NIH Information

What is NIH?

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.

Where to begin for NIH?

Identify a public health issue related to your field
Narrow in on Aims for a tight study
Make sure you can do it
What would you have to learn in order to develop an effective intervention in your area?

Find out what is being funded in your topic area by using NIH RePORTER.

There are three kinds of NOFOs:

Parent Announcements – broad funding opportunities for “investigator-initiated” proposals
Program Announcements – encourage applications in a specific area of interest
Requests for Applications – invite applications in a well-defined area of scientific interest

Helpful NIH Links to find NOFOs:

Notices of Special Interest (NOSI) are also released to allow Institutes to express interest in proposals on a specific scientific topic. Current NOSIs can be found here using the advanced search.

Faculty and staff at UT also have access to Pivot to search for federal funding opportunities and other sources of funding.

Types of NIH grants typically applied for by PRC faculty:

Research: R01, R21, R03 (see checklists below)
Programs (reach out to grants@prc.utexas.edu for a particular program project checklist)

Funding opportunities for graduate students and postdocs:

Career: K01, K99/R00 (see checklists below)
Training and Fellowships (see checklists below)

Research Grants Comparison by Mechanism

	R01	R21	R03
Length of Research Strategy	12 pages	6 pages	6 pages
Preliminary Data?	Yes	No	No
Special criteria/favorable payline for new investigators?	Yes	No	No
Length of project	Up to 5 years	2 years	2 years
Budget limits	$250,000 in direct costs per year for modular budgets; detailed budgets if more than $250K in any one year; permission is needed for more than $500K per year	$100,000 over 2 years	$275,000 over 2 years

Get familiar with the SF424 guide and review the table of page limits. Application instructions for applying to NIH grants are found in the SF424 guides. Type-specific instructions are linked below:

Checklist for common NIH mechanisms:

NIH Standard Due Dates are found here.

	Cycle I	Cycle II	Cycle III
R01 (new)	February 5	June 5	October 5
R01 (resubmission)	March 5	July 5	November 5
R21, R03 (new)	February 16	June 16	October 16
R21, R03 (resubmission)	March 16	July 16	November 16
K series (new)	February 12	June 12	October 12
K series (resubmission)	March 12	July 12	November 12
F series (new and resubmission)	April 8	August 8	December 8

Standard Form 424

PDF copies of forms found in electronic application packages can be found here and are for reference only.

Formatting your Documents

Refer to think link for specific instructions for documents requirements. Font and line spacing requirements need to be followed. All documents must have 0.5-inch margins and information should be removed from the headers and footers.

Hypertext, Hyperlinks, and URLs

Refer to NOT-OD-20-174: Reminder: NIH Policy on Use of Hypertext in NIH Grant Applications.
Hyperlinks and URLs are only allowed when specifically noted in funding opportunities and/or form field instructions. It is highly unusual for a funding opportunity to allow links in Specific Aims, Research Strategy, and other page-limited attachments.
Hyperlinks and URLs may not be used to provide information necessary to application review. Applications must be self-contained and reflect the information available at time of review.
Reviewers are not obligated to view linked sites and are cautioned that they should not directly access a website (unless the link to the site was specifically requested in application instructions) as it could compromise their anonymity.

Research Strategy

When writing your Research Strategy, you will need to address rigor and reproducibility.

Significance: Rigor of, and weakness and gaps in, prior research
Approach: How your project will address weaknesses in the rigor of prior research; Scientific rigor of your project (design, methodology, procedures to achieve robust and unbiased results); How biological variables (e.g., sex, age, weight, underlying health conditions) will be incorporated into your study design and data interpretation.

Biosketch

NIH biosketch template and instructions
Anyone listed as senior/key personnel must have an NIH biosketch
Biosketches can also be prepared using SciENcv.
Anyone listed as senior/key must have an eRA Commons username. If you are collaborating with someone who is in need of an eRA Commons username and cannot obtain one from their home institution, please let us know and we can request one through UT OSP.

Budget

PRC staff are experts in helping you develop a budget that meets institutional and NIH guidelines and will also draft your budget justification and personnel justification. The current budget template for proposal budget development is found here.

Letters of Support

Letters should stipulate expectations for co-authorship, and whether cell lines, samples, or other resources promised in the letter are freely available to other investigators in the scientific community or will be provided to the particular investigators only.
For consultants, letters should include rate/charge for consulting services and level of effort / number of hours per budget period anticipated. In addition, letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service.
For consultants and collaborators that are working independently of their home institution and that will be serving as a consultant on an NIH project, they must fill out this short Conflict of Interest form here.

Data Management and Sharing Plan

Applicants proposing to conduct research that will generate scientific data are subject to the NIH Data Management and Policy. See the SF424 for specific guidance and also the resources below

Writing a Data Management & Sharing Plan
DMP Tool (sign in with your EID credentials)
UT Austin Research Data Services

Human Subjects Research

If you are unsure if your proposal will be considered human subjects research, NIH has developed a decision tool to assist you with determining if your research involves human subjects. See Decision Tool: Am I Doing Human Subjects Research?
If your proposal will include human subjects research, you will need to include information for the Human Subjects and Clinical Trials form, and follow the instructions here.

NIH Receipt and Referral

The NIH Center for Scientific Review (CSR) assigns the proposal to a specific NIH Institute for potential funding.
CSR assigns the proposal to a study section.
Not sure which study section to request? Use ART – Assisted Referral Tool (ART)

NIH Grant Submission, Review, and Decision Process

Review and Award Cycles

	Cycle I	Cycle II	Cycle III
Application Due Dates	Jan 25 – May 7	May 25 – Sep 7	Sep 25 – Jan 7
Scientific Merit Review	Jun – Jul	Oct – May	Feb – Mar
Advisory Council Round	Aug or Oct*	Jan	May
Earliest Project Start Date	Sep or Dec*	Apr	Jul

*Advisory Council Round for Cycle I applications may be August or October, and their earliest project start date may be September or December respectively. See Standard Due Dates.

Initial Scientific Peer Review

Once your application is submitted it is assigned to a Scientific Review Officer (SRO). The SRO is the only person to contact if you would like to request a different study section assignment. The SRO and study section reviewers do the following:

The SRO checks each application for completeness.
Reviewers of the panel go through list of applications and declare any conflicts of interest.
The SRO assigns the proposal to 3 reviewers on the panel.
The SRO recruits additional reviewers as needed based on their expertise.
Reviewers get their assignments and have 4-6 weeks to review them and write up their critiques.
Once reviewers submit their reviews online, the SRO then ranks the proposals according to their overall impact scores.
Typically, the top half are discussed at the study section.
The bottom half are “triaged” – they do not get scored or discussed; the investigator does not get a copy of the written reviews.

NIH now uses the Simplified Peer Review Framework for most research project grants. See FAQs.

Study Section Meeting

Who is in attendance:
- Scientific Review Officer (SRO) and another CSR staff person
- Chair, who is a researcher outside NIH
- Section members, who are typically NIH-funded researchers (regular and ad-hoc)
- Program officers (as visitors)
For each proposal:
- Reviewer typically spend only 15 minutes on each proposal.
- Everyone with a conflict leaves the room.
- The chair reads the title, names the PI, and states the grant type and if it is a resubmission.
- All reviewers state their Overall Impact scores.
- The primary reviewer summarizes the proposal and their critique.
- Second and third reviewers provide additional comments.
- There is an open discussion.
- Initial 3 reviewers are asked if they want to revise their scores; they state new Overall Impact scores.
- Chair announces the range of impact scores and asks if anyone is voting outside the range.
- Anyone voting outside the range must raise their hand and say why they are doing so.

NIH Scoring System

Overall Impact or Criterion Strength	Score	Descriptor
High	1	Exceptional
	2	Outstanding
	3	Excellent
Medium	4	Very Good
	5	Good
	6	Satisfactory
Low	7	Fair
	8	Marginal
	9	Poor

Other relevant NIH and UT-specific documents and links:

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