Transcript Inducements To pay or not to pay

CITI
Collaborative Institutional Training Initiative
Building Integrity in the Research Enterprise
www.citiprogram.org
Paul Braunschweiger Ph.D.
Professor, Radiation Oncology
CITI Co-Founder
University of Miami
Integrity in Human Subjects
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.
September 18, 2006
Recent Violations of the Public Trust
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2005 Woo Suk Hwang, fabricated and falsified Stem Cell lines.
– 8-2006, Advanced Cell Technology “Ethical Stem Cells” report misleading and
false.
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2005 Eric Poehlman fabricated and falsified data from clinical aging
studies.
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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
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8-2006 Ward Churchill, CU Professor of Ethnic Studies.
– Fired for Research Misconduct.
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9-1-06 Elizabeth Goodwin. falsification and fabrication.
– Resigned -Science September 1, 2006.
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9-10-06 NIH Thomas Walsh >$100,000 from Pharma.
Violation of the Public Trust is Nothing New
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Isaac Newton (1642) & Gregor Mendel (1822-1884)
– Data too good, may have altered original data to fit the model
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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 New
Antoine Lavoisier 1778
– Failed to credit Scheele
and Priestly for prior
discovery of O2.
By J.L. David
• Piltdown Man
– Fraud by Charles Dawson
went undiscovered for 40
years.
– >500 doctoral theses
written on the subject.
The 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
Education
• Why does scientific misconduct occur?
– Mental disorder.
– Powerful and increasing professional pressure to
publish studies.
– $$$$$$$$$$$$$$$$$$
– Inadequate mentoring.
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Ignorance of the rules.
Poor ethical decision skills.
Ill prepared to “do the right thing”.
Cultural differences in ethical standards.
• Research Ethics Education
The Ethical Foundations for
Trust are Based in Education.
• 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 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 – Organization
9-2006
Participating Institutions and Organizations (~660)
RCR
CITI Developer Group (~50)
CITI Editorial Board (15)
Intl.
GCP
CITI Administration – Office of Research Education, University of Miami
CITI Developers Group has
semiannual meetings
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Provide oversight to the Program
Review CITI user feedback.
Develop and review new content.
Plan new initiatives.
September 18, 2006
CITI “Help Desk”
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Resolve learner problems
– Registrations
– Technical Issues
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Institution set up support
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305 243-7970
[email protected]
September 18, 2006
Learner Groups
Program Curriculum
Institutional page setup
Adding institutional
content
Coordinator Support
– Changes in contact
information
– Implement Modifications.
– Report Utilities
CITI – Startup Organizations
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University of Miami
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Fred Hutchinson Cancer Research Center
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Bruce Gordon, MD, Ernie Prentice, Ph.D.
Group Health Cooperative
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Diane Paul, MS
University of Nebraska
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Ada Sue Selwitz, MA, Norma Epley, MS
The National Comprehensive Cancer Network
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Liz Bankert, MA
University of Kentucky
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Susan Kornetsky, MPH
Dartmouth College
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Jeff Cooper, MD
Children's Hospital-Boston
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Karen Hansen, BA
Albany Medical Center
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Paul Braunschweiger,Ph.D., Ken Goodman, Ph.D.
Barbara Young, Ph.D., Janelle Erickson, MPH
University of Washington
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Helen McGough, MS
9-2000
SUNY and CITI
SUNY CITI Member Site
http://www.suny.edu/student/campuses_map.cfm
September 18, 2006
CITI 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 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 Materials
Responsible Conduct of Research (Fall 2006)
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Scientific Misconduct
Data Management
Conflict of Interest
Collaborative Science
Responsible Authorship
Mentoring
Peer Review
Lab Animal Welfare
Human Subjects Protection
The CITI Target Audience
The Clinical Investigator
The Anatomy Lecture of Dr. Nicolaes Tulp, Rembrandt 1632
September 18, 2006
The Social & Behavioral Scientist
“The Psychologist” by Charles Bragg
September 18, 2006
www.charlesbragg.com
The Basic Science
Investigator
Florescence In Situ Hybridization
September 18, 2006
Students
“The Student” by Rembrandt
September 18, 2006
The IRB
Frans Hals, Regents of the St Elizabeth Hospital of Haarlem - 1641
September 18, 2006
The IRB Coordinator
The Tribunal of the Brabant Mint in Antwerp 1594, by Marten de Vos 1523 – 1603
Justice triumphs over deceit and violence
September 18, 2006
Chair of the IRB
Hans HOLBEIN, the Younger, Henry VIII and the Barber Surgeons c. 1543
September 18, 2006
The Institutional Official
September 18, 2006
CITI Course Site Usage
CITI Program Growth
CITI PARTICIPANTS 2000 TO 2006
PARTICIPATING ORGANIZATIONS
700
600
500
400
200
100
0
September 18, 2006
*
300
*
Monthly Usage
20000
Registrants
NEW LEARNERS
18000
16000
>89% Completion Rate
14000
12000
10000
Completion Reports
8000
6000
4000
2000
0
September 18, 2006
Basic course = 79%
Refresher course = 21%
CITI Cumulative Registrations
500
450
400
Thousands
300
Registrations
350
200
250
Version 6
150
100
Version 5
Version 3 Version 4
50
Ver 1 & 2
0
September 18, 2006
Participating 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
100%
650
Total
* Increased since 9-05
September 18, 2006
Thousands of Learners
0
2004
2005
2006
July
April
January
October
July
April
January
October
July
April
Course Site Usage by SUNY
Learners
18
16
14
12
10
8
6
4
2
CITI Usage per SUNY Site
SUNY Site
Learners
SUNY Site
Learners
University at Stony Brook
3672
Binghamton University
425
University at Albany
2859
SUNY SPServices
119
Upstate Medical University
2456
University at Buffalo
118
College at Brockport
1510
College of Optometry
101
Health Science Center at Brooklyn
1483
Buffalo State
96
Empire State College
51
16
College at Plattsburgh
987
Purchase College
College at Fredonia
676
Canton
8
College at Cortland
543
College at Oneonta
6
New Paltz
497
Total 9-12-06
College at Potsdam
496
16,119
New 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.
September 18, 2006
Data from January 2006
International Access
CITI International
International Human Subject
Research
• US Regulations regarding training pertain to international
collaborators on NIH funded projects.
• CITI International www.irbtraining.org
• Spanish
• French
• Portuguese
• Chinese
• Arabic
– Used by foreign investigators collaborating on NIH
funded projects.
IRB enhancement grants to KH @FHCRC and to PB @ U of Miami.
CITI is committed will maintain and update this course site.
September 18, 2006
CITI International Program
• International Demonstration Projects
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Caribbean
Taiwan
Costa Rica
South America
• International “mini” Site
– www.IRBtraining.org
• International participants at:
– www.citiprogram.org
September 18, 2006
New CITI Modules
September 18, 2006
New 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 Course
September 18, 2006
HIPS Course
September 18, 2006
HIPS Curriculum
September 18, 2006
The Responsible Conduct of Research
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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 Course
Biomedical Sciences
Social & Behavioral Sciences
Physical Sciences
Arts & 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
September 18, 2006
Responsible Conduct of Research
CITI Course Site and Admin
Tools
September 18, 2006
CITI Course Site and Admin Tools
September 18, 2006
• In Summary
– New Modules
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IRB Member
Student Researcher
IRB Coordinator (1-1-07)
Public Health Research (1-1-07)
– New courses
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GCP,
HIPS
RCR
Lab animal welfare
• Utilities
• Order forms provided
• Help Desk available to help you use the program.
September 18, 2006