citi collaborative institutional training initiative
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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
AT
ING
OR
GA
NIZ
AT
ION
SP
AR
TIC
IPA
TIN
G O
RG
AN
IZA
TIO
NS
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
1-06
NE
W L
EA
RN
ER
S
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
Dec-0
3
Feb-0
4
Apr-04
Jun-0
4
Aug-04
Oct-0
4
Dec-0
4
Feb-0
5
Apr-05
Jun-0
5
Aug-05
Th
ou
sa
nd
sT
ho
us
an
ds
Reg
istr
atio
ns
Reg
istr
atio
ns
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
r
Janu
ary
Ap
ril
July
2004 2005 2006
Th
ou
san
ds
of
Lea
rner
s
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.
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