Office of Research Integrity Orientation Session

1. Office of Research IntegrityOrientation Session November 8, 2012 ECSS 2.102

2. 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

3. 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

4. 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/

5. 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

6. 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/

7. 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

8. 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/

9. 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

10. 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

11. 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/

12. 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

13. 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/

14. Contact Us Sanaz 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 3.218 Website:http://www.utdallas.edu/research/ori/