Instruction in The Protection of Human Research Subjects a web based model Paul Braunschweiger Ph. D



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Instruction in The Protection of Human Research Subjects A web based model

  • Paul Braunschweiger Ph.D.

  • Department of Radiation Oncology

  • Director, Office of Research Education

  • University of Miami

  • Co-Founder, CITI Program pbraunsc@med.miami.edu


Talking Points

  • PHS HSR Training mandate

  • Why the web?

    • Pros and cons
    • How to get started
  • CITI Program as an example of a web based platform

    • CITI Program Overview
    • How is the CITI course site is used
  • DL Software Demo and Admin utilities www.citiprogram.org

  • Evaluation of the web based program



June 2000 DHHS Mandates Training in Human Subjects Protection



June 2000 DHHS Mandates Training in Human Subjects Protection



CITI – Startup Organizations 9-2000

  • University of Miami

  • Fred Hutchinson Cancer Research Center

    • Karen Hansen, BA
  • Albany Medical Center

    • Jeff Cooper, MD
  • Children's Hospital-Boston

    • Susan Kornetsky, MPH
  • Dartmouth College

    • Liz Bankert, MA
  • University of Kentucky

    • Ada Sue Selwitz, MA, Norma Epley, MS
  • The National Comprehensive Cancer Network

    • Diane Paul, MS
  • University of Nebraska

    • Bruce Gordon, MD, Ernie Prentice, Ph.D.
  • Group Health Cooperative

    • Barbara Young, Ph.D., Janelle Erickson, MPH
  • University of Washington

    • Helen McGough, MS


Web based instruction

  • Basic instruction

  • Refresher courses.

    • Economy of time for investigators
    • Economy of time for trainers.
    • Economy of time for administrators.
    • Cost efficient for institutions.
      • 20 clinicians @ 2 hrs/session >$10,000/session
      • $50,000 for a 4hr tutorial – Thousands of learners.
      • CITI is $1,000 / institution for unlimited usage.
      • NCI tutorial is “Free”
  • Flexible

    • Rather easy to update and modify
    • CITI reviews and updates semiannually
  • Learners like using the web for instruction.

    • Some like it less




Web based instruction What do you need to get started from scratch.

  • Content (html) and content providers

    • Content reviewers
  • Distance Learning Software and support

  • Servers and IT support.

  • Administrative support

    • Help Desk


Useful Features of most DLS Packages

  • User ID and Password protected.

  • HTML, slideshow +/- audio, video presentations

  • Linear presentation of course content

  • Hyperlinks to other information sources on the web

  • Assessment of achievement = quiz

    • Feedback
    • Minimum level of understanding
  • Records and stores data to document compliance.

  • Administrator access to the database to track usage and compliance.

  • Certificate of achievement



Is there a downside to web based instruction?

  • Learning styles vary.

    • Some people would rather listen than read.
    • Little or no opportunity for real time question and answer period.
  • Web Navigation can be frustrating for some users.

    • browsers, ISPs, internet, bandwidth, software issues.
  • “Gaming the software” – Cheating

    • Hard to prevent but, not impossible.
  • Development costs might be prohibitive for small organizations.

    • Multi-institutional agreements


A web based model The Collaborative Institutional Training Initiative (CITI)

  • www.citiprogram.org



What is the CITI Program?

  • CITI is a volunteer organization whose goal is to develop and distribute high quality, peer reviewed educational resources designed to raise awareness to human subjects protection issues for all members of the research team.

  • CITI maintains an educational website where participating organizations can design and roll out a customized curriculum for their investigators, staff and administrators.



CITI – Organization



Semi-annual Developer Meetings



CITI Institutional Members (578)



International Participants



80% of AAHRPP accredited institutions utilize the CITI program as a component of their HSR educational

  • Cedars-Sinai Medical Center

  • Chesapeake Research Review Inc.

  • Children's Hospital Boston

  • Copernicus Group IRB

  • Dana-Farber/Harvard Cancer Center

  • East Tennessee State University

  • Fox Chase Cancer Center

  • Hunter Holmes McGuire Veterans Affairs Medical Center

  • Iowa Health - Des Moines

  • Massachusetts General Hospital

  • Brigham & Women's Hospital

  • Michigan State University

  • New England Institutional Review Board



CITI program and the VA

  • Financial support

  • Software

  • Software development

  • Software and IT support.



CITI - The Content

  • CITI Basic Course www.citiprogram.org

    • 12 Biomedical Modules
    • 11 Social / Behavioral Research Modules
    • 5 General Interest Modules
    • Quizzes
  • CITI Refresher Course www.citiprogram.org

    • Case studies and scenarios
    • Biomed Refresher I,
    • Biomed Refresher II
    • SBR Refresher I
    • SBR Refresher II (6-2006)
  • CITI International Research Course www.irbtraining.org

    • Chinese, Spanish,
    • Arabic, Portuguese, French
  • Good Clinical Practice (GCP) Spring 2006

  • HIPAA Summer 2006

  • RCR – Summer 2006

  • Lab Animal Welfare - Summer 2006 www.researchtraining.org



CITI – Program Review

  • The CITI Content is extensively reviewed and critiqued.

    • CITI Developers
    • CITI Editorial Board
    • External peer reviewers
    • Professional editorial services (LERA Group, PTC of NY)
    • Our Participants via user satisfaction surveys
      • Quiz questions
      • Recommendations for new course content
      • RCR


CITI Program The Participating Institution:

  • Registers with CITI

    • Institutional user fee, unlimited access
  • Establishes Learner Groups

    • Biomedical Research
      • PI’s, IRB Members, Administrators, Lab Researchers, Students
    • Social & Behavioral Research
      • PI’s, IRB Members, Administrators, Interviewers, Students
  • Designs a specific curriculum for each Learner Group

    • Choose “required” and “optional” modules
    • Set passing score
    • Set recertification requirement timeline.
  • Provides additional organization specific instructional materials.



How do member organizations use the CITI Program?

  • Investigator certification.

  • IRB member training.

  • IRB coordinator training

  • Refresher course, re-certification, continuing education.

  • Web based alternative to seminars or lectures.

  • Undergraduate / graduate bioethics or research methods courses.



Coordinator “Survey says”:



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


The Target Audience



The Clinical Investigator



The Social & Behavioral Scientist



The Basic Science Investigator



Students



The IRB



The IRB Coordinator



Chair of the IRB



The Institutional Official



CITI Learner Characteristics



Software must be user friendly The Learner



Software must be user friendly Institutional Coordinator / Administrator

  • Has access to the database

    • Download aggregate training data.
    • Retrieve individual learner’s record.
    • Review user comments.
  • Receives individual completion report by email.





CITI Course Site Usage



CITI Program Growth



Recent Monthly Usage



International Access



CITI Cumulative Registrations





CITI Program Course Site Administrator tools

  • www.citiprogram.org





Program Evaluation What is the effectiveness of web based instruction.

  • IRB Coordinator Perspective



Utility: Coordinator “Survey says”:



Acceptance by learners Coordinator “Survey says”:



Impact: Coordinator “Survey says”:



Value: Coordinator “Survey says”:



Value: Coordinator “Survey says”:



Program Evaluation What is the effectiveness of web based instruction.

  • Learner’s Perspective











Impact



Since completing the CITI Course, I may be more willing to join an IRB or a Data Safety Monitoring Board to take a more active role in protecting human subjects.







Program Evaluation

  • Learner Perspectives at 22 months



REFRESHER COURSE SURVEY



REFRESHER COURSE SURVEY



REFRESHER COURSE



Refresher Course Survey



Refresher Course Survey



REFRESHER COURSE SURVEY



In Summary

  • What have we learned about web based instruction from the CITI program experience.

  • The www as a tool

    • Web instruction can provide rich content in a time and cost effective manner.
    • A web program can play a central role in an organization’s HSR education program.
    • A web program can be utilized for both basic and refresher instruction.
    • A web platform is overwhelmingly preferred by investigators and training coordinators.
    • But, alas, the web is not for everyone.. and alternatives are advisable.


In Summary

  • What have we learned from the CITI program experience.

  • Organization

    • A dynamic committed organization can keep the instruction fresh and current.
      • Frequent updates.
      • Learner satisfaction surveys are very important to obtain feedback and guidance to improve the program.
    • Help desk


In Summary

  • What have we learned from the CITI program experience.

  • Utility

    • World wide training resource can be delivered in a cost effective and value added manner.
    • Customization capabilities are a key.
    • Institutional page to provide institution specific materials is VERY well received and a extensively used by some participating institutions.


In Summary

  • What have we learned about web based instruction from the CITI program experience.

  • Evaluations

    • Learners indicate the course helped them understand human subjects protection issues and that the time required to complete the course is time well spent.
    • Learners indicate that the instruction has provided the confidence to take a more active roll in the protection of human subjects.
    • Institutional coordinators exhibit a high degree of satisfaction with the web based program.


Instruction in The Protection of Human Research Subjects

  • www.citiprogram/org

  • Paul Braunschweiger Ph.D.

  • pbraunsc@med.miami.edu



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