Office of Research Compliance Office of the Vice Chancellor for Research & Innovation

1. Office of Research ComplianceOffice of the Vice Chancellor for Research & Innovation Jason Ramage Assistant Vice Provost for Research & Director, Research Compliance ramage@uark.edu 479-575-2105 109 MLKG 1424 West Martin Luther King, Jr. Boulevard Fayetteville, AR 72701 Phone: 479-575-4572 Fax: 479-575-6527 https://research.uark.edu/units/rscp/

2. Areas of Oversight • Animal Care and Use • Biological Safety • Conflict of Interest/Conflict of Commitment • Export Control • Human Subjects Research • Research Misconduct

3. Additional Areas of Support • Toxic Substances and Radiation Safety Committees* • Data Use Agreements** • Training Agreements** • Material Transfer Agreements** • DEA Licensing * in collaboration with the Office of Environmental Health and Safety ** in collaboration with the Office of General Counsel, as needed

4. Animal Care and Use

5. Animal Care and Use • The Institutional Animal Care and Use Committee (IACUC) oversees all research, teaching, and training activities involving animals covered by either the PHS Policy on Humane Care and Use of Laboratory Animals (“PHS Policy”) or the USDA Animal Welfare Act and Regulations (AWAR) • The IACUC conducts the semiannual inspections of University facilities and animal program review. A report is submitted to the Institutional Official (Dan Sui, VCRI). Annual reports are submitted to USDA and to the Office of Laboratory Animal Welfare (OLAW). • The Office of Research Compliance maintains the University’s Animal Welfare Assurance with OLAW. • The Office of Research Compliance operates the Central Laboratory Animal Facility (CLAF) and supports animal activities at the off-campus Engineering Research Center (ENRC)

6. What to Look For • Any research proposal involving the use of live, vertebrate animals in research and teaching must be submitted to and reviewed by the IACUC. • Live, vertebrate animals include (this is not a comprehensive list): • Mice - Chickens - Cows • Rats - Fish - Pigs • Hamsters - Snakes - Horses • It excludes bugs (Drosophila [fruit fly] projects don’t need IACUC approval), worms, octopi, crabs, sponges • UA Policy does not permit research with domestic dogs, domestic cats, or nonhuman primates • Projects that use tissues or other materials, rather than live animals, won’t require IACUC review but may require IBC or IRB review

7. Studies involving passive observation of animals in nature (e.g. counting the number of birds that alight on a particular tree in the park) do not require IACUC approval • If anyone interacts in any way with those animals (e.g. tagging animals, or catching them and bringing them to the lab) then IACUC approval is required • Non-stressful observations of farm animals in farm management practices, as part of Ag teaching, does not require IACUC approval

8. Biological Safety

9. Oversight of biological safety is a responsibility shared by the Office of Research Compliance and the Office of Environmental Health and Safety EHS and the Biological Safety Officer (Jim Hogan) are responsible for laboratory safety, inspections, and training. Research Compliance is responsible for the review and approval of biological research protocols, through the Institutional Biosafety Committee.

10. Institutional Biosafety Committee (IBC) • The Institutional Biosafety Committee (IBC) reviews and approves all university protocols subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules • The IBC also oversees university research involving Risk Group 2 and Risk Group 3 microbial agents; biological toxins; human and non-human primate materials; transgenic plant; and mammalian tumor cell lines • The IBC is registered with the NIH Office of Science Policy (OSP) • The Office of Research Compliance works closely with Environmental Health & Safety for ongoing oversight.

11. What to Look For Research proposals involving rDNA (recombinant and/or synthetic nucleic acid molecules [DNA, RNA]; Risk Group 2 or Risk Group 3 microorganisms; transgenic plants; transgenic animals; biological toxins; bloodborne pathogens; human and/or nonhuman primate materials (blood, serum, tissues, etc.); and mammalian tumor cell lines must be reviewed and approved by the IBC Ebola

12. Human Subjects Research

13. Human Subjects Research • The Institutional Review Board (IRB) oversees all university human subjects research, including unfunded research, to ensure compliance with The Common Rule and other applicable regulations • The Office of Research Compliance, in collaboration with the IRB, is updating University policies and procedures to align with revisions to federal regulations that were effective on January 21, 2019 • The IRB is registered with the HHS Office of Human Research Protections (OHRP) • The Office of Research Compliance maintains the University’s Federalwide Assurance

14. What is Human Subjects Research? Question 1: Is it Research? Research, as defined in 45 CFR 46, means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Question 2: Does it involve human subjects? As defined in 45 CFR 46, human subject means a living individual about whom an investigator (whether professional or student) conducting research: a) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; b) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Activities meeting both these conditions are considered HSR and subject to review and approval by the Institutional Review Board (IRB) regardless of funding source or status.

15. Examples of activities not considered HSR (and therefore don’t require submission of a protocol to the IRB) • Scholarly and journalistic activities including oral histories; journalism; biographies; literary criticism; legal research; historical research. • Public health surveillance activities including collection and analyses of biospecimens conducted, supported, requested, ordered, required, or authorized by a public health authority. • Collection and analyses of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or a court order solely from criminal justice or investigative purposes. • Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions. • Data collection for administrative purposes (e.g. teaching evaluations; customer service surveys) • Information-gathering interviews focused on things, products, or policies • Class projects designed to provide training in research methodology • Program evaluation/quality improvement/quality assurance projects. These activities may involve human subjects but do not meet the definition of research.

16. Export Controls

17. Three Main U.S. Agencies Department of State (Directorate of Defense Trade Controls [DDTC]) Defense articles & services (International Traffic in Arms Regulations [ITAR]/United States Munitions List [USML]) Department of Commerce (Bureau of Industry and Security [BIS]) Dual use items (Export Administration Regulations [EAR]/Commerce Control List [CCL]) Department of Treasury (Office of Foreign Assets Control [OFAC]) Embargoes & sanctions (Foreign Assets Control Regulations [FACR])

18. Complex Framework of Laws Directed At: • Restriction on exports of items that could contribute to the military capabilities of our rivals • Prevention of proliferation of weapons of mass destruction (nuclear, biological, chemical) • Compliance with trade agreements and sanctions against nations/parties • Prevention of terrorism Export Control Restrictions Items: • International shipment of tangible items • Technology & source code to non-U.S. persons (even within U.S.) Contingent On: • What is it? (classification) • Where is it going? (country/foreign nationals) • Who will receive it? (restricted party screening) • What will they do with it? (ultimate end-user/end-use)

19. What Can You Do? Engage RSCP For Guidance if Research Includes: • Any activity in embargoed country (Cuba, Iran, North Korea, Sudan (North), Syria or Crimean region of Ukraine) • Collaboration or transactions with foreign persons or entities • Confidential/proprietary technology • Publication, participation or access restrictions • Military or defense related items • International shipments or travel

20. Research Misconduct The Office of Research Compliance assists the Research Integrity Officer (VCRI Dan Sui) in reviewing and investigating allegations of misconduct involving: • Fabrication • Falsification • Plagiarism Allegations of misconduct involving students may be handled through the Academic Integrity Policy

21. Conflict of Interest/ Conflict of Commitment • COI Disclosures must be filled out and submitted on an annual basis AND whenever a new conflict or potential conflict arises • A Conflict Management Plan may be required • Faculty members (tenured and tenure-track) may require the approval of the Provost for outside employment activities • The UA COI Policy is being revised to be more accessible and helpful

22. DUAs, MTAs, Training Agreements • Signing authority for these agreements has been delegated to the Research Compliance Director • The Office of Research Compliance will review incoming agreements and will work with researchers to develop outgoing agreements as needed • Agreements will be sent to the Office of General Counsel as needed for legal review

23. Who yagonna call? Shatara Porchia-White Candita Meek IBC Coordinator Export Compliance Coordinator ibc@uark.educanditam@uark.edu - IBC; Biological Safety - ITAR/EAR/OFAC 479-575-2671 - Foreign Travel; Foreign Visitors and Collaborations 479-575-5054 Tina Poseno Sarah Santos IACUC Coordinator & CLAF Manager Compliance Coordinator iacuc@uark.edussantos@uark.edu - IACUC; Animal Facility - Radiation Safety and Toxic Substances 479-575-2994 - CLAF Billing; RSCP Accounting 479-575-6725 Ro Windwalker IRB Coordinator irb@uark.edu - IRB; Human Subjects Research 479-575-2208 In-depth training on each area is available through EDP! Subscribe to the RSCP Listserv for compliance updates!