Preparation of NIH Grant Applications

Karl SalzwedelNIH Grantsmanship Workshop

Kuala Lumpur, MalaysiaJuly 2, 2013

Find Answers and Plan Your Approachwww.niaid.nih.gov

The NIH Grant Application Lifecycle

www.niaid.nih.gov/researchfunding/grant

Where to Start

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?

Researching the best fit for you is critical

Which grant mechanism is right for you?

K22 R01

Ph.D. Career Development AwardsK22- Research Scholar Development AwardK99/R00- Pathway to Independence Award

R21R03K99/R00

M.D. Career Development AwardsK08- Mentored Clinical Scientist Development Award

K23- Mentored Patient-Oriented Research Career Development AwardIndependent Research GrantsR03- Small GrantR21- Exploratory/Developmental Research GrantR01- Research grant

Ph.D.

M.D.

Training Faculty position Independent PI

K08 K23

www.grants.nih.gov/grants/guide/parent_announcements

Career Award Selectionwww.grants.nih.gov/training/kwizard

K22 K23

K08

K99

K01

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

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-oriented

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

http://funding.niaid.nih.gov/researchfunding/tool/pages/traincareercomp.aspx

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

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

Specific Aims The most critical page in the application A one 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

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

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

• 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 applicant and 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

Summary: Hallmarks of an Outstanding Grant Application

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

“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 applicationGMS - Grants Management Specialist

– Responsible for the fiscal and federal policy administration of your grant

NIAID Funding Opportunities in HIV/AIDS

ResearchKarl Salzwedel

Division of AIDS, NIAID, NIHJuly 2, 2013

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately

prevent infectious, immunologic, and allergic diseases.

The Division of AIDS (DAIDS)

Scientific Programs• Basic Sciences Program• Therapeutics Research Program• Prevention Sciences Program• Vaccine Research Program

Steps Along the HIV Cure Pathway

Basic Research

Translational Research

Pilot Clinical Studies

Phase I-IV

Clinical Trials

Delivering Therapeutics to Residual Active HIV Reservoirs RFA (R01)

Martin Delaney Collaboratory:  Towards an HIV-1 Cure (U19)

Beyond HAART:  Innovative Therapies to Control HIV-1 (P01)

Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33)

Clinical Trials Networks: Cure Agenda (UM1)

FY11

FY14

FY13

FY12

FY14

Basic Research

Translational Research

Pilot Clinical Studies

Phase I-IV

Clinical Trials

Targeting Latently Infected Cells Without Reactivation (R01)

Beyond HAART II Innovative Therapies to Control HIV (U19)

Pilot Clinical Trials to Eliminate the Latent

Reservoir (U01)

Quantitative Viral Outgrowth Assay (Q-VOA) Service Resource (N01)

Innovative Assays to Quantify the Latent HIV Reservoir (R21, R01)

Delivering Therapeutics to Residual Active HIV Reservoirs RFA (R01)

Martin Delaney Collaboratory:  Towards an HIV-1 Cure (U19)

Beyond HAART:  Innovative Therapies to Control HIV-1 (P01)

Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33)

Clinical Trials Networks: Cure Agenda (UM1)

New

New

NewNew

New

New Funding Initiatives for 2015

NIH AIDS Reagent Program

• 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

Provides standardized reagents and new technologies to the AIDS research community

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

CFAROne 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

CFARs are a Trans-NIH ProgramCo-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)

CENTERS FOR AIDS RESEARCH

CFAR projects funded 2009-2012

India (5)

China (4)

Peru (3)

Brazil (1)

Tanzania (11)

South Africa (20)

Zambia (5)

CFAR-Funded International HIV/AIDS Research

Malawi (8)

Kenya (26)

Cameroon (1)

Uganda (12)

Botswana (10)

Mexico (4)

Updated June 2012

Cambodia (1)

Zimbabwe (2)

Mozambique (4)

Namibia (2)

Rwanda (4)

Russia (1)

Canada (1)

Democratic Republic of Congo (1)

Ethiopia (1)Ghana (2)

Guatemala (1)

Haiti (1)

Romania (1)

Australia (2)

www.cnihr.org

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

These are U01, collaborative grants, which establish international

regional centersFoster collaboration on HIV research on

regional and global levelAdvance methodology for collection

and harmonization of dataAddress research questions using data

sets

Region 1: North America

Region 2: Latin America & Caribbean (CCASAnet)

Region 5: Australia, China, India, Pakistan, Asia (excluding Central Asia)

Region 10: East AfricaRegion 11: South AfricaRegion 9: Central AfricaRegion 8: West Africa

7 Funded Regions

International Research in Infectious Diseases including AIDS (IRIDA) Program (R01)

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):

Opendra Sharma, Ph.D.Telephone: (301) 496-9041

Email: osharma@niaid.nih.gov

http://grants.nih.gov/grants/guide/pa-files/PAR-11-145.html

PAR-11-145

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