1. Office Of Research Assurances (ORA)
5/29/2018
Overview of the
Office Of Research Assurances (ORA)
Office of Research Assurances
205 Albrook, Pullman
Updated January 2015

2. January 16, 2015 Recording date of this workshop is
5/29/2018
Recording date of this workshop is
January 16, 2015
Some of the rules and procedures discussed in this workshop are subject to change.
Please check university resources
before relying exclusively
on this recorded presentation.
Template-WSU Hrz 201.ppt

3. WSU Office of Research Assurances
ORA

4. Overview of ORA Introduction
5/29/2018
Overview of ORA
Introduction
Institutional Animal Care and Use Committee (IACUC)
Institutional Biosafety Committee (IBC)
Institutional Review Board (IRB)
Radiation Safety Committee (RSC)
Conflict of Interest Committee (COIC)
Export Controls
Responsible Conduct of Research
Hazardous Materials Shipping
Contacts

5. 5/29/2018
Introduction
ORA, 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By staying in compliance we avoid funding delays, funding denials, unpublished research, and in some cases fines and jail.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.

6. Care and Use Committee (IACUC)
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Institutional Animal
Care and Use Committee (IACUC)

7. IACUC The IACUC will… Monitor animal research
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IACUC
The IACUC will…
Monitor animal research
Address occupational health requirements
Address training requirements
Inventory and track animals used for research at all campuses
In order for…
Animals to be used safely and humanely in research at WSU

8. Who Oversees Animal Research?
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IACUC
Who 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

9. Animals can be used safely and humanely in research
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IACUC
Training requirements:
Animal Awareness Seminars and the Animal Contact Program
Review procedures that use animals.
Address occupational health requirements
Review of protocols to minimize ethical cost by following:
Replacement
Reduction
Refinement
Animals can be used safely and humanely in research

10. Institutional Biosafety Committee (IBC)
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Institutional Biosafety
Committee
(IBC)

11. 5/29/2018
IBC
Reviews procedures for working with potentially hazardous biological materials including:
Genetically Modified Organisms (GMOs)
Infectious Agents and Pathogens
Human
Animal
Plants
Human Tissue and Cells (used in research)
Verifies containment practices and facilities
Biosafety levels (BSL-1, -2, -3)

12. Who Oversees Research With Biological Materials?
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IBC
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

13. Institutional Review Board (IRB)
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Institutional Review Board
(IRB)

14. US National Research Act 1974
IRB
US National Research Act 1974
Established National Commission for Protection of Human Subjects
The Belmont Report, 1979
Code of Federal Regulations, 1981
Institutional Review Boards (IRBs)
Informed Consent
Common Rule (45 CFR Part 46), 1991
HIPAA Privacy Rule (45 CFR Parts 160, 162, & 164), 2003

15. 5/29/2018
IRB
The 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 Persons Beneficence Justice

16. Who Oversees Human Subjects Research?
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IRB
Who 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

17. Radiation Safety Office/Radiation Safety Committee (RSO/RSC)
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Radiation Safety Office/Radiation Safety Committee
(RSO/RSC)

18. RSO/RSC As Low Reasonably Achievable
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RSO/RSC
The 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.  As
Low
Reasonably
Achievable 

19. Who Oversees Radiation Safety?
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RSO/RSC
Who Oversees Radiation Safety?
NRC U.S. National Radioactivity Commission
DOH Washington Department of Health
WSU’s RSC and RSO

20. RSO/RSC Reviews procedures involving work with radioactive materials.
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RSO/RSC
Reviews procedures involving work with radioactive materials.
Addresses training requirements
Monitors radiation exposure of personnel
Inventories and tracks radioactive materials
Manages radioactive waste disposal
Audits labs for procedures, documentation, and properly working equipment.

21. Conflict of Interest Committee (COIC)
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Conflict of Interest Committee
(COIC)

22. COIC The COI Committee will… Increase accountability Add transparency
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COIC
The COI Committee will…
Increase accountability
Add transparency
Enhance 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.

23. Who Oversees Conflict of Interest?
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COIC
Who Oversees Conflict of Interest?
PHS U.S. Public Health Service
NSF National Science Foundation
FDA U.S. Food and Drug Administration
Other funding agencies
Professional organizations
WSU’s COIC

24. 5/29/2018
COIC
The 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.

25. 5/29/2018
Export Controls

26. 5/29/2018
Export Controls
It 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

27. Who Oversees Export Controls?
5/29/2018
Export Controls
Who 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

28. Export Controls Responsibilities of PIs:
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Export Controls
Responsibilities 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 Countries
Delivery 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.

29. 5/29/2018
Responsible
Conduct
of Research
(RCR)

30. Who Oversees RCR? RCR State of Washington NIH/NSF
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RCR
Who Oversees RCR?
State of Washington
NIH/NSF
Professional Organizations
Vice President for Research
Office Research Assurances
Principal Investigators

31. RCR RCR trainings on MyResearch for both Faculty/Staff and students.
5/29/2018
RCR
RCR 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 Ownership
Conflict of Interest and Commitment
Use of Humans
Use of Animals
Research Misconduct
Publishing Practices and Authorship
Mentor/Trainee Relationships and Responsibilities
Peer Review
Collaborations

32. Hazardous Materials Shipping (HMS)
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Hazardous Materials Shipping
(HMS)

33. Hazardous Materials Shipping
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Hazardous Materials Shipping
If 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
Hazardous 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.

34. If your material is hazardous or you are not sure, call:
5/29/2018
Hazardous Materials Shipping
Is my shipment (potentially) hazardous?
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
*Radiation Safety

35. Conclusion IBC DHHS/OHRP NIH IACUC WSU RSO WSU EHS USDA/APHIS IRB FDA
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Conclusion
IBC
DHHS/OHRP
WSU Policy/Procedure
NIH
IACUC
WSU RSO
WSU EHS
USDA/APHIS
IRB
FDA
DOT/FAA
PHS
WSU BSO

36. 5/29/2018
ORA/RSO Contacts
Director (Interim) &
Biological Safety Officer (BSO)
Mike Kluzik
IACUC Coordinator
Rani Muthukrishnan
IRB Coordinator
Malathi Jandhyala
IRB & IBC Program Coordinator
Patrick Conner
Biosafety and Hazmat Shipping (HMS) Industrial Hygienist
Ryan Schwager
COI, Export Controls, RCR, & HMS Sheri Glaesman
IRB Coordinator
Ayesha Ahmed

37. 5/29/2018
ORA/RSO Contacts
Radiation Safety Officer Jean Cloran Health Physicist Kreta Johnson Radiation Safety Technician III Sonja Fenimore
Assistant RSO Rey McGehee Radiation Safety Technician III Scott Finch

38. 5/29/2018
Thank You!

39. This has been a WSU Training Videoconference
5/29/2018
This has been a WSU Training Videoconference
If 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:
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