- Hello, my name is Jasenka Borzan.
I'm a scientific review officer
at the National Institute of Mental Health.
Welcome to the first segment of a four-part presentation
on the NIH peer review process.
This presentation will focus on
the general overview of the process
and fundamental aspects of submitting an application to NIH.
As you may know, National Institutes of Health
are composed of 27 institutes or centers,
each with a specific research mission,
often focusing on a particular disease or a body system.
When applying for funding to NIH,
your application may be funded
by one of 24 funding institutes.
The other three centers do not fund extramural research,
but have other responsibilities within NIH.
Important to notice for this talk
is the Center for Scientific Review,
highlighted in green here,
which serves as the portal for all NIH grant applications
and their review for scientific merit.
We'll talk about that in more detail in just a minute.
First, in order to give you a broad overview
of the NIH activities,
you can see that, in the fiscal year 2021,
more than 80% of the 43 billion budget
was spent on extramural research grants,
on training and contracts.
About 11% of the budget funds intramural scientists at NIH
across all institutes.
However, the largest part, almost 60%,
is awarded to institutions
supporting individual principal investigators
through research projects.
So what does it take to go from an idea
to a funded research project?
Let's look at the so-called lifecycle
of a grant application.
As a principal investigator,
you would write an application, and your institution,
be it university or institute or another organization,
would submit it then to NIH through Grants.gov.
All applications are then first received
at the Center for Scientific Review,
more specifically the division of Receipt and Referral.
From there, each application is assigned
to a funding NIH Institute, for example, NIMH,
and to a specific scientific review group, sorry.
Center for Scientific Review
has the largest number of such review groups
and reviews about 70 to 80% of applications received by NIH.
However, each funding institute has a review branch as well,
and reviews applications
that are of special interest to that institute.
In any case, once the application is assigned
to an institute in terms of scientific interest
and to a review for evaluation of scientific merit,
the review process is said to have two levels.
The first is evaluation of scientific merit,
organized by a scientific review officer, such as myself.
What we do is we recruit a panel of experts
to evaluate and score the applications.
However, we do not make funding decisions.
We only focus on the evaluation
of the scientific merit of applications
and forward the recommendations about that
to the institute council members
and program officers at specific institutes.
They're the ones who make funding decisions
in this second part of the review process.
The advisory councils recommend
specific applications for funding to the institute director,
and then, based on those council recommendations,
the institute director makes final funding approval,
after which the funds are finally allocated
to the respective applicant institutions.
And it is at that point that the principal investigator,
such as, perhaps, yourself,
receives the award and can begin research.
It is certainly not a simple process,
but I hope that we can guide you through it
with some fundamental information and that will help you
if you decide to apply for NIH funding.
The first rule of successfully applying for NIH funding
is follow the instructions,
so begin by following
the SF424 application guide instructions.
The link to this guide is included
in every funding opportunity announcement, or FOA,
and also, importantly, section four of every FOA
includes application and submission information
that states what part of the SF424 guide
are relevant to the FOA and explains
any additional application requirements for that FOA.
Importantly, the instructions in the FOA
supersede the instructions in the guide.
For example, the application instructions in the FOA
may state to follow instructions in the SF424,
as in some examples on this slide,
or may include additional or different instructions,
such as different page limitations for some sections
or specific requirements about the types of information
that must be included in the application.
The bottom line is
make sure you follow the instructions in the FOA.
And just to tell you a little bit about the important staff
who are involved in the grant process,
I wanted to introduce you to a few names or abbreviations.
So an SRO or SRA you already are familiar with.
They are people like myself who organize review meetings
and are your primary point of contact
after you submit your application,
but before the review actually happens.
We manage the scientific review
by organizing special emphasis panels
and recruiting reviewers of appropriate expertise to them.
And we're also responsible for generating
summary statement reports after each review meeting.
SROs can work at the Center for Scientific Review
or within review branches of individual institutes.
The second person you should know
are program officers or directors.
They work at funding institutes and manage
specific portfolios of awarded grants or contracts.
They're probably the best first contact at NIH
when you are applying for a grant.
When you have an idea and you're thinking about applying,
the POs can answer questions
about the scientific priorities at their institute
and how responsive your ideas may be
for specific funding opportunity announcements.
Once a grant is awarded,
program officers are also responsible
for monitoring scientific progress on that award.
Grants management specialists
are equally important in this process.
They work at specific institutes
and are responsible for the fiscal stewardship
of a portfolio of awarded grants.
They monitor the financial progress of each award.
When you're applying for an NIH grant
applicant institutions have to complete
and maintain registration in a number of systems,
such as Grants.gov, eRA Commons,
and System for Award Management.
As a principal investigator,
you need to be familiar with two of those systems,
Grants.gov and eRA Commons.
Grants.gov is an online portal
that's used to find and also apply for most federal grants
within and also outside of NIH.
It also provides access
to all the current application forms.
eRA Commons is a system for receiving applications
and communicating information about review dates,
outcomes of the review, and also awards.
Every applicant as a principal investigator
must have an eRA Commons account
that is associated with their institution or organization.
Also, as I mentioned previously,
it is institutions or organizations
who submit applications to NIH,
and in order to do so, every institution must be registered
in the System for Award Management, or SAM,
and also in eRA Commons prior to submission.
The institutions are responsible for completing
and maintaining institutional registration in SAM,
as well as registering
principal investigators in eRA Commons.
Applications are submitted using the Grants.gov or ASSIST,
which means Application Submission System and Interface
for Submission Tracking portals.
The NIH applications must be in response
to an open funding opportunity announcement,
or FOA, in Grants.gov.
There are many ways you can search
for open funding opportunity announcements.
One way is to go to Grants.gov
and search for current parent announcements
using the website listed on the slide.
You could search for FOAs
based on specific scientific topics of interest,
or you could decide to narrow your search
based on specific institute of interest
by going to their website
and searching their current announcements.
What is important is that you download
the specific application package from Grants.gov
each time that you apply for an NIH grant
based on a FOA of your choice,
and the reason for that
is to make sure that you don't have outdated forms
or that you're not missing
any new potential requirements in the FOA.
So, to tell you a little bit
about the types of FOAs you can apply for,
there are three main categories
of funding opportunity announcements at NIH.
Parent announcements, or PA, funding opportunities
are also called unsolicited
or investigator-initiated applications,
because they're open to broad scientific interests
within the scope of the NIH mission.
These include many different types of grants
or so-called activity codes, like an R01 application,
or other research grants, training, and fellowship grants.
These applications utilize
three standard receipt dates per year.
PARs are program announcements with special receipt,
referral, or review requirements.
These FOAs are more narrowly focused
in soliciting applications
for a specific scientific topic or area,
and they're often reviewed in institute review branches
and have special receipt dates.
The third category are RFAs, or requests for applications,
in defined and high priority
or high opportunity areas of science
for one or more institutes.
These are RFAs, or requests for applications.
I will discuss a few important details about these
in just a moment, but, first,
what I would like to do is provide you
with a little bit of more information,
just a second, about the different types
of parent announcements that exist.
So, as you can see from this table, for example,
these are quite broad.
They can be R01s, they can be smaller research grants,
grants that support conferences or scientific meetings,
or small business grants.
They can also be training grants,
like T32s, Ks, or fellowship grants.
The full list of parent announcements can be found
following the link at the bottom of this slide.
An important note again here is that institutes choose
what parent announcements they wish to support,
so you need to check in the FOA
whether your institute of interest is accepting applications
for that activity code before you submit your application.
Now, a little bit more about the RFAs.
As I mentioned, these FOAs are focused on
specific scientific interests of one or more institutes.
They're typically very specific
in terms of scientific goals, desired outcomes,
and also application requirements, so it's critical
that you read the RFA very carefully before applying.
RFAs are shaped in consultation
with advisory council members of each institute,
and they have set aside funds
to support a specific number of awards each year,
and they typically have special receipt dates.
These FOAs often have special eligibility requirements,
submission instructions, and review criteria.
Once you select the appropriate FOA
and you write your application,
you will need to submit it using Grants.gov.
You can fill out appropriate forms
using Workspace in Grants.gov.
This is typically done in collaboration
with your grants office at your institution,
and this process generates PDF files
for a lot of the administrative pages, like the cover page,
key personnel information, budget, and so on.
And the main documents, such as the research strategy
or biosketches that you have, are uploaded in the system
as separate PDF attachments to the application.
As mentioned a few times already,
the most important thing is to carefully read
and follow instructions in the SF424 guide,
as well as the FOA.
So just a couple of more details that I wanted to mention,
when you're thinking about applying for an application,
one of them is, if your project requires
a multidisciplinary team of scientists,
you may want to consider whether applying
as multiple principal investigators
might be appropriate for your project.
In this case, even though one person
is designated as a contact PI,
every principal investigator on the MPI team
is responsible for the success of that project,
although they don't have to devote equal effort.
Specific roles have to be clearly defined, in that case,
in the MPI leadership plan,
and a conflict resolution plan has to be described as well.
Most types of research project grants
allow MPI designations,
although there are some activity codes that do not,
such as career development or K awards
or fellowship applications.
The second detail I wanted to mention is,
if you are working in an area
that is similar to global health
or you anticipate having foreign collaborators,
it is important that you check whether the FOA allows
participation of foreign institutions or foreign components
as part of the FOA.
You can find that information
in section three of every FOA, and this brings us back
to the picture of the grant life cycle.
In this first segment,
I hope you gained a good understanding
of the overall application and award cycle,
as well as more specific information
about the first part of the process,
namely that you, as an investigator, are writing the idea
and preparing your application, and then your institution,
by way of authorized institutional official,
submits the application to Grants.gov.
Once submitted, you can actually view
your assembled application in eRA Commons.
If you notice any errors in the final version
of the documents you submitted,
you can contact the eRA Service Desk
for help on how to correct those errors.
And additionally, the filled out forms and attachments
are electronically validated,
and applications with administrative errors
are flagged by the system as well.
The most important thing again here
is that you start preparing your application early enough
and submitting it before the actual deadline for receipt,
and the reason for that is so that,
if you notice any errors in your application,
you have enough time to revise them
and re-upload all of the components again in the system
before the receipt date.
After that, you would not be able to make any corrections.
And with that, I want to thank you for your attention.