Research Funding: NIH and Beyond November 19, 2014

Research Funding: NIH and Beyond November 19, 2014 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 Albert Einstein College of Medicine

Office of Grant Support Location: Belfer 917 (718) 430-3642 www.aecom.yu.edu/ogs Success rates of applications from medical school pediatrics departments for NIH research project grants (RPG), 2004-2013 Fiscal Year 2004 2005

2006 2007 2008 2009 2010 2011 2012 2013 Medical School Department Name PEDIATRICS

PEDIATRICS PEDIATRICS PEDIATRICS PEDIATRICS PEDIATRICS PEDIATRICS PEDIATRICS PEDIATRICS PEDIATRICS Number of Applications Reviewed

1,078 1,168 1,291 1,205 1,156 1,107 1,220 1,280 1,357 1,370 Number of Applications Awarded2

256 228 229 228 262 236 295 213 223 232 Success Rate

23.8% 19.5% 17.7% 18.9% 22.7% 21.3% 24.2% 16.6% 16.4% 16.9% NIH Overall

26.40% 23.20% 20.90% 22.50% 23.30% 22.00% 22.00% 19.00% 19.00% 18.40% RPGdefinedasR00,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,andDP5. RPG 4

U.S. BIOMEDICAL AND HEALTH R&D SPENDING 2012 $130,383,000,000 Have something to say, and say it as clearly as you can. That is the only secret Matthew Arnold The Costs of Research Direct Costs

Indirect Costs SALARIES SPACE UTILITIES CUSTODIAL SERVICES SECURITY LIBRARY ANIMAL FACILITIES INFORMATION SYSTEMS SHARED RESEARCH FACILITIES IRB IACUC

BIOSAFETY PAYROLL PURCHASING GRANT MANAGEMENT FRINGE BENEFITS CONSULTANTS EQUIPMENT SUPPLIES TRAVEL PATIENT COSTS ANIMALS SUBJECT COSTS PUBLICATION COSTS

SERVICE CONTRACTS 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 The Costs of Research Direct Costs Total Costs = + Indirect Costs Direct Costs Indirect Costs

(estimated) = X Indirect Rate 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 The Costs of Research Example: Annual Direct Costs = $100,000 Federally negotiated Indirect Rate = 67% Total Annual Costs = $167,000 Total Budget Request = $100-167K Indirect Cost Rates Federal research (on-site) Federal research (off-site) Federal other (on-site)

Federal other (off-site) Federal training 67.0% 26.0% 28.5% 21.1% 8.0% Private non-profit Source policy* or 25-33%

Industry (grants <$32,500) (grants >$32,500) (clinical trials) 25-54% 67% 25-33% Types of Funding Contract Project originates with funder Stresses deliverables

Cooperative Agreement Contract-Grant hybrid Funder has programmatic input Grant Project originates with grantee Few deliverables Gift Noncompetitive

Unrestricted Types of Grants Fellowship Travel Research Equipment Training Construction

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

U.S. BIOMEDICAL AND HEALTH R&D SPENDING 2012 $130,383,000,000 INDUSTRY US BIOMEDICAL Pharmaceutical Biotechnology Medical Technology AND HEALTH R&D SPENDING

36,810,000,000 $130,383,000,000 19,300,000,000 13,059,000,000 2012 28.2% 14.8% 10.0% Total Industry 53.1% FEDERAL GOVERNMENT National Institutes of Health Department of Defense

Department of Agriculture National Science Foundation Department of Energy Environmental Protection Agency CDC Food and Drug Administration Other Federal Agencies 30,012,000,000 2,412,000,000 1,953,000,000 2,075,000,000 1,020,000,000 568,000,000

408,000,000 406,000,000 2,162,000,000 23.0% 1.8% 1.5% 1.6% 0.8% 0.4% 0.3% 0.3% 1.7% Total Federal

OTHER SOURCES Universities State and Local Government Independent Research Institutes Philanthropic Foundations Voluntary Health Associations 31.5% 12,445,000,000 3,819,000,000 1,538,000,000 1,322,000,000

1,074,000,000 9.5% 2.9% 1.2% 1.0% 0.8% Total Other 15.5% Types of NIH Grants aka Grant Mechanisms 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 FY 2013 actual SBIR/STTR $638,517,000 (2.2%) 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 Commercialization Stage

Use of non-SBIR/STTR Funds Searching for Funding Opps Office of Grant Support Funding Sources http://www.einstein.yu.edu/administration/grant-support/funding-opportunities.aspx SciVal Funding Search Tool http://www.funding.scival.com/home Google !! e.g. funding for pediatric research https://researchfunding.duke.edu/search.asp Know Your Funder

Area of funding interest Type of funding Typical size of grants Application and review procedure Eligibility restrictions: Type of institution Citizenship Faculty status Prior funding Previous awardees Geography Age/Sex/Ethnicity Cost sharing

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 Applying for Funding 1) Theory 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. Conclusion: Most grants are not awarded to principal investigators. Rather, your institution will be awarded a grant on your

behalf. The Institution as Awardee Proposal review and approval Indirect costs Compliance Grant management ($$) Commitment 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. Responsible Conduct of Research Human Subjects Research Research with Animals Fiscal Responsibility Conflict of Interest NIH Public Access Policy Environmental Health & Safety Export Control 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 Research Administration: -- Protecting the research enterprise

by complying with federal regulations -- Facilitating faculty research through supporting services Applying for Funding 2) Practice 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 The Basics Principal Investigator Einstein Central Admin Funding Agency

Account Principal Investigator Award Einstein Central Admin Funding Agency

Account Principal Investigator Award Einstein Central Admin Progress Report / Renewal

Funding Agency The Details Principal Investigator Einstein Central Admin Funding Agency

Department Administrator Principal Investigator Einstein Central Admin Funding Agency

CCI MMC Grant Accounting OGS Einstein Central Admin Department Administrator

EH&S Principal Investigator Animal Institute Deans Office Funding Agency

CCI MMC Grant Accounting DOD OGS Cayuse Department

Administrator S2S EH&S Principal Investigator Grants.gov Animal Institute Deans

Office NIH Submitting Electronic NIH Grant Proposals Cayuse S2S Grants.gov NIH eRA

Commons 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. Submitting Electronic NIH Grant Proposals

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

Proposals with errors must be corrected and resubmitted Cayuse S2S Grants.gov NIH eRA Commons Error-free proposals proceed to

referral/ review process in 48 hours Peer Review The limiting factor in the quality of a proposal is the underlying idea. IDEA PROPOSAL Grantsmanship cannot improve a bad idea.

To prove that an idea is great, you must show: Need Feasibility [Should it be done?] [Can it be done?] Components of the Research Grant Application Administrative Scientific

Face page/Title Abstract (summary + relevance) Key Personnel Budget Biosketch Other Support (JIT) Resources Checklist Research Plan: Specific Aims Background/Significance Preliminary Data

Methods Human Subjects Vertebrate Animals Literature cited Appendices aim (m) Etymology: ME aimen < OFr esmer (< L aestimare: see estimate) Noun 1. 2.

the act of aiming 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 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. 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.

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. 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.

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. 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. 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 http://www.niaid.nih.gov/ncn/grants/app/app.pdf ; page 17] 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. 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? 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.

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. 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] Common Reasons for Poor Reviews (First Time Applicants) 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 The institution should provide a document on institutional letterhead that describes its commitment to the candidate and the candidates career development, independent of the receipt of the award. The document should include the institutions 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] 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.

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

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/ Team Science

Percentage of New Multiple PI Grants Out of Total Number of NIH Grants Funded by R-Mechanisms from 2006-2013 Percentage of MPI grants 25 20 15 10 5 0 2006 2007 2008 2009 2010 2011 2012 2013

R01 R03 R21 R41-44 Team Science Collaborative Cross-disciplinary: Multidisciplinary Interdisciplinary Transdisciplinary Focuses on complex problems with multiple causes

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 aresuggesting that the process of knowledge creation has fundamentally changed. Wuchty,S.,Jones,B.F.,&Uzzi,B.(2007).TheIncreasingDominanceOfTeamsInProductionOf Knowledge.Science,316(5827),1036-1038. ChristineOgilvieHendren,Ph.D.,ExecutiveDirectorand

ResearchScientist,CenterfortheEnvironmentalImplicationsof NanoTechnology(CEINT),DukeUniversity 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

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.

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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