIH Shut down the project.
• Research Project permanently shut down.
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Outcome
Animal Welfare Act – USDA / APHIS
Public Law 99-198,
December 23, 1985, Food Security Act of 1985.
Subtitle F - Animal Welfare
HREA & AWA -1985
• Grounded in the 3Rs and the Guide. Created:
– Institutional Official
– Attending Veterinarian
– Creation of the IACUC
• Composition.
• Responsibilities.
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Oversee all teaching and research activities with animals.
Minimize pain and distress
Education program.
Inspect facilities.
Investigate concerns
• Appointed by CEO
• Manage the potential conflicts of interest.
Conflict of Interest (CoI)
• A conflict of interest is a situation where financial or
other personal considerations can compromise or bias
one’s professional judgment and/or objectivity.
• A potential conflict of Interest is a situation where a
reasonable person would think that the professional's
judgment is likely to be compromised.
• A conflict of interest implies only some potential for bias, not
a likelihood.
• Potential Conflicts should be managed to prevent unethical
behavior.
Understanding and Managing the Conflict of Interest
who are the stake holders?
• The Public’s Interests
– Society demands medical advances.
– Society understands that animal subjects:
• Are necessary before a clinical trial. (Nuremberg #3)
• Cannot understand the research.
• Cannot consent to participate in what may cause them
harm, pain or death.
– Society demands documentation that animal
research is ethically designed and conducted.
Understanding and Managing the Conflict of Interest
who are the stakeholders?
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• The investigator Interests
– Get the data, publish the papers, get the grants, support their
labs, get promoted and get a raise.
• The Interests of the Veterinarians
– Animal welfare / compliance Vs. Helping investigators get their
work done. Well funded investigators can bring significant
pressure to bear on the veterinary staff.
• Institutional interests
– Institutions want the grants, patents and indirect costs.
The IACUC specifically empowered by the Federal Regulations and UM Policy to manage the
tensions and conflicts.
Understanding and Managing the Conflict of Interest
Who manages the conflicting interests?
• The Public’s Interests
The IACUC specifically empowered by the Federal
Regulations and institutional Policies to manage the
tensions and conflicts between the stakeholders.
• The investigator Interests
• The Interests of the Veterinarians
• Institutional interests
The IACUC and Conflict
Management
• IACUC has the oversight responsibility for
all animal use at the University.
– Investigates instances of non-compliance.
• Can suspend activities that are not being
conducted ethically and put animals at risk.
– Reports the good, the bad and ugly to:
• Institutional Official
• OLAW and USDA
• IACUC appointed by highest institutional
authority.
– Protect the University’s interests
– Manage the CoI
– Maintain the Public’s trust
Consequences of betrayal of the
Public Trust
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Puts subjects at risk
Federal inquiry / intervention
Institutional embarrassment
Fines
Wasted resources
Personal embarrassment
Loss of funding, Loss of livelihood
Jail
Justification and / or vindication for
groups with anti-research agenda.
A.L.F.
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Animal Rights
• The movement seeks to:
– End the rigid moral and legal distinction drawn
between human and non-human beings.
– End the status of animals as property.
– End to their use in the research, food, clothing.
– End use in the entertainment industries.
• Bull fighting
• Movies
• Commercials
Increase Integrity in Your
Animal Care and Use Program
Increasing the integrity of your animal
care and use program.
• Service oriented IACUC.
– Think of the investigator as your client.
– Review your process make it easy for
investigators to comply.
• Review the performance of your IACUC
members.
• Find an alternate for each regular IACUC
member. Use the alternates in the
protocol review process.
Increasing the integrity of your animal
care and use program.
• Use the designated review process for
low risk protocols and amendments.
AAALAC
• Post ApprovalAccreditation
Protocol Monitoring (PAM)
• Implement a rigorous education program
for investigators, staff and students.
– Web based, classroom, wet labs
CITI
Collaborative Institutional Training Initiative
Educational opportunities
CITI Program
www.citiprogram.org
CITI Program Founders
CITI Program is a web based bioethics education program designed to
promote the responsible conduct of research. March-2000
Karen Hansen,
Fred Hutchinson Cancer Research Center,
Seattle, WA., USA
Paul Braunschweiger Ph.D.
University of Miami
Miami, Fl. USA
www.citiprogram.org
CITI – Program
4-2010
Participating Institutions and Organizations (~1310)
CITI Developer Group (~70)
Biosafety
RCR
CITI Executive Advisory Committee
Founders
L.A.W.
CITI Editorial Board (15)
Intl.
HSRP
HIPS
GCP
www.citiprogram.org
CITI Administration – Office of Research Education, University of Miami
CITI Program Milestones
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10 Participating Institutions in 2000.
New Courses added 2004.
~ 1140 Participating Institutions in 3- 2010.
~ 30,000 Learners per month. 40- 60%
students
• >360,000 Learners since 3-1-2009.
• >1.4 million people have completed a course
since 9-1-2000.
• Subscriber Profile
– Universities, colleges, medical centers, community
hospitals, societies, government, commercial IRBs,
industry
CITI Program Milestones
• International Initiatives
– CITI - Collaborative International Training Initiative
• Multi-language Course Site. 11-2007 updated 2-2009
– Spanish
– Portuguese
– Chinese, Japanese, Russian, Mongolian, French, Thai
CITI Program Courses
• Human Subject Protection
– Good Clinical Practice (15)
– Refresher Courses
• Health Information Privacy and Security (HIPS)
– Basic
– Refresher
• The Responsible Conduct of Research.
– 5 Disciplines
– Text, cases, quizzes.
• Laboratory Animal Welfare (L.A.W.)
– Basic
– Refresher
CITI Lab Animal Welfare
Program
• 10-2007 – CITI Lab Animal Welfare Working Group.
– Michael Mann Ph.D. working group Leader
• 2004 - Collaboration between CITI and Dr, M.
Fallon at the Atlanta, VA.
• 2008 - 2009 - Comprehensive review and updating
• 2007
VA decided
to close the
of the–course
content.
www.ResearchTraining.org LAW course site.
•• 5-2007
CITI
offered the Collaborating
CITI Version of
RT.org to
2009 CITI
International
Centers.
our participating institutions.
• 2010
– New Case Based Refresher Course IACUC members
– Working with Fish in The Field and in The Laboratory.
RCR 12-29-07
March 28, 2008
CITI Lab Animal Working Group
Mike Mann Ph.D. (Leader)
Andrew Perkins BS
Cynthia S. Gillett, DVM, ACLAM, CPIA
Ernie Prentice Ph.D.
Gwenn S.F. Oki MS
Jenny Kalishman DVM
Kathy Wadsworth MS
Mark Christensen, Professor
Molly Greene MS
Michael Fallon DVM, Ph.D.
Paul Braunschweiger PH. D.
Randall J. Nelson, Professor
Susan Miller, MD
Susan Silk MS
Thomas Zimmerman, DVM, MPVM, DACLAM
BI Choe Ph.D.
Fernando Lolas MD
University of Nebraska- Medical Center (Ret.)
UCLA
University of Minnesota
University of Nebraska-Medical Center
City of Hope Medical Center
Washington University-St. Louis, MO
UCLA
Lourdes College
Michigan State University
Veterans Affairs
University of Miami
University of Memphis
Weill Medical College, Cornell University
Office of Laboratory Animal Welfare (OLAW)
SUNY - Stony Brook
Catholic University, Korea
University of Chile
March 28, 2008
What is the CITI Program
Web based instructional program in Lab Animal Care and Use.
Collaboration between the VA (Researchtraining.org) and the CITI Program.
• Basic Courses
– "Working with the IACUC" for Investigator,
Students and staff.
– “Post-Procedure Care of Mice and Rats in
Research: Reducing Pain and Distress”
– “Essentials for IACUC Members“
– Refresher Courses
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March 28, 2008
What is the CITI Program
Web based instructional program in Lab Animal Care and Use.
Collaboration between the VA (Researchtraining.org) and the CITI Program.
• Specialized Model Specific Courses
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Working with Amphibians
Working with Mice
Working with Rats
Working with Hamsters
Working with Gerbils
Working with Guinea Pigs
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Working with Rabbits
Working with Cats
Working with Dogs
Working With Swine
Working With Nonhuman
Primates
• Lab Animal Research Working Group.
– IACUC Chairs, IACUC Members, Coordinators, Vets, Ethicists.
– Meet semi-annually
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www.citiprogram.org
Establishing an Institutional
Curriculum
• Each institution can establish their own
curriculum from the L.A.W. Content Library.
• Curriculum can be customized according to:
– Role in LAW research.
– Species / models used.
• Basic courses and refresher courses.
– Reminder notifications
RCR 12-29-07
New Utilities of Institutional
Coordinators
CITI Knowledge Base
• CITI Program offers a searchable FAQ utility.
• Users can submit Queries from the knowledgebase page
• Topics cover many topics navigation to information for CITI
administrators.
• More than 150 users/month visited the page
• It can be accessed directly:
http://citiprogram.supportcenterpro.com/knowledgebase or
in the CITI site from the contact us page:
https://www.citiprogram.org/contactus.asp?language=engli
sh
Helpdesk Chat
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Implemented April 2010
Well received
Average of 20 sections per week
Chat utility permits quick answers to questions
Only CITI Program during business hours.
It can be accessed directly:
http://citiprogram.supportcenterpro.com/liveagent/
chat/ or in the CITI site from the contact us page:
https://www.citiprogram.org/contactus.asp?langu
age=english
Webinars
How to get the most from the CITI Program
• New and experienced CITI institutional
administrators
• Administrators of any participating institutions can
take advantage of these training sessions.
• Since December 2009
– Total of 55 sections with 725 participants were conducted
– High level of satisfaction with the CITI webinars.
• Information of how to enroll can be found at:
http://citiprogram.supportcenterpro.com/knowledge
base/citi-administrators/.citi-administratorwebinars.html
Learner Feedback
• Satisfaction Survey
– Navigation
– Content
– Quiz question
– Utility
– Value
Now that I have completed the course, I am more confident in my ability
to advise a student or a colleague on how to apply the "3Rs" to insure
that their lab animal studies are conducted to the highest ethical
standards
9%
69%
After completing this instruction, I now have a better understanding of how to
apply the "3Rs" to insure that my lab animal studies are conducted to the
highest ethical standards?
30%
9%
68%
% Responders (n=1311)
25%
20%
15%
10%
5%
0%
1
2
3
Strongly disagree
4
5
6
7
8
Strongly agree
9
I intend to take a more active role in assuring that lab animal
research at my institution is conducted to the highest ethical
standards by pursuing professional certification, or by joining an
ethics committee or Institutional Animal Care and Use Committee
(IACUC).
30%
14%
58%
% Responders (n=1297)
25%
20%
15%
10%
5%
0%
1
2
3
Strongly disagree
4
5
6
7
8
9
Strongly agree
Responsible Conduct of
Research
NIH, NSF requirements
Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices
http://edocket.access.gpo.gov/2009/pdf/E9-19930.pdf
NSF Requirements
Section 7009 of the America COMPETES Act.
• RCR Training for NSF post docs and
students. 1-1-10
– NSF
• No specific standards, No specific content.
• Will not dictate pedagogical approach.
• Must document.
•
“Therefore, it is the responsibility of each institution to determine
both the content and the delivery method for the training that will
meet the institution’s particular needs for RCR training in all areas
at that institution for which NSF provides support.”
NIH Requirements
• Training Grants
– Who needs training
– Topics to be included.
– How instruction should be delivered.
– How often.
– When training should be applied.
– Grant review process.
CITI RCR Course
Biomedical Sciences
Social & Behavioral Sciences*
Physical Sciences
Arts & Humanities
Engineering
Science Administrators
Supported by a contract from DHHS / ORI
The Responsible Conduct of Research
• Public Access vs. Subscriber access
• Topics
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Research Misconduct
Data Acquisition and Management
Conflicts of Interest
Responsible Authorship
Responsible Peer Review
Human Subjects Protection
Lab Animal Welfare
Mentoring
Responsible Collaborative Research
• Customized courses.
• Text, cases, videos and quizzes
CITI RCR Courses.
• CITI RCR COURSES
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Cover the 9 topic areas as indicated by ORI and NSF.
Text, cases, video cases, quizzes.
Discipline specific.
Can be customized according to the needs of
institution, investigator or student.
• Best used as an Introduction to RCR in a
programmatic approach to RCR education.
• Public access availability at the CITI Program
Home Page www.citiprogram.org
Content Format
Publication Practices and Responsible Authorship
• Introductory video cases - 10
– 10, 3 minute video cases.
– 3 new “introductory” video case studies
for the SBR investigators and students.
• Misconduct
• Data Acquisition
• Conflicts of Interest
Lab Animal Welfare
Other new projects
Course in Bio-safety and Bio-security
Bio-Safety and Bio-Security
Module #
19
10
2
11
3
12
4
13
5
14
6
15
7
16
8
Module Title
Overview
Risk Management - Emergency Procedures
Lab
OSHA
Associated
Blood-borne
Infections
Pathogens
Risk
NIH Recombinant
Assessment DNA Guidelines
Medical
Human Gene
Surveillance
Transfer
Risk
Select
Management
Agents, Biological
– WorkSecurity,
Practices
and Bioterrorism
Risk
Shipping
Management
and Transport
– Personal
of Regulated
Protective
Bio-Materials
Equipment
Risk
Animal
Management
Biosafety – Engineering Controls
Risk
Nanotechnology
Managementand
– Lab
Safe
Design
Practices
Summary
• The active promotion of integrity in the
research enterprise is essential to maintain
the Public Trust.
– Without the Public Trust there can be now
research
• Management of conflicts of interest
between
– Investigators, the institution, and the subjects
is crucial to well run research enterprise
“Integrity” by Joris Plu 2005
Summary
• Promoting Integrity is everyone’s
responsibility.
– Leads to good animal care
– Leads to good science.
– Compliance
• The Responsible Conduct of Research
is beyond simply being compliant with
Federal regulations.
It is just The “right thing to do”.
“New Integrity” by Artibella Avanti
CITI Support Staff
Absent: Richard Sprince and 1 TBN content specialist
“An Experiment on a Bird in The Air Pump “ by Joseph Wright (1734-1797)
British National Gallery- London
Joseph Wright (September 3, 1734 - August 29, 1797),