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GEMS Grants Writing D.C. Rao I.Basics & Various Steps II. II.Research Plan: Review Structure &...

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GEMS Grants GEMS Grants Writing Writing D.C. Rao I. I. Basics & Various Steps Basics & Various Steps II. Research Plan: Review Structure & Format III.Designing Family/Genetic Studies & Consent Issues; Types of Grants; Assignment IV. Human Subjects Issues & IRB; Revising a Grant V. Review Assignments in Class ACKNOWLEDGMENTS Kelle H. Moley , MD; Dept of OB/GYN Linda Pike , Ph.D.; Dept of Biochem & Mol Biophysics
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GEMS Grants GEMS Grants WritingWritingD.C. Rao

I.I. Basics & Various StepsBasics & Various StepsII. Research Plan: Review Structure & FormatIII. Designing Family/Genetic Studies & Consent

Issues; Types of Grants; AssignmentIV. Human Subjects Issues & IRB; Revising a GrantV. Review Assignments in Class

ACKNOWLEDGMENTSKelle H. Moley, MD; Dept of OB/GYN

Linda Pike, Ph.D.; Dept of Biochem & Mol Biophysics

Grant Writing Grant Writing I. Basics & All the Steps II. Basics & All the Steps Involved in

Grant WritingConceive an innovative ideaAnd testable hypothesis

Evaluate feasibility & reality If not funded the first time, consider

revision and re-submission; learn how to revise

Carry out literature review effectively & responsivelyAnd prepare the background

Generate preliminary data Revise as necessary & submit to the funding agency

Prepare the grant application keepingAn appropriate funding agency & study It often helps to have it critiqued

Section in mind By a couple of experienced investigators

Grant WritingGrant Writing: Some Facts: Some Facts

In general, better grants get funded but not In general, better grants get funded but not all all good grants are funded; good grants are funded; sometimes not-so- good ones also get funded! Learning to write a good grant is a life long Learning to write a good grant is a life long learning experience; learning experience; there are no short cuts! These days, NIH grants are rarely funded upon the These days, NIH grants are rarely funded upon the 11stst time; time; successful grants are usually funded upon 2 revisions There is no safe, reliable, and dependable There is no safe, reliable, and dependable method; method; the same approach works sometimes but not always!!

Grant Writing: Some FactsGrant Writing: Some Facts

Funding of a grant depends on several factors Funding of a grant depends on several factors not all of which are under the PI’s controlnot all of which are under the PI’s control

Well written grant Composition of the particular Study section, the specific reviewers of your grant What are you willing to do to maximize the chances of funding?

Submission of a grant does not guarantee funding, but not submitting a grant guarantees no funding! Also, submission of a bad grant guarantees rejection!

Components of a Good Components of a Good GrantGrant

These are necessary, but can not guarantee success1. Sound, creative and innovative idea & a testable hypothesis

2. Determination and commitment to make it work; translate determination into action!

o Explore the feasibility & discuss with experienced colleagueso Generate pilot data/ preliminary studieso Articulate the idea into an attractively written granto Seek frank critiques from experienced colleagues and improve the

presentation prior to submission

3. Never submit a grant too soon. Since successful NIH grants usually take a total of 3 submissions, it is some times tempting to start early knowing that anyway it will take 3 submissions.

4. Avoid such temptation since most of the 2nd submissions are NOT funded! You have just 3 chances to make it work, and make good use of every opportunity you have!

Grant WritingGrant WritingIssues to ConsiderIssues to Consider

1. How to write a good grant? Feasible, realistic, and timely

2. How to select a Funding Agency (say, NIH), Institute within the NIH, and a Study Section?

3. How to revise a grant in a responsive and effective manner?

Grant Writing: Complete Grant Writing: Complete PackagePackage

1.1. Title pageTitle page2.2. Abstract page and Key personnelAbstract page and Key personnel3.3. Contents pageContents page4.4. Budgets & Budget justificationBudgets & Budget justification5.5. Biographical Sketches with Other SupportBiographical Sketches with Other Support6.6. Resources & EnvironmentResources & Environment7.7. Research Plan (A, B, C, D)Research Plan (A, B, C, D)8. Human Studies9. Inclusion of Women and Minorities10. Inclusion of Children11. Vertebrate Animals12. Consortium/Contractual Arrangements13. Letters of Support14. Data/Resource Sharing Plan15. Appendix16. Literature Cited

Research Plan: Contents for Research Plan: Contents for PlanningPlanning

1. SPECIFIC AIMS2. BACKGROUND AND SIGNIFICANCE

1. Limitations and Critical Barriers to Gene Discovery2. Modulation of genetic effects by age 3. Modulation of genetic effects by obesity 4. Metabolic and CVD risk factors as a Major Public Health Problem 5. Uniqueness and Significance of the Proposed Study

3. PRELIMINARY STUDIES1. Experience of the Investigators in Genetic Epidemiology Research2. The GenSalt Family Study 3. Preliminary results on exploring the new direction to gene discovery

4. RESEARCH DESIGN AND METHODS1. Brief Overview and Rationale of the Research Plan 2. Characteristics of the GenSalt Study Participants

1. Methods for Specific Aim 1 1. Definition of Primary and Secondary Phenotypes 2. Variance Components Linkage Analysis Methods 3. Gene-Age Interactions in Linkage Analysis 4. Statistical Power 5. Anticipated findings, future studies, and potential problems/ resolutions

2. Methods for Specific Aim 2 1. Definition of Phenotypes 2. Gene-Obesity Interactions in Linkage Analysis 3. Statistical Power

3. Multiple Testing 4. Potential Limitations and Backup Plans5. Timeline

5. Protection of Human Subjects6. Inclusion of Women & Minorities7. Inclusion of Children8. Vertebrate Animals9. Consortium/Contractual Arrangements10. Letters of Support11. Resource Sharing Plan12. Appendix13. Bibliography

Grant WritingGrant WritingII. Research Plan: Review II. Research Plan: Review

Structure & FormatStructure & Format

D.C. RaoDivision of Biostatistics

Washington University in St. LouisSchool of Medicine

ACKNOWLEDGMENTSKelle H. Moley, MD; Dept of OB/GYN

Linda Pike, Ph.D.; Dept of Biochem & Mol Biophysics

Research PlanResearch Plan Up to 25 pages depending on the type of grant

R21: 15 pages R21 does not require “Preliminary Studies”, however, it would be

desirable to include some preliminary data and justify that the proposed work is feasible!

R01: 25 pages Requires convincing “Preliminary Studies” and some publications

and/or abstracts.

When planning for an R01, it is generally advisable to generate limited preliminary data first and then apply for an R21 for generating the necessary preliminary studies for subsequently preparing the R01 application.

NIH-acceptable format for preparing grant applications include:

Arial font 11, single space, with ½ inch margins all around

Specific Aims: Specific Aims: Generally one Generally one pagepage

Lead Paragraph: Rationale and motivation: Lead Paragraph: Rationale and motivation: Set the Set the general background with a dramatic but factual general background with a dramatic but factual opening, e.g.:opening, e.g.:

“High dietary sodium and low potassium intake are associated with increased blood pressure (BP) in observational studies. Dietary sodium reduction and potassium supplementation lower BP in randomized trials, although the BP reduction varies among individuals. The relationship between sodium and Potassium sensitivity and risk of hypertension has not been well studied”.

“Despite major advances in the control and treatment of Coronary Heart Disease (CHD), CHD continues to be a major cause of mortality in the US and throughout the world, constituting a serious public health challenge”.

Identify gaps in the knowledgebaseIdentify gaps in the knowledgebase

Second Paragraph: Objective and Proposed StudySecond Paragraph: Objective and Proposed StudyThe objective of the proposed study is to investigate and characterize the relationship between sodium and potassium sensitivity and risk of hypertension. ……………. Toward this objective, we propose the following specific aims:

Specific Aims: Specific Aims: Generally one page Generally one page (continued)(continued)

Specific Aim 1:Specific Aim 1: To determine …..

Specific Aim 2:Specific Aim 2: To evaluate ….Usually 2 to 4 Aims (hypotheses may be stated as part of each Aim

Concluding (Salesmanship) Paragraph: Innovation & Expected BenefitsConcluding (Salesmanship) Paragraph: Innovation & Expected Benefits: Recall the novelty, innovation, and the potential benefits:

“Upon completion of this work, we expect to learn …Thus, these findings are ultimately expected to have a significant impact on the filed of ….”.

“This study is expected to make a significant contribution to the understanding of how ..”.

“We anticipate that the findings of this exploratory study (R21) have the potential to open up new avenues of research relating to the discovery of the genetic architecture underlying common complex traits ….”

Specific Aim:Specific Aim: Investigate the degree to which obesity modulates the genetic effect on cardiovascular and metabolic risk factors, with particular emphasis on risk factors related to insulin resistance and blood pressure, by incorporating gene-obesity interactions as part of the analysis method.

HypothesisHypothesis:: Obesity modulates genetic effects on cardiovascular and metabolic risk factors.

Background & SignificanceBackground & SignificanceGenerally 2-3 pagesGenerally 2-3 pages

Lead Paragraph: Provide an attractive opening Lead Paragraph: Provide an attractive opening paragraph to Backgroundparagraph to Background

1.1. Review literature, identifying significant and critical Review literature, identifying significant and critical gaps in knowledgegaps in knowledge

2.2. Relate the gaps to your specific aims, reiterating Relate the gaps to your specific aims, reiterating the importance of the proposed research.the importance of the proposed research.

3.3. Organize into multiple sub-sectionsOrganize into multiple sub-sections

Conclude with a “Significance” Paragraph: Stress why this study is important to conduct, what the significant benefits would be if this is performed, and what are the negative consequences if it is not conducted!

Preliminary Studies (Progress Preliminary Studies (Progress Report)Report)

Generally Up to 8 pagesGenerally Up to 8 pages

It is a good place to emphasize the expertise,It is a good place to emphasize the expertise,experience, and the unique strengths of theexperience, and the unique strengths of theinvestigative team (which may not be clearinvestigative team (which may not be clearfrom the Bio’s or the preliminary studies!from the Bio’s or the preliminary studies!

Also describe any special circumstances Also describe any special circumstances pertaining to this study which may not otherwise pertaining to this study which may not otherwise be clear.be clear.

Describe all relevant preliminary studies:

Avoid discussing results which are not very relevant

More is not better, relevance is important

Research Design & Research Design & MethodsMethods

1. Provide an “Overview” section describing in broad strokes your overall research strategy

2. Organize all methodological detail for each Aim into separate sections

Sample/Assays/Experiments etc Data Generated Statistical Methods of Analysis Statistical Power for testing each hypothesis Desirable to include a section devoted to “Anticipated

findings, future (follow up) studies, and potential problems and resolutions”. Alternatively, such a section may be added after all the methods for all the aims, and address the issues globally.

3. Various grant formats have additional requirements (which may not be considered against the page budget) (e.g., Data Sharing, Resource Sharing, Multiple PIs etc)

Grant WritingGrant WritingIII. III. Designing Family/Genetic Studies &

Consent Issues; Types of Grants; Assignment

D.C. RaoDivision of Biostatistics

Washington University in St. LouisSchool of Medicine

ACKNOWLEDGMENTSKelle H. Moley, MD; Dept of OB/GYN

Linda Pike, Ph.D.; Dept of Biochem & Mol Biophysics

Designing a “Genetic Study”

Family study or Population study? Choice must be justifiable Recruitment and Informed consent issues are different for the

two types of study Population Genetic Study: Each individual (potential) participant is

contacted independently of all other (potential) participants, and each one gives informed consent for himself/herself

Family Study: We should first target a certain individual (propositus, proband etc, who satisfies certain inclusion/ exclusion criteria; e.g., un-medicated hypertensive with age at diagnosis below 55 years of age) and seek his/her consent for participation in the study, and also seek his/her assistance & consent for contacting other specific types of family members (eg, spouse and children, all sibs and parents etc). Recruitment criteria for families can be more complex and challenging. How to ensure that families with at least 2 sibs (say) will actually participate in the clinical/genetic study?

Handling biological materials (like DNA) & genetic information (like marker data) requires special attention

Does the study involve Human Subjects?Does the study involve Human Subjects? Level of Informed Consent

Keep in mind that sharing of data and biological materials with investigators outside your immediate study requires appropriate level of consent. Examples of levels of consent for a hypertension study:

Very restricted: Data and biological materials may be used by the study investigators exclusively for the purposes of the study at hand.

Limited access to outside investigators: Data and biological materials may be used for hypertension and cardiovascular research in general.

Unrestricted: Data and biological materials may be used for biomedical research to improve human health.

Protect confidentiality of the data and never violate the informed consent

A government laptop computer containing sensitive medical information on 2,500 patients enrolled in a NIH study was stolen in February, potentially exposing seven years' worth of clinical trial data, including names, medical diagnoses and details of the patients' heart scans. The information was not encrypted, in violation of the government's data-security policy.

The incident is the latest in a number of failures by government employees to properly secure personal information. This month, the Government Accountability Office found that at least 19 of 24 agencies reviewed had experienced at least one breach that could expose people's personal information to identity theft.

NIH officials said the laptop was taken Feb. 23 from the locked trunk of a car driven by an NHLBI laboratory chief named Andrew Arai, who had taken his daughter to a swim meet in Montgomery County. They called it a random theft. Arai oversees the institute's research program on cardiac magnetic resonance imaging and signed the letters to those whose data was exposed.

In the letter, Arai told the patients that "some personally identifiable information" was on the stolen computer, including names, birth dates, hospital medical record numbers and MRI information reports, such as measurements and diagnoses. Social Security numbers, phone numbers, addresses and financial information were not on the laptop, officials said.

Arai's letter said that the NIH Center for Information Technology determined that the theft posed "a low likelihood of identity fraud" or financial harm. "It is, however, an unfortunate breach of our commitment to protect the confidentiality of your research records," he wrote.

Patients' Data on Stolen Laptop: Identity Fraud Not Likely, NIH Says

By Ellen Nakashima and Rick Weiss, Washington Post Staff Writers

Monday, March 24, 2008March 24, 2008; A01

AssignmentAssignment 1. Select one of the two actual grants provided, critique it

thoroughly, with particular emphasis on Specific Aims and Methods.

2. Prepare a one page written “Summary Statement” by evaluating the grant application, and submit the day before the presentations are due (item 3 below):

One paragraph summary of the grant proposal One paragraph summarizing the strengths of the proposal One paragraph summarizing the weaknesses of the proposal

3. Present your review in class in 3 minutes at the time of our last session (you may do this with or without slides; only 3 slides allowed)

4. Page limits and time limits will be strictly enforced!

Types of GrantsTypes of Grants

Investigator Initiated Research Grants: Investigator Initiated Research Grants: – R03R03 Limited data analysis grantsLimited data analysis grants– R21R21 Two year exploratory grants for Two year exploratory grants for

generating pilot data for R01’sgenerating pilot data for R01’s– R01R01 Fully mature investigationsFully mature investigations

Career Development Awards: Career Development Awards: – K-Awards of several types (handout)K-Awards of several types (handout)

Comparison of K Awards across Institutes & Centers:K01 K02 K08 K12

Program: Mentored Research Scientist Development Award (K01)

Program: Independent Scientist Award (K02) Program: Mentored Clinical Scientist Research Career Development Award (K08)

Program: Mentored Clinical Scientist Development Program Award (K12): Multiple FOAs - See K Kiosk

General Objective: The K01 provides support for a sustained period of “protected time” for intensive research career development under the guidance of an experienced mentor leading to research independence. (See IC Specific Information)

General Objective: The K02 is intended to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. (See IC Specific Information)

General Objective: The K08 supports didactic study and mentored research for individuals with clinical doctoral degrees (e.g., M.D., D.D.S., D.M.D., D.O., D.C., O.D., N.D., D.V.M., Pharm.D., or Ph.D. in clinical disciplines).

General Objective: The K12 provides support to an institution for the development of independent clinical scientists.

Award Duration: 3, 4, or 5 years Award Duration: 3, 4, or 5 years Award Duration: 3, 4, or 5 years Award Duration: Generally 5 yearsEffort: Minimum 75% (or 9.0 calendar months) of full-time professional effort

Effort: Minimum 75% (or 9.0 calendar months) of full-time professional effort

Effort: Minimum 75% (or 9.0 calendar months) of full-time professional effort

Effort: Minimum 75% (or 9.0 calendar months) of full-time professional effort

Salary Limit: Varies by IC Salary Limit: Varies by IC Salary Limit: Varies by IC Salary Limit: Contact IC staffResearch Costs: Varies by IC Research Costs: Varies by IC Research Costs: Varies by IC Research Costs: Contact IC staffProgram: Mentored Research Scientist Development Award (K01)

Program: Does not support this mechanism Program: Mentored Clinical Scientist Research Career Development Award (K08)

Program: Paul Calabresi Career Development Award For Clinical Oncology (K12)

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See link aboveSalary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per candidate per year

Research Costs: Up to $30,000 per year Research Costs: Up to $30,000 per year Research Costs: Up to $30,000 per candidate per year

NCI K01: NCI Mentored Career Development Award to Promote Diversity (K01)

NCI K08: NCI Mentored Clinical Scientist Award to Promote Diversity (K08)

Program: Does not participate in the Omnibus Announcement (see NHLBI announcements below)

Program: NIH Omnibus K02 Announcement Program: Mentored Clinical Scientist Research Career Development Award (K08)

Program: Does not support this mechanism

IC Specific Information: IC Specific Information: See IC Table IC Specific Information: See IC TableSalary Limit: Salary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per yearResearch Costs: Research Costs: No research development support Research Costs: Up to $25,000 per yearNHLBI K01: Mentored Career Award for Faculty at Minority InstitutionsNHLBI K01: Mentored Career Development Award to Promote Faculty Diversity in Biomedical Research

Program: NIH Omnibus K01 Announcement Program: NIH Omnibus K02 Announcement Program: Mentored Clinical Scientist Research Career Development Award (K08)

Program: NICHD accepts applications for K12s only in response to active RFAs

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See link aboveSalary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per year Salary Limit: See link aboveResearch Costs: Up to $25,000 per year Research Costs: Up to $25,000 per year Research Costs: Up to $25,000 per year Research Costs: See link aboveProgram: NIH Omnibus K01 Announcement (see NIDDK-specific announcement in this box)

Program: Does not support this mechanism Program: Mentored Clinical Scientist Research Career Development Award (K08)

Program: Does not support this mechanism

IC Specific Information: See IC Table IC Specific Information: See IC TableSalary Limit: Up to $90,000 per year Salary Limit: Up to $90,000 per yearResearch Costs: Up to $25,000 per year Research Costs: Up to $25,000 per yearNIDDK K01: NIDDK Mentored Research Scientist Development AwardDoes not participate in the Omnibus Announcement (see NIGMS program below)

Program: Does not support this mechanism Program: Mentored Clinical Scientist Research Career Development Award (K08)

Program: Institutional Research and Academic Career Development Award (K12)

IC Specific Information: See MORE Faculty Development Awards

IC Specific Information: See IC Table IC Specific Information: See link above

Salary Limit: Salary Limit: Up to $75,000 per year Salary Limit: Consistent with the established salary structure at the applicant institution

Research Costs: Research Costs: Up to $20,000 per year Research Costs: Supplies, travel, and statistical services including personnel and computer time

Program: NIH Omnibus K01 Announcement Program: NIH Omnibus K02 Announcement Program: Mentored Clinical Scientist Research Career Development Award (K08)

Program: Does not support this mechanism

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See IC TableSalary Limit: Up to $90,000 per year Salary Limit: Up to $90,000 per year Salary Limit: Up to $90,000 per yearResearch Costs: Up to $50,000 per year Research Costs: Generally none Research Costs: Up to $50,000 per year

NIDDK Training

NIGMS Training

NIMH Training

NIH K Kiosk

NCI Training

NHLBI Training

NICHD Training

Comparison of K Awards across Institutes & Centers:K22 K23 K25 K99/R00

Program: Career Transition Award (K22): Multiple FOAs - See K Kiosk

Program: Mentored Patient-Oriented Research Career Development Award (K23)

Program: Mentored Quantitative Research Career Development Award (K25)

Program: NIH Pathway to Independence (PI) Award (K99/R00)

General Objective: The Career Transition Award (K22) generally supports an individual postdoctoral fellow in transition to a faculty position. Applicants may be in an NIH Intramural Program. Some ICs also accept applicantions from extramural scientists.

General Objective: The purpose of the K23 is to support the career development of investigators with research or health professional doctoral degree, who have made a commitment to focus their research endeavors on patient-oriented research.

General Objective: The purpose of the K25 is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease.

General Objective: The primary goal of the K99/R00 pilot initiative is to facilitate receiving an R01 award earlier in a research career and to assist investigators in securing a stable research position during the critical transition stage of their career.

Award Duration: Generally 1-2 years of Mentored support, and up to 3 years of Independent support

Award Duration: 3, 4, or 5 years Award Duration: 3, 4, or 5 years Award Duration: Mentored phase: 1-2 years; Independent phase: Up to 3 years

Effort: Minimum 75% (or 9.0 calendar months) of full-time professional effort for Mentored phase

Effort: Minimum 75% (or 9.0 calendar months) of full-time professional effort

Effort: Minimum 75% (or 9.0 calendar months) of full-time professional effort

Effort: Minimum 75% (or 9.0 calendar months) of full-time professional effort during Mentored phase

Salary Limit: Contact IC staff Salary Limit: Varies by IC Salary Limit: Varies by IC Salary Limit: Contact IC staffResearch Costs: Contact IC staff Research Costs: Varies by IC Research Costs: Varies by IC Research Costs: Contact IC staffProgram: NCI Transition Career Development Award (K22)

Program: Mentored Patient-Oriented Research Career Development Award (K23)

Program: Mentored Quantitative Research Career Development Award (K25)

Program: NIH Pathway to Independence (PI) Award (K99/R00)

IC Specific Information: See link above - For Federal (intramural) and non-Federal (extramural) scientists

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See IC Table & the Howard Temin Award in this box

Salary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per year Budget (Mentored phase): Up to $50,000 for salary, and up to $30,000 for research costs

Research Costs: Up to $50,000 per year Research Costs: Up to $30,000 per year Research Costs: Up to $40,000 per year Budget (Independent phase): Total direct cost may not exceed $249,000 per year

NCI K22: NCI Transition Career Development Award to Promote Diversity

NCI K23: Mentored Patient-Oriented Research Award to Promote Diversity (K23)

NCI K99/R00: Howard Temin Pathway to Independence Award in Cancer Research

Program: NHLBI Career Transition Award Program: Mentored Patient-Oriented Research Career Development Award (K23)

Program: Mentored Quantitative Research Career Development Award (K25)

Program: NIH Pathway to Independence (PI) Award (K99/R00)

IC Specific Information: See link above (for Intramural Scientists Only)

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See IC Table

Salary Limit: Up to $75,000 per year (Extramural phase)

Salary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per year Budget (Mentored phase): Up to $50,000 for salary, and up to $20,000 for research costs

Research Costs: Up to $75,000 per year (Extramural phase)

Research Costs: Up to $30,000 per year Research Costs: Up to $ $40,000 per year Budget (Independent phase): Total direct cost may not exceed $249,000 per year

Program: NICHD Career Transition Award Program: Mentored Patient-Oriented Research Career Development Award (K23)

Program: Mentored Quantitative Research Career Development Award (K25)

Program: NIH Pathway to Independence (PI) Award (K99/R00)

IC Specific Information: See link above (for Intramural Scientists Only)

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See IC Table

Salary Limit: Up to $75,000 per year (Extramural) Salary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per year Budget (Mentored phase): Up to $50,000 for salary, and up to $20,000 for research costs

Research Costs: Up to $125,000 per year (Extramural phase)

Research Costs: Up to $25,000 per year Research Costs: Up to $25,000 per year Budget (Independent phase): Total direct cost may not exceed $249,000 per year

Program: NIDDK Career Transition Award (K22) in Patient-Oriented Research

Program: Mentored Patient-Oriented Research Career Development Award (K23)

Program: Mentored Quantitative Research Career Development Award (K25)

Program: NIH Pathway to Independence (PI) Award (K99/R00)

IC Specific Information: See link above (for Intramural Scientists Only)

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See IC Table

Salary Limit: Up to $75,000 per year (Extramural phase)

Salary Limit: Up to $90,000 per year Salary Limit: Up to $90,000 per year Budget (Mentored phase): Up to $75,000 for salary, and up to $25,000 for research costs

Research Costs: Up to $100,000 per year (Extramural phase)

Research Costs: $25,000 to $50,000 per year Research Costs: Up to $40,000 per year Budget (Independent phase): Total direct cost may not exceed $249,000 per year

Program: Does not support this mechanism Program: Mentored Patient-Oriented Research Career Development Award (K23)

Program: Mentored Quantitative Research Career Development Award (K25)

Program: NIH Pathway to Independence (PI) Award (K99/R00)

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See IC Table

Salary Limit: Up to $75,000 per year Salary Limit: Up to $75,000 per year Budget (Mentored phase): Up to $50,000 for salary, and up to $20,000 for research costs

Research Costs: Up to $20,000 per year Research Costs: Up to $40,000 per year Budget (Independent phase): Total direct cost may not exceed $249,000 per year

Program: NIMH no longer accepts new applications for the K22

Program: Mentored Patient-Oriented Research Career Development Award (K23)

Program: Mentored Quantitative Research Career Development Award (K25)

Program: NIH Pathway to Independence (PI) Award (K99/R00)

IC Specific Information: See IC Table IC Specific Information: See IC Table IC Specific Information: See IC TableSalary Limit: Up to $90,000 per year Salary Limit: Up to $90,000 per year Budget (Mentored phase): Up to $50,000 for salary, and up to

$20,000 for research costsResearch Costs: Up to $50,000 per year Research Costs: Up to $50,000 per year Budget (Independent phase): Total direct cost may not exceed

$249,000 per year

NIDDK Training

NIGMS Training

NIMH Training

NIH K Kiosk

NCI Training

NHLBI Training

NICHD Training

Types of K-Awards by NHLBITypes of K-Awards by NHLBI

K08K08 K23K23 K25K25

Program: Mentored Patient-Oriented Research Career Development Award (K23)

Program: Mentored Clinical Scientist Research Career Development Award (K08)

Program: Mentored QuaProgram: Mentored Quantitative Research Carentitative Research Career Development Award (er Development Award (K25)K25)

Salary Limit: Up to $75,000 per year

Research Costs: Up to $ $40,000 per year

Grant WritingGrant WritingIV. Revising a Grant, Discussion of IV. Revising a Grant, Discussion of

Specific Aims prepared for the Specific Aims prepared for the other course, and Open Discussion other course, and Open Discussion about Designing Genetic Studiesabout Designing Genetic Studies

D.C. RaoDivision of Biostatistics

Washington University in St. LouisSchool of Medicine

ACKNOWLEDGMENTSKelle H. Moley, MD; Dept of OB/GYN

Linda Pike, Ph.D.; Dept of Biochem & Mol Biophysics

Grant WritingGrant Writing Things to Consider When Revising a Grant

Application1. Read the summary statement carefully (and “walk away

from it for a few days”, but stay focused!)2. Read it again and compile all criticisms into one list of

“Significant Concerns”, grouping them as necessary. All relatively minor concerns my be grouped into “Other miscellaneous concerns”).

3. Make a prioritized list of the major criticisms (usually 2 to 5) & prepare a response plan for each of them. Some of them may require additional pilot/preliminary data or simulations.

4. Avoid the temptation of re-submitting the revision for the immediately available dead line; inadequate revision and premature re-submission can and often does backfire, faring even worse than before (thus wasting one of 2 or 3 windows of opportunity)

5. Patience is a virtue but procrastination is not!

Grant WritingGrant Writing Things to Consider When Revising a Grant Application

# 21. Remember, the reviewers are also expert scientists like you and me. While your

anger at the reviewers’ disapproval of your grant is understandable, avoid directing your anger at the reviewers

2. It would be more productive for you to assume that you have failed to present your grant in a convincing and compelling manner.

3. Remember, most submitted grants are good. Yours has to be at the top of good grants! Therefore, simply revising a grant rapidly based on the criticisms may not be enough to secure funding. Take advantage of every opportunity you have for continuing to improve the grant.

4. Remember, reviewers have no obligation to us but they work hard for us, so be gentle and make them feel appreciated (“Inspired by the cogent comments of the reviewers, we have undertaken an extensive revision”).

5. Reviewers are also human and some times they do make mistakes (especially if our grants are not well written to start with). Avoid the temptation to use offensive language (preferable to say “we respectfully submit that ….”).

6. Prepare the best possible INTRODUCTION section (up to 3 pages). For revised applications, if this section has not convinced the reviewer, may be nothing else is going to! Be very well organized, clear, and succinct. Salesmanship is key!

Open Discussion about Designing Genetic Studies, andOpen Discussion about Designing Genetic Studies, and

Grant WritingGrant Writing

1.1. Presentation & Discussion of Presentation & Discussion of Specific AimsSpecific Aims

2.2. Discussion about Design of Genetic Discussion about Design of Genetic StudiesStudies

3.3. Discussion about the AssignmentDiscussion about the Assignment

4.4. Next Session: Assignments due Next Session: Assignments due (written & oral presentations(written & oral presentations

Grant WritingGrant WritingV. Last SessionV. Last Session

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