research compliance
DESCRIPTION
Research Compliance. Presented by Research and Graduate Studies Elizabeth Peloso. Compliance Areas. Human Subjects Animal Welfare Conflict of Interest Responsible Conduct of Research Export Controls. Human Subjects. 45 CFR 46 (The Common Rule) Ethical Principles Belmont Report FWA - PowerPoint PPT PresentationTRANSCRIPT
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Research Compliance
Presented by Research and Graduate Studies
Elizabeth Peloso
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Compliance Areas• Human Subjects
• Animal Welfare
• Conflict of Interest
• Responsible Conduct of Research
• Export Controls
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Human Subjects
• 45 CFR 46 (The Common Rule)
• Ethical Principles– Belmont Report
• FWA– ALL HS research on campus is covered
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HS Review Categories
• Exempt from Review
• Expedited Review
• Full Board Review
Expedited and full board protocols must be renewed annually
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Changes in Human Subjects
• Training required for ALL HS researchers
• Online Training available through CITI
• http://www.citiprogram.org
• Standard submission form available
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IACUC/IRB forms
RGS website
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Animal Research• PHS regulated through the Office of
Laboratory Animal Welfare
• Institutional Animal Care and Use Committee
• IACUC coordinator Cathie Ramone
• Animal Facility Manager, Frank Warren
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IACUC Procedures• Meeting dates, forms and submission
deadlines on RGS website
• Protocols good for 3 years, with annual review each of those years
• Lab/Facility Inspections
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Conflict of Interest
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Potential Conflict of Interest
Possibility from the perspective of an independent observer that an individual’s private financial interest or family’s interests may influence professional actions, decisions, or judgment
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Conflict of Interest
• Section: PersonnelPolicy Number: 4-26Policy Name: Faculty Conflict of Interest and Ethical ConductDate: June 5, 1989Revisions: August 28, 2003
• PURPOSE• To define expectations of ethical conduct for University
faculty members.
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Conflict of Interest• Section: Research
Policy Number: 6-11Policy Name: Faculty and Professional Staff Involvement in Commercial Enterprises That Have Relationships With The University of DelawareDate: November 15, 1989Revisions: March 1, 1996; February 18, 2002
• PURPOSE
To delineate policy and guidelines governing the involvement of faculty and professional staff with commercial enterprises to minimize potential conflicts of interest and to provide means for managing conflicts if they arise
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COI Policy
• http://www.udel.edu/ExecVP/polprod/6-11.html
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What is a Conflict?• Possibility that individual’s financial
interests (personal or family) might influence professional actions– Not possible or desirable to eliminate– Need to manage
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Common areas of Potential Conflict
• Consulting agreements (subcontracts)
• Licensing agreements
• Procurement
• Mentoring
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Consulting Agreements• Disclose the agreements
• Use of University facilities/staff
• Review NDAs– Mutual non-disclosure– Time limits – IP ownership– Publication– Individual vs University agreement
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Licensing Agreements• Compromise of basic university
commitments?
• University management of equity
• Protection of integrity of research results
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Procurement• Personal ownership of significant financial
interest in companies doing business with university
• Family member ownership/interest if related to purchases made by PI
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Mentoring Relationships
• Mentor as employer– Need to balance obligation to promote
careers of junior faculty, post-docs, grad students with benefit of employment
Publications
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Who needs to file?
• http://www.udel.edu/research/researchers/policies-forms.html?panel=1#conflict
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Who does the management?• UD policy seeks management at the most
local level possible:– Department chair (or committee)– College committee– University committee
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Export Controls
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What is an Export?
• Shipment of goods out of the U.S.
• Electronic transmission out of the U.S.
• Release of technology to foreign national
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Regulatory Environment• Department of State
– ITAR (International Traffic in Arms)
• Department of Commerce– EAR (Export Administration Regulations)
• Department of theTreasury– OFAC (Office of Foreign Asset Controls)
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ITAR
• Weapons, items, and technology for military use
• Contracts with DOD
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EAR
• “dual-use” items– Potential military use (e.g. missile guidance,
avionics, GPS)
• May also apply to solely civil use items– Depending on the end use/end user
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Fundamental Research Exclusion
734.8 (b) (1) –University Based Research.
Information resulting from basic and applied research in science and engineering conducted at an accredited institution of higher education in the U.S. that is ordinarily published and broadly shared within the scientific community.
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Implications
• Any contract with publication restrictions will be subject to controls– Review vs approval
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Implications
• Any work conducted outside the U.S. will be subject to controls (even if all equipment/technology will be returned to the U.S.)
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Deemed Exports
• The transfer or disclosure (including visually or orally) of controlled “technologies” or “technical data” to a foreign entity or individual anywhere, including the U.S. (15 CFR 734.2; 22 CFR 120.17)
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Implications
• Foreign national staff (including students) may be deemed export if do not have permanent resident status/ full time employment.
• Visiting foreign national colleagues may be deemed export.
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Penalties for Violating Regulations
• 10/20 years imprisonment
• $250,000 fines
• Civil penalties of up to $120,000 per national security violation
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Be Aware
• If you think any aspect of your research may be subject to export controls AND /OR you have deemed export concerns, please contact the research office.
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Responsible Conduct of Research
• All the policies and procedures are to safeguard responsible conduct of research
• Training opportunities