Transcript What’s New at The CITI Program

What’s New at The CITI
Program
Paul Braunschweiger Ph.D.
Professor Radiation Oncology
University of Miami Miller School of Medicine
www.citiprogram.org
Talking points
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Historical perspective
Organizational structure
New materials through CITI
New curriculum structure opportunities.
New registration, enrollment and navigation aids
New administrator utilities
PRIM&R Member Access
New look for 2009
CITI Founders
March 2000
Karen Hansen FHCRC, Seattle
Paul Braunschweiger – U of Miami
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.
July 2000 Developer Group
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Co-Founders - Karen Hansen, BA; Paul Braunschweiger Ph.D.
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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.
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
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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?
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
• >300,000 Learners since 1-1-2008.
• >980,00 people have completed a course since 9-12000.
• Subscriber Profile
– Universities, colleges, medical centers, community hospitals,
societies, government, commercial IRBs, industry
Growth in New Users
50,000
45,000
Learners / month
40,000
35,000
30,000
25,000
20,000
15,000
10,000
5,000
0
May
2004
Nov
May
2005
Nov
May
2006
Nov
May
2007
Nov
May Sept
2008
Feb-07
Apr-07
Jun-07
Aug-07
Oct-07
Dec-07
Feb-08
Apr-08
Jun-08
Aug-08
Oct-08
Maximum concurrent users.
Maximum Concurrent per Month
1800
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1200
1000
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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
CITI Worldwide Footprint
World wide n > 950
International n = 47sites / 35 countries
CITI – Program
11-2008
Participating Institutions and Organizations (~950)
CITI Developer Group (~60)
RCR
CITI Executive Advisory Committee
Founders
L.A.W.
CITI Editorial Board (15)
Intl.
HSRP
HIPS
GCP
www.citiprogram.org
CITI Administration – Office of Research Education, University of Miami
CITI Support Staff
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
CITI Program Courses
• Human Subject Protection
– Basic Courses
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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)
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
CITI RCR Course
Biomedical Sciences
Social & Behavioral Sciences
Physical Sciences
Arts & Humanities
Administrators
Supported by a contract from DHHS / ORI
The Responsible Conduct of Research
• Public Access vs. subscriber access
• Topics
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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)
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
Lab Animal Welfare
• Basic course for investigators
• Course for IACUC Members.
• Model / species specific modules.
– Ethics of animal research
– Conducting field studies
Multilanguage Course Site
Informed Consent In International Research
CITI Multilanguage Course Site
• New for 2009
– GCP
• French, Japanese, Chinese, Russian
– Basic HSR Protections in:
• Chinese, Thai, Mongolian, Russian
• Spanish and Portuguese.
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.
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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
Curriculum Development
Required 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
Curriculum design
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CITI Course order forms are available at www.citiprogram.org
Institutional Administrator menu
Curriculum Modifications
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CITI Course order forms are available at www.citiprogram.org
Institutional Administrator menu
Institutional Modules
Developed by organizations
specifically for their research
community.
Institutional Modules
Institution Specific Modules and Programs
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Time and Effort Reporting
– University of Wisconsin (9)
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Lab Animal Welfare
– Clemson Univ. Field Studies; Emory Univ. ; University of Miami Aseptic Technique
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Conflict of Interest Policies.
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Biosafety, Recombinant DNA, Blood borne pathogens
– LifeSpan Corporation (7); University of Chicago; VA
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Stem Cell Research
– University of Wisconsin
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Privacy and Security Programs
– University of Miami (18); LifeSpan Corp., VA
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Human Subjects - Consent Process
– Rockefeller University (12)
– University of Miami (9)
Rockefeller University
Informed 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.
Registration, Enrollment and
Navigation
REGISTRATION
Add Customizable fields
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
Learner Menu
Grade Book
Integrity Statement
Integrity Statement
Administrator Utilities
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
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Human subjects
RCR
Lab Animal
HIPS
Course listing
• Review a completion Report
View the data
Download the data
Cane ID Last Name
First Name
Email
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Axxxx
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Date
Curriculum
Group
Stage
Completed
Course in the Protection of Human Group 1. Basic
1/8/2008
Research Subjects
Course
Course in the Protection of Human Group 4. Refresher 2 1/30/2008
Research Subjects
Course
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Bxxxx
xxxxxx
xxxxxxx
xxx
Cxxxx
xxxxxx
xxxxxxx
xxx
Dxxxxx
xxxxxx
xxxxxxx
xxx
Exxxxx
xxxxxx
xxxxxxx
Course in the Protection of Human Group 1. Refresher 3 4/7/2008
Research Subjects
Course
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Fxxxxx
xxxxxx
xxxxxxx
Course in the Protection of Human Group 2. Refresher 2 6/28/2008
Research Subjects
Course
xxx
Gxxxx
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xxx
Hxxxx
xxxxxx
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xxx
Ixxxx
xxxxxx
xxxxxxx
Course in the Protection of Human Group 2. Basic
Research Subjects
Course
Course in the Protection of Human Group 1. Basic
Research Subjects
Course
Course in the Protection of Human Group 3. Basic
Research Subjects
Course
Course in the Protection of Human Group 1. Basic
9/6/2008
Research Subjects
Course
Course in the Protection of Human Group 1. Refresher 1 7/17/2008
Research Subjects
Course
3/25/2008
4/27/2008
6/17/2008
Look up a specific learner
Other data management
options available
• Bulk data download
– CITI will provide institution specific URL to download the
institution’s 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; [email protected]
https://www.citiprogram.org/members/siteadministrators/manageinstitutions/downloadaccesscodes.asp?st
rKeyID=XXXXXXXXXXXXXXXXXXXXXXXXX73
Other data management
options
• CITI can now be placed behind your institutional Portal
System.
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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.
PRIM&R Member Access
PRIM&R Member Access
• Go to Main Menu
• “Affiliate with
another institution”
• “Register as
PRIM&R Member”
Contact Information for PRIM&R Member
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PRIM&R Member Affiliation
Complete
New initiatives for 2009
• Courses and modules
– Human subjects (Spring 2009)
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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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