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April 4, 2006
Contracts & Regulations in Laboratory Management
Mary Louise Trammell and Patrick Jones, OTT University of Arizona
www.ott.arizona.edu
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.
www.ott.arizona.edu
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
www.ott.arizona.edu
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
www.ott.arizona.edu
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
www.ott.arizona.edu
ObligationsMoney 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
www.ott.arizona.edu
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
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.
Example: Work Breakdown
Project XDeliver Y
Subcontract to Z for B
Meld A & B
Alt to B
Create A
Prove A Make A
Test B
Integrate & Test
Test A/B
Prove A
Sub ZTest B
Meld A&BTest A/B
Project
Make A
Alt to B
www.ott.arizona.edu
Federal T&C’s Grants
Each Agency Has Specific Nuances – See Their Web Site
Incorporate Office of Management and Budget Circularshttp://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
www.ott.arizona.edu
Ethical IssuesArise Through A Conflict Among Obligations To Employers To Profession (Including Students & Patients) To Sponsors of ResearchAnd Desires For Recognition For Monetary Gain For Avoidance Of ResponsibilitiesEnabled By Our Authority To Act or Not Act
www.ott.arizona.edu
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
www.ott.arizona.edu
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/compliance601 Administration Building520-621-5196520-621-7507 (fax)[email protected]
www.ott.arizona.edu
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 ... )
www.ott.arizona.edu
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
www.ott.arizona.edu
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
www.ott.arizona.edu
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.
www.ott.arizona.edu
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)
www.ott.arizona.edu
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.
www.ott.arizona.edu
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.
www.ott.arizona.edu
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.
www.ott.arizona.edu
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
www.ott.arizona.edu
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.
www.ott.arizona.edu
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
www.ott.arizona.edu
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
www.ott.arizona.edu
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
www.ott.arizona.edu
Industrial Support of ResearchUnlike 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
www.ott.arizona.edu
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