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Research Funding: NIH and Beyond November 19, 2014.

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Presentation on theme: "Research Funding: NIH and Beyond November 19, 2014."— Presentation transcript:

1 Research Funding: NIH and Beyond November 19, 2014

2 Where to Get Info Mentors Departmental administrators Colleagues working in your field Scientists working in other fields Institutional research administrators Program officers at funding agencies Anyone skilled in expository writing

3 Albert Einstein College of Medicine Office of Grant Support Location: Belfer 917 (718)

4 RPG 4 ​​ ”RPG” defined as R00, R01, R03, R15, R21, R22, R23, R29, R33, R34, R35, R36, R37, R55, R56, RC1, RC2, RC3, RC4, RF1, RL1, RL2, RL5, RL9, P01, P42, PN1, PM1, RM1, UA5, UC1, UC2, UC3, UC4, UC7, UF1, UH2, UH3, UH5, UM1, U01, U19, U34, DP1, DP2, DP3, DP4, and DP5. Success rates of applications from medical school pediatrics departments for NIH research project grants (RPG),

5 U.S. BIOMEDICAL AND HEALTH R&D SPENDING 2012 $130,383,000,000

6 Have something to say, and say it as clearly as you can. That is the only secret… Matthew Arnold

7 The Costs of Research Direct CostsIndirect Costs SALARIES FRINGE BENEFITS CONSULTANTS EQUIPMENT SUPPLIES TRAVEL PATIENT COSTS ANIMALS SUBJECT COSTS PUBLICATION COSTS SERVICE CONTRACTS SPACE UTILITIES CUSTODIAL SERVICES SECURITY LIBRARY ANIMAL FACILITIES INFORMATION SYSTEMS SHARED RESEARCH FACILITIES IRB IACUC BIOSAFETY PAYROLL PURCHASING GRANT MANAGEMENT

8 Indirect Costs Aka….facilities and administration (F&A) and overhead. Costs that cannot be attributed to a specific sponsored project and are reimbursed to the Institution for expenses incurred for objectives common to most research projects. Made up of three types of costs: Facility-related costs: Building Depreciation, Equipment Depreciation, Interest Expense, and Operations and Maintenance Service-related costs (typically comprised of one item): Library Administrative costs: General, Department, Sponsored Programs

9 The Costs of Research Direct Costs Total Costs =+ Indirect Costs Direct Costs Indirect Costs = X (estimated) Indirect Rate

10 The indirect cost base does NOT include: Equipment (single items >$3000) Alterations/renovations Portion of sub-awards >$25,000 Patient care costs Off-site rental fees Student tuition

11 The Costs of Research Example: Annual Direct Costs = $100,000 Federally negotiated Indirect Rate = 67% Total Annual Costs = $167,000 Total Budget Request = $ K

12 Indirect Cost Rates Federal research (on-site) 67.0% Federal research (off-site)26.0% Federal other (on-site)28.5% Federal other (off-site)21.1% Federal training 8.0% Private non-profitSource policy* or 25-33% Industry (grants <$32,500)25-54% (grants >$32,500) 67% (clinical trials)25-33%

13 Types of Funding ContractProject originates with funder Stresses deliverables Cooperative Agreement Contract-Grant hybrid Funder has programmatic input GrantProject originates with grantee Few deliverables GiftNoncompetitive Unrestricted

14 Types of Grants Fellowship Research Training Career Development Travel Equipment Construction Program/Service

15 Types of Funders Federal Government State Government Voluntary Health Orgs (aka Public Charities) Professional Associations Private Foundations Corporate Foundations Corporations (Direct giving programs) Individuals

16 U.S. BIOMEDICAL AND HEALTH R&D SPENDING 2012 $130,383,000,000

17 US BIOMEDICAL AND HEALTH R&D SPENDING 2012 $130,383,000,000 INDUSTRY Pharmaceutical36,810,000, % Biotechnology19,300,000, % Medical Technology13,059,000, % Total Industry 53.1% FEDERAL GOVERNMENT National Institutes of Health30,012,000, % Department of Defense2,412,000,0001.8% Department of Agriculture1,953,000,0001.5% National Science Foundation2,075,000,0001.6% Department of Energy1,020,000,0000.8% Environmental Protection Agency568,000,0000.4% CDC408,000,0000.3% Food and Drug Administration406,000,0000.3% Other Federal Agencies2,162,000,0001.7% Total Federal 31.5% OTHER SOURCES Universities12,445,000,0009.5% State and Local Government3,819,000,0002.9% Independent Research Institutes1,538,000,0001.2% Philanthropic Foundations1,322,000,0001.0% Voluntary Health Associations1,074,000,0000.8% Total Other 15.5%

18 Types of NIH Grants R-series = Research Grants R01- Research Project Grant R21- Exploratory/Developmental Grant R03- Small Grant K-series = Research Career Development Grants K23- Mentored Patient-Oriented RCDA K08- Mentored Clinical Scientist RCDA aka “Grant Mechanisms”

19 Total NIH budget authority FY 2013 actual SBIR/STTR $638,517,000 (2.2%)

20 SBIR/STTR: 3-Phase Program PHASE I Feasibility Study $150K and 6-month (SBIR) or 12-month (STTR) Award PHASE II Full Research/R&D $1.0M and 2-year Award (SBIR/STTR) PHASE III Ü Commercialization Stage Ü Use of non-SBIR/STTR Funds

21 Searching for Funding Opps Office of Grant Support Funding Sources SciVal Funding Search Tool Google !! e.g. “funding for pediatric research” https://researchfunding.duke.edu/search.asp

22 Know Your Funder Area of funding interest Type of funding Typical size of grants Application and review procedure Eligibility restrictions: Type of institutionPrevious awardees CitizenshipGeography Faculty statusAge/Sex/Ethnicity Prior fundingCost sharing

23 Know Your NIHese PA vs. RFA NINDS R03 vs. NICHD R03 Feb-June-Oct vs. March-July-Nov Success Rate vs. Percentile Rank SRO vs. Program Officer eRA vs. IRG Revision vs. Resubmission

24 Applying for Funding 1) Theory

25 Compliance Research activities at all universities are overseen by regulatory and compliance committees imposed by federal laws. Non-compliance may result in severe penalties to the institution and in some instances to the individual. It is the responsibility of all researchers to be familiar with university policies relating to areas of research requiring compliance with government regulations.

26 Conclusion: Most grants are not awarded to principal investigators. Rather, your institution will be awarded a grant on your behalf.

27 The Institution as Awardee Proposal review and approval Indirect costs Compliance Grant management ($$) Commitment

28 Cost Accounting Standards e.g. Consistency in Estimating, Accumulating, and Reporting Costs Consistency in Allocating Costs Incurred for Same Purpose Allocation of Direct and Indirect Costs e.g. Criteria for determining how costs are charged or allocated to cost objectives.

29 Responsible Conduct of Research Human Subjects Research Research with Animals Fiscal Responsibility Conflict of Interest NIH Public Access Policy Environmental Health & Safety Export Control

30 Assurances and Certifications Human Subjects Animal Welfare Handicapped Individuals Sex Discrimination Age Discrimination Ethical Conduct Intellectual Property Human Embryonic Stem Cells Drug-free Workplace Combating Trafficking in Persons Conflict of Interest Delinquent Debt

31 Research Administration: -- Protecting the research enterprise by complying with federal regulations -- Facilitating faculty research through supporting services

32 Applying for Funding 2) Practice

33 Institutional review and approval is mandatory whenever any of the following are true: 1)Institutional signatures are required 2)The submission will be the final communication before an award is made 3)A detailed budget is submitted 4)Commitment of institutional resources (other than personnel and supplies) is made or implied

34 Principal Investigator Funding Agency Einstein Central Admin The Basics

35 Principal Investigator Funding Agency Einstein Central Admin AwardAccount

36 Principal Investigator Funding Agency Einstein Central Admin AwardAccount Progress Report / Renewal

37 Principal Investigator Funding Agency Einstein Central Admin The Details

38 Department Administrator Funding Agency Einstein Central Admin Principal Investigator

39 Department Administrator Funding Agency Einstein Central Admin Principal Investigator EH&S CCI Grant Accounting Animal Institute OGS MMC Dean’s Office

40 Department Administrator NIH Cayuse S2S Principal Investigator EH&S CCI Grant Accounting Animal Institute OGS MMC Dean’s Office DOD Grants.gov

41 Submitting Electronic NIH Grant Proposals NIH eRA Commons Grants.gov Cayuse S2S

42 “Registrations” for Submission of Electronic Proposals Principal investigators do NOT register with Grants.gov !! Principal investigators DO register with NIH eRA Commons, NSF Fastlane, HRSA Handbooks, etc. Contact OGS. Existing agency accounts need to be “affiliated” with Einstein.

43 Submitting Electronic NIH Grant Proposals Errors? NIH eRA Commons Grants.gov Cayuse S2S

44 Submitting Electronic NIH Grant Proposals NIH eRA Commons Grants.gov Cayuse S2S Proposals with errors must be corrected and resubmitted Error-free proposals proceed to referral/ review process in 48 hours

45 Peer Review

46 IDEAPROPOSAL Grantsmanship cannot improve a bad idea. The limiting factor in the quality of a proposal is the underlying idea.

47 To prove that an idea is great, you must show: Need [Should it be done?] Feasibility [Can it be done?]

48 Components of the Research Grant Application Scientific Research Plan: Specific Aims Background/Significance Preliminary Data Methods Human Subjects Vertebrate Animals Literature cited Appendices Administrative Face page/Title Abstract (summary + relevance) Key Personnel Budget Biosketch Other Support (JIT) Resources Checklist

49 aim (ām) Etymology: ME aimen < OFr esmer (< L aestimare: see estimate)estimate Noun 1.the act of aiming 2. a. the ability to hit a target b. a weapon's accuracy 3.the object to be attained; intention or purpose 4. OBSOLETE a guess or conjecture

50 A. Specific Aims List the broad, long-term objectives and the goal of the specific research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.

51 Specific Aims Well-defined objectives from which the project is derived and level of success is determined. Should present a framework that helps to organize the rest of the Research Plan. Often used by reviewers as an initial triage tool.

52 Specific Aims Clearly presents a gap in knowledge that will be filled by the proposed work. For NIH applications, does not confuse “significance” with “health relevance”.

53 Specific Aims Be brief and specific. Make each Aim a single sentence. Add detail paragraph under Aim if needed. Most successful applications have 2-4 specific aims.

54 Specific Aims Often begins with an opening paragraph that summarizes the problem, background, rationale, and long-term goals. Should be understood by scientists outside your field. Provides a summary for non-primary reviewers. The less technical information is presented first.

55 Specific Aims Should make the reader eager to read the rest of your application. MUST make the primary reviewer eager to read the rest of your application. The most important page in most applications. Should be the first page written and the last page revised.

56 R01 Specific Aims – Sample #1 3 Aims, 1007 words [Excerpt] The specific aims are designed to provide a comprehensive assessment of the agr-independent regulatory functions of sar. 1. Correlate the production of each sar transcript with the production of functional SarA. The only recognized protein product of the sar locus is the SarA DNA-binding protein. However, Northern blot analysis reveals… [See ; page 17]

57 R01 Specific Aims – Sample #2 3* Aims, 565 words [Excerpt] The specific aims of the study are: To test the effectiveness of a couples group intervention in decreasing specific components of psychological distress that are common in male couples of mixed HIV status. Hypothesis 2 (H2): When compared to control condition, couples in the treatment condition will demonstrate: H2a: a significant decrease in occasions of unprotected sex and increase in satisfaction with safer sex. H2b: a significant improvement in dyadic adjustment and couple satisfaction.

58 R01 Specific Aims – Sample #3 5 Aims, 74 words [Full text] We shall address the following principal questions in this study: 1. Is fluoxetine effective for primary depression in alcoholics compared to placebo? 2. Is improvement in depression accompanied by improvement in alcoholism? 3. Is medication response maintained in follow up? 4. Does fluoxetine decrease drinking even in patients whose depression does not improve based on an independent effect of serotonin re-uptake? 5. Can predictors be developed to better match patients to combination psychosocial and medication treatment?

59 Reviewers are Humans Grant proposals are not reviewed at review panel meetings. Proposals are reviewed prior to panel meetings in homes and offices and airports by busy people doing extra work without extra pay. If you make the reviewers happy, they will make you happy.

60 Advice from current and former NIH Study Section members: "What I like is an entertaining read. Bad spelling and bad grammar definitely turn me off." "Use all the buzzwords." "If you have a sexy idea, make sure you put it up front." "Clarity...clarity...clarity." "Small fonts drive me crazy." “Simple and straightforward is not boring. Boring is boring!“ “Reviewers are never wrong and never right. We just assess the material you provide.”

61 “Both the experimental design and the written description of it, like many other aspects of this application, do not make it clear that these investigators would be capable of addressing their stated specific aims in either a rigorous or a timely manner.” [Reviewer comment, NIH proposal summary statement]

62 Insufficient or unclear justification for significance of problem. Too little detail about proposed studies. Too much work proposed. Failure to make preliminary data the cornerstone of Specific Aims Common Reasons for Poor Reviews (First Time Applicants)

63 “The institution should provide a document on institutional letterhead that describes its commitment to the candidate and the candidate’s career development, independent of the receipt of the award. The document should include the institution’s agreement to provide adequate time and support for the candidate to devote the proposed protected time to research and career development for the entire period of the proposed award. The institution should provide the equipment, facilities, and resources necessary for a structured research career development experience. It is essential to document the institution's commitment to the retention, development and advancement of the candidate during the period of the award. “ [NIH K Award Guidelines]

64

65 Crowdfunding Harnessing the power of the crowd; raising funds by pooling together donations from many individuals. Goal: support of a proposed project. How: web-sites present projects (what? why? how?), a funding $$ goal, and a time limit to raise the funds.

66 Crowdfunding Models: Donation-based crowdfunding sites allow people to donate to a project or cause. Equity-based crowdfunding targets investors pledging for an equity stake in a start-up company.

67

68 Crowdfunding Institutional regulation and administration Compliance Intellectual Property Reporting Grant Office or Development Office???

69 Popular crowdfunding websites: Kickstarter.com [http://www.kickstarter.com/] Rockethub.com [http://www.rockethub.com/] Petridish.org [http://www.petridish.org/] Scifundchallenge.org [http://scifundchallenge.org/] Innovocracy.org [http://www.innovocracy.org/] Indiegogo.com [http://www.indiegogo.com/] Artistshare.com [http://artistshare.com/v4/] Artspire.org [http://artspire.org/home.aspx] Crowdtilt.com. [https://www.crowdtilt.com/] Microryza https://www.microryza.com/

70 Team Science

71 Percentage of New Multiple PI Grants Out of Total Number of NIH Grants Funded by R-Mechanisms from Percentage of MPI grants

72 Team Science Collaborative Cross-disciplinary: Multidisciplinary Interdisciplinary Transdisciplinary Focuses on complex problems with multiple causes

73 Teams increasingly dominate solo authors in the production of knowledge. Research is increasingly done in teams. Teams typically produce more frequently cited research than individuals do. Teams produce the exceptionally high-impact research, even where that distinction was once the domain of solo authors. These results are…suggesting that the process of knowledge creation has fundamentally changed. Wuchty, S., Jones, B. F., & Uzzi, B. (2007). The Increasing Dominance Of Teams In Production Of Knowledge. Science, 316(5827),

74 Christine Ogilvie Hendren, Ph.D., Executive Director and Research Scientist, Center for the Environmental Implications of NanoTechnology (CEINT), Duke University

75 Outreach: to translate findings from within organizations and projects outward. “We must acknowledge that Inreach – knowledge transfer and feedback among disciplines and sectors – is in itself an independent and critical aspect of effective interdisciplinary team science, and further, that these information flows cannot be facilitated effectively by someone residing only within one box, no matter their competence.” https://www.teamsciencetoolkit.cancer.gov/Public/ExpertBlog.aspx?tid=4

76 Interdisciplinary Executive Scientist New career path: to amass expertise about what information is needed to cross-pollinate among fields and help enable decisions to be made. Eligibility Criteria: Must possess specialized project management skills and understand the interdisciplinary science approach Have specific fluency in the type of “wicked problem” being addressed, along with a deep understanding of fundamentals in at least one related area of the underlying science and an appreciation of the science from multiple disciplinary perspectives.

77 Science of Team Science Conference (SciTS) August 6-8, 2014 Austin, TX Sessions: Group Concept Mapping and Interaction Analysis Framing the Workspace Boundary Spanning Ties Effects of Institutions’ Governance Assessing Readiness


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