NIH Funding Opportunities: How to frame the best application.

NIH Funding Opportunities: How to frame the best application. Linda Nebeling, PhD, MPH, RD, FADA Chief, Health Promotion Research Branch Behavioral Research Program Division of Cancer Control & Population Sciences nebelinl@mail.nih.gov U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health

Applying For A Grant Key Gateways and Resources U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health

Gateways to Information: NIH grants1.nih.gov/grants

Gateways to Information: NIH New Investigators Program grants1.nih.gov/grants/new_investigators

Gateways to Information: Center for Scientific Review (CSR) cms.csr.nih.gov

NIH Center for Scientific Review Process National Cancer Institute

Gateways to Information: DCCPS cancercontrol.cancer.gov

DCCPS Web Page: Step-By-Step Grant Help Visit DCCPS Funding Opportunities Web section for Step-By-Step Grant Help with links to learning about: Resources and opportunities for cancer control research funding Grant funding mechanisms Submission procedures Application receipt dates and review timelines Peer-review process Resources to help develop your idea Tips on writing a strong grant application Other possible funding sources Web site: cancercontrol.cancer.gov/funding (application information)

Types of Funding Opportunity Announcements (FOA) Program Announcement (PA): Statement of ongoing research interest by Institute/Center No set-aside monies (usually) Investigator-initiated awards are now in response to a parent PA PA-07-070--Parent R01: http://grants.nih.gov/grants/guide/pa-files/pa-07-070.html Request for Applications (RFA): Special research initiative Set-aside monies and specially assembled review group

Types of Grant Mechanisms R03 Small Research Grants R21 Exploratory/Developmental Grants R01 Research Projects R13 Conference Grants P01 Research Program Projects K-Awards NCI Training Awards http://deainfo.nci.nih.gov/flash/awards.htm

R03: Small Research Grants Provide short-term awards for testing new techniques, secondary analyses of existing data, and development of innovative projects that could provide a basis for more extended research Characteristics: < $50K per year, 2-year maximum (nonrenewable) 3 submissions initial and 2 amended Special NCI review committee R03

R21: Exploratory/Developmental Grants Support development of pilot projects, feasibility studies, and intervention studies that are creative, novel, high-risk/high-payoff, and produce innovative advances Characteristics: Up to $275K/year for 2 years (nonrenewable) 3 submissions initial and 2 amended Only in response to Program Announcement R21

R01: Research Project Grants Traditional investigator-initiated grant providing support for discrete, specified research If > $500K/year, need to request NIH Center for Scientific Review (CSR)/Institute Program Director approval to submit at least 6 to 8 weeks before submission deadline for NCI DCCPS Up to 5 years (usually 3 5 years) 3 submissions initial and 2 amended R01

R13: Conference Grants Provide support for national and international meetings valued for promoting Institute/Center goals Prior approval required before submission of application; contact Program Director Any U.S. organization eligible Typically $10 25K/year for up to 5 years Amount dependent on score, timeliness, budget, NIH interest 3 submissions initial and 2 amended R13

P01: Research Program Projects Support an integrated, multiproject research approach involving a number of independent investigators who share knowledge and common resources and have a shared, well-defined research program goal There is a defined central research focus involving several disciplines or several aspects of one discipline DCCPS-supported examples: Collaborative Genetic Study of Nicotine Dependence Statistical Methods for Medical Studies Etiologic Studies of Gastric Cancer P01

General Funding Opportunities Information To learn about a specific funding opportunity, see: NIH Guide for Grants and Contracts: grants.nih.gov/grants/guide search by announcement number

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Writing a Grant Application

PHS398 or SF424 (R&R) Requirements Forms/Egrants/NIH Commons Assurance Number and IRB Registration Certificates of Confidentiality Data Safety and Monitoring all studies with human subjects DSM board required for all intervention studies Inclusion/Exclusion of Women, Children, and Minorities IRB approval is not needed before submission, but application must address human subjects protection Appendices

Typical Sequence for Thinking Through Proposal Development Problem or need Significance/Background Specific aims Theoretical model, if appropriate Preliminary studies/progress report Research plan Methods, design, sampling measures, analysis, strengths and limitations, future plans Human subjects, data and safety monitoring plan Budget Biographical sketches, institution signatures Abstract

Outline of Research Proposal Literature search Use articles that directly support aims Be current, up to month of submission Look up publications of potential reviewers Tip: Look for Study Section roster on NIH Center for Scientific Review (CSR) Web site: cms.csr.nih.gov Theoretical model(s) Essential in intervention-level studies If no model, explain why When possible, use diagrams or figures to accompany text Assume reviewer is unfamiliar with the chosen theory Critical components of theory should be reflected in identified variables, assessment tools, and statistical analyses

Outline Cont d Hypotheses and specific aims Rarely more than 3 overall hypotheses, with 2 3 aims Operationalize definitions State null and alternative hypotheses (directional) Implications if hypotheses are/are not supported Research design Describe design (e.g., 3-group, cross-sectional, nested, cross-over)

Outline Cont d Methods Setting Subject selection Power analysis for each aim Numerators/Denominators describe population Describe who, when, where, why of recruitment Attrition procedures to minimize dropouts Procedures for recruiting hard-to-reach populations Measures Reliability and validity, population norms Rationale for use

Outline Cont d Potential results Implications for public health, health care system, community, individuals, and their families Describe how proposed research, if successful, will lead to future funding applications Limitations of study Describe limitations and how they will be addressed Budget and, if appropriate, cost-effectiveness analysis Strengths of study Describe Dissemination of results, if appropriate (how? whom?) Oral presentations at professional conferences, posters Peer-review journals Provide opportunities to obtain results in lay language

Outline: Abstract (Re)Write after completing the body of the proposal Most-often-read section of grant application Summary of the proposal 2 4 sentences background 1 2 sentences rationale 2 3 sentences aims/objectives 1 sentence theoretical approach 5 7 sentences methods 1 2 sentences implications for anticipated results and contribution to science

Outline: Budget and Justification Justify effort and expertise for all personnel New: NIH Policy on Multiple Principle Investigators grants1.nih.gov/grants/multi_pi/index.htm New PI should be at > 20% effort Do not use to be announced for key personnel Justify equipment and supply requests Consultants from other institutions are less expensive than co-investigators Anticipate salary/operating increases for future years Include 1 2 trips for conference presentations Tip: Use of existing and shared resources is valued.

Outline: Submission Timeline Submission dates for investigator-initiated applications (R01, etc.): October 1, February 1, June 1 R03 (Small Grants): December 20, April 20, August 20 (Program Announcements that are PARs may have different submission deadlines.) Small Business Grants: April 1, August 1, December 1 Study Section review 3 4 months after submission: February March, June July, October November Advisory Council about 2 months after review: May June, September October, January February Earliest possible award ~10 months from submission date (NIH is pilot testing shortening this period.)

Scores and Funding Implications Priority Scoring (significant merit) 1.0 (highest merit) to 5.0 (lowest merit) generally not scored if below a 2.5 Not Scored Lower half or more of applications reviewed Requires unanimous consent Does not mean no scientific merit; can resubmit Percentile Ranking Scores are converted to percentile rankings based on the scores assigned by the Study Section (improves comparability) Funding Established by NCI Executive Committee for each Fiscal Year Based on budget appropriations Dependent upon previous funding commitments, availability of funds, new scientific opportunities, new initiatives, program priorities, congressional mandates, and other needs

Submission Cont d Electronic submission process and application form SF424 (R&R) grants.nih.gov/grants/forms.htm Cover letter Request Institute/Center Assignment and Review Group if you have a preference Check for conflict of interest with reviewers Resubmission: 1 page allowed to respond to reviewers comments

Types of Research Training Opportunities U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health

Research Training/Career Development Opportunities Postdoctoral training and fellowships Extramural (outside NCI), as well as Intramural (at NCI) K Awards: Career Development NCI Comprehensive Minority Biomedical Branch Non-NCI Training/Career Awards NCI s central training Web page: Access cancer.gov and search training

NCI Training and Career Development Guiding principles: Portability Protected time Continuity (mentored to independent) Selected emphases

Training/Career Development Grants How to know which grant mechanism is for you Access NIH Training Opportunities Web site: grants1.nih.gov/training Use the NIH Career Award Wizard: grants1.nih.gov/training/kwizard/index.htm Contact NCI Training Branch: (301) 496-8580, or e-mail Carl Oberholtzer, M.D., Ph.D.: oberholtzerc@mail.nih.gov See NCI training Web page: cancer.gov and search training

Training Grants K Awards Career Development Awards K07: Cancer Prevention, Control, Behavioral, and Population Sciences Career Development Award K22: NCI Transition Career Development Award K23: Mentored Patient-Oriented Research Career Development Award K24: Mid-Career Investigator Award in Patient- Oriented Research K99/R00: NIH Pathway to Independence Award

New K Award! NIH Pathway to Independence Award (K99/R00): < 5 years, with two phases Phase 1: mentored support, 1 2 years Phase 2: independent support, 3 years; contingent on securing independent research position Web site: grants.nih.gov/grants/new_investigators

Training Opportunities for Minority Scientists NCI Comprehensive Minority Biomedical Branch (CMBB) Minority supplements to grants NCI training programs NIH National Institute of General Medicine NIH Minority Access to Research Careers Program NIH Office of Minority Health and Research CMBB Web site: minorityopportunities.nci.nih.gov

NCI Cancer Training Branch Staff Branch Chief..Carl Oberholtzer, M.D., Ph.D. oberholtzerc@mail.nih.gov Cancer prevention, control,.. Lester Gorelic, Ph.D. behavioral, and population gorelicl@mail.nih.gov sciences (CPCBPS); and clinical, basic, and cancer education CPCBPS and clinical science.. Dorkina Myrick, M.D., Ph.D. myrickd@mail.nih.gov CPCBPS and basic science.. David Eckstein, Ph.D. eckstein@mail.nih.gov CPCBPS and basic science.. Nancy Lohrey, M.D. lohreyn@mail.nih.gov

Helpful Web Sites NIH Grants and Funding Opportunities grants2.nih.gov/grants/index.cfm NIH Guide for Grants and Contracts (subscription option) grants2.nih.gov/grants/guide New Investigators Program (including Pathway to Independence Award) grants2.nih.gov/grants/new_investigators Center for Scientific Review cms.csr.nih.gov

Helpful Web Sites Cont d NIH Cont d Electronic submission of Grant Applications (and access to The Commons site) (subscription option to newsletter) era.nih.gov/electronicreceipt/ Regional Seminars on Grant Funding and Administration (2 yearly) grants2.nih.gov/grants/seminars.htm HHS Office of Human Research Protections www.hhs.gov/ohrp Single Access to Federal Grant Programs Grants.gov

Helpful Web Sites Cont d Training NIH At NIH: www.training.nih.gov Extramural (External): grants.nih.gov/training/extramural.htm NCI (in-house and external) www.cancer.gov/researchandfunding/training NCI Comprehensive Minority Biomedical Branch minorityopportunities.nci.nih.gov

Helpful Web Sites Cont d NCI Planning documents: Strategic Plan, Plan and Budget Priorities (bypass budget), site-specific Progress Review Reports planning.cancer.gov Cancer Trends Progress Report: Update 2007 progressreport.cancer.gov Everything You Wanted to Know About the NCI Grants Process But Were Afraid to Ask www3.cancer.gov/admin/gab Cancer Control PLANET (state cancer profiles, tested interventions, partners, and more) cancercontrolplanet.cancer.gov

Helpful Web Sites Cont d Division of Cancer Control and Population Sciences (DCCPS) cancercontrol.cancer.gov DCCPS Funding Opportunities cancercontrol.cancer.gov/funding Step-By-Step Grant Help cancercontrol.cancer.gov/grant_help Surveillance, Epidemiology, and End Results (SEER) Program (cancer statistics, statistical tools) seer.cancer.gov Other potential government and private funding sources www.cancer.gov/researchandfunding/organizations

Helpful Web Sites Cont d President s Cancer Panel Annual Report 2006-2007 http://deainfo.nci.nih.gov/advisory/pcp/pcp07rpt/pcp07rpt.pdf Trust for America's Health Obesity Report 2007: F as in Fat. http://www.healthyamericans.org