Grants and Research Support Workshop Agenda

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Grants and Research SupportWorkshop Agenda

• 800-930 - Erik L. Hewlett, MD Norma S.
  Miller
• 945-1000 - Coffee Break
• 1000-1030 - Inhye Son
• 1030-1050 - Questions/discussion
• 1100-1145 - Human Investigation (Jordan
  Auditorium)
• Susie R. Hoffman, RN, BSN
• Animal Research (Jordan G1-G2)
• Patricia L. Foley, DVM
• 1145-1200 Evaluation

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Office for ResearchMcKim Hall, 3rd Floor, Room
3052982-4334

• The Office for Research functions
• to support and promote basic and
• clinical investigation in the School
• of Medicine and to facilitate research
• cooperation and interaction
• within the school and with other
• schools of the University.

• Oversight of and Interactions with
• Medical Student Summer Research Program
• Clinical Trials Office
• Office of Grants and Contracts
• Administration
• Office of the Vice-President for Research and
  Graduate Studies
• University of Virginia Patent Foundation
• Institutional Shared Facilities
• Community of Science Database

Terry Howell Becky Ellwood Julie Burns Erik L.
Hewlett, M.D. Steven Wasserman, Ph.D. Margaret
Shupnik, Ph.D. Jay Fox, PhD
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Office of Grants Contracts AdministrationMcKim
Hall, 3rd Floor, Room 3115924-8426http//www.hea
lthsystem.virginia.edu/internet/grants/

• The School of Medicine Office of Grants and
  Contracts assists SOM research investigators with
  the following

• Review and approve proposals and contracts
• Current information and forms
• Budget development and application process
• Negotiate terms and conditions
• Clinical trial agreements
• Material transfer agreements
• Confidentiality agreements
• Consulting agreements
• Distribute Notice of Awards (NOAs)
• Distribute funding opportunity information
• Account close-out
• Problem solving

Norma Miller S. Dean Smith Elizabeth (Betty)
Pincus Sarah Fornadel Cheryl Bryan Heather
Faris Elaine Lloyd Kathy Boswell
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Whos Who at the NIH

• SRA (Scientific Review Administrator) -
  scientist/administrator who is in charge of study
  section operation employed by NIH/Center for
  Scientific Review (CSR)
• Program Officer - scientist/administrator who
  oversees program areas within an institute
• Grants Administrator - administrator who oversees
  fiscal aspects of grant after it is awarded.
• Scientific Council- experts in the field of the
  institute who make final recommendations on
  funding.

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The NIH Extramural Team
Review
Grants Management
Program
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NIH Institutes and Centers
Center for Scientific Review
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Study Section Composition and Procedures

• 20-25 scientists active in the subject area
• Current membership available at NIH website
  
• http//grants1.nih.gov/grants/peer/peer.htm
• 2-4 reviewers assigned to each application, but
  everyone votes a score
• 10-15 minutes for presentation/discussion per
  application

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Review Criteria for R01 Applicationshttp//grants
.nih.gov/grants/guide/notice-files/not97-010.html

• Significance Is this an important problem?
  Will completion of aims advance the field?
• Approach conceptual framework, design
  (including study population), methods, analyses
  problem areas and solutions.
• Innovation novel concepts/approaches/methods
  does the project challenge existing paradigms or
  develop new methodologies?

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Review Criteria for R01 Applications
http//grants.nih.gov/grants/guide/notice-files/no
t97-010.html

• Investigator appropriately trained, well suited
  to carry out this work Is the work appropriate
  to level of PI?
• Environment contribution to likelihood of
  success utilization of unique features of the
  department/institution evidence of institutional
  support.

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Review Criteria for R01 Applicationshttp//grants
.nih.gov/grants/guide/notice-files/not97-010.html

• Protection of Human Subjects from Research Risk
• Inclusion of Women, Minorities and Children in
  Research
• Care and Use of Vertebrate Animals in Research

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Outcome/Funding Recommendations

• Who funds applications?
• - Institutes
• On what are funding recommendations based?
• - Scientific merit as determined by Initial
  
• Review Group
• - Programmatic considerations
• - Availability of funds

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K Award Information

• http//grants1.nih.gov/training/careerdevelopmenta
  wards.htm

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K Awards

• 75 Effort
• Salary up to 90,000 plus fringe benefits
• (NIH Institute Specific)
• Research Allowance 20,000 - 25,000
• (NIH Institute Specific)

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NIH Policy Change

• Transition to R-series support
• Concurrent support - K Award and Research Grant
• Requirements
• Last 2 years of Career Award support
• Recipient must be
• Principal Investigator
• Research Grant (R01,R03)
• Cooperative Agreement (U01)
• Project Leader
• Multicenter (P30)
• Effort on K Award Reduced
• Not lt50 Effort

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Types of Awards Rs

• R01 Research Projects
• R03 Small Grants Program
• 50,000/yr.
• Up to 2 years
• R21 Exploratory Grants
• 275,000
• 2 years
• R34 Clinical Trial Planning Grant
• Development of Phase III Clinical Trials
• 100,000/yr
• 1 year

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Types of Awards R, F, T, U Ps (Continued)

• F32 - Individual Post-Doctoral Fellowship
• T32 - Institutional Training Grant
• Pre-Doctoral and Post-Doctoral
• Us Ps - Specialized Centers and Program
  Projects
• R41 - STTR
• R43 - SBIR

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10 Most Common Reasons forProposal Failure

• 1. Lack of original ideas
• 2. Diffuse, unfocused, or superficial Research
  Plan
• 3. Lack of knowledge of published relevant work
• 4. Lack of experience in essential methodology
• 5. Uncertainty concerning future directions

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10 Most Common Reasons forProposal Failure

• 6. Questionable reasoning in experimental
  approach
• 7. Absence of acceptable scientific rationale
• 8. Unrealistically large amount of work
• 9. Lack of sufficient experimental detail
• 10. Uncritical approach

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Planning a Grant Application

• Begin at least 1 year in advance
• Discuss the overall plan with colleagues,
  collaborators and mentors
• Generate pilot data to establish feasibility and
  methodologic competence
• Outline, write, rewrite and rewrite

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Abstract and Specific Aims

• Abstract must fit in designated space and should
  contain introduction to the problem, the field of
  study, specific aims and methodologies (public
  document)
• Specific Aims are most important part of the
  application - simple, direct and logical
• 3-4 Specific Aims appropriate, 5 or more is too
  many
• Specific Aims are the hypotheses of the project

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Preparing the Budget

• Direct Costs
• Allowable direct costs may include
• Salaries and fringe benefits of principal
  investigators and supporting staff.
• Expenditures for project-related equipment and
  supplies.
• Fees and supporting costs for consultant
  services.
• Expenses for travel beneficial to the research.
•  

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Preparing the Budget(Direct Costs Continued)

• Inpatient and outpatient costs for research
  subjects.
• Alterations and renovations.
• Publications and other miscellaneous expenses.
• Contract services.
• Costs for consortium participants.

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Preparing the Budget (Continued)

• Facilities and Administrative Costs
• UVA Negotiated Rate
• 52.5 Modified Total Direct Costs

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Budget Formats

• Standard
• Modular
• Just-In-Time

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Standard Budgets

• Applications requesting in excess of 250,000
  direct costs per year
• Specific RFAs

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Modular Budgets

• R01, R03, R21, R41, R43
• Request total direct costs in modules of 25,000
• Not to exceed 250,000
• 8 modules _at_ 25,000 200,000
• Request the same number of modules in each year
• Exception one time costs such as equipment

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Modular Budgets (Continued)

• Provide budget narrative for key personnel by
  position, role, and level of support, for any
  variation in number of modules, e.g. equipment,
  and for any Consortium/Contractual arrangements
• Describe specific aims for research ongoing or
  completed in the last 3 years as part of the
  Biographical Sketch
• Biographical Sketch 4 page limit

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Just-In-Time Budgets

• K- Awards
• Form page 5 (PHS 398)
• Direct costs for each year of the proposed
  project period
• Total direct costs for proposed project

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Attachments

• Sample Budgets
• Standard
• Modular with Equipment
• Modular
• Just-in-Time
• University of Virginia Internal Proposal Approval
  Form
• University of Virginia Release Time Proposal for
  Professional Personnel
• PHS 398 Face Page populated with UVa information

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Other Just-In-Time Features

• Following Peer Review the following should occur
• Humans involved in project? Submit application to
  HIC
• Animals involved in project? Submit protocol to
  IACUC
• NIH will request current Other Support information

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School of Medicine Requirements

• Budget which includes list of faculty with
  effort devoted to project
• Salary equal to effort devoted to project
• Consortium/subcontract (Face page, budget,
  checklist)
• Patient Care Costs
• Tuition Remission

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Post-Award Considerations

• UVa is required to ensure that all costs charged
  to modular awards are in accordance with
  applicable cost principles, the NIH Grants Policy
  Statement and legislatively imposed restrictions
  (e.g. specific justification for expending funds
  for general administrative expenses such as
  clerical and administrative salaries, office
  supplies, and postage).
• Issued by NIH without direct cost categorical
  breakdowns, the NIH significant re-budgeting
  notification is no longer required.

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Submit to UVa School of MedicineOriginal 2
copies

• Face Page
• Abstract
• Budget (Standard, Modular or Just-In-Time)
• Narrative Budget Justification
• Biographical Sketch
• Resources and Environment
• Scientific Sections
• Checklist
• School of Medicine Requirements
• Proposal Approval Sheet
• Time Release Form

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Biosketch, Resources and Environment

• Biosketch should be edited to be consistent with
  the subject matter of the grant no abstracts and
  presentations for filler Ongoing and completed
  research projects from last 3 years, especially
  those most relevant to the current application.
  This highlights prior research accomplishments
• Total effort gt100 is not allowed
• Resources/Environment must be adequate to do
  work, but not conflict with requested equipment

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Background and Significance

• Succinct, but engaging
• Establish importance, attract interest of
  reviewers, convince them of likelihood for
  success by leading into the plan
• Clinical relevance

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Progress Report/Preliminary Studies

• Transition from Background/Significance to
  Experimental Design and Methods, showing
  involvement of PI and members of project team
• Establish scientific credibility and technical
  competence of the personnel
• Demonstrate feasibility of methodologies and
  their use in the involved labs
• Supplement text with figures, diagrams and other
  illustrations, even if already published

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Experimental Design and Methods

• Follow logic and flow begun with Specific Aims
• Methods section with boring details segregated to
  initial separate section or supplement (primary
  reviewers only)
• Include alternative strategies, analysis of
  likelihood of success and potential pitfalls
• Use simple diagrams and flow charts

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Example

• Critique
• A weakness of the proposal is that it is overly
  ambitious.
• In addition, details regarding experimental
  design and implementation are not always
  provided.
• Finally, the proposal would be strengthened by a
  more careful consideration of potential pitfalls
  and alternative experimental strategies.

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Supplementary Material

• Use judiciously, not just to circumvent page
  limitations
• Send late breaking results just prior to study
  section

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Grants and Research Support Workshop

• CA 90851 Role of PKC-? in regulating
  astrocytoma invasive
  growth submitted June 2000
• SA1. Does regulation of PKC-? expression or
  activation differ between neoplastic and
  non-neoplastic human astrocytes?
• SA2. How is expression of PKC-? controlled in
  astrocytic tumor cells?
• SA3. Does manipulation of PKC-? expression alter
  growth, migration/invasion or apoptotic
  properties of neoplastic astrocytes?

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Grants and Research Support Workshop

• CA90851-01 Summary Statement November 2000
• Priority score 250 Percentile
  48.1
• Strengths importance of the topic, fine group
  of collaborators, exciting preliminary data.
• Weaknesses lack of preliminary data for SA1 and
  SA2 broad nature, overly ambitious and unfocused
  SA3 (a number of different topics that could be
  divided into several aims).

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Grants and Research Support Workshop

• CA 90851-01A1 Revision submitted March 2001,
  including data on PKC-? expression in two
  additional cell lines and normal fetal astrocytes
  and focus of SA3 on astrocyte proliferation and
  apoptosis, not motility and migration.

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Grants and Research Support Workshop

• CA90851-01A1 Summary Statement July 2001
• Priority score 224 Percentile 36.0
• SA1. The PI has preliminary data to support that
  a difference in expression of PKC-? between
  non-neoplastic brain and tumorsbut, the PI does
  not specify how many tissues will be utilized,
  how many tissues from each grade of tumor or from
  non-neoplastic brain will be used.
• SA2. lacks discussion on the anticipated
  results and their interpretation.
• SA3. is a large aim that could easily be
  divided into two aims, but it is thought that PI
  will successfully complete these experiments.

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Grants and Research Support Workshop

• Final score based on
• considerable amount of preliminary data that is
  exciting
  
  
  regarding the role of PKC-?.
• the applicant has been very responsive to the
  reviews.
• still a concern that the PI is not an
  independent investigator not physical
  laboratory space, but intellectual independence.
• a letter was sent indicating the PI has moved
  to another university.

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Grants and Research Support Workshop

• CA90851-01A2 Revision submitted November 2001,
  including extensive description of PIs academic
  independence, as reflected by authorship on
  publications, training experience and
  relationship with co-authors, additional
  preliminary data and assurance/evidence of
  continued faculty status at the University of
  Virginia.
• CA90851-01A2 Summary Statement March 2002
• Priority score 160 Percentile 8.1

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The Thoroughness of the Applicants Proposal
Reflects the Care with Which She Performs Her
Experiments
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Funding Opportunities(Seed Money)

• Cancer Center
• Childrens Medical Center http//healthsystem.virg
  inia.edu/internet/library/collections/grant/index.
  cfm
• Office of Vice President for Research and
  Graduate Studies
• http//www.virginia.edu/vprgs/
• R D Committee
• http//www.healthsystem.virginia.edu/internet/gran
  ts/
• Jeffress Foundation http//www.healthsystem.virgin
  ia.edu/internet/grants/jeffressdocs.pdf

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Our Thanks to

• Terry Howell, Office for Research
• Elaine Lloyd, Office of Grants and Contracts
• Dr. Isa Hussaini, Pathology
• Speakers at this workshop- Inhye Son, Susie
  Hoffman and Patricia Foley
• Elizabeth Graham and Dr. Karen Rheuban
• Sharon Hostler, M.D.
• Steven S. Wasserman, Ph.D.

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Office for ResearchMcKim Hall, 3rd Floor,
Room 3052http//www.healthsystem.virginia.edu/int
ernet/research

• Erik L. Hewlett, M.D.Senior Associate Dean for
  Research(eh2v_at_virginia.edu), 434-982-4334
• Margaret A. Shupnik, Ph.D.Associate Dean for
  Basic Research(mas3x_at_virginia.edu),
  434-243-7088
• TBAAssociate Dean for Clinical
  Research434-982-4334Steven S. Wasserman,
  Ph.D.Assistant Dean for ResearchDirector of
  the Office for Research (ssw3an_at_virginia.edu),
  434-243-7088
• Jay W. Fox, Ph.D.Assistant Dean for Research
  Support  
• (jwf8x_at_virginia.edu), 434-924-0050
•                    

• Terry S. HowellAdministrative Assistant for Dr.
  Hewlett(tsh5s_at_virginia.edu) 434-982-4334
• Becky J. EllwoodAdministrative Assistant for
  Drs. Shupnik and Wasserman(bje3m_at_Virginia.edu)
  434-243-7088
• Julie BurnsAdministrative Assistant for Dr.
  Fox(jb9v_at_virginia.edu), 434-924-2356
• Address/contact
•     Office for Research     School of
  Medicine     P.O. Box 800419     McKim Hall
  Room 3052     Charlottesville, VA
  22908-0419     [phone]
•      [phone] FAX

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Office of Grants and Contractshttp//healthsystem
.virginia.edu/internet/grants/

• Contact Information
• Grants Administrator Contact by Department
•  
• Contracts Administrator Contact by Department
• LOCATION
• Office of Grants and Contracts Administration
• McKim Hall Room 3115
• Phone [phone]
• Fax [phone]
•  
•  
• Mailing Address
• P.O.  Box 800793, Charlottesville, VA 22908-0793
   
•  
•  
• FedEx Address

STAFF Norma S. MillerDirector(434)
924-8426 Cheryl Bryan Grants Administrator(434)
243-6379   Heather FarisGrants
Administrator(434) 924-2197   Sarah
FornadelGrants Administrator  [phone]  Be
tty Pincus Contracts Administrator(434)
243-9594(434) 243-5080 (FAX) Elaine LloydOffice
ManagerWeb Developer [phone] Kathy
BoswellAdministrative Assistant(434) 924-8426
(McKim Hall)[phone] (Blake Center)