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Overview of the Office of Research Assurances (ORA)
February 7, 2007
David R. Clark ([email protected])Director, Office of research Assurances
www.research-compliance.wsu.edu
David R. Clark, Office of Research Assurances
Overview of the Office of Research Assurances
I. General Laboratory Safety Regulations (EHS) & (BSO)
II. Radiation Safety Office/Radiation Safety Committee
III. IACUC (Institutional Animal Care and Use Committee)
IV. IBC (Institutional Biosafety Committee)V. IRB (Institutional Review Board)VI. Export ControlsVII. Conflict of InterestVIII. Research MisconductIX. Responsible Conduct of ResearchX. Additional Regulations (DOT/FAA/OFAC/…)XI. Conclusion
David R. Clark, Office of Research Assurances
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.
David R. Clark, Office of Research Assurances
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)
David R. Clark, Office of Research Assurances
General Laboratory Safety RegulationsWho’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/
David R. Clark, Office of Research Assurances
Radiation Safety
Who’s Overseeing Radiation Safety ?
NRC (national)
DoH (State of WA)
WSU RSO (local)
http://www.wsu.edu/~wsurso/index.html
David R. Clark, Office of Research Assurances
III. IACUC
(Institutional Animal Careand Use Committee)
David R. Clark, Office of Research Assurances
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
David R. Clark, Office of Research Assurances
IACUCWho’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/
David R. Clark, Office of Research Assurances
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/
http://www.bio-safety.wsu.edu/biosafety/BSO Biological Safety Officer
BAF(BioSafety Approval Form)
David R. Clark, Office of Research Assurances
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
David R. Clark, Office of Research Assurances
IRB
Who’s Overseeing Research Involving Human Subjects ?
HHS/OHRP (national) http://ohrp.osophs.dhhs.gov/
FDA (national)
IRB (local) Protocol
http://www.research-compliance.wsu.edu/
(IRB Forms)
David R. Clark, Office of Research Assurances
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
3) 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
David R. Clark, Office of Research Assurances
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.
David R. Clark, Office of Research Assurances
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
David R. Clark, Office of Research Assurances
• 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/
VIII. Research Misconduct
http://ori.dhhs.gov/html/misconduct/regulation_subpart_a.asp
David R. Clark, Office of Research Assurances
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.
IX. Responsible Conduct of Researchhttp://ori.dhhs.gov/html/misconduct/regulation_subpart_a.asp
David R. Clark, Office of Research Assurances
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 WSU
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 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
Responsible Conduct of Research
David R. Clark, Office of Research Assurances
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
David R. Clark, Office of Research Assurances
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
David R. Clark, Office of Research Assurances
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.
David R. Clark, Office of Research Assurances
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
David R. Clark, Office of Research Assurances
XI. Conclusion
IBC
DHHS/OHRP
WSU Policy/Procedure
NIHIACUC WSU RSO
WSU EHS
USDA/APHISIRB
FDA
DOT/FAA
DHHS/ORI
WSU BSO
David R. Clark, Office of Research Assurances
Cooperation is Essential to Maintain a Successful Research Program
WSU Researchers
Research Compliance Office,IACUC, IBC, IRB, RSO, BSO,
OGRD, EH&S
Federal and StateRegulations
David R. Clark, Office of Research Assurances
Assistance and Resources• Director, Office of Research Assurances
David Clark, Phone 335-1585, [email protected]• IACUC & IBC & COI Coordinator
Rebecca Van Wyck, Phone 335-9661, [email protected]• IRB Coordinator
Malathi Jandhyala, Phone 335-9661, [email protected]• Biological Safety Officer
Lorraine McConnell, Phone 335-9661, [email protected]
Office of Research Assurances website: http://www.research-compliance.wsu.edu/forms (IACUC, IBC, IRB): http://www.ogrd.wsu.edu/forms.asp