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Preparation of NIH Grant Applications. Karl Salzwedel NIH Grantsmanship Workshop Kuala Lumpur, Malaysia July 2, 2013. Find Answers and Plan Your Approach www.niaid.nih.gov. The NIH Grant Application Lifecycle. www.niaid.nih.gov / researchfunding / grant. Where to Start.

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Preparation of NIH Grant Applications


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    1. Preparation of NIH Grant Applications Karl Salzwedel NIH Grantsmanship Workshop Kuala Lumpur, Malaysia July 2, 2013

    2. Find Answers and Plan Your Approach www.niaid.nih.gov

    3. The NIH Grant Application Lifecycle www.niaid.nih.gov/researchfunding/grant

    4. Where to Start Researching the best fit for you is critical Some things to consider: To which grants are you eligible to apply ? What is the best grant mechanism for your situation? How much preliminary data do you have? What is the potential impact of your research to the field? How novel is your idea? Is this something that the NIH is looking to fund (solicited vs. unsolicited)? Is it best to apply as a principal investigator, co-investigator or collaborator?

    5. Which grant mechanism is right for you? www.grants.nih.gov/grants/guide/parent_announcements Ph.D. Career Development Awards K22- Research Scholar Development Award K99/R00- Pathway to Independence Award M.D. Career Development Awards K08- Mentored Clinical Scientist Development Award K23- Mentored Patient-Oriented Research Career Development Award Independent Research Grants R03- Small Grant R21- Exploratory/Developmental Research Grant R01- Research grant R03 R21 R01 K22 K99/ R00 Ph.D. M.D. K08 K23 Training Faculty position Independent PI

    6. Career Award Selection www.grants.nih.gov/training/kwizard K23 K99 K22 K08 K01

    7. K22 and the K99/R00 Award Features K22 • 2 yr award • No mentored phase • Awardee gets funds at the time of becoming asst. professor • $150K (year 1) direct costs + $100K (year 2) direct costs + 8% F&A • Must have less than 5 years postdoctoral experience K99/R00 • 3 year award only • Up to 1 yr mentored phase ($90K/yr) • Awardee becomes asst. professor- No peer review • 2 yr independent R phase ($249K/yr TC) • Citizenship and green card not required- unique to this K mechanism • Must have less than 5 years postdoctoral experience http://grants.nih.gov/training/careerdevelopmentawards.htm

    8. K08 and the K23 Award Features K08 • Up to 5 year award • Mentored clinical research • Minimum 75% effort required • Allows other support in last 2 years* • Up to $75K salary + fringe benefits+ $25K research costs • Does not support new clinical trials K23 • Up to 5 year award • Mentored patient-orientedresearch • Minimum 75% effort required • Allows other support in last 2 years* • Up to $75K salary + fringe benefits+ $25K research costs • Does not support new clinical trials http://funding.niaid.nih.gov/researchfunding/tool/pages/traincareercomp.aspx

    9. International Applicants • Most K-awards require U.S. citizenship (exception:K99) • Eligible for R03, R21, R01 research grants • Opportunities specific to international scientists (RFAs) www.niaid.nih.gov/researchfunding/int

    10. What does the NIH currently fund?www.projectreporter.nih.gov

    11. Specific Aims • The most critical page in the application • Aone page summary of the application • Why is this problem significant? • What is the exciting preliminary data? • What are the hypotheses supported by the data? • How will this project significantly impact the field? • Make sure to emphasize important points that you absolutely want the reviewer to know • Make them want to keep reading • Avoid simply listing things you are going to do

    12. Common Pitfalls • Proposed project is not novel or innovative • Even if project is successful will have questionable impact to the field • Failure to convince reviewers of scientific rationale for proposed studies • Research is mainly descriptive or correlative –’looking at’ bad, testing good • Lack of clear, testable hypothesis – ‘fishing expedition’ • Inadequate preliminary data to support a large investment • Unfocused research plan • Lack of experience in the proposed methodology • Insufficient publication record • Uncertainty concerning the future directions • Failure to consider potential pitfalls/alternative approaches • Unrealistically large amount of work • Lack of statistical considerations

    13. Things to keep in mind • Don’t work in a vacuum - actively seek out advice, collaborators/consultants to strengthen your proposal • Follow instructions - page limits, font size, margins • Be concise and clear - tables, figures clearly numbered with legends/footnotes • Letters of collaboration should clearly state what the collaborators/consultants have to offer • Allow sufficient time for honest feedback on draft proposal from colleagues/peers • Reviewers’ have zero tolerance for typos and bad grammar

    14. Summary: Hallmarks of an Outstanding Grant Application Strong significance to an important problem in public health: IMPACT is high High degree of novelty and innovation Strong track record by a well qualified applicantand collaborators Clear rationale Relevant and supportive preliminary data Clear and focused approach that provides unambiguous results Careful attention to details Presentation, readability, clarity of data, graphics, error bars, spelling, etc

    15. www.niaid.nih.gov/researchfunding/ann/pages/opps

    16. “I’m from the government and I’m here to help” • PO - Program Officer • Responsible for directing and evaluating research programs and scientific administration of your grant • SRO - Scientific Review Officer • Responsible for peer review of your application • GMS - Grants Management Specialist • Responsible for the fiscal and federal policy administration of your grant

    17. NIAID Funding Opportunities in HIV/AIDS Research Karl Salzwedel Division of AIDS, NIAID, NIH July 2, 2013

    18. NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.

    19. The Division of AIDS (DAIDS) Scientific Programs Basic Sciences Program Therapeutics Research Program Prevention Sciences Program Vaccine Research Program

    20. Steps Along the HIV Cure Pathway • Clinical Trials Networks: Cure Agenda (UM1) FY14 FY12 Beyond HAART:  Innovative Therapies to Control HIV-1 (P01) Delivering Therapeutics to Residual ActiveHIV Reservoirs RFA (R01) FY14 • Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33) FY13 FY11 Martin Delaney Collaboratory:  Towards an HIV-1 Cure (U19)

    21. New Funding Initiatives for 2015 • Clinical Trials Networks: Cure Agenda (UM1) Pilot Clinical Trials to Eliminate the Latent Reservoir (U01) New New Beyond HAART II Innovative Therapies to Control HIV (U19) Beyond HAART:  Innovative Therapies to Control HIV-1 (P01) Delivering Therapeutics to Residual Active HIV Reservoirs RFA (R01) Quantitative Viral Outgrowth Assay (Q-VOA) Service Resource (N01) New Targeting Latently Infected Cells Without Reactivation (R01) New • Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33) Innovative Assays to Quantify the Latent HIV Reservoir (R21, R01) New Martin Delaney Collaboratory:  Towards an HIV-1 Cure (U19)

    22. NIH AIDS Reagent Program Provides standardized reagents and new technologies to the AIDS research community • Viruses • Cell lines, hybridomas • Monoclonal and polyclonal antibodies • DNA clones, DNA libraries, expression vectors • Recombinant proteins, synthetic peptides • Reference panels for: • PCR • HIV subtyping • Drug resistant viruses • Neutralizing antibodies and sera • Antiviral drug standards http://www.aidsreagents.org

    23. U.S. institutions with funding to provide shared infrastructure support for HIV research CFARs support a multidisciplinary, collaborative environment that promotes basic, clinical, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. Web site: www.niaid.nih.gov/LabsAndResources/resources/cfar

    24. CFAR • One mission of the CFAR is to strengthen capacity for HIV/AIDS research in developing countries. • CFARs accomplish this through a variety of ways including: • Establishment of Cores abroad which provide training, services and expertise to local investigators • Provide funding for pilot projects with an international component through the CFAR Developmental Core • Offer training/mentorship in-country or in US • Access to databases, repositories, computer-based training

    25. CFARs are a Trans-NIH Program Co-funded by nine NIH Institutes: National Institute of Allergy and Infectious Diseases (NIAID) National Cancer Institute (NCI) National Institute of Child Health and Human Development (NICHD) National Heart, Lung and Blood Institute (NHLBI) National Institute on Drug Abuse (NIDA) National Institute on Mental Health (NIMH) National Institute on Aging (NIA) National Institute of General Medical Sciences (NIGMS) National Institute of Nursing Research (NINR) Co-managed by the NIH Institutes above, and by: Office of AIDS Research (OAR) Fogarty International Center (FIC)

    26. CENTERS FOR AIDS RESEARCH

    27. CFAR-Funded International HIV/AIDS Research India (5) Romania (1) Russia (1) Canada (1) China (4) Cambodia (1) Democratic Republic of Congo (1) Haiti (1) Ethiopia (1) Mexico (4) Uganda (12) Ghana (2) Kenya (26) Guatemala (1) Rwanda (4) Tanzania (11) Cameroon (1) Mozambique (4) Peru (3) Zambia (5) Zimbabwe (2) Namibia (2) Brazil (1) Malawi (8) Australia (2) Botswana (10) South Africa (20) CFAR projects funded 2009-2012 Updated June 2012

    28. Creative and Novel Ideas in HIV Research (CNIHR)Encouraging Innovation in HIV Research • Goal: to attract both international and U.S.-based early stage investigators from outside the field of HIV research • Up to 2 yrs, $150k per year Direct Costs • Concept sheets (2 pages) will be submitted by October 16, 2013 www.cnihr.org

    29. These are U01, collaborative grants, which establishinternational regional centers • Foster collaboration on HIV research on regional and global level • Advance methodology for collection and harmonization of data • Address research questions using data sets

    30. 7 Funded Regions Region 1: North America Region 5: Australia, China, India, Pakistan, Asia (excluding Central Asia) Region 2: Latin America & Caribbean (CCASAnet) Region 8: West Africa Region 9: Central Africa Region 11: South Africa Region 10: East Africa

    31. International Research in Infectious Diseases including AIDS (IRIDA) Program (R01) PAR-11-145 Objective: to advance the development of local scientific expertise, build local research infrastructure, and to increase collaborative research partnerships at resource limited eligible foreign countries that propose research related to infectious diseases that are of interest to that country Application Receipt Date for AIDS Applications: August 23, 2013 Contact (for HIV/AIDS Research): OpendraSharma, Ph.D. Telephone: (301) 496-9041 Email: osharma@niaid.nih.gov http://grants.nih.gov/grants/guide/pa-files/PAR-11-145.html

    32. In Summary There are many opportunities − researching the best fit for what you wish to do is critical. • Karl Salzwedel, salzwedelkd@niaid.nih.gov • Diana Finzi, dfinzi@niaid.nih.gov • Ann Namkung Lee,anamkung@niaid.nih.gov