Promoting Integrity in Your Human Subjects Research Program

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

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

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

The Public Trust • • The “Public” supports most of. Trust the research in the To preserve the Public’s there must US. be: • Sponsored research is a privilege and not an – Accountability. entitlement. – Documentation of ethical conduct. • Society to conduct research • USTrusts Federalinvestigators Regulations (45 CFR 46) specifically ethically anddocumentation responsibly. of ethical behavior. require • Violation of the public’s trust, brings Regulation. • Regulatory requirements to document ethical behavior are designed to: – Help investigators conduct research responsibly and to – Preserve the Public’s Trust in biomedical research.

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

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

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

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.

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

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

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.

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.

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.

Institutional Modules Developed by organizations specifically for their research community.

Special Topics WABTP Clement Adebamowo Ph. D.

CITI International Initiatives

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

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

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

New Utilities of Institutional Coordinators

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=engli sh

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? langu age=english

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/knowledge base/citi-administrators/. citi-administratorwebinars. html

Learner feedback CITI Satisfaction Survey

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 60% 50% % of The Responders 50% 40% 30% 20% 17% 10% 0% 7% 0% 0% 0% 1 2 3 Strongly disagree 19% 6% 1% 4 5 6 7 8 9 strongly agree

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 30% 27% % of The Responders 25% 20% 14% 15% 21% 15% 10% 5% 2% 2% 1 2 3% 4% 3 4 0% Strongly disagree 5 6 7 8 9 strongly agree

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 25% 23% 20% 19% 18% 7 8 17% 15% 11% 10% 5% 3% 3% 4% 3 4 2% 0% 1 2 Strongly disagree 5 6 9 strongly agree

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. 25% 20% 22% Refresher Course 19% 21% 20% 12% 14% 15% 10% 5% 2% 2% 3% 27% Basic Course 25% 15% 30% 10% 3% 5% 2% 0% 2% 3% 4% 2 3 4 0% 1 2 3 strongly disagree 4 5 6 7 8 9 strongly agree 1 strongly disagree 5 6 7 8 9 strongly agree

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/E 9 -19930. pdf

NSF Requirements Section 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. ”

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), NOTOD-10 -019, issued November 24, 2009.

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

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

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

Content Format Publication 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

Embedded Case Studies

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

Bio-Safety and Bio-Security Module # 19 10 2 11 3 12 4 13 5 14 6 15 7 16 8 Module Title Risk Management - Emergency Procedures Overview OSHA Blood-borne Pathogens Lab Associated Infections NIH Recombinant Risk Assessment DNA Guidelines Human Gene Transfer Medical Surveillance Select Agents, Biological and Bioterrorism Risk Management – Work. Security, Practices Shipping and Transport of Regulated Bio-Materials Risk Management – Personal Protective Equipment Animal Biosafety – Engineering Controls Risk Management Nanotechnology Safe Practices Risk Managementand – Lab Design

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

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

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

Biomedical Modules Group Harms: Research With Culturally or Medically Vulnerable Groups 111 History and Ethical Principles FDA-Regulated Research 212 Basic Institutional Review Board (IRB) Regulations and Review Process International Research 313 Informed Consent Human Subjects Research at the 414 Social and Behavioral Research for. VA Biomedical Researchers HIPAA and Human Subjects Research 515 Records-Based Research Workers. Research as Research Subjects-A Vulnerable Population 616 Genetic in Human Populations Hot Topics 717 Research With Protected Populations - Vulnerable Subjects: An Overview Conflicts of. Subjects Interest-in. Researchwith Involving Human Subjects 818 Vulnerable Prisoners Stem Cell Research 919 Vulnerable Subjects -Oversight Research Involving Minors Modules 10 Vulnerable Subjects - Research. Other Involving Pregnant Women and Fetuses in Utero IRB Administrator You want to be an IRB Community Member, Now what?

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

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