1. Office of Research Compliance working to support Research Integrity Lisa Kelly, R-LATG Compliance Training Coordinator Quality Assurance Coordinator

2. Office of Research Compliance 2 conformity in adhering to official requirements

3. Office of Research Compliance 3 …An unwavering commitment to do the right thing

4. Office of Research Compliance Reduce Burden 4  Streamline regulatory process  Provide good customer service  Reduce administrative burden  Facilitate Science 42% of a Researcher’s time is consumed by administrative tasks

5. Office of Research Compliance Departments and Program 5 Research Integrity

6. Office of Research Compliance 6 Oversight of the use of animals in scientific investigation and instruction managing the compliance activities of the IACUC administering the research support functions of URAR

7. Office of Research Compliance Federal Laws and Guidelines 7 Animal Welfare Act / Regulations PHS Policy U.S.Govt Principles The “Guide” The “Ag Guide” LAWGUIDELINES

8. Office of Research Compliance UGA’s Animal Care and Use Program 8  Biomedical and Veterinary Program are PHS-Assured – so UGA can accept federal funding  Biomedical and Veterinary Program are fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) – Gold Seal for ACU Program

9. Office of Research Compliance 9 Institutional Animal Care and Use Committee 5 Veterinarians 7 Scientists 1 Animal Care Technician 2 Non-Scientists Unaffiliated “Community Members” 1 Environmental Safety Professional 1 Biosafety Professional

10. Office of Research Compliance Animal Use Protocol 10 Must be faculty to submit an Animal Use Protocol (AUP). AUPs are categorized A-D depending on the potential for pain or distress. AUPs have a 3-year lifespan but are renewed annually. Training compliance is required prior to AUP approval.

11. Office of Research Compliance Animal Care and Use Training 11  IACUC 101 (Refresher every 3 years)  Staying Healthy Both found on the AALAS Learning Library Now access through the GEAR website at http://gear.ovpr.uga.edu Use UGA MyID and Passwordhttp://gear.ovpr.uga.edu  1 hour of CE every 3 years  Occupational Health Questionnaire Must return even if participation is declined

12. Office of Research Compliance 12 You cannot use animals in research or instruction without an APPROVED Animal Use Protocol.

13. Office of Research Compliance Office of Animal Care and Use 13  Dr. Chris King – Director  Tammy Bridges– Administrative Specialist  Eric Smith – IACUC Coordinator  Chris Carter – Compliance IT Administrator  Lisa Kelly – Compliance Training Coordinator

14. Office of Research Compliance University Research Animal Resources 14 Provides appropriate husbandry and handling of laboratory animals through animal facility management, technical assistance, training and consultation Life Sciences and Vet Med divisions are in the process of consolidating.

15. Office of Research Compliance URAR Personnel 15 Life SciencesVeterinary Medicine  Dr. Leanne Alworth (Dir/AV)) Robin Kavanaugh (manager) Lauren Luken (office)  Lisa Wilson – Coverdell  Kristine Wilcox – Life ADS Psychology  Todd McDaniel – Biosciences Other off campus facilities  Dr. Stephen Harvey (Dir/AV) Angelia Chappelear (office) Ben Bonner (manager)  Frank Waters – VBF  Missy Waters – Central  Jeffrey Martin – AHRC Greg Eidson (manager) – PDRC Other off campus Vet Med facilities Will soon have a URAR Director

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17. Office of Research Compliance 17 Provides guidance and assistance to protect faculty, staff and students from exposure to biohazardous materials and to guard against the release of these material. Biosafety also provides administrative support to the IBC and administers the SA program for UGA.

18. Office of Research Compliance Federal Laws, Guidelines and Programs 18  NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules  National Select Agent Registry (SAP) Title 42 CFR Part 73, Title 9 CFR Part 121, Title 7 CFR Part 331 US Govt Policy for Oversight of Life Sciences Dual Use Research of Concern  Other state and federal laws that apply to biological research  Biosafety in the Microbiological & Biomedical Laboratory (BMBL)  OSHA Bloodborne Pathogens Standard  Arthropod Containment Guidelines (ACG)  Etiologic Agent Import Permit Program (EAIPP)  USDA APHIS Permitting Program Animal and Animal Products Veterinary Biologics Biotechnology (e.g. genetically engineered organisms) Plant, Organisms, and Soil

19. Office of Research Compliance When is an IBC protocol required? 19 For all research and teaching projects involving:  Recombinant DNA (including transgenic animals and plants)  Select Agents and Toxins  All human or plant pathogens, RG2 or greater  Animal pathogens that cause diseases reportable to the State Veterinarian  Plant pathogens that are not indigenous to the state  Any diagnostic testing that involves propagation of RG3 pathogens or Select Agents and Toxins for use as a test reagent

20. Office of Research Compliance Questionnaire 20 Paper form found on the Biosafety website at www.ovpr.uga.edu/biosafetywww.ovpr.uga.edu/biosafety Must be faculty to submit an IBC Protocol. Post-docs may submit if faculty is listed as Co-PI. IBC Protocols must be renewed yearly using Annual Renewal Form for up to 5 years. Training dependent on Biosafety Risk Group assessment.

21. Office of Research Compliance 21 Institutional Biosafety Committee 5 Scientists 1 Biosafety Professional 1 Laboratory Technician 2 Unaffiliated “Community Members” 1 is an Occ Health Physician 1 Environmental Safety Professional 1 Attending Veterinarian

22. Office of Research Compliance Risk Groups and Biosafety Levels 22  BSL1 – Well characterized agents not known to cause disease in healthy adults  BSL2 – Agents associated with human disease which is rarely serious or for which preventive or therapeutic interventions are often available  BSL3 – Agents that are associated with serious or lethal human disease for which preventative or therapeutic interventions may be available (high individual risk, low community risk) The correlation between Risk Group and Biosafety level depends on risk assessment (e.g. quantity, how it is used, etc.)

23. Office of Research Compliance Biosafety Training 23  Recommended for anyone working with biohazardous materials – “Proficiency in Standard and Special Microbiological Practices” form on Biosafety website Required of Select Agent Program personnel  Anyone working with human pathogens – PI-lead orientation prior to beginning work and annually thereafter  Human (maybe NHP) body fluids, tissues or cell lines – Board of Regents Bloodborne Pathogens Training – www.usg.edu/facilities/training/pathogens/ www.usg.edu/facilities/training/pathogens/  Select Agents – agent specific training as required by the Responsible Official  Occupational Health Questionnaire (same form as OACU) Must return even if participation is declined

24. Office of Research Compliance IBC Protocol Types 24  Full Committee Recombinant DNA research All BSL3 or higher work Research involving a Select Agent or Toxin  Subcommittee Research involving reportable animal pathogens Research involving non-indigenous plants Risk Group 2 human or zoonotic pathogens (not Select Agents)

25. Office of Research Compliance 25 You cannot begin to work with rDNA, biological agents or toxins until you have an approved IBC protocol.

26. Office of Research Compliance Other Reasons to Contact Biosafety 26  Shipping or receiving biohazardous material  Applying for USDA permit  Questions about use or certification of biological safety cabinets or other primary containment devices  Questions about sharps safety or disposal  Need assistance with a waste solution assessment  To request Laboratory Operations Review (new or existing lab: review not an inspection) (all RG levels)

27. Office of Research Compliance BioSafety Office 27  Patrick Stockton – Director / RO  Manley Kiser – Associate Director / AHRC ARO  Nancy Mead – IBC Coordinator / ARO  Kelly Crumley – Select Agent Program Manager  Chad Cheely – Biosafety Specialist  Suzanne Cook – Administrative Specialist  Chris Carter – Compliance IT Administrator  Lisa Kelly – Compliance Training Coordinator

28. 28

29. Office of Research Compliance 29 Works to provide a safe workplace for all personnel involved in research using animals or biohazardous agents.

30. Office of Research Compliance Occupational Health and Safety 30 The OHSP applies to any UGA employee (faculty, staff, students, volunteers, visitors) who… Works with vertebrate animals, or animal tissues, fluids, secretions, and/or excretions Works with biohazardous agents Handles cages and related equipment contaminated by animal tissues, fluids, secretions and/or excretions; or routinely enters into facilities where animals are maintained

31. Office of Research Compliance Questionnaire 31 Must complete this section and return if you decline to participate

32. Office of Research Compliance 32 Professionally and administratively supports the IRB, the research oversight committee charged with ensuring that human subjects research is conducted in compliance with applicable laws, policies and guidelines

33. Office of Research Compliance Federal Agencies and Laws 33  National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974) Belmont Report – Ethical Principals and Guidelines for the Protection of Human Subjects of Research (1979)  Codified in Federal Registry Title 45 CFR Part 46 Subpart A – “Common Rule” Subpart B – Protection for Pregnant Women, Human Fetuses and Neonates Subpart C – Protection for Prisoners Subpart D – Protection for Children Subpart E – Institutional Review Board  Health Insurance Portability and Accountability Act (HIPAA)  Family Educational Rights and Privacy Act (FERPA)  The Office of Human Subjects Protections (OHRP)

34. Office of Research Compliance UGA’s Human Subjects Program 34  Program has Federalwide Assurance (FWA) – so that UGA may accept federal funding  In the process of obtaining Association for the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation

35. Office of Research Compliance Institutional Review Board 35 7 Scientists 3 Non-Scientists 1 alternate non-scientist community member represents prisoners 1 Physician 1 Community Member

36. Office of Research Compliance Human Subjects Training 36  Human Subjects Social & Behavioral Research or  Human Subjects Bio-Medical Research  And additional modules as required by the IRB Examples: Modules on Children, International Research, Internet Research, Prisoners Repeat Training every 5 years

37. Office of Research Compliance 37 Training compliance is required prior to IRB Protocol submission. Must be faculty or senior staff to submit an IRB Protocol. Certain IRB Protocols must receive continuing review annually. Approval is good for 5 years and then you must resubmit a new Protocol. Review of Consent Documents, Recruiting Documents, and Data Collection Instruments, not just Protocol, required. IRB Protocol

38. Office of Research Compliance IRB Protocol Types 38  Exempt Examples (6 federal + 2 institutional): Minimal risk use of existing or prospective identifiable data/documents without sensitive information (no federal funding) Minimal risk research involving qualitative data collection procedures and non-physically invasive tasks or manipulations (no federal funding)  Expedited No more than minimal risk and fits within certain categories described in the federal regulations (9 categories)  Full Committee

39. Office of Research Compliance 39 You cannot begin to recruit volunteers until you have an approved IRB protocol.

40. Office of Research Compliance Human Subjects Office 40  Dr. Benilda Pooser – Director  Kim Fowler – Assistant Director  Angela Bain – IRB Specialist  Tammi Childs – IRB Coordindator  Mysti Scheuer – IRB Coordinator  Chris Carter – Compliance IT Administrator  Lisa Kelly – Compliance Training Coordinator

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42. Office of Research Compliance 42 New to the University of Georgia Providing oversight to access of scientific instruments, technologies, software and materials by foreign nationals in order to comply with federal export control regulations. In addition, this office will provide support and training to those individuals that conduct business with the international community.

43. Office of Research Compliance Export Control Regulation 43 Department of State, Directorate of Defense Trade Controls International Traffic in Arms Regulations (ITAR)  Relates to military and defense articles and services Department of Commerce, Bureau of Industry and Security Export Administration Regulations (EAR)  Relates to “dual use” items, information or software Department of Treasury, Office of Foreign Assets Control  Administers and enforces economic and trade sanctions

44. Office of Research Compliance Fundamental Research Exclusion (FRE) 44 Basic and applied research in science and engineering conducted at a U.S. research institution, the results of which ordinarily are published and shared broadly within the scientific community, are typically exempt from many Export Control regulations.

45. Office of Research Compliance Development of Export Control Program 45  Focal Point Administrators for units with export compliance risks  Training initiative to educate those in risk-sensitive research areas and operational groups  “Classification and Jurisdiction Determination” process and identify items that need a “Control Plan”  Working with International Education to link H1 VISA beneficiary assignment with EAR/ITAR access requirements for licensing and technology control purposes

46. Office of Research Compliance High-Risk Departments 46  Marine Sciences  Geography  Physics/Astronomy  Engineering  Areas with Restricted Funding UGA currently has no Restricted Funding. No UGA Policy on Restricted Funding.

47. Office of Research Compliance Office of Export Control 47  Dan Runge – Export Compliance Officer  Chris Carter – Compliance IT Administrator  Lisa Kelly – Compliance Training Coordinator

48. 48 Research Compliance Export Control

49. Office of Research Compliance 49 Provides guidance to UGA faculty, staff and students on the safe use of chemical agents, radiation safety and laser safety.

50. Office of Research Compliance Research Safety 50 Chemical and Lab Safety Radiation Safety New lab openings RadiationX-RaysLasers

51. Office of Research Compliance Chemical Safety 51 Public Employee Hazardous Chemical Protection and Right to Know Act of 1988 Training:  Initially  When a new hazard is introduced  Annually http://www.usg.edu/facilities/rtk-ghs

52. Office of Research Compliance OSHA 52  Must meet or exceed OSHA standards  Considered as reasonable benchmarks or “Best Practices”

53. Office of Research Compliance Radiation Safety 53  Each permit holder must designate an Advanced Radiation Safety Worker 4 x 4hr live modules and annual online Refresher Training  All Radiation Safety Workers Training by Advanced Radiation Safety Worker with documentation and annual online Refresher Training Additional online training for those working with X-Rays or Lasers

54. Office of Research Compliance 54 You cannot order radioisotopes until you have an approved Radioactive Material Permit and a designated Advanced Radiation Worker.

55. Office of Research Compliance Research Safety Office 55  Zeke Barrera - Director  Regena Curry – Administrative Associate  Wesley Kolar – HazMat Operations Coordinator  Bruce Hild – Research Safety Specialist  Ken McDaniel – Research Safety Specialist  Star Scott – Research Safety Specialist  Jody Jacobs – Radiation Safety Manager  Dennis Widner – Radiation Safety Specialist  Lauren Palmer – Radiation Safety Specialist  John Pyle – Radiation Safety Technician  Chris Carter – Compliance IT Administrator  Lisa Kelly – Compliance Training Coordinator

56. 56 Research Compliance Export Control

57. Office of Research Compliance 57 Providing information and training on federal Good Laboratory Practices (GLP), the recognized rules governing the conduct of non-clinical safety studies that ensure quality, integrity and reliability of study data. This office also conducts audits of facilities, data and research as required under GLP regulations. Research Compliance Export Control

58. Office of Research Compliance Federal Laws and Guidelines 58  Good Laboratory Practice Regulations – research intends to support applications for permits for products regulated by the FDA or the EPA FDA – Title 21 CFR Part 58 EPA – Title 40 CFR Part 160 Currently UGA has no active GLP studies.

59. Office of Research Compliance Quality Assurance 59  Lisa Kelly – Quality Assurance Coordinator

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61. Office of Research Compliance 61 Research Integrity Providing oversight and training to ensure the highest ethical standards in research at the University of Georgia. provides instruction in Responsible Conduct of Research and Conflict of Interest. The Research Integrity Officer investigates allegations of research misconduct.

62. Office of Research Compliance Research Integrity 62 Research Misconduct

63. Office of Research Compliance RCR Focus Evolves Over Decades 63 1966 Animal Welfare Act 2009 NSF requires RCR 1989 IOM: RCR important for health sciences 1979 Belmont Report 1991 NRSA: Training grants require RCR 2000 NIH requires RCR

64. Office of Research Compliance RCR Training Requirement 64  National Science Foundation – anyone paid (conference, travel, symposium and workshop grants are exempt) CITI RCR Course (4 versions, 7 of 9 topics)  Physical Sciences  Bio-Sciences  Behavioral and Social Sciences  Arts and Humanities (Refresher required every 4 years)  National Institutes of Health (K and T Grants) 8 hours of face-to-face education (CBIO 8080; Genetics 8650, GSRC 8550, Pharmacy 7230, Qualitative Research 8595, VetMed 8550)

65. Office of Research Compliance RCR Topics 65 1. Protection of Human Subjects 2. Welfare of Animal Subjects 3. Conflicts of Interest 4. Research Misconduct 5. Data Management and Data Sharing 6. Mentor Responsibilities 7. Authorship 8. Peer Review 9. Collaborative Research

66. Office of Research Compliance Exception for RCR Training 66 Currently waivers or exemptions will only be given for: high school students/teachers paid a stipend, employees working exclusively in an administrative role on an NSF research project, individuals who have completed a commensurate program of RCR education that can substituted for the CITI program, and employees whose project roles are deemed not related (for example, washing glassware or animal care). Email Chris King exception requests and keep records for NSF auditors.

67. 67 Setting off on the road to the responsible conduct of research

68. Office of Research Compliance What is Research Misconduct? 68 “Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results” OTSP Definition

69. Office of Research Compliance Research Misconduct 69 Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

70. Office of Research Compliance Not Research Misconduct 70 Research misconduct does not include honest differences of opinion!

71. Office of Research Compliance Legal Parameters 71  Represents a “significant departure” from accepted practices  Has been “committed intentionally, or knowingly, or recklessly”  Can be “proven by a preponderance of evidence.” (Burden rests with UGA) NO STATUTE OF LIMITATION (even if person has left UGA employ)

72. Office of Research Compliance Applicability 72  Everyone at UGA, including visitors/guests Student might be an exception  If hired on restricted account, Misconduct Policy applies  If not hired on restricted account, Academic Honesty Policy applies

73. Office of Research Compliance Reporting Misconduct 73 Everyone has a duty to report suspected misconduct! Concern! (RIO response) in writing (e.g. email) verbally to RIO You are protected by Federal Whistleblower Protections!

74. Office of Research Compliance If in Doubt, Don’t! 74

75. Office of Research Compliance Conflicts of Interest are not Research Misconduct! 75 Disclosure and Management are REQUIRED!

76. Office of Research Compliance Conflict of Interest Definitions 76 def. – the simultaneous existence of conflicting primary and secondary interests whenever financial considerations may have the potential to compromise or have the appearance of compromising an investigator’s professional judgment and independence in the design, conduct, or publication of research. COI’s occur whenever a reasonable person concludes that there is a probability that an individual might emphasize his or her personal interests over other interests for which he/she has responsibility.

77. Office of Research Compliance 3 Elements required for COIs 77 1.Acting in a professional or official capacity or having a position of trust (spiritual, fiduciary, etc.) 2.While having a personal interest (usually financial) 3. That interferes with objective decision making (or creates the appearance that decision making is compromised)

78. Office of Research Compliance Typical COIs 78  Self-dealing  Acting in roles that conflict  Accepting benefits and personal gratuities  Influence peddling  Using or disclosing confidential information  Conflicting outside employment or other allegiances

79. Office of Research Compliance Most Common Faculty COIs 79 Consulting Procurement Licensing Tech Recruiting Research Participants Mentoring

80. Office of Research Compliance Conflict of Interest Snafu’s 80 Believing too moral or too wise to have COIs Confident in wisdom and virtue to manage COIs on your own

81. Office of Research Compliance Financial Conflict of Interest 81 Must complete Investigator Disclosure if submitting PHS units and you have a SFI (Significant Financial Interest) Retrospective for 12 months prior to proposal submission Update within 30 days of discovering unreported SFI Cover all financial interest >$5000, even if value is not readily ascertainable UGA employees disclose on eResearch Portal at research.uga.edu/compliance-training/fcoi/ Non-UGA employee complete “Annual Disclosure of Financial Interest for Non-University of Georgia Investigators” at research.uga.edu/compliance-training/fcoi/

82. Office of Research Compliance Conflict of Interest Training 82 PHS grant or cooperative agreement Investigators must complete CoI Training Training must be complete prior to award Through CITI Refresher required every 4 years

83. Office of Research Compliance Reporting Fiscal Irregularities 83 Ethics and Compliance Reporting Policy research.uga.edu/docs/policies/ugarf/UGARF-Ethics-and-Compliance- Reporting-Policy.pdf  All levels responsible for preventing and detecting Fiscal Irregularities  Obligated to report To immediate supervisor or Office of the UGARF General Counsel Anonymously at 877-516-3467 or www.tnwinc.com/uga/

84. 84 Research Integrity (RCR, CoI)

85. Office of Research Compliance 85 Working to increase the knowledge of and facilitate the highest standards of responsible research and compliance with federal, state and university regulations and guidelines.