Office of Research Assurances 205 Albrook Pullman httpwwworawsuedu Updated January 2015 Recording date of this workshop is January 16 2015 Some of the rules and procedures discussed in this workshop are subject to change ID: 777335
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Overview of the Office Of Research Assurances (ORA)Office of Research Assurances205 Albrook, Pullmanhttp://www.ora.wsu.edu
Updated January
2015
Slide2Recording date of this workshop is January 16, 2015Some of the rules and procedures discussed in this workshop are subject to change.Please check university resources before relying exclusively on this recorded presentation.
Slide3WSU Office of Research Assurances
ORA
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Slide4IntroductionInstitutional Animal Care and Use Committee (IACUC)Institutional Biosafety Committee (IBC)Institutional Review Board (IRB)Radiation Safety Committee (RSC)Conflict of Interest Committee (COIC)Export ControlsResponsible Conduct of ResearchHazardous Materials Shipping ContactsOverview of ORA4
Slide5ORA, established in 2002, is part of the overall effort of WSU to ensure the responsible conduct of research.We work collaboratively with researchers to stay in compliance with applicable internal and external policies and regulations. By staying in compliance we avoid funding delays, funding denials, unpublished research, and in some cases fines and jail.Our philosophy is centered on customer service and helping PIs and departments navigate the labyrinth of laws and policies that affect research at WSU.Introduction5
Slide6Institutional Animal Care and Use Committee (IACUC)6
Slide7The IACUC will…Monitor animal researchAddress occupational health requirementsAddress training requirementsInventory and track animals used for research at all campusesIn order for…Animals to be used safely and humanely in research at WSUIACUC7
Slide8IACUCWho Oversees Animal Research?
USDA
U.S. Department of Agriculture
NIH
National Institutes of Health
OLAW
Office of Lab Animal Welfare
OCV
Office
of the Campus
Vet (WSU)
IACUC
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Slide9IACUCTraining requirements:Animal Awareness Seminars and the Animal Contact Program Review procedures that use animals. Address occupational health requirementsReview of protocols to minimize ethical cost by following:Replacement
Reduction
Refinement
Animals can be used safely and humanely in research
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Slide10Institutional Biosafety Committee (IBC)10
Slide11Reviews procedures for working with potentially hazardous biological materials including:Genetically Modified Organisms (GMOs)Infectious Agents and PathogensHumanAnimalPlantsHuman Tissue and Cells (used in research)Verifies containment practices and facilitiesBiosafety levels (BSL-1, -2, -3)IBC11
Slide12IBC
Who Oversees Research With Biological Materials?
NIH
National Institutes of Health
USDA
U.S. Department of Agriculture
APHIS
Animal and Plant Health Inspection Service
BSO
Biological Safety Officer (Local – WSU’s ORA)
WSU’s IBC
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Slide13Institutional Review Board (IRB)13
Slide14IRBUS National Research Act 1974Established National Commission for Protection of Human SubjectsThe Belmont Report, 1979Code of Federal Regulations, 1981Institutional Review Boards (IRBs)Informed ConsentCommon Rule (45 CFR Part 46), 1991HIPAA Privacy Rule (45 CFR Parts 160, 162, & 164), 200314
Slide15The Institutional Review Board IRB is responsible for the review and approval of all research activities involving human subjects. The IRB protects the rights and welfare of human subjects to ensure that all are treated in such a way as to minimize risk and avoid harm.The guiding principles of the IRB are:Respect for PersonsBeneficenceJusticeIRB15
Slide16IRBWho Oversees Human Subjects Research?
HHS
U.S. Department of Health and Human Services
OHRP
Office for Human Research Protections
FDA
U.S. Food and Drug Administration
WSU’s IRB
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Slide17Radiation Safety Office/Radiation Safety Committee (RSO/RSC)17
Slide18The WSU Radiation Safety Office and Radiation Safety Committee ensures the safe use of radioactive materials and radiation machines on the Pullman campus and other WSU sites around the state. RSO/RSC18As Low As Reasonably
A
chievable
Slide19RSO/RSCNRC U.S. National Radioactivity CommissionDOH Washington Department of HealthWSU’s RSC and RSO
Who Oversees Radiation Safety?
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Slide20RSO/RSCReviews procedures involving work with radioactive materials.Addresses training requirementsMonitors radiation exposure of personnelInventories and tracks radioactive materials
Manages radioactive waste disposal
Audits labs for procedures, documentation, and properly working equipment.
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Slide21Conflict of Interest Committee(COIC)21
Slide22The COI Committee will…Increase accountabilityAdd transparencyEnhance regulatory compliance and effective administrative management of PIs’ financial conflicts of interest. We want to manage conflicts and potential conflicts in order to support entrepreneurship while protecting the reputations of PIs and WSU.COIC22
Slide23COICPHS U.S. Public Health ServiceNSF National Science FoundationFDA U.S. Food and Drug AdministrationOther funding agenciesProfessional organizationsWSU’s COIC
Who Oversees Conflict
of Interest
?
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Slide24COICThe COI Committee reviews all pertinent documentation, including COI management plans, relating to potential or actual financial COI applications.The COIC has the responsibility and authority to assess whether a potential conflict exists assess the extent of the conflict and manage, reduce or eliminate the conflict before approving the research or technology transfer activity.
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Slide25Export Controls25
Slide26Export Controls26It is ultimately each person’s obligation to comply with Export Regulations in respect to their WSU associated activities.Most research activities at WSU are exempted through the Fundamental Research Exemption. Operation of export controlled equipment is allowed for foreign nationals who would otherwise be restricted because of a very specific definition of “use”: operating installing maintaining repairing overhauling and refurbishing
Slide27Export ControlsWho Oversees Export Controls?U.S. Department of Commerce (Bureau of Industry and Security) controls dual-use items
Export Administration Regulations (EAR) – Commerce Control List
U.S. Department of State (Office of Defense Trade Controls) controls defense articles, defense services, and related technical data
International Traffic in Arms Regulations (ITAR) – US Munitions List
U.S. Department of the Treasury oversees U.S. trade embargoes (Office of Foreign Assets Control)
List of specifically designated nations, nationals, and individuals
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Slide28Export ControlsResponsibilities of PIs: Review in advance research for potential EAR/ITAR issues. Apply for a license BEFORE project begins--process can take 2-6 months or longer.*Embargoed CountriesDelivery of services to embargoed countries is not allowed without a license or exception. Contact the ORA before entering into an agreement or providing a service to individuals or institutions from Cuba, Iran, North Korea, Sudan, or Syria.
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Slide29Responsible Conduct of Research(RCR)29
Slide30RCRWho Oversees RCR?State of Washington NIH/NSF
Professional
Organizations
Vice President for Research
Office
Research Assurances
Principal
Investigators
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Slide31RCRRCR trainings on MyResearch for both Faculty/Staff and students.Retraining is required every 5 years. Anyone who is credited on a grant must be current on training. Data Acquisition, Management, Sharing and OwnershipConflict of Interest and CommitmentUse of HumansUse of AnimalsResearch
Misconduct
Publishing Practices and
Authorship
Mentor/Trainee Relationships and
Responsibilities
Peer
Review
Collaborations
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Slide32Hazardous Materials Shipping(HMS)32
Slide33Hazardous Materials ShippingIf a person knowingly, willingly, or recklessly violates a hazardous material regulation, special permit, or approval issued by the DOT, this is considered to be a criminal violation.ORA Hazmat Shipping 509-432-3869Hazardous materials shipments from WSU are handled by the ORA Shipping Coordinators. We will come to your lab or main office, pick up your package with a completed/signed request for shipment, and generate a label and verify that contents are packaged according to the shipping regulations.33
Slide34Hazardous Materials ShippingIs my shipment (potentially) hazardous?34
Dry Ice
Chemicals (including preservatives)
Pathogens
Human specimens
Animal specimens
Radioactive materials*
If your material is hazardous or you are not sure, call:
ORA Hazmat Shipping 509-432-3869
*Radiation Safety 335-8916
Slide35Conclusion
IBC
DHHS/OHRP
WSU Policy/Procedure
NIH
IACUC
WSU RSO
WSU EHS
USDA/APHIS
IRB
FDA
DOT/FAA
PHS
WSU BSO
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Slide36Director (Interim) & Biological Safety Officer (BSO) Mike Kluzik 335-9553 mkluzik@wsu.eduIACUC Coordinator Rani Muthukrishnan 335-7951 rani_m@wsu.eduIRB Coordinator Malathi Jandhyala 335-3668 mjandhyala@wsu.eduIRB & IBC Program Coordinator Patrick Conner 335-7183 patrick_conner@wsu.eduORA/RSO ContactsBiosafety and Hazmat Shipping (HMS) Industrial Hygienist
Ryan Schwager 335-4462
rschwager@wsu.edu
COI, Export Controls, RCR, & HMS Sheri Glaesman 335-0039
sglaesman@wsu.edu
IRB Coordinator
Ayesha Ahmed 368-6667
ayesha.ahmed@wsu.edu
Slide37ORA/RSO ContactsRadiation Safety OfficerJean Cloran 335-7057jcloran@wsu.eduHealth Physicist Kreta Johnson 335-7058 kretaj@wsu.eduRadiation Safety Technician III Sonja Fenimore 335-8175 katmere@wsu.eduAssistant RSORey McGehee 335-6763 rmcgehee@wsu.eduRadiation Safety Technician III Scott Finch 335-4221 sfinch@wsu.edu
Slide38www.ora.wsu.eduThank You!
Slide39If you attended this live training session and wish to have your attendance documented in your training history, please notify Human Resource Services within 24 hours of today's date: hrstraining@wsu.edu
This has been a WSU Training Videoconference