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 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: Personnel Policy Number: 4-26 Policy Name: Faculty Conflict of Interest and Ethical Conduct Date: June 5, 1989 Revisions: August 28, 2003 PURPOSE To define expectations of ethical conduct for University faculty members.

Conflict of Interest Section: Research Policy Number: 6-11 Policy Name: Faculty and Professional Staff Involvement in Commercial Enterprises That Have Relationships With The University of Delaware Date: November 15, 1989 Revisions: 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 11.htmlhttp:// 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? policies-forms.html?panel=1#conflicthttp:// 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 (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 )

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 Elizabeth Peloso -