Transcript Document

Office of Research Integrity
Office of Research Integrity
Orientation Session
November 8, 2012
ECSS 2.102
Office of Research Integrity
Office of Research Integrity
• Institutional Review Board (IRB)
• Institutional Animal Care and Use Committee
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(IACUC)
Lab Safety
Responsible Conduct of Research (RCR)
Conflict of Interest (COI)
Export Control
Office of Research Integrity
Institutional Review Board (IRB)
• Protection of rights of human subjects in UTD
affiliated research studies
– Review all research activities done by UTD faculty, staff,
and/or students with human subjects
– Research located on and off campus
– Research collaborations with other universities
– Funded and non-funded
Office of Research Integrity
IRB: Approval Process
• Acquire IRB approval before research begins (includes
pre-testing, recruiting, and analyzing archival data)
• Categories: Minimal, Expedited, and Full Board Review
– Consult with Sanaz Okhovat or Saki McCallister prior to
completing applications
– Download applications from IRB website to ensure use of
current forms
• Complete human subjects training through NIH or CITI
and submit a copy of certificate
• Please allow ample time for review process
http://www.utdallas.edu/research/ori/irb/
Office of Research Integrity
IACUC
• The Institutional Animal Care and Use Committee
(IACUC) reviews research involving live animals
– The Committee is mandated by two Federal agencies: the
United States Department of Agriculture (USDA) and
National Institutes of Health (NIH)
– The Committee is charged with reviewing the UTD Lab
Animal Research program, approving research protocols,
and inspecting the vivarium and laboratories where animal
research is conducted
Office of Research Integrity
IACUC
• Research is carried out in compliance with regulatory agencies
overseeing the use of animals including: the USDA, Office of
Laboratory Animal Welfare (OLAW), and the NIH
– In conjunction with the ORI, the IACUC, and attending Veterinarians, research
facilities provide care and housing for animals used judiciously in scientific
research
– Instruction and hands-on training provided in the use of approved lab animal
models
– Provides support to Research Investigators throughout protocol terms
• For questions, please contact Kathan McCallister @ (972) 8832465 or by e-mail at [email protected]
http://www.utdallas.edu/research/ori/iacuc/
Office of Research Integrity
Lab Safety
• Campus-wide training coordination and delivery of
laboratory safety courses
• Implementation of web-based system for training
content delivery
– Lab-based management of content
– Training assignment integrated with multiple lab-based
compliance needs
– Repository for training records
• Inter-university partnership for best practices for
content development
Office of Research Integrity
Lab Safety
• Training Management System
– Lab-based structure
• Each PI has a lab account
• Research personnel are registered to a lab
• System access using NetID and password
– Training courses
• Based on activities conducted by members in the lab
• Web-based content delivery and ability to schedule live sessions
– Linked to other compliance features
• Inspections
• Hazardous Chemicals
• Lab Equipment
http://www.utdallas.edu/research/ori/lab_safety_training/
Office of Research Integrity
Responsible Conduct of Research
• Research misconduct is defined as “fabrication, falsification,
or plagiarism in proposing, performing, or reviewing research,
or in reporting research results” (NSF, http://www.nsf.gov/oig)
• Responsible conduct of research (RCR) encompasses all
aspects of research with the goal of fostering integrity and
deterring misconduct in research
• NSF and NIH requirements
– Training requirements vary for NSF and NIH Grants
– Resources and training provided as necessary based on specific
research requirements
Contact Office of Research Integrity by email at [email protected]
www.citiprogram.org
Office of Research Integrity
Conflict of Interest (COI) Disclosure
• The Research Investigator Financial Disclosure
must be completed annually by all UT Dallas
principal and co-principal investigators on
external grants
• Annual reminders are sent via email
• Changes in financial interest occurring within the
reporting period must be disclosed by submitting
an updated disclosure
• NIH-funded investigators are also required to
complete an online conflict of interest training
hosted by CITI
Office of Research Integrity
Conflict of Interest Management
• The Office of Research Integrity uses the Research
Investigator Financial Disclosure to collect information
from researchers regarding financial interests related to
their Institutional Responsibilities at UTD
• Most financial interests disclosed by UTD researchers do
not require management under the COI policy
• When a COI is identified, the Office of Research Integrity
implements a COI Management Plan to mitigate or
manage the COI
http://www.utdallas.edu/research/ori/conflict_of_interest/
Office of Research Integrity
Export Control
• Export Control Regulations involve:
– Export Administration Regulations (EAR), which regulate
the export of dual-use technologies listed on the
Commerce Control List; and
– International Traffic in Arms Regulations or ITAR, which
regulate the export of military technologies listed on the
United States Munitions List (USML)
• University research traditionally falls under the
Fundamental Research Exclusion, which includes
basic or applied research in science
Office of Research Integrity
Export Control
• Fundamental Research Exclusion does not apply if a
grant of contract includes clauses that:
– Give a sponsor the right to approve publication; or
– Restrict participation of foreign nationals in research
• ORI will assist PI to develop a Technology Control Plan
to address requirements
• International Travel requires a B16 form signed and
approved by ORI
http://www.utdallas.edu/research/ori/export_control/
Office of Research Integrity
Contact Us
Sanaz Okhovat: Senior Director of Research Integrity
phone: (972) 883-4579 email: [email protected]
Saki McCallister: Research Integrity Coordinator: IRB
phone: (972) 883-4577 email: [email protected]
Shane Solis: Research Integrity Coordinator: Lab Safety/RCR
phone: (972) 883-4730 email: [email protected]
Conor Wakeman: Research Integrity Coordinator: COI/Export Control
phone: (972) 883-4718 email: [email protected]
Kathan McCallister: Animal Program Manager/IACUC
phone: (972) 883-2465 email: [email protected]
Office: AD 3.218
Website: http://www.utdallas.edu/research/ori/