Research%20Compliance

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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 individuals private
  financial interest or familys 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 ResearchPolicy 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 individuals 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?panel1conflict

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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

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References

• www.udel.edu/research
• Elizabeth Peloso - email epeloso_at_udel.edu