legal issues related to research at nc state david e. broome, jr. senior associate general counsel...

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