Creating Successful Research Projects: Navigating the Process

Report
Creating Successful
Research Projects:
Navigating the Process
---New Faculty Orientation--December 16, 2010
Walker Ames Room
Kane Hall
WELCOME
David Eaton, PhD
Interim Vice Provost for Research
NEW UW FACULTY
• 1st new faculty orientation
• 375 new faculty in 2009-2010
– Transfers from other institutions
– First faculty position
• “…we are partners in a shared future.”
(Interim President Phyllis Wise, December 2010)
WORLD LEADERS IN RESEARCH
We have grown into the most successful public
research university in the nation in attracting support
for our research.
Ours is a proud culture of innovation,
collaboration and discovery that has
transformational impact.
From the UW Mission Statement
WE ARE:
• World leaders in research
• One of the most successful public research university
in the nation in attracting support for our research
• Innovative & collaborative
• Impacting our community, nation and the world
IMPACT
• UW research makes far-reaching impacts
• Locally, nationally, and globally
WE ARE HERE TO HELP
• Offices presenting today are part of the central
oversight and support for your research enterprise.
• We will work with you to ensure your projects meet
sponsor requirements, state & federal law, and
UW policy.
TODAY’S WORKSHOP
• Introduction to the central research support offices
• Learn how to navigate the UW Processes
• Maneuver through the multiple regulatory and
compliance considerations within the grant lifecycle
• Manage the pre and post award process at UW
Successful acquisition & management
of grants requires many partners
• Individual faculty, and their departmental and Dean’s office support staff
• Office of Research – all components
• Grant and Contract Accounting
• Management Accounting & Analysis
• Human Resources
• Purchasing
• Facilities Management
• Environmental Health & Safety
• Animal Welfare
OR - MAJOR ADMINISTRATIVE UNITS
• Office of Sponsored Programs (OSP)
Director of OSP & Assistant Vice Provost for Research, Lynne Chronister
• Human Subjects Division (HSD)
Director of HSD & Assistant Vice Provost for Research, Karen Moe
• Office of Research Information Services (ORIS)
Director of ORIS & Assistant Vice Provost, Jim Kresl
• Office of Research - Central (OR)
Interim Vice Provost for Research, David Eaton
Associate Vice Provost-Compliance and Operations, Jeff Cheek
Associate Vice Provost-External Relations, Mani Soma
TODAY’S SPEAKERS
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Office of Sponsored Programs - Lynne Chronister
Office of Research Information Services - Patti McClure
Grant & Contract Accounting - Tami Sadusky
Management Accounting & Analysis - Mike Anthony
Center for Commercialization - Linden Rhoads
Environmental Health & Safety - Jude Van Buren
Office of Animal Welfare - Nona Phillips
Human Subjects Division - Karen Moe
Internal Audit - Zenaida Shattuck
Conflict of Interest – Jeffrey Cheek
RESOURCES AVAILABLE
• A resource table is set up at the back of the
room. Please stop by and collect materials you
feel can assist you in creating successful
research projects.
• This PowerPoint deck will be posted on the OSP
website tomorrow.
• Evaluation form – please tell us how we did!
Lynne Chronister, Assistant Vice Provost for Research & Director OSP
OFFICE OF SPONSORED
PROGRAMS (OSP)
OSP MISSION
The Office of Sponsored Programs, a unit in the
Office of Research, supports and advises the entire
academic community in securing external support for
sponsored projects and collaborations.
We review, negotiate, approve, and provide
administrative oversight related to proposals and
establishment of awards on behalf of the University of
Washington in accordance with all applicable
policies, and regulations.
OSP RESPONSIBILITIES
What do we do?
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Review and approve proposals
Submit electronic proposals
Negotiate and sign awards and subcontracts
Liaison with sponsor for award life
Coordinate close-out of awards
Implement Grant & Contract policies (financial, legal, and
regulatory)
• Provide customer support to UW faculty and staff
OSP STRUCTURE
• Each unit on campus assigned to Team A or Team B
• Team C reviews all Industry-Sponsored Clinical Trials
• Subcontracts Team manages all outgoing subcontracts
and required reporting
• Team Structure:
– Administrator
– Grant & Contract Coordinator
– Program Coordinator
GIM 19
Business Sections
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Face Page
List of Personnel
Biosketches
Budget
Budget Justification
Checklist
Required Additional Information
Scope of Work
• Description of the Research
• (The Science)
Final Version by
Day – 7
Draft Version by
Day – 7
Final Version by
Day - 3
PROPOSAL
BUSINESS PROCESS
1. Identify sponsor & complete application
Hints: read & follow instructions, contact your OSP admin if
you have questions
2. Fill in SAGE eGC1, attach application & route for
internal approvals
3. Review & approve by OSP
OSP will work with PI & Dept to ensure the best application
can be submitted to the sponsor
4. Submit application per sponsor instructions
o
o
Application is submitted by OSP/PI
Via electronic, paper, web formats
AWARD
BUSINESS PROCESS
• Sponsor may notify PI or OSP that application is
fundable
• Award documents arrive
• OSP negotiates & accepts award (exceptions)
• OSP creates eFA and sends to GCA
ADMINISTRATIVE
BUSINESS PROCESS
• Advanced Budgets (if allowed by sponsor)
• Modification to an award (PI, dates, re-budgeting,
etc.) must be processed by OSP and may require
sponsor approval
• No-Cost Extensions
• Sub-Awards are made through OSP
SPONSORED PROGRAM
POLICY
GIMs (Grant Information Memoranda)
• Provide policy and guidance on submitting and
managing awards
• Linked from the OSP Home page
• Currently “Under Construction”
OSP HINTS
• Contact your OSP Administrator early in the
process with questions.
• What does the PI sign?
Nothing that will create liability or commitment
• What does OSP sign?
Anything that commits the institution
New Facilities and Administrative (F&A) Rates
Location
Negotiated Rates (FY 2010-2014)
On-campus
54% -- FY 2010-2012
54.5% -- FY 2013-2014
Off-campus
26%
South Lake Union
66% -- FY 2010; 68% FY 2011;
72% -- FY 2012; 73% -- FY 2013;
74% -- FY 2014
Regional Primate Center
42% (A)/
78% (A+B)/
83% (A+B+C)
Applied Physics Lab
17%
Other Sponsored Activity
33.8% (on-campus)
26% (off-campus)
Vessel
25% (S&W)
Instruction
53.0% (on-campus)
26% (off-campus)
OSP RESOURCES
• Grants Information Memoranda (GIM)
• OSP Web Page
• Researcher’s Guide
• Monthly Research Administration Meetings (MRAM)
o Subscribe to List Serve - get meeting announcements & email updates
o MRAM Web site
o Monthly in-person updates to campus
CLINICAL RESEARCH
• School of Medicine – Clinical Research
• Richard Meisinger, PhD, Ass’t Dean for Planning and
New Initiatives, Office of Research and Graduate
Education, School of Medicine, [email protected]
• Ella Mae Kurashige, Director, Clinical Research
Services, [email protected]
• Office of Clinical Research Budget & Billing (CRBB)
• Clinical Trial start-up and web resources
Patti McClure – Educational Outreach Specialist
Tiffany Austin – Learning Specialist
OFFICE OF RESEARCH
INFORMATION SERVICES (ORIS)
OFFICE OF RESEARCH
INFORMATION SERVICES (ORIS)
Serving UW's research community
through IT solutions
Web Services
Data Reporting
SAGE
System to
Administer Grants
Electronically
Research Road Map
Hosted Services
SAGE
(System to Administer Grants Electronically)
• Create, route, and manage the electronic routing form
(eGC1) required for all UW grants and contracts/research
applications
• Centrally store and share grant proposal information
• Access grant proposal information from any internetconnected location
WHEN TO USE SAGE?
Activity in SAGE
The Idea
Generate the idea
Identify potential sponors
Synthesize idea with
sponsor's mission
Begin drafting proposal
Consider budget
The Application
Create an eGC1
Create a budget
Complete proposal &
gather documents
Upload final
documents to eGC1
Route eGC1 for
approval
Submit to sponsor
The Award
Confirmation from sponsor
Request Advance Budget
Gather Just in Time
approvals
Receive funding
Manage your award
The Research
Conduct research
Report findings
Generate new ideas
SAGE BUDGET
An easy-to-use budget worksheet customized to comply
with Research and UW Accounting Rules
• Supports UW object code accounting
• Provides up-to-date salary & benefits information
• Identifies correct F&A rate(s) for your budget
• Attaches to eGC1
eGC1 APPROVALS
• Routes your eGC1 to the appropriate parties for online review
and approval
• Enables you to check on routing status of your eGC1
GET STARTED WITH SAGE
• Request access from your department
• Practice on the training server
• Enroll in SAGE 101 training course
www.sage.washington.edu
CONTACTS & QUESTIONS
• SAGE Learning
– Email: [email protected]
• SAGE Help Desk
– Email: [email protected]
– Telephone: 685-8335
• Questions?
Tami Sadusky, Executive Director
GRANT AND CONTRACT
ACCOUNTING/EQUIPMENT INVENTORY
OFFICE
Division of Research Accounting & Analysis within
Finance & Facilities
Finance & Facilities
RESEARCH ACCOUNTING
& ANALYSIS (RAA)
RAA Mission: We help people who change the world
Research
Accounting &
Analysis (RAA)
Grant & Contract
Accounting (GCA)
Equipment
Inventory Office
(EIO)
Management
Accounting &
Analysis (MAA)
GCA RESPONSIBILITIES
What do we do?
• Set up grant and contract budgets in the University’s Financial
Accounting System (FAS)
• Prepare and submit required invoices and financial reports to
sponsoring agencies
• Manage grant and contract cash transactions and payments
• Provide oversight and guidance on compliance issues
• Coordinate financial close-out of budgets
• Monitor grant related transactions on a sampling basis
• Work with Internal Audit on all grant related audits
• Provide customer support to UW faculty and staff
EIO RESPONSIBILITIES
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Prepare Closing Inventory Reports
Facilitate State, Federal, and Agency inventories
Assist departments with equipment fabrications
Print and distribute asset tags to departmental inventory
contacts
Train departments on General Inventory Procedures, OASIS
Access, and Inventory processing
Assist PI’s taking equipment out of the country
Review and approve transfers of equipment out of the
University
Facilitate annual depreciation for the University’s financial
statements
GCA/EIO Structure
• ‘Streams’ of Fiscal Analysts handle core processes:
– Budget set up
– Reporting
- Invoicing
- Closing
• Cash Team handles grant related cash transactions and
applications
• Grant Analysts handle all campus communication
including outreach and training
• Complex Grant Analysts handle complex grants and
contracts
• Equipment Team handles all equipment processes
POST AWARD PROCESS
Proposal &
Award Process
Academic Dept/Office
of Sponsored Programs
Assignment of Budget Numbers
Receipt and processing of eFA
(Electronic Funding Action)
Active Grant Period
Expenditure Allowability
Payment requests to sponsors
Closing
Fiscal Reporting
External to Grant and
Contract Accounting
Audits
AWARD LIFECYCLE
Award Step
Identify funding
Prepare proposal
Review and submit proposal
Negotiate and accept award
Set up award
Perform work
Financial management
Technical reporting
Monitor activity
Invoice and collect payments
Monitor accounts receivable
Close-out award
Responsible Party
PI
PI & Department Staff
PI & Office of Sponsored Program (OSP)
OSP
Grant & Contract Accounting (GCA)
PI
PI, Department Staff, GCA
PI
PI & Department Staff
GCA
GCA & Department Staff
PI, Department Staff, GCA & OSP
THE BUDGET
• Provides the framework for financial compliance
• GCA creates a budget number for an award to
accumulate costs associated with the project.
• The budget is allocated in the financial accounting
system (FAS):
– Direct costs
– Facilities and Administration (F&A or indirect costs)
DIRECT COSTS
Costs that should be directly charged to sponsored
agreements when they can be specifically identified to
the work performed under those agreements.
- Salaries, Wages, and Fringe
Benefits
- Supplies and Materials
- Equipment
INDIRECT COSTS
Cost that are normally considered administrative,
infrastructure or benefit multiple projects
– Administrative and Clerical salaries
– Basic local phone service
– Office supplies
– Routine copying charges
POLICIES
Federal, State, University & Sponsor
Award
Terms
Departmental
Policies
Learn How to
Apply the Policies
Accounting
& Financial
Policies
University Policies &
Procedures
NIH - GPS
A-21, A-110,
FARs
Sponsor Policies
Federal Policies and
Governmental Law
PI/DEPARTMENT
RESPONSIBILITIES
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Assistance in grant and contract reporting/closings
Separation of (high risk) duties, such as payroll or
petty cash
Deficit resolution
Program Income
Cost Sharing/Faculty Effort Reporting
Unexpended balances
Records retention
Faculty Effort Certifications (FECs)
Address problems related to fiscal activities
promptly
HINTS
• Take a proactive approach to grant management
• It’s critical that all parties work together
• Adhere to University, State, Federal and Sponsor
policies and regulations
• Establish proper financial accountability structure
• Ensure proper financial management with attention to
data integrity
GCA RESOURCES
• GCA Web Page
• GCA email/phone:
[email protected] 206-543-8454
• Grant Tracker
• Researcher’s Guide
• Monthly Research Administration Meetings (MRAM)
• Grants Information Memoranda (GIMs)
Michael Anthony, Executive Director
MANAGEMENT ACCOUNTING
& ANALYSIS (MAA)
Division of Research Accounting & Analysis within
Finance & Facilities
Finance & Facilities
RESEARCH ACCOUNTING
& ANALYSIS (RAA)
RAA Mission: We help people who change the world
Research
Accounting &
Analysis (RAA)
Grant & Contract
Accounting (GCA)
Equipment
Inventory Office
(EIO)
Management
Accounting &
Analysis (MAA)
MAA – OFFICE RESPONSIBILITIES
What do we do?
• Calculate and negotiate the University’s Facilities and
Administrative (F&A) rates
• Review and approve Recharge Center/Cost
Center/Program Income rates
• Provide oversight for the Federally mandated effort
reporting process
• Provide support to UW faculty and staff
MAA - STRUCTURE
Major Department Activities/MAA Units:
• F&A rate calculation and negotiation
• Recharge/cost center and program income rate
review and approval
• Effort reporting training and oversight
All units participate in customer service to faculty and staff
F&A RATE CALCULATION
& NEGOTIATION
F&A (Indirect) Costs
• Infrastructure costs necessary to support the UW’s research mission
• Represents ‘real’ institutional costs
• Incurred for common or joint objectives
• Cannot be identified specifically with a sponsored project or other
institutional activity
• Recovered through the application of the F&A rate to funded
sponsored agreements
CURRENT F&A RATES
(effective 7/1/09)
• 54% On-campus Research
• 26% Off-campus
• 33.8% “Other Sponsored Projects” (New rate for UW
will be used for non-research and non-training or
education)
• Other special rates (e.g., Applied Physics Lab; South
Lake Union; Regional Primate Center)
• http://f2.washington.edu/fm/maa/fa/rates
RECHARGE /COST CENTERS
• Recharge/Cost Centers - units or activities providing
goods/services primarily to internal university
operations
• Recharge Centers - charge more than $125,000
annually to federally sponsored agreements OR more
than $1,000,000 in total charges
• Cost Centers - charge less than $125,000 annually to
federally sponsored agreements AND less than
$1,000,000 in total charges
PROGRAM INCOME
• Income generated as a result of a research
activity
• Tied to a specific grant or contract, usually
Federally funded
• Income may be internal and/or external
• These types of activities require prior approval
from the agency that sponsored the original
research
PROGRAM INCOME RATES
• MAA
– Reviews rates to ensure they are compliant with
Federal costing principles
– Verifies costs are not being recovered through other
means, e.g., through the F&A rate process
• GCA
– Establishes program income budgets
– Ensures program income is netted from
reimbursement requests
EFFORT REPORTING
• Federally mandated compliance requirement
• Requires periodic certification that percent salary
charged to sponsored project represents a reasonable
reflection of percent effort devoted to the project
• Includes committed cost shared effort
• Faculty – Accomplished through Faculty Effort
Certification (FEC)
• Non Faculty – Accomplished via Grant and Contract
Certification Report (GCCR)
EFFORT REPORTING
• Faculty Effort Certification (FEC)
– Done every 6 months
– SOM/Dentistry/Public Health/Pharmacy
• January 1 – June 30
• July 1 – December 31
– All other schools/colleges
• September 16 – March 15
• March 16 – September 15
• Grant and Contract Certification Report (GCCR)
– Done on the calendar quarter
MAA - RESOURCES
• GIM (Grants Information Memoranda)
– GIM 13: Indirect Cost Rates
– GIM 22: Facilities and Administrative Costs: An
Explanation
– GIM 35: Effort Reporting Policy for Sponsored
Agreements
• MAA Web Page
• MRAM (Monthly Research Administrators
Meeting)
Linden Rhoads, Vice Provost
CENTER FOR COMMERCIALIZATION
(C4C)
Jude Van Buren, Director
ENVIRONMENTAL
& OCCUPATIONAL HEALTH & SAFETY
(EH&S)
EH&S - MISSION
To support the University of Washington’s teaching,
research, and service missions, the Environmental
Health and Safety Department assists
organizational units in meeting their responsibility
to:
– protect the environment
– provide a safe and healthful place of employment and
learning
EH&S Functional Org Chart
How we are organized to support you
Conducting UW research has many
parallels to running a successful business
• You have employees to protect and supervise
• You have materials
(biologicals/ chemicals/ radiation)
• You may have animals or plants under your care
• You have procedures, methods and protocols for your
processes
• You have approvals and laws that govern your practices
• You have a facility you need to maintain
• You have neighbors you must consider
Local, State and Federal laws that
address your research:
EH&S has responsibilities and authority provided in UW Admin. Policy
Statements (APS) to meet those regulations
State and Federal
Environmental
Pollution Laws
State and Federal Worker
Health & Safety Laws
State and Local Public Health
/Fire Safety Laws
UW APS &
Your
Research
Hazardous
materials laws
Federal sponsor
requirements
Fed. laws: Select Agent,
Agriculture, Animals
Hospital
Operational/
Facility Laws
5 questions on SAGE that will engage
EH&S involvement in your research
1. EHS-1: Any Pathogenic Agents, Potential Biohazards, recombinant
DNA, human tissues or cells, hazardous materials in animal studies
or highly toxic chemicals? If YES – then:
2. EHS-2: Any involvement of acquisition, possession, use transfer or
shipping of Select Agents, Exempted Select Agents or Toxins?
3. EHS-3: Generate hazardous waste without disposal options or
mixed waste (radiation + Hazardous components) or multi-hazard
waste (biological /hazardous /radiological components)?
4. EHS-4: Involvement of uses of radiation: transuranics, gaseous
alpha-emitters or intentional release of radionuclides to
atmosphere?
5. EHS1-A: Does Sponsor require Institutional (UW EH&S) Safety
Review of facility prior to submission to the sponsor.
MUST HAVES – for working with biological
material and/or recombinant DNA
1.
Biological Use Authorization (BUA)
Institutional approval from EH&S and the Institutional Biosafety Committee
(IBC). All work with Recombinant DNA, pathogenic organisms, human or non
human primate tissues (including all cell lines) or other biohazardous agents.
http://www.ehs.washington.edu/rbsresplan/rpha.shtm
2.
Biological Safety Manual use required and made available to staff
http://www.ehs.washington.edu/rbsbiosafe/bsmanualindex.shtm
3.
Biological Safety Training required by NIH for all of above research prior and
annually for work with biohazards
In person class offered monthly – soon to be on-line
4.
Bloodborne pathogen training (BBP) required when working with human blood, blood
byproducts and human tissue – (new and annual trainings – in person and soon on-line)
ALL EH&S trainings can be found on our webpage.
MUST HAVES – for working with
animals and/or hazardous materials
Occupational Health Reviews:
• All researchers and staff working with Animals
• Must complete EH&S Animal Use Medical Screening (AUMS) Form - receive
medical clearance. Review required prior to initiation (IACUC approval)
and every 3 years.
• All Animal Research using hazardous materials
• IACUC approval requires Occupational Health Nurse (OHN) review of
research involving biohazards, chemical hazards
• OHN sends PI letter and IACUC recommendations about these hazards
in their protocol
• PI must review OHN recommendations with staff and adhere to
vaccinations requirements where indicated and work safety practices
including protocols and personal protective equipment
• Highly hazardous chemicals are referred to EH&S Occupational
Hygienist for follow up – possible lab visit and changes to protocols
and SOPS to address hazards
MUST HAVE – engineering controls when
working with chemicals
• Appropriate room ventilation
• Functional safety shower and eye wash
• Fume hood with recent EH&S performance test
• Appropriate chemical storage cabinets
• Spill kits/secondary containment
• Appropriate ventilation if using chemicals in a certified
biosafety cabinet
MUST HAVE administrative controls for
chemical use
•
Chemical management training
• Health Hazards from exposures
• Operations
• Use/storage/Personal Protective Equipment
• Waste/ Spills
• Standard Operating Procedures
•
Chemical inventory, MSDSs (material safety data) and emergency contacts (MyChem)
•
Training for shipping hazardous materials
•
Fire Department hazmat permit
•
EH&S approval for toxic gases
•
All EH&S trainings at
http://www.ehs.washington.edu/psotrain/corsdesc.shtm#initialbloodborne
If you are working with radiological
materials you MUST have:
• Been granted Authorized Investigator (AUI) status by the
EH&S Radiation Safety Office or be working under an
existing AUI.
• X-ray and laser generating equipment must registered
with the Radiation Safety Office.
• Training must be verified and inspection schedules established for
x-ray producing equipment.
• Disposal of these items must be done properly. Users must notify
the RSO prior to disposal.
As a business person you have employees that
you must protect, mentor and govern
Responsibilities you must address for your employees welfare:
1. Report employee accidents
Employee must inform boss and EH&S
http://www.ehs.washington.edu/ohsoars/index.shtm
2. Inform employees of what they are working with:
Worker Right-to-Know Communications
http://www.washington.edu/admin/rules//APS/12.05.html
Identify & label hazardous chemicals appropriately
Access Material Safety Data Sheets (MSDSs)
http://www.ehs.washington.edu/epomychem/msds.shtm
3. Review current Lab Safety Manual, keep it in your lab &
available to staff
http://www.ehs.washington.edu/manuals/lsm
4. Report chemicals used in MyChem – chemical inventory database
http://www.ehs.washington.edu/epomychem/index.shtm
As a business person you have employees
that you must protect, mentor and govern
5.
Identify hazardous procedures and describe employee protective
measures
“Chemical” Lab http://www.ehs/washington.edu/manuals/lsm/lsm6.pdf
“Physical” Lab http://www.ehs.washington.edu/rbsresplan/ppe.shtm
6.
Know your Emergency Procedures/Plans
Ask your Department for their Health and Safety Plans and your building’s Emergency
Evacuation and Operations Plan
7.
Staff Training- required trainings plus trainings to educate new
researchers and staff
Ensure all training is documented, keep training current, train all new staff
http://www.ehs.washington.edu/manuals/lsm/lsm7.pdf
Operating a Research
Lab is like running a
business –
What are the risks?
• Fines/Restrictions
• Health Impacts
• Unable to do
research/Negative Publicity
• UW Mission at risk
Examples of costs of not following
procedures/protocols/regulations
• Failure of researcher to properly
dispose of hazardous waste
(>$10,000 fine -2010)
• Violation of air operating permit
from EPA resulted in a $350,000
fine (Negotiated to $30,000 fine
with program initiation - .5 EH&S
FTE)
• Pending appeal of $66,000 fine
to UW for explosion and
violation of FAA shipping
regulations (2010)
What YOU can do to ensure
accidents, injuries, citations, fines and
loss of research doesn’t occur
It depends on you---• Know and follow the policies
• Know SOPs
• Prepare and practice
• Protect self & employees
• Perform compliance Checks
• Promote worker health and safety and
environmental stewardship
Questions? Contact EH&S at 206.543.7262 or at [email protected]
Nona Phillips, Director, Office of Animal Welfare
OFFICE OF ANIMAL WELFARE
(OAW)
Office of Animal (OAW) - Mission
The Office of Animal Welfare provides support to
the University’s Institutional Animal Care and Use
Committee (IACUC) and provides support and
advice to researchers utilizing live vertebrate
animals for teaching and research.
We review IACUC protocols, grants involving live
vertebrate animals, and provide oversight and
compliance on behalf of the IACUC in accordance
with applicable laws, policies and regulations.
OAW - RESPONSIBILITIES
What do we do?
• Process and review IACUC protocol submissions
• Review grants and provide IACUC approval
information for sponsors
• Provide courses including species-specific procedure
labs
• Provide personal one-on-one post-approval
assistance to researchers via our “Post-Approval
Monitoring” program
• Coordinate IACUC semi-annual site visits to animal
housing and use locations
OAW - STRUCTURE
Administrative Team: Processes IACUC submissions and
informs PIs of upcoming protocol and training expirations.
Scientific Reviewer Team: Reviews IACUC submissions and
grants involving live animals.
Training Unit: In conjunction with Department of Comparative
Medicine veterinary staff, courses are provided including
species-specific labs, surgery, etc.
Site Visit Team: Coordinates all aspects of IACUC semi
annual site visits and tracks deficiencies and corrections.
Post-Approval Monitor Team: Each PI is assigned to an
individual who will meet with them to review protocols and
plans, and advise/assist them as needed.
IACUC Protocol Business Process
1. PI submits new IACUC protocols, renewals, and changes
to protocols.
2. IACUC members receive items semi-monthly.
3. Members have 1 week to review and submit
questions/comments. (Members may request Full
Committee Review of any item)
4. IACUC questions/comments forwarded to PI.
5. PI responds back to committee with answers & protocol
revisions.
IACUC Protocol Business Process
6. OAW scientific reviewer reviews PI answers/
protocol revision.
7. Reviewer works with PI on any outstanding issues and
then either:
• approves the protocol or
• assigns it for the next monthly convened meeting if
Full Committee Review was/is requested by any
IACUC member.
Grants & Contracts
• Competing proposals
– Just-in-Time (after submission to sponsor but prior to
award)
– Copy of the proposal + eGC1
• Non-competing proposals
– At time of proposal submission
– Automatically routes to OAW during SAGE
eApprovals
• IACUC approval info must be included for animal work
at other institutions, if applicable.
Grant/Contract Review
Business Process
1. OAW reviews grant and associated UW
protocol(s) to assure concordance and if
applicable, assures that approvals from other
institutions are documented.
2. OAW provides letter to sponsor re IACUC
approval based on sponsor requirements.
3. Other documents provided as required by the
sponsor.
TRAINING OPPORTUNITIES
• Courses are offered on-line and in-person
• Courses include:
– general laws and regulations
– species-specific labs
– facility orientations
• Training specific to non-human primates is offered by
the Washington National Primate Research Center
• See the Animal Use Training web site for details and
registration instructions
POST APPROVAL MONITORING
• Each research group is assigned a compliance
advisor.
• The compliance advisor meets once or twice yearly
with the PI (and lab manager and/or others per PI’s
preference).
• Visits include review of protocols, operating
procedures, and planned changes, and advice
regarding IACUC review requirements.
IACUC SITE VISIT –
BUSINESS PROCESS
1. The IACUC conducts semi-annual site visits to animal
housing and use rooms during January-April and JulyOctober.
2. OAW requests available times, in advance, from
research groups and then schedules a visit accordingly.
3. The PI or facility supervisor receives a written report
after the visit.
4. If there are deficiencies a reply with correction plan
and completion date(s) is required.
IACUC POLICIES
Policies reviewed and approved by the
IACUC can be viewed and/or
downloaded.
HINTS FOR SUCCESS
• Contact OAW whenever you have questions
regarding your use of animals, including
when you may be unsure of whom to contact.
• We will help you or refer you to the
appropriate office or department.
Consult with OAW when…
• Changing the scope of grants (i.e., adding use of animals
when that was not originally planned and approved by
the sponsor, or adding a foreign component).
• Contracting with outside institutions/ companies for
animal work (e.g., custom antibodies) to assure that an
acceptable institution is chosen.
• When consulting with OAW regarding either of the
above, please visit our website and e-mail a scientific
reviewer.
OAW RESOURCES
• OAW/IACUC Web Page
https://depts.washington.edu/iacuc
• Animal Use Training Web Page
http://depts.washington.edu/auts/index.html
Karen Moe, Asst Vice Provost for Research & Director HSD
HUMAN SUBJECTS DIVISION
(HSD)
HSD - MISSION
The Human Subjects Division (HSD)
is a unit within the Office of Research (OR).
HSD staff support and facilitate the review
of human subjects research by the
Institutional Review Board (IRB). HSD staff
and IRB members partner with researchers
to safeguard the rights and welfare of
human subjects in UW research.
HSD - RESPONSIBILITIES
What do we do?
– Provide oversight, administrative support, and assistance for
research subjects and for researchers
– Support the IRBs in their review of research
– Make determinations about whether an activity is human
subjects research, or qualifies for exempt status
– Post-approval monitoring
– Assure compliance with federal regulations, state laws, and
university policy governing human subjects research
– Develop, deliver, and facilitate access to education and training
in the protection of human research subjects
HSD - STRUCTURE
3 Biomedical IRBs:
3 Social/Behavioral IRBs:
1 Combined IRB:
4 Subcommittees:
(Subcommittees review research that is Exempt or Minimal Risk.)
REVIEW BY NON-UW IRBs
• Western IRB (WIRB)
Reviews industry-sponsored and -initiated clinical trials.
• Cancer Consortium IRB (CC-IRB)
Reviews cancer research from consortium members.
• Cooperative Agreements (Affiliated Institutions)
Reviews conducted by Seattle Childrens, Group Health,
Swedish Hospital, etc. and accepted by the UW IRB.
IRB BUSINESS PROCESS
IRB APPROVAL CRITERIA
1. Risks are reasonable relative to benefits
Anticipated benefits include the importance of the
knowledge that may be expected to result.
2. Risks to subjects are minimized
• Procedures are consistent with sound research design and
do not unnecessarily expose subjects to risk.
• If possible, the research uses procedures already being
performed on subjects.
3. Protection of subject privacy & confidentiality
There are adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of data.
4. Adequate safety monitoring plan
The research plan has adequate provisions for monitoring
the data collected, to ensure the safety of subjects.
IRB APPROVAL CRITERIA
5. Written informed consent obtained
From each prospective subject or the subject’s legally authorized
representative, unless the IRB, per federal criteria:
– Waives the need for written consent.
– Waives the need for consent.
6. The consent process provides all required and appropriate
information
Unless waived by the IRB per federal regulatory criteria.
7. Subject selection is equitable
Taking into account:
– The research purpose and setting, and
– Any special issues associated with vulnerable populations.
IRB APPROVAL CRITERIA
8. Additional safeguards for protected & vulnerable populations
– Additional safeguards are included to protect subjects who may
be vulnerable to undue influence or coercion.
– Includes: children, prisoners, pregnant women, neonates.
– May also include decisionally-impaired, or economically or
educationally disadvantaged subjects.
9. Other ethical & compliance issues
– Researcher conflict of interest.
– Involvement of non-UW institutions and individuals.
– Other compliance requirements.
HINTS FOR SUCCESS
• Allow sufficient time for both preparation of the IRB
application and its review.
• Go to the HSD website to download a new
application each time (things may have changed).
• Don’t leave anything blank on the application – at
least write-in NA, as appropriate.
• Contact HSD with your questions or as issues arise . . .
we’re here to help.
HSD RESOURCES
• HSD Website:
• Get Started >> The IRB Process & IRB Guides
• Policy & Procedures
• Announcements
• eNews from HSD and the IRB (please subscribe)
• Contact HSD:
• [email protected] – general inquiries
• [email protected] – question or suggestion with a form
• [email protected] – request assistance or a session
Zenaida Shattuck, Associate Director
INTERNAL AUDIT DEPARTMENT
WHO AUDITS YOU?
• Federal and state auditors
• Private/non-government sponsors
• Local government auditors
• Financial statement auditors
• Internal Audit
WHEN AN AUDITOR CALLS
• Determine the purpose of the call
• Immediately notify your department
administrator
• If the auditor asks for information, request
for time to consult with staff
WHEN THE AUDITOR ARRIVES
You may have a University representative
present when meeting with an auditor.
– School/Department Administrator
– Internal Audit Liaison
WHEN THE AUDITOR ARRIVES
–Make sure both you and the auditor
understand the audit objective.
–Make sure you understand the question.
–Answer honestly and openly.
WHEN THE AUDITOR ARRIVES
Limit conversation to internal controls and:
–How you are directly involved with your grant
–How expense benefited the grant
–Do not bring in funding issues or departmental
politics
SUGGESTIONS FOR PIs
• Understand state and federal guidelines
• Know who is tracking your grant activity
• Review and initial paperwork on a regular basis
• Know your department administrator and the
Internal Auditor and ask for help
• Remember, you can ask for time to consult with the
staff responsible for the work
INTERNAL AUDIT CONTACTS
Richard Cordova
[email protected]
Zenaida Shattuck
[email protected]
Peter Harris
[email protected]
Jeffrey Cheek, Associate Vice Provost for Research Compliance& Operations,
Office of Research
Conflict of Interest (COI)
FEDERAL RESEARCH STANDARD
Conflicts of financial interest occur “whenever
financial considerations may have the potential to
compromise or have the appearance of
compromising an investigator’s professional
judgment and independence in the design,
conduct, or publication of research.”
- Public Health Service
Potential conflicts of interest occur in all human
processes and are not inherently “bad” if they are
appropriately managed.
COMMON FINANCIAL INTERESTS
•
Money – cash, salary, fees, royalties, honoraria; any monetary
right or obligation (both creditors and debtors have monetary
interests), liabilities
• Property – any physical asset with monetary value or burden;
intellectual and intangible property
• Equity/ownership – stock, partnership, etc.
• Imputed interests – spouse, family, partnership, joint ventures,
other legal relationships
Bottom Line: Anything with economic value
UW SIGNIFICANT FINANCIAL INTEREST
DISCLOSURE POLICY (GIM 10)
• Applies to all research (sponsored and unsponsored) and tech
transfer license transactions
• Addresses conflicts and appearances of conflicts
• Goal is to prevent • Bias in research
• Harm to human subjects
• Misuse of UW and state resources
• Violations of state ethics act
GIM 10
Purpose:
• Ensure no research or tech transfer activities at UW
are adversely affected by outside financial interests
of persons involved in those activities
• GIM 10 Policy complies with PHS and NSF
requirements for policy pertaining to financial
conflicts of interest of research investigators
GIM 10
Disclosure:
• Prior to participating in research or tech transfer
activity, anyone having a significant financial
interest related to the activity must disclose details
• Can occur: when research proposal submitted to
OSP; when application submitted to HSD; when SFI
arises during the course of research; or prior to
concluding technology licensing transaction
TYPICAL SIGNIFICANT
FINANCIAL INTERESTS (SFI)
• Outside salary, honoraria, consulting fees
• Compensation for speaking engagements
• Stock, stock options, other ownership interests
• Intellectual property rights (patents, licenses)
• Invention royalties (UW distributed royalties and
equity not considered SFI for license transactions)
• Imputed interests (spouse, etc.)
UW DEFINITION OF
“Significant Financial Interest”
1. For a Clinical Trial, any Financial Interest.
2. For Human Subjects Research other than a Clinical Trial (i) any
Financial Interest exceeding $5,000 in value, (ii) any Equity Interest;
or (iii) any Intellectual Property Interest.
3. For all Research other than Human Subjects Research and all
Technology Transfer Transactions, (i) any Financial Interest (including a
Compensation Interest, an Equity Interest and an Intellectual Property
Interest) exceeding $10,000 in value, or (ii) any Equity Interest
representing more than a 5% ownership in any single entity.
(PHS/NSF definitions)
NOTE: PHS/NIH currently revising guidelines (and perhaps definitions of SFI); new
regulations and/or guidance anticipated by Fall of 2011.
UNIVERSITY OUTSIDE
PROFESSIONAL WORK POLICY
• Pre-approval required (chair, dean, Office of the Provost)
• Subject to pre-approval, faculty may engage in outside work for
compensation
• Policy (and accompanying form) requires disclosure of days and
nature of work, not compensation (not true for SOM faculty)
www.washington.edu/admin/acadpers/forms/approval_compensation.pdf
• Approval for up to 13 days per quarter
• Annual report listing all outside professional activities, whether or
not compensated, must be filed
OUTSIDE WORK SUMMARY
• UW policy supports approved outside work
• Advance approval required
• Form not required for some non-profit work
• Requests involving potential conflicts of interest are
scrutinized
• SoM Supplement form required
• De minimis use of UW resources permitted
2005 STATE ETHICS ACT CHANGES
- Effect •
Alternate compliance system for “University Research Employees”
at state universities (research faculty/employees engaged in
research/tech transfer – not other employees)
•
Universities allowed to adopt administrative processes, with the
approval of the Governor, that apply in place of obligations
otherwise imposed by Ethics Act
•
Ethics board retains authority to enforce violations of alternative
compliance system
•
Liberalization of permitted de minimis uses
•
See our FAQs on Office of Research website
LIMITATIONS TO KEEP IN MIND
1. Faculty who own 50% or more of a company may be required
to take a whole or partial leave to do work for it.
2. Faculty member cannot be an investigator in a clinical trial
involving faculty member’s invention or product.
3. The UW will not conduct a clinical trial of a UW invention or for
a company in which it has a substantial equity position.
4. Except for allowed de minimis uses, UW resources and facilities
can only be used to support a company through established
processes (sponsored research, contracts, etc).
5. UW intellectual property cannot be transferred through
consulting or other “backdoor” methods.
Lynne Chronister, Assistant Vice Provost for Research & Director OSP
Wrap-Up
UNIVERSITY OF WASHINGTON
• Leaders in research and education
• Positively impacting our community, nation and
the world
• It Takes a Village:
– We are all partners in this successful research
enterprise
TODAY’S WORKSHOP
• Introduction to the central research support offices
• Learn how to navigate the UW Processes
• Maneuver through the multiple regulatory and
compliance considerations within the grant
lifecycle
• Manage the pre and post award process at UW
WE ARE HERE TO HELP
• Offices presenting today are part of the
central oversight and support for your research
enterprise.
• We will work with you to ensure your projects
meet sponsor requirements, state & federal
law, and UW policy.
• Contact us with your questions.
RESOURCES AVAILABLE
• A resource table is set up at the back of the room.
Please stop by and collect materials you feel can
assist you in creating successful research projects.
• This PowerPoint deck will be posted on the OSP
website tomorrow.
• Evaluation form – please tell us how we did!
THANK YOU

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