Contracts & Regulations in Laboratory Management

1. Contracts & Regulations in Laboratory Management Mary Louise Trammell and Patrick Jones, OTT University of Arizona

2. OTT's Mission: is to protect, manage, and transfer University of Arizona-owned intellectual property to benefit society, to expand public-private relationships, and to further the University's mission.

3. OTT’s Role In Sponsored Research • OTT advises faculty, student and staff on intellectual property matters • OTT interprets and implements UA Intellectual Property (IP) Policy • OTT, as delegated by the VPR and policy, has the final authority on non standard IP language in contracts

4. Support of Research • Basically All Research Activities At UA Are Externally Supported • A Grant or Contract Is Really Two Things • A Proposal Setting Out The Statement Of Work • The Terms & Conditions (T&C’s) • The Combination Sets Obligations On Deliverables Especially Intellectual Property Rights As A Deliverable • PI Is Responsible For Conduct of Research And Meeting Of Obligations

5. Academic Freedom • Control of the Conduct and Direction of Research – Freedom of Inquiry, Scepticsim • Right to Publish and Exert Quality Control on Publications – Freedom to Disseminate • Right to Exercise Judgment in Academic Matters • Concerning Teaching • Students • Research

6. Obligations Money Always Travels With Paperwork Detailing Obligations On : • How The Money Is To Be Spent • The Conduct Of The Work • The Dissemination Of The Results • The Sponsor’s Access To The Results

7. Basic Project Management Concepts • Statement of Work (SoW) • What the Work Will Be • Level of Detail Depends Upon Funding Source • Work Breakdown Structure (WBS) • The Organization of Tasks to Accomplish the Statement of Work • A Way to Break Down a Complex Activity Into a Series of Discrete Steps • Milestones • Unambiguous Markers of Progress Towards Completing Sow or Tasks • Control Points

8. Example SoW Statement of Work for UA subcontract under the STI Optronics SBIR proposal entitled : Development of Robust, Miniature, Light-weight Mass Spectrometer UA will be working on the following tasks under Phase I Objective #1: Development Criteria for Compact Designs for Ionizer, Ion Optics, & Detector. Task 1: Degradation of MS signal performance with MS operating pressure – Dr. X will examine the effect of the Compact Mass Spectrometer operating pressure on system throughput and detector performance using the breadboard built by the UA and STI. Dr. X will measure signal loss and broadening, current leakage, and background noise as a function of background pressure of He or N2 at ten values between 10 -6 and 10 -3 Torr. The measurements will be done using the existing glow discharge source as a surrogate for a Penning source. The results will be inputs into the design specification of an integrated system. Task 2: Scaling Issues for Source & Ion Optics: interaction with the magnetics – … . All UA results will be summarized in a final report provided to STI Optronics.

9. Project X Deliver Y Example: Work Breakdown Subcontract to Z for B Create A Integrate & Test Prove A Make A Test A/B Meld A & B Test B Alt to B Prove A Make A Sub Z Test B Alt to B Meld A&B Test A/B Project

10. Federal T&C’s • Grants • Each Agency Has Specific Nuances – See Their Web Site • Incorporate Office of Management and Budget Circulars http://www.whitehouse.gov/omb/circulars/index.html • Reference Federal Acquisition Regulations (FARs) http://www.arnet.gov/far/ • Contracts • Start With the FARs • Include Specific Performance and Deliverables

11. Ethical Issues Arise Through A Conflict Among Obligations • To Employers • To Profession (Including Students & Patients) • To Sponsors of Research And Desires • For Recognition • For Monetary Gain • For Avoidance Of Responsibilities Enabled By Our Authority To Act or Not Act

12. Types Of Problems • Conflicts-of-interest • Conflicts-of-commitment • Misuse of Academic Freedom For Personal Gain • Balance of Academic Power Relations • Misuse of Public Resources And Other Ethics in Public Service Issues e.g. Misuse of Employer Resources

13. Research Compliance Program at UA • Program exists to facilitate the adherence of University research programs to the federally required compliance regulations and to act as a conduit for information that cuts across individual compliance areas in order to foster integrity in the scholarship and research carried out at the University. • Alice C. Langen (Vice President for Research and Graduate School), Director of Research Compliance http://www.vpr.arizona.edu/compliance 601 Administration Building520-621-5196520-621-7507 (fax)langena@email.arizona.edu

14. Research Integrity • Research Guidelines for Participation as a Principal Investigator • The National Academy of Sciences, National Academy of Engineering, and Institute of Medicine stated in an article titled “Scientific Conduct”, 2 February 1994 that “…as members of the professional research community, we should strive to develop and uphold standards that are broader than those addressed by the governmental regulatory and legal framework for dealing with misconduct in science.” (more ... )

15. Maintaining Public Confidence In Research Data • Quality Assurance – guided by VPR Office • Program in Research Integrity Education – guided by US Office of Management and Budget • Conflict of Interest –guided by ABOR and State of AZ statutes - UA monitors potential and real conflicts between an Investigator’s research and his/her outside obligations, financial interests or employment

16. Laboratory Safety • UA Office of Risk Management and Safety • Laboratory Chemical Hygiene – • Responsibilities of lab members • Standard operating procedures • Information and Training • Environmental and medical surveillance • Emergency procedures • Recording keeping • Program evaluation

17. Federal Regulations UA offices conduct training for, and monitor compliance with: -Bio-Safety Level (“BLS”) regulations for research with DNA and other bio-hazards established by NIH and CDC Rules for Institutional Bio-safety -EPA and OSHA Rules for Use and Disposal of Hazardous Material, including Radioactive Material.

18. Animal and Human Research • Institutional Animal Care and Use Committee (IACUC) – NIH and USDA • University Animal Care Program • Human Subjects Protection Program – OHRP, DHHS • HIPAA (Health Insurance Portability and Accountability Act) • Human Subjects Training Course in the Protection of Human Research Subjects (CITI)

19. Animal Research Protections • Oversees the university's animal care and use programs, facilities and procedures ensuring the appropriate care, use and humane treatment of animals being used for research, testing and education.

20. IACUC, cont. • Serves as resource to faculty and staff, providing guidance in fulfilling the obligation to plan and conduct all animal use procedures with the highest scientific, humane, and ethical principles. • Reviews all requests for use of vertebrate in research. • Inspects all areas and laboratories where animals are housed and used, and • Oversees training and educational programs.

21. Human Subjects Protection Program • Program oversees safety of humans who volunteer as subjects in behavioral or medical research • Federal and UA policies enacted by Institutional Review Board (IRB) • Comprised of UA research peers, Human Subjects Office personnel, and community members.

22. IRB, cont. • does not comment on research protocol, which is the responsibility of the Investigator • reviews protocols for patient safety issues according to federal guidelines • conducts annual review of on-going studies

23. HIPAA • The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research and non-research purposes. The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research and non-research purposes, and their rights to access information about them.

24. Cooperating Offices at the UA • Vice President for Research and Graduate Studies • Office of Research and Contract Analysis • Sponsored Projects Services • Office of Technology Transfer • Office of Research Compliance

25. Industrial Support of Research • Approval Process Is the Same for Any Proposal • However • Contact With Sponsor • Pattern of Relationships & Roles • Terms & Conditions Are Not Fixed by Federal Law

26. Industry-University Differences • Business Missions Differ: Affects Perceptions on • Publication • Confidentiality • Types of Work We Will Undertake • Business Structures Differ: • Universities Are More Like A Partnership • Costing Approach Differs

27. Industrial Support of Research Unlike Proposals to Federal Agencies • Narrow the Focus of the Proposal • Address Specific, Defined Problem • Write Statement of Work Appropriately You Do Not Want SoW in a Proposal to Industry to Overlap Other Work in Your Lab. Creates Conflicting Contractual Obligations

28. Material Transfers & Confidentiality • MTA is an agreement to transfer research materials either into or out of an institution • CDA is an agreement to transfer information either into or out of an institution • Both Deal with Risk Allocation, Responsibilities and Allowed Activities • See www.ott.arizona.edu or www.orca.arizona.edu for examples