Legal Issues Related to Research
at
NC State
David E. Broome, Jr.
Senior Associate General Counsel
NC State University
27 March 2002
Introduction
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
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?
Introduction, Part II

Regulatory Compliance

Sponsored Research Agreements
REGULATORY
COMPLIANCE


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Human Subjects
Animal Subjects
Lab Safety
Integrity in Scholarship
 Conflicts
of Interest
 Research Misconduct
Human Subjects


Federal Law
http://www.ncsu.edu/sparcs/IRB/hu
man.html
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
Keys to Compliance
 Disclosure
 IRB Approval
 Informed
or Exemption
Consent
Animals in Research
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

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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
LAB SAFETY
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http://www2.ncsu.edu/ehs/www99/i
ndex.html
Biological
Radiation
Chemical
OSHA
Integrity in Scholarship:
Misconduct

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“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
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
Integrity in Scholarship:
Conflicts of Interest &
Commitment


REPORT FULLY! (then you’re
“covered”)
Once Identified:
 Manage
 Reduce
 Eliminate
SPONSORED
RESEARCH
AGREEMENTS
Basic Requirements

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Written Agreement
Clearly Defined Responsibilities
Signed by an Authorized Official
(http://www1.acs.ncsu.edu/ncsuleg
al/Signature%20Delegation%20Re
gulation.html)
No Purchase Orders from Other
Party
Key Issue: Patent
Ownership

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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
Key Issue:
Option/License Rights

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Typical License Rights Give
Sponsors Freedom to Utilize
Inventions
Insuring Commercialization
Key Issue: Publication
of Research Results

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Core University Policy; BOG
Guidelines
NO COMPROMISE
Export Laws and Regulations
Tax Reform Act
Do We Want to Publish Sponsor’s
Confidential Information?
Key Issue:
Indemnification
Agreements
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Meaning of Indemnity
Sovereign Immunity; General
Assembly Authority to Waive
Authority to Tax
Is NC State Dodging Liability??
Key Issue: Binding Arbitration

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AG Advice
Mostly Business Reasons
Other Forms of ADR are OK
Key Issue: Governing
Law

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Must Be NC or “Silence is Golden”
Sovereign Immunity and General
Principals of Sovereignty
AG Approval Needed
Key Issue: Forum
Selection
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Similar Reasons to Choice of Law
Clear Business Reasons
“Fact Sheets” on Key
Issues

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One Page Summaries of Legal and
Policy Reasons for NCSU
Positions on Key Clauses
http://www.fis.ncsu.edu/ncsulegal/
ResearchAgreements.htm
We Aren’t Just Looking
For Things To Argue
About


Sponsor’s Divide and Conquer
Strategy
I Feel Your Pain