Regulatory Compliance at NAU - Northern Arizona University

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Office of the Vice President for Research
www.research.nau.edu
Commitment to Research Integrity
Northern Arizona University is committed to the
highest quality research conducted with integrity and
accountability. Through its Responsible Conduct of
Research (RCR) program, the Office of the Vice
President for Research provides training on research
ethics to faculty, students, and staff.
Responsible Conduct of Research
(RCR)
 Ethical research practices are not just expected, but
required from everyone in the NAU community
(faculty, students, and staff)
 Relates to ALL research, whether biological, social &
behavioral, educational, etc.
 RCR courses available online
 See the VPR website for related policies on Research
Misconduct and Conflict of interest
Areas of Compliance
and Research Accountability
 Ethical and responsible
 Laboratory safety
conduct of research
 Protection of human
participants (IRB)
 Protection of animals in
research (IACUC)
 Protection against
biohazards and
biological agents (IBC)
 Occupational health and
safety
 Export control
 Permits
 Conflict of interest
IRB – Institutional
Review Board
What is
the
purpose
of the
IRB?
 To review all research involving
human participants and make
sure federal and state guidelines
are followed
 To ensure minimization of risks
to participants
 To ensure confidentiality of
private information
 To ensure full disclosure of
research methods, procedures,
outcomes, risks, and benefits
What projects require IRB review?
 Any research involving interaction with living
individuals or the collection of personal identifiable
information
 Educational, social & behavioral and biomedical
research whether funded or unfunded
 Dissertations and theses involving human subjects
 Research that is published, presented, or contributes
to the field as generalizeable knowledge
 See research.nau.edu/compliance/IRB for more
information
IACUC –
Institutional Animal
Care and Use
Committee
What is
the
purpose
of the
IACUC?
 To review all research involving
vertebrate animals and make
sure federal and state guidelines
are followed
 To assist with expert care of
animals throughout research
phases
 To provide training in animal
lab techniques and lab animal
science
What projects require IACUC
review?
 Any work in labs or in the field involving live vertebrate
animals in teaching, laboratory demonstrations, or
research
 Animals euthanized for research, teaching purposes, or
tissues obtained from a live animal
 All personnel listed on IACUC protocols and all individuals
who have contact with animals (in labs or in the field) must
complete training before working with animals
 See research.nau.edu/compliance/IACUC for information
regarding IACUC policies and animal related research
IBC – Institutional
Biosafety Committee
What is
the
purpose
of the
IBC?
 To ensure expert review and




monitoring of potentially hazardous
materials and experiments
To ensure adequate containment of
potentially hazardous biologicals,
recombinants, toxins and
transgenic/KO animals
To monitor, at a minimum, on an
annual basis the experiments and the
facilities
To provide a means of communication
among researchers, management,
IACUC, IRB and IBC the potentially
hazardous protocols
To ensure that NIH and other
regulatory guidelines are followed,
documented and reviewed
What requires IBC review?
 Any research involving recombinant DNA, toxins,
transgenic/knockout animals and level 2 & 3
biological agents
 Any work with hazardous plants, animals, and
insects
 New labs and research facilities that may house
the projects listed above
 Reviews are required before the work begins or any
materials are procured
 See research.nau.edu/compliance/orc/biosafety
Environmental Health & Safety (EH&S)
Office of Regulatory Compliance (ORC)
 Manages chemical and radiation safety programs
 Manages environmental (air, water, and waste)
program
 Coordinates the loss prevention program
 Provides hazard evaluation, compliance assessment,
and hazardous material shipping
 Provides applicable training and manuals
Assistance available for:
 job hazard
 ergonomic
assessments
 compliance audits
 exposure
monitoring
 safety training, or
materials
 hazardous waste
disposal
assessment
 environmental
permitting
questions
 asbestos inspections
 Contact EH&S at
research.nau.edu/co
mpliance/ORC
Permits are required for:
 the import or export of any material that contains
biologics, e.g., soils, DNA, animals and plants or
animal/plant parts or pieces,
 certain chemicals and radioactive material
 controlled pharmaceuticals
 access to reservation lands
 the banding/tracking of wild animals
How to get a permit:
 Permits can take anywhere from 2 weeks to 6 months
to get, depending on the agency
 Contact John McGregor (John.McGregor@nau.edu),
Director of Regulatory Compliance, for a permit or
question about permits
 See research.nau.edu/compliance/ORC for more
information
Export Control
 Due to national security concerns, the remittance of
certain items and materials outside of the United
States may require a permit from a government agency
 If you are not sure if something you are sending,
delivering, or carrying with you out of U.S. requires a
permit, contact ORC and they will research the
regulations for you
 Contact research.nau.edu/compliance/ORC
Conflict of Interest
 All university employees embarking on research must
disclose their or their spouse’s financial interests
greater than $10,000
 Disclosures are reported to and reviewed by the Office
of the Vice President for Research and enforced by the
Grant & Contract Services
 Failure to comply could result in disciplinary action
taken by the University or funding agency
 For more information, see
research.nau.edu/compliance/policies
More Resources
 For RCR, IRB, and IACUC online trainings, go to
www.citiprogram.org
 For NAU Research policies, see
research.nau.edu/compliance/policies
 The U.S. Department of Health and Human Services,
Office of Research Integrity is at ori.dhhs.gov
Any QUESTIONS??
Our contact information:
 Sarah Ells, Loss Prevention Coordinator, 523-3961,
Sarah.Ells@nau.edu
 Paula Garcia McAllister, IRB Director, 523-4236,
Paula.Garcia@nau.edu
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