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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. Historical perspective Organizational structure New materials through CITI New curriculum structure opportunities.

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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
Talking points

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

CITI Program is a web based bioethics education program designed to promote the responsible conduct of research.

CITI Founders

Karen Hansen,

Fred Hutchinson Cancer Research Center, Seattle, WA., USA

Paul Braunschweiger Ph.D.

University of Miami

Miami, Fl. USA

slide4

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 trainingbefore conducting human subjects research.
citi program 11 2008
CITI – Program11-2008

Participating Institutions and Organizations (~1150)

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

citi program milestones
CITI Program Milestones
  • 10 Participating Institutions in 2000.
    • CITI - Collaborative IRB Training Initiative
  • New Courses added 2004.
  • ~ 1150 Participating Institutions in 11- 2008.
    • CITI - Collaborative Institutional Training Initiative
  • Lab Animal Welfare Course – 5-2007
  • ~ 35,000 Learners per month. 40- 60% students
  • >105,000 Learners since 1-1-2009.
  • > 12,000 Lab Animal Course learners since 1-1-2009
  • >1,000,00 people have completed a CITI course since 9-1-2000.
  • Subscriber Profile
    • Universities, colleges, medical centers, community hospitals, societies, government, commercial IRBs, industry
citi program milestones1
CITI Program Milestones
  • International Initiatives
    • CITI - Collaborative International Training Initiative
  • Multi-language Course Site. 11-2007 updated 2-2009
    • Spanish
    • Portuguese
    • Chinese, Japanese, Russian, Mongolian, French, Thai
citi worldwide footprint
CITI Worldwide Footprint

World wide n > 1150

International n = 49sites / 35 countries

citi program courses
CITI Program Courses
  • Human Subject Protection
    • Good Clinical Practice (15)
    • Refresher Courses
  • Health Information Privacy and Security (HIPS)
    • Basic
    • Refresher
  • The Responsible Conduct of Research.
    • 5 Disciplines
    • Text, cases, quizzes.
  • Laboratory Animal Welfare (L.A.W.)
    • Basic
    • Refresher
lab animal welfare program

RCR 12-29-07

Lab Animal Welfare Program

2004 - Collaboration between CITI and Dr, M. Fallon at the Atlanta, VA.

2007 – VA decided to close the www.ResearchTraining.org LAW course site.

5-2007 CITI offered the CITI Version of RT.org to our participating institutions.

10-2007 – CITI Lab Animal Welfare Working Group.

2008 - 2009 - Comprehensive review and updating of the course content.

2009 CITI International Collaborating Centers

citi l a w course library

RCR 12-29-07

CITI L.A.W. Course Library
  • CITI Basic Courses.
    • Working with the IACUC
    • Essentials for IACUC Members
  • Special Courses
    • Aseptic Technique
    • Minimizing Pain and Distress in Rodents.
establishing an institutional curriculum

RCR 12-29-07

Establishing an Institutional Curriculum
  • Each institution can establish their own curriculum from the L.A.W. Content Library.
  • Curriculum can be customized according to:
    • Role in LAW research.
    • Species / models used.
  • Basic courses and refresher courses.
    • Reminder notifications
top 10 institutional users
Top 10 Institutional Users

*First 3 months of 2009

** 151 VA sites have access to the CITI Program.

citi l a w working group
CITI L.A.W. Working Group

*CITI L.A.W. Working group leader

l a w working group

RCR 12-29-07

L.A.W. Working Group
  • Review learner comments
    • Modify the content if appropriate.
  • New Content
    • Susan Silk MS, Director of the Division of Policy and Education, OLAW
      • “Using Animals in Research: Information for PHS-funded Investigators.” will provide a comprehensive overview of the regulations and guidelines for PHS-funded researchers including institutional and investigator responsibilities, applying for funding, receiving an award and post award responsibilities.
    • Mark Christensen, Prof. of Ethics, Lourdes College
      • 5 module course on the Ethics of conducting research with Lab animals.
      • Ethical considerations related to the use of live animal subjects in scientific research. In this module we will briefly highlight some philosophical theories about ethics and moral standing and their relation to the use of animals as research subjects.
    • Conducting Field Studies Responsibly.
    • Case based refresher course.
l a w working group1

RCR 12-29-07

L.A.W. Working Group
  • Recently completed updating and editing course content for:
    • Working With the IACUC
    • Essentials for IACUC Members
  • Quiz questions Reviewed and updated.
    • Feedback for all of the questions in all of the modules.
    • Posting in June 2009.
  • Antibody production
    • New Course on antibody production
curriculum design

RCR 12-29-07

Curriculum design
  • Curriculum design is institutional responsibility
  • Stratified Curriculum to meet educational needs.
    • Research Focus
      • Model / species specific modules.
    • Role in research
      • IO, IACUC Member / staff, PI, Investigators, research staff, students.
    • Institution specific modules
      • Policies and Procedures.
      • Materials not covered by CITI Courses
        • Special species or model systems
        • Field studies.
        • Lab Animal Research Ethics.
curriculum development required vs optional vs elective

RCR 12-29-07

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
curriculum design1
Curriculum design

CITI Course order forms are available at www.citiprogram.org

Institutional Administrator menu

curriculum modifications
Curriculum Modifications

CITI Course order forms are available at www.citiprogram.org

Institutional Administrator menu

quiz questions utilities

RCR 12-29-07

Quiz Questions Utilities
  • Integrity Assurance.
  • New presentation paradigms.
    • Randomized questions from a pool
    • Using a case study as a stem.
  • New psychometric tools to evaluate quiz questions.
institutional modules

Institutional Modules

Developed by organizations specifically for their research community.

examples of institutional l a w modules

RCR 12-29-07

Examples of Institutional L.A.W. Modules

Medical Surveillance Program

General Zoonotic Training

Farm Animals

Wild Animals

Fish, Amphibians and Reptiles

Introduction to Surgical Research

Antibody Production

Occupational Health and Safety

Other models (e.g., Birds)

CU Policy on the Care and Use of Animals in Research and Teaching.

Conducting Potentially Painful/Distressful Procedures in Lab Animals At The University of Miami

enrollment questions
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
enrollment questions1
Enrollment Questions
  • Choose the most appropriate research focus or role in research
  • Software then shows the next series of questions appropriate for the learner.
slide45
CITI Program Knowledge Basehttp://citiprogram.supportcenterpro.com/knowledgebase/orCITI Home Page, Contact Us

The CITI Program Knowledge Base provides helpful information to assist in the use of the CITI Program website.

Provide support, resources, hints, tips, links and answers to frequently asked questions about the CITI Program, all in one place.

We welcome contributions and feedback from learners and CITI institutional administrators.

Please use the “Submit New Ticket” ticket link to the right of the screen to share comments, questions, and feedback with the CITI Support team.

citi program knowledge base
CITI Program Knowledge Base

Please use the “Submit New Ticket” ticket link to the right of the screen to share comments, questions, and feedback with the CITI Support team.

admin access to user data
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
course listing
Course listing

Review a completion Report

view the data
View the data

Links to download the data in various formats

other data management options available
Other data management options available

https://www.citiprogram.org/members/siteadministrators/manageinstitutions/downloadaccesscodes.asp?strKeyID=XXXXXXXXXXXXXXXXXXXXXXXXX73

  • 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; citisupport@med.miami.edu
other data management options
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.
prim r member access1
PRIM&R Member Access

Go to Main Menu

“Affiliate with another institution”

“Register as PRIM&R Member”

new initiatives for 2009
New initiatives for 2009
  • Courses and modules
    • Software updates
      • “Look back” Utility
      • Non-English authoring utilities.
      • Knowledge Base.
      • Username and Password security
      • Verification and Portal pass through.
    • Human subjects (Summer 2009)
      • ESCRO (1 modules)
      • New Refresher Modules
      • Community Member Module
      • Research Coordinators
      • CBPR
new initiatives for 20091
New initiatives for 2009
  • Courses and modules
    • RCR
      • RCR for Engineers.
      • RCR for Arts and Humanities. (Fall 2009)
    • Biosafety and Bio-security (Summer 2009)
      • 15 module course
    • Lab animal
      • Ethics and Lab Animal Research
      • Field Studies
      • Zebra Fish
download this slide show
Download this Slide Show

Slide show available

back

the current course site presents the materials in a way that is easy for me to understand and learn
The current course site presents the materials in a way that is easy for me to understand and learn

Strongly Disagree Strongly Agree

slide69
If you have previously completed a Lab Animal Welfare course, how does this CITI Course compare with others you have completed?

61%

Strongly Disagree Strongly Agree

slide70

Although training in Laboratory Animal Welfare issues is mandated by the Federal government and by my institution, I believe that this training is really not very useful for new faculty and students?

Strongly Disagree Strongly Agree

it was easy to register and enroll in the appropriate course
It was easy to register and enroll in the appropriate course.

Strongly Disagree Strongly Agree

the quiz questions addressed the relevant issues in the modules
The quiz questions addressed the relevant issues in the modules

Strongly Disagree Strongly Agree

slide73
Now that I have completed the CITI Lab Animal Welfare Course, I feel that the time I invested was time well spent.

Strongly Disagree Strongly Agree

slide74

After completing this instruction, I now have a better understanding of how to apply the "3Rs" to insure that my lab animal studies are conducted to the highest ethical standards?

71%

Strongly Disagree Strongly Agree

slide75

Now that I have completed the course, I am more confident in my ability to advise a student or a colleague on how to apply the "3Rs" to insure that their lab animal studies are conducted to the highest ethical standards?

68%

Strongly Disagree Strongly Agree

slide76

Now that I have completed this course on the ethical conduct of studies with laboratory animals, I intend to take a more active role in assuring that lab animal research at my institution is conducted to the highest ethical standards by pursuing professional certification, by joining an ethics committee or an Institutional Animal Care and Use Committee (IACUC)

60%

Strongly Disagree Strongly Agree

slide77

The "Essentials for IACUC Members" Course has provided we with the knowledge base and confidence to take a more active role in the business of the IACUC.

64%

Strongly Disagree Strongly Agree

slide79

The presentation model used by CITI permits you to scroll through the content as if you were reading a book or a journal. Other web based models require that the learner click from "page to page” in order to read the material in smaller segments.