Promoting Integrity In The Research Enterprise

1. Promoting Integrity In The Research Enterprise CITIand Paul Braunschweiger Ph.D. Professor of Radiation Oncology Co-Founder of the CITI-Program University of Miami, Miller School of Medicine pbraunsc@med.miami.edu

2. Talking Points • Integrity in The Research Enterprise • Research Education for Investigators, Staff and Students. • CITI Program • UM Requirements and Options • UM CITI Program Usage. • Learner acceptance of the CITI Program. • What’s Under Development?

3. 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.

4. Integrity in The Research Enterprise "Integrity Protecting the Works of Man." John Quincy Adams Ward, 1903  • Starts with Institutional Commitment • Promoted and nurtured by the IRB, IACUC, Sponsored Programs Research Administrators • Embraced by the investigators, staff and students as • “The right thing to do”

5. Integrity & Responsible Conduct of Research “Integrity” Fredric Terral 2007 • Accepted practices for the RCR can vary from discipline to discipline and even from laboratory to laboratory. • Shared values for the RCR that bind all researchers together: • Honesty - conveying information truthfully and honoring commitments. • Accuracy- reporting findings precisely and taking care to avoid errors. • Efficiency -using resources wisely and avoiding waste. • Objectivity - letting the facts speak for themselves and avoiding improper bias. • Compliance with regulatory requirements to document ethical behavior. • Integrity in the Research

6. Why Does Integrity Matter in Research? 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

7. The Public Trust • 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. • To preserve the Public’s Trust there must be: • Institutional Accountability. • Documentation of ethical research practices. • Federal Regulations (AWA; 45CFR46; OMB Circular A-21.) specifically require documentation of ethical behavior. • Regulatory requirements to document are designed to: • Help investigators conduct research responsibly and toPreserve the Public Trust in research.

8. Aristotle, You are my brightest student. You will go far and do great things. Just remember, preserving the Public Trust is everyone’s responsibility. Plato and Aristotle From: The School of Athens, Raphael. 1509

9. The Ethical Foundations for Trust are Based in Education.

10. June 2000 DHHS Mandates Training in Human Subjects Protection A. TERMS OF THE FEDERALWIDE ASSURANCE (FWA) FOR INSTITUTIONS WITHIN THE UNITED STATES. Announced Dec. 2000; implemented, 2005 • 12. Educational Training • OHRP strongly recommends that the Institution and the designated IRB(s) establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, the following: relevant ethical principles; relevant federal regulations; written IRB procedures; OHRP guidance; other applicable guidance, state and local laws; and institutional policies for the protection of human subjects. Furthermore, OHRP recommends that a) IRB members and staff complete relevant educational training before reviewing human subjects research; and b) research investigators complete appropriate institutional educational training before conducting human subjects research.

11. Request for Information and Comments on the Implementation of Human Subjects Training and Education Programs (Federal Register Notice dated July 1, 2008) • Regulation or Guidance • What kinds of training programs are being used? • Do all institutions need training programs? • Who should be required to have training? • Content? • How often? • Has failure to institute a rigorous training program resulted in non-compliance. • One size fits all or customized training according to type of research and role? • Assessment of understanding of research ethics?

12. Plato, You are a great mentor. I’ve learned so much, but, there are so many others here that can benefit from your teaching. Research Ethics Instruction From: The School of Athens, Raphael. 1509

13. Who needs research ethics education? • Ethics is an applied art. Knowledge base and understanding of basic ethical concepts. • Skill in ethical decision making requires instruction and practice. • Ho - Ethics education must reach all members of the research team to be effective. • Ho - Without good team ethical decision making skills, the INTEGRITY of the research enterprise is at risk. • Ho – Educational opportunities should be applied early, often and in multiple formats.

14. 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 effective, very costly, less time intensive, may not be convenient. • External consultants • Can be effective, very costly. • Web based training. • Effective, inexpensive, convenient, timely, assessments. • 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

15. What is The CITI Program www.citiprogram.org • Web based bioethics education program designed to promote the responsible conduct of research. • June 2000 to meet the Federal education mandate. • Braunschweiger P G and Goodman K. The CITI Program: An International Online Resource for Education in Human Subjects Protection and the Responsible Conduct of Research. Academic Medicine Vol. 82 , 2007 • Litewka S, Goodman K, Braunschweiger P. The CITI Program: An Alternative for the Education on Research Ethics in Latin America. ActaBioethica, 2008; 14(1) 54-60. • 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 (HIPS) • RCR • 5 discipline specific course.

16. CITI – Program8-2008 Participating Institutions and Organizations (~960) CITI Developer Group (~60) 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

17. CITI Program Milestones • 10 Participating Institutions in 2000. • CITI - Collaborative IRB Training Initiative • New Courses added 2006. • ~ 960 Participating Institutions in 2008. • CITI - Collaborative Institutional Training Initiative • ~ 22,000 Learners per month. 40- 6 0% students • >240,000 Learners since 1-1-2008. • >979,00 Learners have completed a course since 9-1-2000. • International Initiatives • CITI - Collaborative International Training Initiative • Multi-language Course Site. 11-2007 • Spanish • Portuguese • Chinese, Japanese, Russian, Mongolian, French, Thai

18. CITI Worldwide Footprint World wide n = 960 International n = 45sites / 34 countries

19. Multilanguage Course Site

20. Informed Consent In International Research

21. CITI Requirements. • Biomedical HSR CourseRequired for all personnel involved primarily in biomedical research; and for all personnel performing both biomedical and social/behavioral research • Drug and devices • Non drug or device biomedical • Data and specimens only • Social and Behavioral HSR Course Required for all personnel involved primarily in social and behavioral research. • IRB Chairs, Members, Coordinators and staff • VA • Refresher Course q 2 years

22. Other courses Good Clinical Practice HIPS Responsible Conduct of Research Lab Animal Welfare

23. CITI Course Usage by University of Miami Investigators and Staff in 2007 and 2008

24. RCR Program Evaluation“Learning From The Learners” Voluntary User Satisfaction Survey Reviewed and approved by the UM IRB

25. User Satisfaction SurveyProgram Evaluation www.citiprogram.org Announcements and FAQ • Voluntary, Anonymous. IRB Approved. • Topics addressed • Demographic Information. • Role, age, gender, country, language • Usability • Registration, navigation, Time • Opinions. • Quizzes, internet, presentation, web based education • New Knowledge base • Confidence in the new knowledge base. • Willingness to apply the new knowledge • Intent to promote ethical behavior • Overall rating • Other issues as they arise

26. 50% 40% 30% 20% 10% 0% 1 2 3 4 5 6 7 8 9 10 TOTALLY UNNECESSARY ABSOLUTELY VITAL On a scale of 1 - 10, how necessary is the requirement that all key personnel engaged in human subjects research must participate in a human subjects protection educational program? 4% 85% % of the Responders; n = 6559 CITI Program Satisfaction Survey, 2005

27. 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

28. 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

29. Value to the Learner I believe that the course I just completed will help me do better science. 13% 62% Strongly Disagree Strongly Agree

30. Implementation of knowledge base 10%67% Strongly Disagree Strongly Agree

31. Intent to actively promote HSR Protections Now that I have completed this instruction in the protection of human research subjects, I intend to take a more active role in assuring that the research at my institution is conducted to the highest ethical standards. I intend to go to more seminars on human subjects issues, pursue professional certification (e.g., CIP), join an IRB / Research Ethics Committee or join a Data Safety Monitoring Board (DSMB) or take a course in Good Clinical Practice? 23% 44% Strongly Disagree Strongly Agree

32. 2yr follow-up on Intent to actively promote HSR Protections 62% 38% / 44%

33. If you gave the course a low rating (4 or less), we are concerned. Please tell us the one single issue that most influenced your opinion. (~6%)

34. “An Experiment on a Bird in The Air Pump “ by Joseph Wright (1734-1797) British National Gallery- London

35. Summary “New Integrity” by Artibella Avanti • The foundation of research integrity is education. • Early, often, multiple formats • Evaluate your education programs. Are they working? How can you improve them? • Listen to the feedback from your learners. • Promoting Integrity is everyone’s responsibility. • Protect subjects. • Leads to good science. • Compliance with Regulations and Policies • Protect the Public Trust

36. Summary “Integrity” by Joris Plu 2005 • Without thePublic Trust • Public apathy • Research enterprise becomes politicized. • Increased regulation. • Research funding may suffer. • Limits on the types of research conducted. • Without research the Public’s “Well Being” is at risk.

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

38. Promoting Integrity In The Research Enterprise CITIand (the) Paul Braunschweiger Ph.D. Professor of Radiation Oncology Co-Founder of the CITI-Program University of Miami, Miller School of Medicine pbraunsc@med.miami.edu