Specific Aims - College of Nursing

advertisement
Dr. Kathleen Jett, Research Consultant
Pam Selby, Editor
Chris Anthony, Grants Specialist
Angela Gifford, Senior Accountant
Beth Auten, Reference and Liaison Librarian
NIH
Proposal
Writing
Right on Target
for 2011
2
Working with Your Editor: Avoid Confusing Versions
Around grant deadlines, you all know it can get pretty intense. To avoid confusion
from multiple “versions” of the same grant, please consider the following:
Although the “Details” view of files will show the date and time, I have learned that
including these in the actual title of the document can be a big help, particularly
the closer you are to your deadline.
1. Early in revision process, include the date and your initials on every version
(e.g., Yoon_Aims_5-8-10_sy). Once having relinquished your draft to the editor,
allow “wait time” to get it back. The editor will send it back with the date she
finished editing it and her initials (Yoon_Aims_5-9-10_ps).
2. If you want the editor to work on a particular section only, let her know. That
way, you can continue to work on other sections. This gets tricky around
deadlines, so save doc with specific info: section worked on/date/time/initials
(e.g., Human Subjects and References_8-7-10_215pm_ps).
3. For FINAL documents, include “FINAL” in title: (e.g., FINAL Specific Aims_5-1310_4pm_sy and ps). Once FINAL version is ready, send to Grants Specialist to
convert Word docs to pdf and enter into appropriate section in application.
4. *It makes everyone’s job easier if you send the Grants Specialist ONLY the
FINAL edited version of each grant section.
3
Page Limits
Specific Aims
1 page maximum in any proposal requiring Specific Aims
(does NOT count toward overall page length—separate doc).
Research Strategy
6 pages for activity codes R03, R13/U13, R21, R36, R41, R43, Fellowships (F),
SC2, SC3, and X01.
12 pages for activity codes R01, single project U01, R10, R15, R18, U18, R24,
R33, R34, U34, R42, R44, DP3, G08, G11, UH2, UH3, and SC1. For more info on
activity codes and proposal types, see: http://grants.nih.gov/grants/funding/funding_program.htm
NOTE: Even for SBIR proposals that include 12 pages for research strategy and 12 pages for the business plan,
RESUBMISSIONS are only allowed 1 page for introduction (response to reviewers).
Biosketch
4 pages, 15 or less clearly relevant citations.
K-Codes
For individual Career Development (K) proposals, the Research Strategy does not include the Candidate
Information section. The combined page limit for the Research Strategy and items 2-5 of the Career
Development (K) Award Supplemental Form will be 12 pages. Items 2-5 are:
•Candidate’s Background
•Career Goals & Objectives
•Career Development/Training Activities During Award Period
•Training in the Responsible Conduct of Research
4
Section Lengths, Organization, and Formatting
1. Lettering and numbering sections Depending on the length of your
application and its complexity, You may
want to letter and number subsections
under the Research Strategy.
Introductions (resubmissions) and Specific
Aims page are submitted as separate pdf
documents.
Note: Although NIH format changes do not
specify a Preliminary Studies section, if you
are applying for an R01, reviewers may
look for this section. In addition, lettering
and numbering the Approach subsections
may make it easier for reviewers to find
information.
2. Project Narrative is restricted to a
maximum of 3 easy-to-read sentences.
3. Abstract is 30 lines maximum.
4. Title of proposal is still 81 characters,
including spaces. Title should distill
ESSENCE of proposed work.
5.
6.
7.
8.
Facilities and Other Resources section not limited in
page length, but include only what is relevant to
proposal (Workbook, p. 159.)
Appendices - There is no page length restriction for
the Appendices; you are allowed 3 separate ones.
Include items the PI considers vital and, as the
guidelines say, be brief!
Font size and styles: As it says in the instructions,
“Use an Arial, Helvetica, Palatino Linotype, or
Georgia typeface, a black font color, and a font size
of 11 points or larger. (A Symbol font may be used to
insert Greek letters or special characters; the font
size requirement still applies.)” In Tables and
Figures, font may be smaller if easy to read. Use
color sparingly—make sure colors enhance, not
detract, from the table/figure, and print out in
grayscale to see. For more information refer to the
Forms and Applications.
Margins and spacing: Not only do some consultants
assert that using 1-inch margins looks better, they
urge the writer to use as much white space between
sections as possible, NOT to write short little
paragraphs in sections, and to justify margins with
hyphenation (Russell & Morrison, 2009).
5
Biosketches
To streamline process of collecting biosketches from key personnel, a template of your own
biosketch should be sent to each member of the team to ask if they would be willing to cut and
paste information into it (big timesaver and uniform look throughout proposal). In addition: Ask
your team members to PLEASE include Pubmed Central reference numbers or NIH manuscript
reference numbers for each reference. Tell them it is a requirement (see Slide 26 for detailed
info). Your editor or the part-time ORS program asst. may not have enough time to get this info.
I. Maximum of 4 pages and 15 references—ALL should be highly relevant to
proposal.
II. The Personal Statement, a new feature, should reflect why the person
described has been included on the research team:
•
•
•
•
•
•
Relevance of expertise?
Relevance of experience?
Role in developing preliminary data?
Provides access to resources/technology?
Prior record of working with research team?
Proximity to other members of the team?
• Tailored to research aims/objectives, not just routine biographical info.
For template and sample of 2010 NIH biosketch see: http://research.unl.edu/docs/NIHbiosketchexample.pdf
6
Titles
According to experts, the proposal title should emphasize the “payoff” or product
resulting from the research proposed (Russell & Morrison, 2009, pp. 177-179).
You have a total of exactly 81 characters, including spaces and punctuation to create a compelling title—the
FIRST thing reviewers see. Think of it like a book or even a documentary title.
(1) Create a title that clearly defines your research purpose/goal(s).
(2) Key terms should be easily understood—use acronyms ONLY if necessary and readily understood by reader
(e.g., ICU, HIV)
(3) Avoid ambiguity (see “poor” title in second example ).
(4) Get rid of unneeded words (see “best” title in first example).
Poor: Describing the Experience of Self Managing Close Calls for Old Homebound Women (78)
Better: Describing the Experience of Self Managed Close Calls for Elderly Homebound Women (81)
Best: Experiences of Elderly Homebound Women in Managing Potentially Serious Incidents (80)
Poor: Caring for Both Ends of the Leash: Effect of Owners Visiting Their Dogs While Hospitalized (91)
Better: Caring for Both Ends of the Leash: Effect on Patients Visited by Their Dogs in the Hospital (86)
Best: Caring for Both Ends of the Leash: Effect of Dog Visits on Hospitalized Owners (78)
*For more info about titles, see CON share drive: Everyone>Faculty Resources>NIH and HRSA
Grants>Project Titles
7
Project Narrative
The following suggestions from Russell and Morrison can be found in
The Grant Application Writer’s Workbook, 2009, pp. 180-182.
The Project Narrative is the two
to three-sentence (max)
explanation of how your project
is relevant to public health.
It is submitted as a separate pdf
document. Accordingly, you may
want to begin the first or second
sentence with something like
“The proposed project is relevant
to public health because… .”
Sample (2 sentences)
Infectious disease is a major global
cause of death and disability. The
proposed study is relevant to public
health because it will allow us to
collect preliminary data on ___ as a
means of fighting infection and
reducing personal, social, financial
and health burden costs.
8
Project Summary/Abstract
The following suggestions from Russell and Morrison can be found in
The Grant Application Writer’s Workbook, 2009, pp. 180-182.
• Maximum of 30 lines.
• Possibly the most important section during review,
because it will be read by all reviewers, not just those
assigned.
• Must be interpretable by laypersons.
• Avoid writing in the first person.
• Write it last, but not at the last minute.
• Do not use to summarize past accomplishments or to review
background material.
• Should be stand-alone section that makes it crystal clear to
reviewers what problem/gap you are addressing, its relevance
to public health, how it fits with funding agency’s
mission/priority, why it has a good chance of succeeding,
benefits to public health, and how it leads to next step in
research trajectory.
• Since the abstract becomes part of the public domain, protect
what you don’t want revealed.
See more writing tips on Share drive>Everyone>Faculty Resources>NIH and
HRSA Grants>How Not to Kill an Abstract
9
Former NIH Main
Narrative Structure
A. Specific Aims* (included in page length)
B. Background and Significance
Review of Relevant Literature
C. Preliminary Studies
D. Research Design and Methods
D.1 Design
D.2. Sample, etc.
D.3. Measures
D.4. Recruitment/enrollment
D.5. Procedures for data collection
D.6. Data and power analyses
D.7. Timeline
*Many proposals included a conceptual model after
Aims or in Design section.
2010 NIH Main
Narrative Structure
Specific Aims (one separate page)
Research Strategy (main heading, centered, 12 pages
R01/R15: 6 pages R21/R03)
Significance
Innovation
Approach
Design
Sample, etc.
Measures
Recruitment/enrollment
Procedures for data collection
Data and power analyses
Potential Problems and Alternative Strategies
Future directions
Timeline
*An alternate outline is available from Russell & Morrison, who
are experts in career development awards, recommend
organizing the Approach section by Aim (Russell, S.W. &
Morrison, D.C. , 2009). The Grant Application Writer’s
Workbook, National Institutes of Health, Grant Writers’
Seminars and Workshops, LLC., pp. 84-99). For direct queries
about this workbook, contact: info@grant6central.com
10
Specific Aims
To develop a compelling flow of logic that leads clearly and reasonably to your aims and expected
outcomes, an outline can help you see links between ideas and help you avoid wordy or repetitious detail.
The following outline, extracted from pp. 62-68 of Russell & Morris’s Workbook, may prove helpful.*
Introduction Paragraph
I.
In the opening paragraph, the first sentence should immediately establish the relevance of your proposal research
to human health (Russell & Morrison, 2009).
II.
What gap/need exists? (Is it gap in knowledge, a critical need, or both?)
III.
What is current status quo: Knowledge? Standard of care? Approach?
IV.
Why is it a problem?
Second Paragraph
I.
Purpose: What do you seek to accomplish by the end of the proposed research (must link to either the gap or the
need from paragraph 1).
II.
As someone who has carefully reviewed and researched all possibilities, how do you plan to test the objective?
Justify approach—prelim studies, literature, etc.
III.
Rationale: What will become possible as a result of you accomplishing your purpose/objective(s)?
IV.
Long-term goal(s)?
Aims Paragraph
I.
Make sure each aim clearly links with your purpose/objectives. (See Russell and Morrison, p. 66, to avoid setting
yourself up by writing an Aim that leaves you vulnerable to invalid results.)
Payoff Paragraph
I.
At least one important outcome as a result of accomplishing each aim.
II.
In general, how will this fill the gap, address the need, advance the field, contribute to NIH mission?
*Pages 25-29 in Russell & Morrison provide important detail about section headings and writing strategies.
11
Specific Aims
Linkage, achieved by outlining, is a sound strategy for
constructing the Aims page.
I. Introductory Paragraph
Opening sentence
What is known
Unknown or need
Unknown/need as a problem
II. What, Why, Who Paragraph
Long-term goal
Overall purpose/objective of application
Rationale/justification for proposed work
III. Specific Aims Paragraph
Specific aims
Working hypothesis for each aim
IV. “Payoff” Paragraph
Expected outcomes
General positive impact
Congruent w/NIH mission/priority
Again, these are suggestions by Russell and Morrison for writing the Specific Aims page.
12
Alternate Intro/Aims Strategy
I. Introduction (first paragraph)
A. Introduce the problem (could use brief, general but relevant statistics)
B. NIH mission/priority (that fits with your proposal purposes/objectives)
C. What your proposed research is about (how it fits with NIH
mission/priorities)
D. Results (what is known) from previous funded grants that make this
proposal the next logical and critically important step. (Note: this strategy
may work best with proposals with strong preliminary results.)
E. What is unknown (research questions).
F. Purpose of proposed study.
II. Long-term Goals
A. Can repeat problem briefly, now that reviewer understands , and zero
in on your specific area that leads logically to long-term goal to
address problem.
B. Knowledge gained is expected to: How does it fulfill NIH
mission/priorities? How is it critically relevant to public health? How
does it advance the field? Why is it a crucial next step?
III. Specific Aims
A. Aims and hypotheses
13
Definitions of Significance and Innovation
According to expert NIH reviewers, a common problem grant writers encounter in these
two sections is repetition—repeating in Innovation what was already said in Significance (Russell &
Morrison, 2009, p. 77). They also advise fitting these major sections on one page if possible, but this
advice is not necessarily supported by other grant writing experts, especially if one is writing an R01.
Definition of Significance:
the positive effect/impact that
successful completion of your
proposed research will have on (1)
filling a critical gap or (2) addressing
a critical need related to NIH mission
or priority (concrete benefits
expected as a result of completing
the study).
Definition of Innovation:
novel or substantially different way of
considering, approaching, or
addressing an important public health
problem that results in departure from
the status quo, thereby vertically
advancing the field and/or enabling
new directions pertinent to NIH
mission or priority.
14
Outline for Significance
The Significance section needs to convey
the positive impact your research contribution is likely to have
on something relevant to the targeted agency.
Most important of the core criteria.
Avoid small paragraphs. Make linkage between ideas evident. The
following parts may constitute one or two paragraphs (suggested ½ 1 ½ pages, depending on your mechanism—R03/R21 vs. R01/R15).
• Part 1: Substantiate/explain in more detail the gap/critical
problem or need/barrier to progress in the field that your
study will address (Can use both literature and preliminary
findings.)
• Part 2: Italicized statement of significance. Explain how the
proposed project will improve scientific knowledge, technical
capability, and/or clinical practice in one or more broad fields.
• Part 3: List of benefits that can credibly be expected to add
new knowledge and/or address critical public health need, and
furnish essential data for next step in research trajectory. In
other words, describe how the concepts, methods,
technologies, treatments, services, or preventative
interventions that drive this field will be enhanced/changed if
the proposed aims are achieved.
15
Alternate Outline for Significance
(This outline may work best with proposals built on strong preliminary results.)
I. Although the section is now headed Significance,
write it as you used to write Background and
Significance. Keep opening paragraph brief and get
to major findings from literature. Organize lit
review so at the end of each section, you can write
in how the proposed study will significantly
contribute to/fill a gap in what has been found
before.
(Note: The UMBRELLA heading for this section is RESEARCH
STRATEGY, centered on page.)
16
Outline for Innovation
(Suggested length 1/2 - 3/4 page) for R03/R21; 1-1 ½ pp. for R01
I.
Explain how the application challenges and seeks to shift current research
or clinical practice paradigms.
II.
Describe any novel theoretical concepts, approaches or methodologies,
instrumentation or interventions to be developed or used, and any
advantage over existing methodologies, instrumentation, or interventions.
III. Explain any refinements, improvements, or new applications of theoretical
concepts, approaches or methodologies, instrumentation, or
interventions.
17
REVIEW
NIH Main Narrative Structure
Specific Aims (one separate page)
Research Strategy (12 pages R01: 6 pages R21/R03)
Significance
Innovation
Approach*
Research Strategy (main heading, centered, 12 pages R01/R15: 6 pages R21/R03)
Significance
Innovation
Approach
Design
Sample, etc.
Measures
Recruitment/enrollment
Procedures for data collection
Data and power analyses
Potential Problems and Alternative Strategies (suggested by Russell and Morrison)
Future directions (suggested by Russell and Morrison)
Timeline
NOTE: You may want to consult with our expert, Dr. Jett, about organizing this section.
18
Approach Strategy 1
Retrieved verbatim on 7-30-2010: http://research.unl.edu/stories/story.php?ID=390
• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project.
Include how the data will be collected, analyzed, and interpreted, and any resource sharing plans as appropriate, unless
addressed separately in Item 15 (Resource Sharing Plan).
• Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. You
also may wish to include a discussion of future directions for your research, as well as a project timeline, in this section.
• If project is in early stages of development, describe any strategy to establish feasibility, and address management of
any high risk aspects of the proposed work.
• Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised
(can be detailed later in section).
• Preliminary Studies for New Applications: For new applications, include information on Preliminary Studies as part of
the Approach section. Discuss the PD/PI’s preliminary studies, data, and or experience pertinent to this application.
Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research
Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application
and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include
preliminary data (however, for R01 applications, reviewers will be instructed to place less emphasis on the preliminary
data in application from Early Stage Investigators than on the preliminary data in applications from more established
investigators).
• Progress Report for Renewal and Revision Applications. For renewal/revision applications, provide a Progress
Report as part of the Approach section. Provide the beginning and ending dates for the period covered since the last
competitive review. Summarize the specific aims of the previous project period and the importance of the findings, and
emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any
new directions including changes to the specific aims and any new directions including changes resulting from
significant budget reductions. A list of publications, patents, and other printed materials should be included in Item 5
(Progress Report Publication List); do not include that information here.
19
Approach Outline 2
The following outline employs organizational strategies suggested by expert NIH reviewers (Russell & Morrison,
2009). This is only one possible way to organize your Approach section.
I. Introduction (suggested length is 1/4 to 1/3 page)
Begin with sentence that justifies why work under this aim needs to be done, including overall problem to be
addressed. Next, write objective (put word in italics) and tell reviewer how you will attain it—by testing this
particular aim’s working hypothesis—this should repeat VERBATIM what was said on Aims page. EX: To attain the
objective of this aim, we will test the working hypothesis that… . (If aim is driven by need, substitute that here.)
Follow this with sentence or two about overall strategy/approach used to test working hypothesis. EX: “We will test
working hypothesis by using the approach of … . Next, sentence provides rationale—why you want to undertake this
research. EX: The rationale for this aim is that successful completion will contribute… . Acquisition of this knowledge
is critical to … . Last, summarize overall expected positive impact of this aim. EX: Findings are expected to yield…this
would be of importance because… .
II. Justification and Feasibility (no page length suggested—approx. 1/2 page?)
NOTE: For ideas about how/where to cite references and save room throughout proposal, see p. 94.
The authors suggest you leave this paragraph blank until you are done with other paragraphs for each aim - Chapter
11). In this paragraph, Review of Relevant Literature and Preliminary Studies are included. Authors highly suggest
that you do Research Design paragraph first, to select the most relevant citations from that to use in this section.
Primary literature only—exception: if one of your reviewers has pertinent review, cite. Lit Review should be critical
analysis—use to point out critical gaps, etc. to justify need for proposed research. Avoid long citation strings (cite
first 2 authors unless more info needed). Purpose of Feasibility section is to establish competence of PI and team to
successfully accomplish proposed work. Select only the most relevant/essential preliminary work showing this.
Feasibility of the aim must also be supported. Note: Early Stage PIs way less emphasis on prelim studies. According
to authors, for an R03, reviewers expect small amount of prelim data, despite what NIH instructions say. For an R21,
carefully selected preliminary data that supports proposed research despite risk of failure. The authors suggest that
one of the most important writing essentials for this paragraph is to show reviewer exactly HOW you came to
conclusions about justification and feasibility. EX. We concluded, from data presented in Figure 1, that…. This lead to
………. The authors also suggest that you “mix it up” in terms of using text and figures/tables, etc., depending on
how much room each takes.
20
Outline for Approach cont’d.
III. Research Design
The authors suggest that you use the listed categories (p. 87) to find the most relevant info to include for the
aim:
1. Approach to be used.
2. Overview of methods: They suggest asking these questions when trying to determine how much
methodological detail to include: (a) Has anyone on team published using these methods? (If so, reference
the publication—no need to describe); (b) Does your experience make it obvious that you can accomplish
study? (c) Do any of your prelim data make it clear you can successfully use these methods? (See p. 88 for
more detail).
3. Critical equipment needed
4. # of subjects needed and how derived.
5. Statistical analysis needed.
6. Controls (VERY important).
7. Detailed expectations (VERY important).
8. How results will be interpreted.
9. Major potential problems to be addressed (see pp. 89-90 for more detail).
10.Time required to complete work of aim.
IV. Expected Outcomes (suggested length is 1/3-1/2 page)
Note: Authors emphasize this is a critical component to include for each aim.
A suggested strategy for crafting this paragraph is to first collect all expected outcomes from preceding
Research Design paragraph(s) and copy/paste them into a new file. Organize the paragraph by (a)
summarizing expected outcomes and (b) convey how they collectively achieve the aim’s objective, thereby
advancing the field and accomplishing the application’s overall objective. Authors caution overstating
expectations but emphasize the importance of adding this section with its own subheading.
21
Outline for Approach (by Aim) cont’d.
V. Potential Problems and Alternative Strategies (suggested length is 1/3-1/2 page)
NOTE: Authors emphasize NOT including MAJOR problems in this section—major problems should be dealt with in
Research Design (see #9 above ).
Authors describe this section as chance to anticipate and eliminate justified concerns of reviewers. Can organize by
presenting the important/probable potential problems associated with aim and alternative strategies for
overcoming them. For each identified problem, address the following using conditional language (e.g., In the unlikely
event that…., we would….see bottom of p. 89 for more detail):
1. Nature of perceived problem.
2. Reasons you think it may arise.
3. Alternative approaches/strategies planned for addressing problem should it arise.
4. Reasonable expectation that you expect alternative approach to work—and qualify any potential limitations.
5. Supportive evidence that you have successfully used alternative approach in past.
EX: Although our preliminary data (see Justification and Feasibility subsection) solidly supports the hypothesis for
this aim and are complemented by [member of research team] work (cite), there is a remote possibility that ……. In
that unlikely event, we would…. (see p. 90 for more detail about writing this section).
VI. Timeline (1/4-1/3 page?)
See p. 90 for more details on this. NOT for each aim.
VII. Projecting Future Directions (best guess is 1/4 - 1/3 page)
Final “bang-for-the-buck” subsection regarding positive impact of accomplishing the aims. Begin by briefly
summarizing where you expect to be at conclusion of study and how this sets foundation for next study.
22
REVIEW
2010 Main Narrative
Structure
Specific Aims (one separate page)
Research Strategy (12 pages R01: 6 pages R21/R03)
Significance
Innovation
Approach*
Design
Sample, etc.
Measures
Recruitment/enrollment
Procedures for data collection
Data and power analyses
Potential Problems and Alternative Strategies
Future directions
Timetable
* Only a suggested outline.
23
Potential Problems and Alternative Strategies
The importance of this Approach subsection cannot be
underestimated, according to expert NIH reviewers
(Russell & Morrison, pp. 89-90).
I.
Example of problem to address: the
potential for an invalid hypothesis.
• Identify nature of potential problem.
• Reasons(s) why it is unlikely to arise.
• Alternative approaches/strategies you
would employ, should it happen.
(If this happens, we would….)
24
Human Subjects Outline
BIG change: Allow yourself TIME for this section. Depending on your grant, it may require more
specificity than it did previously, so it’s not a “cut and paste” situation. (The following outline was
taken from NIH guidelines; however, it will be necessary to TAILOR/CONDENSE this section to fit your proposal.)
I. PROTECTION OF HUMAN SUBJECTS
II. RISKS TO HUMAN SUBJECTS
Human Subjects Involvement, Characteristics, and Design
Involvement of Human Subjects
Characteristics of Sample
Recruitment and Retention Strategies
Vulnerable Populations
Random Assignment
Collaborating Sites
Sources of Materials
Description of Data
Access to Data
Potential Risks
Psychological Stress from Study Participation
Other Potential Risk
25
Human Subjects Outline cont’d
III. ADEQUACY OF PROTECTION AGAINST RISKS
Recruitment and Informed Consent
Recruitment
Informed Consents
Protections Against Risk
Risk to Privacy
New Data and Treatment Information for Subjects
Financial Conflict of Interest
IV. POTENTIAL BENEFITS OF PROPOSED RESEARCH TO HUMAN SUBJECTS AND OTHERS
V. IMPORTANCE OF KNOWLEDGE TO BE GAINED
VI. DATA AND SAFETY MONITORING PLAN
Risk Assessment
VII. See rest of sections on UF IRB Addendum N: Data Safety Monitoring Plan on share
drive at: Everyone>Faculty Resources>NIH and HRSA Grants>Human Subjects>Data
and Safety Monitoring Blurbs
26
Bibliography and References Cited
NIH guidelines state: “The references should be limited to relevant and current
literature. While there is not a page limitation, it is important to be concise and to
select only those literature references pertinent to the proposed research.”
Russell and Morrison (p. 102) suggest the following:
• mostly primary literature, not reviews.
• up-to-date, especially if you are resubmitting.
• information for each reference must be complete.
• consider using what these reviewers say is more “reader-friendly”—APA.
• page numbers accompany appropriate citations (e.g., page in a book).
• avoid using submitted manuscripts or conference proceedings.
• Manuscripts in press should be submitted in their entirety as appendices.
• Include the NIH manuscript reference number (e.g., NIHMS97531) or the Pubmed
Central reference number (e.g., PMCID234567) when citing articles that that either fall under
the Public Access Policy or were authored/co-authored by the applicant and arose from NIH
support. If the PMCID is not yet available, indicate
PMC Journal - in Process (see http://publicaccess.nih.gov/submit_process_journals.htm).
• citations that are available in a free, online journal (and not covered by Public Access policy)
may include the URL, along with the full reference.
• URLs should not be used in the text.
NOTE: The ORS cannot use Endnote to help anyone who has not used the Cite-While-You-Write feature of
Endnote while composing the grant (not a cut and paste situation)! If you need Endnote training, contact Beth
Auten at the HSC library. We MAY be able to help by manually inserting APA-style references, but we need
advance warning, PLEASE.
27
Tips for Writing
Facilities and Other Resources
• Not routine equipment and resources.
• Emphasize only those things that distinguish your
environment from those elsewhere.
• Key collaborative arrangements and other unique features
that enhance probability of success.
• Extraordinary institutional commitment.
• Intellectual environment conducive to successful completion
of your research.
Please see detailed instructions and updated blurbs in share drive: Everyone>faculty
Resources>NIH>Facilities and Other Resources Blurbs
28
Appendices/Attachments
LIMITATIONS:
1. You are not technically limited on how many attachments you can add, and you could even
convert as many documents as you want to one file; therefore, it is not about the number.
Be judicious in what you attach and follow the guidelines about what is allowed vs. not
allowed. Appendices should always be supplemental and not critical to the review (i.e. ,if
you need a diagram to explain something ,the diagram should be in the research strategy,
not appendix).
2. If the article is not publicly available but is highly pertinent to the research, then it should go
in the appendix. However, only 3 publications may be included, so the PI needs to decide
which are most pertinent. Here is notice regarding appendices
http://grants.nih.gov/grants/guide/notice-files/not-od-07-018.html and
http://grants.nih.gov/grants/guide/notice-files/not-od-10-077.html
3. According to SF434 guide: Manuscripts in press (chronological order) should include article
in entirety. The individual may choose to include selected publications based on recency
(should still be highly relevant to proposed work), importance to the field, and/or relevance
to the proposed research. Copies of publicly available publications are not acceptable as
appendix material).
4. Note: The important thing is that you follow the rules above (#2). You may be able to
attach quite a few files, but the key is following the allowable appendices rules. Also,
appendix limitations/rules may vary by program announcement or RFA. Reviewers are not
obligated to review appendices.
29
Appendices cont’d
Materials Allowed in the Appendix: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html
(Accessed 6-25-10)
Publications:
Applicants may submit up to 3 of the following types of publications. Any exceptions will be noted in specific FOAs.
Manuscripts and/or abstracts accepted for publication but not yet published.
Published manuscripts and/or abstracts only when a free, online, publicly available journal link is not available.
Patents materials directly relevant to the project.
Other:
•Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents may be
submitted in the Appendix as necessary.
•Paper PHS398 applications only may include full-sized glossy photographs of material such as electron
micrographs or gels in the Appendix; however, an image of each (may be reduced in size but readily legible) must
also be included within the page limitations of the Research Plan.
Format of Appendix Materials
•For electronic submission using the SF 424 (R&R) forms and Grants.gov, Appendix materials must be submitted in
PDF format.
•For paper submission using the PHS 398, Appendix materials may be submitted in paper format; five collated sets
are needed.
•Applicants are encouraged to send Appendix materials submitted with paper PHS 398 applications on a CD in PDF
format in lieu of the five collated sets. See application instructions for details on preparing CDs. Only a single CD
need be sent.
•For materials that cannot be submitted electronically or materials that cannot be converted to PDF format; (e.g.,
medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Administrator for
instructions following notification of assignment of the application to a study section. If the SRA is listed in the FOA,
they should be contacted in advance to address acceptability of materials .
30
For more
information about
professional writing,
including APA style,
please see Writing
Resources for
Nursing Faculty and
Students on the
CON’s website at:
http://www.nursing.
ufl.edu/research/res
earch_resources_wri
ters_students.shtm
“Life’s A Beach”
From Proposal to the NOA
By: Chris Anthony
Proposal Time Line
•
•
•
•
You do not want there to be a “First Time”
Allow review time of final application
Signatures cause the greatest delay
Timely Submission allows the College and
DSR to Review for errors
Intent to Submit
ORS Grant Timeline
Proposal Flow Chart
PI Submit Final Proposal
Documents to Grant
Specialist
• Proposal is entered into PS
for Dept and Subprojects
• Budget is entered into PS by
Grants Specialist
Attach
Grants.gov
application in PS,
Excel Budget,
and Signatures
not available via
PS
Work List in PS
created
All PI’s
Approved
All College
Deans Approve
All Dept
Chairs Approve
AOR approval and
submitted by Research
Administrator at DSR
to NIH
Correspondence
between Grants
Specialist & DSR
relating to
Corrections or
Concerns
After all signatures it
will appear on DSR
Work Flow list
Email Received from
DSR and ERA
Commons for NIH
errors
Cover Sheet every
error explained
unless errors
corrected same
day***Only before
Deadline starting
1/25/2011
48 hours for
correction ***Only
before Deadline
starting 1/25/2011
Email from DSR stating
NIH acceptance
NEW NIH Guidelines
• Beginning January 25, 2011Correcting eRAidentified errors and warning after the deadline will no
longer be an option
• The Application viewing window will still be available
but no corrections can be made after the deadline
• NIH pleas “Please Submit Early”
• Starting September 25, 2010 no post submission
grant materials will be accepted by NIH unless
unforeseen administrative issues, departure of a
participant, natural disaster has occurred, NOT TO
CORRECT OVERSIGHTS?ERRORS discovered after
submission.
Signatures
• Each level of approval through PS depends on
completion of the prior level
• Any other faculty with a % of effort on your
project will receive a subproject if internal and a
sub award if external
• All subprojects have to go through signature
process of which the dept and college will have
to sign for approval
• To obtain approval from other dept’s budget has
to be completed and project has to be entered
into PS (Science is not necessary most of time)
Signature Flow Chart
PI
Signature
Approval
All CO-I
Signature
Approval
PI Dept
Chair
Signature
Approval
All CO-I
Dept Chair
Signature
Approval
PI Dean of
College
Signature
Approval
Health
Science
Center for
Clinical
Approval
AOR of
Institution
at DSR
Approval
Work Flow Approval Sample
Budget:Think it Through
• Second most scrutinized part of the proposal
so dedicate time to ensure your budget is
competitive
• A clear concise budget supported by a strong
budget justification can increase the chances of
a proposal being funded
• Think through every cost of the project
because the proposal budget can become the
actual award budget
Examine the Budget
• Important each cost is Allowable, Allocable,
Reasonable, and Consistently Treated
• No “educated Guesses” of estimates
• Only apply costs that can be explained or
verified and are reality-based
• NIH Streamlining only top 50% get assigned a
score, where would your budget stand?
Fringe Rate 2010-2011
Budget Sample
Budget Sample
Grants.gov Submission
• No longer cut and paste sections
• Attach PDF completed Documents
• Very important that no symbols or spaces in
the name of documents
• No symbols in the title of the Project
• NIH ERA Commons ID Required for PI an
prefers for all other Co-I
Grants.gov Submission
Grants.gov Submission
Proposal Mail Log
UF Proposal Processing
Temp Advance
• Complete Temp Advance Request Memo
• Obtain Signatures
• Can request up to 25% of total funding
guaranteed and IDC
• Included needs to be correspondence from
Agency stating that funding will be given by
email or letter.
Temp Advance Sample Memo
Contact! Contact! Contact!
• Contact the program officer in the early
stages of planning
• Find out the institute’s interest in your
research area and the scientific direction
• Utilize email because Program Officers are
very busy and the feedback is written so you
will be able to review later
Utilize Your Grants Specialist
• Searches can be provided with detail of grants
funded in your area of research, these can be
used to assess your competition and use as
collaborators to improve your strength
• Searches can be completed through UF Office for
Research to assist with finding funds from
Foundations and other access to agency’s we as
departments do not have
• Guidelines for Forms, Templates, and directions
for proposal submission
Links
• Proposal Mail Log
http://apps.research.ufl.edu/research/pml.cfm
• Proposal Processing
http://www.research.ufl.edu/research/proposal.ht
ml
• NIH Center for Scientific Review
http://cms.csr.nih.gov/
• NIH Guidelines
http://grants.nih.gov/grants/funding/424/SF424_RR
_Guide_General_Adobe_VerB.pdf
Chris Anthony, Grants Specialist
Phone 273-6518
chrisanthony@ufl.edu
Where do I begin?
Salary
Distributions
Operating
Expenses
Justifications
Reporting
Cost Sharing
(if applicable)
•Payroll Versus Effort
•Can not report less effort than what is being paid
•CAS Violations
•Grant Term Restrictions
•Computer Purchases
•Salary Retros
•Expense Transfers
•Monthly Reports
•Quarterly Reports (if applicable)
•For large grants, I can create a unique report that will monitor expenses/projections for
the entire grant period based on the original or revised budget.
•Cost Sharing Certification Form
•Status Emails sent out twice a semester
•Please remember that all purchases require authorization before
expenditure of funds, whether those purchases are paid with P-cards, from
grant or other College accounts, or with personal funds. Request to
Purchase forms are the in-house method to document such authorization.
•The person who must authorize the request varies depending upon the
account to which the purchase will be charged. Required signatures are
listed on the back (or on page 2) of the Request to Purchase form. Please
remember that Joe Burley, as our Information Security Administrator, must
sign all requests for computer hardware, including any portable devices,
and software. Joe will not sign the request form after a purchase occurs.
•If a faculty or staff member makes a purchase without prior approval,
he/she will not be reimbursed for that purchase.
•For purchases paid with grant funds, please verify with me first to make sure
that you indeed have sufficient funding available to cover the cost and that
it is allowable per CAS and your grant terms. If not allowable, you may have
to use another source of funds, submit a CAS exemption form, prepare a
revised budget to funding agency, or just forego the purchase.
Per DSR’s Researcher’s Handbook:
Consultant payments on sponsored projects must represent compensation to
individuals who are independent of the university and who render independent
services. Consultant payments may not be made by faculty to colleagues where an
employer/employee relationship exists. Rather, in these situations colleagues should
be compensated for services via the University personnel/payroll system according to
percent effort of committed time; or donate their services as professional courtesy. If
overload can be demonstrated for short-term teaching situations, permission must be
obtained from the Division of Continuing Education (DOCE).
On the whole, it is expected that consulting needs can be satisfied from resources
within the University community. When outside consulting services are needed for a
grant or contract, all of these conditions must be met:
•There must be evidence that the services provided are essential and cannot be
provided by persons receiving salary support under the sponsored project.
•There must be evidence that a selection process was employed to secure the most
qualified person available.
•There must be evidence that the charge is appropriate considering the qualifications
of the consultant, normal charges, and the nature of the services rendered.
In accordance with Public Law 103-333, the “Departments
of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act of 1995,” the
following provisions are applicable to this grant award:
Section 507: “Purchase of American-Made Equipment and
Products - It is the sense of the Congress that, to the
greatest extent practicable, all equipment and products
purchased with funds made available in this Act should be
American-made.”
Items Not Allowed To Be Charged To A Federal Grant:
•Administrative and Clerical Salaries
•Office Supplies
•Postage
•Basic Telephone(basic service, local, and cellular)
•Memberships
•Subscriptions
•General Computer Software/Supplies
If you believe that your project has special circumstances that
would warrant an exemption of these costs, you must complete and
submit a CAS Exemption Form to the Division of Sponsored Research
(DSR) for approval.
Because computers and electronic devices are generally used for many different
activities (for example, instruction, research, administration, email, personal use), the
default presumption is that these devices cannot meet the threshold requirements
to allow the direct charging of their acquisition to a sponsored project.
Just because you may have had a computer listed on your proposed budget does
not necessarily make it allowable.
If you feel strongly that your computer should be charged to the grant, then you
can submit a justification to Contracts & Grants for approval.
Justification Requirements:
•Contracts & Grants require a letter in writing with the PI’s signature.
•It should say something along the lines of the purchase of a computer
was necessary in order to conduct the research for this grant alone.
•If the computer is to be used for several grants, then the cost will need to
be allocated and its use for each grant detailed.
•If you have a copy of your agency approved budget that has a
computer listed, that will need to be included as backup.
Any retroactive salary (beyond current pay period)
being charged to a federal or non-federal grant must
now be justified and approved by Contracts & Grants.
Any other expenses that were incorrectly or temporarily
charged to another account that must be transferred to
the grant must now be justified and approved by
Contracts & Grants.
Reasons for Change:
• To help manage grants more effectively
• To provide better audit trails
• To manage additional documentation
• To respond to recent audit recommendations
In order for the grant end date to be extended, I must receive a copy of the
updated IRB letter. Once received, I will forward to DSR for processing.
Acceptable Online Approval
Acceptable Approval Letter
For NIH, Miscellaneous Donors, & Multiple Sponsor Awards:
•Principal Investigators may submit their no cost extension requests
directly to DSR via email. DSR does not require a Department Chair or
Dean endorsement on no cost extension requests.
•Extension requests should be submitted to DSR no later than 30-days
prior to the grant's current expiration date. This allows plenty of time to
meet our deadlines.
•Upon approval of an internal extension, DSR must provide written
notification to Federal Agency's Grant Officer. This notification must be
received by the agency at least (10) ten days prior to the original
expiration date of the award.
•If this notification deadline is missed, DSR may not exercise its ability to
extend the grant, without the sponsor's approval.
General Guidelines
DSR may extend the final budget period of a project one time for a period
not to exceed (12) twelve months beyond the original expiration date, as
long as there will be no change in the project's originally approved scope
or objectives, and at least one of the following applies:
•Additional time beyond the established expiration date is required to
ensure adequate completion of the originally approved project.
•Continuity of Sponsor grant support is required while a competing
continuation application is under review.
•The extension is necessary to permit an orderly phase out of a project
that will not receive continued support.
•The fact that funds are anticipated to remain unspent is not sufficient
justification for an Extension. Awards that contains a zero funds
balance will not be extended.
Procedures and Required Information
The Principal Investigator (PI) must transmit the request to ufawards@.ufl.edu.
The email subject line should state: No Cost Extension Request for UF Project Number
########.
In the body of the e-mail please provide the following information:
Sponsor:
Sponsor Award Number:
Current Expiration Date:
Length of Extension (up to 12 months):
Scientific/Programmatic Justification explaining the need for the extension of time. This
narrative should be written as if you were writing your Program Officer requesting an
extension. In the case of Federal grants, DSR forwards this narrative section (as provide
by the PI) to the awarding agency.
For any internal subprojects or external subawards that require the extension, please identify
and provide the necessary information and justification similar to the above.
For those grants that are extended DSR will issue the eNOA extending the UF Project/s.
For external subawards, DSR will authorize the extension by issuing a formal amendment to
the existing subaward.
Per DSR’s Researcher’s Handbook:
When there is a change of PI or Co-PI, the Department chairperson in
conjunction with the original PI should notify the sponsor in writing of the
upcoming change. The letter should explain the situation, introduce the
new PI, highlight his or her special qualifications which assure
continuance of the research as originally approved, and attach their
curriculum vitae. A new DSR-1 Form should be sent along with this letter
to DSR. This document will be countersigned by DSR and forwarded to
the agency. Depending on the project period and the date of
proposed change of PI, the agency may issue a new award letter or
merely confirm its agreement in writing.
Per DSR’s Researcher’s Handbook:
With the exception of training grants, researchers who decide to leave the
University of Florida may be allowed to transfer their research grant to their
new institution. Faculty should notify the agency of their relocation plans
and request proper forms and instructions to effect the transfer. The
documentation must be routed through DSR for endorsement. Due to the
wide variation in procedures among sponsors, faculty are encouraged to
check with Award Administration with regard to specific guidelines.
A faculty member who accepts an appointment with another university
may wish to transfer research equipment purchased with sponsored project
funds. (Note: Research equipment that was purchased with state funds may
not be transferred.). A list should be prepared indicating the type of
equipment, property identification number, date of purchase, acquisition
cost, and account number to which it was charged. This list should be
submitted to the University Property Services. Property Services will check the
listing against its records, and if correct, will process the transfer. Any
questions will be settled by a phone call from Property Services to the
researcher. Approval will be required by the department or center,
University Property Services, and DSR.
Indirect Funds are transferred every November to an Overhead
Account based on the below breakdown:
Funds in an Overhead Account can be used to purchase
anything “Research” related and there is no expiration date.
Email Notifications Regarding Closeout Procedures
Notify Employees of Termination(if applicable)
Closeout all Open PO’s and TA’s
Make Sure Cost Sharing Met (if applicable)
Sign Closeout Memo
Prepare Final Reports
Prepare Carryover Request (if applicable)
DSR’s Researcher’s Handbook:
http://www.research.ufl.edu/research/handbook/re
searcher_handbook/index.html
DSR’s Award Administration Webpage:
http://www.research.ufl.edu/research/award.html
DSR Award Search:
http://apps.research.ufl.edu/research/search/
DSR and C&G Mail Logs (Use to check the status of
an Award):
http://www.research.ufl.edu/research/maillogs.html
Any Questions?
Beth Auten, MLIS, MA
Reference and Liaison Librarian
westauten@ufl.edu
352-273-8410
http://guides.uflib.ufl.edu/westauten
Liaison Librarian Services
• Providing information consultations to assist students, faculty, and
staff with literature searching and other information gathering
• Developing and teaching library orientations or information-related
classes based on your recommendations
• Meeting with you in person, by phone or over e-mail to discuss any
of your information needs, including copyright, bibliographic
citations or bibliographic software (such as RefWorks and EndNote)
• Presenting at department meetings or journal clubs
• Creating customized online interactive tutorials for use by on- and
off-campus faculty, staff, and students
• Conducting literature searches for HSC faculty and staff
• Taking your recommendations for expanding electronic and print
resources for the HSC Libraries' collection
• Collaborating with you on publications and grants
Citation Management Software
The UF Libraries provide access to RefWorks and
EndNote Web for UF faculty, students, and staff.
• Accessible though the Health Science Center
library website:
http://www.library.health.ufl.edu/writing/
• We provide support, including instruction to
classes or other groups, for EndNote, EndNote
Web, and RefWorks
Information About Open Access
Open Access (OA) is free, permanent, web-based access to
scholarly publications. OA is the principle that research should
be readily available immediately after publication and to
anyone with an Internet connection. It is improving the way
scholarly information is shared.
UF Open Access Resources:
Open Access at UF: http://www.uflib.ufl.edu/oa/
Open Access and Open Access Publishing Fund:
http://guides.uflib.ufl.edu/OpenAccess
Information About Copyright
Copyright FAQs and Helpful Information:
Copyright Policies, Practices and Resources
http://www.uflib.ufl.edu/admin/Copyright/Smathers_Libraries
_Policies_and_Procedures.html
Legal FAQs – UF General Counsel
http://www.generalcounsel.ufl.edu/faq/
For specific, in-depth questions, it is recommended that you
consult the Office of the Vice President and General
Counsel.
Download