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[NIH K Award Guidelines] Crowdfunding Harnessing the power of the crowd; raising ... 67% (clinical trials) 25-33% Types ... – PowerPoint PPT presentation

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Title: Research Funding:


1
Research Funding NIH and Beyond November 19,
2014
2
Where to Get Info
Mentors Departmental administrators Colleagues
working in your field Scientists working in other
fields Institutional research administrators Progr
am officers at funding agencies Anyone skilled in
expository writing
3
Albert Einstein College of Medicine Office of
Grant Support Location Belfer 917 (718)
430-3642 www.aecom.yu.edu/ogs
4
Success rates of applications from medical
school pediatrics departments for NIH research
project grants (RPG), 2004-2013
??RPG defined as R00, R01, R03, R15, R21, R22,
R23, R29, R33, R34, R35, R36, R37, R55, R56, RC1,
RC2, RC3, RC4, RF1, RL1, RL2, RL5, RL9, P01, P42,
PN1, PM1, RM1, UA5, UC1, UC2, UC3, UC4, UC7,
 UF1, UH2, UH3, UH5, UM1, U01, U19, U34, DP1,
DP2, DP3, DP4, and DP5.
RPG 4
5
U.S. BIOMEDICAL AND HEALTH RD SPENDING
2012 130,383,000,000
6
Have something to say, and say it as clearly as
you can. That is the only secret
Matthew Arnold
7
The Costs of Research
Direct Costs Indirect Costs
SALARIES FRINGE BENEFITS CONSULTANTS EQUIPMENT SUPPLIES TRAVEL PATIENT COSTS ANIMALS SUBJECT COSTS PUBLICATION COSTS SERVICE CONTRACTS SPACE UTILITIES CUSTODIAL SERVICES SECURITY LIBRARY ANIMAL FACILITIES INFORMATION SYSTEMS SHARED RESEARCH FACILITIES IRB IACUC BIOSAFETY PAYROLL PURCHASING GRANT MANAGEMENT
8
Indirect Costs
Aka.facilities and administration (FA) and
overhead. Costs that cannot be attributed to a
specific sponsored project and are reimbursed to
the Institution for expenses incurred for
objectives common to most research
projects. Made up of three types of
costs Facility-related costs Building
Depreciation, Equipment Depreciation, Interest
Expense, and Operations and Maintenance Service-r
elated costs (typically comprised of one item)
Library Administrative costs General,
Department, Sponsored Programs
9
The Costs of Research
Direct Costs Direct Costs Direct Costs
Total Costs
Indirect Costs Indirect Costs Indirect Costs

Direct Costs Direct Costs Direct Costs
Indirect Costs X
(estimated) Indirect Rate Indirect Rate Indirect Rate
10
The indirect cost base does NOT
include Equipment (single items
gt3000) Alterations/renovations Portion of
sub-awards gt25,000 Patient care costs Off-site
rental fees Student tuition
11
The Costs of Research
Example Annual Direct Costs
100,000 Federally negotiated Indirect Rate
67 Total Annual Costs 167,000 Total Budget
Request 100-167K
12
Indirect Cost Rates
Federal research (on-site) 67.0 Federal
research (off-site) 26.0 Federal other
(on-site) 28.5 Federal other
(off-site) 21.1 Federal training
8.0 Private non-profit Source
policy or 25-33 Industry (grants
lt32,500) 25-54 (grants
gt32,500) 67 (clinical
trials) 25-33
13
Types of Funding
Contract Project originates with funder Stresses deliverables
Cooperative Agreement Contract-Grant hybrid Funder has programmatic input
Grant Project originates with grantee Few deliverables
Gift Noncompetitive Unrestricted
14
Types of Grants
Fellowship Research Training Career
Development
Travel Equipment Construction Program/Service
15
Types of Funders
Federal Government State Government Voluntary
Health Orgs (aka Public Charities) Professional
Associations Private Foundations Corporate
Foundations Corporations (Direct giving
programs) Individuals
16
U.S. BIOMEDICAL AND HEALTH RD SPENDING
2012 130,383,000,000
17
US BIOMEDICAL AND HEALTH RD SPENDING
2012 130,383,000,000
INDUSTRY
Pharmaceutical 36,810,000,000 28.2
Biotechnology 19,300,000,000 14.8
Medical Technology 13,059,000,000 10.0
Total Industry 53.1
FEDERAL GOVERNMENT
National Institutes of Health 30,012,000,000 23.0
Department of Defense 2,412,000,000 1.8
Department of Agriculture 1,953,000,000 1.5
National Science Foundation 2,075,000,000 1.6
Department of Energy 1,020,000,000 0.8
Environmental Protection Agency 568,000,000 0.4
CDC 408,000,000 0.3
Food and Drug Administration 406,000,000 0.3
Other Federal Agencies 2,162,000,000 1.7
Total Federal 31.5
OTHER SOURCES
Universities 12,445,000,000 9.5
State and Local Government 3,819,000,000 2.9
Independent Research Institutes 1,538,000,000 1.2
Philanthropic Foundations 1,322,000,000 1.0
Voluntary Health Associations 1,074,000,000 0.8
Total Other 15.5
18
Types of NIH Grants
aka Grant Mechanisms
R-series Research Grants R01- Research Project
Grant R21- Exploratory/Developmental Grant R03-
Small Grant K-series Research Career
Development Grants K23- Mentored
Patient-Oriented RCDA K08- Mentored Clinical
Scientist RCDA
19
Total NIH budget authority FY 2013 actual
SBIR/STTR 638,517,000 (2.2)
20
SBIR/STTR 3-Phase Program
  • PHASE I
  • Feasibility Study
  • 150K and 6-month (SBIR)
  • or 12-month (STTR) Award

PHASE II Full Research/RD 1.0M and 2-year
Award (SBIR/STTR)
  • PHASE III
  • Commercialization Stage
  • Use of non-SBIR/STTR Funds

21
Searching for Funding Opps
Office of Grant Support Funding
Sources http//www.einstein.yu.edu/administration/
grant-support/funding-opportunities.aspx SciVal
Funding Search Tool http//www.funding.scival.com/
home Google !! e.g. funding for
pediatric research https//researchfunding.duke.e
du/search.asp
22
Know Your Funder
Area of funding interest Type of
funding Typical size of grants Application and
review procedure Eligibility restrictions Type
of institution Previous awardees Citizenship G
eography Faculty status Age/Sex/Ethnicity Prior
funding Cost sharing
23
Know Your NIHese
PA vs. RFA NINDS R03 vs. NICHD
R03 Feb-June-Oct vs. March-July-Nov Success
Rate vs. Percentile Rank SRO vs. Program
Officer eRA vs. IRG Revision vs.
Resubmission
24
Applying for Funding 1) Theory
25
Compliance

Research activities at all universities are
overseen by regulatory and compliance committees
imposed by federal laws. Non-compliance may
result in severe penalties to the institution and
in some instances to the individual. It is the
responsibility of all researchers to be familiar
with university policies relating to areas of
research requiring compliance with government
regulations.
26
Conclusion Most grants are not awarded to
principal investigators. Rather, your
institution will be awarded a grant on your
behalf.
27
The Institution as Awardee
Proposal review and approval Indirect
costs Compliance Grant management
() Commitment
28
Cost Accounting Standards e.g. Consistency in
Estimating, Accumulating, and Reporting
Costs Consistency in Allocating Costs Incurred
for Same Purpose Allocation of Direct and
Indirect Costs e.g. Criteria for determining how
costs are charged or allocated to cost
objectives.
29
Responsible Conduct of Research Human Subjects
Research Research with Animals Fiscal
Responsibility Conflict of Interest NIH Public
Access Policy Environmental Health Safety
Export Control

30
Assurances and Certifications Human Subjects
Animal Welfare Handicapped Individuals Sex
Discrimination Age Discrimination Ethical
Conduct Intellectual Property Human Embryonic
Stem Cells Drug-free Workplace Combating
Trafficking in Persons Conflict of
Interest Delinquent Debt
31
Research Administration -- Protecting the
research enterprise by complying with federal
regulations -- Facilitating faculty research
through supporting services

32
Applying for Funding 2) Practice
33
  • Institutional review and approval is mandatory
    whenever any of the following are true
  • Institutional signatures are required
  • The submission will be the final communication
    before an award is made
  • A detailed budget is submitted
  • Commitment of institutional resources (other than
    personnel and supplies) is made or implied

34
The Basics
Einstein Central Admin
Principal Investigator
Funding Agency
35
Award
Account
Einstein Central Admin
Principal Investigator
Funding Agency
36
Award
Account
Einstein Central Admin
Principal Investigator
Funding Agency
Progress Report / Renewal
37
The Details
Einstein Central Admin
Principal Investigator
Funding Agency
38
Einstein Central Admin
Department Administrator
Funding Agency
Principal Investigator
39
CCI
Grant Accounting
MMC
OGS
Einstein Central Admin
Department Administrator
Funding Agency
EHS
Deans Office
Principal Investigator
Animal Institute
40
CCI
Grant Accounting
MMC
DOD
OGS
Cayuse S2S
Department Administrator
Grants.gov
EHS
NIH
Deans Office
Principal Investigator
Animal Institute
41
Submitting Electronic NIH Grant Proposals
NIH eRA Commons
Cayuse S2S
Grants.gov
42
Registrations for Submission of Electronic
Proposals Principal investigators do NOT
register with Grants.gov !! Principal
investigators DO register with NIH eRA Commons,
NSF Fastlane, HRSA Handbooks, etc. Contact
OGS. Existing agency accounts need to be
affiliated with Einstein.
43
Submitting Electronic NIH Grant Proposals
Errors?
Errors?
NIH eRA Commons
Cayuse S2S
Grants.gov
44
Submitting Electronic NIH Grant Proposals
Proposals with errors must be corrected and
resubmitted
NIH eRA Commons
Cayuse S2S
Grants.gov
Error-free proposals proceed to referral/ review
process in 48 hours
45
Peer Review
46
The limiting factor in the quality of a proposal
is the underlying idea.
IDEA
PROPOSAL
Grantsmanship cannot improve a bad idea.
47
To prove that an idea is great, you must show
Need Should it be done? Feasibility
Can it be done?
48
Components of the Research Grant Application
  • Scientific
  • Research Plan
  • Specific Aims
  • Background/Significance
  • Preliminary Data
  • Methods
  • Human Subjects
  • Vertebrate Animals
  • Literature cited
  • Appendices
  • Administrative
  • Face page/Title
  • Abstract (summary relevance)
  • Key Personnel
  • Budget
  • Biosketch
  • Other Support (JIT)
  • Resources
  • Checklist

49
  • aim (am)
  • Etymology ME aimen lt OFr esmer (lt L aestimare
    see estimate)
  • Noun
  • 1. the act of aiming
  • 2. a. the ability to hit a target
  • b. a weapon's accuracy
  • the object to be attained intention or purpose
  • 4. OBSOLETE a guess or conjecture

50
  • Specific Aims
  • List the broad, long-term objectives and the
    goal of the specific research proposed, e.g., to
    test a stated hypothesis, create a novel design,
    solve a specific problem, challenge an existing
    paradigm or clinical practice, address a critical
    barrier to progress in the field, or develop new
    technology.

51
Specific Aims
  • Well-defined objectives from which the project is
    derived and level of success is determined.
  • Should present a framework that helps to organize
    the rest of the Research Plan.
  • Often used by reviewers as an initial triage tool.

52
Specific Aims
  • Clearly presents a gap in knowledge that will be
    filled by the proposed work.
  • For NIH applications, does not confuse
    significance with health relevance.

53
Specific Aims
  • Be brief and specific.
  • Make each Aim a single sentence.
  • Add detail paragraph under Aim if needed.
  • Most successful applications have 2-4 specific
    aims.

54
Specific Aims
  • Often begins with an opening paragraph that
    summarizes the problem, background, rationale,
    and long-term goals.
  • Should be understood by scientists outside your
    field. Provides a summary for non-primary
    reviewers. The less technical information is
    presented first.

55
Specific Aims
  • Should make the reader eager to read the rest of
    your application.
  • MUST make the primary reviewer eager to read the
    rest of your application.
  • The most important page in most applications.
    Should be the first page written and the last
    page revised.

56
R01 Specific Aims Sample 1 3 Aims, 1007 words
Excerpt The specific aims are designed to
provide a comprehensive assessment of the
agr-independent regulatory functions of sar. 1.
Correlate the production of each sar transcript
with the production of functional SarA. The only
recognized protein product of the sar locus is
the SarA DNA-binding protein. However, Northern
blot analysis reveals See http//www.niaid.nih
.gov/ncn/grants/app/app.pdf page 17
57
R01 Specific Aims Sample 2 3 Aims, 565 words
Excerpt The specific aims of the study are To
test the effectiveness of a couples group
intervention in decreasing specific components of
psychological distress that are common in male
couples of mixed HIV status. Hypothesis 2 (H2)
When compared to control condition, couples in
the treatment condition will demonstrate H2a a
significant decrease in occasions of unprotected
sex and increase in satisfaction with safer
sex. H2b a significant improvement in dyadic
adjustment and couple satisfaction.
58
R01 Specific Aims Sample 3 5 Aims, 74 words
Full text We shall address the following
principal questions in this study 1. Is
fluoxetine effective for primary depression in
alcoholics compared to placebo? 2. Is improvement
in depression accompanied by improvement in
alcoholism? 3. Is medication response maintained
in follow up? 4. Does fluoxetine decrease
drinking even in patients whose depression does
not improve based on an independent effect of
serotonin re-uptake? 5. Can predictors be
developed to better match patients to combination
psychosocial and medication treatment?
59
Reviewers are Humans
Grant proposals are not reviewed at review panel
meetings. Proposals are reviewed prior to
panel meetings in homes and offices and airports
by busy people doing extra work without extra
pay. If you make the reviewers happy, they will
make you happy.
60
Advice from current and former NIH Study Section
members "What I like is an entertaining read.
Bad spelling and bad grammar definitely turn me
off." "Use all the buzzwords." "If you have a
sexy idea, make sure you put it up
front." "Clarity...clarity...clarity." "Small
fonts drive me crazy." Simple and
straightforward is not boring. Boring is
boring! Reviewers are never wrong and never
right. We just assess the material you provide.
61
  • Both the experimental design and the written
    description of it, like many other aspects of
    this application, do not make it clear that these
    investigators would be capable of addressing
    their stated specific aims in either a rigorous
    or a timely manner.
  • Reviewer comment, NIH proposal summary
    statement

62
Common Reasons for Poor Reviews (First Time
Applicants)
  • Insufficient or unclear justification for
    significance of problem.
  • Too little detail about proposed studies.
  • Too much work proposed.
  • Failure to make preliminary data the cornerstone
    of Specific Aims

63
The institution should provide a document on
institutional letterhead that describes its
commitment to the candidate and the candidates
career development, independent of the receipt of
the award. The document should include the
institutions agreement to provide adequate time
and support for the candidate to devote the
proposed protected time to research and career
development for the entire period of the proposed
award. The institution should provide the
equipment, facilities, and resources necessary
for a structured research career development
experience. It is essential to document the
institution's commitment to the retention,
development and advancement of the candidate
during the period of the award. NIH K
Award Guidelines
64
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65
Crowdfunding Harnessing the power of the crowd
raising funds by pooling together donations from
many individuals.   Goal support of a proposed
project.   How web-sites present projects
(what? why? how?), a funding goal, and a
time limit to raise the funds.
66
Crowdfunding Models Donation-based
crowdfunding sites allow people to donate to a
project or cause. Equity-based crowdfunding
targets investors pledging for an equity stake in
a start-up company.
67
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68
Crowdfunding Institutional regulation and
administration Compliance Intellectual
Property Reporting Grant Office or Development
Office???
69
Popular crowdfunding websites Kickstarter.com
http//www.kickstarter.com/ Rockethub.com
http//www.rockethub.com/ Petridish.org
http//www.petridish.org/ Scifundchallenge.org
http//scifundchallenge.org/ Innovocracy.org
http//www.innovocracy.org/ Indiegogo.com
http//www.indiegogo.com/ Artistshare.com
http//artistshare.com/v4/ Artspire.org
http//artspire.org/home.aspx Crowdtilt.com.
https//www.crowdtilt.com/ Microryza
https//www.microryza.com/
70
Team Science
71
Percentage of New Multiple PI Grants Out of Total
Number of NIH Grants Funded by R-Mechanisms from
2006-2013
Percentage of MPI grants
72
Team Science Collaborative Cross-disciplinary
Multidisciplinary Interdisciplinary Transdisc
iplinary  Focuses on complex problems with
multiple causes
73
Teams increasingly dominate solo authors in the
production of knowledge. Research is
increasingly done in teams. Teams typically
produce more frequently cited research than
individuals do. Teams produce the exceptionally
high-impact research, even where that distinction
was once the domain of solo authors. These
results aresuggesting that the process of
knowledge creation has fundamentally changed.
Wuchty, S., Jones, B. F., Uzzi, B. (2007). The
Increasing Dominance Of Teams In Production Of
Knowledge. Science, 316(5827), 1036-1038.
74
Christine Ogilvie Hendren, Ph.D., Executive
Director and Research Scientist, Center for the
Environmental Implications of NanoTechnology
(CEINT), Duke University
75
Outreach to translate findings from within
organizations and projects outward. We must
acknowledge that Inreach knowledge transfer and
feedback among disciplines and sectors is in
itself an independent and critical aspect of
effective interdisciplinary team science, and
further, that these information flows cannot be
facilitated effectively by someone residing only
within one box, no matter their
competence. https//www.teamsciencetoolkit.cance
r.gov/Public/ExpertBlog.aspx?tid4
76
Interdisciplinary Executive Scientist   New
career path to amass expertise about what
information is needed to cross-pollinate among
fields and help enable decisions to be
made.   Eligibility Criteria Must possess
specialized project management skills and
understand the interdisciplinary science
approach   Have specific fluency in the type of
wicked problem being addressed, along with a
deep understanding of fundamentals in at least
one related area of the underlying science and
an appreciation of the science from multiple
disciplinary perspectives.
77
Science of Team Science Conference (SciTS) August
6-8, 2014 Austin, TX Sessions Group Concept
Mapping and Interaction Analysis Framing the
Workspace Boundary Spanning Ties Effects of
Institutions Governance Assessing Readiness
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