Transcript Pediatrics Seminar - Albert Einstein College of Medicine

Research Funding:
NIH and Beyond
November 19, 2014
Where to Get Info
Mentors
Departmental administrators
Colleagues working in your field
Scientists working in other fields
Institutional research administrators
Program officers at funding agencies
Anyone skilled in expository writing
Albert Einstein College of Medicine
Office of Grant Support
Location: Belfer 917
(718) 430-3642
www.aecom.yu.edu/ogs
Success rates of applications from
medical school pediatrics departments for
NIH research project grants (RPG), 2004-2013
Fiscal Year
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
Medical School
Department
Name
PEDIATRICS
PEDIATRICS
PEDIATRICS
PEDIATRICS
PEDIATRICS
PEDIATRICS
PEDIATRICS
PEDIATRICS
PEDIATRICS
PEDIATRICS
Number of
Applications
Reviewed
1,078
1,168
1,291
1,205
1,156
1,107
1,220
1,280
1,357
1,370
Number of
Applications
2
Awarded
256
228
229
228
262
236
295
213
223
232
Success
Rate
23.8%
19.5%
17.7%
18.9%
22.7%
21.3%
24.2%
16.6%
16.4%
16.9%
NIH Overall
26.40%
23.20%
20.90%
22.50%
23.30%
22.00%
22.00%
19.00%
19.00%
18.40%
”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
U.S. BIOMEDICAL AND HEALTH
R&D SPENDING
2012
$130,383,000,000
Have something to say, and say it
as clearly as you can. That is the
only secret…
Matthew Arnold
The Costs of Research
Direct Costs
Indirect Costs
SALARIES
SPACE
UTILITIES
CUSTODIAL SERVICES
SECURITY
LIBRARY
ANIMAL FACILITIES
INFORMATION SYSTEMS
SHARED RESEARCH FACILITIES
IRB
IACUC
BIOSAFETY
PAYROLL
PURCHASING
GRANT MANAGEMENT
FRINGE BENEFITS
CONSULTANTS
EQUIPMENT
SUPPLIES
TRAVEL
PATIENT COSTS
ANIMALS
SUBJECT COSTS
PUBLICATION COSTS
SERVICE CONTRACTS
Indirect Costs
Aka….facilities and administration (F&A) 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-related costs (typically comprised of one item):
Library
Administrative costs: General, Department, Sponsored
Programs
The Costs of Research
Direct Costs
Total Costs
=
+
Indirect Costs
Direct Costs
Indirect Costs
(estimated)
=
X
Indirect Rate
The indirect cost base does NOT
include:
Equipment (single items >$3000)
Alterations/renovations
Portion of sub-awards >$25,000
Patient care costs
Off-site rental fees
Student tuition
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
Indirect Cost Rates
Federal research (on-site)
Federal research (off-site)
Federal other (on-site)
Federal other (off-site)
Federal training
67.0%
26.0%
28.5%
21.1%
8.0%
Private non-profit
Source policy*
or 25-33%
Industry (grants <$32,500)
(grants >$32,500)
(clinical trials)
25-54%
67%
25-33%
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
Types of Grants
Fellowship
Travel
Research
Equipment
Training
Construction
Career Development
Program/Service
Types of Funders
Federal Government
State Government
Voluntary Health Orgs (aka Public Charities)
Professional Associations
Private Foundations
Corporate Foundations
Corporations (Direct giving programs)
Individuals
U.S. BIOMEDICAL AND HEALTH
R&D SPENDING
2012
$130,383,000,000
INDUSTRY
US BIOMEDICAL
Pharmaceutical
Biotechnology
Medical Technology
AND
HEALTH R&D SPENDING
36,810,000,000
$130,383,000,000
19,300,000,000
13,059,000,000
Total Industry
FEDERAL GOVERNMENT
National Institutes of Health
Department of Defense
Department of Agriculture
National Science Foundation
Department of Energy
Environmental Protection Agency
CDC
Food and Drug Administration
Other Federal Agencies
14.8%
10.0%
53.1%
30,012,000,000
2,412,000,000
1,953,000,000
2,075,000,000
1,020,000,000
568,000,000
408,000,000
406,000,000
2,162,000,000
23.0%
1.8%
1.5%
1.6%
0.8%
0.4%
0.3%
0.3%
1.7%
Total Federal
OTHER SOURCES
Universities
State and Local Government
Independent Research Institutes
Philanthropic Foundations
Voluntary Health Associations
2012
28.2%
31.5%
12,445,000,000
3,819,000,000
1,538,000,000
1,322,000,000
1,074,000,000
9.5%
2.9%
1.2%
1.0%
0.8%
Total Other
15.5%
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
Total NIH budget authority
FY 2013 actual
SBIR/STTR
$638,517,000
(2.2%)
SBIR/STTR: 3-Phase Program
PHASE I
Feasibility Study
$150K and 6-month (SBIR)
or 12-month (STTR) Award
PHASE II
Full Research/R&D
$1.0M and 2-year Award
(SBIR/STTR)
PHASE III
Ü
Ü
Commercialization Stage
Use of non-SBIR/STTR Funds
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.edu/search.asp
Know Your Funder
Area of funding interest
Type of funding
Typical size of grants
Application and review procedure
Eligibility restrictions:
Type of institution
Citizenship
Faculty status
Prior funding
Previous awardees
Geography
Age/Sex/Ethnicity
Cost sharing
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
Applying for Funding
1) Theory
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.
Conclusion:
Most grants are not awarded
to principal investigators.
Rather, your institution will be
awarded a grant on your
behalf.
The Institution as Awardee
Proposal review and approval
Indirect costs
Compliance
Grant management ($$)
Commitment
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.
Responsible Conduct of Research
Human Subjects Research
Research with Animals
Fiscal Responsibility
Conflict of Interest
NIH Public Access Policy
Environmental Health & Safety
Export Control
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
Research Administration:
-- Protecting the research enterprise
by complying with federal regulations
-- Facilitating faculty research through
supporting services
Applying for Funding
2) Practice
Institutional review and approval is
mandatory whenever any of the following
are true:
1) Institutional signatures are required
2) The submission will be the final communication
before an award is made
3) A detailed budget is submitted
4) Commitment of institutional resources (other than
personnel and supplies) is made or implied
The Basics
Principal
Investigator
Einstein
Central
Admin
Funding
Agency
Account
Principal
Investigator
Award
Einstein
Central
Admin
Funding
Agency
Account
Principal
Investigator
Award
Einstein
Central
Admin
Progress Report / Renewal
Funding
Agency
The Details
Principal
Investigator
Einstein
Central
Admin
Funding
Agency
Department
Administrator
Principal
Investigator
Einstein
Central
Admin
Funding
Agency
CCI
MMC
Grant
Accounting
OGS
Einstein
Central
Admin
Department
Administrator
EH&S
Principal
Investigator
Animal
Institute
Dean’s
Office
Funding
Agency
CCI
MMC
Grant
Accounting
DOD
OGS
Cayuse
Department
Administrator
S2S
EH&S
Principal
Investigator
Grants.gov
Animal
Institute
Dean’s
Office
NIH
Submitting Electronic NIH Grant
Proposals
Cayuse
S2S
Grants.gov
NIH
eRA
Commons
“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.
Submitting Electronic NIH Grant
Proposals
Errors?
Errors?
Cayuse
S2S
Grants.gov
NIH
eRA
Commons
Submitting Electronic NIH Grant
Proposals
Proposals with
errors must be
corrected and
resubmitted
Cayuse
S2S
Grants.gov
NIH
eRA
Commons
Error-free proposals proceed to
referral/ review process in 48
hours
Peer Review
The limiting factor in the quality of a
proposal is the underlying idea.
IDEA
PROPOSAL
Grantsmanship cannot improve a bad idea.
To prove that an idea is great,
you must show:
Need
Feasibility
[Should it be done?]
[Can it be done?]
Components of the Research Grant
Application
Administrative
Scientific
Face page/Title
Abstract (summary +
Research Plan:
relevance)
Key Personnel
Budget
Biosketch
Other Support (JIT)
Resources
Checklist
Specific Aims
Background/Significance
Preliminary Data
Methods
Human Subjects
Vertebrate Animals
Literature cited
Appendices
aim (ām)
Etymology: ME aimen < OFr esmer (< L aestimare: see estimate)
Noun
1.
2.
the act of aiming
a. the ability to hit a target
b. a weapon's accuracy
3. the object to be attained; intention or
purpose
4.
OBSOLETE
a guess or conjecture
A. 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.
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.
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”.
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.
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.
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.
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]
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.
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?
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.
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.”
“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]
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
“The institution should provide a document on institutional
letterhead that describes its commitment to the candidate and
the candidate’s career development, independent of the
receipt of the award. The document should include the
institution’s 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]
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.
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.
Crowdfunding
Institutional regulation and administration
Compliance
Intellectual Property
Reporting
Grant Office or Development Office???
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/
Team Science
Percentage of New Multiple PI Grants Out of Total Number
of NIH Grants Funded by R-Mechanisms from 2006-2013
Percentage of MPI grants
25
20
15
10
5
0
2006 2007 2008 2009 2010 2011 2012 2013
R01
R03
R21
R41-44
Team Science
Collaborative
Cross-disciplinary:
Multidisciplinary
Interdisciplinary
Transdisciplinary
Focuses on complex problems with
multiple causes
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 are…suggesting 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.
Christine Ogilvie Hendren, Ph.D., Executive Director and
Research Scientist, Center for the Environmental Implications of
NanoTechnology (CEINT), Duke University
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.cancer.gov/Public/ExpertBlog.aspx?tid=4
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.
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