Promoting Integrity in Your Human Promoting Integrity in Your Human Subjects Research Program Subjects Research Program

Paul Braunschweiger Ph.D.Paul Braunschweiger Ph.D.Professor, Radiation OncologyProfessor, Radiation Oncology

U.M. Ethics Programs U.M. Ethics Programs CITI Program Co-Founder.CITI Program Co-Founder.

University of MiamiUniversity of Miami

CITI Program Research Ethics EducationCITI Program Research Ethics Education

IntegrityIntegrity

A personal and steadfast commitment A personal and steadfast commitment to a set of moral or ethical standards to a set of moral or ethical standards defined by your religion, community or defined by your religion, community or professional discipline. professional discipline.

"Integrity" by Canneto, Columbus, OH "Integrity" by Canneto, Columbus, OH

Why Does Integrity Matter in Why Does Integrity Matter in Research?Research?

The Lack of IntegrityThe 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.

The Public TrustThe Public Trust

• The The “Public”“Public” supports most of the research in the supports most of the research in the US. US.

• Sponsored research is a privilege and not an Sponsored research is a privilege and not an entitlement. entitlement.

• Society Society TrustsTrusts investigators to conduct research investigators to conduct research ethically and responsibly.ethically and responsibly.

• Violation of the public’s trust, brings Violation of the public’s trust, brings RegulationRegulation..

• To preserve the To preserve the Public’s TrustPublic’s Trust there must there must be:be:– Accountability.Accountability.– Documentation of ethical conduct.Documentation of ethical conduct.

• US Federal Regulations (45CFR46) specifically US Federal Regulations (45CFR46) specifically require documentation of ethical behavior. require documentation of ethical behavior.

• Regulatory requirements to document Regulatory requirements to document ethical behavior are designed to:ethical behavior are designed to: – Help investigators conduct research Help investigators conduct research

responsibly and to responsibly and to – Preserve the Preserve the Public’s TrustPublic’s Trust in biomedical in biomedical

research. research.

Integrity in the research enterpriseIntegrity 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 as Embraced by the investigators, staff and students as

““The right thing to do”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 

Deceit and Professionalism Deceit and Professionalism

• Professions where deceit is overlooked or Professions where deceit is overlooked or even encouraged.even encouraged. – SportsSports– EntertainmentEntertainment

• MagicianMagician• IllusionsIllusions

– Music digitally altered sound tracks Music digitally altered sound tracks – Art – Photo-shopped imagesArt – Photo-shopped images

• Situations where deception is pervasive.Situations where deception is pervasive.– Political discoursePolitical discourse– Commercial advertizing – buyer beware!!!!Commercial advertizing – buyer beware!!!!– Personal relationshipsPersonal relationships

Scientists are not in the business of Scientists are not in the business of deceptiondeception

• Professionalism in science requires. Professionalism in science requires. – HonestyHonesty - conveying information truthfully - conveying information truthfully

and honoring commitments. and honoring commitments. – AccuracyAccuracy- reporting findings precisely and - reporting findings precisely and

taking care to avoid errors. taking care to avoid errors. – ObjectivityObjectivity - letting the facts speak for - letting the facts speak for

themselves and avoiding improper bias and themselves and avoiding improper bias and hyperbole.hyperbole.

– Providing appropriate credit Providing appropriate credit to others.to others.– Compliance Compliance with regulatory requirements to with regulatory requirements to

document ethical behavior. document ethical behavior. ““IntegrityIntegrity” Fredric Terral 2007” Fredric Terral 2007

So, embedded in a culture of deception and dishonest So, embedded in a culture of deception and dishonest discourse, how do scientists, students and staff learn discourse, how do scientists, students and staff learn to pursue and administer science in a responsible and to pursue and administer science in a responsible and ethical fashion? ethical fashion?

– Plato would argue, idealistically, that such Plato would argue, idealistically, that such responsibility comes from within, by responsibility comes from within, by introspection and reflection.introspection and reflection.

– Aristotle would be more realistic and Aristotle would be more realistic and argue that ethical behavior must be argue that ethical behavior must be learned by through observation, learned by through observation, interaction, practice and reflection.interaction, practice and reflection.

Promoting Integrity in The Clinical Promoting Integrity in The Clinical Research EnterpriseResearch Enterprise

• Teaching the Responsible Conduct Teaching the Responsible Conduct of Research.of Research.– Books, Journal articlesBooks, Journal articles– MentoringMentoring– Classroom experienceClassroom experience– Seminars and conferencesSeminars and conferences

• Professional SocietiesProfessional Societies

– Web based courses and tutorials.Web based courses and tutorials.

CITI Program FoundersCITI Program Founders

Karen Hansen, Karen Hansen,

Fred Hutchinson Cancer Research Center, Seattle, Fred Hutchinson Cancer Research Center, Seattle, WA., USAWA., USA

Paul Braunschweiger Ph.D. Paul Braunschweiger Ph.D.

University of MiamiUniversity of Miami

Miami, Fl. USA 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

CITI – ProgramCITI – Program 4-20104-2010

CITI Administration – Office of Research Education, University of Miami CITI Administration – Office of Research Education, University of Miami

Participating Institutions and Organizations (~1310)Participating Institutions and Organizations (~1310)

CITI Developer Group (~70)CITI Developer Group (~70)

CITI Editorial Board (15)CITI Editorial Board (15)

Intl.Intl.

GCPGCP

RCRRCR CITI Executive Advisory CommitteeCITI Executive Advisory Committee

HSRPHSRP

Founders

L.A.W.L.A.W.

HIPSHIPS

www.citiprogram.org

BiosafetyBiosafety

What is The CITI Program What is The CITI Program www.citiprogram.orgwww.citiprogram.org

• CITI Program is subscription based CITI Program is subscription based – >1311 participants from around the world>1311 participants from around the world– ~35,000 new learners per month complete a CITI Course~35,000 new learners per month complete a CITI Course– >1.5 million people since 9-1-00>1.5 million people since 9-1-00– ~470,000 new learners since 4-1-09~470,000 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, Universities, colleges, medical centers, community hospitals, societies, government, commercial IRBs, industry. societies, government, commercial IRBs, industry.

How do Institutions use CITI ProgramHow do Institutions use CITI Program

• Basic Research Ethics TrainingBasic Research Ethics Training– Ethics Committee Members, Investigators, Ethics Committee Members, Investigators,

Staff, Administrators, and Students.Staff, Administrators, and Students.

• Refresher or recertificationRefresher or recertification• Institution specific features Institution specific features

– Institutions can set their own curriculum.Institutions can set their own curriculum.• Curriculum can be set for a specific role in research or Curriculum can be set for a specific role in research or

interests.interests.

– Institutions establish expectations and set the Institutions establish expectations and set the bar.bar.

– Institution specific materials.Institution specific materials.

The CITI Program Courses The CITI Program Courses

• Modular CoursesModular Courses– Protection of Human Subjects.Protection of Human Subjects.

– Good Clinical Practice.Good Clinical Practice.

– Health Information Privacy and Security.Health Information Privacy and Security.

– Laboratory Animal WelfareLaboratory Animal Welfare

– Responsible Conduct of Research.Responsible Conduct of Research.

– BiosafetyBiosafety

• Disciplines.Disciplines.• Institutions design their own curriculumInstitutions design their own curriculum• Institutions can add their own content.Institutions can add their own content.

Institutional ModulesInstitutional Modules

Developed by organizations Developed by organizations specifically for their research specifically for their research

community.community.

Special Topics Special Topics WABTPWABTP

Clement Adebamowo Ph.D.Clement Adebamowo Ph.D.

CITI International InitiativesCITI International Initiatives

World wide n > 1311 +20/monthInternational n >65sites / 39 countries

CITI International InitiativesCITI International Initiatives

Multilanguage Course SiteMultilanguage Course Site

EnglishSpanishPortugueseFrenchRussianThaiChineseJapanese

www.citiprogram.orgwww.citiprogram.org

Multilanguage Course SiteMultilanguage Course SiteMulti-language Course Site Updated in 2009Multi-language Course Site Updated in 2009

• Languages.Languages.– EnglishEnglish– Spanish (NIAID, FIC)Spanish (NIAID, FIC)– Portuguese (NIAID, FIC)Portuguese (NIAID, FIC)– ChineseChinese– Japanese Japanese – French (NIAID)French (NIAID)– Thai (US Army)Thai (US Army)– Russian Russian (US Army, NIAID)(US Army, NIAID)– KoreanKorean– Kartuli (FIC)Kartuli (FIC)– ArabicArabic

New Utilities of Institutional New Utilities of Institutional CoordinatorsCoordinators

CITI Knowledge BaseCITI 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 Topics cover many topics navigation to information for CITI

administrators.administrators.• More than 150 users/month visited the pageMore than 150 users/month visited the page• It can be accessed directly: It can be accessed directly:

http://citiprogram.supportcenterpro.com/knowledgebasehttp://citiprogram.supportcenterpro.com/knowledgebase or or in the CITI site from the contact us page: in the CITI site from the contact us page: https://www.citiprogram.org/contactus.asp?https://www.citiprogram.org/contactus.asp?language=englishlanguage=english

Helpdesk ChatHelpdesk 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 questions Chat utility permits quick answers to questions • Only CITI Program during business hours.Only CITI Program during business hours.• It can be accessed directly: It can be accessed directly:

http://citiprogram.supportcenterpro.com/liveagent/http://citiprogram.supportcenterpro.com/liveagent/chat/chat/ or in the CITI site from the contact us page: or in the CITI site from the contact us page: https://www.citiprogram.org/contactus.asp?https://www.citiprogram.org/contactus.asp?language=englishlanguage=english

WebinarsWebinarsHow to get the most from the CITI ProgramHow to get the most from the CITI Program• New and experienced CITI institutional New and experienced CITI institutional

administratorsadministrators• Administrators of any participating institutions can Administrators of any participating institutions can

take advantage of these training sessions.take advantage of these training sessions.• Since December 2009Since December 2009

– Total of 55 sections with 725 participants were conductedTotal of 55 sections with 725 participants were conducted– High level of satisfaction with the CITI webinars.High level of satisfaction with the CITI webinars.

• Information of how to enroll can be found at: Information of how to enroll can be found at: http://citiprogram.supportcenterpro.com/knowledgebhttp://citiprogram.supportcenterpro.com/knowledgebase/citi-administrators/.citi-administrator-ase/citi-administrators/.citi-administrator-webinars.htmlwebinars.html

Learner feedbackLearner feedback

CITI Satisfaction SurveyCITI Satisfaction Survey

Human subjects research is crucial for finding cures for debilitating diseases, Human subjects research is crucial for finding cures for debilitating diseases, the prevention of deadly pandemics and providing a better understanding of the prevention of deadly pandemics and providing a better understanding of

who we are and why we do the things we do.who we are and why we do the things we do.September 2009, n= 14,956September 2009, n= 14,956

Strongly disagree strongly agree

% o

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he R

espo

nder

s

Now that I have completed the course, I am more confident in my 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 ability to advise a student or a colleague on an issue of human subjects protection and the ethical conduct of human subjects subjects protection and the ethical conduct of human subjects

research.research.September 2009 , n=13,716September 2009 , n=13,716

Strongly disagree strongly agree

% o

f T

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espo

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s

Looking back, I believe that the CITI Basic course, I Looking back, I believe that the CITI Basic course, I completed previously, provided me with the ethical foundation completed previously, provided me with the ethical foundation to conduct my human subjects research to the highest ethical to conduct my human subjects research to the highest ethical

standards?standards?Median time from completing the basic course = 2 yrs.Median time from completing the basic course = 2 yrs.

Strongly disagree strongly agree

% o

f T

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espo

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s

Looking back, since completing the Basic Course I am more Looking back, since completing the Basic Course I am more likely to have the confidence to engage in a discussion of likely to have the confidence to engage in a discussion of

human subjects protection or the ethical conduct of human human subjects protection or the ethical conduct of human subjects research with students and colleagues.subjects research with students and colleagues.

Median time since completion of the basic course is 2 yrs.Median time since completion of the basic course is 2 yrs.

Basic CourseRefresher Course

strongly disagree strongly agree strongly disagree strongly agree

Responsible Conduct of Responsible Conduct of ResearchResearch

NIH, NSF requirementsNIH, NSF requirements

Federal Register / Vol. 74, No. 160 / Thursday, August 20, 2009 / Noticeshttp://edocket.access.gpo.gov/2009/pdf/E9-19930.pdf

NSF RequirementsNSF Requirements Section 7009 of the America COMPETES Act.Section 7009 of the America COMPETES Act.

• RCR Training for NSF post docs and RCR Training for NSF post docs and students. 1-1-10students. 1-1-10– NSFNSF

• 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 Therefore, it is the responsibility of each institution to determine both the content and the delivery method for the training that will both the content and the delivery method for the training that will meet the institution’s particular needs for RCR training in all areas meet the institution’s particular needs for RCR training in all areas at that institution for which NSF provides support.”at that institution for which NSF provides support.”

NIH RequirementsNIH Requirements

• Training GrantsTraining Grants– Who needs training Who needs training – Topics to be included.Topics to be included.– How instruction should be delivered.How instruction should be delivered.– How often.How often.– When training should be applied.When training should be applied.– Grant review process.Grant review process.

• National Institutes of Health (NIH), NOT-National Institutes of Health (NIH), NOT-OD-10-019, issued November 24, 2009.OD-10-019, issued November 24, 2009.

CITI RCR CourseCITI RCR CourseBiomedical SciencesBiomedical Sciences

Social & Behavioral Sciences*Social & Behavioral Sciences*

Physical SciencesPhysical Sciences

Arts & HumanitiesArts & Humanities

Supported by a contract from DHHS / ORI Supported by a contract from DHHS / ORI

Science AdministratorsScience Administrators

EngineeringEngineering

The Responsible Conduct of ResearchThe Responsible Conduct of Research

• Public Access Public Access vs.vs. Subscriber access Subscriber access• TopicsTopics

– Research MisconductResearch Misconduct– Data Acquisition and ManagementData Acquisition and Management– Conflicts of InterestConflicts of Interest– Responsible AuthorshipResponsible Authorship– Responsible Peer ReviewResponsible Peer Review– Human Subjects ProtectionHuman Subjects Protection– Lab Animal WelfareLab Animal Welfare– MentoringMentoring– Responsible Collaborative ResearchResponsible Collaborative Research

• Customized courses.Customized courses.• Text, cases, videos and quizzesText, cases, videos and quizzes

CITI RCR Courses.CITI RCR Courses.

• CITI RCR COURSESCITI RCR COURSES– Cover the 9 topic areas as indicated by ORI and NSF.Cover the 9 topic areas as indicated by ORI and NSF.– Text, cases, video cases, quizzes.Text, cases, video cases, quizzes.– Discipline specific.Discipline specific.– Can be customized according to the needs of Can be customized according to the needs of

institution, investigator or student. institution, investigator or student.

• Best used as an Introduction to RCR in a Best used as an Introduction to RCR in a programmatic approach to RCR education.programmatic approach to RCR education.

• Public access availability at the CITI Program Public access availability at the CITI Program Home Page Home Page www.citiprogram.org www.citiprogram.org

Content FormatContent Format Publication Practices and Responsible AuthorshipPublication Practices and Responsible Authorship

• Introductory video cases - 10 Introductory video cases - 10 – 10, 3 minute video cases.10, 3 minute video cases.– 3 new “introductory” video case studies 3 new “introductory” video case studies

for the SBR investigators and students.for the SBR investigators and students.• MisconductMisconduct• Data AcquisitionData Acquisition• Conflicts of InterestConflicts of Interest

Embedded Case StudiesEmbedded Case Studies

Other new projectsOther new projects

Course in Bio-safety and Bio-securityCourse in Bio-safety and Bio-security

CITI CITI Collaborative Institutional Training InitiativeCollaborative Institutional Training Initiative

Bio-Safety and Bio-SecurityBio-Safety and Bio-Security

Module # Module Title1 Overview2 Lab Associated Infections3 Risk Assessment4 Medical Surveillance5 Risk Management – Work Practices6 Risk Management – Personal Protective Equipment7 Risk Management – Engineering Controls8 Risk Management – Lab Design

Module # Module Title9 Risk Management - Emergency Procedures

10 OSHA Blood-borne Pathogens 11 NIH Recombinant DNA Guidelines12 Human Gene Transfer13 Select Agents, Biological Security, and Bioterrorism14 Shipping and Transport of Regulated Bio-Materials15 Animal Biosafety16 Nanotechnology and Safe Practices

SummarySummary

• The active promotion of integrity in the The active promotion of integrity in the research enterprise is essential to research enterprise is essential to maintain the maintain the Public’s TrustPublic’s Trust. . – Without the Public Trust there can be now Without the Public Trust there can be now

researchresearch

• Research ethics education for the all Research ethics education for the all members of the research team is members of the research team is essential to promote integrity in the essential to promote integrity in the research enterprise.research enterprise.

• Programmatic approach to ethics Programmatic approach to ethics education is highly desirable.education is highly desirable.

““Integrity” by Joris Plu 2005Integrity” by Joris Plu 2005

SummarySummary

• Promoting Integrity is everyone’s responsibility.Promoting Integrity is everyone’s responsibility.– Protection of Human subjects.Protection of Human subjects.– Leads to good science.Leads to good science.– Compliance with all federal regulations Compliance with all federal regulations – Protect the Publics trustProtect the Publics trust

• The Responsible Conduct of Research is beyond The Responsible Conduct of Research is beyond simply being compliant with Federal regulations.simply being compliant with Federal regulations.

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

““New Integrity” by Artibella Avanti New Integrity” by Artibella Avanti

In SummaryIn Summary

Absent: Richard Sprince, Lucas Canning, Rachel Chueng,

Biomedical ModulesBiomedical Modules

1 History and Ethical Principles 2 Basic Institutional Review Board (IRB) Regulations and Review Process 3 Informed Consent 4 Social and Behavioral Research for Biomedical Researchers 5 Records-Based Research 6 Genetic Research in Human Populations 7 Research With Protected Populations - Vulnerable Subjects: An Overview 8 Vulnerable Subjects - Research with Prisoners 9 Vulnerable Subjects - Research Involving Minors

10 Vulnerable Subjects - Research Involving Pregnant Women and Fetuses in Utero

11 Group Harms: Research With Culturally or Medically Vulnerable Groups 12 FDA-Regulated Research 13 International Research 14 Human Subjects Research at the VA 15 HIPAA and Human Subjects Research 16 Workers as Research Subjects-A Vulnerable Population 17 Hot Topics 18 Conflicts of Interest in Research Involving Human Subjects 19 Stem Cell Research Oversight

Other ModulesIRB Administrator You want to be an IRB Community Member, Now what?

SBR ModulesSBR Modules

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

10 International Research - SBR 11 Internet Research - SBR 12 Students in Research - SBR

CITI HIPS CourseCITI HIPS CourseHealth, 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

CITI HIPS CourseCITI HIPS CourseHealth, 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