Overview of the Office of Research Assurances (ORA)

1. Overview of the Office of Research Assurances (ORA) David R. Clark (drclark@wsu.edu) Director, Office of Research Assurances http://www.research-compliance.wsu.edu/

2. Recording date of this workshop is January 17, 2014. Some of the rules and procedures discussed in this workshop are subject to change. Please check university resources before relying exclusively on this recorded presentation.

3. ORA WSU - Office of Research Assurances

4. Overview of the Office of Research Assurances • General Laboratory Safety Regulations (EHS) & (BSO) • Radiation Safety Office/Radiation Safety Committee • IACUC (Institutional Animal Care and Use Committee) • IBC (Institutional Biosafety Committee) • IRB (Institutional Review Board) • Export Controls • Conflict of Interest • Research Misconduct • Responsible Conduct of Research • Additional Regulations (DOT/FAA/OFAC/…) • Conclusion

5. Office of Research Assurances Mission • The goal of ORA is to assist faculty so their research enterprise can be accomplished. ORA facilitates and assists WSU researchers in identifying and complying with all pertinent regulations and guidelines. • We work collaboratively with researchers to facilitate and implement WSU policies and procedures which assure compliance with minimal impact on research programs. • ORA, established in 2002, is part of the overall effort of WSU to ensure the responsible conduct of research.

6. Office of Research Assurances (ORA) The ORA accomplishes our mission primarily through the following Presidential Committees: • Institutional Animal Care and Use Committee (IACUC) • Institutional Biosafety Committee (IBC) • Institutional Review Board (IRB) • Conflict of Interest (COI) • Radiation Safety Committee (RSC)

7. I. General Laboratory Safety Regulations

8. General Laboratory Safety Regulations Who’s Overseeing General Laboratory Safety ? Federal Laws & Regulations (OSHA, RCRA, CAA, NIH, USDA, …) State of Washington (WAC’s) Consensus Standards (ANSI, NIOSH, ASSE, …) WSU EHS (local) http://www.ehs.wsu.edu/

9. II. Radiation Safety

10. Radiation Safety Who’s Overseeing Radiation Safety ? NRC (national) DoH (State of WA) WSU RSO (local) http://www.wsu.edu/~wsurso/index.html

11. III. IACUC(Institutional Animal Careand Use Committee)

12. IACUC IACUC’s must … • Address the training requirement • Review procedures that use animals • Monitor animal research • Address occupational health requirements Animals can be used safely and humanely in research

13. IACUC Who’s Overseeing Animal Research ? USDA (national) NIH (national) OLAW (national) Office of the Campus Veterinarian (OCV) IACUC (local) ASAF http://www.aphis.usda.gov/ac/ http://campusvet.wsu.edu/ http://www.research-compliance.wsu.edu/

14. IV. IBCs (Institutional Biosafety Committee)

15. IBC & WSU Biosafety Officer (BSO) Who’s Overseeing Research With Biological Materials (incl. rDNA) ? NIH (national) NIH Guidelines for Research Involving Recombinant DNA Molecules USDA (national) IBC(local) http://www4.od.nih.gov/oba/ BAF(BioSafety Approval Form) BSO Biological Safety Officer http://www.bio-safety.wsu.edu/biosafety/

16. V. IRB (Institutional Review Board)

17. IRB US National Research Act 1974 • Established National Commission for Protection of Human Subjects • The Belmont Report, 1979 • Code of Federal Regulations, 1981 • Institutional Review Boards (IRBs) • Informed Consent • Common Rule (45 CFR Part 46), 1991 • HIPAA Privacy Rule (45 CFR Parts 160, 162, & 164), 2003

18. IRB Who’s Overseeing Research Involving Human Subjects ? HHS/OHRP (national) http://ohrp.osophs.dhhs.gov/ FDA (national) IRB (local) Protocol (IRB Forms) http://www.research-compliance.wsu.edu/

19. VI. Export Controls Three U.S. Export Control and Licensing Programs: 1) U.S. Department of Commerce (Bureau if Industry and Security) controls dual-use items (goods and technology with both civilian and military uses). Export Administration Regulations (EAR) – Commerce Control List 2) U.S. Department of State (Office of Defense Trade Controls) controls defense articles, defense services, and related technical data (including most space related articles). International Traffic in Arms Regulations (ITAR) – US Munitions List • U.S. Department of the Treasury oversees U.S. trade embargoes (Office of Foreign Assets Control) and enforces all three programs at U.S. borders (Customs Service) List of specifically designated nations, nationals, and individuals

20. Export Controls • Except for certain, limited types of research university researchers and the academic community have not traditionally been impacted by export control regulations. “Fundamental research” has been used to exempt most university activities. • In the post 9/11 world, a number of recent reports and activities appear to be indicating that export control regulations will be impacting a wider range of researchers and research activities.

21. Ethical Considerations

22. VII. Conflict of Interest • Regulation (42 CFR 50 Subpart F July 31, 1995) applicable to institutions that receive funding from the National Institutes of Health (NIH). Similar requirement from the National Science Foundation (NSF). http://grants2.nih.gov/grants/policy/emprograms/overview/ep-coi.htm • Investigators are required to disclose a listing of Significant Financial Interests (including those of spouses and dependents) that would reasonably appear to be affected by the research proposed for funding. • WSU EP#27 and OGRD Memo#3

23. VIII. Research Misconduct http://ori.dhhs.gov/html/misconduct/regulation_subpart_a.asp • The Department of Health and Human Services (DHHS)/Office of Research Integrity (ORI) published regulations (42 CFR Part 50 Subpart A, August 8, 1989), “Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science” • “…institutions shall foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct associated with research…” http://www.primr.org/

24. Responsible Conduct of Research WSU Responsible Conduct of Research Education (RCR) … • https://myresearch.wsu.edu/ • Required for faculty beginning in January 2006 • Required for graduate students beginning August 2006 Introduction: The responsibilities of Principal Investigators (PIs) at Washington State University (WSU) include the direction of research and scholarly activities and the education and training of students. There is responsibility and trust placed upon PIs with respect to their conduct of research and scholarly activities. University policy and all other federal and state regulations, guidelines, and sponsor requirements help the PI know about these roles. The information and material presented in this WSU Responsible Conduct of Research education provides an overview of many complex topics. This review is an introduction to these topics. Mandatory education in the Responsible Conduct of Research for all WSU faculty and graduate students began in January 2006. Regardless of your level of expertise and experience, I hope this material will be helpful. All WSU PIs should seek out additional information and material when confronted with situations requiring more in depth analysis. Finally, I thank Stanford University for allowing WSU to use sections of their compliance training in these modules. Howard D. Grimes, Ph.D. Vice President for Research and Dean of the Graduate School August 2008

25. Ethical Considerations Who’s Overseeing Ethics in Research ? NIH/NSF (national) Professional Organizations State of Washington (State) Vice President for Research and Dean of the Graduate School OGRD (memos) http://www.ogrd.wsu.edu/ Office Research Assurances Principal Investigator

26. X. Additional Regulations • Department of Transportation (DOT): Regulations concerning the shipping of hazardous chemicals and biological materials. • Federal Aviation Administration (FAA): Regulations concerning the transport of hazardous chemicals and biological materials on board aircraft (carry-on and/or checked luggage). • Investigational New Animal Drugs (INADs): • Experimental Use Pesticides (EUPs): http://www.research-compliance.wsu.edu/Shipping/ http://www2.faa.gov/passengers/Baggage.cfm

27. IACUC WSU RSO NIH IBC WSU EHS DOT/FAA WSU BSO DHHS/OHRP FDA DHHS/ORI USDA/APHIS WSU Policy/Procedure IRB XI. Conclusion

28. Cooperation is Essential to Maintain a Successful Research Program

29. Assistance and Resources • Director, Office of Research Assurances David Clark, 335-1585, drclark@wsu.edu • IACUC Coordinator Rani Muthukrishnan, 335-7951, rani_m@wsu.edu • IRB Coordinator Malathi Jandhyala, 335-3668, mjandhyala@wsu.edu • Biological Safety Officer & Hazardous Materials Shipping Mike Kluzik, 335-9553, mkluzik@wsu.edu • Research Integrity & Hazardous Materials Shipping Sheri Glaesman, 335-0039, sglaesman@wsu.edu • Program Coordinator IRB & IBC Patrick Conner, 335-7183, patrick_conner@wsu.edu • Biosafety & Hazardous Materials Shipping Ryan Schwager, 335-4462, rschwager@wsu.edu

30. Overview of the Office of Research Assurances

31. WSU employees attending this session via videoconferencing and who wish to have it documented on their training history must notify Human Resource Services within three days of the session date: hrstraining@wsu.edu