Slide 0 - Research at OSU

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Office of Research Integrity
Navigating the regulatory framework
October 23, 2014
ORI Units
COI
DS
IACUC
Int’l Comp.
IRB
Conflict of Interest program
Scientific Diving and Small Boat Use
Institutional Animal Care and Use Committee
Export Control and International Compliance
Institutional Review Board
IBC*
Institutional Biosafety Committee
F&A – RO Compliance Connections
VP for Finance & Administration
Glenn Ford
Interim VP for Research
Ron Adams
Asst. VP for HR, Facilities, Risk Mgmt, & Public Safety
Dave Blake
Assoc. VP for Research
Rich Holdren
Chief Risk Officer, Enterprise Risk Srvcs
Patrick Hughes
Director, ORI
Adam Schultz
Asst. Director, Enterprise Risk Srvcs, EH&S
Dan Kermoyan
Radiation Safety
Chemical Safety
IRB
IACUC
COI
Int’l Compliance
Scientific Diving & Boating
University Health & Safety
Biosafety
Mission
Promote a culture that fosters ethical research
Maintain the integrity of OSU research
Protect the public trust
Provide guidance and support
Partner with researchers to ensure compliance
Require training to enhance personal safety*
Commitment from OSU Leadership
“…[Research] activities undertaken by OSU faculty,
staff, and students should be conducted in accordance
with strict ethical principles and in compliance with
institutional policies, federal and state laws and
regulations, and other applicable requirements.”
-Edward J. Ray, President
What?
Assist researchers in complying with ethical, regulatory, and
legal responsibilities in research involving:
• Live vertebrate animals
• Human subjects
• Scientific diving and small boat use
• Financial conflicts of interest
• International components or foreign nationals
• Recombinant nucleic acids and infectious agents
• Collaboration with committees in EH&S
Why?
History.
Why else?
“Public funding is based on the principle that
the public good is advanced by science
conducted in the interest of humanity.”
-National Research Council
Conflict of Interest
Nicole Wolf
Administrator
(541) 737-4692
A312 Kerr Admin Bldg
coi@oregonstate.edu
Conflict of Interest
1,826
32
25
Declarations in FY 2014
Managed Conflicts
Potential COIs under review
Conflict of Interest
contact for
• Disclosure of financial interests
• COI training
• Managing conflicts of interest in
research
Conflict of Interest
Disclosures are required for
• Professorial faculty, Research Associates, and Post-Doctoral
Fellows/Scholars
• Individuals who serve or intend to serve as an investigator on
a sponsored project, including but not limited to Professional
Faculty, Faculty Research Assistants, Senior Faculty Research
Assistants, Instructors, and Emeritus, Courtesy and Visiting
Faculty
• Other individuals as identified by the Conflict of Interest
Officer, a college dean or unit head
Scientific Diving & Small Boats
Kevin Buch
Diving and Small Boat
Safety Officer
(541) 737-6893
B308 Kerr Admin Bldg
kevin.buch@oregonstate.edu
Diving & Small Boats
2013 Dive Statistics
2572 dives
88% research
12% training
40
divers
1600 hours
20+ projects
Diving & Small Boats
contact for
• Scientific diver training
• Dive plan approval
• Approval to operate or crew small vessels
IACUC
Administrator:
Coordinator:
Program Specialist:
Student:
Rebecca Henry
Rob Gaebel
Mary Samuel
Max Gilbert
(541) 737-2762
B308 Kerr Admin Bldg
iacuc@oregonstate.edu
IACUC
128
308
154
23
New Submissions (FY 2014)
Currently active protocols
Principal Investigators
Depts/Units Represented
Triennial AAALAC accreditation site visit
Recommended for continued full accreditation
AAALAC site visitors noted campus-wide collegiality
IACUC
contact for
 Use of live vertebrate animals in research,
teaching, testing and other use
 Animal welfare concerns and incidents
International Compliance
Mark Peters
Export Control & Int’l Compliance Officer
(541) 737-0647
A312 Kerr Admin Bldg
mark.peters@oregonstate.edu
International Compliance
contact for
• International travel or
shipping
• Foreign visitors
• Restrictions on
publication or foreign
participation
• Fundamental Research
Exemption (FRE)
IRB
Administrator: Lisa Leventhal
Coordinators: Cathleen Gal
Jillian Grant
Amy Neuman
Specialist:
Tiffany Cicerchi
Student:
Demi Sether
(541) 737-8008
B308 Kerr Administration Building
irb@oregonstate.edu
IRB
1230 Active studies
200 Students advised annually
200 In-office reviews in CY 2014
IRB
contact for
• Research determination
• Review of human subjects section of grant
applications
• Pre-submission consultation
• Review of research protocols
• Presentations to faculty or students
EH&S
Institutional Biosafety Committee
Chemical Safety Committee
Radiation Safety Committee
University Health and Safety Committee
Environmental Health & Safety
100 Oak Creek Building
3015 SW Western Blvd
(541) 737-2273
http://oregonstate.edu/ehs/
Committees & Boards
Comprised of your peers
Members from across the University
Some include community members
Some include students
They want your research to be successful!
Most Frequently Asked Question
How long does it take?
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