Supporting research that is the foundation for disease diagnosis, treatment, and prevention NIH 101

Transcription

1 Supporting research that is the foundation for disease diagnosis, treatment, and prevention NIH 101 Miles A. Fabian, Ph.D. Program Director National Institute of General Medical Sciences Division of Pharmacology, Physiology & Biological Chemistry

2 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

3 Mission & Budget NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. Annual Budget $30.9 Billion Fiscal Year 2012 Mgmt & Support Other Research Grants Research Centers All Other Training R&D Contracts 3% 5% 3% 6% Research Project Grants (RPG) 10% 53% 10% 11% Intramural Research

4 NIH Appropriations $40.8 $40 $35 $30 $27.1 $28.0 $28.6 $28.6 stimulus funding $10 B $29.2 $29.5 $31.1 $30.7 $30.9 Billions of Dollars $25 $20 $15 $13.7 $15.6 $17.8 $20.5 $23.3 $10 $5 $ DOUBLING Appropriation in 1998 Dollars

5 Early History of NIH President John Adams Castle Island 1797 Marine Hospital Service Established by President John Adams as an act for the relief of sick and disabled seamen Joseph James Kinyoun 1803 Marine Hospital The first permanent Marine hospital was authorized to be built in Boston, MA 1887 Laboratory of Hygiene Established by Dr. Joseph J. Kinyoun at the Marine Hospital, Staten Island, NY for research on cholera and other infectious diseases 1930 National Institute of Health Ransdell Act redesignated the Hygienic Laboratory as the National Institute of Health, authorizing $750,000 for construction of two buildings and a system for fellowships 1937 National Cancer Institute Act Congress authorized annual funding for cancer research. The National Cancer Institute (NCI) was formed in 1939 through the merger of the Office of Cancer Investigations at Harvard University and a pharmacology division at the National Institute of Health Bethesda Campus President Franklin D. Roosevelt dedicated the new NIH campus on land donated by Mr. & Mrs. Luke Wilson, Senator Ransdell (LA) th & E Streets, NW Washington 1891 Move to Washington The Hygienic Laboratory moved to the Butler Building in Washington, DC 1916 Dr. Ida Bengtson The first woman to be hired as a bacteriologist in the Hygienic Laboratory 1944 PHS Act Approved Consolidating and revising existing public health legislation, giving NIH the legislative basis for its postwar program, with general authority to conduct research. Under this act NCI became a division under NIH Research Grants Office Office of Scientific Research and Development projects transferred to the PHS to operate a program of extramural research grants and fellowship awards Dr. Bengtson NIH campus ~1947, NCI Building 6 (right) New Institutes Health organizations motivated Congress to create institutes for research on mental health, dental diseases, and heart disease. The original National Institute of Health was divided into two additional institutes.

6 27 Institutes & Centers Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse 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 of Allergy and Infectious Diseases 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 for Complementary and Alternative Medicine Fogarty International Center National Center for Advancing Research Translational Resources Sciences National Library of Medicine National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities Clinical Center Center for Information Technology Center for Scientific Review no funding authority Different Missions, Responsibilities and Constituencies

7 Institute Funding Direct responsibility for funding research and training relevant to their mission. Cancer Allergy, Infectious Heart, Lung, Blood General Medical Sciences Diabetes, Kidney Neurology Mental Health Child Health Aging Drug Abuse Eye Environmental Health 685 NCATS 575 Arthritis 535 Genome Alcohol Abuse Deafness Dental Library Bio Imaging Minority Health Nursing Comp. Med. Buildings & Facilities Fogarty International ,103 1,059 1,480 Office of the Director 1,459 1,321 1,626 1,797 2,430 3,079 4,490 $0 $1,000 $2,000 $3,000 $4,000 $5,000 (Dollars in millions) 5,072 Fiscal Year 2012 $30.9 Billion

8 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

9 Submission & Award Process University Submits Application Electronic Submission National Institutes of Health Applicant Initiates Research Idea Conducts Research FUNDING CYCLE Assign to Institute and Study Section Peer Review Allocation of Funds Take Action Institute Director Recommend Action Leaders in the biological and medical sciences, education, health care, and public affairs. Advisory Council Evaluate Relevance Institute (24 with funding authority) 1 st NIH Study Section 1946 Review of Scientific Merit

10 Receipt, Review & Award Cycles 3 Overlapping Funding Cycles Per Year Cycle Receipt Dates Review Meetings Advisory Council Potential Start Date 1 Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec 2 May June July Aug Sept Oct Nov Dec Jan Feb Mar Apr 3 Sept Oct Nov Dec Jan Feb Mar Apr May June July Aug

11 R Mechanism Research Awards R01 R03 R13 R15 R21 R41/R42 R43/R44 Research Project Grant Primary funding mechanism for investigator initiated research Up to 5 years and $500K per year (prior required approval for projects greater than $500K). Small Research Grant Project Up to 2 years and $50K per year Not all ICs support this mechanism Support for Conferences and Scientific Meetings Academic Research Enhancement Award (AREA) Small-scale health-related research projects at eligible domestic institutions Up to 3 years and $300K total direct costs Exploratory Development Research Grant Foster the introduction of novel scientific ideas, model systems, tools, agents, targets and technologies Break new ground or extend previous discoveries toward new directions or applications Up to 2 years and $275K total direct costs Small Business Technology Transfer Grant (STTR) Small Business Innovation Research Grant (SBIR)

12 High Risk Research Pioneer Award support individual scientists of exceptional creativity who propose pioneering approaches to major challenges in many areas of science from neuroscience to chemistry to behavioral science Highly competitive $500,000 direct costs for five years NIHRoadmap.nih.gov/pioneer Transformative R01 Support exceptionally innovative, high risk, original and/or unconventional research projects Create new or challenge existing paradigms Budgets commensurate with project Up to $25 million (total costs) in FY2011 Great projects outside the box NIHRoadmap.nih.gov/T-R01

13 Applicants, Awardees, & Success Rate R01 Grants

14 Average Award Size R01 Grant

15 R01 Awards by NIH Institute 1200 NCCAM NCI Number of R01 Awards NIGMS NCRR NEI NHGRI NHLBI NIA NIAAA NIAID NIAMS NIBIB NICHD NIDA NIDCD NIDCR 200 NIDDK NIEHS NIGMS Fiscal Year NIMH NIMHD NINDS

16 New Investigators A principle investigator who has not previously competed successfully for a significant NIH independent research award. Commitment to New Investigators Over the past three years about ~25% of all R01 awards have gone to new investigators. Institutes maintain success rates for new investigators - better paylines Longer award length Separate clustering during review Designations Early Stage Investigator (ESI): Within 10 years of receiving terminal degree New Investigator (NI): No record of significant independent support Average age of first R01 award Success Rate by Career Stage

17 Mechanisms of Interest to New Investigators K awards (K01, K08, K22, K23, K25) Pathway to Independence Award (K99/R00) Assist transition to independent research position 1-2 years mentored support (K99, $90K/yr) Up to 3 years of independent research support (R00, up to $249K/yr) Small grant (R03) Exploratory/developmental grant (R21) Academic Research Enhancement Award (R15) NIH Director s New Innovator Award (DP2, $1.5M/5 years) Exceptionally innovative research with potential for significant impact Open to new investigators within 10 years of terminal degree Preliminary data optional Research project grant (R01)

18 R01 Applications & Success Rates New Investigators 1,400 Reviewed Awarded 18% Success Rate 1,200 Applications and Awards 1, % 22% 19% 15% 21% 17% 16% 17% 18% % 17% 11% 21% 28% 25% 25% 22% 14% 28% 33% 10% 19% 0 NCI NHLBI NIGMS NIAID NIDDK NINDS NIMH NICHD NIA NIDA NIAMS NIBIB NIEHS NEI NIDCD NIDCR NIAAA NINR NLM FIC NHGRI NCCAM NCRR Institute or Center

19 Eligibility New Innovator Award Early Stage Investigator (ESI) No citizenship or residency required Early Independence Award Pioneer Award Transformative R01 PhD or MD within 12 months of application No citizenship or residency required All career stages No citizenship or residency required All career stages No citizenship or residency required Institution Only US Only US Max 2 appl/inst. Only US Foreign Institutions eligible Goal ESI with uncommonly high potential impact research Outstanding junior scientists on fast track for independent career Individuals proposing paradigm shifting research Individuals or teams proposing transformative research with large budget Budget and duration Reference letters $300,000/year up to 5 years $250,000/year up to 5 years $500,000/year up to 5 years No limits but budget over $500,000/year Requires prior approval None 3-5 letters 3 letters none Review Mail reviewers, review panel Mail reviewers, review panel, interview of finalists Mail reviewers, review panel Interview of finalists Mail reviewers, review panel RFA or PA 2012 RFA will be issued shortly, October 2011 subm 2012 RFA? 2012 RFA coming soon, possible Oct submission 2012 RFA?

20 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

21 Everything is here, but you may still want to try grants.nih.gov/grants/oer.htm

22 NIH Guide for Grants & Contracts Official notification of NIH policies, notices and availability of funds grants.nih.gov/grants/oer.htm Contains all Funding Opportunities (PAs/RFAS) for new or ongoing interest from one or more Institutes in supporting research, training or resources. Sign up to receive weekly NIH Guide updates Program Announcement (PA) Addresses a broad category of research No set-aside budget Submit on regular receipt dates Regular review criteria for mechanism of application Request for Applications (RFA) Addresses a well defined area of research Set-aside budget Submit on special, one-time receipt date Often special eligibility and/or review criteria Often special application format and/or submission instructions

23 Use Parent Announcements NIH is committed to investigator-initiated research and we want your unsolicited applications! Since all applications now must be submitted in response to a Funding Opportunity Announcement (FOA) we ve created Parent FOAs Apply using the Parent electronic application package for your chosen mechanism Parent FOAs Research (R) R01, R03, R13, R15, R21, R41, R42, R43, R44 grants.nih.gov/grants/oer.htm Training (T) T32, T35 Career Development (K) K01, K02, K07, K08, K23, K24, K25, K99 Career Development (F) F30, F31, F32, F33

24 Funding Announcements All the details are here! Participating Organizations Title Announcement Type Program Announcement Number Link to Apply Electronically Key Dates Summary / Overview Specifics Objectives Award Information Eligibility Application / Submission Review Information Award Administration Agency Contacts

25 Download Forms at grants.gov

26 Funding Opportunity Announcements What shall you look for? FOA = funding opportunity announcements Two types of FOA: PA = program announcement RFA = request for application RFA Funds set aside for projects? Yes Usually not (PAS) Special submission deadlines? Yes Usually not How long active? Until deadline PA 3 years Special review panel? Often Usually not Science? Usually more general than RFA

27 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

28 Preparing Your Application There is no amount of Grantsmanship that will turn a bad idea into a good one.... But there are many ways to disguise a good idea. Dr. William Raub Past Deputy Director, NIH

29 Choosing a Research Project What makes a research project outstanding? Addresses an important problem clearly Potential to lead to seminal new observations or new ways of thinking Lays the foundation for further research in the field Addresses a difficult problem in a way that seems simple in retrospect. Makes reviewers wonder why they didn t think of the idea themselves All aspects of the project are clearly linked

30 What gets funded Key Features of Successful Applications Hypothesis A meaningful hypothesis AND a means of testing it A sound rationale for the hypothesis Preliminary Data Documents feasibility of the proposed project Shows training for research proposed and ability to interpret results Include alternative interpretations and address limitations of methods Well Organized Research Plan Aims focused (relate to each other and the hypothesis) Rationale for methods proposed, with alternatives Research flow and priorities clearly indicated Sufficient experimental detail to show you understand methods Emphasize MECHANISM (avoid descriptive data gathering )

31 What s Your Strategy Preparing to Write a Grant Application Critically assess yourself Do you have the necessary expertise, resources, personnel and preliminary data to be competitive? Assess the competition Who are the important contributors to the field? What have they accomplished? Search the literature and the NIH RePORTER database of funded grants in the field Assess the potential for your idea Remember they might be your reviewers! What has already been done, reported and funded in your area? What are the gaps? How can you take it a step farther?

32 Expenditures and Results of NIH-Funded Research projectreporter.nih.gov Search Many New Categories Over 200 disease categories Keywords RFA/PA Investigator Organization Funding mechanism Recovery Act Location RePORTER Study Section

33 Shorter Page Limits Convey Impact in Less Detail and Space! Focus on strategy Rather than detailing all your experiments, describe your strategy Detail experiments that highlight your work Rather than detailing all your experiments, describe your strategy Limit your aims ~1 aim per year funding Know when detail is needed Preliminary to show you re on the right track. New or unique methods Know details to skip Published methods If you ve used a method before, point it out, cite and skip the description new page limits

34 Consider the Review Criteria Overall Impact Significance Investigators Innovation Approach Environment Is this project likely to exert a sustained, powerful influence on the research field(s) involved based on consideration of the review criteria? Does this study address an important problem or barrier to success in the field? How will scientific knowledge, technical capability or clinical practice be improved? Are the PIs, collaborators and other researchers well suited to the project? If ESIs or NIs, do they have appropriate experience and training? If established, do they have an ongoing record of accomplishments? Does the application challenge and seek to shift current paradigms? Are the concepts, approaches, or instrumentation novel or applied in new ways? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims? Are potential problems, alternative strategies, and benchmarks presented? Will feasibility be established and will risky aspects be managed? Will the scientific environment contribute to the probability of success? Are the institutional support and physical resources adequate? Will the project benefit from unique features (e.g. subject populations, collaborations)?

35 Know Your Audience Two audiences of reviewers: - a small number familiar with your techniques or field - the majority who have more general expertise Reviewers are Informed strangers Inherently skeptical and critical Extremely busy Make their job easier Write a well organized, clear and concise application Guide reviewers with graphics - flow diagrams, charts, figures and clear timelines Demonstrate enthusiasm with strong active verbs Sell your application - show why NIH should fund your application Avoid things that irritate Exceeding page limits, small margins, and/or font too small Information in the wrong section Omitting or mislabeling references/figures Spelling, grammar, math errors

36 Know Your Audience

37 Write, Edit, and Proof Like a Pro Reviewers Appreciate a Highly Readable Application Start with an outline Write a topic sentence for each main point A topic sentence is usually the first one in the paragraph and is supported by more information in the next few sentences. Make only one point in each paragraph, stating it clearly as a topic sentence This is key for your reviewers to be able to read or scan your application. Keep it short and simple: Keep paragraphs short. Start with basic ideas and progress to more complex ones. State key points as non-technically as possible. Use short sentences with a basic structure: subject, verb, and object. Break up long, involved sentences; avoid introductory phrases longer than six words. Keep sentences to 20 or words or less. Include transitions At the beginning of a new paragraph or concept, add a transition to your next point by relating it to your previous one. Use statements such as "furthermore," "additionally," "in another area," "in contrast," and "following the same path," to show a relationship between ideas. Keep related ideas and information together, e.g., put clauses and phrases as close as possible to -- preferably right after -- the words they modify. Use strong, active verbs -- they are the workhorses of effective sentences. For example, write "We will develop a cell line," not "A cell line will be developed." Use verbs instead of abstract nouns: Turn dull abstract nouns ending in "ion" and "ment" into verbs. For example, say "creating the assay leads to..." rather than "the creation of the assay leads to..." If writing is not your forte, get help.

38 Common Problems Cited by Peer Reviewers Problem not important enough. Study not likely to produce useful information. Studies based on a shaky hypothesis or data. Alternative hypotheses not considered. Methods unsuited to the objective. Problem more complex than investigator appears to realize. Not significant to health-related research. Too little detail in the Research Plan to convince reviewers the investigator knows what he or she is doing, i.e., no recognition of potential problems and pitfalls. Topic scientifically premature. Over-ambitious Research Plan with an unrealistically large amount of work. Direction or sense of priority not clearly defined, i.e., experiments do not follow one another and lack a clear starting or finishing point. Lack of focus in hypotheses, Specific Aims, or Research Plan. Lack of original or new ideas. Investigator too inexperienced with the proposed techniques. Proposed project a fishing expedition lacking solid scientific basis, i.e., no basic scientific question being addressed. Proposal driven by technology, i.e., a method in search of a problem. Rationale for experiments not provided, i.e., why they are important or how they are relevant to the hypothesis. Experiments too dependent on success of an initial proposed experiment. Lack of alternative methods in case the primary approach does not work out. Proposed model system not appropriate to address the proposed questions. Relevant controls not included. Proposal lacking enough preliminary data, or preliminary data do not support project's feasibility. Insufficient consideration of statistical needs. Not clear which data were obtained by the investigator and which were reported by others.

39 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

40 Grant Writing Resources Manuals & Books The Grant Application Writer s Workbook available at GrantCentral.com Writing the NIH Grant Proposal: A Step-by Step Guide by William Gerin Grant Application Writers Handbook (4 th Ed) by Liane Reif-Lehrer Guide to Effective Grant Writing: How to Write a Successful NIH Grant Application by Otto O. Yang How to Succeed in Academics by Edward R. B. McCabe and Linda McCabe

41 Grant Writing Resources NIH Central Resource Site grants.nih.gov/grants/grant_tips.htm New Investigators NIGMS NCI NIAID NINDS NIH Websites grants.nih.gov/grants/new_investigators/ deainfo.nci.nih.gov/extra/extdocs/gntapp.htm NIMH

42 NIAID New Investigator Website

43 NIGMS Feedback Loop NIGMS Newsletter Now Interactive Website (blog) loop.nigms.nih.gov Get NIGMS news as it happens! Updates on funding opportunities Regularly updated Post your comments Ask questions Sign up for updates or RSS feed

44 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

45 era Commons Where the NIH exchanges electronic information Study Section and Institute Assignments Priority Score Summary Statement Notice of Grant Award View errors/warnings associated with electronic submissions View assembled applications 2 day window Individual accounts through your Office of Sponsored Research Only place to access this information!

46 Submitting Your Application Make sure your application is complete and correct as submitted! Start early: Register for both Grants.gov and era Commons Read the instructions thoroughly and follow them carefully Get feedback from a senior investigator with review experience prior to submission Poor grammar, missing information, confused figure legends, etc will be very apparent to reviewers NIH receives over 76,000 applications annually, pages can NOT be changed after submission is complete Contact the Scientific Review Officer (SRO) if you need to send corrected information after submission

47 Multiple PI, Collaborators & Consultants Multiple Primary Investigators (PI) Each PI must have a leadership role and responsibility for their projects Application should state which PIs are responsible for which aims One PI serves a contact PI, coordinating communication between all PIs and NIH ESI status only if all PIs are new investigators Leadership plan must be included with application Collaborators Always play an active role in the research Do not get a fee, but may get part of their salary through a subaward Always include a letter of collaboration with application Consultants Usually provide advice or services May participate significantly in the research, typically fill in smaller gaps No salary, may receive a fee Recommend including a letter of support with application

48 Cover Letter What to include... your title grant mechanism FOA title & number main scientific discipline institutes which may have an interest in your research topic appropriate study sections program director you ve discussed your application list of scientific areas that are important for understanding the application primarily for multidisciplinary applications Example What not to include... potential reviewers anything you re not certain!!! CSR is excellent at assigning an appropriate study section and institute. Not making a suggestion may be the best alternative.

49 Institute & Study Panel Assignment After Submission Is it possible to change the Institute and/or Study Panel assignment? When? How? YES. BEFORE the review of the application (after it is almost impossible) Contact the Scientific Review Officer (SRO) of the assigned study section and provide in writing a justification for the desired change If my application has a secondary Institute assignment, does the secondary Institute consider automatically my application if the primary Institute does not fund it? NO. Contact the Program Officer at the secondary Institute if you want your application considered.

50 Application Number 2 R01 GM A1 type mechanism institute serial year suffix Application Type 1 - New 2 - Competing Continuation 5 - Noncompeting Continuation Mechanism R01, R03, R15, K01, F32, etc... Institute GM (NIGMS), CA (NCI), etc... Serial Number Sequential numbering of applications submitted to particular Institute Support Year All new applications start at -01 Suffix additional identifier A1 - amended application S1 - supplement

51 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

52 What Happens After Submission? Center for Scientific Review (CSR) Central receipt point for all applications for the NIH Assigns applications NIH Institute/Center as potential funding component Manages ~200 Scientific Review Groups ( Study Sections ) 76,000 applications received, 52,000 reviewed, 2000 meetings Institutes share interest areas, so multiple assignments possible

53 What CSR does... Division of Receipt and Referral Review cover letter Review past history (if any) of application/applicant Identify research area Where it gets reviewed CSR Study Sections Research project grants (R01, R03, R21) Small business innovation research Pre- and Postdoctoral Fellowship (F) applications Institute Review Offices Career development (K series) and Training Complex and special types of grants Multi-site clinical trials Responses to RFAs, specialized PAs, and RFPs Other mission-targeted applications

54 Review Process Scientific Review Officer (SRO) assigns your application to 3 primary reviewers Reviewers submit preliminary scores (1-9) with comments through era Commons SRO determines Review Order Best scoring application first New investigators (best-to-worst) Everyone else (best-to-worst) Application by application discussion Persons with conflicts of interest excused Primary reviewers (3) give preliminary scores (1-9) Discussion of application s scientific and technical merit Other panel members join discussion Primary reviewers give final scores (1-9) All panel members (except those in conflict) score privately Assignment of codes for animals and human subjects protection Budget recommendations. About 50% applications will be discussed, remainder triaged (ND, not discussed)

55 Scoring Assigned to each criterion score then a score given for overall impact All impact scores averaged and multiplied by 10 to get final impact score

56 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

57 Feedback from Review Priority Score & Percentile era Commons 1-2 days after meeting Impact/Priority score is average reviewer score (1-9) times ten (10-90) Percentile: relative ranking of application with last 3 meetings of study panel Not all application get percentiled Summary Statement era Commons SRO prepares and releases 4-6 weeks after meeting Summary of discussion written by SRO Criteria scores from assigned reviewers Critiques from assigned reviewers Budget recommendations Administrative notes Codes for Animal Vertebrates and Human Subjects Assigned Program Officer Typically present at review meeting Interpret comments Advice on resubmission

58 So You ve Been Unscored... Most Common Reasons for Unscored or Not Recommended for Further Considerations Rationale for hypothesis or methods not sound or not supported by preliminary data Unfocused or superficial research plan Aims do NOT address hypothesis Flaws in experimental approaches Models not relevant to human situation Unrealistically large amount of work proposed Work not new or original (lack of appreciation of published relevant work) Lack of experience in essential methods Insufficient experimental detail Serious risks to human subjects or use of animals

59 Resubmission & Advice Only ONE resubmission allowed! Do not waste it by rushing! NIH allows a shorten review cycle for New Investigator R01 Applications: Submission Review Council A0 June 5 th October January Normal A1 March 5 th June October Shorten A1 December 10 th February May NOT RECOMMENDED You have 37 months from the A0 application date to resubmit. Any applications submitted after the 37 month will be considered a new application.

60 Resubmission? Deciding whether and when to resubmit: Only one resubmission allowed! Digest your summary statement Talk with your program officer

61 What is a New Application? New vs. A2 identification Examples of Changes that Are Substantial Using significantly different model systems Using a similar methodological approach for a substantially different question Asking a significantly different question Using a very different methodological approach to address a similar issue Examples of Changes that Are Not Substantial Rewording large sections of the application while retaining the scientific goals and objectives Adding one or more new collaborator(s) Changing the Principal Investigator Changing the application in response to the previous reviewers critiques Deleting parts of the Approach such that the subsequent application is merely a subset of the old one or a concurrent submission What if my new application is withdrawn by CSR before review as a like A2? You may appeal in writing the CSR decision by replying to the Division of Receipt and Referral officer mentioned in the withdrawal notice. Your appeal should be approved by your Authorized Organization Representative. Before acting on it you might want to discuss with your program officer.

62 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

63 Funding Decision What factors determine funding? Availability of Funds Most of budget already committed to continuing grants and programs A flat NIH budget means tighter paylines Scientific Merit Percentile ranking (priority score) Each Institute sets its own paylines Paylines vary for different types of grants More liberal payline for New Investigators (R01 applications) Programmatic Considerations A balance of models, geographic sites, approaches, etc in portfolio

64 NIGMS Funding Practices NIGMS does not use a rigid payline! Once you know one Institute, you only know one Institute Factors considered in the funding decision Percentile / Priority Score (scientific merit) New Investigator status NIGMS priorities and program balance Scientific overlap Council recommendation Other Support

65 NIH NIH Mission 2. Grant Mechanism 3. Forms & Information 4. Grantsmanship 5. Resources 6. Submission 7. Review 8. Priority Score 9. Award 10. Assistance

66 NIH Staff Scientific Review Officer (PhD/MD) CSR or Institute Staff Organizes and manages study section Liaison between applicant and reviewers Prepares summary statements Program Officer (PhD/MD) Institute Staff Manages a portfolio of awarded grants Monitors scientific progress made on grant Inform, interpret, intervene, facilitate and advise applicants and grantees Stewardship of scientific area Grants Management Officer Institute Staff Fiscal stewardship of portfolio of awarded grants Negotiates fiscal aspects of awards Monitors financial progress made on grants

67 When & Who When Pre-application Submission Receipt & Referral Review Who Colleagues, Institute Staff, CSR Staff Your Office of Sponsored Research, era Helpdesk Scientific Review and Program Officers Only Scientific Review Officer Summary Statement Advisory Council Resubmit - or not? Program Director Funding Decision Award Program Director or Grant Specialist

68 NIGMS

69 National Institute of General Medical Sciences NIGMS The general purpose of the National Institute of General Medical Sciences is the conduct and support of research, training, and as appropriate, health information dissemination, and other programs with respect to general or basic medical sciences and related natural or behavioral sciences which have significance for two or more national research institutes or are outside the general area of responsibility of any other national research institute. Director Jeremy Berg and NIGMS Staff Natcher Building

70 NIGMS Mission To support research that increases understanding of life processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. Provide leadership in training the next generation of scientists to assure the vitality and continued productivity of the research enterprise.

71 NIGMS Recent Nobel Laureates NIGMS has funded the Nobel Prize-winning work of 74 scientists. NAME Year NOBEL PRIZE OFFICIAL CITATION Ei-ichi Negishi 2010 Chemistry For palladium-catalyzed cross couplings in organic synthesis Venkatraman Ramakrishnan, Thomas A. Steitz & Ada E. Yonath 2009 Chemistry For studies of the structure and function of the ribosome Elizabeth H. Blackburn, Carol W. Greider & Jack W. Szostak 2009 Physiology or Medicine For the discovery of how chromosomes are protected by telomeres and the enzyme telomerase Osamu Shimomura, Martin Chalfie & Roger Tsien 2008 Chemistry For the discovery and development of the green fluorescent protein, GFP Mario R. Capecchi & Oliver Smithies 2007 Physiology or Medicine For the discovery of principles for introducing specific gene modifications in mice by the use of embryonic stem cells Roger D. Kornberg 2006 Chemistry For his studies of the molecular basis of eukaryotic transcription Andrew Z. Fire & Craig C. Mello 2006 Physiology or Medicine For the discovery of RNA interference gene silencing by doublestranded RNA Robert H. Grubbs & Richard R. Schrock 2005 Chemistry For the development of the metathesis method in organic synthesis Avram Hershko & Irwin Rose 2004 Chemistry For the discovery of ubiquitin-mediated protein degradation Paul C. Lauterbur 2003 Physiology or Medicine For discoveries concerning magnetic resonance imaging Roderick MacKinnon 2003 Chemistry For discoveries concerning channels in cell membranes H. Robert Horvitz 2002 Physiology or Medicine For discoveries concerning genetic regulation of organ development and programmed cell death John B. Fenn 2002 Chemistry For the development of methods for identification and structure analyses of biological macromolecules Leland H. Hartwell 2001 Physiology or Medicine For discoveries of key regulators of the cell cycle K. Barry Sharpless 2001 Chemistry For work on chirally catalyzed oxidation reactions

72 Chemistry at NIGMS Division of Pharmacology, Physiology, & Biological Chemistry Anesthesiology Biochemistry Bioenergetics Bio-organic and Bio-inorganic Chemistry Biotechnology and Metabolic Engineering Drug Absorption, Distribution, Metabolism, Excretion, and Predictive Toxicology Enzymology Glycochemistry and Glycobiology Molecular Immunobiology Pharmacogenetics/pharmacogenomics Pharmacology and Clinical Pharmacology Physiology Synthetic and Medicinal Chemistry Trauma and Burn Injury Wound Healing

73 NIGMS Mentoring Workshop for Chemistry Faculty Mentoring is more than teaching someone to be just like you! Most graduate students and postdocs receive little training in critical, nontechnical career skills. Awards Success Rate Applicants Many junior faculty lack senior faculty mentors and/or feel compelled to figure it out on their own. Junior faculty start-up packages are massive. Competition for research funding is fierce. The old sink or swim model for junior faculty development makes no sense. Everyone wins when young scientists are successful! Chemistry Mentoring Workshop for New Faculty Provide advice on key non-technical career skills Stress the value of mentoring and being mentoring Stress communication skills Introduce junior faculty to NIH procedures and NIH staff Promote networking among young scientists and with senior role models 30 Junior faculty participants in organic chemistry and chemical biology 6-8 Senior faculty mentors plus NIH staff 3 Days of discussions, presentations, and networking Must be nominated by Department Chair

74 Other NIH Support for Chemistry Various NIH Institutes & Centers Organic Synthesis & Medicinal Chemistry Diagnostic and Molecular Imaging Developmental Therapeutics Control and Prevent Disease Radiotherapy Development Microscopy of Molecules and Cells Modeling Biodefense Research Analytical Methods Instrumentation NCI Developmental Therapeutics Program (DTP) Experimental Therapeutics Program (NExT), Roadmap Molecular Libraries Program (MLP) Therapeutics for Rare and Neglected Diseases Program (TRND)

75 Internal Directions Five Themes for NIH Taking advantage of advances in high-throughput technologies to understand the fundamentals of biology and how specific diseases are activated. Emphasis of the translation of research into medicine Putting science to work for the benefit of health care reform through comparative effectiveness research, behavioral science, health information technology, health research economics and further research on health disparities Dr. Francis Collins August 7, 2009 Greater focus on global health Empowering the biomedical research community by considering future budgets, training, peer review and workforce diversity

76 Institutional Development Award (IDeA) IDeA Program established in Authorized in NIH Revitalization Act of 1993 Congressional intent to enhance geographical distribution of research funds and increase research capacity. Comparable to NSF Experimental Program to Stimulate Competitiveness in Research (EPSCoR), established in EPSCoR-like programs across 7 Federal Agencies (NIH, NSF, USDA, NASA, DOE, DOD, EPA.

77 Primary Programmatic Mechanisms of IDeA Program Centers of Biomedical Research Excellence (COBRE), began FY 2000, currently 84 centers. Biomedical Research Infrastructure Networks (BRIN), began FY Re-competed FY 2004 as IDeA Networks of Biomedical Research Excellence (INBRE), currently 23 INBRE networks For more information Dr. Fred Taylor

78 NIGMS Science Education Publications nigms.nih.gov/publications Findings Online magazine Findings, where you can discover how cutting-edge science improves health. The Chemistry of Health Describes basic chemistry and biochemistry research that spurs a better understanding of human health. Computing Life Showcases the exciting ways that scientists are using the power of computers to expand our knowledge of biology and medicine. Medicines for You Describes how genes affect the way people respond to medicines and answers questions about this field of research, known as pharmacogenetics. Medicines by Design Discusses the many different ways medicines work in the body and how this information guides the hunt for drugs of the future. The New Genetics Explains the role of genes in health and disease, the basics of DNA and its molecular cousin RNA and new directions in genetic research. Inside the Cell Makes cell biology come alive through vivid descriptions and stunning images. The Structures of Life Reveals how structural biology provides insight into health and disease and is useful in developing new medications. Curiosity Creates Cures Conveys the importance of basic biomedical research in leading to new medicines, technologies, scientific tools and other payoffs.

79 New at the NIGMS website publications.nigms.nih.gov/chemhealth/

80 Visit for more information Additional Topics Animal & Human Subjects Roadmap Special Initiatives Program Projects Contracts Sub-awards Resource Sharing Plan Model Organism Sharing Data Sharing Genome-Wide Association Studies Research with Stem Cells Foreign Applications & Collaborators

81 Miles Fabian, Ph.D. National Institute of General Medical Sciences Program Director Division of Pharmacology, Physiology & Biological Chemistry