Promoting the RCR
Video Case Studies: Resources and Evaluation
Paul Braunschweiger, Ph.D.
Professor, Radiation Oncology
CITI Co-Founder
Council of Graduate Schools – Graduate Education in a Global Context , 12-3-08
Disclaimer and Disclosures
• Dan Vasgird Ph. D. UN-L.
– CITI Developer Group
– RCR working group.
– 2006 CGS Grant to develop video vignettes
(trigger cases) for RCR education.
– 2007 Cases added to CITI RCR Program.
• Disclaimer and Disclosure.
Talking Points
•
•
•
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RCR education paradigms.
University of Nebraska – RCR videos
Application of RCR videos in the CITI Program.
Distribution of the RCR videos.
– CITI Program.
– Global Context.
• Evaluation of the RCR video resources.
– Learner Feedback
• Resources
Integrity in The Research Enterprise
•
•
•
"Integrity" by Canneto, Columbus, OH
Starts with Institutional Commitment
Promoted and nurtured by the IRB, CoIC,
IBC, IACUC, Sponsored Programs,
Research Administrators.
Embraced by the investigators, staff and
students as just:
“The right thing to do”
Why Does Integrity and
Professionalism Matter?
• 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
– Research becomes politicized.
• CoI and Pharmaceutical Industry
– Justification and / or vindication for groups with
anti-research agenda. (PETA, ALF)
The Foundations for Trust are
Based in the Documentation of
Ethical Behavior and Education.
Mandated Ethics Training
•
Human Subjects Protections.
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•
Lab Animal Welfare
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•
Basics for Investigators, staff and students
The Responsible Conduct of Research
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•
Investigators
Administrators
Biological Safety and Security
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•
Basics for Investigators, staff and students
IACUC Member
Model / species specific / procedure specific
HIPPA (Privacy and Security)
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–
•
Basic for investigators, staff and students.
GCP
IRB Professional
Basics for investigators, staff and students
Administrators.
Grants and Contracts, Sponsored Programs
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–
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Grants management
Financial responsibility
CoI
Institutional Approaches
Research Ethics Education
• Bottom up Approach
– Research Ethics is integrated in the academic and
professional develop of students and fellows by the
research faculty.
• Top down Federal /institutional mandate.
– Animal Welfare
– Human Subjects Protection
– HIPAA
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 time intensive, Less effective, very costly, may not be
convenient.
•
External consultants
– Can be effective, very costly.
•
Web based training.
– Convenient, effective, inexpensive, timely, assessment.
– 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
Web based training
Assuming a similar time commitment, would you prefer another vehicle for
this mandated instruction?
80%
70%
80%
% Responders n=2953
80%
70%
70%
% Responders n=2722
% Responders n=104001
90%
60%
50%
40%
30%
20%
60%
50%
40%
30%
20%
Web
web
Vid
class
book
audio
40%
30%
20%
0%
0%
0%
50%
10%
10%
10%
60%
Vid
Class
book
audio
Alternatives
Web
Class
Vid
book
Alternatives
Alternatives
HSR
Lab Animal Welfare
CITI Learner Satisfaction Survey results 1-1-08
RCR
audio
Video Presentation Paradigms
• Virtual Video Libraries
– Reference Resource
– UNL, SU, ORI, AAAS etc.
• Optional exercises in a web based tutorial.
– NIU
• Query-Video Presentation-Query (QVQ)
– UAB
• 2-3 minute video clips of exemplars providing expert
opinions on various aspects of the RCR.
– Columbia University
• Cases and videos embedded in the RCR foundation text.
– CITI Program
University of Nebraska RCR
video vignettes
• CGS Funded Project
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–
–
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Grad. Faculty and Students
3 topics of greatest interest.
Student actors
Primary target at UN-L about 100 grad
students/year.
– Live and online evaluations
– http://www.unl.edu/gradstudies/facstaff/rcr/
http://www.unl.edu/gradstudies/facstaff/rcr/
Integration of the UN-L RCR Vids
into the CITI RCR Courses.
CITI Program RCR Courses
Biomedical Sciences
Social & Behavioral Sciences
Physical Sciences
Arts & Humanities
Administrators
Supported by a resource development contract from DHHS / ORI
The Responsible Conduct of
Research
• Research Misconduct
– Historical perspectives
– Whistle Blowing
•
•
•
•
•
•
•
•
Data Acquisition and Management
Responsible Authorship
Responsible Peer Review
Mentoring
Conflicts of Interest
Responsible Collaborative Research
Human Subjects Protection
Lab Animal Welfare
RCR Program Paradigm
•
•
•
•
•
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Public Access, subscriber access
Customized courses.
Text, cases, videos and quizzes
Helpdesk (305 243-7970) for students and trainers
Completion Certificates
Institution specific training materials easily
incorporated to the curriculum.
• Training data storage and retrieval system
• Voluntary Learner Satisfaction Survey
• Research Misconduct
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Discipline Specific Title
Links
Introductory Video Scenarios
Exemplar video presentations
Imbedded Case Studies
Quiz
Who should take advantage of RCR education?
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.
60%
RCR Learner Satisfaction Survey
HSR Learner Satisfaction Survey
60%
% Responders (n=3183)
50%
40%
30%
7%
84%
20%
% Responders (n=109,427)
50%
40%
30%
11%
78%
20%
10%
10%
0%
0%
1
2
3
Strongly disagree
4
5
6
7
8
9
Strongly agree
3
2
1
Strongly disagree
CITI Learner Satisfaction Survey results 1-1-08
4
5
6
7
9
8
Strongly agree
What is The CITI Program
www.citiprogram.org
• 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
– The RCR
• 5 discipline specific course.
• RCR for engineers.
• RCR for the humanities.
CITI Support Staff
CITI Program Milestones
10-2000
• 10 Participating Institutions.
2006
• New SBR Course added.
2008
• ~950 Participating Institutions
• ~22,000 Learners per month. 40-60% students
• >337,000 Learners since 1-1-2008.
• >960,000 Learners have completed a course since 9-1-2000.
Global Context
• International Initiatives
• Multi-language Course Site. 11-2007
– Spanish
– Portuguese
– Chinese, Japanese, Russian, Mongolian, French, Thai
CITI Worldwide Footprint
World wide n = 950
International n = 47sites / 35countries
Pan American Bioethics Initiative
CITI and U of M Ethics Programs
• Fogarty International / NIH Funded R25 grant
– P. Braunschweiger, K. Goodman and S. Litewka.
• Research Ethics Education and Training Program
development in Latin America, Brazil, and the
Caribbean.
• Decision markers, policy architects in government,
academia and industry.
• Charge to the Fellows:
– Develop robust research ethics education program for
their organization, implement, promote.
– PABI Workshops, ethics committee capacity building,
CITI Platform.
– Fellows recruit and mentor peers.
RCR Program Evaluation
From: The School of Athens, Raphaelo. 1509
User Satisfaction Survey
Program Evaluation
• Voluntary, Anonymous. IRB Approved.
• Topics addressed
– Demographic Information.
• Role, age, gender, country, language
– Usability
• Registration, navigation, quizzes, Internet, Presentation, Time
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Knowledge base.
Confidence in the new knowledge base
Willingness to apply the new knowledge
Intent to promote the RCR
Overall rating
Other
Evaluation
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RCR Course Usage
Case study usage
Video vignette usage
Learner feedback
RCR Course Usage
Certificates Awarded
Year
2008* 2007
Public Access
2,290
Participating Institutions 14,726
Total
17,016
*December 1, 2008
2,600
3,669
6,269
Total
4,890
18,395
23,285
How Many Introductory Videos Did
You Review
70%
% Responders, n=2228
60%
50%
40%
30%
20%
10%
0%
0
At least 1
2 or 3
3
The 3 minute video case studies
were:
80%
% Responders, n = 918
70%
60%
50%
40%
30%
20%
10%
0%
too short
too long
about right
The Introductory video case studies were helpful to frame the
content before I started reading.
100%
% Responders, n=818
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
No
Yes
After completing the CITI RCR Course, I have a better
understanding of the ethical issues central to the research
enterprise so that I can conduct my work with the highest level
of integrity.
35%
% Responders, n = 2194
30%
25%
20%
15%
10%
5%
0%
1
2
Strongly disagree
3
4
5
6
7
8
9
Strongly agree
Now that I have completed the CITI RCR Course, I
am more confident in my ability to advise a student
or a colleague on an issue involving the
Responsible Conduct of Research.
% Responders, n = 2209
25%
12%
66%
20%
15%
10%
5%
0%
1
2
Strongly disagree
3
4
5
6
7
8
9
Strongly agree
Having completed the CITI Course in the Responsible Conduct of Research
and gained a better understanding of how damaging research misconduct can
be to students, to the institutions and to other investigators, I am now more
likely to report a clear act of research misconduct to an appropriate person at
my organization.
% Responders, n= 2016
30%
25%
20%
15%
10%
5%
0%
1
2
Strongly disagree
3
4
5
6
7
8
9
Strongly agree
New CITI RCR Videos
• Peer Review
http://medweb02.med.miami.edu/CITIvideo/2peer.wmv
• Mentoring
http://medweb02.med.miami.edu/CITIvideo/3mentor.wmv
• Data Management
http://medweb02.med.miami.edu/CITIvideo/4data.wmv
• Collaborative Research
http://medweb02.med.miami.edu/CITIvideo/1collab.wmv
Summary
• The foundation of research integrity is
research ethics education.
– Early, often, multiple formats
• Video
– Evaluate your education programs. Are they
working? How can you improve them?
– Listen to the feedback from your learners.
“New Integrity” by Artibella Avanti
Summary
• Web based educational approaches to ethics education:
– Can increase the ethics knowledge base of a wide audience.
– Can prepare the learner for advanced instruction and debate.
– Can provide the opportunity to customize the message to multiple
audiences.
– Should be a tool in a larger institutional RCR Program.
– Web based education is not for everyone. Alternatives.
• The Responsible Conduct of Research is beyond simply being
compliant with Federal regulations and Institutional Policies;
It is just the “right
thing to do”.
RCR Video Resources
RCR Video Resources
ORI / DHHS www.ori/dhhs.gov
•
General
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•
Data acquisition and management
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NIU, http://www.niu.edu/rcrportal/datamanagement/dmmain.html
CITI, www.citiprogram.org
AAAS http://www.aaas.org/spp/video/thevideos.htm
Conflicts of Interest
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•
17 Video Vignettes on Research Ethics and Academic Integrity.
Syracuse University
http://gradschpdprograms.syr.edu/resources/videos.php
*Cleveland State University (flash)
UN-L http://www.unl.edu/gradstudies/facstaff/rcr/
AAAS http://www.aaas.org/spp/video/thevideos.htm
Research Misconduct, Whistle Blowing
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UN-L http://www.unl.edu/gradstudies/facstaff/rcr/
UAB, http://www.uab.edu/researchintegrityandimages/default.html
CITI www.citiprogram.org
AAAS http://www.aaas.org/spp/video/thevideos.htm
RCR Video Resources
ORI / DHHS www.ori/dhhs.gov
•
Mentoring
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Collaborative Research
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CITI www.citiprogram.org
NIU (Flash) http://www.niu.edu/rcrportal/cfront.html
Authorship
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•
UAB, http://www.uab.edu/researchintegrityandimages/default.html
CITI, www.citiprogram.org
NIU Flash simulation
http://www.niu.edu/rcrportal/mentoring/overview/overview.html
UAB, http://www.uab.edu/researchintegrityandimages/default.html
UNL http://www.unl.edu/gradstudies/facstaff/rcr/
CITI www.citiprogram.org
AAAS http://www.aaas.org/spp/video/thevideos.htm
Peer Review
–
CITI www.citiprogram.org
RCR Video Resources
ORI / DHHS www.ori/dhhs.gov
•
•
Lab Animal welfare
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AALAS, *Wake Forest University, IACUC Inspection Virtual Walkthrough
OLAW. http://grants.nih.gov/grants/olaw/TrainingVideos.htm
–
Nonhuman Primates, Laboratory Dog, Survival Rodent Surgery, Basic Biomethodology for
Laboratory Mice.
Human Subjects
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–
•
HSRA - Protecting Human Subjects Training.
Children’s Hospital Boston, video
Case studies http://ori.hhs.gov/education/products/ucla/default.htm
Other
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Journal editor’s tool
http://www.uab.edu/researchintegrityandimages/default.html
The role of the RIO , Michigan State University http://ori.hhs.gov/rio/riovideo/
RCREC http://rcrec.org/
RCR Web Resources
Tutorials and courses
Human subjects research tutorials
•
•
•
•
PRIM&R - IRB 101/ 201 CD
Dunn and Chadwick Book
NIH/NCI – new version
CITI Program
– Biomedical
– Social and Behavioral
Good Clinical Practice
–
–
–
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ACRP
SOCRA
GeneEd $$$/ learner
Infonetica GCP http://www.gcptraining.org.uk/
$$$$/learner
• Multiple languages
– Kaplan $$$$/learner
– ClinfoSource
https://www.clinfosource.com/index.asp $$$$$$ /
learner
– CITI $ /institution or organization
Lab Animal Welfare
– AALAS, LAWTE
• Basic courses investigators, staff, students
• IACUC members
• Species / model / procedure specific modules
– OLAW , Webinars
• IACUC Members
• IACUC Coordinators
• IO
– CITI
• Basic courses investigators, staff, students
• IACUC members
• Species / model / procedure specific modules
Health Insurance Portability and
Accountability Act (HIPAA)
• Investigator , Administrator
– http://myhipaatraining.com/
– www.HRClassRoom.com/HIPAA
– http://www.training-hipaa.net/
– Health Information Privacy and Security (HIPS)
• CITI Program, www.citiprogram.org
The Responsible Conduct of
Research
• Biological Safety
– Basics for Investigators, staff and students
• UN Medical Center http://www.unmc.edu/dept/ibc/index.cfm?L1_ID=7&CONREF=11
• The Responsible Conduct of Research
– Basics for investigators, staff and students. (ORI funded)
• UC Davis http://ethics.ucsd.edu/courses/integrity/index.html
• Columbia University http://ccnmtl.columbia.edu/projects/rcr/
• NIU http://www.niu.edu/rcrportal/
• University of Montana http://www.umt.edu/research/ethics/research_ethics.html
• UNH http://www.unh.edu/rcr/index.html
• Boston College http://www.bc.edu/research/rcradmin/
• ORI website http://ori.hhs.gov/
• CITI RCR Program www.citiprogram.org
Research Administration
Professional Societies
•
NCURA
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Sponsored Programs
Grants management
Financial Administration
Contracts Management
Clinical trials management
SRAI
–
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Management & Operations
Research Integrity
Financial Management
Research Law
Sponsored Prog. Administration
Sponsors & Agencies
Boston College / ORI – Administrators and the RCR
www.CITIProgram.org
CITI Program Resources.
Responsible Conduct of Research.
Public Access at www.citiprogram.org
I plan to take a more active role in promoting
ethical research practices by :
•
I intend to do little more than I am currently doing.
33%
•
Attending more ethics related seminars
32%
•
Becoming a mentor to a student or young faculty member
27%
•
Encouraging my institution to adopt a formal RCR education
requirement for students and faculty
16%
•
Taking an advanced research ethics course
13%
•
Adding a research ethics module to a course I teach
11%
n=3896
RCR for Engineers
• Coming Winter 2009
Adapted for CITI from materials developed by Steve Erickson Ph.D. and Karen M.T.
Muskavitch, Ph.D “Administrators and the Responsible Conduct of Research” funded by
ORI/DHHS http://www.bc.edu/research/rcradmin/default.html
CITI RCR Course Design
• Publication and Authorship
– Discipline Specific Title and
hyperlinks
– Introductory Video Scenarios
– Imbedded Case Studies
– Quiz
CITI – Program
11-2008
Participating Institutions and Organizations (~950)
CITI Developer Group (~60)
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
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