Promoting the RCR Video Case Studies: Resources and Evaluation

1. Promoting the RCRVideo Case Studies: Resources and Evaluation Paul Braunschweiger, Ph.D. Professor, Radiation Oncology CITI Co-Founder Council of Graduate Schools – Graduate Education in a Global Context , 12-3-08

2. Disclaimer and Disclosures • Dan Vasgird Ph. D. UN-L. • CITI Developer Group • RCR working group. • 2006 CGS Grant to develop video vignettes (trigger cases) for RCR education. • 2007 Cases added to CITI RCR Program. • Disclaimer and Disclosure.

3. Talking Points • RCR education paradigms. • University of Nebraska – RCR videos • Application of RCR videos in the CITI Program. • Distribution of the RCR videos. • CITI Program. • Global Context. • Evaluation of the RCR video resources. • Learner Feedback • Resources

4. Integrity in The Research Enterprise • Starts with Institutional Commitment • Promoted and nurtured by the IRB, CoIC, IBC, IACUC, Sponsored Programs, Research Administrators. • Embraced by the investigators, staff and students as just: • “The right thing to do” "Integrity" by Canneto, Columbus, OH

5. Why Does Integrity and Professionalism Matter? • Risks to subjects, Risks to society. • Federal inquiry / intervention/ audit / suspensions. • Wasted resources $$$$ • Institutional embarrassment • Personal embarrassment • Loss of funding, Loss of livelihood • Legal actions, $$$$, Jail • Undermines the Public Trust • Research becomes politicized. • CoI and Pharmaceutical Industry • Justification and / or vindication for groups with anti-research agenda. (PETA, ALF)

6. The Foundations for Trust are Based in the Documentation of Ethical Behavior and Education.

7. Mandated Ethics Training • Human Subjects Protections. • Basic for investigators, staff and students. • GCP • IRB Professional • Lab Animal Welfare • Basics for Investigators, staff and students • IACUC Member • Model / species specific / procedure specific • HIPPA (Privacy and Security) • Investigators • Administrators • Biological Safety and Security • Basics for Investigators, staff and students • The Responsible Conduct of Research • Basics for investigators, staff and students • Administrators. • Grants and Contracts, Sponsored Programs • Grants management • Financial responsibility • CoI

8. Institutional Approaches Research Ethics Education • Bottom up Approach • Research Ethics is integrated in the academic and professional develop of students and fellows by the research faculty. • Top down Federal /institutional mandate. • Animal Welfare • Human Subjects Protection • HIPAA

9. Delivering the Message • 1:1 training • Effective, labor and time intensive, costly • Small group training • Effective, labor intensive, less time intensive, costly, • Subcontracted • Large group training, • less time intensive, Less effective, very costly, may not be convenient. • External consultants • Can be effective, very costly. • Web based training. • Convenient, effective, inexpensive, timely, assessment. • Provides knowledge base for advanced training. • Lacks direct interaction with instructor, most programs are very textual, problems with presentation, formatting, ISPs and the internet. ~15% would prefer something else. • Combined programmatic approach

10. Web based training Assuming a similar time commitment, would you prefer another vehicle for this mandated instruction? HSR Lab Animal Welfare RCR CITI Learner Satisfaction Survey results 1-1-08

11. Video Presentation Paradigms • Virtual Video Libraries • Reference Resource • UNL, SU, ORI, AAAS etc. • Optional exercises in a web based tutorial. • NIU • Query-Video Presentation-Query (QVQ) • UAB • 2-3 minute video clips of exemplars providing expert opinions on various aspects of the RCR. • Columbia University • Cases and videos embedded in the RCR foundation text. • CITI Program

12. University of Nebraska RCRvideo vignettes • CGS Funded Project • Grad. Faculty and Students • 3 topics of greatest interest. • Student actors • Primary target at UN-L about 100 grad students/year. • Live and online evaluations • http://www.unl.edu/gradstudies/facstaff/rcr/

13. http://www.unl.edu/gradstudies/facstaff/rcr/

14. Integration of the UN-L RCR Vids into the CITI RCR Courses.

15. CITI Program RCR Courses Biomedical Sciences Social & Behavioral Sciences Physical Sciences Arts & Humanities Administrators Supported by a resource development contract from DHHS / ORI

16. The Responsible Conduct of Research • Research Misconduct • Historical perspectives • Whistle Blowing • Data Acquisition and Management • Responsible Authorship • Responsible Peer Review • Mentoring • Conflicts of Interest • Responsible Collaborative Research • Human Subjects Protection • Lab Animal Welfare

17. RCR Program Paradigm Public Access, subscriber access Customized courses. Text, cases, videos and quizzes Helpdesk (305 243-7970) for students and trainers Completion Certificates Institution specific training materials easily incorporated to the curriculum. Training data storage and retrieval system Voluntary Learner Satisfaction Survey

18. Research Misconduct • Discipline Specific Title • Links • Introductory Video Scenarios • Exemplar video presentations • Imbedded Case Studies • Quiz

19. Who should take advantage of RCR education?I believe that it is very important that the entire research team and not just the PI, should have a clear understanding of the Responsible Conduct of Research / human subjects protections. RCR Learner Satisfaction Survey HSR Learner Satisfaction Survey 11%78% 7%84% CITI Learner Satisfaction Survey results 1-1-08

20. What is The CITI Program www.citiprogram.org • 8 web based courses: • Human subjects Protection • Basic courses – Biomedical • Basic course – SBR • Refresher Courses - Biomedical and SBR • Good Clinical Practice • Lab Animal Welfare • Health Information Privacy and Security • The RCR • 5 discipline specific course. • RCR for engineers. • RCR for the humanities.

21. CITI Support Staff

22. CITI Program Milestones 10-2000 • 10 Participating Institutions. 2006 • New SBR Course added. 2008 • ~950 Participating Institutions • ~22,000 Learners per month. 40-60% students • >337,000 Learners since 1-1-2008. • >960,000 Learners have completed a course since 9-1-2000. Global Context • International Initiatives • Multi-language Course Site. 11-2007 • Spanish • Portuguese • Chinese, Japanese, Russian, Mongolian, French, Thai

23. CITI Worldwide Footprint World wide n = 950 International n = 47sites / 35countries

24. Pan American Bioethics InitiativeCITI and U of M Ethics Programs • Fogarty International / NIH Funded R25 grant • P. Braunschweiger, K. Goodman and S. Litewka. • Research Ethics Education and Training Program development in Latin America, Brazil, and the Caribbean. • Decision markers, policy architects in government, academia and industry. • Charge to the Fellows: • Develop robust research ethics education program for their organization, implement, promote. • PABI Workshops, ethics committee capacity building, CITI Platform. • Fellows recruit and mentor peers.

25. Aristotle, this web based ethics education stuff is really cool, but, what are your measurables and deliverables. RCR Program Evaluation From: The School of Athens, Raphaelo. 1509

26. User Satisfaction SurveyProgram Evaluation • Voluntary, Anonymous. IRB Approved. • Topics addressed • Demographic Information. • Role, age, gender, country, language • Usability • Registration, navigation, quizzes, Internet, Presentation, Time • Knowledge base. • Confidence in the new knowledge base • Willingness to apply the new knowledge • Intent to promote the RCR • Overall rating • Other

27. Evaluation RCR Course Usage Case study usage Video vignette usage Learner feedback

28. RCR Course UsageCertificates Awarded *December 1, 2008

29. How Many Introductory Videos Did You Review

30. The 3 minute video case studies were:

31. The Introductory video case studies were helpful to frame the content before I started reading. % Responders, n=818

32. After completing the CITI RCR Course, I have a better understanding of the ethical issues central to the research enterprise so that I can conduct my work with the highest level of integrity. Strongly disagree Strongly agree

33. Now that I have completed the CITI RCR Course, I am more confident in my ability to advise a student or a colleague on an issue involving the Responsible Conduct of Research. 12% 66% Strongly disagree Strongly agree

34. Having completed the CITI Course in the Responsible Conduct of Research and gained a better understanding of how damaging research misconduct can be to students, to the institutions and to other investigators, I am now more likely to report a clear act of research misconduct to an appropriate person at my organization. Strongly disagree Strongly agree

35. New CITI RCR Videos Peer Reviewhttp://medweb02.med.miami.edu/CITIvideo/2peer.wmv Mentoringhttp://medweb02.med.miami.edu/CITIvideo/3mentor.wmv Data Managementhttp://medweb02.med.miami.edu/CITIvideo/4data.wmv Collaborative Researchhttp://medweb02.med.miami.edu/CITIvideo/1collab.wmv

36. Summary “New Integrity” by Artibella Avanti • The foundation of research integrity is research ethics education. • Early, often, multiple formats • Video • Evaluate your education programs. Are they working? How can you improve them? • Listen to the feedback from your learners.

37. Summary • Web based educational approaches to ethics education: • Can increase the ethics knowledge base of a wide audience. • Can prepare the learner for advanced instruction and debate. • Can provide the opportunity to customize the message to multiple audiences. • Should be a tool in a larger institutional RCR Program. • Web based education is not for everyone. Alternatives. • The Responsible Conduct of Research is beyond simply being compliant with Federal regulations and Institutional Policies; It is just the “right thing to do”.

38. RCR Video Resources

39. RCR Video ResourcesORI / DHHS www.ori/dhhs.gov • General • 17 Video Vignettes on Research Ethics and Academic Integrity. Syracuse University http://gradschpdprograms.syr.edu/resources/videos.php • Data acquisition and management • NIU, http://www.niu.edu/rcrportal/datamanagement/dmmain.html • CITI, www.citiprogram.org • AAAS http://www.aaas.org/spp/video/thevideos.htm • Conflicts of Interest • *Cleveland State University (flash) • UN-L http://www.unl.edu/gradstudies/facstaff/rcr/ • AAAS http://www.aaas.org/spp/video/thevideos.htm • Research Misconduct, Whistle Blowing • UN-L http://www.unl.edu/gradstudies/facstaff/rcr/ • UAB, http://www.uab.edu/researchintegrityandimages/default.html • CITI www.citiprogram.org • AAAS http://www.aaas.org/spp/video/thevideos.htm

40. RCR Video ResourcesORI / DHHS www.ori/dhhs.gov • Mentoring • UAB, http://www.uab.edu/researchintegrityandimages/default.html • CITI, www.citiprogram.org • NIU Flash simulation http://www.niu.edu/rcrportal/mentoring/overview/overview.html • Collaborative Research • CITI www.citiprogram.org • NIU (Flash) http://www.niu.edu/rcrportal/cfront.html • Authorship • UAB, http://www.uab.edu/researchintegrityandimages/default.html • UNL http://www.unl.edu/gradstudies/facstaff/rcr/ • CITI www.citiprogram.org • AAAS http://www.aaas.org/spp/video/thevideos.htm • Peer Review • CITI www.citiprogram.org

41. RCR Video ResourcesORI / DHHS www.ori/dhhs.gov • Lab Animal welfare • AALAS, *Wake Forest University, IACUC Inspection Virtual Walkthrough • OLAW. http://grants.nih.gov/grants/olaw/TrainingVideos.htm • Nonhuman Primates, Laboratory Dog, Survival Rodent Surgery, Basic Biomethodology for Laboratory Mice. • Human Subjects • HSRA - Protecting Human Subjects Training. • Children’s Hospital Boston, video • Case studies http://ori.hhs.gov/education/products/ucla/default.htm • Other • Journal editor’s tool http://www.uab.edu/researchintegrityandimages/default.html • The role of the RIO , Michigan State University http://ori.hhs.gov/rio/riovideo/ • RCREC http://rcrec.org/

42. RCR Web Resources Tutorials and courses

43. Human subjects research tutorials • PRIM&R - IRB 101/ 201 CD • Dunn and Chadwick Book • NIH/NCI – new version • CITI Program • Biomedical • Social and Behavioral

44. Good Clinical Practice • ACRP • SOCRA • GeneEd $$$/ learner • Infonetica GCP http://www.gcptraining.org.uk/ $$$$/learner • Multiple languages • Kaplan $$$$/learner • ClinfoSource https://www.clinfosource.com/index.asp $$$$$$ / learner • CITI $ /institution or organization

45. Lab Animal Welfare • AALAS, LAWTE • Basic courses investigators, staff, students • IACUC members • Species / model / procedure specific modules • OLAW , Webinars • IACUC Members • IACUC Coordinators • IO • CITI • Basic courses investigators, staff, students • IACUC members • Species / model / procedure specific modules

46. Health Insurance Portability and Accountability Act (HIPAA) • Investigator , Administrator • http://myhipaatraining.com/ • www.HRClassRoom.com/HIPAA • http://www.training-hipaa.net/ • Health Information Privacy and Security (HIPS) • CITI Program, www.citiprogram.org

47. The Responsible Conduct of Research • Biological Safety • Basics for Investigators, staff and students • UN Medical Center http://www.unmc.edu/dept/ibc/index.cfm?L1_ID=7&CONREF=11 • The Responsible Conduct of Research • Basics for investigators, staff and students. (ORI funded) • UC Davis http://ethics.ucsd.edu/courses/integrity/index.html • Columbia University http://ccnmtl.columbia.edu/projects/rcr/ • NIU http://www.niu.edu/rcrportal/ • University of Montana http://www.umt.edu/research/ethics/research_ethics.html • UNH http://www.unh.edu/rcr/index.html • Boston College http://www.bc.edu/research/rcradmin/ • ORI website http://ori.hhs.gov/ • CITI RCR Program www.citiprogram.org

48. Research AdministrationProfessional Societies • SRAI • Management & Operations • Research Integrity • Financial Management • Research Law • Sponsored Prog. Administration • Sponsors & Agencies Boston College / ORI – Administrators and the RCR www.CITIProgram.org • NCURA • Sponsored Programs • Grants management • Financial Administration • Contracts Management • Clinical trials management

50. CITI Program Resources. Responsible Conduct of Research. Public Access at www.citiprogram.org