Transcript Title goes here

Translational and Transformative
Research and Contract
Management
April 20, 2011
Gerberding Hall 142, University of Washington
Faculty Brown Bag Series on Research
Speakers
Beth Hacker, Research Navigator
ITHS, School of Medicine
Lynne Chronister, Asst Vice Provost of Research
& Director of Sponsored Programs, OSP
Faculty Brown Bag Series on Research
Translational Research and the Institute
of Translational Health Sciences (ITHS)
Beth Hacker, Ph.D.
ITHS Research Navigator
[email protected]
Faculty Brown Bag Series on Research
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
Faculty Brown Bag Series on Research
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)
Faculty Brown Bag Series on Research
The ITHS is part of a nationwide consortium
of Clinical Translational Science Award sites
funded by the NIH
Faculty Brown Bag Series on Research
The ITHS is a working partnership between
Regional Institutions and other CTSAs
Faculty Brown Bag Series on Research
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
Faculty Brown Bag Series on Research
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
Faculty Brown Bag Series on Research
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!
Faculty Brown Bag Series on Research
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**
Faculty Brown Bag Series on Research
Education and Training
www.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)
Faculty Brown Bag Series on Research
Pilot Funding
www.iths.org/funding
30% 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
Faculty Brown Bag Series on Research
How we can help you
• ITHS Navigator ([email protected])
-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!
Faculty Brown Bag Series on Research
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
Faculty Brown Bag Series on Research
Dr. Beth Hacker
ITHS Research Navigator
[email protected]
206-616-3875
www.iths.org
Faculty Brown Bag Series on Research
Faculty Brown Bag Series on Research
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
Faculty Brown Bag Series on Research
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.
Faculty Brown Bag Series on Research
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.
Faculty Brown Bag Series on Research
Grants
Grants are 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.
Faculty Brown Bag Series on Research
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.
Faculty Brown Bag Series on Research
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).
Faculty Brown Bag Series on Research
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 “flowdown”) .
Faculty Brown Bag Series on Research
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?
Faculty Brown Bag Series on Research
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?
Faculty Brown Bag Series on Research
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?
Faculty Brown Bag Series on Research
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.
Faculty Brown Bag Series on Research
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”.
Faculty Brown Bag Series on Research
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!
Faculty Brown Bag Series on Research
What Can Happen if it
all Goes South?
Faculty Brown Bag Series on Research
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.
Faculty Brown Bag Series on Research
Roles & Responsibilities
Role/Responsibility
PI
Make contact with sponsor to discuss possible research
funding/possible projects
X
Dept
OSP
Review conflict of interest (COI/SFI)
X
Negotiate Non-Disclosure Agreement (if applicable)
X
Negotiate budget/work with CRBB (if required)
X
X
Communicate with sponsor on contract issues
X
Negotiate and sign contracts
X
Understand the obligations for the agreement
X
X
Obtain human subjects approval from IRB
X
X
Create a project calendar
X
X
Submit reports & deliverables
X
X
Monitor expenses and payments
X
X
Monitor Subcontracts
X
X
Submit invention statements to C4C
Faculty Brown Bag Series on Research
X
X
X
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.
Faculty Brown Bag Series on Research
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.
Faculty Brown Bag Series on Research