Overview of the Application Changes Application forms will be revised in three sections:  Research Plan  Biographical Sketch  Resources and Facilities 1

Not identifying personnel correctly when providing elements Key, Non-key Personnel, Other Significant Contributor, etc.? Consultants from the Univ. of Pittsburgh not permitted. People from the same institution as the PI cannot be called “consultants”. Subcontracts/subaccounts When people are on a project from another Pitt or another institution, it takes weeks to find contacts, communicate and obtain the documentation required to process and submit the application. Changes to personnel-need to restart all grant prep activities from scratch. Everyone is added in alphabetical order. One change affects entire personnel section. Takes a lot of time to fix. Even changes in OSCs. Credentials Need eRA Commons username Biosketches Not in the right format or on the correct form Application Preparation Pitfalls

Formatting style in Adobe is critical Failure to provide Project Narrative (what is it???) Letters of Support or Cover Letters are not on institutional letterhead, or do not contain a signature. Facilities & Other Resources-Need to update this section re animal or clinical activities to match the project! Failure to provide Research Sharing Plan-The PA states this should be provided. Also if you meet the criteria defined in the NIH PHS instructions, you must provide RSP (over 500K, sharing model organisms or Genome-Wide Research). In general, not reading or following grant instructions or guidelines Font type and size - Arial, Helvetica, Palatino Linotype or Georgia and a font size of 11 points or larger

Unable to delete – no delete function era commons name

If yes, then 8-10 If yes, then 12 Project Narrative

Need all four attachments if you said “yes” to human subjects Required Required – if animal research

Do NOT SCALE

Major Changes to the Research Plan requires new language about the impact of the proposed research.  Specific Aims requires new language about the impact of the proposed research. will be created as a new section and includes 3 of “present” sections  Research Strategy will be created as a new section and includes 3 of “present” sections –Background and Significance –Preliminary Studies/Progress Report –Research Design and Methods 8

New Research Plan Components Introduction Specific Aims Background and Significance Preliminary Studies/Progress Report Research Design and Methods Inclusion Enrollment Report Bibliography and References Cited Human Subjects Sections…. protections, women/minorities, enrollment, children Other Research Plan Sections…. animals, select agents, multi PD/PI, consortium, support, resource sharing Appendix 9 New!! “Research Strategy”

Key PersonnelBiosketchEra nameEffortSupport Letter Co-InvestigatorREQUIRED NO Other Significant Contributors REQUIREDOptionalNot permittedGood Practice ConsultantNO NO – fee for service REQUIRED Post DocOnly if Key, not recommended YESIf KeyNO Graduate Student Researcher Only if Key, not recommended NoIf KeyNO Role on Project – Documents

Changes to Biographical Sketch  Personal Statement added: –“Briefly describe why your experience and qualifications make you particularly well- suited for your role in the project”  Publications revised: –Limit the list of publications or manuscripts to no more than 15 (5 “most relevant to application” and 10 of importance to field) –Make selections based on recency, importance to the field, and/or relevance to the application 11

Changes to Biographical Sketch: NOTE: The Biographical Sketch may not exceed four pages. A.Personal Statement Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application. C.Selected Peer-reviewed Publications NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at: Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PMCID numbers along with the full reference (note that copies of publicly available publications are not accepted as appendix material.)

TOTAL OF 15 PUBLICATIONS – w/ PMCID or PMID numbers

DO NOT LIST EFFORT! DO NOT LIST DOLLAR AMOUNTS!

Changes to Resources and Facilities  Instructions added to Resources: –Provide a description of how the scientific environment will contribute to the probability of success of the project –For Early Stage Investigators (ESIs), describe the institutional investment in the success of the investigator 21

Resources – All applications Identify the facilities to be used (laboratory, clinical, animal, computer, office, other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work. Provide any information describing the Other Resources available to the project (e.g., machine shop, electronic shop) and the extent to which they would be available to the project. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport). In describing the scientific environment in which the work will be done, discuss ways in which the proposed studies will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements.

Resources – if applicable For Early Stage Investigators, describe institutional investment in the success of the investigator, e.g., resources for classes, travel, training; collegial support such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the ESIs project, and availability of organized peer groups; logistical support such as administrative management and oversight and best practices training; and financial support such as protected time for research with salary support. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances. Note: Information about Select Agents must be described in the Research Plan, (Select Agent Research).

Basic Elements of NIH Grant “Science” – 13 pages [ enhancing-peer-review.nih.gov/docs/application_changes.pdf]  Specific Aims1  Research Strategy12  Significance0.5  Innovation0.5  Approach~5-6  Preliminary Studies~5-6 Freeman will try for 2/10:

Specific Aims [enhancing-peer-review.nih.gov/docs/application_changes.pdf]  Overall goal (excitement)  Importance of research (why?)  Preliminary data (why you?)  Hypothesis (innovation)  Specific aims (plan)  Impact (so what)

Specific Aims This is the blueprint for the proposal. It is the most important page in the entire application.  ONE PAGE ONLY!  Define the problem and key issues first.  Briefly state the background, basis, scientific rationale (can be based on your preliminary data) for the hypothesis.  State a clear, succinct, focused, and testable hypothesis which stems from the information above.  List 2 – 5 one sentence Specific Aims (# of aims depends on application type and funding period/time requested) which are obvious tests of the hypothesis. Brief experimental approaches can be included.  Finish with a significance statement, i.e., what it will all mean and do for us if completed. The project should have relevance to a human health issue.

Background and Significance Does Not Exist Anymore!!! ► Refer to and analyze relevant literature with current citations. ► Short paragraphs to one-half page sections with a boldface heading. Use schemes to simplify concepts/paradigms. ► Lay the foundation for your preliminary studies and experimental aims (establish their significance). If you base a statement on your preliminary studies, make note where the data will appear (page and figure #’s). ► Identify (diplomatically) gaps in knowledge and discrepancies in the literature. ► Summarize key issues and gaps in knowledge that you will address in the proposal.

Significance [enhancing-peer-review.nih.gov/docs/application_changes.pdf]  Importance of the problem  Critical barrier to progress  Improve knowledge  Drive the development of the field

Regarding Significance  Will original and important contributions be made?  Fundamental “science” and/or clinical relevance is important. Be sure to highlight disease relevance.  Addresses gaps in present knowledge

Innovation [enhancing-peer-review.nih.gov/docs/application_changes.pdf]  Shifts current research paradigm  Novel concepts, approaches, or interventions  Application of innovation/results

Regarding Innovation  Will the proposed studies change the view of a scientific issue or clinical problem?  Stress new technologies brought to bear in research plan  Studies viewed as observational, correlative, phenomenology, fishing expeditions, simple data gathering, etc., don’t fly.

Approach [enhancing-peer-review.nih.gov/docs/application_changes.pdf]  Overall strategy  General methods  Specific methods  Problems/alternative  Feasibility

Regarding Approach For each Aim: Restate Specific Aim Overall strategy and rationale General experimental approach Specific experimental approach Anticipated results and potential pitfalls Statistical Analysis Check for mandates/guidelines re page allocations for the various sections. Approach should be approximately 40% of grant text pages. Getting our point across is becoming more challenging as page limits are reduced!

Regarding Approach ► Note what you expect to observe and how these results will fill a gap in our understanding of this subject. ► Acknowledge potential weaknesses and technical limitations in the experimental plan. Be introspective and forthright. ► Do not state: “Since we’ve already done this lots of times before, we anticipate no problems with the proposed studies.” ► Propose alternative approaches to test or circumvent weaknesses, limitations, and “surprising” results.

Preliminary Results [enhancing-peer-review.nih.gov/docs/application_changes.pdf]  Expertise of investigators and investigative team  Results relevant to area of research and specific to aims  What you have speaks to feasibility

Regarding Preliminary Results A principal function of preliminary studies is to provide support for your hypothesis and demonstrate your capabilities to perform the proposed work. ► Show key data using challenging methodologies. ► Preliminary does not mean below publication quality! ► Summarize your recent research in 3 – 5 points. Outline what is coming up. ► Say why you are showing specific data. (E.g., a key finding that supports your hypothesis, documents a new method, demonstrates feasibility to perform the experiments, etc.) ► Don’t waste space, waste the reviewers’ time, or confuse the issue by showing irrelevant data.

Don’t want your application to be funded?  Let NIH assign your grant to a SS they choose.  Mislabel figures and tables or don’t use them at all.  Don’t use legends, after all they just take up space.  Propose studies using reagents that you do not have and are challenging to generate.  Propose to generate a KO mouse  Ignore statistical analysis

 Don’t include potential pitfalls, alternative approaches, or interpretations of the experiments you propose.  “We do not envisage any problems with the proposed studies.”  No letters of support  Take “inspiration” from mentor’s R01 – neither your mentor nor the study section will notice????  In a revised application, ignore key reviewers’ comments  Add new specific aims when not prompted by the review. Don’t want your application to be funded?

Final Points to Consider Don’t use appendices as a means to circumvent the page limit. Don’t rely on the reviewers to read your appendices. Look at a successful grant to get the global picture of how one all fits together. Sending in a haphazard, poorly thought out or “flawed” grant costs more time to achieve success than missing a deadline to improve it for later submission. Paying attention to detail can dramatically improve your potential to succeed!

New NIH R01 Notification of Proposal SubmissionThursday, December 03, 2009 Initial Elements (Form Attached)Thursday, December 10, 2009 Final BudgetWednesday, December 23, 2009 Non-Science Final DocumentsThursday, January 07, 2010 Non-Science ReviewThursday, January 21, 2010 Final ResearchWednesday, January 27, 2010 To Office of ResearchThursday, January 28, 2010 Due to AgencyFriday, February 05, 2010

Application Alignment with Review Criteria: Major Examples CriteriaApplication SignificanceResearch Strategy a. Significance Investigator(s)Biosketch InnovationResearch Strategy b. Innovation ApproachResearch Strategy c. Approach EnvironmentResources 41

Overview of Shorter Page Limits Current Page Limit (Section 2-5 of the Research Plan) New Page Limit (Research Strategy) < >25Follow FOA Instructions Note: Follow FOA page limit requirements if different from the application instructions. Full table of page limits available at: