Transcript Slide 1

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
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Puts subjects at risk.
Injures careers
Wastes Resources
Wastes Time
Undermines the Public Trust.
The Public Trust
• The
“Public” supports
most ofTrust
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 (45CFR46)
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, CoIC.
• Embraced by the investigators, staff and students as
“The right thing to do”
Deceit and Professionalism
• Professions
Situations where
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
–toHonesty
information
truthfully
pursue- conveying
and administer
science
in a responsible and
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
Miami, Fl. USA
www.citiprogram.org
CITI – Program
4-2010
Participating Institutions and Organizations (~1310)
CITI Developer Group (~70)
Biosafety
RCR
CITI Executive Advisory Committee
Founders
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
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>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
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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 >65sites / 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
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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%
% of The Responders
50%
50%
40%
30%
20%
17%
10%
7%
0%
0%
0%
19%
6%
1%
0%
1
2
3
Strongly disagree
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
% of The Responders
30%
27%
25%
20%
21%
20%
14%
15%
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%
2%
0%
1
2
Strongly disagree
3
4
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%
22%
Refresher Course
19%
20%
21%
15%
15%
Basic Course
30%
25%
20% 21%
20%
12%
14%
15%
10%
5%
27%
15%
10%
3%
2% 2% 3%
5%
0%
2%
2%
3%
4%
1
2
3
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0%
1 2 3 4 5 6 7 8 9
strongly disagree
strongly agree
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/E9-19930.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
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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
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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
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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
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16
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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
– WorkSecurity,
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
forVA
Biomedical Researchers
HIPAA and Human
Subjects Research
515 Records-Based
Research
WorkersResearch
as Research
Subjects-A
Vulnerable Population
616 Genetic
in Human
Populations
Hot Topics
717 Research
With Protected Populations - Vulnerable Subjects: An Overview
Conflicts ofSubjects
Interest-inResearch
Researchwith
Involving
Human Subjects
818 Vulnerable
Prisoners
Stem Cell Research
919 Vulnerable
Subjects -Oversight
Research Involving Minors
Modules
10 Vulnerable Subjects - ResearchOther
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
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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
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