As the Compliance
World Turns
Sherrie Settle
Assistant Director, Research Compliance
October 7, 2009
Three Topics in 20 Minutes
Ready, set, go!
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
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
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
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
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
So what are the questions?
And what happens to the
answers?
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
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.
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.
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
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
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
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
Something Carolina Blue
Research administration and compliance:
A perfect partnership!
Questions?
Top Related