National Institutes of Health http://www.nih.gov/icd/ Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering Largest SBIR/STTR set-asides
for Grants NIH GUIDE and Contracts U.S. Department of Health and Human Services Announces NIH Scientific Initiatives Provides NIH Policy and Administrative Information Available on the NIH Web Site : http://www.nih.gov
NIH GRANT MECHANISMS TYPE CODE YEARS Regular research grant R01 3-5 MERIT award R37 8-10 Program project grant P01 3-5 Conference grant R13 1-5 Small grant R03 2 Exploratory/developmental grant R21 2 Phased Innovation award R21/33 2/2-3 SBIR grant R/U43/44 0.5/2 STTR grant R/U41/42 1/2
NIH Opportunities for Young Investigators National Research Service Individual Fellowship (F32) Howard Temin Bridging Award (K01) Clinical Oncology Research Career Development Award (K12) Transition Career Development Award (K22) Mentored Patient-Oriented Research Career Development Award (K23) Small Grant (R03) Academic Research Enhancement Award (R15) Exploratory/Developmental Grant (R21)
Cycle 1---- Cycle 2---- Cycle 3---- Typical Timeline for a New Individual Research Project Grant Application (R01) There are three overlapping cycles per year: Submit in February (June, October) Review in June (October, February) Council in September (January, May) Earliest award in December (April, July)
Applications Submitted to NIH Approximately 80,000 grant applications are submitted to NIH each year, of which 25-30% are funded Competing grant applications are received for three review cycles per year
Review Process for a Research Grant National Institutes of Health Research Grant Application Initiates Research Idea Conducts Research School or Other Research Center Submits Application Allocates Funds Center for Scientific Review Assigns to IRG/Study Section & IC Study Section Evaluates for Scientific Merit Institute Evaluates for Program Relevance Advisory Councils and Boards Recommends Action Institute Director Takes final action for NIH Director
Types of Scientific Review Groups Where are Applications Reviewed? GROUPS CSR IRGs Study Sections Special Emphasis Panels INSTITUTES Scientific Review Groups Contract Review Committees APPLICATIONS REVIEWED Research Projects Academic Research Enhancement Awards Postdoctoral Fellowships Small Business Innovation Research Shared Instrumentation Program Projects Centers Institutional Training Grants Conference Grants Career Awards Small Grants RFAs Contracts
Role of Scientific Review Administrator Performs administrative and technical review of applications Selects reviewers Manages study sections Prepares summary statements Determines acceptance of supplemental materials for review
Role of Program Director Advise Applicants: Application Process New or Revised Grant Applications Make Funding Recommendations Competing and Non-Competing Grants Attend Study Section Meetings Initiate or Encourage Interest in a Scientific Area of High Priority to the NCI through: Program Announcements, Request for Applications, Grant Exceptions, Workshops
Who Do You Contact & When? Program Review Pre-Application + + Review - + Post-Review + - Award + - Renewal + +
Pre-application Advice Be Familiar with the Peer Review System Be Proactive and Well-Prepared Before Submission = Better Application & As Good a Score as Possible the First Time Talking to SRA & Program Director Talking to mentors/colleagues
PROACTIVE APPROACH Discuss Ideas Before Writing Get Feedback As You Write the Application Suggest Study Section(s) Suggest Institute Assignment Submission of supplemental material to the Scientific Review Administrator
Proactive Approach - Why? Are there Advantages? Less # of Revisions = less downtime AER = Accelerated Executive Review Only Unamended R01 Applications Eligibility differs between basic and POR applications Exception funding to the payline Private Foundations New Investigators Minority Investigators
Useful booklet Everything you wanted to know about the NCI Grants Process. but were afraid to ask. (NIH Publication No. 02-1222, Revised April 2002) http://www3.cancer.gov/admin/gab /index.htm
Problem Areas in Clinical Research Grant Applications Lacks a testable hypothesis Unfocused specific aims Poor prioritization of specific aims Lack of milestones and time tables Lack of critical assessment including alternative plans Lack of sufficient preliminary data Poor selection and documentation of study population
Problem Areas in Clinical Research Grant Applications Unclear relationship between laboratory and clinical studies Statistical power deficiencies Clinical trial itself Laboratory correlative studies Poor presentation style and proof reading Failure to follow PHS 398 instructions
APPLICATIONS RECEIVED BY FISCAL YEAR 90,000 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10,000 0 1998 1999 2000 2001 2002 2003 2004* # Appl. * projected
NCI BUDGET PICTURE for 2004 FY 2003 Budget $4,592,000,000 Omnibus Bill Budget 04 $4,771,000,000 Difference = 3.9% increase $ 178,000,000 Less 2 set-asides, new money= $ 150,000,000 Less non-competing commitments $ 37,000,000 (i.e. ~ 1.5% increase in RPG funds)
Set- aside Initiatives NIH Roadmap - ~ $1000 M over 5 yrs cabig - ~ $100 M over 3 yrs CTWG - $113 M over 5 yrs Proteomics - $ 104 M over 5 yrs
Program Announcement (PA) Invites grant applications in a given research area May describe new or expanded interest in a particular extramural program May be a reminder of a continuing interest in a particular extramural program Generally has no funds set aside Applications reviewed in CSR along with unsolicited grant applications
Requests for Applications (RFA) Announcement describing an institute initiative in a well-defined scientific area Invitation to the field to submit research grant applications for a one-time competition Set-aside of funds for a certain number of awards Applications generally reviewed within the issuing institute
Exploratory/Developmental Grants (R21) UTILIZED FOR PILOT OR FEASIBILITY STUDIES TO SUPPORT NOVEL, HIGH RISK/HIGH PAYOFF RESEARCH MINIMAL PRELIMINARY DATA REQUIRED SHORT TERM RESEARCH PROJECTS (UP TO TWO YEARS) LIMITED FUNDS (100,000 250,000 DIRECT COSTS) NON-RENEWABLE BUT INITIATIVE MAY INCLUDE OPTION OF SUPPORT THROUGH R33 MECHANISM
Program Announcements for Exploratory Grants (R21) PAR 00-047 QUICK TRIALS for Novel Cancer Therapies PA 03-003 Exploratory Studies in Cancer Detection, Diagnosis and Prognosis PA 03-064 Correlative Studies Using Specimens from Multi-institutional Prevention and Treatment Trials PA 04-045 In Vivo Cancer Imaging PAR 03-124 Development of Novel Technologies for In Vivo Imaging (R21/33)
QUICK-TRIALS for Novel Cancer Therapies PAR-03-005 Provides support for clinical trials and associated patient monitoring and laboratory studies using R21 exploratory/developmental grant mechanism Maximum of $250,000 direct costs per year for two years Three receipt dates per year with rapid review and funding (six months) Clinical protocol included as part of the grant application
Small Grants Program (R03) SUPPORTS PRELIMINARY SHORT TERM STUDIES TO TEST NEW IDEAS FUNDS LIMITED TO $50,000 DIRECT COSTS SHORT TERM RESEARCH PROJECTS (UP TO TWO YEARS) TIME INTERVAL FROM APPLICATION TO FUNDING IS SHORTENED INSTITUTE REVIEW COMMITTEE NON-RENEWABLE GRANTS
Numerous established and new NCI initiatives and programs support interdisciplinary teams. Academic Public-Private Partnership Programs, cancer Biomedical Informatics Grid and consortium (cabig) new Centers for Cancer Nanotechnology Excellence, new Clinical Proteomics and Biomarker Discovery Program, Clinical Trials Cooperative Group Program, Early Detection Research Network, In Vivo Cellular and Molecular Imaging Centers, Integrative Cancer Biology Programs, Network for Translational Research Optical Imaging, Interdisciplinary Research Teams for Molecular Target Assessment,
RRP / Medical Physics Technology Development Workshops Monte Carlo ( with DOE ) Optimization (with NSF) Image guided RT (with CIP) New Investigator WS ( with NIBIB) Cooperative efforts Web-based tools (NSF) Meetings with vendors (Varian, Siemens --) Research programs
FDA reform plans
Why Imaging? validated image data could lead to: Smaller clinical trials with fewer patients Earlier go - no go decisions on compounds Faster regulatory approval Shorter time to market
http://www.aecom.yu.edu/ogs/nihinfo/paylines.htm
HUMAN SUBJECTS?? obtaining identifiable private information or identifiable specimens for research purposes constitutes human subjects research. EXEMPTION??? Exemption 4: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects CALL YOUR Program Director!!!
Small Business Programs SBIR: Set-aside Program for Small Business Concerns to engage in Federal R&D-- with potential for commercialization. STTR: Set-aside Program to facilitate cooperative R&D between Small Business Concerns and U.S. Research Institutions-- with potential for commercialization.
SBIR / STTR Participating Agencies TOTAL ~ $2.0 + B FY 2004 υ DOD SBIR/STTR υ HHS SBIR/STTR υ NASA SBIR/STTR υ DOE SBIR/STTR υ NSF SBIR/STTR υ DHS SBIR υ USDA SBIR υ DOC SBIR υ ED SBIR υ EPA SBIR υ DOT SBIR υ HUD New New
SBIR/STTR: 3-Phase 3 Program PHASE I Feasibility Study PHASE II $100K and 6-month (SBIR) or 12-month (STTR) Award Full Research/R&D $750K and 2-year Award PHASE III (SBIR/STTR) Commercialization Stage Use of non-sbir/sttr Funds
SBIR PROGRAM ELIGIBILITY CHECKPOINTS Organized for- profit U.S. business At least 51% U.S.- owned by individuals and independently operated Small Business located in the U.S. 500 or fewer employees P.I. s primary employment with small business during project
STTR PROGRAM ELIGIBILITY CHECKPOINTS Applicant is Small Business Concern Formal Cooperative R&D Effort Minimum 40% by small business Minimum 30% by U.S. research institution U.S. Research Institution College or University; other non-profit research organization; Federal R&D center Intellectual Property Agreement Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization
SBIR AND STTR PROGRAMS υ CRITICAL DIFFERENCES Research Partner SBIR: Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Requires research institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)] AWARD ALWAYS MADE TO SMALL BUSINESS
SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES υ Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated [PI can be from research institution and/or from small business concern*] *DISCUSS WITH AGENCIES
NIH SBIR/STTR FUNDING RATES FISCAL YEAR 2003 Success Rate (%) 45 40 35 30 25 20 981 24% 327 18 44% 43% 61 95 27% 5 28% $563 M SBIR/STTR (set aside $556 Phase I Phase II 15 22% Fast-Track 10 5 0 SBIR STTR