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Translational and Transformative Research and Contract Management

Translational and Transformative Research and Contract Management. April 20, 2011 Gerberding Hall 142, University of Washington. Speakers. Beth Hacker, Research Navigator ITHS, School of Medicine Lynne Chronister, Asst Vice Provost of Research & Director of Sponsored Programs, OSP.

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Translational and Transformative Research and Contract Management

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  1. Translational and Transformative Research and Contract Management April 20, 2011 Gerberding Hall 142, University of Washington

  2. Speakers Beth Hacker, Research NavigatorITHS, School of Medicine Lynne Chronister, Asst Vice Provost of Research & Director of Sponsored Programs, OSP

  3. Translational Research and the Institute of Translational Health Sciences (ITHS) Beth Hacker, Ph.D. ITHS Research Navigator ithsnav@uw.edu

  4. What is Translational Research? Lab Clinic Community • Uses knowledge from basic sciences to produce drugs, devices and treatment options for patients • Dissemination and implementation of new treatments to target populations • Multidisciplinary in nature

  5. Examples of Translational Research Projects Funded by the ITHS • Using electronic communications to improve hypertension in the community (health care team, community, bioinformatics) • Developing policy to overcome barriers for tissue biorepository sharing (scientists, clinicians, bioinformatics, ethics)

  6. The ITHS is part of a nationwide consortium of Clinical Translational Science Award sites funded by the NIH

  7. The ITHS is a working partnership between Regional Institutions and other CTSAs

  8. ITHS Services • Study Design and Data Management • -Biomedical statistics (study design, randomization) • -REDCap (Research Electronic Data Capture): free • web-based tool for data entry, tracking and export • -Electronic Medical Records data extraction • Regulatory and Bioethics • -Research Coordinator Core: trained research support staff • -Data Monitoring Committee for multicenter trials • -Bioethical issues in research: vulnerable populations

  9. ITHS Services • Pre-Clinical Research Development Core • -Development of a device that delivers therapeutics to the brain via upper nasal cavity • -Ultrasound device to improve kidney stone imaging and expulsion • Community Outreach and Research Translation • -Health information sharing using Center for Native Digital Storytelling • -Created a research network of WWAMI community practices • -ResearchToolkit.org: help guide multisite collaborations

  10. ITHS Helps You Find Resources www.iths.org/resources • Look up over 150 Research Core Facilities and Services throughout the WWAMI region • Includes clinical, behavioral, population assessment, genomics, cell culture, fabrication and much more!

  11. Education and Training Lifelong Learning Programs www.iths.org/training/online • Clinical Research Education Series-monthly • -April: ”Statistical Issues in the Design and Conduct of Clinical Trials” • Career Development Series-monthly • -March: ”Tips to Get an Early Investigator Award” • ITHS Bootcamp-Fall 2012 • -Intensive lecture series addressing all aspects of translational research • Comparative Effectiveness Research (CER)-2012 date not set • -Discussion of methods, implementation and dissemination **Most seminars are webcast and archived on ITHS website**

  12. Education and Trainingwww.iths.org/education Structured Learning Programs • TL1 Predoctoral Training • -Summer 2013 applications due March 2013 (12 slots) • -Yearlong applications due Winter 2012 (12 slots) • KL2 Postdoctoral Program • -Training for up to 5 years • -Applications for 2013 class due Oct 2012 • Tuition Support Fellows Program • -MS/MPH Epidemiology or Health Services • -Applications due Oct 2012(5 slots)

  13. Pilot Fundingwww.iths.org/funding30% of completed ITHS pilot projects went on to receive follow up funding • Small Pilot Project Grants-twice yearly • Ignition Awards-preclinical • ITHS Visiting Scholars Program Awards-WWAMI region • Community/Practice/Tribe-based Research Activity Funding • Multiple one time funding opportunities available throughout the year

  14. How we can help you • ITHS Navigator (ithsnav@uw.edu) • -Point you to resources and answer questions • -Contact person for Letter of Support • Membership benefits (www.iths.org/membership) • -Membership is free and open to anyone • -Eligible for ITHS funding • -Reduced rates for ITHS sponsored resources • Letter of Support -5 day lead time • Think Ahead and Start Early!

  15. ResearchMatch A free, NIH sponsored online recruitment database of volunteers interested in learning more about research studies (not just clinical trials) Researchers with UW approved IRB can request recruitment access Researchmatch.org

  16. Dr. Beth Hacker ITHS Research Navigator ithsnav@uw.edu 206-616-3875 www.iths.org

  17. Contract Supported Research: How is it Different from Grant and Gift Support? Michael A. Corn, J.D. Associate Director Office of Sponsored Programs Faculty Brown Bag Series Friday, April 20, 2012

  18. Primary Distinction Contract-supported research has the most stringent performance requirements Gift-support research has the least stringent performance requirements Grants are somewhere between contracts and gifts Note: “Grant” terminology can be misleading and inconsistent. Sometimes, a non-federal grant is really a gift and sometimes it is really a grant.

  19. What is a (Charitable) Gift? A gift is a voluntary transfer of something of value from a donor to a donee without consideration. No quid pro quo– all benefits from a charitable gift accrue to the general public, not to the donor. Gifts may be either restricted or unrestricted (most gifts are restricted and must be used for the purpose specified by the donor). Restrictions that provide special benefits to the donor can invalidate a charitable gift.

  20. Grants Grantsare assistance. There is generally some flexibility in scope of work with spending and outcomes unknown. Other than reports, a deliverable is typically not required for grant-supported research, only effort. Federal grants are guided by OMB Circulars A-110 and A-21. Grants are not benefits or entitlements. A federal grant is an award of financial assistance from a federal agency to carry out a public purpose and is authorized by a law of the United States. Grant awards are still documented through a contract or other writing with the sponsor, but they are not contract-supported research.

  21. What is a Contract? A contract is a legally enforceable agreement between two parties setting forth the parties’ rights and obligations. A contract requires the assent of legally competent parties. A contract must be supported by consideration to be enforceable – each party generally ends up with both benefits and burdens. A contract does not always need to be in writing, but most are.

  22. More about Contracts Federal prime contracts (contracts between the US Government and its contractors) are subject to federal law, including Federal Acquisition Regulations (FAR’s). FAR’s are typically referenced by numbers. Industry contracts that are federal flow through are also governed by FAR’s. Other industry contracts are governed by other state laws and codes such as the Uniform Commercial Code (UCC).

  23. Federal Flow Through A contract may be in the form of a secondary award from a prime awardee under an original federal contract. Project funds are treated as federal funds – there will be additional special federal terms and conditions. Many of the original federal contract terms and FAR’s will apply to the subawardee/subcontractor (they will “flow-down”) .

  24. When the Contract First Arrives… If you must achieve milestones in order to get paid, are the schedule and other performance requirements reasonable? Are there deliverables or guarantees? Is it cost reimbursable or fixed price? What about unexpended funds at project end? Can you meet the reporting requirements?

  25. Academic Contract Issues… Freedom to publish? Sponsor review (not approval) and publication delay rights? Confidentiality requirements? Intellectual property rights? Personnel restrictions? Limitations on working with third parties? Is it research or service/testing work?

  26. Financial Issues… Spending restrictions and re-budgeting authority? Is there flexibility in the work plan? Who pays if there are unusual problems? Ownership of purchased equipment? Travel reimbursement? Indirect cost/overhead rates? Salary limits? Cost-sharing?

  27. The Most Important Thing to Remember (Business Risk 101)!!! Contract-supported research typically requires providing deliverables in addition to reporting results. A failure to deliver exactly what is agreed may mean the sponsor does not have to pay! The risk of non-payment is a local burden (PI and department), not a central administration responsibility.

  28. Who Signs? The duly-authorized representatives of both parties sign the agreement – the sponsor and UW. Only OSP has the authority to sign for the UW. Principal Investigator may sign as having “read and reviewed”.

  29. Some Important Reminders… The research contract is between UW and the sponsor. The UW has an employment contract with the researcher. The official UW signatory must be a person authorized by the UW Regents. If refunding or non-payment occurs…. the pain flows down!

  30. What Can Happen if it all Goes South?

  31. Call of the Wild UW enters into an agreement with a government agency at the request of a faculty member. She is not able to provide the agreed upon training programs because of lack of cooperation with the unit to be trained. No one is informed by the PI, so the UW continues to auto-invoice and the sponsor auto-pays. A whistleblower informs the state auditor and the information ends up on the news. UW (and the PI) is required to repay the funds.

  32. Roles & Responsibilities

  33. Best Practices Review contract terms carefully with both OSP and department administrators before the project begins. Keep in mind this is a contract, not a grant or gift. Make note of special conditions. Submit reports and provide deliverables exactly as committed in the contract. Follow agreed upon timelines and methodology. Work with OSP to obtain in writing any changes in scope, timelines or reporting.

  34. More Best Practices Do not charge expenses to a cost-reimbursement contract unless they are part of the budget and are directly related to the work. If the sponsor has title to equipment, do not use UW funds to purchase it and do not use outside of project. Be sure to clearly understand the terms of any material transfer agreement (MTA). Closely monitor subawards. The OSP website has guidance and forms and information on two classes on subaward monitoring. Do not rely on verbal agreements or enter into side agreements with sponsor.

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