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

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

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

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  1. Instruction in The Protection of Human Research SubjectsA web based model Paul Braunschweiger Ph.D. Department of Radiation Oncology Director, Office of Research Education University of Miami Co-Founder, CITI Programpbraunsc@med.miami.edu

  2. 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 2-23-06

  3. June 2000 DHHS Mandates Training in Human Subjects Protection On a scale of 1 - 10, how necessary is the PHS requirement that all key personnel engaged in human subjects research must participate in a human subjects protection educational program? 50% 45% Mean 40% 35% 30% 25% 20% N=6559 15% 10% 5% 0% 1 2 3 4 5 6 7 8 9 10 TOTALLY UNNECESSARY ABSOLUTELY VITAL 2-23-06

  4. June 2000 DHHS Mandates Training in Human Subjects Protection In my opinion, the June 2000 Federal education mandate HAS raised the level of awareness of investigators and staff at my institution to the vulnerabilities of human subjects in research. 45% 40% 35% Mean 30% % of Responders (729) 25% 20% 15% 10% 5% 0% 1 2 3 4 5 6 7 8 9 10 Strongly disagree strongly agree 2-23-06 N=764, 22 months

  5. CITI – Startup Organizations9-2000 • University of Miami • Paul Braunschweiger,Ph.D., Ken Goodman, Ph.D. • 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 2-23-06

  6. 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 2-23-06

  7. Assuming an equal time commitment, would you prefer any of the following to this web-based program? 80.0% 70.0% 60.0% 50.0% % of Responders 40.0% 30.0% 20.0% 10.0% 0.0% Audio Video Classroom Paper No Change N=1132 2-23-06

  8. Web based instructionWhat 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 2-23-06

  9. 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 2-23-06

  10. 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 2-23-06

  11. A web based modelThe Collaborative Institutional Training Initiative (CITI) www.citiprogram.org

  12. 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. www.citiprogram.org 2-23-06

  13. CITI – Organization Participating Institutions and Organizations (~580) CITI Developer Group (~40) CITI Editorial Board (15) CITI Administration – Office of Research Education, University of Miami 2-23-06

  14. Semi-annual Developer Meetings Seattle Florida 2-23-06

  15. CITI Institutional Members (578) 2-23-06

  16. International Participants

  17. 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 • Newton-Wellesley Hospital • Saint Francis Hospital and Medical Center • The University of Iowa • The University of New Mexico Health Sciences Center • The University of South Dakota • University of Arkansas for Medical Sciences • University of Louisville • University of Maryland, Baltimore • University of Minnesota • University of Pittsburgh • Vanderbilt University • Washington University in St. Louis • Western Institutional Review Board 2-23-06

  18. CITI program and the VA • Financial support • Software • Software development • Software and IT support. Special Thanks to Drs. Joan Porter and Mike Fallon 2-23-06

  19. CITI - The Content • CITI Basic Coursewww.citiprogram.org • 12 Biomedical Modules • 11 Social / Behavioral Research Modules • 5 General Interest Modules • Quizzes • CITI Refresher Coursewww.citiprogram.org • Case studies and scenarios • Biomed Refresher I, • Biomed Refresher II • SBR Refresher I • SBR Refresher II (6-2006) • CITI International Research Coursewww.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 2-23-06

  20. 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 2-23-06

  21. 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. • The Institutional Page 2-23-06

  22. 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. 2-23-06

  23. Coordinator “Survey says”: N=248, 64% http://www.surveymonkey.com/Report.asp?U=133513842908 2-23-06

  24. 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 CITI “Help Desk” 2-23-06

  25. The Target Audience

  26. The Clinical Investigator The Anatomy Lecture of Dr. Nicolaes Tulp, Rembrandt 1632

  27. The Social & Behavioral Scientist “The Psychologist” by Charles Bragg www.charlesbragg.com

  28. The Basic Science Investigator Florescence In Situ Hybridization 2-23-06

  29. Students “The Student” by Rembrandt

  30. The IRB Frans Hals, Regents of the St Elizabeth Hospital of Haarlem - 1641

  31. The IRB Coordinator The Tribunal of the Brabant Mint in Antwerp 1594, by Marten de Vos 1523 – 1603Justice triumphs over deceit and violence

  32. Chair of the IRB Hans HOLBEIN, the Younger, Henry VIII and the Barber Surgeons c. 1543

  33. The Institutional Official 2-23-06

  34. Role in Human Subjects Research Social Worker Data manager Administrator Lab Researcher IRB Member or Coordinator Interviewer Study coordinator or Study nurse Research Assistant Other Clinical Investigator PI Student 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% % of The Survey Responders CITI Learner Characteristics n=1130

  35. Software must be user friendly The Learner www.citiprogram.org Registers Username & Password Chooses Learner Group Completes the Required modulesMultiple sessions Prints / Saves Completion Report Completes any Optional modules CME / CEU User Survey Institutional Trainer Refresher Notification DatabaseArchive Log Off

  36. Software must be user friendlyInstitutional 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. 2-23-06

  37. CITI Course Site Usage

  38. CITI Program Growth CITI PARTICIPANTS 2000 TO 2005 600 500 400 PARTICIPATING ORGANIZATIONS 300 200 100 0 1-jJan-06 1-Aug-00 1-Aug-05 17-Apr-01 15-Aug-02 13-Aug-03 15-Aug-04 2-23-06

  39. Recent Monthly Usage 20000 Registrants 18000 Completion Reports 16000 14000 12000 NEW LEARNERS 10000 87% Completion Rate 8000 6000 Basic course = 88% Refresher course = 12% 4000 2000 0 July May March November September January 2005 January 2006 2-23-06

  40. Data from January 2006 International Access

  41. CITI Cumulative Registrations 350 300 Thousands Version 6 250 200 150 Registrations 100 Version 5 Version 3 Version 4 50 Ver 1 & 2 0 Jang-06 Jun-01 Jun-02 Jun-03 Jun-04 Jun-05 Oct-00 Oct-01 Oct-02 Oct-03 Oct-04 Feb-01 Feb-02 Feb-03 Feb-04 Feb-05 Apr-01 Apr-02 Apr-03 Apr-04 Apr-05 Dec-00 Dec-01 Dec-02 Dec-03 Dec-04 nov-05 Aug-00 Aug-01 Aug-02 Aug-03 Aug-04 Aug-05 2-23-06

  42. Which "Basic" Course did you complete? 50.0% 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% % of the Responders 15.0% 10.0% 5.0% 0.0% Biomedical Social Behavioral Both 2-23-06

  43. CITI Program Course SiteAdministrator tools www.citiprogram.org

  44. 2-23-06

  45. Program EvaluationWhat is the effectiveness of web based instruction. IRB Coordinator Perspective http://www.surveymonkey.com/Report.asp?U=133513842908

  46. Utility: Coordinator “Survey says”: http://www.surveymonkey.com/Report.asp?U=133513842908 2-23-06

  47. Acceptance by learnersCoordinator “Survey says”: http://www.surveymonkey.com/Report.asp?U=133513842908 2-23-06

  48. Impact:Coordinator “Survey says”: 70% http://www.surveymonkey.com/Report.asp?U=133513842908 2-23-06

  49. Value:Coordinator “Survey says”: http://www.surveymonkey.com/Report.asp?U=133513842908 2-23-06

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