CITI CITI Collaborative Institutional Training InitiativeCollaborative Institutional Training Initiative

Building Integrity in the Research EnterpriseBuilding Integrity in the Research EnterprisePaul Braunschweiger Ph.D. Paul Braunschweiger Ph.D.

Professor, Radiation OncologyProfessor, Radiation OncologyCITI Co-FounderCITI Co-Founder

University of MiamiUniversity of Miamiwww.citiprogram.org

September 18, 2006

Integrity in Human Subjects Integrity in Human Subjects Research is The Key to Success Research is The Key to Success

• Reduces risks to subjects.• Conserves Resources.• Promotes acceptance of the

research. • Minimizes the time for implementation

of new affective therapies.• Preserves the Public Trust.

Recent Violations of the Public TrustRecent Violations of the Public Trust

• 2005 Woo Suk Hwang, fabricated and falsified Stem Cell lines.– 8-2006, Advanced Cell Technology “Ethical Stem Cells” report misleading and

false.

• 2005 Eric Poehlman fabricated and falsified data from clinical aging studies.

– June 28, 2006, Eric Poehlman was sentence to 366 days in jail.

• 8-2006 40 Ohio U Engineering grad students accused of plagiarism.– Revocation of degrees

• 8-2006 Ward Churchill, CU Professor of Ethnic Studies.– Fired for Research Misconduct.

• 9-1-06 Elizabeth Goodwin. falsification and fabrication. – Resigned -Science September 1, 2006.

• 9-10-06 NIH Thomas Walsh >$100,000 from Pharma.

Violation of the Public Trust is Nothing NewViolation of the Public Trust is Nothing New

• Isaac Newton (1642) & Gregor Mendel (1822-1884) – Data too good, may have altered original data to fit the model

• Louis Pasteur 1822 -1895– May have plagiarized the work of others– May have been less than candid about how his anthrax vaccine

was prepared.

Violation of the Public Trust is Nothing NewViolation of the Public Trust is Nothing New

Antoine Lavoisier 1778– Failed to credit Scheele and

Priestly for prior discovery of O2.

• Piltdown Man

– Fraud by Charles Dawson went undiscovered for 40 years.

– >500 doctoral theses written on the subject.

By J.L. David

The Public TrustThe Public Trust• Research with human subjects is a privilege and not an

entitlement. • Society trusts investigators to conduct research ethically.• The Regulations – because the public trust was violated.• Public Trust must be protected.

– Public trust maintained through accountability.– Accountability is accomplished through documentation of

ethical conduct.– Federal Regulations specifically require documentation of

ethical behavior. • Regulatory requirements to document are designed

to: Preserve the Public Trust in research.

Preserving the Public Trust Through Preserving the Public Trust Through EducationEducation

• Why does scientific misconduct occur?– Mental disorder. – Powerful and increasing professional pressure to

publish studies. – $$$$$$$$$$$$$$$$$$ – Inadequate mentoring.

• Ignorance of the rules.

• Poor ethical decision skills.

• Ill prepared to “do the right thing”.

• Cultural differences in ethical standards.

• Research Ethics Education

The The EthicalEthical Foundations for Foundations for Trust Trust are Based in are Based in EducationEducation..

• Mentoring of students and young investigators.

• Classroom courses.• Web based instruction.• CITI is positioned to help meet the

educational needs of the human subjects research community.

Talking PointsTalking Points• Background• The CITI program.

– The CITI Developer Group– Course Content– Course Site Usage

• All participants• SUNY

– The CITI International Program.• Demo new CITI courses.

– GCP– HIPS– RCR

• Demo course site utilities• Summary

CITI – CITI – Organization Organization 9-20069-2006

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

Participating Institutions and Organizations (~660)Participating Institutions and Organizations (~660)

CITI Developer Group (~50)CITI Developer Group (~50)

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

GCPGCP

RCRRCR

September 18, 2006

CITI Developers Group has CITI Developers Group has semiannual meetingssemiannual meetings

• Provide oversight to the Program• Review CITI user feedback.• Develop and review new content.• Plan new initiatives.

September 18, 2006

CITI “Help Desk”CITI “Help Desk”• Resolve learner problems

– Registrations– Technical Issues

• Institution set up support– Learner Groups– Program Curriculum– Institutional page setup– Adding institutional content

• Coordinator Support– Changes in contact

information– Implement Modifications.– Report Utilities

305 243-7970citisupport@med.miami.edu

CITI – CITI – Startup OrganizationsStartup Organizations 9-20009-2000• University of MiamiUniversity of Miami

– Paul Braunschweiger,Ph.D., Ken Goodman, Ph.D.Paul Braunschweiger,Ph.D., Ken Goodman, Ph.D.• Fred Hutchinson Cancer Research CenterFred Hutchinson Cancer Research Center

– Karen Hansen, BAKaren Hansen, BA• Albany Medical Center Albany Medical Center

– Jeff Cooper, MDJeff Cooper, MD• Children's Hospital-Boston Children's Hospital-Boston

– Susan Kornetsky, MPHSusan Kornetsky, MPH• Dartmouth CollegeDartmouth College

– Liz Bankert, MALiz Bankert, MA• University of Kentucky University of Kentucky

– Ada Sue Selwitz, MA, Norma Epley, MSAda Sue Selwitz, MA, Norma Epley, MS • The National Comprehensive Cancer NetworkThe National Comprehensive Cancer Network

– Diane Paul, MSDiane Paul, MS• University of NebraskaUniversity of Nebraska

– Bruce Gordon, MD, Ernie Prentice, Ph.D.Bruce Gordon, MD, Ernie Prentice, Ph.D. • Group Health Cooperative Group Health Cooperative

– Barbara Young, Ph.D., Janelle Erickson, MPHBarbara Young, Ph.D., Janelle Erickson, MPH• University of Washington University of Washington

– Helen McGough, MSHelen McGough, MS

September 18, 2006

SUNY and CITISUNY and CITI

http://www.suny.edu/student/campuses_map.cfm

SUNY CITI Member Site

CITI Course MaterialsCITI Course Materials• Basic course human subjects protection

– 12 modules for biomedical research investigators.– 11 modules for social & behavioral research investigators– 5 general interest modules.

• Human Subjects Refresher courses – 2 Biomedical– 2 Social & Behavioral

• Institutional Modules– Institutional Policies – Specific procedures– Special Interest HSR modules.

New CITI Course MaterialsNew CITI Course Materials

• Good Clinical Practice (GCP) and ICH (summer 2006)– 12 modules for investigators and staff

• Health Information Privacy and Security– 18 content modules

New CITI Course MaterialsNew CITI Course Materials

Responsible Conduct of Research (Fall 2006) – Scientific Misconduct– Data Management– Conflict of Interest– Collaborative Science– Responsible Authorship– Mentoring– Peer Review– Lab Animal Welfare– Human Subjects Protection

The CITI Target AudienceThe CITI Target Audience

September 18, 2006

The Clinical InvestigatorThe Clinical Investigator

The Anatomy Lecture of Dr. Nicolaes Tulp, Rembrandt 1632

September 18, 2006

The Social & Behavioral ScientistThe Social & Behavioral Scientist

“The Psychologist” by Charles Bragg www.charlesbragg.com

September 18, 2006

The Basic Science The Basic Science InvestigatorInvestigator

Florescence In Situ Hybridization

September 18, 2006

StudentsStudents

“The Student” by Rembrandt

September 18, 2006

The IRB The IRB

Frans Hals, Regents of the St Elizabeth Hospital of Haarlem - 1641

September 18, 2006

The IRB CoordinatorThe IRB Coordinator

The Tribunal of the Brabant Mint in Antwerp 1594, by Marten de Vos 1523 – 1603Justice triumphs over deceit and violence

September 18, 2006

Chair of the IRBChair of the IRB

Hans HOLBEIN, the Younger, Henry VIII and the Barber Surgeons c. 1543

September 18, 2006

The Institutional OfficialThe Institutional Official

CITI Course Site UsageCITI Course Site Usage

September 18, 2006

CITI Program GrowthCITI Program Growth

00

100100

200200

300300

400400

500500

600600

PA

RT

ICIP

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AT

ION

SP

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1-Aug-00

17-Aug-01

15-Aug-02

13-Aug-03

15-Aug-04

1-Aug-05

CITI PARTICIPANTS 2000 TO 2006CITI PARTICIPANTS 2000 TO 2006

1-Sept-06

700700

*

*

September 18, 2006

Monthly UsageMonthly Usage

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

1-053-05

5-057-05

9-0511-05

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Basic course = 79%Refresher course = 21%

Registrants

Completion Reports

>89% Completion Rate

6-068-06

September 18, 2006

CITI Cumulative RegistrationsCITI Cumulative Registrations

00

5050

100100

150150

200200

250250

300300

Aug-00

Aug-00

Oct-0

0

Oct-0

0

Dec-0

0

Feb-0

1

Apr-01

Jun-0

1

Aug-01

Oct-0

1

Dec-0

1

Feb-0

2

Apr-02

Jun-0

2

Aug-02

Oct-0

2

Dec-0

2

Feb-0

3

Apr-03

Jun-0

3

Aug-03

Oct-0

3

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3

Feb-0

4

Apr-04

Jun-0

4

Aug-04

Oct-0

4

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4

Feb-0

5

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Reg

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Nov-05

Jan-0

6

350350

Version 6

Version 5

Version 4Version 3

Ver 1 & 2

400400

Mar

-06

June-

06

500500

450450

Aug-06

Oct-0

6

September 18, 2006

Participating OrganizationsParticipating Organizations

Category % Number

Universities / Colleges 33%* 215

VA 23% 152

Research Medical Centers 17%* 110

Government 9%* 58

HealthCare Systems 8% 55

Industry 4% 27

Foundations 3% 17

International Sites 2% 16

Total 100% 650

* Increased since 9-05

Course Site Usage by SUNY Learners

02

4

6

810

12

14

16

18

Ap

ril

July

Oct

obe

r

Janu

ary

Ap

ril

July

Oct

obe

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Janu

ary

Ap

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July

2004 2005 2006

Th

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Lea

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CITI Usage per SUNY SiteCITI Usage per SUNY Site

SUNY SiteSUNY Site LearnersLearners

University at Stony BrookUniversity at Stony Brook 36723672

University at AlbanyUniversity at Albany 28592859

Upstate Medical UniversityUpstate Medical University 24562456

College at BrockportCollege at Brockport 15101510

Health Science Center at BrooklynHealth Science Center at Brooklyn 14831483

College at PlattsburghCollege at Plattsburgh 987987

College at FredoniaCollege at Fredonia 676676

College at CortlandCollege at Cortland 543543

New PaltzNew Paltz 497497

College at PotsdamCollege at Potsdam 496496

SUNY SiteSUNY Site LearnersLearners

Binghamton UniversityBinghamton University 425425

SUNY SPServicesSUNY SPServices 119119

University at BuffaloUniversity at Buffalo 118118

College of OptometryCollege of Optometry 101101

Buffalo StateBuffalo State 9696

Empire State CollegeEmpire State College 5151

Purchase CollegePurchase College 1616

CantonCanton 88

College at OneontaCollege at Oneonta 66

Total 9-12-06Total 9-12-06 16,11916,119

September 18, 2006

New CITI FeaturesNew CITI Features

• International participation.• New Human subjects Research materials.

– New CITI Modules• IRB Member

• Students in Research

– Refresher Materials– GCP Content– HIPS

• Responsible Conduct of Research Course.

Data from January 2006

International AccessInternational Access

CITICITI InternationalInternational

September 18, 2006

International Human Subject International Human Subject ResearchResearch

• US Regulations regarding training pertain to international US Regulations regarding training pertain to international collaborators on NIH funded projects.collaborators on NIH funded projects.

• CITI International CITI International www.irbtraining.org • SpanishSpanish• FrenchFrench• PortuguesePortuguese• ChineseChinese• Arabic Arabic

– Used by foreign investigators collaborating on NIH Used by foreign investigators collaborating on NIH funded projects. funded projects.

IRB enhancement grants to KH @FHCRC and to PB @ U of Miami.IRB enhancement grants to KH @FHCRC and to PB @ U of Miami.CITI is committed will maintain and update this course site. CITI is committed will maintain and update this course site.

September 18, 2006

CITI International ProgramCITI International Program

• International Demonstration Projects– Caribbean– Taiwan– Costa Rica– South America

• International “mini” Site – www.IRBtraining.org

• International participants at:– www.citiprogram.org

September 18, 2006

New CITI ModulesNew CITI Modules

September 18, 2006

New CoursesNew Courses

• Good Clinical Practice & ICH• HIPS• Responsible Conduct of

Research

https://www.citiprogram.org Register as

Responsible Conduct of Research or

ARENA / PRIM&R

September 18, 2006

CITI Good Clinical Practice CourseCITI Good Clinical Practice Course

September 18, 2006

HIPS CourseHIPS Course

September 18, 2006

HIPS CurriculumHIPS Curriculum

September 18, 2006

The Responsible Conduct of ResearchThe Responsible Conduct of Research

• Research Misconduct• Data Management• Conflict of Interest• Collaborative Science• Responsible Authorship• Mentoring• Peer Review• Lab Animal Welfare (1-1-07)• Human Subjects Protection

DHHS, Office of Research Integrity

September 18, 2006

CITI RCR CourseCITI RCR Course

Biomedical SciencesBiomedical Sciences

Social & Behavioral SciencesSocial & Behavioral Sciences

Physical SciencesPhysical Sciences

Arts & HumanitiesArts & Humanities

September 18, 2006

CITI RCR Course for the Biomedical Sciences

• Basic foundation text for each RCR topic• Discipline specific case studies for each RCR topic.• Case studies are embedded in the text or presented as

stand alone modules after the text.• Quizzes• Totally customizable by institution or instructor.• Can be used “top down” or “bottom up.”

www.citiprogram.org Responsible Conduct of Research

September 18, 2006

CITI Course Site and Admin CITI Course Site and Admin ToolsTools

September 18, 2006

CITI Course Site and Admin ToolsCITI Course Site and Admin Tools

September 18, 2006

• In Summary– New Modules

• IRB Member• Student Researcher• IRB Coordinator (1-1-07)• Public Health Research (1-1-07)

– New courses• GCP, • HIPS • RCR• Lab animal welfare

• Utilities• Order forms provided• Help Desk available to help you use the program.