1. Legal Issues Related to Research at NC State David E. Broome, Jr. Senior Associate General Counsel NC State University 27 March 2002

2. Introduction n Are we really so hard to get along with? n If so, is there a reason? n Is it part of Dave Broome’s job to kill projects?

3. Introduction, Part II n Regulatory Compliance n Sponsored Research Agreements

4. REGULATORY COMPLIANCE n Human Subjects n Animal Subjects n Lab Safety n Integrity in Scholarship u Conflicts of Interest u Research Misconduct

5. Human Subjects n Federal Law n http://www.ncsu.edu/sparcs/IRB/hu man.html http://www.ncsu.edu/sparcs/IRB/hu man.html

6. Definitions [45 CFR Part 46 ] n Human Subject: a living individual about whom an investigator (professional or student) conducting research obtains u data through intervention or interaction with the individual, or u identifiable private information n Research: systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

7. Keys to Compliance u Disclosure u IRB Approval or Exemption u Informed Consent

8. Animals in Research n Federal Law n IACUC: Institutional Animal Care and Use Committee n http://www.ncsu.edu/sparcs/compli ance/iacuc1.html http://www.ncsu.edu/sparcs/compli ance/iacuc1.html n Any use of vertebrate animals in research is covered

9. LAB SAFETY n http://www2.ncsu.edu/ehs/www99/i ndex.html http://www2.ncsu.edu/ehs/www99/i ndex.html n Biological n Radiation n Chemical n OSHA

10. Integrity in Scholarship: Misconduct n “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results; not honest error or differences of opinion” n Internal inquiries and investigations n Sanctions n External Review if Federal Money

11. Integrity in Scholarship: Conflicts of Interest & Commitment n Commitment: When pursuit of outside activities involves an inordinate investment of time that interferes with one’s obligations to University responsibilities n 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

12. Integrity in Scholarship: Conflicts of Interest & Commitment n REPORT FULLY! (then you’re “covered”) n Once Identified: u Manage u Reduce u Eliminate

13. SPONSORED RESEARCH AGREEMENTS

14. Basic Requirements n Written Agreement n Clearly Defined Responsibilities n Signed by an Authorized Official (http://www1.acs.ncsu.edu/ncsuleg al/Signature%20Delegation%20Re gulation.html) n No Purchase Orders from Other Party

15. Key Issue: Patent Ownership n BOG and NC State Policies n State Property n Bayh-Dole Act; No Assignment w/o Agency OK n Tax Reform Act of 1986; Avoid Private Purpose Use

16. Key Issue: Option/License Rights n Typical License Rights Give Sponsors Freedom to Utilize Inventions n Insuring Commercialization

17. Key Issue: Publication of Research Results n Core University Policy; BOG Guidelines n NO COMPROMISE n Export Laws and Regulations n Tax Reform Act n Do We Want to Publish Sponsor’s Confidential Information?

18. Key Issue: Indemnification Agreements n Meaning of Indemnity n Sovereign Immunity; General Assembly Authority to Waive n Authority to Tax n Is NC State Dodging Liability??

19. Key Issue: Binding Arbitration n AG Advice n Mostly Business Reasons n Other Forms of ADR are OK

20. Key Issue: Governing Law n Must Be NC or “Silence is Golden” n Sovereign Immunity and General Principals of Sovereignty n AG Approval Needed

21. Key Issue: Forum Selection n Similar Reasons to Choice of Law n Clear Business Reasons

22. “Fact Sheets” on Key Issues n One Page Summaries of Legal and Policy Reasons for NCSU Positions on Key Clauses n http://www.fis.ncsu.edu/ncsulegal/ ResearchAgreements.htm

23. We Aren’t Just Looking For Things To Argue About n Sponsor’s Divide and Conquer Strategy n I Feel Your Pain