Seven Steps Carol E. Nicholson, Md, Ms, Faap I Have A Step Wise ...
SEVEN STEPS
Carol E. Nicholson, MD, MS, FAAP
I have a step-wise process that I use to help investigators approach
the NIH for the first time...so far it is working pretty well. I invented it
over the last five years, so it really isn't validated yet! To START:
please read ALL SEVEN STEPS through, before you DO anything!
WARNING: There are never any guarantees in the funding world,
private or public. But, getting all the way through these steps, and
generating an application will be a rewarding process in and of itself,
and many have found the process and product rewarding. (***One
thing that I have noticed is, that people my own age (55 at the time
these were written) find it very hard to DO THE STEPS. So, I am
looking for a volunteer to help me write a version for the more
seasoned in seeking support: IF YOU ARE INTERESTED IN DOING
THAT, PLEASE WRITE TO ME at nicholca@mail.nih.gov***)
Step I: Your Notebook
Get a BIG Notebook with dividers.
Quietly peruse all the material at:
http://grants.nih.gov/grants/grant_basics.htm
http://grants.nih.gov/grants/grants_process.htm until you feel ready to
print out what you will need for your notebook. This will take an hour
or so.
And, I think it is helpful to have a hardcopy of these forms in your
Notebook so that you can flip through it when you are preparing your
esubmission. So, go there, and add that now to your notebook, unless
you are able to do without it.:
http://grants.nih.gov/grants/forms.htm
A. Download Forms and Instructions and make a Notebook with table
of contents and Dividers….some people find that their funding
mechanism or opportunity is NOT going to have esubmission….and
so, they need to use paper!
So, here is the link to clarify that….go there!!!
http://era.nih.gov/ElectronicReceipt/
And, for the old 398, if you or your mentor are used to that, and need
to orient yourself.
ftp://ftp.grants.nih.gov/forms/phs398.pdf
In either case, You will need ALL the pages handy, and the table of
contents...I also think it is useful to keep a blank PHS form in the front
pocket of the notebook, and to download the FAQs as well and keep
them there. Then, if you are applying to a specific RFA or PA from the
NIH Guide, When you have questions that you need to ask someone
besides me, you can call the grants info staff at 301-435-0714 or email
them at GrantsInfo@nih.gov. They are very friendly, and when you
have questions about electronic submission, mailing, labels, copies,
FEDEX, etc....they are always there to help. Of course, we really love
to hear from the investigators as well!
B. When you get to steps 4 and 5, below, it is helpful to keep handy
the material at
http://sciencecareers.sciencemag.org/career_development/previous_issues/articl
es/2006_11_10/nih_s_center_for_scientific_review/
. So think about checking this out in the early stages, so you know
what is there; you are writing for an audience of reviewers. Try to take
their point of view by cruising the NIH CSR website, looking at the
instructions given to reviewers.
C. You can read the instructions to reviewers, and I really recommend
doing this ahead of time. This is how the reviewers are told by NIH to
review your application. Your scientific priority score will be assigned
using these guidelines. The instructions for reviewers can be accessed
at :
http://www.csr.nih.gov/guidelines/guidelines.htm
I think it will be very helpful for you to spend some time cruising
through the CSR ( Center for Scientfic Review) website ( checkout
http: //www.csr.nih.gov/Committees/rosterindex.asp#A )before you
go any further. You can see the roster and content area of many study
sections. If you are responding to an RFA, you need to realize, that a
special, one-time only study section will be convened to review the RFA
applications, and the roster won’t be on the site….BUT the guidelines
for the review of the funding mechanism specified in the RFA are….and
the RFA itself will be very specific about the review criteria!
****Before you start, though, let me review your step #2 "three
things"...*** (so, don’t plunge in yet!) So, this may be the time that
you contact the NIH program staff…
D. Identify NIH program staff who will advise you. If not sure,
contact me and I will help you find someone. If you and/or your
research, do not fit into my program, we will find an NIH home
together for your proposal.
Do not worry about that, please, at this stage. YOU are the
investigator, and it is your scientific vision you are sending to the
NIH….so, YOU will get to choose where it is submitted! But, you need
help, no matter where you are submitting it, oK? Or if you are so
experienced and successful that you do NOT need help, you do not
need to do the SEVEN STEPS!
E. Make a timeline for the following six steps, working backward from
your identified due date. Look at the NIH review cycles in your
notebook/online, and think about what will work with your onservice
time, etc. Your timeline should be written, realistic and generous.
F. So, that is it for today!
I really suggest that you review your notebook, and think about your
three things
( see below) a little. Now, take a day to think about your commitment
to research, and the NIH process. Promise yourself that it is your
research career, and you will stay connected with YOUR vision, to
make things BETTER !!!Let me know if you need more help with this
very important FIRST step!
Step II: Getting you and your science ready for peer review
A. Email the three things you would accomplish for medicine, science
and children with critical illnesses and/or disabilities to your me or
your identified program staff.
B. These three things will be criticized and tightened up, hypotheses
and null hypotheses suggested where appropriate, and emailed back
to you . The programmatic appropriateness of these three research
aims will be evaluated. At this stage, you may be directed to another
NIH IC or Program Director….wherever you will have the best chance
is where you need to be!
Step III: Look at the scientific mandates of the work you propose:
Remember, the SCIENCE has to be startling, clear, and compelling.
So, no amateur hour analytic plans for your findings, ok?
A. Obtain formal professional biostatistical help, giving the
biostatistician the research aims. Ask for a power analysis, and a
synopsis of the biostatistical modelling/analysis which will be used.
Make sure you understand the concepts well, so that it is easier to
formulate a research plan. Remember to take notes as the biostat
professional speaks, look them up in your biostat book, so it stays
inside your mind as you write. It helped me to find an example of
work unrelated to mine, but similar in statistical analysis approach
and read it.
B. Read and reread the world's literature, especially paying attention
to studies similar to yours, and search CRISP, the public database of
NIH funded projects, available at:
http://crisp.cit.nih.gov/crisp/crisp_query.generate_screen . Crisp
can be tricky to use, so give yourself a couple of hours JUST TO LOOK
at Crisp. And, of course PUBMED.How is your work/ approach to this
problem different than that already being done?
Step IV: Making a Grant Proposal
A. Make a very detailed ( what species of rats or pigs, what reagents,
how many human subjects over what period of time, exclusion,
inclusion criteria, what medical centers, which pathologist and
why…etc, etc, ) outline of your research plan; This usually takes
about four weeks.
B. Give the above programmatically critiqued “ three things”, power
analysis, and detailed outline to an R01, or roadmap- funded
researcher at your institution who is NOT POLITICALLY
CONNECTED to you in any way. Ask for a harsh criticism, and ask
them for any suggestions. Give them a full three weeks to do it.
****The reason for this is that it is likely that although all of the
reviewers in the study group who evaluate and score your work
will be accomplished scientists, many will not be in your field. ****
You would be surprised how many things that are patently apparent to a
person from one discipline , are obscure to those from another. I believe that
your ability to make your case in this very competitive peer-reviewed arena will
be enhanced by going to the SCIENCE magazine website(
http://www.sciencemag.org/ ), and reviewing the work of a beetle
doctor, anthropologist or astronomer. Besides, if you click on NEXT
WAVE, a whole world of help with grant writing and funding will be opened to
you. They have a Grant Doctor, and a Funding Search Engine, to
match you with private supporters of research. And, they have the
R01 toolkit mentioned above.
C. While IVB is being done, get the IRB OR IACUC forms together on
your desk, and line up letters of support, and start writing the
Introduction, Aims, Background, Significance and Research plan,
following the directions in your notebook very carefully. PAGE
limits are STRICT at the NIH…. Call program staff for any
clarifications or questions. I really think that at this stage you are
best served by listening to us….we want to help!
D. As you begin to write, keep in mind the purpose of the published
RFA or PA (if any), and the NIH evaluation/scoring criteria, which
you should have memorized by now.
If it is possible for you to take a writing class at your university….just
a part time one…..it would help! Especially the kind where you learn
to convey vision, tension, conflict and solutions succinctly, and
rapidly. If they offer a beginning screenwriting class, that would be
ok, short stories, poetry, whatever would help you learn to
communicate your vision to others. You might think this is not
necessary, but several of my R01 successful applicants who
reluctantly did it were amazed at how much it helps!
V. An NIH Application Emerges
A. When the critiqued outline is available, back from the R01
researcher (don’t forget a thank you note), make a grant out of it.
Complete a draft of the entire proposal, including the budget. Most
budgets these days are modular, and this should save you some
aggravation. You should allow eight full time weeks for this
transition. And, the idea is, even if it gets revised after this, YOU HAVE
A DRAFT….you can ask the scientist who helped you in step 2 to take
a look at it, and your colleagues, too… At the end of this time, your
proposal should look like a grant. Follow the instructions in your
notebook carefully,*** adhere to page limits.*** PUT IT AWAY.
B. After at least a five day break, look at the grant again, and tune
and tweak. Get your institutional and departmental signoffs.
C. Chip away at your IRB submission, so that it is ready to turn in the
week before your peer review(or sooner). You do NOT have to have
IRB approval before you send in the grant, but they will not release
the funds to you until you have this.
Step VI: Get it to the NIH, and get the Institute, Program and Review
Assignments that seem right to YOU!
A. Compose the cover letter. In my own opinion, It is very important
to contact program staff for editing assistance with this...probably
you will back and forth it a couple of times. You will use it to request
for consideration of funding , and study group assignment for
review. FUNDING AND REVIEW ARE SEPARATE. This still seems to
confuse everyone…
A. FEDEX paper submissions ( overnight)to the NIH.... 10 days before
the due date.
5 days later, make sure it is here.
Contact information for receipt and referral: 301-435-0714 or email
them at GrantsInfo@nih.gov.
C. Put it in a drawer for a while, but keep attending to the world
literature and to CRISP
D. Find out who the SRA is for your review, and the study section
assignment. You will use your eRA commons account for that.
E. After review, it is important for you to go over your summary
statement in detail with program staff, who will also be able to give
you guidance re: likelihood of funding at this point, or after
resubmission. If you have to do rewrites, wait until you have read
and digested the summary statement. Ask the R01 level researcher
to review the summary statement with you as well.
VII.REST, don't quit, REST, don't quit!
Carol E. Nicholson, MD, MS, FAAP
Program Director, Pediatric Critical Care
and Rehabilitation Research (PCCR)
email: (nicholca@mail.nih.gov)
telephone: 301-435-6843
FAX: 301-402-0832
6100 Executive Boulevard
Room 2A03 MSC 7510
Bethesda, MD 20892-0001
** If sending FEDEX replace last line with Rockville, MD 20852
