Promoting Integrity in Your Laboratory Promoting Integrity in Your Laboratory Animal Welfare Research Program Animal Welfare Research Program

The CITI Program The CITI Program

Paul Braunschweiger PhD Paul Braunschweiger PhD Chair, University of Miami IACUC Chair, University of Miami IACUC

CITI Program Co-Founder CITI Program Co-Founder University of Miami Miller School of MedicineUniversity of Miami Miller School of Medicine

Foundations for the Ethical Treatment of Foundations for the Ethical Treatment of Animals in researchAnimals in research

• AristotleAristotle– Student of Plato, Teacher to Alexander the Great.Student of Plato, Teacher to Alexander the Great. – Research - Empirical observation and experience.Research - Empirical observation and experience.– Scientific method.Scientific method.– Animals: Animals:

• Sensation, Passion, memory, understand Sensation, Passion, memory, understand relationships. relationships.

• NOT Capable of Thought or reasoningNOT Capable of Thought or reasoning– Aristotle believed that creatures were arranged in a Aristotle believed that creatures were arranged in a

graded scale of perfection.graded scale of perfection. – Man at a higher state of perfection because Man at a higher state of perfection because

Man can reason and reflect.Man can reason and reflect.– Animals and plants exist for man’s use, but Animals and plants exist for man’s use, but

not abuse.not abuse.

Plato and Aristotle – Plato and Aristotle –

““The Athens School” by RaphaelThe Athens School” by Raphael

Foundations for the Ethical Treatment Foundations for the Ethical Treatment of Animals in Researchof Animals in Research

• Ethical basis for animal welfareEthical basis for animal welfare– 1818thth Century - Jeremy Bentham 1748 - 1832 Century - Jeremy Bentham 1748 - 1832

• Utilitarianism, The moral status of animals Utilitarianism, The moral status of animals • Animals had moral status and rights to be treated Animals had moral status and rights to be treated

humanely. humanely. • ““Cruelty towards animals is an incentive to cruelty Cruelty towards animals is an incentive to cruelty

towards men.”towards men.”

• In response to Descartes:In response to Descartes:

““The question is not, Can they reason? The question is not, Can they reason?

nor, Can they talk? but, Can they suffer?nor, Can they talk? but, Can they suffer?””1748 - 18321748 - 1832

Foundations for the Ethical Treatment Foundations for the Ethical Treatment of Animals in Researchof Animals in Research

In 1831, he outlined five principles to govern animal experimentation. In 1831, he outlined five principles to govern animal experimentation. Of the Principles of Investigation in Of the Principles of Investigation in PhysiologyPhysiology. Lancet 1 (1856), pp. 393–394.. Lancet 1 (1856), pp. 393–394.

• Marshall Hall (1790–1857), a physician and Marshall Hall (1790–1857), a physician and noted physiologist, supported animal research noted physiologist, supported animal research but stated: but stated:

• ‘‘Unhappily… the subjects of animal physiology Unhappily… the subjects of animal physiology are sentient, and every experiment is attended are sentient, and every experiment is attended by pain and suffering.’by pain and suffering.’

• 5 guiding principles of animal research:5 guiding principles of animal research:– i) the lack of an alternativei) the lack of an alternative– ii) a clear objectiveii) a clear objective– iii) the avoidance of repetition of workiii) the avoidance of repetition of work– iv) the need to minimize sufferingiv) the need to minimize suffering– v) full and detailed publication of the results.v) full and detailed publication of the results.

1790–1857

The Principles of Humane Experimental The Principles of Humane Experimental TechniqueTechnique

Russell WMS and Burch RL (1959)Russell WMS and Burch RL (1959)""The Principles of Humane Experimental Technique"The Principles of Humane Experimental Technique"

– 3Rs3Rs– Reduction Reduction – ReplacementReplacement– Refinement Refinement

Foundations for the Ethical Treatment of Foundations for the Ethical Treatment of Animals in ResarchAnimals in Resarch

• The Regulatory RequirementsThe Regulatory Requirements– 2020thth Century – Organizations, Codes and Century – Organizations, Codes and

LegislationLegislation• Nuremburg Code – Point 3Nuremburg Code – Point 3• AALAS -1963AALAS -1963• The Guide to the Care and Use of Laboratory Animals The Guide to the Care and Use of Laboratory Animals

(NRC) (NRC) – 1963, 1996, 20101963, 1996, 2010

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Betrayal of the Public Trust Brings Betrayal of the Public Trust Brings RegulationRegulation

• 1984 Univ. Penn. Head Trauma Study.1984 Univ. Penn. Head Trauma Study.– PETA and ALF alleges inhumane research practices.PETA and ALF alleges inhumane research practices.– VideosVideos– NIH investigated. Research activities not conducted according NIH investigated. Research activities not conducted according

the existing policies.the existing policies.• Lack of adequate anesthesia and analgesia.Lack of adequate anesthesia and analgesia.• Lack of sterile technique. Lack of sterile technique. • Lack of supervision by PI.Lack of supervision by PI.• Lack of training of laboratory personnel.Lack of training of laboratory personnel.

– NIH Shut down the project.NIH Shut down the project.• Research Project permanently shut down.Research Project permanently shut down.

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OutcomeOutcome

Animal Welfare Act – USDA / APHIS

Public Law 99-198, December 23, 1985, Food Security Act of 1985.

Subtitle F - Animal Welfare

HREA & AWA -1985HREA & AWA -1985• Grounded in the 3Rs and the Guide. Created:

– Institutional Official– Attending Veterinarian– Creation of the IACUCCreation of the IACUC

• Composition. Composition. • Responsibilities.Responsibilities.

– Oversee all teaching and research activities with animals.Oversee all teaching and research activities with animals.– Minimize pain and distressMinimize pain and distress– Education program.Education program.– Inspect facilities.Inspect facilities.– Investigate concernsInvestigate concerns

• Appointed by CEO Appointed by CEO • Manage the potential conflicts of interest.Manage the potential conflicts of interest.

Conflict of Interest Conflict of Interest (CoI)(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 Understanding and Managing the Conflict of InterestManaging the Conflict of Interestwho are the stake holders?who are the stake holders?

• The Public’s InterestsThe Public’s Interests– Society demands medical advances.Society demands medical advances.

– Society understands that animal subjects:Society understands that animal subjects:• Are necessary before a clinical trial. (Nuremberg #3)Are necessary before a clinical trial. (Nuremberg #3)• Cannot understand the research. Cannot understand the research. • Cannot consent to participate in what may cause them harm, Cannot consent to participate in what may cause them harm,

pain or death.pain or death.

– Society demands documentation that animal research is Society demands documentation that animal research is ethically designed and conducted. ethically designed and conducted.

Understanding and Managing the Conflict of InterestUnderstanding and Managing the Conflict of Interestwho are the stakeholders?who are the stakeholders?

•

• The investigator InterestsThe investigator Interests

– Get the data, publish the papers, get the grants, support their Get the data, publish the papers, get the grants, support their labs, get promoted and get a raise. labs, get promoted and get a raise.

• The Interests of the VeterinariansThe Interests of the Veterinarians– Animal welfare / compliance Vs. Helping investigators get their Animal welfare / compliance Vs. Helping investigators get their

work done. Well funded investigators can bring significant work done. Well funded investigators can bring significant pressure to bear on the veterinary staff.pressure to bear on the veterinary staff.

• Institutional interestsInstitutional interests– Institutions want the grants, patents and indirect costs. Institutions want the grants, patents and indirect costs.

The IACUC specifically empowered by the Federal Regulations and UM Policy to manage the The IACUC specifically empowered by the Federal Regulations and UM Policy to manage the tensions and conflicts.tensions and conflicts.

The IACUC specifically empowered by the Federal The IACUC specifically empowered by the Federal Regulations and institutional Policies to manage the Regulations and institutional Policies to manage the tensions and conflicts between the stakeholders. tensions and conflicts between the stakeholders.

Understanding and Managing the Conflict of InterestUnderstanding and Managing the Conflict of InterestWho manages the conflicting interests?Who manages the conflicting interests?

• The investigator InterestsThe investigator Interests• The Interests of the VeterinariansThe Interests of the Veterinarians• Institutional interestsInstitutional interests

• The Public’s InterestsThe Public’s Interests

The IACUC and Conflict The IACUC and Conflict ManagementManagement

• IACUC has the oversight responsibility for all IACUC has the oversight responsibility for all animal use at the University.animal use at the University.– Investigates instances of non-compliance.Investigates instances of non-compliance.

• Can suspend activities that are not being conducted Can suspend activities that are not being conducted ethically and put animals at risk.ethically and put animals at risk.

– Reports the good, the bad and ugly to:Reports the good, the bad and ugly to:• Institutional OfficialInstitutional Official• OLAW and USDAOLAW and USDA

• IACUC appointed by highest institutional IACUC appointed by highest institutional authority.authority.– Protect the University’s interestsProtect the University’s interests– Manage the CoIManage the CoI– Maintain the Public’s trustMaintain the Public’s trust

Consequences of betrayal of the Consequences of betrayal of the Public TrustPublic Trust

• Puts subjects at riskPuts subjects at risk• Federal inquiry / interventionFederal inquiry / intervention• Institutional embarrassmentInstitutional embarrassment• FinesFines• Wasted resources Wasted resources • Personal embarrassmentPersonal embarrassment• Loss of funding, Loss of livelihood Loss of funding, Loss of livelihood • JailJail• Justification and / or vindication for Justification and / or vindication for

groups with anti-research agenda.groups with anti-research agenda.

A.L.F.

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Animal Rights Animal Rights

• The movement seeks to:The movement seeks to:– End the rigid moral and legal distinction drawn between human and End the rigid moral and legal distinction drawn between human and

non-human beings. non-human beings. – End the status of animals as property. End the status of animals as property. – End to their use in the research, food, clothing.End to their use in the research, food, clothing.– End use in the entertainment industries.End use in the entertainment industries.

• Bull fighting Bull fighting • MoviesMovies• CommercialsCommercials

Increase Integrity in Your Increase Integrity in Your Animal Care and Animal Care and UseUse Program Program

Increasing the integrity of your animal Increasing the integrity of your animal care and use program.care and use program.

• Service oriented IACUC.Service oriented IACUC.– Think of the investigator as your client.Think of the investigator as your client.– Review your process make it easy for Review your process make it easy for

investigators to comply.investigators to comply.• Review the performance of your IACUC Review the performance of your IACUC

members.members.• Find an alternate for each regular IACUC Find an alternate for each regular IACUC

member. Use the alternates in the member. Use the alternates in the protocol review process. protocol review process.

Increasing the integrity of your animal Increasing the integrity of your animal care and use program.care and use program.

• Use the designated review process for Use the designated review process for low risk protocols and amendments. low risk protocols and amendments.

• Post Approval Protocol Monitoring (PAM)Post Approval Protocol Monitoring (PAM)

• Implement a rigorous education program Implement a rigorous education program for investigators, staff and students.for investigators, staff and students.– Web based, classroom, wet labsWeb based, classroom, wet labs

AAALAC AccreditationAAALAC Accreditation

Educational opportunitiesEducational opportunities

CITI ProgramCITI Programwww.citiprogram.orgwww.citiprogram.org

CITI CITI Collaborative Institutional Training InitiativeCollaborative Institutional Training Initiative

CITI Program FoundersCITI Program Founders

Karen Hansen, Karen Hansen, Fred Hutchinson Cancer Research Center, Fred Hutchinson Cancer Research Center, Seattle, WA., USASeattle, WA., USA

Paul Braunschweiger Ph.D. Paul Braunschweiger Ph.D. University of MiamiUniversity of MiamiMiami, Fl. USA Miami, Fl. USA

CITI Program is a web based bioethics education program designed to promote the responsible conduct of research. March-2000

www.citiprogram.org

CITI – ProgramCITI – Program 4-20104-2010

CITI Administration – Office of Research Education, University of Miami CITI Administration – Office of Research Education, University of Miami

Participating Institutions and Organizations (~1310)Participating Institutions and Organizations (~1310)

CITI Developer Group (~70)CITI Developer Group (~70)

CITI Editorial Board (15)CITI Editorial Board (15)Intl.Intl.

GCPGCP

RCRRCR CITI Executive Advisory CommitteeCITI Executive Advisory Committee

HSRPHSRP

FoundersL.A.W.L.A.W.

HIPSHIPS

www.citiprogram.org

BiosafetyBiosafety

CITI Program MilestonesCITI Program Milestones

• 10 Participating Institutions in 2000.10 Participating Institutions in 2000.• New Courses added 2004.New Courses added 2004.• ~ 1140 Participating Institutions in 3- 2010.~ 1140 Participating Institutions in 3- 2010.• ~ 30,000 Learners per month. 40- 60% ~ 30,000 Learners per month. 40- 60%

studentsstudents• >360,000 Learners since 3-1-2009.>360,000 Learners since 3-1-2009.• >1.4 million people have completed a course >1.4 million people have completed a course

since 9-1-2000.since 9-1-2000.• Subscriber ProfileSubscriber Profile

– Universities, colleges, medical centers, community Universities, colleges, medical centers, community hospitals, societies, government, commercial IRBs, hospitals, societies, government, commercial IRBs, industryindustry

CITI Program MilestonesCITI Program Milestones

• International InitiativesInternational Initiatives– CITI - Collaborative International Training InitiativeCITI - Collaborative International Training Initiative

• Multi-language Course Site. 11-2007 updated 2-2009Multi-language Course Site. 11-2007 updated 2-2009– SpanishSpanish– Portuguese Portuguese – Chinese, Japanese, Russian, Chinese, Japanese, Russian, Mongolian, French, ThaiMongolian, French, Thai

CITI Program CoursesCITI Program Courses• Human Subject ProtectionHuman Subject Protection

– Good Clinical Practice (15)Good Clinical Practice (15)– Refresher CoursesRefresher Courses

• Health Information Privacy and Security (HIPS)Health Information Privacy and Security (HIPS)– Basic Basic – RefresherRefresher

• The Responsible Conduct of Research.The Responsible Conduct of Research.– 5 Disciplines5 Disciplines– Text, cases, quizzes.Text, cases, quizzes.

• Laboratory Animal Welfare (L.A.W.)Laboratory Animal Welfare (L.A.W.)– Basic Basic – RefresherRefresher

CITI Lab Animal Welfare CITI Lab Animal Welfare ProgramProgram

• 2004 - Collaboration between CITI and Dr, M. 2004 - Collaboration between CITI and Dr, M. Fallon at the Atlanta, VA.Fallon at the Atlanta, VA.

• 2007 – VA decided to close the 2007 – VA decided to close the www.ResearchTraining.org LAW course site.www.ResearchTraining.org LAW course site.

• 5-2007 CITI offered the CITI Version of RT.org to 5-2007 CITI offered the CITI Version of RT.org to our participating institutions. our participating institutions.

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• 10-2007 – CITI Lab Animal Welfare Working Group. 10-2007 – CITI Lab Animal Welfare Working Group. – Michael Mann Ph.D. working group LeaderMichael Mann Ph.D. working group Leader

• 2008 - 2009 - Comprehensive review and updating 2008 - 2009 - Comprehensive review and updating of the course content. of the course content.

• 2009 CITI International Collaborating Centers.2009 CITI International Collaborating Centers.

• 2010 2010 – New Case Based Refresher Course IACUC membersNew Case Based Refresher Course IACUC members– Working with Fish in The Field and in The Laboratory.Working with Fish in The Field and in The Laboratory.

CITICITI Lab Animal Working GroupLab Animal Working Group

March 28, 2008

Mike Mann Ph.D. (Leader) University of Nebraska- Medical Center (Ret.)Andrew Perkins BS UCLACynthia S. Gillett, DVM, ACLAM, CPIA University of MinnesotaErnie Prentice Ph.D. University of Nebraska-Medical CenterGwenn S.F. Oki MS City of Hope Medical CenterJenny Kalishman DVM Washington University-St. Louis, MOKathy Wadsworth MS UCLAMark Christensen, Professor Lourdes CollegeMolly Greene MS Michigan State UniversityMichael Fallon DVM, Ph.D. Veterans AffairsPaul Braunschweiger PH. D. University of MiamiRandall J. Nelson, Professor University of MemphisSusan Miller, MD Weill Medical College, Cornell UniversitySusan Silk MS Office of Laboratory Animal Welfare (OLAW)Thomas Zimmerman, DVM, MPVM, DACLAM SUNY - Stony BrookBI Choe Ph.D. Catholic University, KoreaFernando Lolas MD University of Chile

March 28, 2008

What is the CITI ProgramWhat is the CITI ProgramWeb based instructional program in Lab Animal Care and Use.Web based instructional program in Lab Animal Care and Use.

Collaboration between the VA (Researchtraining.org) and the CITI Program.Collaboration between the VA (Researchtraining.org) and the CITI Program.

• Basic CoursesBasic Courses– ""Working with the IACUC" for Investigator, " for Investigator,

Students and staff. Students and staff. – ““Post-Procedure Care of Mice and Rats in Post-Procedure Care of Mice and Rats in

Research: Reducing Pain and Distress”Research: Reducing Pain and Distress”– ““Essentials for IACUC Members“Essentials for IACUC Members“– Refresher CoursesRefresher Courses

   

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March 28, 2008

What is the CITI ProgramWhat is the CITI ProgramWeb based instructional program in Lab Animal Care and Use.Web based instructional program in Lab Animal Care and Use.

Collaboration between the VA (Researchtraining.org) and the CITI Program.Collaboration between the VA (Researchtraining.org) and the CITI Program.

• Specialized Model Specific Courses  Specialized Model Specific Courses  – Working with Amphibians Working with Amphibians – Working with Mice Working with Mice – Working with Rats Working with Rats – Working with Hamsters Working with Hamsters – Working with Gerbils Working with Gerbils – Working with Guinea Pigs Working with Guinea Pigs

• Lab Animal Research Working Group.Lab Animal Research Working Group.– IACUC Chairs, IACUC Members, Coordinators, Vets, Ethicists.IACUC Chairs, IACUC Members, Coordinators, Vets, Ethicists.– Meet semi-annuallyMeet semi-annually

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    – Working with Rabbits Working with Rabbits – Working with Cats Working with Cats – Working with Dogs Working with Dogs – Working With SwineWorking With Swine– Working With Nonhuman Working With Nonhuman

Primates Primates

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Establishing an Institutional Establishing an Institutional CurriculumCurriculum

• Each institution can establish their own Each institution can establish their own curriculum from the L.A.W. Content Library.curriculum from the L.A.W. Content Library.

• Curriculum can be customized according to:Curriculum can be customized according to:– Role in LAW research.Role in LAW research.– Species / models used.Species / models used.

• Basic courses and refresher courses.Basic courses and refresher courses.– Reminder notifications Reminder notifications

RCR 12-29-07

New Utilities of Institutional New Utilities of Institutional CoordinatorsCoordinators

CITI Knowledge BaseCITI Knowledge Base

• CITI Program offers a searchable FAQ utility.CITI Program offers a searchable FAQ utility.• Users can submit Queries from the knowledgebase pageUsers can submit Queries from the knowledgebase page• Topics cover many topics navigation to information for CITI Topics cover many topics navigation to information for CITI

administrators.administrators.• More than 150 users/month visited the pageMore than 150 users/month visited the page• It can be accessed directly: It can be accessed directly:

http://citiprogram.supportcenterpro.com/knowledgebasehttp://citiprogram.supportcenterpro.com/knowledgebase or or in the CITI site from the contact us page: in the CITI site from the contact us page: https://www.citiprogram.org/contactus.asp?https://www.citiprogram.org/contactus.asp?language=englishlanguage=english

Helpdesk ChatHelpdesk Chat• Implemented April 2010Implemented April 2010• Well receivedWell received• Average of 20 sections per weekAverage of 20 sections per week• Chat utility permits quick answers to questions Chat utility permits quick answers to questions • Only CITI Program during business hours.Only CITI Program during business hours.• It can be accessed directly: It can be accessed directly:

http://citiprogram.supportcenterpro.com/liveagent/http://citiprogram.supportcenterpro.com/liveagent/chat/chat/ or in the CITI site from the contact us page: or in the CITI site from the contact us page: https://www.citiprogram.org/contactus.asp?https://www.citiprogram.org/contactus.asp?language=englishlanguage=english

WebinarsWebinarsHow to get the most from the CITI ProgramHow to get the most from the CITI Program• New and experienced CITI institutional administratorsNew and experienced CITI institutional administrators• Administrators of any participating institutions can Administrators of any participating institutions can

take advantage of these training sessions.take advantage of these training sessions.• Since December 2009Since December 2009

– Total of 55 sections with 725 participants were conductedTotal of 55 sections with 725 participants were conducted– High level of satisfaction with the CITI webinars.High level of satisfaction with the CITI webinars.

• Information of how to enroll can be found at: Information of how to enroll can be found at: http://citiprogram.supportcenterpro.com/knowledgebahttp://citiprogram.supportcenterpro.com/knowledgebase/citi-administrators/.citi-administrator-webinars.htmlse/citi-administrators/.citi-administrator-webinars.html

Learner FeedbackLearner Feedback

• Satisfaction SurveySatisfaction Survey– NavigationNavigation– ContentContent– Quiz questionQuiz question– UtilityUtility– ValueValue

Now that I have completed the course, I am more confident in my 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 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 insure that their lab animal studies are conducted to the highest ethical standardsstandards

9%9% 69%69%

After completing this instruction, I now have a better understanding of how to 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 apply the "3Rs" to insure that my lab animal studies are conducted to the

highest ethical standards?highest ethical standards?

9% 9% 68%68%

0%0%

5%5%

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20%20%

25%25%

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11 22 33 44 55 66 77 88 99Strongly disagree Strongly agreeStrongly disagree Strongly agree

I intend to take a more active role in assuring that lab animal I intend to take a more active role in assuring that lab animal research at my institution is conducted to the highest ethical research at my institution is conducted to the highest ethical

standards by pursuing professional certification, or by joining an standards by pursuing professional certification, or by joining an ethics committee or Institutional Animal Care and Use Committee ethics committee or Institutional Animal Care and Use Committee

(IACUC).(IACUC).

0%0%

5%5%

10%10%

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20%20%

25%25%

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11 22 33 44 55 66 77 88 99Strongly disagree Strongly agreeStrongly disagree Strongly agree

14% 14% 58% 58%

Responsible Conduct of Responsible Conduct of ResearchResearch

NIH, NSF requirementsNIH, NSF requirements

Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / NoticesFederal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Noticeshttp://edocket.access.gpo.gov/2009/pdf/E9-19930.pdf

NSF RequirementsNSF Requirements Section 7009 of the America COMPETES Act.Section 7009 of the America COMPETES Act.

• RCR Training for NSF post docs and RCR Training for NSF post docs and students. 1-1-10students. 1-1-10– NSFNSF

• No specific standards, No specific content.No specific standards, No specific content.• Will not dictate pedagogical approach.Will not dictate pedagogical approach.• Must document.Must document.

• ““Therefore, it is the responsibility of each institution to determine Therefore, it is the responsibility of each institution to determine both the content and the delivery method for the training that will both the content and the delivery method for the training that will meet the institution’s particular needs for RCR training in all areas meet the institution’s particular needs for RCR training in all areas at that institution for which NSF provides support.”at that institution for which NSF provides support.”

NIH RequirementsNIH Requirements

• Training GrantsTraining Grants– Who needs training Who needs training – Topics to be included.Topics to be included.– How instruction should be delivered.How instruction should be delivered.– How often.How often.– When training should be applied.When training should be applied.– Grant review process.Grant review process.

CITI RCR CourseCITI RCR CourseBiomedical SciencesBiomedical Sciences

Social & Behavioral Sciences*Social & Behavioral Sciences*

Physical SciencesPhysical Sciences

Arts & HumanitiesArts & Humanities

Supported by a contract from DHHS / ORI Supported by a contract from DHHS / ORI

Science AdministratorsScience Administrators

EngineeringEngineering

The Responsible Conduct of ResearchThe Responsible Conduct of Research

• Public Access Public Access vs.vs. Subscriber access Subscriber access• TopicsTopics

– Research MisconductResearch Misconduct– Data Acquisition and ManagementData Acquisition and Management– Conflicts of InterestConflicts of Interest– Responsible AuthorshipResponsible Authorship– Responsible Peer ReviewResponsible Peer Review– Human Subjects ProtectionHuman Subjects Protection– Lab Animal WelfareLab Animal Welfare– MentoringMentoring– Responsible Collaborative ResearchResponsible Collaborative Research

• Customized courses.Customized courses.• Text, cases, videos and quizzesText, cases, videos and quizzes

CITI RCR Courses.CITI RCR Courses.

• CITI RCR COURSESCITI RCR COURSES– Cover the 9 topic areas as indicated by ORI and NSF.Cover the 9 topic areas as indicated by ORI and NSF.– Text, cases, video cases, quizzes.Text, cases, video cases, quizzes.– Discipline specific.Discipline specific.– Can be customized according to the needs of Can be customized according to the needs of

institution, investigator or student. institution, investigator or student.

• Best used as an Introduction to RCR in a Best used as an Introduction to RCR in a programmatic approach to RCR education.programmatic approach to RCR education.

• Public access availability at the CITI Program Public access availability at the CITI Program Home Page Home Page www.citiprogram.org www.citiprogram.org

Content FormatContent Format Publication Practices and Responsible AuthorshipPublication Practices and Responsible Authorship

• Introductory video cases - 10 Introductory video cases - 10 – 10, 3 minute video cases.10, 3 minute video cases.– 3 new “introductory” video case studies 3 new “introductory” video case studies

for the SBR investigators and students.for the SBR investigators and students.• MisconductMisconduct• Data AcquisitionData Acquisition• Conflicts of InterestConflicts of Interest

Lab Animal WelfareLab Animal Welfare

Other new projectsOther new projects

Course in Bio-safety and Bio-securityCourse in Bio-safety and Bio-security

Bio-Safety and Bio-SecurityBio-Safety and Bio-Security

Module # Module Title1 Overview2 Lab Associated Infections3 Risk Assessment4 Medical Surveillance5 Risk Management – Work Practices6 Risk Management – Personal Protective Equipment7 Risk Management – Engineering Controls8 Risk Management – Lab Design

Module # Module Title9 Risk Management - Emergency Procedures

10 OSHA Blood-borne Pathogens 11 NIH Recombinant DNA Guidelines12 Human Gene Transfer13 Select Agents, Biological Security, and Bioterrorism14 Shipping and Transport of Regulated Bio-Materials15 Animal Biosafety16 Nanotechnology and Safe Practices

SummarySummary

• The active promotion of integrity in the The active promotion of integrity in the research enterprise is essential to maintain research enterprise is essential to maintain the the Public TrustPublic Trust. . – Without the Public Trust there can be now Without the Public Trust there can be now

researchresearch• Management of conflicts of interest Management of conflicts of interest

between between – Investigators, the institution, and the subjects Investigators, the institution, and the subjects

is crucial to well run research enterpriseis crucial to well run research enterprise

““Integrity” by Joris Plu 2005Integrity” by Joris Plu 2005

SummarySummary

• Promoting Integrity is everyone’s Promoting Integrity is everyone’s responsibility.responsibility.– Leads to good animal careLeads to good animal care– Leads to good science.Leads to good science.– Compliance Compliance

• The Responsible Conduct of Research is beyond The Responsible Conduct of Research is beyond simply being compliant with Federal regulations. simply being compliant with Federal regulations.

It is just The “right thing to do”.It is just The “right thing to do”.

““New Integrity” by Artibella Avanti New Integrity” by Artibella Avanti

CITI Support StaffCITI Support Staff

Absent: Richard Sprince and 1 TBN content specialist

““An Experiment on a Bird in The Air Pump “ by Joseph Wright (1734-1797)An Experiment on a Bird in The Air Pump “ by Joseph Wright (1734-1797)British National Gallery- London British National Gallery- London

Joseph Wright (September 3, 1734 - August 29, 1797),