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

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

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

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

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

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

7. Scientists are not in the business of deception Professionalism in science requires.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. “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? –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.

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

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

10. CITI – Program 4-2010 CITI Administration – Office of Research Education, University of Miami Participating Institutions and Organizations (~1310) CITI Developer Group (~70) CITI Editorial Board (15) Intl. GCP RCR CITI Executive Advisory Committee HSRP Founders L.A.W. HIPS www.citiprogram.orgBiosafety

11. What is The CITI Program www.citiprogram.org www.citiprogram.org CITI Program is subscription basedCITI 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 ethicsCourses in all areas of research ethics Subscriber ProfileSubscriber Profile –Universities, colleges, medical centers, community hospitals, societies, government, commercial IRBs, industry.

12. How do Institutions use CITI Program Basic Research Ethics TrainingBasic Research Ethics Training –Ethics Committee Members, Investigators, Staff, Administrators, and Students. Refresher or recertificationRefresher or recertification Institution specific featuresInstitution specific features –Institutions can set their own curriculum. Curriculum can be set for a specific role in research or interests.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 CoursesModular Courses –Protection of Human Subjects. –Good Clinical Practice. –Health Information Privacy and Security. –Laboratory Animal Welfare –Responsible Conduct of Research. –Biosafety Disciplines.Disciplines. Institutions design their own curriculumInstitutions design their own curriculum Institutions can add their own content.Institutions can add their own content.

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

15. Special Topics WABTP Clement Adebamowo Ph.D. Special Topics WABTP Clement Adebamowo Ph.D.

16. CITI International Initiatives

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

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

19. Multilanguage Course Site Multi-language Course Site Updated in 2009 Languages.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.CITI Program offers a searchable FAQ utility. Users can submit Queries from the knowledgebase pageUsers can submit Queries from the knowledgebase page Topics cover many topics navigation to information for CITI administrators.Topics cover many topics navigation to information for CITI administrators. More than 150 users/month visited the pageMore 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=engli shIt 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=engli sh http://citiprogram.supportcenterpro.com/knowledgebase https://www.citiprogram.org/contactus.asp?language=engli sh http://citiprogram.supportcenterpro.com/knowledgebase https://www.citiprogram.org/contactus.asp?language=engli sh

23. Helpdesk Chat Implemented April 2010Implemented April 2010 Well receivedWell received Average of 20 sections per weekAverage of 20 sections per week Chat utility permits quick answers to questionsChat utility permits quick answers to questions Only CITI Program during business hours.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?langu age=englishIt 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?langu age=english http://citiprogram.supportcenterpro.com/liveagent/ chat/ https://www.citiprogram.org/contactus.asp?langu age=english http://citiprogram.supportcenterpro.com/liveagent/ chat/ https://www.citiprogram.org/contactus.asp?langu age=english

24. Webinars How to get the most from the CITI Program New and experienced CITI institutional administratorsNew and experienced CITI institutional administrators Administrators of any participating institutions can take advantage of these training sessions.Administrators of any participating institutions can take advantage of these training sessions. Since December 2009Since 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/knowledge base/citi-administrators/.citi-administrator- webinars.htmlInformation of how to enroll can be found at: http://citiprogram.supportcenterpro.com/knowledge base/citi-administrators/.citi-administrator- webinars.html http://citiprogram.supportcenterpro.com/knowledge base/citi-administrators/.citi-administrator- webinars.html http://citiprogram.supportcenterpro.com/knowledge base/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 Strongly disagree strongly agree % of The Responders

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 Strongly disagree strongly agree % of The Responders

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. Strongly disagree strongly agree % of The Responders

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

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 Requirements Section 7009 of the America COMPETES Act. RCR Training for NSF post docs and students. 1-1-10RCR Training for NSF post docs and students. 1-1-10 –NSF No specific standards, No specific content.No specific standards, No specific content. Will not dictate pedagogical approach.Will not dictate pedagogical approach. Must document.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.”“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 GrantsTraining 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.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 Supported by a contract from DHHS / ORI Science Administrators Engineering

34. The Responsible Conduct of Research Public Access vs. Subscriber accessPublic Access vs. Subscriber access TopicsTopics –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.Customized courses. Text, cases, videos and quizzesText, cases, videos and quizzes

35. CITI RCR Courses. CITI RCR COURSESCITI 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.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.orgPublic access availability at the CITI Program Home Page www.citiprogram.org www.citiprogram.org

36. Content Format Publication Practices and Responsible Authorship Introductory video cases - 10Introductory video cases - 10 –10, 3 minute video cases. –3 new “introductory” video case studies for the SBR investigators and students. MisconductMisconduct Data AcquisitionData Acquisition Conflicts of InterestConflicts of Interest

37. Embedded Case Studies

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

39. Bio-Safety and Bio-Security Module #Module Title 1Overview 2Lab Associated Infections 3Risk Assessment 4Medical Surveillance 5Risk Management – Work Practices 6Risk Management – Personal Protective Equipment 7Risk Management – Engineering Controls 8Risk Management – Lab Design Module #Module Title 9Risk Management - Emergency Procedures 10OSHA Blood-borne Pathogens 11NIH Recombinant DNA Guidelines 12Human Gene Transfer 13Select Agents, Biological Security, and Bioterrorism 14Shipping and Transport of Regulated Bio-Materials 15Animal Biosafety 16Nanotechnology and Safe Practices

40. Summary The active promotion of integrity in the research enterprise is essential to maintain the Public’s Trust.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.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.Programmatic approach to ethics education is highly desirable. “Integrity” by Joris Plu 2005

41. Summary Promoting Integrity is everyone’s responsibility.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.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 1History and Ethical Principles 2Basic Institutional Review Board (IRB) Regulations and Review Process 3Informed Consent 4Social and Behavioral Research for Biomedical Researchers 5Records-Based Research 6Genetic Research in Human Populations 7Research With Protected Populations - Vulnerable Subjects: An Overview 8Vulnerable Subjects - Research with Prisoners 9Vulnerable Subjects - Research Involving Minors 10Vulnerable Subjects - Research Involving Pregnant Women and Fetuses in Utero 11Group Harms: Research With Culturally or Medically Vulnerable Groups 12FDA-Regulated Research 13International Research 14Human Subjects Research at the VA 15HIPAA and Human Subjects Research 16Workers as Research Subjects-A Vulnerable Population 17Hot Topics 18Conflicts of Interest in Research Involving Human Subjects 19Stem Cell Research Oversight Other Modules IRB Administrator You want to be an IRB Community Member, Now what?

45. SBR Modules 1History and Ethical Principles - SBR 2Defining Research with Human Subjects - SBR 3The Regulations and The Social and Behavioral Sciences - SBR 4Assessing Risk in Social and Behavioral Sciences - SBR 5Informed Consent - SBR 6Privacy and Confidentiality - SBR 7Research with Prisoners - SBR 8Research with Children - SBR 9Research in Public Elementary and Secondary Schools - SBR 10International Research - SBR 11Internet Research - SBR 12Students in Research - SBR

46. CITI HIPS Course Health, Information, Privacy and Security (HIPS) Privacy Rules: Introduction to Federal and State Requirements Privacy Rules: Clinicians Privacy Rules: Clinical Investigators Privacy Rules: Students and Instructors Privacy Rules: Fundraisers Privacy Rules: Marketers Security Rules: Basics of Being Secure, Part 1 Security Rules: Basics of Being Secure, Part 2 Security Rules: Protecting your Computer Security Rules: Picking and Protecting Passwords Security Rules: Protecting your Portables Security Rules: Protecting your identity Security Rules: Safer Email-ing and IM-ing, Part 1 Security Rules: Safer Email-ing and IM-ing, Part 2 Security Rules: Safer Web Surfing Security Rules: Introduction to Federal and State Requirements Security Rules: Issues for Work/Workers Off-Site Completing the CITI Privacy & Security Course

47. CITI HIPS Course Health, Information, Privacy and Security (HIPS) Privacy Rules: Introduction to Federal and State Requirements Privacy Rules: Clinicians Privacy Rules: Clinical Investigators Privacy Rules: Students and Instructors Privacy Rules: Fundraisers Privacy Rules: Marketers Security Rules: Basics of Being Secure, Part 1 Security Rules: Basics of Being Secure, Part 2 Security Rules: Protecting your Computer Security Rules: Picking and Protecting Passwords Security Rules: Protecting your Portables Security Rules: Protecting your identity Security Rules: Safer Email-ing and IM-ing, Part 1 Security Rules: Safer Email-ing and IM-ing, Part 2 Security Rules: Safer Web Surfing Security Rules: Introduction to Federal and State Requirements Security Rules: Issues for Work/Workers Off-Site Completing the CITI Privacy & Security Course