As the Compliance World Turns - UNC Researchresearch.unc.edu/files/2013/03/CCM1_031475.pdf · World...
Transcript of As the Compliance World Turns - UNC Researchresearch.unc.edu/files/2013/03/CCM1_031475.pdf · World...
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As the Compliance
World Turns
Sherrie Settle
Assistant Director, Research Compliance
October 7, 2009
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Three Topics in 20 Minutes
Ready, set, go!
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Something Old: Conflict of Interest
• > 22,000 records created since
January 2, 2008
• >85% “spontaneous compliance”
• < 4% require committee review
• > 40 management plans
• Most involve corporate sponsorship
• 13 FCOI reported to NIH in FY2009
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Certification Pitfalls
• Investigators listed on the IPF are not working on the project or have left the University
• Investigators identified in the proposal are not listed as investigators on the IPF
• IPF Personnel changed after initial submission (e.g. faculty sponsors)
• Incorrect University directory information
• Right name, wrong person
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A Note About COI and
External Activity Reporting
Conflict of Interest:
• Event-based for sponsored research, IRB protocols and technology transfer
• Annual disclosure for administrative responsibilities
External Professional Activities for Pay:
• UNC General Administration Policy
• Filed prior to activity
• Approved by Department Chair
• Expire June 30
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What Activities are Exempt from
External Professional Activities for Pay
Reporting?
• Activities unrelated to area of scholarly expertise
• Activities for which no compensation is received, even if travel is reimbursed
• Service to professional associations and learned societies
• Professional review or advisory panels
• Guest lectures, paper presentations, concerts, exhibits
• Reviewing or editing scholarly publications
• Accreditation bodies
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Something New: Export Control
IPF Questions
• IPF section review
• Lots of email noise, little signal
• Proposal usually is not a trigger for Export
Control issues
• Contract language, project initiation, hiring,
procurement, shipping, etc.
• Only ask for what will be used
• New questions arriving in November
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So what are the questions?
And what happens to the
answers?
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1) Have you signed or been asked
to sign a DD Form 2345 “Militarily
Critical Technical Data Agreement”
related to this project?
Notifies University Counsel
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2) Do you anticipate that the project
work may involve sending/transporting/
transmitting/carrying any material or
equipment related to this project outside
the US (examples include: GPS,
biologicals, diagnostic kits, reagents)?
What items do you plan to ship or
transport out of the US? To what
countries?
Notifies Environment, Health and Safety at time of award.
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3) Do you anticipate that the
project work may involve travel
outside the U.S?
Automatic email of international
travel considerations to PI and
business manager at time of award.
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4) Transmitting funds (through
payments, for example) or goods or
technology to any of the following
countries on the OFAC list: Balkans,
Burma, Cuba, Iran, Iraq, Ivory Coast,
Liberia, Libya, North Korea, Rep. of
Congo, Sudan, Syria or Zimbabwe?
Email OFAC sanctions to PI and
Business Manager + notice to University
Counsel
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5) Do you anticipate that the project
work may involve:
Non-commercial encryption or
information security software?
Any equipment, technology, materials or
software specifically designed, modified,
or adapted (even slightly) for a military
purpose or that may involve national
security?
Any classified materials, equipment,
technology or data?
Email foreign national participation
guidance + notice to University Counsel
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Something Borrowed: NSF Training
Requirements
• America COMPETES Act
• Required training in Responsible Conduct
of Research (RCR) for trainees supported
on National Science Foundation awards
• Menu of training programs to meet
requirement, based on existing programs
• Training database to record completion,
modeled on human subjects training
database
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NSF Training Requirements
• Applies to proposals submitted on or after
January 4, 2010
• Part of institutional official certification
• No language required for grant proposal
• No reporting (not part of progress report)
• Essential that payroll reflects work
assignment
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Something Carolina Blue
Research administration and compliance:
A perfect partnership!
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Questions?