Legal Issues Related to Research at NC State

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

2. 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?

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

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

5. Human Subjects • Federal Law • http://www.ncsu.edu/sparcs/IRB/human.html

6. 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

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

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

9. LAB SAFETY • http://www2.ncsu.edu/ehs/www99/index.html • Biological • Radiation • Chemical • OSHA

10. 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

11. 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

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

13. SPONSORED RESEARCH AGREEMENTS

14. 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

15. 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

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

17. Key Issue: Publication of Research Results • Core University Policy; BOG Guidelines • NOCOMPROMISE • Export Laws and Regulations • Tax Reform Act • Do We Want to Publish Sponsor’s Confidential Information?

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

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

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

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

22. “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

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