East Stroudsburg University Grants Writing Workshop February 27, 2015 Jeanne M Manson, PhD, MSCE

Topics Covered Federal Grants; Part I (grants.nih.gov) Private Foundation Grants, Part II (http://foundationcenter.org

Federal Grants Department of Homeland Security National Endowment for the Arts Department of State Department of Labor National Endowment for Humanities Department Veterans Affairs National Institute of Health National Science Foundation Environmental Protection Agency Food and Drug Administration

NIH Institute Centers National Cancer Institute (NCI) National Eye Institute ((NEI) National Heart, Lung Blood (NHLBI) National Human Genome Research Institute ((NHGRI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal/Skin Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering ((NIBIB) National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Diabetes and Digestive/Kidney Disease (NIDDK) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences

26 Institute Centers with intramural and extramural programs NIH Institute Centers National Institute of General Medical Sciences (NIGMS) National Institute of Mental Health (NIMH National Institute on Minority Health and Health Disparities (NIMHD) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) National Library of Medicine (NLM) Center for Information Technology (CIT) Center for Scientific Review ((CSR) National Center for Complementary and Integrative Health (NCCIH) National Center for Advancing Translational Sciences (NCATS) NIH Clinical Center 26 Institute Centers with intramural and extramural programs

Develop a Strategy Planning on your own: It can take a significant amount of time to get organized, refine your ideas, collect preliminary data, write the grant application, obtain institutional approval for your budget, and approval for working with human subjects or animal subjects, etc. Develop a realistic timeline that includes draft application deadlines, and give yourself enough time to meet them. Plan for 3 months from start to finish, and 3 drafts of the application.

Develop a Strategy Planning within your organization: Plan your timeline to ensure you get your application to your Office of Sponsored Research on time, especially when collaborating investigators are involved. Find someone at your institution who can assist you in understanding all the steps necessary to complete your application. This person may be in a central grants office, another investigator, a departmental administrator, or a mentor. Select the right type of grant application:

Types of Funding Opportunity Announcements Receipt Date Money Set Aside Peer Review Specificity of Topic Advantage Parent Announcement Standard receipt dates (Jan 25, May 25, Sept 25) None Standing committees in CSR Investigator initiated unsolicited research May submit any topic within the breadth of the NIH mission Specific Program Announcement (PA) Often broadly defined or a reminder of a scientific need; Competition tied mainly to the IC's overall payline Request for Applications (RFA) Single Specifies funds and targets number of awards Same review committee (Special Emphasis Panel) for all applications convened on a one-time basis NIH-Requested Research; Well-defined scientific area Competition depends on number of applicants and dollars set aside

Utilization by Institute Centers Research Grants Type of Grant Purpose Utilization by Institute Centers Funding Levels R01 Used to support discrete, specified, circumscribed research projects NIH’s most commonly used grant program No specified dollar amount; generally awarded for 3-5 yrs R03 Limited funding for a short period of time to support a variety of projects, including: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, etc Utilized by more than half of Institute Centers (IC) Limited to 2 yrs funding; direct costs up to $50,000 R13 Used to support conferences and scientific meetings Requires advanced permission from the IC Support for up to 5 yrs possible; amounts vary R15 Support small research projects in the biomedical and behavioral sciences in schools that have not been major recipients of NIH research grant funds No preliminary data necessary; most ICs utilize Direct cost limited to $300,000 over entire project period ; limited to 3 yrs

Utilization by Institute Centers Research Grants Type of Grant Purpose Utilization by Institute Centers Funding Levels R21 Encourages new, exploratory research projects by providing support for the early stages of project development.  Sometimes used for pilot and feasibility studies. No preliminary data necessary; most ICs utilize Limited to 2 yrs funding up to $275,000 direct costs R41/42 Small business technology transfer; assists small business and research communities in commercializing innovative technologies Utilized by more than half of Institute Centers (IC) I, feasibility study 1 yr $150,000; II full R&D effort $1,000,000; III, commercialization phase no NIH funding R43/44 Small business innovative research Utilized by most IC Same as above R56 High priority, short-term project award Will fund for 1-2yrs high-priority new or competing renewal R01 applications with priority scores that fall just outside the funding limits of IC. Investigators may not apply for R56 grants; decisions made by IC

Utilization by Institute Centers Research Grants Type of Grant Purpose Utilization by Institute Centers Funding Levels U01 Research project cooperative agreement; supports discrete, specified, circumscribed projects to be performed by investigator(s) in an area representing their specific interests and competencies Used when substantial programmatic involvement is anticipated between the awarding Institute and Center No specified dollar amount K99/R00 Pathway to independence award; candidates have clinical or research doctorates with no more than 5 yrs of postdoctoral training Recipient will be expected to compete successfully for an R01 award during the career transition period Provides up to 5 yrs support; 1-2 years of mentored support for postdoctoral research scientists; up to 3 yrs independent support contingent on obtaining an independent research position

Program Project/Center Grants Type of Grant Purpose Utilization by Institute Centers Funding Levels P01 Research program project grant Support for integrated, multi-project research projects involving a number of independent investigators who share knowledge and common resources Dollar limit unspecified P20 Exploratory grants used to support planning activities associated with large program project grants Utilized by most IC P30 Center core grants used to support resources and facilities for program project grants Integrated into the program project/center grant but funded independently from them P50 Specialized center supports multidisciplinary attack on a specific disease entity or biomedical problem area. Centers serve as regional or national resources for special research purposes

Utilization by Institute Centers Resource Grants Type of Grant Purpose Utilization by Institute Centers Funding Levels R24 Resource related research grants Provide resources for problems where multiple expertise is needed to focus on a single complex problem in biomedical research or to enhance research infrastructure Dollar limit unspecified R25 Education projects Promote interest in biomedical research, provide additional training in specific areas, and develop ways to disseminate scientific discovery into public health and community applications  X01 Resource access programs Eligible institutions to seek access to NIH research resources P50 Specialized center supports multidisciplinary attack on a specific disease entity or biomedical problem area. Centers serve as regional or national resources for special research purposes

Writing the Application: Get Prepared Carefully read the funding opportunity announcement (FOA) for any special instructions. Solicit feedback from colleagues and/or mentors on your research idea while it is still in the concept state. Prepare an outline following the application framework and structure described in the application guide. Make sure you have adequate preliminary data, if necessary. Develop a feasible timeline with draft application deadlines. Be realistic about the time it can take to write and revise the application. Ask your colleagues or your Office of Sponsored Research for copies of successfully completed NIH grant applications. Examine them closely. Make sure that your institution will allow you enough time to accomplish the research, if funded. Become familiar with the NIH peer review criteria; reviewers will use them to rate your application

Is your idea original? Check the literature to verify that the exact project you are considering has not been done before. Search the literature and the NIH RePORTER database to minimize overlap with similar studies. Assess the competition. See which projects in your field are being funded, and consider turning competitors into collaborators to improve the strength of your proposal. Carve out a niche that will allow you to significantly advance knowledge in your respective field.

Peer Review Process Scientific Review Officer (SRO) -responsible for ensuring applications receive an objective and fair review -Recruits qualified reviewers (2 per application) -Evaluates any conflicts of interest between reviewers and applicants -an excellent contact person to interpret the process and goals of the program Reviewers -Identify reviewers from the SRO -Determine most likely reviewers of your application (do not contact reviewers) -Make recommendations concerning the scientific and technical merit of applications under review, in the form of final written comments and numerical scores.

NIH Peer Review Criteria Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved. Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Investigator(s). Are the PD/PI well suited to the project? If Early Stage Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed

NIH Peer Review Process Environment. Will the scientific environment in which the work is to be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Additional review criteria. Protections for Human Subjects, Inclusion of Women, Minorities, and Children, Vertebrate Animals, Biohazards, Resubmission, Renewal, Revision Scoring. The NIH utilizes a 9-point rating scale (1 = exceptional; 9 = poor) for all applications. Before the SRG meeting, each reviewer and discussant assigned to an application gives a separate score for each of the five review criteria. For each application that is discussed at the meeting, a final impact score is given by each committee member; scores are then averaged. Appeals. Investigators may request reconsideration of the initial review results if, after consideration of the summary statement, they believe the review process was flawed (get advice before doing this).

Start Writing Abstract: write this section at the very end. It should be clear, concise and compelling Specific Aims: Limit to no more than 4. Be sure the first objective is readily obtainable. Background and Significance: Review of the literature; highlight what is known and where critical data gaps exist; stress the significance of your proposed work. Generate an hypothesis on how you will address critical data gaps. Preliminary Results: Demonstrate mastery of technology proposed. Research Design and Methodology: Be specific! Anticipated Results; Be compelling, talk about benefits rather than process

Common Mistakes in Grant Writing Problems with Significance Not significant nor exciting new research; lack of compelling rationale; incremental and low impact research Problems with Approach Too ambitious, too much work proposed; Unfocused aims, unclear goals; Limited aims and uncertain future directions; Too much unnecessary experimental detail; Not enough detail on approaches, especially untested ones; Not enough preliminary data to establish feasibility; Feasibility of each aim not shown; Little or no expertise with approach; Lack of appropriate controls; Not directly testing hypothesis; Inadequate consideration of power; Experiments not directed towards mechanisms; No discussion of alternative models or hypotheses; No discussion of potential pitfalls; No discussion of interpretation of data.

Common Mistakes in Grant Writing Problems with Innovation Not clearly addressed in application; Not innovative Problems with Investigator Inadequate demonstration of expertise or publications in approaches; Low productivity, few recent papers; No collaborators recruited or no letters from collaborators; Need a more senior collaborator Problems with Environment Little demonstration of institutional support; Little or no necessary equipment; Little evidence of effective collaboration among institutions, if applicable.

What to Do If you Are not Funded Read your summary statement carefully to answer two questions: Are the application's problems fixable? Was it reviewed by the right study section? Contact the Program Officer to help you understand your summary statement and possibly give you more insights into the review meeting. Connect with senior colleagues, mentors, or other investigators at your institution to get their opinion on the reviewers' critiques and advice on how to proceed. Maybe you were assigned to the wrong study section: Did the reviewers' expertise fit your topic? Were they knowledgeable about your methods? Did they understand the rationale for your research? The following problems are either not fixable or nearly impossible to correct; low-impact research topic; philosophical issues, e.g., the reviewers do not think the work is important; hypothesis is not sound or not supported by the data; work has already been done; methods proposed were not suitable for testing the hypothesis. If these problems exist, start over with a new topic. If these problems do not exist, revise and resubmit your application as soon as possible.