What

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Whats New at The CITI Program

• Paul Braunschweiger Ph.D.
• Professor Radiation Oncology
• University of Miami Miller School of Medicine
• www.citiprogram.org

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Talking points

• Historical perspective
• Organizational structure
• New materials through CITI
• New curriculum structure opportunities.
• New registration, enrollment and navigation aids
• New administrator utilities
• PRIMR Member Access
• New look for 2009

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CITI Founders

• March 2000
• Karen Hansen FHCRC, Seattle
• Paul Braunschweiger U of Miami

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June 2000 DHHS Mandates Training in Human
Subjects Protection
A. TERMS OF THE FEDERALWIDE ASSURANCE (FWA) FOR
INSTITUTIONS WITHIN THE UNITED STATES. Announced
Dec. 2000 implemented, 2005
12. Educational Training OHRP strongly
recommends that the Institution and the
designated IRB(s) establish educational training
and oversight mechanisms (appropriate to the
nature and volume of its research) to ensure that
research investigators, IRB members and staff,
and other appropriate personnel maintain
continuing knowledge of, and comply with, the
following relevant ethical principles relevant
federal regulations written IRB procedures OHRP
guidance other applicable guidance, state and
local laws and institutional policies for the
protection of human subjects. Furthermore, OHRP
recommends that a) IRB members and staff complete
relevant educational training before reviewing
human subjects research and b) research
investigators complete appropriate institutional
educational training before conducting human
subjects research.
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July 2000 Developer Group

• Co-Founders - Karen Hansen, BA Paul
  Braunschweiger Ph.D.
• Elizabeth Bankert, MA
• Gary Chadwick, PharmD, MPH, CIP
• Jeff Cooper, MD
• Deborah Dickstein, JD
• Janelle Erickson, MPH
• David Forster, JD, MA, CIP
• Ken Goodman, Ph.D.
• Bruce Gordon, MD  
• Susan Kornetsky, MPH
• Helen McGough, MA
• Diane Paul, MS, RN
• Joan P Porter, DPA, MPH
• Ernie Prentice, Ph.D.
• Ada Sue Selwitz, MA
• Barbara Young, Ph.D.

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Request for Information and Comments on the
Implementation of Human Subjects Training and
Education Programs (Federal Register Notice dated
July 1, 2008)

• Regulation vs. Guidance
• What kinds of training programs are being used?
• Do all institutions need training programs?
• Who should be required to have training?
• Content?
• How often?
• Has failure to institute a rigorous training
  program resulted in non-compliance.
• One size fits all or customized training
  according to type of research and role?
• Assessment of understanding of research ethics?

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CITI Program Milestones

• 10 Participating Institutions in 2000.
• CITI - Collaborative IRB Training Initiative
• New Courses added 2004.
• 950 Participating Institutions in 11- 2008.
• CITI - Collaborative Institutional Training
  Initiative
• 25,000 Learners per month. 40- 60 students
• gt300,000 Learners since 1-1-2008.
• gt980,00 people have completed a course since
  9-1-2000.
• Subscriber Profile
• Universities, colleges, medical centers,
  community hospitals, societies, government,
  commercial IRBs, industry

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Growth in New Users
Learners / month
2004 2005
2006 2007
2008
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Maximum Concurrent per Month
Maximum concurrent users.
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CITI Program Milestones

• International Initiatives
• CITI - Collaborative International Training
  Initiative
• Multi-language Course Site. 11-2007
• Spanish
• Portuguese
• Chinese, Japanese, Russian, Mongolian, French,
  Thai

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CITI Worldwide Footprint
World wide n gt 950 International n 47sites / 35
countries
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CITI Program 11-2008
Participating Institutions and Organizations
(950)
CITI Developer Group (60)
Founders
RCR
CITI Executive Advisory Committee
L.A.W.
CITI Editorial Board (15)
Intl.
HSRP
GCP
HIPS
www.citiprogram.org
CITI Administration Office of Research
Education, University of Miami
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CITI Support Staff
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Recent Publications

• Braunschweiger PG and Goodman K. The CITI
  Program An International Online Resource for
  Education in Human Subjects Protection and the
  Responsible Conduct of Research. Academic
  Medicine Vol. 82, 1977.
• Litewka S, Goodman K, Braunschweiger P. The CITI
  Program An Alternative for the Education on
  Research Ethics in Latin America. Acta Bioethica,
  2008 14(1) 54-60

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CITI Program Courses

• Human Subject Protection
• Basic Courses
• Biomedical Focus (12)
• Social and Behavioral Research Focus. (10)
• Student Research (1)
• New IRB Member (1)
• Good Clinical Practice (15)
• Refresher Courses
• Biomedical (2 1)
• SBR (1 1)

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Health Information Privacy and Security (HIPS)

• HIPAA
• Data management.
• Privacy Rules
• Data Security
• Elective Modules cover such topics as
• Protecting your Computer
• Picking and Protecting Passwords
• Protecting your Portables
• Protecting your identity
• Safer Email-ing and IM-ing
• Safer Web Surfing
• Issues for Work/Workers Off-Site
• New HIPS Refresher Course

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CITI RCR Course
Biomedical Sciences
Social Behavioral Sciences
Physical Sciences
Arts Humanities
Administrators
Supported by a contract from DHHS / ORI
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The Responsible Conduct of Research

• Public Access vs. subscriber access
• Topics
• 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, quizzes
• New Courses (text, cases, quiz)
• The RCR and Research Administrators.
• RCR for Engineers (February 2009)

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Adapted for CITI from materials developed by
Steve Erickson Ph.D. and Karen M.T. Muskavitch,
Ph.D Administrators and the Responsible Conduct
of Research funded by ORI/DHHS
http//www.bc.edu/research/rcradmin/default.html
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Lab Animal Welfare

• Basic course for investigators
• Course for IACUC Members.
• Model / species specific modules.
• Ethics of animal research
• Conducting field studies

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Multilanguage Course Site
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Informed Consent In International Research
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CITI Multilanguage Course Site

• New for 2009
• GCP
• French, Japanese, Chinese, Russian
• Basic HSR Protections in
• Chinese, Thai, Mongolian, Russian
• Spanish and Portuguese.

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Curriculum design

• Curriculum design is institutional responsibility
• Stratified Curriculum to meet educational needs.
• Research Focus
• Biomedical vs SBR
• Role in research
• IO, IRB Member / staff, PI, research staff,
  students, lab investigator.
• For example
• IRB Member
• Biomedical PI doing drug and device studies.
• Biomedical research staff
• SBR Investigator
• SBR student doing no more than minimal risk
  research
• Data or Specimens only

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Curriculum DevelopmentRequired vs. Optional vs.
Elective

• Required
• Learner is required to complete modules in this
  category.
• Elective
• Institution can designate several Elective
  modules (e.g., 10) and require that the learner
  complete a specific number (e.g., 8) that are of
  interest.
• Optional
• Optional modules are made available to the
  learner after all required and elective modules
  are completed.
• Passing score set by the institution
• Learner must attain an aggregate score that meets
  the institutional requirement to get a Completion
  Report

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Curriculum design

• CITI Course order forms are available at
  www.citiprogram.org
• Institutional Administrator menu

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Curriculum Modifications

• CITI Course order forms are available at
  www.citiprogram.org
• Institutional Administrator menu

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Institutional Modules

• Developed by organizations specifically for their
  research community.

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Institutional ModulesInstitution Specific
Modules and Programs

• Time and Effort Reporting
• University of Wisconsin (9)
• Lab Animal Welfare
• Clemson Univ. Field Studies Emory Univ.
  University of Miami - Aseptic Technique
• Conflict of Interest Policies.
• VA
• Biosafety, Recombinant DNA, Blood borne pathogens
  
• LifeSpan Corporation (7) University of Chicago
  VA
• Stem Cell Research
• University of Wisconsin
• Privacy and Security Programs
• University of Miami (18) LifeSpan Corp., VA
• Human Subjects - Consent Process
• Rockefeller University (12)
• University of Miami (9)

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Rockefeller UniversityInformed Consent
RU 1 - Bridging Language Barriers Communicating Effectively Through An Interpreter (ID 1109)
RU 2 - Informed Consent An Introduction (ID 1112)
RU 3 - Improving the Readability of The Informed Consent Document (ID 1107)
RU 4 - Culturally Competent Informed Consent (ID 1111)
RU 5 - IRB Policies on The Use of Translations And Interpreters (ID 1114)
RU 6 - Pediatric Informed Consent (ID 1115)
RU 7 - Pediatric Research Ethics (ID 1118)
RU 8 - Research Documentation and Quality Assurance in Data Management (ID 1119)
RU 9 - Recruiting Members of Minorities as Participants in Research (ID 1128)
RU 10 - Reporting and Managing Adverse Events (ID 1129)
RU 11 - Research Using Stored Samples or Data (ID 1136)
RU 12 - Addressing Therapeutic Misconception and Psychological Barriers during the Informed Consent Process (ID 1137)
The creation of these educational modules at The
Rockefeller University Hospital was supported by
a Human Subjects Research Enhancement Program
grant (RR018141-02) and by a General Clinical
Research Center grant (M01-RR00102) from the
National Center for Research Resources at the
National Institutes of Health.
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Registration, Enrollment and Navigation
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REGISTRATION
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Add Customizable fields
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Enrollment Questions

• Curriculum Selection

• New page to page branching logic enrollment
  process
• Learner self-identifies research areas.
• Chooses topics
• Choices determine the next series of choices

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Enrollment Questions

• Choose the most appropriate research focus or
  role in research
• Software then shows the next series of questions
  appropriate for the learner.

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Special Course Enrollment
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Learner Menu
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Grade BookIntegrity Statement
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Integrity Statement
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Administrator Utilities
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Admin Access to User Data

• All CITI Institutional administrators have access
  to user data
• Can be restricted according to admin role.
• Receive completion reports
• Responsible for segments of the training program
• Human subjects
• RCR
• Lab Animal
• HIPS

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Course listing

• Review a completion Report

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View the data
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Download the data
Cane ID Last Name First Name Email Curriculum Group Stage Date Completed
xxx Axxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 1. Basic Course 1/8/2008
xxx Bxxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 4. Refresher 2 Course 1/30/2008
xxx Cxxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 1. Basic Course 9/6/2008
xxx Dxxxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 1. Refresher 1 Course 7/17/2008
xxx Exxxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 1. Refresher 3 Course 4/7/2008
xxx Fxxxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 2. Refresher 2 Course 6/28/2008
xxx Gxxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 2. Basic Course 3/25/2008
xxx Hxxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 1. Basic Course 4/27/2008
xxx Ixxxx xxxxxx xxxxxxx Course in the Protection of Human Research Subjects Group 3. Basic Course 6/17/2008
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Look up a specific learner
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Other data management options available

• Bulk data download
• CITI will provide institution specific URL to
  download the institutions training data.
• Username and password protected.
• Data for each course (HSR, lab Animal) can be
  downloaded together or separately
• The data fields to be included in the download is
  customizable.
• Suitable format to upload to data management
  system.
• Contact CITI Helpdesk - 305 243-7970
  citisupport_at_med.miami.edu

https//www.citiprogram.org/members/siteadministra
tors/manageinstitutions/downloadaccesscodes.asp?st
rKeyIDXXXXXXXXXXXXXXXXXXXXXXXXX73
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Other data management options

• CITI can now be placed behind your institutional
  Portal System.
• User authentication
• Username and password conservation.
• Increased data and password security.
• Data can be automatically added to training
  database.
• Contact CITI helpdesk
• 1 time cost for programming and implementation.

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PRIMR Member Access
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PRIMR Member Access

• Go to Main Menu
• Affiliate with another institution
• Register as PRIMR Member

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Contact Information for PRIMR Member
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PRIMR Member Affiliation Complete
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New initiatives for 2009

• Courses and modules
• Human subjects (Spring 2009)
• ESCRO (2 modules)
• New Refresher Modules
• Research Participants
• Research Coordinators
• RCR
• Engineers. (Feb 2009)
• Humanities. (Fall 2009)
• Biosafety and Bio-security (Summer 2009)
• Lab animal
• History and Ethics
• Field Studies

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CITI 2009 New Look
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Main Menu
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Administrator Utilities