contract

tastelesscowcreekBiotechnology

Oct 4, 2013 (4 years and 9 days ago)

73 views

Brown Bag Series on Research

Faculty

Translational and Transformative
Research and Contract
Management

April 20, 2011

Gerberding Hall 142, University of Washington

Brown Bag Series on Research

Faculty

Speakers


Beth Hacker, Research Navigator

ITHS, School of Medicine


Lynne Chronister, Asst Vice Provost of Research
& Director of Sponsored Programs, OSP


Brown Bag Series on Research

Faculty

Translational Research and the Institute
of Translational Health Sciences (ITHS)

Beth Hacker, Ph.D.

ITHS Research Navigator

ithsnav@uw.edu

Brown Bag Series on Research

Faculty

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

Brown Bag Series on Research

Faculty

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)

Brown Bag Series on Research

Faculty

The ITHS is part of a nationwide consortium

of Clinical Translational Science Award sites

funded by the NIH

Brown Bag Series on Research

Faculty

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

Brown Bag Series on Research

Faculty

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


Brown Bag Series on Research

Faculty


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

ITHS Services

Brown Bag Series on Research

Faculty

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!

Brown Bag Series on Research

Faculty

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**

Brown Bag Series on Research

Faculty

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)

Brown Bag Series on Research

Faculty

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

Brown Bag Series on Research

Faculty

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!


Brown Bag Series on Research

Faculty

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

Brown Bag Series on Research

Faculty

Dr. Beth Hacker

ITHS Research Navigator

ithsnav@uw.edu

206
-
616
-
3875


www.iths.org


Brown Bag Series on Research

Faculty

Brown Bag Series on Research

Faculty

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

Brown Bag Series on Research

Faculty

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.

Brown Bag Series on Research

Faculty

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.

Brown Bag Series on Research

Faculty

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.

Brown Bag Series on Research

Faculty

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.


Brown Bag Series on Research

Faculty

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).


Brown Bag Series on Research

Faculty

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”) .


Brown Bag Series on Research

Faculty

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?


Brown Bag Series on Research

Faculty

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?


Brown Bag Series on Research

Faculty

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?



Brown Bag Series on Research

Faculty

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.

Brown Bag Series on Research

Faculty

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”.

Brown Bag Series on Research

Faculty

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!

Brown Bag Series on Research

Faculty




What Can Happen if it
all Goes South?




Brown Bag Series on Research

Faculty





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.

Brown Bag Series on Research

Faculty

Roles & Responsibilities

Role/Responsibility

PI

Dept

OSP

Make contact with sponsor to discuss possible research
funding/possible projects

X

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

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

X

X

Brown Bag Series on Research

Faculty

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.

Brown Bag Series on Research

Faculty

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.