Regulatory Compliance at NAU - Northern Arizona University
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Transcript Regulatory Compliance at NAU - Northern Arizona University
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 ([email protected]),
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,
[email protected]
Paula Garcia McAllister, IRB Director, 523-4236,
[email protected]