1/14/2015 Overview of the Office Of Research Assurances (ORA) - - PDF document

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1/14/2015 Overview of the Office Of Research Assurances (ORA) - - PDF document

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1/14/2015 Overview of the Office Of Research Assurances (ORA) Office of Research Assurances 205 Albrook, Pullman http://www.ora.wsu.edu January 2015 Recording date of this workshop is January 16, 2015 Some of the rules and procedures

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Overview of the Office Of Research Assurances (ORA)

Office of Research Assurances 205 Albrook, Pullman http://www.ora.wsu.edu

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. Please check university resources before relying exclusively

  • n this recorded presentation.

WSU Office of Research Assurances

ORA

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  • 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

Overview of ORA

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  • 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unpublished research, and in some cases fines and jail.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.

Introduction

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Institutional Animal Care and Use Committee (IACUC)

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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

IACUC

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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

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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:

Animals can be used safely and humanely in research

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Institutional Biosafety Committee (IBC)

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  • 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)

IBC

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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

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Institutional Review Board (IRB)

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IRB

US National Research Act 1974

  • Established National Commission for Protection
  • f 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

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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:

IRB

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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

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

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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.

RSO/RSC

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RSO/RSC

NRC U.S. National Radioactivity Commission DOH Washington Department

  • f Health

WSU’s RSC and RSO

Who Oversees Radiation Safety?

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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.

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Conflict of Interest Committee (COIC)

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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

  • rder to support entrepreneurship while protecting the

reputations of PIs and WSU.

COIC

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COIC

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

Who Oversees Conflict of Interest?

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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.

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Export Controls

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Export Controls

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  • 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”:

  • perating
  • installing
  • maintaining
  • repairing
  • verhauling and
  • refurbishing

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

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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.

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Responsible Conduct

  • f Research

(RCR)

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RCR

Who Oversees RCR?

  • State of Washington
  • NIH/NSF
  • Professional Organizations
  • Vice President for Research
  • Office Research

Assurances

  • Principal Investigators

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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

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Hazardous Materials Shipping (HMS)

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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 509-432-3869

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.

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Hazardous Materials Shipping Is my shipment (potentially) hazardous?

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  • 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 Conclusion

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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Director (Interim) & Biological Safety Officer (BSO) Mike Kluzik 335-9553 mkluzik@wsu.edu IACUC Coordinator Rani Muthukrishnan 335-7951 rani_m@wsu.edu IRB Coordinator Malathi Jandhyala 335-3668 mjandhyala@wsu.edu IRB & IBC Program Coordinator Patrick Conner 335-7183 patrick_conner@wsu.edu

ORA/RSO Contacts

Biosafety 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

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ORA/RSO Contacts

Radiation Safety Officer Jean Cloran 335-7057 jcloran@wsu.edu Health Physicist Kreta Johnson 335-7058 kretaj@wsu.edu Radiation Safety Technician III Sonja Fenimore 335-8175 katmere@wsu.edu Assistant RSO Rey McGehee 335-6763 rmcgehee@wsu.edu Radiation Safety Technician III Scott Finch 335-4221 sfinch@wsu.edu

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:

hrstraining@wsu.edu

This has been a WSU Training Videoconference

www.ora.wsu.edu

Thank You!