Office of Research Integrity Navigating the regulatory framework October 23, 2014.
26
Office of Research Integrity Navigating the regulatory framework October 23, 2014
-
Upload
alisha-carroll -
Category
Documents
-
view
215 -
download
2
Transcript of Office of Research Integrity Navigating the regulatory framework October 23, 2014.
Office of Research IntegrityNavigating the regulatory framework
October 23, 2014
ORI Units
COIDSIACUCInt’l Comp.IRB
IBC*
Conflict of Interest programScientific Diving and Small Boat UseInstitutional Animal Care and Use CommitteeExport Control and International ComplianceInstitutional Review Board
Institutional Biosafety Committee
F&A – RO Compliance ConnectionsInterim VP for Research
Ron Adams
Director, ORIAdam Schultz
IRB IACUC
COI
Scientific Diving & Boating
VP for Finance & AdministrationGlenn Ford
Asst. VP for HR, Facilities, Risk Mgmt, & Public Safety Dave Blake
Asst. Director, Enterprise Risk Srvcs, EH&SDan Kermoyan
Biosafety
Radiation Safety
Chemical Safety University Health & Safety
Chief Risk Officer, Enterprise Risk SrvcsPatrick Hughes
Assoc. VP for ResearchRich Holdren
Int’l Compliance
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
1,826 Declarations in FY 201432 Managed Conflicts25 Potential COIs under review
Conflict of Interest
contact for
• Disclosure of financial interests• COI training • Managing conflicts of interest in
research
Conflict of InterestDisclosures 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 BuchDiving and Small Boat Safety Officer(541) 737-6893B308 Kerr Admin [email protected]
Diving & Small Boats
2013 Dive Statistics
2572 dives88% research12% training
40 divers1600 hours20+ projects
Diving & Small Boats
contact for
• Scientific diver training• Dive plan approval• Approval to operate or crew small vessels
IACUC
Administrator: Rebecca HenryCoordinator: Rob GaebelProgram Specialist: Mary SamuelStudent: Max Gilbert
(541) 737-2762B308 Kerr Admin [email protected]
IACUC
128 New Submissions (FY 2014)308 Currently active protocols154 Principal Investigators23 Depts/Units Represented
Triennial AAALAC accreditation site visitRecommended for continued full accreditation
AAALAC site visitors noted campus-wide collegiality
IACUCcontact for
Use of live vertebrate animals in research, teaching, testing and other use
Animal welfare concerns and incidents
International Compliance
Mark PetersExport Control & Int’l Compliance Officer(541) 737-0647A312 Kerr Admin [email protected]
International Compliancecontact for
• International travel or shipping• Foreign visitors• Restrictions on
publication or foreign participation• Fundamental Research
Exemption (FRE)
IRBAdministrator: Lisa LeventhalCoordinators: Cathleen Gal
Jillian GrantAmy Neuman
Specialist: Tiffany CicerchiStudent: Demi Sether
(541) 737-8008B308 Kerr Administration [email protected]
IRB
1230 Active studies200 Students advised annually200 In-office reviews in CY 2014
IRBcontact for
• Research determination• Review of human subjects section of grant
applications• Pre-submission consultation• Review of research protocols• Presentations to faculty or students
EH&SInstitutional Biosafety CommitteeChemical Safety CommitteeRadiation Safety CommitteeUniversity Health and Safety Committee
Environmental Health & Safety100 Oak Creek Building3015 SW Western Blvd (541) 737-2273http://oregonstate.edu/ehs/
Committees & Boards
Comprised of your peersMembers from across the UniversitySome include community membersSome include students
They want your research to be successful!
Most Frequently Asked Question
How long does it take?
![[PPT]FDA Regulatory Perspective: Data Integrity · Web viewFDA Regulatory Perspective: Data Integrity Steve Wilson, Dr.P.H., CAPT USPHS Deputy Director, Division of Biometrics II,](https://static.fdocuments.net/doc/165x107/5af0bcc27f8b9a572b8fca3e/pptfda-regulatory-perspective-data-viewfda-regulatory-perspective-data-integrity.jpg)
