Overview of the Office of Research Assurances (ORA) February 7, 2007

1. Overview of the Office of Research Assurances (ORA) February 7, 2007 David R. Clark (drclark@wsu.edu) Director, Office of research Assurances www.research-compliance.wsu.edu

2. ORA WSU - Office of Research Assurances

3. 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

4. Office of research Assurances Mission The mission of the ORA is to facilitate and assist WSU researchers in identifying and complying with all pertinent regulations and guidelines. We work collaboratively with researchers to develop and implement WSU policies and procedures which assure compliance with minimal impact on research programs. This Office is part of the overall effort of WSU to ensure the responsible conduct of research. The ORA was established in December 2002.

5. 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)

6. I. General Laboratory Safety Regulations

7. 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/

8. II. Radiation Safety

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

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

11. 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

12. 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/

13. IV. IBCs (Institutional Biosafety Committee)

14. 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/

15. V. IRB (Institutional Review Board)

16. 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

17. 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/

18. 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

19. 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.

20. Ethical Considerations

21. 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

22. 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/

23. IX. Responsible Conduct of Research http://ori.dhhs.gov/html/misconduct/regulation_subpart_a.asp Additional regulations may be coming … Responsible Conduct of Research (RCR) On December 1, 2000 the ORI published draft policy that sought to supplement the existing regulations (42 CFR Part 50 Subpart A, August 8, 1989). The draft policy (since suspended) stated, “… research staff at extramural institutions shall complete a basic program of instruction in the responsible conduct of research…”. Although ORI has suspended the policy they are funding (via grants) voluntary programs to help institutions develop and implement such training programs.

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 approximately by August 2006.   Introduction to Responsible Conduct of Research at WSUThe 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 a tremendous amount of responsibility and trust placed upon PIs with respect to research and scholarly activities.  These crucial roles must be carried out in compliance with University policy, and all other federal and state regulations, guidelines, and sponsor requirements.  The information and material presented in the WSU Responsible Conduct of Research education is meant to provide an overview of many complex topics.  The topics covered are an introduction and are not an exhaustive exploration of topics.  Education in the Responsible Conduct of Research is mandatory for all WSU faculty beginning in January 2006.   Regardless of your level of expertise and experience I hope that you will find this material to be helpful and thought provoking.  I hope that all WSU PIs will be encouraged to seek out additional information and material when confronted with situations requiring more in depth analysis. In addition, I would like to thank Stanford University for allowing WSU to use sections of their compliance training in these modules.  Jim Petersen, Vice Provost for Research - January 2006

25. Ethical Considerations Who’s Overseeing Ethics in Research ? NIH/NSF (national) Professional Organizations State of Washington (State) Vice Provost for Research (OVPR) 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://hazmat.dot.gov/rules.htm http://www2.faa.gov/passengers/Baggage.cfm

27. Hot Topics • Biosecurity • The NIH Office of Biotechnology Activities (OBA) has been charged to administer the National Science Advisory Board for Biosecurity (NSABB). • Institutional Biosafety Committees (IBCs) may become Institutional Biosafety and Biosecurity Committees (IBBCs). • Export Controls • Increasing scrutiny of universities. • WSU Adhoc committee.

28. Hot Topics continued … • Research Involving Human Subjects • IRB Accreditation Gaining momentum • Committee reviewing the scope of the WSU IRB • Responsible Conduct of Research (RCR) • Conflict of Interest (COI) • Integration of the State ethics law • Field testing of plants engineered to produce pharmaceuticals and industrial compounds (biopharming) and other genetically engineered organisms

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

30. Cooperation is Essential to Maintain a Successful Research Program

31. Assistance and Resources • Director, Office of Research Assurances David Clark, Phone 335-1585, drclark@wsu.edu • IACUC & IBC & COI Coordinator Rebecca Van Wyck, Phone 335-9661, vanwycrj@wsu.edu • IRB Coordinator Malathi Jandhyala, Phone 335-9661, mjandhyala@wsu.edu • Biological Safety Officer Lorraine McConnell, Phone 335-9661, lorrmcc@wsu.edu Office of Research Assurances website: http://www.research-compliance.wsu.edu/ forms (IACUC, IBC, IRB): http://www.ogrd.wsu.edu/forms.asp

32. Overview of the Office of Research Assurances