NIH

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NIH

• Annual Budget 28.6 billion
• Funds available for open competition 8.4 billion

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Think

• New PIs should plan on applying to an NIH grant
  three times. Rebecca Claycamp, NIH Chief
  Grants Management Officer
• (Panel NIH 101 Primer at the National Council
  of University Research Administrators national
  conference, 2006, Washington, D.C.)

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What are the odds?

• NIH receives 40,000 applications for open grant
  competitions (2005).
• Panels of 3 reviewers were given 120 applications
  each.
• Panel has to recommend 10.
• ODDS 121 for first-time submissions

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How To Increase the Odds?

• Request reviewers comments, revise with care, and
  re-submit.
• By third submission, the odds are substantially
  more in your favor.
• NIH asks you to identify if your application is
  new or a re-submission, as reviewers look forward
  to the latter.

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Another Recommended Strategy

• Identify Program Officer (PO) for your
  discipline.
• Send PO a two-sentence email State your idea for
  research, then ask PO to point you in right
  direction
• PO will clarify if s/he is the right one for you,
  or point you toward the correct PO
• Then send the second, follow-up, lengthier email
  describing your research project and ask for
  response.

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Why Do All This?

• NIH is largest federal funder.
• NIH has 98 different grant types.
• Treasure of opportunities to enrich your research
  and career.
• This is a blessing and a curse. NIH has many
  opportunities. Which one is right for you?
  Susanne Fisher, Director, Division of Receipt
  and Referral, NIH Center for Scientific Review,
  NIH Training Session, 12/5/06, Bethesda, MD

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Start Browsing

• First Visit NIH Guide for Grants Office of
  Extramural Research Homepage
• Identify categories of grants good for you.
• Visit Award Trend for New Investigator Help
• All this can be a challenge, so talk to grants
  associate if necessary.
• Open up a great line of communication between
  your grants officer and you. Chocolate works.
  Marcia Hahn, Director, NIH Division of Grants
  Policy, NIH Training Session, 12/5/06, Bethesda,
  MD

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Category Research Project Grants (RPGs)

• Usually investigator-initiated
• Includes most R (Research) grants R01, R03,
  R15, R21, R22, R23, R33, R35, R36, R37, R55, RC1,
  PO1, P42, PN1, U01, UC1, and NIGMS P41
• Other R grants termed other research

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Category Research Project Grants (RPGs)

• Four best bets
• R15 150,000 total to stimulate research at
  colleges and universities that dont receive
  significant NIH support. Project can run 1-3
  years.
• R21 Two-year grant for exploratory/
  developmental research (100,000 Year 1 and
  175,000 Year 2).
• R03 50,000 x 2 years for small projects
  completed in short period.
• R01 Original and historically oldest NIH grant
  mechanism. Award for health-related research
  fulfilling missions of NIH. No funding limit
  typical award runs up to 250,000.
• Note These are the only four R grants allowed
  to use the modular (translationsimplified)
  budget.

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Category Research Project Grants (RPGs)

• R15, investigator-initiated grant, is tailored
  for faculty at colleges.
• R15 was developed to stimulate research at
  colleges that are not major recipients of NIH
  support.
• R15 is known as AREA, Academic Research
  Enhancement Award, grant.
• Award runs up to 150,000 (direct costs) for 1-3
  year research project.

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Category Research Project Grants (RPGs)

• R15 goals
• Enable faculty who would not otherwise have the
  chance to conduct independent research.
• Strengthen research environment at colleges.
• Give students exposure to and participation in
  research in biomedical and behavioral sciences.
• R15 is research (not training) award. Do not map
  training for undergrads or grads but design
  exposure for them to meritorious research.

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Category Research Project Grants (RPGs)

• R15 unique opportunities
• Special supplements are available to recruit and
  support high school and college students from
  underrepresented populations.
• So check out R15 AREA Award past awardees,
  current guidelines, FAQs, contact information,
  and lots more.
• Other R15 resources
• Sample PI biographical sketch
• Sample Modular Budget
• Contact Information
• Email R15 Chief Program Officer Dr. Henry
  Khachaturian about other questions or NIH-wide
  policy on R15 program.

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CategoryCenter Grants

• Research Center Grants
• Established by Institutes and Centers (ICs) to
  meet special needs
• Research and core facility
• Example
• Specialized (P50, U54)
• Core grants (P30)
• General clinical (M01)

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CategoryResearch Training/Career Awards

• Training Grants (T32)
• Institutional
• Predoctoral and postdoctoral
• FellowshipsKirschstein NRSAs
• Individual
• Predoctoral (F31)
• Postdoctoral (F32)
• Career Awards (Ks)

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CategoryCooperative Agreements

• U01, U10, U13, U19, U24, U54
• Assistance as opposed to Acquisition
• Substantial programmatic involvement by
  college/university and NIH
• Generally referred to as a grant
• Usually initiated by NIH

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Category Parent FOAs

• NIH is committed to investigator-initiated
  research and so wants YOUR unsolicited
  applications.
• All applications must be submitted in response to
  a Funding Opportunity Announcement (FOA).
• NIH created "Parent" FOAs.
• PI applies using parent electronic application
  package for his/her chosen grant award.

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Review Process

• Panel given 120 applications will read
  Abstracts only to make the first 50 cut.
• Only then will reviewers read the Project
  Narratives of the remaining 50 (or 60)
  applications.
• Three most common reasons for first cut
• Dont follow guidelines/directions
• Dont meet agency needs
• Hard to read/poorly written

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Streamlined Review

• Applications eliminated in first 50 cut are not
  discussed by panel.
• These applications still receive summary written
  critique from panel to help with re-submission.
• This streamlined review process allows more
  discussion time for more meritorious
  applications.
• This shortens review process and results in more
  scientists willing to serve as reviewers.

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What Happens Next?

• Recommended applications go to NIH National
  Council for 2nd level peer review/final approval.
• Most become Approved applications en bloc.
• Some do not due to NIH policy considerations.
• Example NIH might be devoting a higher proportion
  of funds this year HIV/AIDS research, so one or
  two highly meritorious proposals on breast
  cancer or adolescent psychology might be bumped
  by a number of good HIV/AIDS applications

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Other Considerations

• NIH program balance
• NIH availability of funds
• NIH funding strategies
• Example Out of 10 recommended applications, 8
  research anorexia or bilumia and 2 research
  obesity. The 2 on obesity have at least a 41
  better chance of making the final cut to
  approved applications.

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Do Some Homework

• Visit NIH Guide for Grants Office of Extramural
  Research Homepage to ascertain available funds,
  program priorities, and funding strategies.
• Then you can make informed decisions about what
  research to develop this year (or next) for NIH.
• When should you begin this process? NOW. Megan
  Columbus, NIH Program Manager for Electronic
  Submission, NIH Training Session, 12/5/06,
  Bethesda, MD

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Develop Proposal for Review

• Meet 5 elements for successful review
• Science (significance)
• Approach (design, methods, analyses, problems and
  alternatives)
• Investigator (training, suitability)
• Innovation (novel concepts or approaches)
• Environment (unique features, distinct
  collaborations, institutional support)
• Review "Updated Criteria for Evaluating Research
  Grant Applications."

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Additional Review Criteria

• The following are considered when reviewers for
  merit and priority score
• Protection of human subjects
• Inclusion of women, minorities, and children in
  research
• Care and use of vertebrate animals in research
• Precautions in use of biohazards
• Meeting current NIH priority areas or Public
  Health Service initiatives such as Healthy People
  2010

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Best Practices

• Visit Grant Writing Tip Sheets. You will find 13
  links to best practices in developing, writing,
  and submitting grants.
• Take advantage of NIH Grants Information. This
  service is provided to answer all inquiries
  related to grants.
• Find answers the Frequently Asked Questions about
  NIH Grants.

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Budget Tips

• Do not create lump sum items.
• Example at NIH seminar 15 pigs _at_ 15,000
• PI had buried all surgical costs in one line
  item.
• PI needed at least five line items
• 15 pigs _at_ 600 each
• Daily maintenance (40/day x 15)
• Surgical procedures (3,000 x 2 operations x 15)
• Surgical equipment (500 x 30 operations)
• Surgical supplies (est. 750)

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Budget Tips

• Brainstorm for six budget categories
• Senior PIs
• Includes salary and fringe benefits (30)
• Other personnel (postdocs, URAs)
• Equipment
• Travel (domestic and foreign)
• Participant/Trainee Support (if allowable)
• Other direct costs (e.g., supplies, consultants,
  rental fees, and agency-specific costs)

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Evaluation Tips

• As the saying goes, Without data, you are just
  another guy (or gal) with an opinion.
• Design SMART assessment tools
• Specific (narrow name target population)
• Measurable (reference quantifiable data)
• Achievable (possible plausible)
• Results-oriented
• Timebound (set deadlines)

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Format Tips

• No headers or footers
• NIH electronic system will do this
• Documents read online format for ease of reading
  electronic form
• Example underline looks truly ugly on screen
• Do not use special characters in file names.
• Do not write protect the .pdf files disable
  all security features so NIH reviewers can mine
  your text.
• Do not scan text attachments use print command
  on a word processed document to convert to a .pdf
  file.

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Format Tips

• Allowable fonts Arial, Helvetica, Palatino
  Linotype, or Georgia
• 11 point of larger
• All type must be black
• 15 characters per inch/6 lines per inch
• Figures, Graphs, Diagrams, Charts.
• Color allowed
• Smaller type size allowed as long as clear and
  black
• Research Plan
• Construct as single document
• Separate for PDF files at last moment
• NIH will not count white space toward page limit
  of entire Research Plan
• Web links
• Do not use because reviewers are not obligated to
  visit
• Reviewers discouraged from visiting as it could
  compromise their anonymity.

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E-Submission Tips

• Agency-specific instructions are denoted with HHS
  logo.
• Fill out SF-424 first because it populates fields
  on many other forms.
• Yellow fields are mandatory for Grants.Gov.
• Select white fields are also mandatory for NIH.
• Example Credential, e.g. agency login
• Similarly, some optional attachments are
  mandatory for specific NIH awards.
• Example If there are 4 budget forms under
  optional attachments, one is mandatory for your
  specific grant
• All attachments must now be in PDF. Do not scan
  documents. Generate PDFs from text files.

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E-Submission Tips

• After submission, PI receives 4 emails
• Submission Receipt (Grants.Gov)
• Validation Receipt (Grants.Gov accepts and
  forwards to federal agency)
• Grantor Agency Retrieval Receipt
• Grantor Agency Tracking Number
• You have 2 weekdays to log onto eRA Commons and
  Check Status of your application (accepted or
  rejected) by NIH.
• If Christmas falls on a weekday, Christmas counts
  in those 2 weekdays.

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E-Submission Tips

• You are responsible to log onto eRA Commons to
  view and validate your entire grant application
• Check all elements, especially check the
  graphics.
• Bookmarks for elements of application will be
  on left side of screen.
• Ask others to check the application, too,
  especially the grants associate.
• Bookmark and refer to NIH Electronic Submission
  of Applications Guide.
• You have two days to do this (holidays included).
• 4 weeks later, you can log on to learn the review
  group (and its contact info) to which your
  application has been assigned.
• You must direct all questions to Scientific
  Review Administrator. If you contact reviewers,
  your application will be disqualified.

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• Frequently Asked Questions
• Avoiding Common Errors
• eRa Commons Help Desk
• Phone [phone]
• Toll Free 866-504-9552
• TTY 301-451-5939
• Business Hours M-F, 7 a.m.-8 p.m. EST
• Contact Grants Info
• Phone [phone]
• TTY 301-451-0088
• Email GrantsInfo_at_nih.gov

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Last Words

• There are new processes and new forms, but its
  still about the science! NIH folks, training
  sessions, Bethesda, MD December 5, 2006