Carmen Ufret-Vincenty:
Hello, everyone, and welcome to today's presentation.
We will be discussing the Notice of Special Interest,
highlighting R13 support for conferences
and scientific meetings to support consensus building
for autoimmune disease research- related common data elements.
My name is Carmen Ufret-Vincenty.
I am the program officer
at the Office of Autoimmune Disease
Research in the Office of Research on Women's Health.
During the presentation,
I will refer to our office by its acronym, OADR.
Dr. Vicki Shanmugam is the director of OADR,
and I want you to recognize her name,
both because of the important work
she is championing in this realm,
and because she is the scientific research contact
for the initiative we will be discussing.
I am excited to be here today
to talk about this key funding opportunity
for advancing autoimmune disease research.
The first part of the presentation will focus
on describing the initiative,
and the second part will provide all the information you need
to help with the application submission process.
The objective of this NOSI is to highlight OADR's interest
in receiving applications that stimulate development
of new NIH-endorsed common data elements
applicable to immune diseases by convening members
of the scientific, clinical, patient,
and advocate community to build consensus
on the appropriate common data elements
to move to NIH endorsement.
The QR code you see takes you to the full NOSI.
To help you plan, keep in mind
that this NOSI expires on December 14, 2026.
Funds available -- funding for this NOSI
is going to be dependent on fund availability,
and this represents a collaboration
between different institutes, centers, and offices.
The NOSI is associated to the parent R13
Notice of Funding Opportunity.
The current number for that NOFO is provided here.
But keep in mind that the NOSI
applies to all reissues of this funding opportunity.
As designed, the award period is one year,
but keep in mind that later in the presentation,
I will provide more context on what this award period
means for the specifics of this NOSI.
Before we delve on the initiative itself,
let's discuss the concept behind NIH endorsement
of common data elements. During the presentation,
I may refer to common data elements as CDEs.
A CDE is a standardized, precisely defined question
paired with a set of allowable responses
that is used systematically across sites,
studies, data repositories, or clinical trials.
And as I say this, I am sure you are immediately
realizing how common data elements
ensure consistent and harmonized data
collection within a specific field.
NIH has endorsed a series of common data elements
through a project at the National Library of Medicine.
And the QR code provided on the slide
takes you to the home of the NIH CDE repository,
where you can find the current list
of NIH-endorsed common data elements and information
related to the process
for achieving NIH endorsement of CDEs.
Use of NIH-endorsed CDEs supports the NIH data management
and sharing policy
and ensures harmonization of data across datasets,
an effort that is foundational
to advancing autoimmune disease research.
Now that we have the definition of what the CDE is,
we can talk about what applications
will be considered responsive to this NOSI.
The final product must be endorsable CDEs
that the community has come to consensus on
and that fulfill the requirements
listed in this slide for CDEs,
which will make them eligible to be submitted for endorsement
by the NIH CDE Governance Committee.
In other words, the goal of the NOSI is endorsable CDEs.
And remember, this process is explained in detail
on the NIH CDE repository website
that we provided in the previous slide.
This means that the conference or series of meetings
that you propose should convene experts and partners
to drive consensus building to arrive
at agreed-upon endorsable CDEs.
Successful applicants are expected to work
with program staff at the Administering Institute
to ensure that the CDEs produced by your approach
meet the requirements of the NIH CDE Governance Committee.
Therefore, the goal of these awards is bringing the community
to consensus on CDEs to move forward for endorsement.
This is distinct from most R13s,
where the meeting is the final product itself.
You may be wondering what autoimmune diseases
qualify for this NOSI.
The image in this slide gives you a high-level visual
of the 144 autoimmune diseases
and related conditions that are part of our research portfolio.
But this font is too small.
I'm not expecting you to read this --
to see it in the slide at least.
So, the QR code takes you to the OADR website,
where you can find a high- resolution version of this image
and a Word file with searchable tables
that lists the full research portfolio.
It is important to know that as an applicant,
you're not required to follow a specific format
for a conference or series of meetings.
The design of the approach you propose will be based
on what you think has the highest probability
to lead you to fulfill the objective of this NOSI.
As you design your approach,
keep in mind that it will be very important
to include the perspectives of the whole community
when building consensus.
Clinicians and scientists with varied expertise,
and most importantly, people living with autoimmune diseases,
caregivers, and advocacy groups.
As long as you bring together
all these different crucial perspectives,
you can be creative in the design of your approach.
For example, it can be a series of virtual meetings.
It can be a one-day
consensus-making in-person meeting,
or you can combine those two approaches.
However, a conference that focuses
only on discussing the state of the field
or the importance of developing CDEs
will be considered non-responsive
because, again, the final product
should be endorsable CDEs.
To submit an application to this NOSI in response to the NOSI,
please refer to the R13 Parent NOFO for instructions.
Currently, the number for that NOFO is PA-25-080,
and the QR code on the slide takes you to the full document.
The application will be submitted under this NOFO,
and I'll show you in later slides
how to enter your application
that you're responding to this NOSI.
But for now, let's talk about what you see in this NOFO.
Keep in mind that the objective of the R13
in the context of this NOSI remains aligned
with the final product we have been highlighting,
to support high-quality conferences or meetings
for developing endorsable CDEs for autoimmune disease research.
This NOFO has a key requirement that requires timely planning.
Advanced permission to submit is required
from both the OADR and administering office,
and this permission needs to be requested no later
than six weeks before the application is due.
Most of the submission instructions are the same
as for other research applications like R01s and R21s,
but there are some unique requirements
that are summarized briefly here
and will be explained later in the presentation.
So, one of those requirements is that the cover letter
needs to include both permission-to-submit letters,
one from OADR and one from the administering office.
You also are required to produce a diversity plan and submit
that with your application.
And the research strategy section
will become your conference plan.
This information is all explained in the parent
R13 NOFO PA-25-080 or any reissues after this.
Be aware that NOFOs are many times reissued
for administrative reasons
due to changes in policy or for other reasons.
So, this is a good example of what just happened.
We just had a reissue of the parent R13 NOFO
that was before PA-24-141.
In the future, if you find an expiration banner
like the one flagged here by the orange arrow,
it means that it has been reissued.
Then you can scroll down on that NOFO,
and under that section that is called "Related Notices,"
section that are flagged here by the orange boxes,
you will find a link to the new NOFO,
which will be the one to submit under in response to this NOSI.
As an applicant interested in responding to this NOSI,
how would you get started?
The first thing to do is to write the specific aims.
These are limited to one page
and must include the disease area of focus,
a landscape analysis of the current state of the field,
and specific details about how you will bring the community
to consensus around specific components of CDEs
not currently endorsed by NIH.
There are two important points here
based on what needs to be included in the specific aims.
Please check the list of NIH-endorsed CDEs
to confirm that you will be working on new CDEs
and include specific details of the approach you will use.
For example, explain if you're planning to use
the Delphi exercise or a different approach.
While planning the specific aims,
reach out to the teams of experts
and partners you are planning to include.
Also, reach out to colleagues
who have successfully competed for R13 funding
so that you have an idea of what to plan and what to expect.
When the specific aims are ready,
but remember, no later than six weeks
before the application due date, reach out to oadrinfo@nih.gov
and request a meeting to discuss your application
and request permission to submit.
The meeting will be with OADR and the Administering Institute.
More than one meeting might be required in some cases,
so please plan ahead and remember to include
the specific aims when you email OADR.
To prepare for the meeting,
confirm that all players will be able to attend the meeting.
Have everyone on the team carefully read and understand
the NOSI, background information on CDEs,
and the goal of the initiative.
Make a decision on the PI and organization
that will handle the submission.
If possible, select someone with expertise
to avoid submission errors that result in the application
not being moved forward to NIH review.
If this is the first time your team is submitting an R13,
we recommend you partner with colleagues
who have successfully competed for R13 funding.
Also, have a cohesive plan with your team
to discuss the specific aims at the meeting,
and have a clear idea of your diversity plan
that includes not just representation
but true engagement from all participants.
If permission to submit is granted,
you will receive letters documenting
this permission from both OADR and the Administering Institute.
File these letters carefully
because both of them must be combined with a cover letter
that will be submitted with your application.
The application will not move forward if the cover letter
does not include the two permissions to submit letters.
Before you start writing,
carefully reread the NOSI and NOFO
so that you do not forget any requirements
or do work that is not needed.
All instructions will apply to your submission.
I want to flag two important sections in the NOFO.
Section 5 explains how your application will be reviewed,
so refer to this section for guidance
on how to tailor each section.
Section 7 provides contact information
for who will help you
at different stages of the submission process
if you run into issues. If you need help, please confirm
that you are emailing the correct contact.
And finally, make sure that you follow
all the recommendations and instructions
that you receive from OADR and the Administering Institute.
Now that you know what this NOSI is highlighting
and searching for,
we can discuss logistics and instructions relevant
to the submission process. The link in the slide
takes you to the full application submission guide,
and the next set of slides will provide high-level information
for key sections of the application,
taking into consideration the R13-specific requirements.
The next couple of slides after this
will look a little bit busy,
and we will not read through all of them,
but they're there for your reference.
They're meant as a high-level example
of how your application might look like
and as a source of links to the sections you will need.
Okay, now we're here at the example of the table contents.
And this represents what you would see
if this is a new R13 application.
Each line will provide links to help you
find the form and instructions
you need to complete each individual section.
We will discuss each of these sections
in the next couple of slides.
But there's one important point I want to make here.
Please make note of the content limits in the abstract,
narrative, diversity plan, and biosketches.
This is the second part of the table of contents,
which is in 51 slide.
So, in here, you can see that the specific aims
and conference plans also have page limits.
Another point, in R13s, the conference plans
take the place of the research strategy.
For all research applications, the different budget sections
are all entered in one form that is linked here at the top.
Again, keep it in mind that this table of contents
is only meant as an example.
Additional requirements may apply
based on your individual situation
or if the application is a resubmission or a revision.
All rules in the NOFO will apply.
So, always confirm that you're following those instructions,
and remember that all required sections
must be completed for your application to move forward.
Now, let me share some details specific to each section.
And first, how to make sure that your application is considered
for this initiative that we're discussing today.
That information is going to be entered on the first page
you see in that table of contents:
the SF-424 Receipt and Referral Application form.
The orange arrows point at the agency routing identifier field.
And this is box 4b.
The NOSI number -- note NOT-OD-24-145,
as written in the slide, no spaces or quotation marks
must be entered in this field. And this is super important
because if this number is missing from this field,
the application will not be considered for this initiative.
How to include the permission to submit letters
that I mentioned so many times?
Well, the two letters documenting permission
to submit,
again, remember, OADR and the Administrative Institute
will send you letters.
They must be combined with one cover letter into one PDF file.
The two letters must be included.
And if one or both are missing,
the application will not move forward.
Permission to submit letters for new application
cannot be recycled for resubmission or a revision.
Rather, a new letter is required
if you have a resubmission or a revision.
So, just make sure that you remember the six-week due date
before the application is due. That still applies.
You need to request a meeting again, receive the letters,
and when you submit a revision or resubmission,
just confirm that you're submitting
the correct version of the letter.
Permission to submit an application
does not guarantee that the application
will be moved forward to NIH review.
That's because only applications
that are deemed responsive to the terms of both the NOSI
and the NOFO will be moved forward
and considered for this initiative.
And finally, permission to submit
does not mean that you're going to be guaranteed funding.
In terms of the format logistics of submitting the cover letter,
this is going to be uploaded as an attachment
in that form we mentioned earlier
that shows up first in the table of contents, right?
That form that is SF-424,
Receipt and Referral Application form.
And you're going to go to page two.
The last field is 21,
and it says "cover letter attachment."
And just so that you know,
there's all these messages in different forums
that say that many times people submit their cover letter,
for some reason, it ends up in field 20.
So, just be mindful of this and make sure that
when you're attaching the cover letter,
it goes to field 21, "cover letter attachment."
For the cover letter, what you want is to have
that first page be the cover letter you're writing,
addressed to the Division of Receipt and Referral.
And that letter should contain the application title,
the title and number of the NOFO and the NOSI,
and a statement that you have attached
the required documentation,
which means these two letters we keep talking about, right?
And then apart from that,
just combine the two permission letters you receive.
And just so that you know, the cover letter will not become
part of your assembled application.
So, when you go to see your assembled application
in eRA commons,
just don't be worried if you don't see the letters there.
They're not there because they're not shared
with peer reviewers.
They're only used for administrative purposes.
So, another R13 requirement we mentioned in that table
of contents, right, was the diversity plan.
Since it is a unique requirement,
let's go through some important points related to this section.
The biggest reminder is if the diversity plan is missing,
your application will not be reviewed.
There's all these requirements for the system to understand
that the diversity plan is a diversity plan.
So, remember to use the correct required file name that is here,
no spaces.
And if the file name is changed, grants.gov might not interpret
that you submitted your diversity plan,
and it's going to flag an error.
And that will result in the application
not being moved forward
to receipt and referral for further attention.
So, make sure that you submit the diversity plan
using field 12 that is called "Other Attachments"
in the Research
and Other Project Information form,
and that form is linked here for you.
The limit of this plan is one page in length.
And during the review, remember that section that I told you,
Section 5 of the NOFO explains this information in more detail.
During review, the diversity plan will be evaluated
based on how it demonstrates your efforts
to enhance diversity
and increase participation of individuals
from diverse backgrounds,
including underrepresented groups,
in the planning, implementation, and engagement.
Always remember that word, engagement,
in the proposed conference and meetings.
In terms of content,
what is expected to be included in the diversity plan?
You can reference this slide for that information.
In summary, it provides specific information
for how you plan to enhance diversity
by increasing participation of individuals
from diverse backgrounds, like we mentioned before,
and that includes the organizing committee,
speakers, and other participants.
Also, demonstrate how you will create mechanisms
to support not only the representation,
but that word, engagement, comes up again.
Demonstrate, you know,
think about childcare, lactation spaces,
and when you describe your diversity plan,
always consider the geographical conference area
of the participants
and the people who will be part of this effort,
the expected size, the composition,
and how your efforts will be assessed after the fact.
Due to the nature of this effort,
it is important to give strong consideration
to who will be your key personnel.
And why is this?
Because you will need a wide range of expertise
and experiences to come up with endorsable CDEs
that move autoimmune disease research forward.
And remember, part of this effort
is reaching consensus on the CDEs.
So, carefully consider the different types of expertise
needed in the context of the disease area of focus.
For example, clinicians, scientists,
clinical research coordinators,
epidemiologists, data scientists, statisticians,
and other people from the research community
or the clinical community.
And then, also remember the people living
with autoimmune diseases, advocacy groups, and caregivers.
Ensure that there is balanced and adequate representation
of different perspectives in the field, again,
including the voice of people
living with autoimmune diseases and caregivers.
Grants.gov requires a valid
Commons ID for each key person in the application,
and this can become a rate-limiting factor
if you don't have that ahead of time.
So always, when you're going to consider
and ask a person to be part of your key personnel,
ask them if they already have a valid Commons ID.
And if they don't, ask them to take care of it right away.
For key participants who are not key personnel,
provide letters of support documenting
that they want to participate,
that they will support this effort when it is appropriate.
For example, think of everybody who's telling you,
"Okay, I'm going to be part of this effort,"
speakers, presenters, moderators,
and always remember the advocacy groups,
the people living with this disease, and the caregivers.
Biosketches are required for each senior key person
in your application,
so please make sure that they're using the correct format,
and remember that they need to use a non-fellowship template.
The QR code in the slide links
to the current instructions for biosketches.
Confirm that the personal statements
reflect the R13 submission and that part of the biosketch
is not talking about a different application.
For the purposes of R13,
they must describe how past experiences, training,
and expertise will contribute to consensus building,
increasing the participation of individuals
from diverse backgrounds, and remember always,
to think of people from underrepresented groups
and development of endorsable CDEs
in the disease area of focus.
So, also remember that all of the attachments
in the application,
and this is also relevant to the diversity plan,
they have to follow the formatting requirements
for attachments.
And that information is linked in the slide,
where you can find instructions
for formatting all the PDF documents
that are going to be attached to the submission.
So, what is allowable in the budget?
You might remember that in the slide talking about the NOSI,
I said the award period is one year,
but let me give you a bit more context about that.
If you're doing this type of project for the first time
and are unsure of how it will evolve,
you can initially request one year of funding
for a set of CDEs
and then submit future applications for additional CDEs
if that is appropriate.
Another option is if you're considering
requesting multiple years of funding.
Just keep in mind, this needs to be discussed
during the meeting with OADR
and the Administering Institute, and if you do that,
we're going to ask that a clear plan
with concrete milestones of CDEs for each year must be specified.
The funds can be applied to salary, conference facilities,
online conference platforms, publications, as appropriate,
as you think is needed. Indirect costs are not allowed.
The NOFO Section 4 will give you all the details
about what can be considered under funding.
The award budget is $75,000 total cost
for one year of funding.
Provide a narrative justification
for each proposed personnel addition,
including the role they will play in the conference
and the proposed level of effort.
Include information regarding efforts to obtain funding
for this conference from other sources.
We include that information there, too.
Reminder, as you write this budget and put it together,
the final product must be endorsable CDEs
that the community has come to consensus on.
How to write the specific aims?
Well, consider if the specific aims
that you originally sent to OADR and the Administering Institute
for that meeting to request permission to submit.
At this point,
by the point of receiving the permission to submit
and putting together your application, there might be --
it might be needed to change some parts of this.
So, always confirm that all of these
are appropriately described,
and also take into account all the guidance
you receive from OADR and the Administering Institute.
Revisit the disease area of focus,
the landscape analysis of the current state of the field,
and again, look at the list of NIH-endorsed CDEs.
Confirm that you're working on new ones,
and provide specific details. This is key.
You need specific details of the approach
you're going to use for that consensus-building exercise
to show that you have a plan to bring the community
to consensus around the specific components of CDE development
that you're proposing.
The applicants are expected to work in consultation with OADR
and the Administering Institute program staff
to ensure that the CDEs developed in this process
meet the requirements of the NIH CDE Governance Committee.
Keep in mind that reviewers will evaluate
if the conference or meetings or approach
that you're going to use addresses an important point,
and how scientific knowledge or clinical practice
will be advanced. Keep this in mind as you write
because it is important that this is clear to the reviewers
when they read your specific aims and the conference plan.
Since the final product must be endorsed with CDEs,
it is expected that the specific aims will focus
on bringing the community together
to build consensus and deliver those CDEs.
It is up to the applicants to strategize
which CDEs to target and when.
What information is needed for the conference plan?
So, this is very clearly explained.
I have the slides here as reference,
but always look at the NOFO
because this part is very clearly explained in the NOFO.
But also remember that you need to think
in the context of these NOSIs.
So, start with describing the approach that you propose
to use to achieve those endorsable CDEs.
And remember, you can decide what approach to use.
And also, think of the pre-work leading up to the conference
or meeting you propose,
and describe that clearly in the application.
Describe the objectives, the specific problem,
and all the logistical arrangements
that you plan to use.
Outline the proposed agenda and the timeline,
and in the timeline, include concrete,
achievable milestones
for building the consensus towards endorsable CDEs.
And this needs to be covered during the period of the award.
Provide a detailed justification for the approach
that you have chosen to take to build that consensus.
And remember to include in that justification
the scientific and clinical need,
the timeliness of the effort,
and the usefulness to the scientific community
and to people living with autoimmune diseases.
Additional information needed for the conference plan.
For in-person meeting attendance for some individuals
will be dependent on family situations
or other situations that may affect their ability to come
to whatever effort you're choosing to move forward with.
So, describe in the application the plans to identify resources
for childcare and other types of family care
at or near the conference and meeting site,
so that when individuals have family care responsibilities,
that does not stop them from being part of this effort.
The information should allow attendees to arrange
as needed for their specific situation.
And we strongly encourage that a hybrid option is always
available to account for unexpected events
like getting sick or having a family member get sick.
Describe the composition and role
of the organizing committee
and provide the names and credentials
of the key participants.
And again, I want to remind everybody
to think of everybody that is included there,
speakers, presenters, moderators,
the advocacy group representatives,
people living with autoimmune diseases, and caregiver.
And include the basis for why these people were selected.
Describe how advocacy groups, caregivers,
and people living with autoimmune diseases
will be part of this effort.
It is so important to garner their input
when completing the CDE questionnaires.
And some questions that come to mind,
but there are many others, are:
Are the questionnaires too burdensome?
Do they measure things that matter to them?
And do the new CDEs will measure things that matter to them?
Estimate anticipated geographic conference area
where participants will come from,
the expected size and composition of the audience,
as well as a method of selection.
Publicity and dissemination of the panel public
are also part of the conference plan.
So, please don't forget to address this
in those six-page limit that is the conference plan.
Describe the plans for publicizing the conference
to all interested participants.
How are you going to raise awareness
of what's happening so that people who are interested
in being part of the effort can be part of the effort?
And keep in mind, publishing the proceedings.
I know that that's not required,
but it's strongly, strongly encouraged.
Publishing costs, by the way,
are an allowable cost under the budget.
Include specifics on groups, associations, institutions,
among others, that will be contacted in efforts
to expand diverse participation
in every role of conference or meeting
or approach you're going to use.
Identify related conference that have been held in the past
within the last three years
and explain how this conference is unique or similar
and how this conference can move the field forward.
So now, we can talk about common pitfalls and solutions.
We want to remind everybody, if this is your first time
submitting an R13, partner with an institution
that has successfully competed for R13 funding.
They're going to be able to tell you things about what to do,
what not to do, what to expect, et cetera.
Attachments must comply with formatting requirements
for the system to upload the PDF document
you are trying to attach.
If you don't use the correct format,
the system is not going to recognize the attachment,
and it will not compile it with the assembled application.
I have some examples here, but there are others.
Some examples to keep in mind
are that the file name has character limits.
Remember, the hyperlinks are not allowed
in any part of the application
except they are allowed in the biosketch,
but only for you to provide the publication list
in the biosketch. Those are two examples.
So, go to the formatting requirements
to know what is important to keep in mind
so that the grants.gov
recognizes the attachment you're trying to upload.
And the biggest solution to problems
that people encounter is to submit early
and view your application before the due date.
When you view your assembled application
and related documents using the eRA Commons Status,
you can confirm that nothing is missing
or that the application was not corrupted
when grants.gov uploaded that PDF document.
This has been known to happen to other people.
If you submit at least two days prior to the deadline,
that allows you time to make corrections before the deadline.
Keep in mind that that two-day viewing window
allows corrections but does not extend the deadline.
That's why it's important to do it early.
If you receive emails from grants.gov notifying you
that there were submission errors,
these submission errors must be resolved
before the application moves forward
from the grants.gov platform to receipt and referral.
If you do not see your application in eRA Commons,
that means your application was not moved forward
from grants.gov to receipt and referral.
Remember that the NOFO has contact information
for when you run into issues during the submission process.
This slide is here just so that you know to raise awareness
that CSR has published guidance for NIH grant applicants,
and it addresses a lot of the topics
that we've discussed today and others.
So, here's an example of how that infographics look like,
but you also have the link and the QR code
that will take you there.
And finally, I wanted to leave you with the due dates
so that you keep in mind --
if you're submitting for whichever due date you choose --
you know when is the due date to reach out to OADR
so that you can request permission to submit,
have the meeting done,
and receive the letters on time so that your submission goes in.
And finally, I want to say thank you.
Thank you for your interest in this funding opportunity.
Thank you for your attention today,
and thank you for your interest in the work being done by OADR.
Here are -- if you have questions,
here are contact information so that you can reach out to us.
Very soon, when you see this video on the website,
you will also have access to the slides so that you have --
so you can use all the links that are provided
when you are submitting your application.
Thank you again.