Opportunities and Resources
- Optimizing Monoclonal Antibodies: The Path to Eliminating the HIV Reservoir
- Be a Part of Pinpointing Ways to Prevent Autoimmune Disease
- A Renewed Opportunity to Affect HIV Incidence
In The News
- The Changeover to FORMS-D Is Imminent
- Policy Changes Accompany the FORMS-D Changeover
- News Briefs
- Dive Into FY 2015 Data on NIH's RePORT Website
- Reader Questions
New Funding Opportunities
One of the objectives of the NIH-Wide Strategic Plan: Fiscal Years 2016-2020 is to foster innovation by setting NIH priorities, which means using paylines and selective pay awards to create research portfolios that fund the best projects while maintaining portfolio balance and flexibility (see page 28 of the Strategic Plan).
Each institute approaches the challenge of optimally leveraging its expertise and resources differently. For example, NIAID must respond to emerging infectious diseases, which necessitates funding research on many diseases in case an outbreak occurs. If the majority of applications we received to study a particular disease were to fall outside the payline, we can use selective pay to guard against scientific gaps in our research portfolio. Gaps can also form in other areas—an imbalance between basic and translational research or an absence of innovative projects in a particular scientific area.
At the same time, we are eager to fund the best scoring applications whenever possible.
What does this look like in practice? Below, you can see a histogram of the investigator-initiated R01 applications received in FY 2015 sorted by percentile score. Blue shaded bars represent the applications that were awarded, red bars represent the applications that were not funded, and yellow bars represent R56-Bridge awards. These groups are roughly separated by the solid green line representing NIAID’s established investigator payline at the 12 percentile. All applications that scored within the payline were funded except for those that were canceled for issues such as concerns over human subjects or principal investigator (PI) retirements.
Note that the chart above includes Method to Extend Research in Time (MERIT) Awards (R37), which provide five years of funding to outstanding R01 grantees. We make approximately 15 MERIT awards each year. See the MERIT Awards and Extensions SOP to learn more.
Interestingly, many applications that fell outside the payline were still awarded. Some of these are applications submitted by new investigators, who benefit from an R01 payline set higher for new PIs, represented by a dotted green line at the 16 percentile. This practice allows us to meet the NIH-wide goal of keeping the R01 success rate for new PIs near that of established PIs. Approximately one-third of the R01 grants awarded in the 13 through 16 percentiles went to new investigators.
Many other awarded R01 applications that fell outside the payline are recipients of selective pay, through a process explained in our Selective Pay SOP. Basically, our staff recommend applications that score outside the payline for four years of R01 funding if they believe the application is especially promising or critical for maintaining portfolio balance.
Program officers look for applications with the potential to be paradigm-changing. Such applications generally have a respectable overall impact/priority score, where the nature of the review panel's criticism centers on riskiness or a lack of preliminary data for an innovative idea with clear potential benefits. In other instances, a difference of scientific opinion or criticism that centers on easily-fixed or minor aspects of the project can prompt a decision for selective pay.
Another discretionary option staff use to direct our research portfolio is the R56-Bridge Award, depicted in yellow in the chart above, following the process laid out in the NIAID R56-Bridge Award SOP. In short, NIAID chooses promising R01 applications that scored outside the payline to fund for one year; awardees are encouraged to improve and resubmit their R01 application in the meantime.
As you can see, we are more likely to select top-scoring applications for Bridge award funding; however, we will fund an application from any scoring percentile if the project advances our scientific research objectives. These are projects for which one year of funding—to gather preliminary data or develop a missing component (e.g., a knockout mouse) or complete proof-of-principle research—will suffice for the investigator to reapply and receive a much-improved score.
Again, NIAID has several goals that accompany our mission to fund the best scoring applications; we want to ensure balance across disciplines, support new PIs, and pursue innovative and high-risk projects with the potential to make a big impact. The R56-Bridge award lets us do so, and we make as many as 150 of them each year.
Requests for Applications
It’s worth noting that the chart does not include applications in response to requests for applications (RFAs). Solicited applications are usually grouped within a peer review panel and funded in overall impact/priority score order, rather than distributed across percentiles to account for multiple review panels. We do this because the pool of applications is smaller and varies by RFA, as explained in NIAID’s Funding Decisions and Your Next Steps and NIAID Paylines. For this reason, arranging those applications into percentiles isn’t always possible.
NIAID, as an institute that publishes its paylines (not all institutes do), handles a large volume of applications, and covers a wide range of scientific topics that range from basic science to clinical research, relies on selective pay and Bridge awards to maintain an optimal research portfolio. We strive to always fund those applications that score best in peer review by percentile, but we also discern which applications outside the payline can best broaden and enrich our scientific portfolio.
Opportunities and Resources
Curing HIV infection remains one of NIH’s highest priorities. However, eliminating cells that harbor latent HIV proviruses is still a major obstacle to finding a cure, as long-lived reservoirs can reactivate and produce infectious virions.
Hence, NIAID is seeking applications for an R01 funding opportunity announcement (FOA) focusing on supporting hypothesis-driven mechanistic studies aimed at optimizing monoclonal antibodies (mAb) or mAb derivatives that recognize and eliminate cells comprising the HIV reservoir.
Research areas of special interest include
- Generating HIV-specific mAb or mAb derivatives with:
- Improved Fab function to increase specificity, potency, avidity, and breadth
- Improved Fc effector function to eliminate cells expressing HIV proteins
- Increased half-life and biodistribution
- Studying polyreactivity, autoreactivity, and immunogenicity
- Assessing pharmacokinetics and efficacy in appropriate animal models
Additionally, for the purposes of this FOA, HIV-specific broadly neutralizing or non-neutralizing mAb; bispecific and multi-specific mAb; and mAb conjugated to other proteins, peptides, or compounds are considered within scope.
Applications proposing the following research topics will not be supported:
- Clinical trials
- Development of new animal models
- Solely isolating and characterizing new mAb
- Current Good Manufacturing Practices product manufacturing
Application budgets are not limited but should reflect the actual needs of the proposed project. The maximum project period is five years.
This FOA has six due dates, the first of which is May 16, 2016. You must use updated FORMS-D application forms and instructions for due dates on or after May 25, 2016. FORMS-D instructions will be posted by March 25, 2016.
Apply early to allow adequate time to correct any application errors found during the submission process.
The goal of a recently reissued funding opportunity announcement (FOA) is an ambitious one: to develop the knowledge base necessary to design selective preventive interventions that could be administered efficiently and safely to the general population or to individuals at risk of autoimmune disease, including infants and children.
If your research can contribute to meeting this goal and you want to participate in the Cooperative Study Group for Autoimmune Disease Prevention (CSGADP), consider responding to this FOA, which uses the U01 cooperative agreement activity code.
Your proposed research project must contribute knowledge critical to designing and administering practical interventions to prevent one or more autoimmune diseases. For this FOA, "to prevent" means to halt the development of an autoimmune disease before clinical onset by mechanisms other than global immunosuppression.
Broad areas of research interest include
- Pathogenic autoreactive T and B cell responses and their regulation by the immune system
- The role of genetic susceptibility and environmental influences in autoimmune disease
- Biomarkers of disease risk, stage, activity, and immune responses
For other examples of research areas as well as specific, suitable topics within the areas, see the FOA. NIAID will consider clinical trials and studies on HIV and/or AIDS as nonresponsive; therefore, these applications will not be reviewed.
Before you submit your application, we encourage you to consult with NIAID's scientific/research contact, Dr. Thomas Esch.
Optional letters of intent are due May 29, 2016. The application deadline is a month later on June 29. You must use FORMS-D application forms and instructions, which will be posted by March 25, 2016.
We strongly recommend that you apply early to allow adequate time to correct any errors found in the application during the submission process.
For complete details, read the February 25, 2016 Guide announcement.
Are you an investigator with a keen interest in discovering new strategies to reduce the incidence of HIV infection?
If so, NIH has reissued an R01 funding opportunity announcement (FOA) that seeks to promote innovative research to improve the identification of populations that are at high risk of HIV-1 infection and have a high proportion of people who are unaware of their HIV status.
This FOA’s purpose is to promote research that addresses one or both of the following objectives:
- Devising optimal strategies to improve the identification of people unaware of their HIV-1 infection and successfully link them to HIV testing, treatment, and prevention interventions
- Developing and examining the feasibility and acceptability of novel integrated interventions of biomedical and behavioral strategies that substantially reduce the likelihood of onward HIV transmission in these populations
Specific research areas of interest include:
- Social, sexual, or drug use network research to characterize groups with people who are unaware of their HIV infection
- Interventions to increase screening and testing for people unaware of their HIV infection, including those with acute HIV infection
- Mathematical modeling of strategies to reduce HIV incidence in these populations
If submitting an application proposing research in the U.S., we encourage you to propose research with high-risk populations that contain a proportion of persons undiagnosed with HIV-1 that is higher than the national average, as defined by CDC. See HIV by Group.
We also encourage applicants to address research in locales that have not received intensive HIV testing outreach in the previous three to five years.
Application budgets are not limited but should reflect the actual needs of the proposed project and projects cannot exceed the maximum project period of five years.
The FOA has multiple due dates: May 16, 2016, May 9, 2017, and May 8, 2018. You must use updated FORMS-D application forms and instructions for due dates on or after May 25, 2016. FORMS-D instructions will be posted by March 25, 2016. We strongly recommend that you apply early to allow adequate time to correct any errors found in your application during the submission process.
In the News
We are entering the period of time in which both FORMS-C and FORMS-D application packages and guides will be available to grant applicants. For certain funding opportunity announcements (FOAs), FORMS-C and FORMS-D application packages will be live simultaneously and you’ll need to choose the correct set. You are also responsible for referencing the correct application guides listed at SF 424 (R&R) Application and Electronic Submission Information.
Check your FOA’s due date. For due dates on or after May 25, 2016, you will use FORMS-D application packages and guides. For due dates before May 25, you will use FORMS-C.
As an example, the next Standard Due Date for new R01 applications is June 5, 2016. That means your next Research Project Grant (Parent R01) application must use FORMS-D (unless the application is AIDS-related).
Conversely, the FOA for the International Research Ethics Education and Curriculum Development Award (R25) has a May 18, 2016 due date. You must use FORMS-C for this due date, even though the FORMS-D application package and guides may already be posted as you apply.
The next due date for AIDS and AIDS-Related Applications is May 7, 2016. As with the R25 example given above, applications submitted for this due date must still use FORMS-C.
The "Apply Online Using ASSIST" and "Apply Using Downloadable Froms" buttons listed in the FOAs will take you to the correct form set, but in some cases you will be prompted to select either the FORMS-C or FORMS-D package along the way.
As stated in the February 12, 2016 Guide notice, if you are eligible for submission under our late, continuous submission, and system issue policies, you will need to pay special attention to the FORMS-D transition dates.
First, consider the due date listed in the FOA, not your anticipated submission date, when deciding which set of forms to use. If the listed due date is May 22, 2016, and you will submit late on May 29, 2016, then you should do so using FORMS-C.
Some FOAs will close following their last due date before May 25 and be immediately reissued with FORMS-D application packages. This includes several parent announcements. Such FOAs will be configured to allow FORMS-C submissions for 14 days after the close date to accommodate late, continuous submission, and system issue policies. This represents a shorter window for continuous submission than is typical.
Similarly, the deadline for continuous submission applications for the May 7, 2016 AIDS due date is May 23, 2016. Again, this is a shorter extension for continuous submission than is normal.
The Rapid Assessment of Zika Virus (ZIKV) Complications (R21) FOA is a special case because it features rolling submission. We haven't yet confirmed the FOA's transition date to FORMS-D but will announce that information as soon as we have it. In the meantime, use FORMS-C.
Finally, several FOAs have no specific due dates—administrative supplements, successor-in-interest (Type 6), and change of institution (Type 7) FOAs. NIH will close the FORMS-C versions of these FOAs on May 25, 2016, and reissue the FOAs with FORMS-D on the same day. You will have 30 days, until June 24, 2016, to submit any FORMS-C applications that were already in progress when the May 25 changeover occurs. Read the February 19, 2016 Guide notice to learn more.
NIH is taking advantage of the form switch to incorporate several minor policy changes, which we previously announced in the November 4, 2015 article “Timeline for NIH Transition to New Application Forms.” The FORMS-D application guide reflects the changes, so the easiest way to comply is to follow that guide’s instructions.
Applications using FORMS-C should follow the FORMS-C application guide and are not required to observe the policy changes below.
Here’s the list of topics undergoing policy changes:
Vertebrate animals—see NOT-OD-16-006.
For training (T) and fellowship (F) grant applications, the vertebrate animals section of the application instructions will be simplified as follows:
- A description of veterinary care is no longer required.
- Justification for the number of animals has been eliminated.
- A description of the method of euthanasia is required only if the method is not consistent with American Veterinary Medical Association guidelines.
The same changes already went into effect for all other grant types on January 25, 2016.
Reviewers will assess your research plan for descriptions of procedures, justifications, minimization of pain and distress, and euthanasia.
Inclusion forms—see NOT-OD-16-004.
We are adding an optional PHS Inclusion Enrollment Report form to FORMS-D application packages. The new form, with additional study descriptors, will replace the optional Planned Enrollment Report and Cumulative Inclusion Enrollment Report forms found in FORMS-C application packages.
Data and safety monitoring plans—see NOT-OD-16-004.
A new data and safety monitoring attachment must be included with all applications involving clinical trials. Although the requirement of a data and safety monitoring plan for clinical trials is not new, the use of a separate attachment to collect this information will emphasize its importance and facilitate systematic enforcement of its presence.
Research training data tables—see NOT-OD-16-007.
We have revised existing research training data tables in grant applications as follows:
- Reduced the number of tables from 12 to 8
- Minimized the reporting of individual-level information
- Extended the tracking of trainee outcomes from 10 to 15 years
Applicants may create tables for their applications and Research Performance Progress Reports either by using fillable tables in MS Word or via the xTRACT system.
New PHS Assignment Request Form—see NOT-OD-16-008.
Applicants who want to communicate requests pertaining to the assignment and initial peer review of applications must use a new PHS Assignment Request Form. The following fields will be included in the new form:
- PHS Awarding Component (including NIH Institute/Center (IC) Requests), both positive ("assign to") and negative ("do not assign to")
- Study Section or Special Emphasis Panel Requests, both positive and negative
- List of potential reviewers in conflict and why
- List of scientific expertise needed to review the application
You will continue to use a cover letter to explain certain circumstances, as listed at Create a Cover Letter.
New font guidelines—see NOT-OD-16-009.
Text in grant applications' PDF attachments must follow these minimum requirements:
- Font size must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100 percent).
- Type density must be no more than 15 characters per linear inch (including characters and spaces).
- Line spacing must be no more than six lines per vertical inch.
- Text color must be black (color text in figures, graphs, diagrams, charts, tables, footnotes, and headings is acceptable as long as it is legible).
Although other fonts are acceptable if they meet the above requirements, NIH recommends Arial, Garamond, Georgia, Helvetica, Palatino Linotype, Times New Roman, and Verdana.
Applications that include PDF attachments that do not conform to the minimum requirements listed above may be withdrawn from consideration.
Biosketch clarifications—see NOT-OD-16-004.
The biosketch application instructions have been rewritten to state:
- A URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography.
- Publications (peer-reviewed and non-peer-reviewed) and research products can be cited in both the personal statement and the contributions to science sections.
- Graphics, figures, and tables are not allowed.
Two other prospective policy changes that we announced back on October 13, 2015, will not be implemented as planned on May 25, 2016. First, an updated Appendix policy will not be part of the FORMS-D changeover. Second, updated application instructions for rigor and transparency in training and fellowship grants will be delayed until sometime in FY 2017, as explained in the December 17, 2015 Guide notice.
Once again, the policies listed above are not applicable to any FORMS-C applications, even if submitted after May 25, 2016, using late or continuous submission. Only applicants using FORMS-D need to account for them.
Effective June 1, 2016, NIH will no longer accept forms or other documentation bearing generic departmental signatures or their electronic equivalent. Instead, signatures must reflect the name of the individual, electronic or otherwise, with the appropriate institutional authority to submit such information. See the February 25, 2016 Guide notice and Definitions of Roles in eRA Commons and Grants.gov to learn more.
NIH staff now review the Federal Awardee Information and Integrity System (FAPIIS) when awarding grants and cooperative agreements. If an institution does not demonstrate a satisfactory record of executing programs, an award may still be considered if it is determined that the information in FAPIIS is not relevant to the award under consideration. Institutional officials, read the February 22, 2016 Guide notice for complete details.
Next time you visit grants.nih.gov, expect to see a new look! The initial launch this Friday, March 25, will change the look and feel of the website. None of the content you've come to depend on will be removed—old links and bookmarks have been edited to redirect you to pages' new locations. Check out A New NIH Grants and Funding Website Is Coming Soon!
NIH recently posted award and spending data for fiscal year 2015 on the Research Portfolio Online Reporting Tools (RePORT) site. The Budget and Spending, NIH Data Book, Success Rates, and Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC) pages are already updated, with Funding Facts soon to follow.
We've previously encouraged you to use the tools available at RePORTER when you See Funded Projects using RePORTER. For example, NIH RePORTER—a free database of NIH-funded projects, investigators, publications, and patents—can help you find potential collaborators and competitors, identify emerging scientific research trends, identify research areas that are highly competitive versus potential areas that are underrepresented in our portfolio, and survey the spectrum of research projects that NIH is funding in your area of expertise.
Take a Snapshot of the Big Picture
You can use RCDC to understand how NIH spends its money on over 250 scientific research categories. Right now, you'll see historical data for FY 2012 through FY 2015. NIH also shares estimates for fiscal years 2016 and 2017, which are projected from actual data.
Click any of the underlined dollar values for details, or try using the search box. If you drill down far enough through the RCDC site, you'll end up in the RePORTER system. You can save your search results at any time using the green Excel Export button.
Speaking of RCDC, the terminology you use in your application is what allows NIH to properly categorize and assign it—go to NIAID's Write Your Research Plan for tips.
If instead you are more interested in seeing NIH or NIAID success rates for research projects arranged by year and funding mechanism, you can do that too. Simply click on Research Project Grants: Success Rates by Type, Activity, and Institute/Center and filter the table accordingly. The Success Rates page also lists training, fellowship, and career development awards.
Or, perhaps you're curious to see how FY 2015's budget totals stack up compared to the year before. Open Grants and Contracts: Number of Awards and Total Funding by Budget Mechanism and Institute/Center on the Budget and Spending page and drill down from there.
Dr. Michael Lauer, NIH deputy director for extramural research, also crunched the data. Read his Open Mike blog post FY 2015 by the Numbers, and a Quick Look at Recent Trends to learn what stood out to him.
Feel free to send us a question at email@example.com. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the Find a Funding Opportunity site, or both.
“If I am currently funded by an F32 and subsequently find a job, is there a penalty for moving into the job and ending the fellowship support?”—Dr. Christian González-Rivera, University of Texas-Houston Medical School
No, there are no penalties for terminating the NRSA Individual Postdoctoral Fellowship (F32) award. Note that your authorized organizational representative must notify the grants management specialist and program officer assigned to the grant.
No, but you can submit one as a renewal and another as a new application that's significantly different.
- RFA-AI-16-012, Pilot Clinical Trials to Eliminate the Latent HIV Reservoir
- BAA-NIAID-DAIDS-NIHAI2016058, Staged Vaccine Development
- RFP-NIAID-DAIDS-NIHAI2015035, Preclinical Development Support
- PAR-16-124, Methods for Prevention Packages Program IV (MP3 IV)
See other announcements at NIAID Funding Opportunities List.