Office of Research Integrity

Office of Research IntegrityOrientation Session

November 8, 2012ECSS 2.102

Office of Research Integrity

Office of Research Integrity• Institutional Review Board (IRB)• Institutional Animal Care and Use Committee (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) 883-2465 or by e-mail at kathan.mccallister@utdallas.edu

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

• 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/

Lab Safety

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 shane.solis@utdallas.edu

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 UsSanaz Okhovat: Senior Director of Research Integrity

phone: (972) 883-4579 email: sanaz.okhovat@utdallas.edu

Saki McCallister: Research Integrity Coordinator: IRBphone: (972) 883-4577 email: saki.mccallister@utdallas.edu

Shane Solis: Research Integrity Coordinator: Lab Safety/RCRphone: (972) 883-4730 email: shane.solis@utdallas.edu

Conor Wakeman: Research Integrity Coordinator: COI/Export Control phone: (972) 883-4718 email: conor.wakeman@utdallas.edu

Kathan McCallister: Animal Program Manager/IACUCphone: (972) 883-2465 email: kathan.mccallister@utdallas.edu

Office: AD 3.218Website: http://www.utdallas.edu/research/ori/