Legal Issues Related to Researchat
NC State
David E. Broome, Jr.
Senior Associate General Counsel
NC State University
27 March 2002
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?
Introduction, Part II
Regulatory Compliance
Sponsored Research Agreements
REGULATORY
COMPLIANCE
Human Subjects Animal Subjects Lab Safety Integrity in Scholarship
Conflicts of Interest Research Misconduct
Human Subjects
Federal Law
http://www.ncsu.edu/sparcs/IRB/human.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 or Exemption
Informed Consent
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
LAB SAFETY
http://www2.ncsu.edu/ehs/www99/index.html
Biological Radiation Chemical OSHA
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
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
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
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
Key Issue: Option/License Rights Typical License Rights Give
Sponsors Freedom to Utilize Inventions
Insuring Commercialization
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?
Key Issue: Indemnification Agreements Meaning of Indemnity Sovereign Immunity; General
Assembly Authority to Waive Authority to Tax Is NC State Dodging Liability??
Key Issue: Binding Arbitration
AG Advice Mostly Business Reasons Other Forms of ADR are OK
Key Issue: Governing Law Must Be NC or “Silence is Golden” Sovereign Immunity and General
Principals of Sovereignty AG Approval Needed
Key Issue: Forum Selection
Similar Reasons to Choice of Law Clear Business Reasons
“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
We Aren’t Just Looking For Things To Argue About
Sponsor’s Divide and Conquer Strategy
I Feel Your Pain
