HOW TO WRITE THE NEW, SHORTER NIH RESEARCH GRANTS. Maureen E. Goode, PhD, ELS Administrative Director 713-500-7924 [email protected] Main CCTS number: 713-500-7900 Offices: UTBP 1100 Web site: http://ccts.uth.tmc.edu.
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No, unless you can wait up to a year or more. It will take that long before study sections review the new proposals.
Now Available: Restructured Application Forms and Instructions for Application Due Dates on or after January 25, 2010
(The previous versions were 11/2007)
READ THE NEW INSTRUCTIONS!
OSP will have a session for UTHSC-H administrators in January on the changes in the forms, but here are three you should address now:
All Personnel Report
“Briefly describe why your experience and qualifications make you particularly well suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application.”
This means you’ll need a different Personal Statement for each proposal—you can no longer use the same biosketch for every proposal.
Check whether you need to include it (probably only renewals do). It replaces the Senior/Key Personnel Report. Anyone working on the project for a least 1 calendar month (8.3% effort or more) in the previous year (whether or not they were paid from the grant itself) has to be included in the All Personnel Report.
For each person listed, you must include
eRA Commons User name (“when applicable”—ask your program officer what that means for your proposal)
Role on Project
Last 4 digits of Social Security number
Date of birth
Effort (calendar months)
Old format: Specific Aims
Background and Significance
Preliminary Studies/Progress Report
Research Design and Methods
Maximum 25 pages (15 for R21s)
New format: Specific Aims
Approach (strategy and methods,
plus Preliminary Studies/ Progress Report)
Maximum 13 pages (7 for R21s)
or page limits,
“State concisely the goals of the proposed research and summarize the expected outcomes, including the impact that the results of the proposed research will exert on the research fields involved.
List succinctly the specific objectives of the 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 are limited to one page.”
has not changed significantly.
Is the most important section of the proposal
Has an introductory paragraph describing the field, the gap in the knowledge the proposed work will fill, and why filling the gap is important
States the hypothesis being tested
Lists the Specific Aims, which should be phrased as hypothesis-oriented (rather than methods-oriented) infinitives (for example, “To determine whether the X gene is overexpressed in the disease Y” rather than “To perform PCR on patients with Y” or “To study X gene expression in Y”)
Should end with a statement on how the proposed work will further the field
Strategy and Methods
Preliminary Studies/Progress Report
Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.
Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.”
Why is this study important?
How will your findings change science or medicine?
Examples: lives will be saved or quality of life improved (state how), new rationales for treatment tested (state why they’re needed)
1 page may be sufficient. Start with enough background information to support the conclusion that the study is important.
Incidence and severity of the disease being studied
Why the current treatment or diagnostic system doesn’t work well, so lots of people are dying or living poor-quality lives
We propose trying X, which we believe will work better for the following reasons…
If our hypothesis is correct, we will have a more
effective treatment/diagnosis system for X that
will save lives or improve the quality of lives
(estimate numbers of people affected from
In 2009, at least 25% of Americans were obese (with a body mass index (BMI) of 25 or greater), and the percentage is predicted to continue to rise…. Obesity is the second leading cause of preventable death in the United States, because it is a risk factor for many chronic diseases, including diabetes (2), heart disease (3), and many forms of cancer, including breast and prostate cancer (4,5)….
Alleviating obesity could reduce the incidence of these diseases and so save lives, but current obesity reduction strategies are not effective…
We therefore will identify the factors that most strongly influence obesity, so that individual weight-loss strategies can be devised… This could save X lives…
Explain how the application challenges and seeks to shift current research or clinical practice paradigms.
Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation or interventions.
Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.”
What’s new about your proposed study?
New methods or approaches?
Not all studies have to be innovative…
(maybe the timing is right…)
Half a page should be sufficient
Our study is innovative because instead of using the same treatment for every patient, we will determine which of the many obesity factors affect a specific patient and use those factors to tailor treatment for that individual…
Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. … include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.
Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.
If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.
Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.”
Use each Specific Aim as a subheading, and under each, describe how you will achieve that aim:
B.3.1.1. Specific Aim 1: To ascertain the
B.3.1.2. Specific Aim 2: To construct a profile…
How samples or subjects will be accrued
Sample size calculation
Assays, tests, etc. to be conducted—why you chose them and how they’ll be performed
(describe as succinctly as possible—cite
references (your own, if you can) wherever possible)
How the data will be analyzed
Possible pitfalls and how you’ll address then
Evidence that the Aims can be achieved and the hypothesis tested
Evidence that you’re the right person to do the study
Brief descriptions of relevant previous studies Prior work relevant to the proposed study
Logistical arrangements for the proposed
study (e.g., system for notification about
potential subjects arriving in ED)
Only enough background and methods to make
the study understandable (1-2 sentences)
Only enough results to be convincing
Emphasize the conclusions (interpretation of
Write the descriptions backwards:
What were the conclusions that support your
What data are essential to support those
What background information has not already
been presented in your application?
Then, arrange the sentences in background—data—conclusions order.
If that’s not possible, make the relationship between the aims and the preliminary studies clear:
“Aim 2 calls for technique X, which we recently established in our laboratory. An example is shown in Figure 1.”
State whether the aim has been achieved or how much work remains to be done on it and why you didn’t finish it.
If you didn’t complete an aim because your findings made you change direction, say so. Reviewers like to see investigators respond to new information and challenges.
Do your very best on your proposal—
You are now allowed only one revised application. If the revision is not funded, you must submit your idea as a new application.