Transcript ORC Intro Provost - West Virginia University

WVU Office of Research Integrity
and Compliance Overview
Daniel R. Vasgird, PhD
Office of Research Integrity & Compliance
West Virginia University
(304) 293-6094
[email protected]
http://oric.research.wvu.edu
“…I know that knowledge can
transform us, that truth is not
only a way of deciphering the
world.”
- Michel Foucault “The
Minimalist Self”
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ORIC Mission:
Foster a culture of integrity and
compliance within the University directed
at ensuring that participants in the West
Virginia University research enterprise
internalize and pursue the goal of selfdirected responsible conduct of research.
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The Harris Poll: 1977-2009
Biggest Changes in Occupations Rated for “Very Great
Prestige” over Last 30+ Years:
• The Harris Poll first asked about occupations in 1977.
• The biggest change since then has been a 22 point
increase from 29% to 51% in those who believe
teachers have very great prestige.
• Two occupations have lost substantial ground since
1977: scientists, down 9 points from 66% to 57%, and
lawyers, down 10 points to 26%.
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Consequences of Ambition
Perseverance, motivation & success,
but possibly increased:
1. Risk for unintentional bias
2. Willingness to cut corners
3. Willingness to commit serious
misconduct
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NSF OIG
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Research Misconduct Actions Since 1998
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Fold Increase
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2
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Year
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
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“The public will support science
only if it can trust the scientists
and institutions that conduct
research.”
Integrity in Scientific Research
IOM & NRC
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RCR Core Areas (ORI, 2000)
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Human Research Protections
Research Protections for Animals
Research Misconduct
Conflict of Interest and Commitment
Mentor/trainee Relationships
Responsible Authorship
Peer Review
Data Management, Sharing and Ownership
Collaborative Science
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ORIC Core Areas
1) Human research protections
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AAHRPP reaccreditation received
Animal care and use in research
Conflict of interest in research
Institutional Biosafety
Export Control
RCR E&T (CITI online & seminars)
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FSGO Compliance Elements
(HHS & NSF)
• Implementing written policies and procedures;
• Designating a compliance officer and
compliance committee;
• Conducting effective training and education;
• Developing effective lines of communication;
• Conducting internal monitoring and auditing;
• Enforcing standards through well-publicized
disciplinary guidelines;
• Responding promptly to detected problems; &
• Defining roles and responsibilities and
assigning oversight responsibility.
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Human Subjects Research
• Any human subjects research conducted
by or under the auspices of any WVU
faculty, student or staff must be reviewed
by the WVU IRB.
• These human subject research projects
must be submitted to the IRB office for
review.
Levels of Review
4 Primary Levels of
Review:
NHSR
Exempt
Expedited
Full Board
IRB Review
• Flexibility is a primary characteristic of WVU
IRBs.
• Minimal risk studies will receive a thorough
but quick review.
• More than minimal risk research will receive
full board review at a convened meeting.
Guiding Belmont Principles
Respect for Persons
• How is this principle exhibited in research?
• Informed consent
Beneficence
• How is this principle manifested in research?
• By ensuring that benefits of research outweigh risks.
Justice
• How is this principle manifested in research?
• By ensuring that one group does not unduly shoulder
the risks (burden) of research or be excluded from
the benefits of research.
Authority of IRB
• Requirement of review
• Approve, disapprove or modify
• Conduct continuing review
• At any time and in person if desired
• Must be done at least once per year
• Observe/verify changes
• Suspend or terminate approval
The New Electronic System Is Here!
• The WVU Research Office and OIT are working
together to replace the current electronic system known
as BRAAN with a new KC IRB module.
• This new system was initiated in May 2012. Complete by
November, 2012.
• Investigators will continue to be able to create & manage
IRB protocols.
• The KC IRB system will operate in parallel with BRAAN
for one year as protocols are manually transferred by the
investigators to the new system through the new protocol
and renewal application process, with BRAAN
eventually becoming an archive system for historical data
only.
Kuali Coeus eRA Project
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Kuali Members
(~45 total)
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Boston University
Brown University
Colorado State University
Cornell University
Duke University
Indiana University
Johns Hopkins University
Massachusetts Institute of Technology
Michigan State University
The University of Arizona
University of California
University of Virginia
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ORIC Communication
http://oric.research.wvu.edu/
• ORIC website: Interactive & deliver news
& information but also allow feedback
about office WVU research community.
• Open forums & seminars: “Meet and
Greet” forums & research ethics
presentations to interact with university
community. Just ask!
• Newsletter & listserv: Information and
announcements are published on online
newsletters and responsibility matrix.
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Takeaway Points:
• When in doubt, please always err on the
side of caution regarding any research
compliance issue.
• Call the ORIC office for advice on
submitting a protocol review or guidance if
there is a problem. This can prevent
misunderstandings and will ensure that
your research is in compliance with federal
regulations.
“One is apt to think of moral
failure as due to weakness of
character: more often it is due
to an inadequate ideal.”
Richard Livingstone
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Case: Credit Where Credit Is Due
Ben, a PhD student, had been working on a research project that
involved an important new experimental technique. For a national meeting in
his discipline, Ben wrote an abstract and gave a brief presentation that
mentioned the new technique. After his presentation, he was surprised and
pleased when Dr. Freeman, a leading researcher from another university,
engaged him in an extended conversation. Dr. Freeman asked Ben extensively
about the new technique, and Ben described it fully. Ben's own faculty advisor
often encouraged his students not to keep secrets from other researchers, and
Ben was flattered that Dr. Freeman would be so interested in his work.
Six months later Ben was leafing through a journal when he noticed an
article by Dr. Freeman. The article described an experiment that clearly
depended on the technique that Ben had developed. He didn't mind; in fact,
he was again somewhat flattered that his technique had so strongly influenced
Dr. Freeman's work. But when he turned to the citations, expecting to see a
reference to his abstract or presentation, his name was nowhere to be found.
What should Ben do?
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