Promoting Integrity in Your Human Subjects Research Program

1. Promoting Integrity in Your Human Subjects Research Program CITI Program Research Ethics Education Paul Braunschweiger Ph.D. Professor, Radiation Oncology U.M. Ethics Programs CITI Program Co-Founder. University of Miami

2. Integrity "Integrity" by Canneto, Columbus, OH A personal and steadfast commitment to a set of moral or ethical standards defined by your religion, community or professional discipline.

3. Why Does Integrity Matter in Research?The Lack of Integrity Puts subjects at risk. Injures careers Wastes Resources Wastes Time Undermines the Public Trust.

4. The Public Trust • To preserve the Public’s Trust there must be: • Accountability. • Documentation of ethical conduct. • US Federal Regulations (45CFR46) specifically require documentation of ethical behavior. • Regulatory requirements to document ethical behavior are designed to: • Help investigators conduct research responsibly and to • Preserve the Public’s Trust in biomedical research. The “Public” supports most of the research in the US. Sponsored research is a privilege and not an entitlement. Society Trusts investigators to conduct research ethically and responsibly. Violation of the public’s trust, brings Regulation.

5. Integrity in the research enterprise "Integrity Protecting the Works of Man." John Quincy Adams Ward, 1903  • Starts with institutional commitment to culture of compliance. • Promoted and nurtured by the IRB, DSMB, IBC, IACUC, CoIC. • Embraced by the investigators, staff and students as • “The right thing to do”

6. Deceit and Professionalism • Situations where deception is pervasive. • Political discourse • Commercial advertizing – buyer beware!!!! • Personal relationships • Professions where deceit is overlooked or even encouraged. • Sports • Entertainment • Magician • Illusions • Music digitally altered sound tracks • Art – Photo-shopped images

7. Scientists are not in the business of deception • Professionalism in science requires. • Honesty - conveying information truthfully and honoring commitments. • Accuracy- reporting findings precisely and taking care to avoid errors. • Objectivity - letting the facts speak for themselves and avoiding improper bias and hyperbole. • Providing appropriate credit to others. • Compliance with regulatory requirements to document ethical behavior. • Plato would argue, idealistically, that such responsibility comes from within, by introspection and reflection. • Aristotle would be more realistic and argue that ethical behavior must be learned by through observation, interaction, practice and reflection. “Integrity” Fredric Terral 2007 So, embedded in a culture of deception and dishonest discourse, how do scientists, students and staff learn to pursue and administer science in a responsible and ethical fashion?

8. Promoting Integrity in The Clinical Research Enterprise • Teaching the Responsible Conduct of Research. • Books, Journal articles • Mentoring • Classroom experience • Seminars and conferences • Professional Societies • Web based courses and tutorials.

9. CITI Program is a web based bioethics education program designed to promote the responsible conduct of research. March-2000 CITI Program Founders Karen Hansen, Fred Hutchinson Cancer Research Center, Seattle, WA., USA Paul Braunschweiger Ph.D. University of Miami Miami, Fl. USA www.citiprogram.org

10. CITI – Program4-2010 Participating Institutions and Organizations (~1310) CITI Developer Group (~70) Biosafety 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

11. What is The CITI Program www.citiprogram.org • CITI Program is subscription based • >1311 participants from around the world • ~35,000 new learners per month complete a CITI Course • >1.5 million people since 9-1-00 • ~470,000 new learners since 4-1-09 • Courses in all areas of research ethics • Subscriber Profile • Universities, colleges, medical centers, community hospitals, societies, government, commercial IRBs, industry.

12. How do Institutions use CITI Program • Basic Research Ethics Training • Ethics Committee Members, Investigators, Staff, Administrators, and Students. • Refresher or recertification • Institution specific features • Institutions can set their own curriculum. • Curriculum can be set for a specific role in research or interests. • Institutions establish expectations and set the bar. • Institution specific materials.

13. The CITI Program Courses • Modular Courses • Protection of Human Subjects. • Good Clinical Practice. • Health Information Privacy and Security. • Laboratory Animal Welfare • Responsible Conduct of Research. • Biosafety • Disciplines. • Institutions design their own curriculum • Institutions can add their own content.

14. Institutional Modules Developed by organizations specifically for their research community.

15. Special Topics WABTPClement Adebamowo Ph.D.

16. CITI International Initiatives

17. CITI International Initiatives World wide n > 1311 +20/month International n >65sites / 39 countries

18. Multilanguage Course Site www.citiprogram.org English Spanish Portuguese French Russian Thai Chinese Japanese

19. Multilanguage Course Site Multi-language Course Site Updated in 2009 • Languages. • English • Spanish (NIAID, FIC) • Portuguese (NIAID, FIC) • Chinese • Japanese • French (NIAID) • Thai (US Army) • Russian (US Army, NIAID) • Korean • Kartuli (FIC) • Arabic

21. New Utilities of Institutional Coordinators

22. CITI Knowledge Base CITI Program offers a searchable FAQ utility. Users can submit Queries from the knowledgebase page Topics cover many topics navigation to information for CITI administrators. More than 150 users/month visited the page It can be accessed directly: http://citiprogram.supportcenterpro.com/knowledgebase or in the CITI site from the contact us page: https://www.citiprogram.org/contactus.asp?language=english

23. Helpdesk Chat Implemented April 2010 Well received Average of 20 sections per week Chat utility permits quick answers to questions Only CITI Program during business hours. It can be accessed directly: http://citiprogram.supportcenterpro.com/liveagent/chat/ or in the CITI site from the contact us page: https://www.citiprogram.org/contactus.asp?language=english

24. Webinars How to get the most from the CITI Program • New and experienced CITI institutional administrators • Administrators of any participating institutions can take advantage of these training sessions. • Since December 2009 • Total of 55 sections with 725 participants were conducted • High level of satisfaction with the CITI webinars. • Information of how to enroll can be found at: http://citiprogram.supportcenterpro.com/knowledgebase/citi-administrators/.citi-administrator-webinars.html

25. Learner feedback CITI Satisfaction Survey

26. Human subjects research is crucial for finding cures for debilitating diseases, the prevention of deadly pandemics and providing a better understanding of who we are and why we do the things we do.September 2009, n= 14,956 % of The Responders Strongly disagree strongly agree

27. Now that I have completed the course, I am more confident in my ability to advise a student or a colleague on an issue of human subjects protection and the ethical conduct of human subjects research.September 2009 , n=13,716 % of The Responders Strongly disagree strongly agree

28. Looking back, I believe that the CITI Basic course, I completed previously, provided me with the ethical foundation to conduct my human subjects research to the highest ethical standards?Median time from completing the basic course = 2 yrs. % of The Responders Strongly disagree strongly agree

29. Looking back, since completing the Basic Course I am more likely to have the confidence to engage in a discussion of human subjects protection or the ethical conduct of human subjects research with students and colleagues.Median time since completion of the basic course is 2 yrs. Basic Course Refresher Course strongly disagree strongly agree strongly disagree strongly agree

30. Responsible Conduct of Research NIH, NSF requirements Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Notices http://edocket.access.gpo.gov/2009/pdf/E9-19930.pdf

31. NSF RequirementsSection 7009 of the America COMPETES Act. • RCR Training for NSF post docs and students. 1-1-10 • NSF • No specific standards, No specific content. • Will not dictate pedagogical approach. • Must document. • “Therefore, it is the responsibility of each institution to determine both the content and the delivery method for the training that will meet the institution’s particular needs for RCR training in all areas at that institution for which NSF provides support.”

32. NIH Requirements • Training Grants • Who needs training • Topics to be included. • How instruction should be delivered. • How often. • When training should be applied. • Grant review process. • National Institutes of Health (NIH), NOT-OD-10-019, issued November 24, 2009.

33. CITI RCR Course Biomedical Sciences Social & Behavioral Sciences* Physical Sciences Arts & Humanities Engineering Science Administrators Supported by a contract from DHHS / ORI

34. The Responsible Conduct of Research • Public Access vs. Subscriber access • Topics • 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, videos and quizzes

35. CITI RCR Courses. • CITI RCR COURSES • Cover the 9 topic areas as indicated by ORI and NSF. • Text, cases, video cases, quizzes. • Discipline specific. • Can be customized according to the needs of institution, investigator or student. • Best used as an Introduction to RCR in a programmatic approach to RCR education. • Public access availability at the CITI Program Home Page www.citiprogram.org

36. Content FormatPublication Practices and Responsible Authorship • Introductory video cases - 10 • 10, 3 minute video cases. • 3 new “introductory” video case studies for the SBR investigators and students. • Misconduct • Data Acquisition • Conflicts of Interest

37. Embedded Case Studies

38. CITI Collaborative Institutional Training Initiative Other new projects Course in Bio-safety and Bio-security

39. Bio-Safety and Bio-Security

40. Summary • The active promotion of integrity in the research enterprise is essential to maintain the Public’s Trust. • Without the Public Trust there can be now research • Research ethics education for the all members of the research team is essential to promote integrity in the research enterprise. • Programmatic approach to ethics education is highly desirable. “Integrity” by Joris Plu 2005

41. Summary • Promoting Integrity is everyone’s responsibility. • Protection of Human subjects. • Leads to good science. • Compliance with all federal regulations • Protect the Publics trust • The Responsible Conduct of Research is beyond simply being compliant with Federal regulations. It is just The “right thing to do”. “New Integrity” by Artibella Avanti

42. In Summary Absent: Richard Sprince, Lucas Canning, Rachel Chueng,

44. Biomedical Modules

45. SBR Modules

46. CITI HIPS Course

47. CITI HIPS Course