Part 8. Assignment and Review

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Table of Contents

• Are You Ready for This Part?
• NIH Checks Your Application
• Applications Get an NIH ID Number
• Applications Are Assigned to an Institute and Integrated Review Group
• Call If You Are Not Satisfied With a CSR Assignment
• If You Need to Send Revised Information
• Initial Peer Review Assesses Scientific Merit
  • Who Peer Reviews Your Application?
  • SROs Assess Completeness, Assign Reviewers
  • Noncompetitive Applications Get a Streamlined Review
  • Basic Layout of Initial Peer Review
  • Most Reviewers Scan Each Application
  • Assigning an Overall Impact Score
  • How NIH Review Criteria Affect Your Score
  • If Your Application Is Not Discussed
  • Comparing Old and New Peer Review Processes
  • Foreign Applications Have an Extra Review Step
  • Reviewers Are Fair But Not Always Right
• When You Can Expect to Hear Back
• Know What a Summary Statement Means
• If Faults Are Fixable
• Prepare Your Just-in-Time Information
  • If You Have Human Subjects Documentation
  • If You Have Animal Research Documentation
  • Prepare Your Other Support Submission
  • If You Have Consortium or Contractual Agreements

Are You Ready for This Part?

Part 8. Assignment and Review describes how NIH processes your application and conducts initial peer review.

Before reading this page, be sure that you . . .

• Know how to use this tutorial and where to find tools. Read How to Use the NIH Grant Cycle in Start Here. Find helpful Tools: application samples, checklists, timelines, and contacts.
• Understand just-in-time information. Read You Will Send Some Materials Just-in-Time in Part 6. Other Application Sections.
• Have an application that passed Commons validation. Read Part 7. Applying.
• Know who your program officer is. See Contact Staff for Help in Start Here.

NIH Checks Your Application

After your application moves to NIH's Center for Scientific Review (CSR), staff there make sure it conforms with administrative and formatting requirements.

Be aware that this check is a potential failure point. NIH may return your application to you without a peer review for the following reasons:

• Including other support (you are supposed to submit this just-in-time).
• Insufficient human or animal documentation, including missing data, assurances, or other required documentation.
• No preapproval documentation to submit an application requesting $500,000 or more in direct costs for any one year. If you want more information, read the Big Grants SOP.
• No preapproval documentation for an investigator-initiated clinical trial -- go to Investigator-Initiated Clinical Trial Resources.
• No documentation of approval for using select agents.
• Detailed rather than modular budget if requesting $250,000 or less in annual direct costs for grant types requiring modular.
• Improper formatting, including font size and margins. See Page Limits, Formats for details.
• Improper submission, for example, emailing the forms to NIH instead of submitting through Grants.gov.
• Not meeting the requirements of a request for applications or institute-specific program announcement, if responding to one of the initiatives. NIAID program staff decide this.
• Contacting a reviewer.

A late application is also a potential failure point. Read more in the Rules for Late Applications and Late Applications SOP.

Applications Get an NIH ID Number

NIH's Center for Scientific Review gives your application a unique identification number that looks like this: 1 R01 AI183723 02 A1 S1.

Each entry tells another snippet of information about your application.

• The first number is the application type (e.g., new is Type 1), which tells NIH whether your application is a new, renewal, noncompeting, or other type of application. Application types are listed in our Glossary.
• Next is the activity code, the type of grant you've applied for, e.g., an R01 research grant.
• The next two-letter abbreviation is the institute code; NIAID's code is AI.
• Next is the unique serial number assigned by the Center for Scientific Review.
• Then comes the suffix showing the support year for the grant.
• The final two are codes for an resubmission, supplement, or fellowship institutional allowance.

In the Commons, you will see this NIH number associated with your application along with the old Grants.gov tracking number. NIH staff will typically refer to your grant or application using the NIH number.

Applications Are Assigned to an Institute and Integrated Review Group

CSR assigns your application to an integrated review group and then to a study section for initial peer review. It also assigns an institute or center for funding.

You can request those assignments in your cover letter. But keep in mind that while CSR staff usually honor your request, they are not required to, and they may make a different assignment based on NIH referral guidelines and workload factors. Read about Requesting an Institute and Requesting a Study Section in Part 6. Other Application Sections. For advice, read the "Stay on Top of Your Application Even After You Apply" article in our New Investigator Series.

Within seven to ten days after you apply, you should find your assignments in the eRA Commons.

• Log in to the Commons to check. If you don't see your assignments within two weeks, call the NIH Referral Office at 301-435-0715.
• At first you might not see the expected study section. Instead, that field may show the umbrella organization, the integrated review group. This item is updated over the next few days when your application is assigned to the study section that actually performs the initial peer review.
• If CSR gives you an assignment you're not happy with, you can request a change. Read more information at Call If You Are Not Satisfied With a CSR Assignment.

After NIAID receives your application, our Referral and Policy Analysis Branch assigns it to a program division using our internal referral guidelines.

The program officer, grants management specialist, and scientific review officer fields will be blank initially in the Commons.

Are you happy with your application's assignment? Yes. Skip ahead to If You Need to Send Revised Information. No. Continue reading.

Call If You Are Not Satisfied With a CSR Assignment

Follow these steps if you are not happy with the assignment made by CSR to a study section or institute:

• Let your scientific review officer know as soon as possible -- well before peer review -- if you see a major problem. For example, a committee member may have a conflict of interest, or you may feel the group doesn’t have the necessary expertise.
• Check the CSR Study Section Roster Index to find an alternative.
• Discuss the alternative with the chief of the integrated review group for your assigned study section.
  • Get this person's contact information on CSR's Office of the Director staff list.
  • Ask your scientific review officer for this person's information if you cannot find it on CSR's Web site.
• Fax a letter to CSR at 301-480-1987 stating the rationale for the change. Here is an example of an acceptable and an unacceptable request:

  Acceptable: "The focus of study section X seems to be more on the structural biology of molecules of immunologic importance. Since my application proposes to develop new antibodies for phase I human studies, the clinical perspective of reviewers on study section Y is critical to appreciate the approaches I have taken."

  Not acceptable: "I don’t want study section X due to lack of expertise Z.”

• If this action does not resolve the problem, you can dispute the assignment with CSR's director of receipt and referral. Call 301-435-0715.
• Also talk to your program officer about the situation.
• Keep in mind that it is often better to wait for the next receipt date than be reviewed by the wrong reviewers.

Appealing after the review. You also have grounds for an appeal if the study section did not have the expertise required for an effective peer review, and as a result, the review turned out poorly. Read our Appeals of Scientific Review of Grant Applications SOP for more information.

Also read our New Investigator Series articles: "Your Application Takes Center Stage" for advice about investigating committees and members and "Stay on Top of Your Application Even After You Apply" for advice about getting the right institute and study section.

If You Need to Send Revised Information

Do you have additional data? No. Skip ahead to Initial Peer Review Assesses Scientific Merit. Yes. Continue reading.

NIH allows you to submit only certain materials before initial peer review:

• Revised budget pages, e.g., due to new funding or equipment.
• Revised biographical sketches, e.g., due to the loss of senior or key personnel.
• Letters of support or collaboration due to a change in senior or key personnel.
• Adjustments resulting from natural disasters, e.g., loss of an animal colony.
• Adjustments resulting from change of institutions, e.g., a PI's move to another university.
• News of an article accepted for publication. (Do not send a copy.)

Use the usual forms, create a PDF, include your authorized organizational representative's signature, and make sure your scientific review officer receives all materials at least one month before the peer review meeting.

When submitting an application responding to an RFA, you may have different rules. Get in touch with the peer review contact listed in the FOA or the scientific review officer to find out what you are allowed to do.

For more information, read NIH's Frequently Asked Questions on the post-submission materials policy. For advice, read the "Stay on Top of Your Application Even After You Apply" article in our New Investigator Series.

Initial Peer Review Assesses Scientific Merit

Your application's most significant test is initial peer review.

Your peers -- successful scientists in your field and related ones -- use the information in your application to assess the merit of the science you've proposed and your ability to get the work done.

Peer review results in a numerical value indicating the reviewers' judgment of the likelihood that your project will have a powerful impact on its area of science. That number is the most important factor in determining your application's success.

The next section details NIH initial peer review. (For a broad overview, read Perspective on Peer Review in our New Investigator Guide to NIH Funding.)

Find more information online:

• Review Criteria SOP and other Peer Review SOPs
• Peer Review questions and answers
• Peer Review Policies and Practices
• After Peer Review questions and answers

Who Peer Reviews Your Application?

NIH peer reviewers are scientists, mostly from academia, who come to NIH three times a year for several days to review applications.

Depending on grant type, initial peer review meetings take place in either CSR or an institute. The process is essentially equivalent in both venues in terms of policy, review criteria, committee composition, conduct of the meetings, and size of the group -- about 20 members.

The key people involved are:

• Review committee chair -- a committee member who leads the discussions.
• Scientific review officer -- NIH staff member who manages the effort and generally has a Ph.D. in a relevant field of science. SROs recruit reviewers, inform them of policies, create lists of streamlined applications, and write summary statements.

CSR Review

• Standard research grants, R01s, are reviewed in CSR.
• CSR structures its review committees, also called study sections, into umbrella organizations, the integrated review groups.
  • Each IRG houses several study sections, which have a narrower scientific focus.
  • See an example of an IRG organization at Infectious Diseases and Microbiology IRG.
• CSR also organizes special panels when special expertise is needed.
• Go to CSR Study Section Roster Index to see members of standing study sections.

NIAID Review

• NIAID has chartered review committees for AIDS; Allergy, Immunology, and Transplantation; and Microbiology and Infectious Diseases.
  • They review applications for program projects, cooperative agreements, training and career development awards, and applications responding to requests for applications. Find our standing review committees on Councils and Committees.
  • For many RFAs, we set up special review groups that have knowledge relevant to the science.

SROs Assess Completeness, Assign Reviewers

Your scientific review officer does an initial check of your application to make sure the key parts are there.

If you're responding to a request for applications, NIAID program staff check to ensure it is responsive to the RFA.

Before sending your application to reviewers, SROs look at the application more thoroughly to make sure it's complete and may contact you if anything is missing. If this happens, send in the information quickly so reviewers receive it well before the review.

SROs assign primary and secondary reviewers (plus at least one additional discussant).

• Assigned reviewers read your application thoroughly and write a critique before the meeting. They also assign preliminary scores for each review criterion and an overall impact score.
• SROs may also ask other members to serve as readers.

Four to six weeks before the meeting. SROs send each committee member a copy of all applications to be reviewed.

Noncompetitive Applications Get a Streamlined Review

NIH uses a process called streamlining so reviewers can focus on applications that have a chance of being funded.

Review committees don't review any application the group unanimously feels is roughly in the bottom half of applications being reviewed at the meeting (that percentage varies by grant type as well as by study section).

Since no institute funds 50 percent of applications assigned to it, there's no need to review the bottom half.

Here is how streamlining works:

• One week before the study section meets, SROs ask members for a list of applications they feel should not be reviewed and prepare a combined list.
• If any reviewer disagrees with a call, the group will review that application.

We describe this in more detail below.

Find more information online:

• Unfunded Application Advice questions and answers
• Are there formal quotas for the percentage of grants not given a formal review and score? in the Peer Review of Applications questions and answers

If you already have your review results, was your application streamlined? Yes. Go to When Your Application Is Not Discussed. No. Your application will be reviewed. Continue reading.

Basic Layout of Initial Peer Review

CSR review committees gather three times a year for a one- or two- day meeting.

Initial peer review meetings take place four to five months after the NIH receipt date for applications other than AIDS, one to two months later for AIDS applications.

At the meeting, the scientific review officers make sure the group adheres to policy and procedure. The group's chairperson, a committee member, facilitates the discussions. To experience a peer review meeting, watch CSR's video of a mock study section Video on Peer Review at NIH.

Our Advice: Know What Happens During Peer Review

Though they do not participate, institute program staff may attend the meeting and can become a source of additional insight into the discussion.

• You might want to ask your program officer if he or she plans to attend the meeting.
• If you need to revise later, your program officer's feedback can be a valuable supplement to the summary statement. (We discuss this further in Contact Your Program Officer for Feedback.)

After the SRO opens the meeting, the primary reviewer presents your application to the group. (Peer reviewers with a conflict of interest leave the room beforehand.)

• Reviewers review applications in the order of their preliminary overall impact scores.
  • This ordering helps them calibrate final scores.
  • Starting with the highest scoring applications also helps them gauge when it is appropriate to stop discussing applications.
    • Generally, review groups do not discuss about half of applications.
    • At that point, they decide if other applications merit discussion.
• The group explores differences of opinion, interacting heavily during the discussion, which generally lasts 10 to 15 minutes.
• Other reviewers ask the assigned reviewers questions and skim the application during the discussion.
• Generally, once the members have found a fatal flaw they all agree to, they stop discussing the application.
  • Examples of fatal flaws are not protecting the safety of lab workers or animals, proposing too much work for the award time, not recognizing a key paper in the field, or including a factual inaccuracy.
• Where possible, reviewers evaluate applications from new and early-stage investigators together as a separate group within each study section. Clustering these applications ensures that the group reviews at least half of them and that NIH can meet its targets for funding new investigators.
• Review materials are confidential.
• Reviewers are not allowed to divulge any information outside the meeting.
• At the end of the meeting, NIH staff collect and destroy all materials used in the review.

Most Reviewers Scan Each Application

Generally, only assigned reviewers will read your application before the review. Other reviewers mostly read just your Abstract, Significance, and Specific Aims.

Reviewers receive dozens of applications for each meeting, totaling thousands of pieces of paper to read in a few weeks -- and they have full-time jobs! They couldn't possibly read all applications in depth.

Keep in mind that about twenty people will score your application even though only a few will have read it in depth. This is the reason you write and organize your Specific Aims for both audiences.

You must make a strong case for your research so the assigned reviewers can readily read, understand, and explain your project to the group. If you haven't had a chance to read our advice, check out the following articles in our New Investigator Series:

• "Your Application Takes Center Stage"
• "May the Force Be With Your Application"
• "Start Writing Your Application"
• "Writing the Research Strategy"
• "Create an Appealing, Blemish-Free Application"
• "Finishing Touches for Your Application"

Assigning an Overall Impact Score

Your overall impact score is the key review outcome, reflecting the reviewers' judgment of the likelihood of your project to exert a sustained, powerful influence on its field.

Here's how reviewers arrive at the score:

• Before the meeting the assigned reviewers score each criterion and determine a preliminary overall impact score.
• The discussion at the meeting may cause assigned reviewers to change the overall impact score they suggest to the group at the end.
• Next, all reviewers vote.
  • Assigned reviewers enter their official scores for each criterion and an overall impact score on the vote sheet. The other reviewers can see these scores.
  • Other reviewers give an overall impact score (and usually have an option of scoring each criterion).
  • Each member marks scores privately on a vote sheet, assigning a whole number from 1 (best) to 9 (worst). For an illustration of the new scores, see the excellent graphic below that NIH created and we adapted.
• At the end of the meeting, the scientific review officer collects vote sheets and adds the scores. After the meeting, reviewers can edit their criterion scores and critiques, but they not change their final overall impact scores.
• To create a raw overall impact score, scores are averaged and rounded mathematically to one decimal place, e.g., a 1.34 average yields 1.3. That number is multiplied by 10 to yield an overall impact score, e.g., 13.
• R01 applications also get a percentile. Learn how NIH creates percentiles at Understanding Percentiles and Paylines in Part 10. Funding Decisions of the NIH Grant Cycle: Application to Renewal.

For more information on funding decisions, see How NIAID Determines Which Applications to Fund.

Scoring Table for Research Grants

How NIH Review Criteria Affect Your Score

To arrive at your overall impact score, NIH review committees use these core review criteria:

• significance
• investigators
• innovation
• approach
• environment

Overall impact may sound like the significance criterion, but it's very different.

• Significance is the importance of your project.
  • Reviewers evaluate the significance of your project, not the field.
  • This assessment is not about your ability to conduct the research. While reviewers can give a bad score if they think success is unlikely, the significance criterion does not reflect that judgment.
• An overall impact score reflects all the review criteria, of which significance is one. It does not reflect a mathematical sum of the criteria, but a gestalt (i.e., it cannot be derived from the sum of its parts).

Read the Review Criteria SOP for additional details. If you're responding to a request for applications, see if it has any special review criteria.

Role of the Review Criteria

Peer reviewers don't score applications strictly by the review criteria. Rather, the criteria are gauges for assessing merit and feasibility.

Your assigned reviewers give your application a score for each criterion as well as the whole application; other reviewers score just the whole application.

As we noted above, the criteria are unweighted and unrelated to the final overall impact score, which reflects the reviewers' judgment of your application as a whole.

It's important to understand how review criteria relate to your score:

• Overall impact and merit. A final score reflects a judgment of the likelihood of a project to have a powerful impact on its area of science.
• Ideal application. To a large extent, reviewers judge your application based on their ideal outstanding application in your field of science.
  • This is similar to a dog show, where dogs are judged for "best of breed," and different breeds do not compete with each other.
  • So there is not a one-to-one relationship between how your application measures up to the review criteria and your score.
• Usage varies. Adherence to the criteria varies by committee.
• Weight varies. An application does not need to be strong in all review criteria to get a high overall impact score, though all criteria can affect your score. Two example:
  • Reviewers may assign an exceptional score to a proposal for important work that is not innovative but is essential to move a field forward.
  • An application with high significance may receive an outstanding overall impact score even if reviewers are less enthusiastic about the other criteria.

Other Critical Factors Can Affect Your Score

Your reviewers will consider other items besides the review criteria.

• Special areas. Depending on the experiments you propose, they will make sure you have complied with NIH policies for recombinant DNA research, human subjects, research animals, and select agents.
• Presentation. Your presentation can make or break your application.
  • Though reviewers assess science, they are also influenced by the writing and appearance of your application. (See the Insider's Guide to Peer Review for Applicants.)
  • If your application has lots of typos and internal inconsistencies, your score can suffer. Read more at "Create an Appealing, Blemish-Free Application" in our New Investigator Series.

If Your Application Is Not Discussed

Three types of applications are not discussed -- they do not receive a full review, overall impact score, or summary statement.  

It's important to keep in mind these applications can still be high quality and possibly fundable. To learn more about this now, read below starting at If Faults Are Fixable.

Keep in mind the length of time it may take from the time you reapply to the time an award may be received. See R01 Planning to Award Timeline for Initial Application and Resubmission, R01 Application Considerations for Each Review Cycle, and R01 Planning to Award Timeline by Review Cycle.

1. Streamlined review. Applications that peer reviewers unanimously judge to be roughly in the bottom half of applications being reviewed at the meeting (though the percentage varies by grant type as well as by study section) get a streamlined review.

Streamlined applications are not discussed at the meeting and do not receive an actual overall impact score. Instead, principal investigators get scores for the individual review criteria and critiques from assigned reviewers.

For more information, see Noncompetitive Applications Get a Streamlined Review above and If Faults Are Fixable below.

2. Not recommended for further consideration. NRFC is used for applications that lack significant and substantial scientific merit or have serious hazards or ethical issues. Such applications do not warrant a review and are generally not eligible for funding.

3. Deferred. A scientific review group can postpone the review of an application if unable to determine its scientific merit because information is missing. The group may contact the applicant right away or request another review at a later review date.

	Do you already know how your application fared in review? No. Skip the next question. Yes. Continue to the next question.
	Was your application not discussed or NRFC? Yes. Read the sections below including If Faults Are Fixable. No. Continue to the next question.
	Is your application foreign? No. Skip ahead to Reviewers Are Fair, But Not Always Right. Yes. Continue reading.

Comparing Old and New Peer Review Processes

The table below highlights the differences between both approaches.

Foreign Applications Have an Extra Review Step

NIH awards grants to foreign applicants if either the expertise or resources are not available here -- for example, access to a unique study population.

• Foreign institutions have an extra review step: reviewers assess whether comparable work is being done in the U.S. If it is, the grant will not likely be funded.
• Reviewers also consider the relevance of the proposed research to NIAID's mission and check whether there is a need for the research. If similar work is being done in the U.S., the application will suffer in review.
• Foreign investigators researching select agents must follow the NIAID Select Agent Research Review and Approval Procedure for New and Continuing Grants that Include Foreign Institutions.
• If using select agents, read NIAID Select Agent Policy for Foreign Institutions questions and answers.

Find more information online:

• Grants Policy and Management Training for Foreign Investigators
• Requirements for Foreign Institutions and Investigators
• NIAID International Awards portal
• Foreign and International Grants and Components SOP
• Foreign Workers on NIH Awards SOP
• International Awards questions and answers

Reviewers Are Fair But Not Always Right

• Peer reviewers themselves go through the same process you're going through. If they aren't fair to you, how could they expect to be treated fairly themselves?
  • If anything, reviewers have tried to capture more funds for their field by giving applications increasingly better scores.
  • Reviewers and scientific review officers are alert to bias and will argue vigorously against it if they perceive a competitor is not being fair.
• Though reviewers generally are fair, they are not always right.
  • They do their best based on the knowledge they have but could miss a point or misunderstand what you've written.
  • For this reason, you'll need to do an outstanding job of writing and organizing your application.
• Any reviewer who has a conflict of interest with an application is not allowed to review it. Reviewers sign conflict of interest statements stating they don't have a financial or other interest in your work.

For details on this subject, see the Conflict of Interest in Peer Review SOP and the Privacy, Conduct, Conflict of Interest, and Clinical Research Ethics questions and answers.

When You Can Expect to Hear Back

NIH releases scores to you and your program officer in the Commons within three business days, and your summary statement within 30 days (10 days for new investigators).

Know What a Summary Statement Means

• See an Annotated Summary Statement Sample (in the old format -- learn why on that page).
• Your summary statement has a lot of information: bulleted critiques from your assigned reviewers, brief summary of the discussion, overall impact score, percentile (for R01s), recommended budget, human and animal subjects codes, and any administrative comments.
• Find the overall impact scores and criterion scores from assigned reviewers.
  • If your summary statement has a code for a bar to award, we can't give you an award until you resolve the issue.
  • Contact your program officer immediately. You may want to read more in the Bars to Grant Awards SOP.
  • Bars reflect concerns about human subjects, animals, or biohazards.
• To find out what the codes mean, see Research Animals Involvement Codes, Human Subjects Involvement Codes, and Human Subjects Inclusion Codes.
• A summary statement is not an exhaustive critique.
  • It is not a teaching tool containing every point reviewers found to be problematic.
  • You'll use this information to revise a fixable application, if necessary.
  • Read Summary Statements Have Their Limitations.

Our Advice. After you read the summary statement, contact your NIAID program officer.

• If you have any questions about your summary statement, ask your program officer.
• Ask whether your application is likely to be funded.
• If funding is not on the horizon, ask whether he or she can give you more feedback from the review.

Go to R01 Planning to Award Timeline for Initial Application and Resubmission, R01 Application Considerations for Each Review Cycle, and R01 Planning to Award Timeline by Review Cycle.

If Faults Are Fixable

Our Advice: If Problems Are Fixable, Start Revising Quickly

If your application misses the payline or is not discussed and its faults are fixable, start revising as soon as you can since you may not have much time to revise after you get the summary statement.

For more information read:

• R01 Planning to Award Timeline for Initial Application and Resubmission
• R01 Application Considerations for Each Review Cycle
• R01 Planning to Award Timeline by Review Cycle.

First, determine whether the problems are fixable -- read Part 11b. Not Funded, Reapply.

	Are you thinking of appealing the review? Yes. Though you can appeal for errors in the review itself, we strongly advise against it. See Should You Appeal?, then continue reading here. No. Continue reading.
	Should you revise? Yes. Go to Part 11b. Not Funded, Reapply. No. Continue reading.

Prepare Your Just-in-Time Information

Just-in-time means you send information to NIAID when we request it. To see how we ask you for this information, go to our Sample Just-in-Time Email From NIH and How and when will I find out if I need to send information just-in-time? in the Just-in-Time questions and answers.

We request this information if your application scored roughly within the top 20 percent. Though you may not get funded, you should prepare your just-in-time information anyway. See If I receive a just-in-time notification, does that mean I'll get an award? in the Just-in-Time questions and answers.

Keep in mind that you must ensure that just-in-time information is accurate and current. You should promptly notify NIH of any substantive changes to previously submitted just-in-time information up to the time of award. This includes changes in PI or key personnel status as well as the use or approval of vertebrate animals or human subjects.

Other support information is always just-in-time. We also request any of the following documentation relevant to your research that you did not include in your application:

• Human subjects
  • Assurance number.
  • Certification of institutional review board approval of Research Plan.
  • Certification of human subjects education.
• Animals
  • Animal welfare assurance number.
  • Certification of institutional animal care and use committee approval.
• Human embryonic stem cells
  • Identify the hESC line from the NIH Human Embryonic Stem Cell Registry. Learn more at NIAID's How to Get a Human Embryonic Stem Cell Line Approved.

End-of-year warning. We may skip over your application if it comes up for funding at the very end of the fiscal year and your just-in-time submission is not ready. While we're waiting for you, we may fund other applications, and you could lose your chance of funding if we run out of money or time.

When it's due. Your institution's business official should submit other support and human subjects training information within two weeks of receiving a just-in-time notice. You don't need to sign this information because you have a signature assurance on file with your institution.

Since institutional review board and institutional animal care and use committee certifications may take more than two weeks, your business official may submit these approvals at the earliest date possible. Whether you send the certifications with your application or just-in-time, they should be sent together, not separately.

NIH prefers that your institution submit the documentation through the just-in-time feature of the eRA Commons in PDF format. For NIAID, the second-best method is to email a PDF to the grants management specialist, copying your program officer. The least preferable approach would be to fax it to your grants management specialist.

Read the next sections for details on the bullets above.

Find more information online:

• Just-in-Time questions and answers
• Just-in-Time SOP

Will you conduct human subjects or animal research? Yes. Read the relevant sections below: If You Have Human Subjects Documentation If You Have Animal Research Documentation No. Skip ahead to Prepare Your Other Support Submission.

If You Have Human Subjects Documentation

If you're conducting human subjects research, your institution's business official needs to submit the following documents.

Wait until you get a just-in-time request if you didn't send this with your application. NIH prefers that your institution submit the documentation through the Commons. If you wish, you may fax it to your grants management specialist.

Human Subjects Assurance

Your institution needs to file a human subjects assurance with the Office for Human Research Protections (OHRP). Typically, it takes the Office for Human Research Protections (OHRP) two weeks or less to approve your FWA application. However, if OHRP spots a problem with your FWA application, it will probably take longer.

You can Search the OHRP Database, or ask your institution to see if it already has an approved assurance. Make sure the new assurance number is on file if it has changed since you submitted your application.

If you have a subaward agreement, check that the subaward organization has a human subjects assurance and IRB approval.

IRB Certification

You also need to obtain and send certification of your institutional review board's approval of your Research Plan. Unlike the assurance, this certification needs to be re-approved every year of your project.

Training Certification

If you haven't submitted it with your application, send us your certification of human subjects education letter stating that each person identified under key personnel has completed an educational program in the protection of human subjects.

Once your grant is under way, you'll need to send the training letter only for new key personnel. Use our Sample Letter to Document Training in the Protection of Human Subjects, and get detailed information on NIH's FAQ.

Find more information online:

• NIAID Human Subjects Application and Grant Handbook
• Part 11a. Managing Your Grant.
• NIAID Human Subjects Resources

If You Have Animal Research Documentation

If you're working with research animals, your institution's business official needs to submit the following documents.

If you didn't send this with your application, wait until you get a just-in-time request.

Animal Welfare Assurance

Your institution needs to file an animal welfare assurance with the Office of Laboratory Animal Welfare (OLAW).

If you have a subaward agreement, make sure that the subaward organization has an animal welfare assurance and IACUC approval. If the subaward organization has an assurance but your institution doesn't, get an inter-institutional assurance. See Is Your Institution Assured by OLAW? for details.

Your institution can submit the documentation through the Commons or email the signed assurance to olawdoa@mail.nih.gov as a PDF.

IACUC Certification

You will provide certification of your institutional animal care and use committee approval and get re-approved at least every three years. For more information about getting certification of IACUC approval, go to Institutional Animal Care and Use Committee.

NIH prefers that your institution submit the certification date through the Commons. If you wish, you may fax the documentation of approval to your grants management specialist.

Find more information online:

• OLAW
  • Animal Welfare Assurance for Domestic Institutions
  • Animal Welfare Assurance for Foreign Institutions
  • NIH Institutional Animal Care and Use Committee tutorial
• How to Write an Application Involving Research Animals
• Animals in Research SOPs
• Part 11a. Managing Your Grant.

Prepare Your Other Support Submission

Just-in-time, you will send NIAID a list of other support -- existing support you have and support you may gain from the current application.

If you have no other support, we will need a letter stating that fact from your institution's business office.

Our Advice: Get Other Support Information Ready Well Before We Make the Award

Your other support information shows the following -- follow the link to the glossary term for additional information:

• No other organization is supporting the research you outlined in your Research Plan -- scientific overlap.
• Your time is not committed more than 100 percent -- commitment overlap.
• You have not requested funding for items paid for by another source -- budgetary overlap.

Overlap and Bridge Awards

• Bridge awards. If you have received an R56-Bridge award from us, include it in your other support information.
• Overlap. Beware of overlap issues, which require us to reduce your award, e.g., if you list Howard Hughes Medical Institute (HHMI) as other support, we will adjust your funding level since HHMI pays 100 percent of salary and fringe benefits.
  • You may submit your application simultaneously to a private foundation or federal agency outside PHS with the same application, but NIH will not fund you if you accept that award.
  • You cannot send the same application to more than one PHS agency at the same time with few exceptions -- contact your business office for details.
  • If you are applying for more than one grant to a PHS agency, point out in your application and in your cover letter that there's no overlap, and make sure the Specific Aims differ.

Find more information online:

• You Will Send Some Materials Just-in-Time
• Other Support format table in the SF 424 Application Guide
• Consultants or Collaborators -- How They Differ
• Where to Add Consortium and Contractual Information

If You Have Consortium or Contractual Agreements

If you have consortium or contractual agreements, send through the Commons just-in-time.

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	The next part of the NIH Grant Cycle: Application to Renewal is Part 9. Second-Level Review.

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