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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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slide2
Maureen E. Goode, PhD, ELSAdministrative [email protected] CCTS number: 713-500-7900Offices: UTBP 1100Web site: http://ccts.uth.tmc.edu
slide4
Starting January 25, 2010, the format and length of the Research Plans of NIH grants will change
slide5
Should you wait to see how NIH study sections like the proposals to be written?

No, unless you can wait up to a year or more. It will take that long before study sections review the new proposals.

slide6
If you’ve already started working on anNIH proposal due January 25, 2010, or later, reread the Funding Opportunity Announcement (FOA) and see if anything has changed.
slide7
READ THIS NOTICE

Now Available: Restructured Application Forms and Instructions for Application Due Dates on or after January 25, 2010

http://grants.nih.gov/grants/

guide/notice-files/NOT-OD-10-016.html

slide8
Use version 6/2009 forms and instructions

http://grants1.nih.gov/grants/forms.htm

(The previous versions were 11/2007)

READ THE NEW INSTRUCTIONS!

slide9
The application has been brought into line with the review criteria:

CriteriaSection changed

Significance Significance

Innovation Innovation

Approach Approach

Investigator Biosketch

Environment Facilities/Resources

slide10
Changes in forms

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:

Biosketches

Facilities/Resources

All Personnel Report

slide11
Biosketches now have a Personal Statement

“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.

slide12
“A. Personal Statement
  • [I am the PI of this proposal.] The goal of the proposed research is to investigate the interaction between drug abuse and normal aging processes. Specifically, we plan to measure changes in cognitive ability and mental and physical health across a five-year period in a group of older drug users and matched controls. I have the expertise, leadership and motivation necessary to successfully carry out the proposed work. I have a broad background in psychology, with specific training and expertise in key research areas for this application. As a postdoctoral fellow at Berkeley, I carried out ethnographic and survey research and secondary data analysis on psychological aspects of drug addiction. At the Division of Intramural Research at the National Institute on Drug Abuse (NIDA), I expanded my research to include neuropsychological changes associated with addiction. As PI or co-Investigator on several previous university- and NIH-funded grants, I laid the groundwork for the proposed research by … In summary, I have a demonstrated record of successful and productive research projects in an area of high relevance for our aging population, and my expertise and experience have prepared me to lead the proposed project.”
slide13
Resources
  • Describe how the scientific environment will help you successfully complete the project
  • Early Stage Investigators (those with no previous major NIH funding who completed their terminal degree or residency less than 10 years ago) must describe how the institution has invested in their success
  • (Mention the CCTS! We can give you a letter of support!)
slide14
All Personnel Report

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.

slide15
All Personnel Report(con’t)

For each person listed, you must include

eRA Commons User name (“when applicable”—ask your program officer what that means for your proposal)

Name

Degrees

Role on Project

Last 4 digits of Social Security number

Date of birth

Effort (calendar months)

slide16
Research Plan

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

Research Strategy

Significance

Innovation

Approach (strategy and methods,

plus Preliminary Studies/ Progress Report)

Maximum 13 pages (7 for R21s)

slide17
If your FOA states other formats

or page limits,

use those.

slide18
Organizing the Research Plan
  • Specific Aims
  • Research Strategy
  • B.1. Significance
  • B.2. Innovation
  • B.3. Approach
  • B.3.1. Methods
  • B.3.2. Preliminary Studies/Progress Report
  • Or,
  • B.3.1. Preliminary Studies/Progress Report
  • B.3.2. Methods
  • (the order will be clarified by NIH soon)
slide19
Specific Aims

“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.”

slide20
So, the Specific Aims section

has not changed significantly.

slide21
Features of Specific Aims Section

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

slide22
Features of Specific Aims Section (Con’t.)

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

slide24
Research Strategy

Significance

Innovation

Approach

Strategy and Methods

Preliminary Studies/Progress Report

slide25
“Significance

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.”

slide26
Significance (con’t)

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.

slide27
Sample Significance Outline

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

disease incidence)

slide28
Sample Significance Section

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…

slide29
“Innovation

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.”

slide30
Innovation (con’t.)

What’s new about your proposed study?

New hypotheses?

New methods or approaches?

Not all studies have to be innovative…

(maybe the timing is right…)

Half a page should be sufficient

slide31
Sample Innovation Statement

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…

slide32
“Approach [strategy and methods]

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.”

slide33
Approach [strategy and methods con’t]

Use each Specific Aim as a subheading, and under each, describe how you will achieve that aim:

B.3.1. Methods

B.3.1.1. Specific Aim 1: To ascertain the

relationships…

B.3.1.2. Specific Aim 2: To construct a profile…

slide34
For each Specific Aim, state how you will achieve the Aim, including:

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

slide35
“Preliminary Studies for New Applications. For new applications, include information on Preliminary Studies as part of the Approach section. Discuss the PI’s preliminary studies, data, and/or experience pertinent to this application. Except for Exploratory/Development Grants (R21/R33), Small Research Grants (R03), Academic Research Enhancement Award (AREA) Grants (R15), and Phase I Small Business Research Grants (R41/R43), preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include preliminary data. (However, for R01 applications, reviewers will be instructed to place less emphasis on the preliminary data in applications from Early Stage Investigators than on the preliminary data in applications from more established investigators.)”
slide36
This section is called Preliminary Studies, not Preliminary Data.

Include:

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)

slide37
Describe published studies briefly:

Only enough background and methods to make

the study understandable (1-2 sentences)

Only enough results to be convincing

Emphasize the conclusions (interpretation of

results)

Write the descriptions backwards:

What were the conclusions that support your

proposed study?

What data are essential to support those

conclusions?

What background information has not already

been presented in your application?

Then, arrange the sentences in background—data—conclusions order.

slide38
If possible, organize Preliminary Studies by Specific Aims: use each Specific Aim as a subheading, and under each one state what you’ve done already to achieve the aim.

If that’s not possible, make the relationship between the aims and the preliminary studies clear:

Technique X

“Aim 2 calls for technique X, which we recently established in our laboratory. An example is shown in Figure 1.”

slide39
“Progress Report for Renewal and Revision Applications. For renewal/revision applications, provide a Progress Report as part of the Approach section. Provide the beginning and ending dates for the period covered since the last competitive review. Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes resulting from significant budget reductions. A list of publications, manuscripts accepted for publication, patents, and other printed materials should be included in 5.5.5; do not include that information here.”
slide40
The Progress Report should be organized by Specific Aims, using each one as subheading and under it describing everything that has been done to achieve the aim. Use the strategy for describing Preliminary Studies.

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.

slide41
A final bit of advice:

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.

slide42
REMEMBER

Use CCTS services and programs to leverage your grant applications

Check our web site for information

http://ccts.uth.tmc.edu/

Contact the CCTS to discuss what we can do for you

713-500-7900

[email protected]

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