Legal Issues Related to Research at NC State
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Legal Issues Related to Researchat
NC State
David E. Broome, Jr.
Senior Associate General Counsel
NC State University
27 March 2002
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Introduction
Are we really so hard to get along with?
If so, is there a reason? Is it part of Dave Broome’s job to
kill projects?
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Introduction, Part II
Regulatory Compliance
Sponsored Research Agreements
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REGULATORY
COMPLIANCE
Human Subjects Animal Subjects Lab Safety Integrity in Scholarship
Conflicts of Interest Research Misconduct
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Human Subjects
Federal Law
http://www.ncsu.edu/sparcs/IRB/human.html
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Definitions [45 CFR Part 46]
Human Subject: a living individual about whom an investigator (professional or student) conducting research obtains data through intervention or interaction
with the individual, or identifiable private information
Research: systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
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Keys to Compliance
Disclosure
IRB Approval or Exemption
Informed Consent
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Animals in Research
Federal Law IACUC: Institutional Animal Care
and Use Committee http://www.ncsu.edu/sparcs/compli
ance/iacuc1.html Any use of vertebrate animals in
research is covered
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LAB SAFETY
http://www2.ncsu.edu/ehs/www99/index.html
Biological Radiation Chemical OSHA
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Integrity in Scholarship: Misconduct “fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in reporting research results; not honest error or differences of opinion”
Internal inquiries and investigations Sanctions External Review if Federal Money
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Integrity in Scholarship: Conflicts of Interest & Commitment Commitment: When pursuit of outside
activities involves an inordinate investment of time that interferes with one’s obligations to University responsibilities
Interest: Having financial or other considerations that may compromise (or have the appearance of compromising) one’s objectivity or independent professional judgment in meeting university duties or responsibilities
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Integrity in Scholarship: Conflicts of Interest & Commitment REPORT FULLY! (then you’re
“covered”)
Once Identified: Manage Reduce Eliminate
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SPONSORED RESEARCH
AGREEMENTS
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Basic Requirements
Written Agreement Clearly Defined Responsibilities Signed by an Authorized Official
(http://www1.acs.ncsu.edu/ncsulegal/Signature%20Delegation%20Regulation.html)
No Purchase Orders from Other Party
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Key Issue: Patent Ownership BOG and NC State Policies State Property Bayh-Dole Act; No Assignment w/o
Agency OK Tax Reform Act of 1986; Avoid
Private Purpose Use
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Key Issue: Option/License Rights Typical License Rights Give
Sponsors Freedom to Utilize Inventions
Insuring Commercialization
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Key Issue: Publication of Research Results Core University Policy; BOG
Guidelines NO COMPROMISE Export Laws and Regulations Tax Reform Act Do We Want to Publish Sponsor’s
Confidential Information?
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Key Issue: Indemnification Agreements Meaning of Indemnity Sovereign Immunity; General
Assembly Authority to Waive Authority to Tax Is NC State Dodging Liability??
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Key Issue: Binding Arbitration
AG Advice Mostly Business Reasons Other Forms of ADR are OK
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Key Issue: Governing Law Must Be NC or “Silence is Golden” Sovereign Immunity and General
Principals of Sovereignty AG Approval Needed
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Key Issue: Forum Selection
Similar Reasons to Choice of Law Clear Business Reasons
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“Fact Sheets” on Key Issues One Page Summaries of Legal and
Policy Reasons for NCSU Positions on Key Clauses
http://www.fis.ncsu.edu/ncsulegal/ResearchAgreements.htm
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We Aren’t Just Looking For Things To Argue About
Sponsor’s Divide and Conquer Strategy
I Feel Your Pain