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– ALL HS research on campus is covered

HS Review Categories

• Exempt from Review

• Expedited Review

• Full Board Review

Expedited and full board protocols must be renewed annually

Changes in Human Subjects

• Training required for ALL HS researchers

• Online Training available through CITI

• http://www.citiprogram.org

• Standard submission form available

IACUC/IRB forms

RGS website

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

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

Conflict of Interest

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

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.

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

COI Policy

• http://www.udel.edu/ExecVP/polprod/6-11.html

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

Common areas of Potential Conflict

• Consulting agreements (subcontracts)

• Licensing agreements

• Procurement

• Mentoring

Consulting Agreements• Disclose the agreements

• Use of University facilities/staff

• Review NDAs– Mutual non-disclosure– Time limits – IP ownership– Publication– Individual vs University agreement

Licensing Agreements• Compromise of basic university

commitments?

• University management of equity

• Protection of integrity of research results

Procurement• Personal ownership of significant financial

interest in companies doing business with university

• Family member ownership/interest if related to purchases made by PI

Mentoring Relationships

• Mentor as employer– Need to balance obligation to promote

careers of junior faculty, post-docs, grad students with benefit of employment

Publications

Who needs to file?

• http://www.udel.edu/research/researchers/policies-forms.html?panel=1#conflict

Who does the management?• UD policy seeks management at the most

local level possible:– Department chair (or committee)– College committee– University committee

Export Controls

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

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)

ITAR

• Weapons, items, and technology for military use

• Contracts with DOD

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

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.

Implications

• Any contract with publication restrictions will be subject to controls– Review vs approval

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.)

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)

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.

Penalties for Violating Regulations

• 10/20 years imprisonment

• $250,000 fines

• Civil penalties of up to $120,000 per national security violation

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.

Responsible Conduct of Research

• All the policies and procedures are to safeguard responsible conduct of research

• Training opportunities

References

• www.udel.edu/research• Elizabeth Peloso - email: epeloso@udel.edu