Contracts

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
OTTs 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 (TCs)
• 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 Sponsors 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
Example Work Breakdown
Project X Deliver Y
Subcontract to Z for B
Create A
Integrate Test
Prove A
Make A
Meld A B
Test A/B
Alt to B
Test B
Prove A
Make A
Sub Z Test B
Alt to B
Meld AB Test A/B Project
10
Federal TCs

• Grants
• Each Agency Has Specific Nuances See Their Web
  Site
• Incorporate Office of Management and Budget
  Circulars
• http//www.whitehouse.gov/omb/circulars/index.htm
  l
• 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 Building520-621-5196520-621-75
  07 (fax)langena_at_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 Investigators 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