Promoting Integrity In The Research Enterprise CITI and 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

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?

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

Integrity in The Research Enterprise "Integrity Protecting the Works of Man." John Quincy Adams Ward, 1903  Integrity in The Research Enterprise 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” The central figure represents Integrity; flanking Integrity are figures  representing the sources of wealth and the means of invention.

Integrity & Responsible Conduct of Research 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 “Integrity” Fredric Terral 2007

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

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 to Preserve the Public Trust in research.

From: The School of Athens, Raphael. 1509 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

The Ethical Foundations for Trust are Based in Education.

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.

Regulation or Guidance 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?

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

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.

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

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. Acta Bioethica, 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.

Participating Institutions and Organizations (~960) CITI – Program 8-2008 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

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

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

Multilanguage Course Site

Informed Consent In International Research

CITI Requirements. Biomedical HSR Course Required 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

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

CITI Course Usage by University of Miami Investigators and Staff in 2007 and 2008   2008 2007 2 YR Totals Basic HSR Group 1 824 139 963 Group 2 393 142 535 Group 3 223 76 299 Group 4 760 254 1014 Group 5 52 27 79 Students 288 210 498 subtotal 2540 848 3388 Refresher Biomed 173 57 230 SBR 115 62 177 Informed Consent 283 128 411 571 247 818 1142 494 1636 GCP GCP Course 201 207 408 HIPS HIPS Course 403 126 529 Totals  4286 1675 5961

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

User Satisfaction Survey Program Evaluation 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 www.citiprogram.org Announcements and FAQ

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? 0% 10% 20% 30% 40% 50% 1 2 3 4 5 6 7 8 9 10 TOTALLY UNNECESSARY ABSOLUTELY VITAL 4% 85% % of the Responders; n = 6559 CITI Program Satisfaction Survey, 2005

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 7% 84% 11% 78% CITI Learner Satisfaction Survey results 1-1-08

Web based training HSR Lab Animal Welfare RCR 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

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

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

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

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

If you gave the course a low rating (4 or less), we are concerned 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%) Reading the content on the computer screen was very tedious or difficult for me. 33% The quiz questions are not well constructed. 24% I believe that this web based approach is NOT a good way to provide research ethics education. 12% I don't think this material is applicable to me. This has been a waste of my time. 11% The content is poorly written. 9% I have been an independently funded investigator for many years. This has been a waste of my time. 7% The software was too difficult for me to use. 4%

British National Gallery- London 1768 An experiment on the bird and the air pump, by Joseph Wright. The Artist subject is not the invention of the vacume pump. But,vhuman drama of watching a bird die a slow and perhaps painful death. The traveling scientist entertaining his patrons The bird will die is the experiment continues Interested youth Fearful children The young lovers interested only in themselves The philosopher deep in thought “An Experiment on a Bird in The Air Pump “ by Joseph Wright (1734-1797) British National Gallery- London

Summary 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 “New Integrity” by Artibella Avanti

Summary Without the Public 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. “Integrity” by Joris Plu 2005

It is just The “right thing to do”. 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”.

Promoting Integrity In The Research Enterprise CITI and (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