NIAID Funding News November 20, 2014

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles.

A Refresher on Subawards

Did you know that you can use a subaward to augment your own expertise and improve the efficiency of your research? If subawards fall outside your area of expertise, read this overview to supplement your knowledge.

What Is It?

A subaward is a collaborative arrangement between a grantee institution and another organization in support of the grantee’s research project. This includes consortium agreements, which are subawards. The subawardee performs research activities on behalf of the grantee.

Subawards are legal agreements. There must be a physical document, drawn up by your institution and signed by both organizations. 

Funds from the grant must flow directly from the grantee to the subawardee. This means that a subawardee cannot create its own subaward with a third party—a “third tier” subaward—using funds from the grantee. Think of subawards like the spokes of a wheel with the grantee in the center—a grant may have a number of subawards, but they must all be directly connected to the grantee.

As the grantee and principal investigator, you must perform a substantive role in conducting the planned research. You cannot merely serve as a conduit of funds to one or more subawardees.

When to Use a Subaward

Primary grantee organizations use subawards to collaborate with one or more other organizations to carry out grant-supported research.

Consider the following examples:

You need Professor Washington’s expertise and assistance to develop unique antigens for your project in her laboratory at State University. She will send these unique antigens to you for the next step in your research project. In this case, you would use a subaward agreement rather than a fee-for-service because Professor Washington is performing a portion of the programmatic or scientific activity of the research. The arrangement would be directly between your institution and State University.

Next, suppose statistics is not your forte and you need help interpreting the data you generate. Your institution could write a subaward to have another organization analyze the results. The agreement might stipulate that the subawardee’s services are required in only the final two years of the grant.

A subaward is not always the optimal solution; often using a fee-for-service or a consultant would make more sense. If you need Outside Company to manufacture 200 mosquito traps for your project, you should use a fee-for-service because this is a purchase of a specific product. This cost would usually be listed under “Other” on your application budget.

Suppose you want to pay Dr. Lincoln, an expert in your field, to advise your project on a limited basis. Given the limited purpose—he will not be performing any research activities—you should treat Dr. Lincoln as a consultant and plan a one-time or annual sum in your budget proposal.

Finally, imagine you are a subawardee on another investigator’s NIAID grant. You have your own subaward budget under the grant and you want to arrange for Private College to carry out a research task using money from your subaward's budget. Under NIH policy, that is not allowed. While you can have a fee-for-service for a specific purchase on a subaward, a third tier subaward removes the grantee’s ability to oversee and control the grant activities.

Application and Budget Information

Grantees must establish a subaward with any outside organizations that performs grant-supported research activities.

When you apply, describe any arrangements in the Consortium/Contractual Arrangements attachment of the Research and Related Budget component. State the roles of the people and organizations involved, and list every research performance site.

Your application should include a letter from your subawardees describing their willingness to participate and their role in your project. We recommend that you send your subawardees a sample letter that they can sign and return.

You also need to include biosketches of any key personnel from your subawardee in the Research and Related Senior/Key Person Profile section and a DUNS number for each subaward in your budget section.

Subawards are paid using facilities and administrative (F&A) funds, formerly known as indirect costs. Thus, they are not included as part of the direct cost base when determining if your application should use the modular format (direct costs of less than $250,000 annually) or if your application is a big grant (direct costs of $500,000 or more annually) and needs prior approval. Also, note that all foreign organizations require a nonmodular budget, regardless of budget size.

Modular grant applications must include an estimate of total subaward costs (direct and F&A costs) each year, rounded to the nearest $1,000. Nonmodular grant applications must include detailed budgets for each subawardee.

Check funding opportunity announcements (FOAs) for additional instructions. For example, you may be instructed to calculate subaward F&A costs as direct costs on your grant application. Be especially mindful when responding to requests for applications (RFAs).

Since subaward agreements are between institutions, your institution is responsible for negotiating an F&A rate. For foreign institutions, the F&A rate is currently limited to eight percent. For-profit entities must have an established F&A rate set with theIndirect Cost Branch of the Division of Financial Advisory Services.

Authorized organizational officials, take note: Your institution must report information to the FFATA Subaward Reporting System for subawards worth more than $25,000 over the course of the grant. Your institution is exempt from this requirement if it is a federal agency or has less than $300,000 in gross income for the previous tax year.

After Award—NIAID’s Involvement 

Generally speaking, NIAID’s involvement in a subaward is minimal.

After your grant has been awarded, you can still establish a new subaward. You need prior approval from NIAID to do so in only two situations:

  • The subawardee is a foreign organization.
  • The terms of the subaward would constitute a change in scope.

Otherwise, a grantee can establish a new subaward during the award period without prior approval. You will still need to follow the budget guidelines listed above.

NIAID does not participate in establishing the terms of the subaward, nor are we responsible for enforcing adherence to those terms. The grantee and subawardee are responsible for solving disagreements. The signed agreement is paramount—it should be the source for resolving conflicts. Be sure to define expectations clearly and include a mechanism for settling disputes when you write a subaward agreement.

Do not rely on your program officer and grants management specialist to communicate with your subawardee directly. NIAID staff are responsible for communicating through the primary grantee only. 

Grantee Responsibilities

The grantee organization is directly accountable to NIAID for the performance of the project, appropriate expenditure of grant funds by all parties, and all other obligations specified in the terms of award. Likewise, the grantee organization is responsible for ensuring that the subawardee has filed assurances and approvals appropriate to research they are conducting (e.g., PHS animal welfare assurance and Institutional Animal Care and Use Committee approval if working with live, vertebrate animals).

Here are a few more management responsibilities that you should be prepared to handle, since NIAID will not work with the subawardee directly:

  • Finding a budget solution if the subawardee wants more money to carry out its part of the project.
  • Answering questions from the subawardee about human subjects or animal research.
  • Reporting possible financial conflicts of interest to NIH involving, say, the subawardee and a fee-for-service provider on the subaward.
  • Requesting prior approval for any large purchases the subawardee makes of over $10,000.
  • Resolving performance issues with the subawardee.

If you have questions about your current award, ask your grants management specialist listed in the Commons. For help with an application, reach out to the grants management contact listed in the FOA.

Related Resources

Header: Opportunities and Resources.

Get Funding for Research on Implementation of HIV Treatment and Care Programs

What's the best way to get adolescents to seek out HIV testing and counseling (HTC) in low- and middle-income countries?

To encourage investigators to address this important question, we're supporting a new funding opportunity from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) that can give you up to $250,000 a year to research an answer.

This opportunity falls into the category of implementation science, which evaluates the success of interventions and clinical practices. For your application, you'll want to propose research that can accomplish at least one of the following goals:

  • Identify interventions that will improve HTC utilization for adolescents most at risk for HIV infection and linkages to appropriate follow-up services in low- and middle-income countries.
  • Identify effective approaches to link, retain, and transition adolescents to treatment, care, and support from HTC in low- and middle-income countries.
  • Evaluate interventions that will help HIV-uninfected adolescents, particularly adolescent girls, in low- and middle-income countries minimize risk and maintain their uninfected status.

You're not limited to strictly clinical settings. Feel free to investigate linkages and partnerships with school health programs and public service providers, as well as any individual, communal, social, economic, and policy factors related to HTC.

Read the October 9, 2014, Guide announcement for background, instructions, eligibility requirements, and examples of potential research topics.

Before you write your application, discuss your idea and any questions you have with Elizabeth Flanagan, NIAID’s program officer and scientific contact.

Optional letters of intent are due December 2, 2014. Applications are due January 2, 2015.

Related Links

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HIV and Mucosal Immunity: Learn More, Share Ideas

We invite you to explore the newly launched Public Library of Science (PLOS) collection, “Advances in HIV Mucosal Immunology: Challenges and Opportunities,” to get the latest information about this field of science. Even if your own research is in another field, your alternative viewpoint could be quite valuable, so share your reactions and ideas using the comment feature on each article.

Learn more by reading Capturing Participant Information for Mucosal Sampling: An Investigator’s Guide. Staff from NIAID, the HIV Vaccine Trials Network (HVTN), and the Global HIV Vaccine Enterprise collaborated to create the Guide in response to a recommendation by the HIV Mucosal Immunology Group(MIG).

Through the PLOS collection and Guide, MIG investigators report the results of their efforts, providing important, practical details on studying immune responses in the genital and rectal mucosa. This information will help guide future studies of HIV prevention with vaccines, topical microbicides, and oral pre-exposure prophylaxis. It may also contribute to a cure for HIV. 

Background on the HIV Mucosal Immunology Group

Among the many challenges to developing an effective HIV vaccine has been the technical difficulty of assessing a vaccine’s impact on the mucosal immune system.  Without reliable methods to evaluate how the mucosal immune system responds to an experimental HIV vaccine, we are missing important information about how well that vaccine worked—and how to improve the next one. 

In 2009, NIAID provided seed funding to the HVTN to establish MIG and address these challenges. Since 2013, the Bill and Melinda Gates Foundation has provided additional funding. 

MIG's expert scientists coordinate their efforts to improve and standardize mucosal sampling, sample processing, and specimen storage and assay technologies, emphasizing methods that gain maximum information from limited amounts of mucosal secretions, cells, and tissues.

Header: Other News.

Two Noteworthy Items About Clinical Trials

Clinical trials seem to be a hot topic at NIH, as reflected by two recent Guide notices. Here's a brief recap in case you missed them.

Defining "Clinical Trial": A Revision

The definition of "clinical trial" has changed a bit. See Revised NIH Definition of Clinical Trial.

NIH revised it to 1) distinguish more clearly between clinical trials and clinical research studies and 2) enhance precision of clinical trial information that NIH collects, tracks, and reports.

The revised definition:

  • Is not intended to expand the scope of the clinical trial category of clinical trials.
  • Will apply to:
    • Competing grant applications submitted for the January 25, 2015, and subsequent due dates.
    • Contract proposals submitted on or after January 25, 2015.

Keep the revised definition in mind when applying for funding opportunity announcements that exclude clinical trials or when determining whether you can apply for an investigator-initiated grant.

For further details, read the October 23, 2014, Guide notice. Go to Clinical Trials on NIH's Office of Science Policy Web site for additional resources, including Questions and Answers Regarding the Revised Definition of "Clinical Trial" and NIH Definition of Clinical Trial Case Studies.

Extending the Clinical Trial Project Period: A Pilot

NIH has launched a pilot program to accommodate clinical trials for which a five-year performance period would be insufficient. For example, those focusing on rare diseases with challenging recruitment needs and those with very long treatment periods or lengthy outcome measures.

The pilot funding opportunity announcement will support only one clinical trial for each six- or seven-year award. Multisite trials will be allowed, but no clinical trial planning or feasibility activities will be allowed.

For more information, read the November 18, 2014, Guide notice.

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Funding Pause for Some Gain-of-Function Research

In accordance with the White House announcement Doing Diligence to Assess the Risks and Benefits of Life Sciences Gain-of-Function Research, NIH will not release new funding for gain-of-function research on influenza, SARS, and MERS viruses that could be reasonably anticipated to increase the pathogenicity or transmissibility in mammals by the respiratory route.

NIH encourages grantees already working on gain-of-function research, which could be subject to the terms of the announcement, to voluntarily pause their research. Under contracts, NIH does have authority to stop ongoing experiments subject to the pause and has already done so through Stop Work Orders. Investigators who receive NIH funding are strongly encouraged to work with their program and project officers to transition the applicable research to research that is not covered by the pause.

During the pause, the government will reassess the risks and benefits of such research and develop new guidelines for this research. The National Science Advisory Board for Biosecurity and the National Research Council of the National Academies will be part of this process and provide opportunities for discussion and deliberation with the broader life-sciences community and the public.

Here are answers to several commonly asked questions following the announcement:

Are experiments involving isolated genes of influenza, MERS-CoV, or SARS included in the funding pause?

  • No. The pause applies to research that would create viruses with certain attributes. If the research does not include production of infectious, replication-competent virus, then it would not be subject to the pause.

Are in silico or modeling studies of influenza, MERS-CoV, or SARS included in the funding pause?

  • Experiments in silico or modeling studies are not covered under the pause unless they also involve work with the actual viruses and meet the criteria.

Are influenza surveillance activities subject to the pause?

  • No.

Can I submit an application that includes research that may fall under the pause?

  • Yes. These applications will continue to be reviewed in accordance with standard NIH Peer Review processes. Potential gain-of-function research would be flagged by a scientific review officer in an administrative note on the summary statement. The presence of such research in a proposal will not impact the overall score.

If you have additional questions about gain-of-function research, or are unsure whether your research falls under this designation, contact your program or project officer, or the scientific contact listed in the funding opportunity announcement to which you are applying.

For more information, read the October 17, 2014, Guide notice, NIH Director Francis Collins' Statement on Funding Pause on Certain Types of Gain-of-Function Research, and Rock Talk’s A Pause in Funding Certain Types of Gain-of-Function Research.

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News Briefs

More Interim Paylines Announced. NIAID has set interim paylines for career development awards (except K99), NRSA fellowships, Academic Research Enhancement Awards (R15), Small Business Technology Transfer Phase I and II (R41, R42), and Small Business Innovation Research Phase I and II (R43, R44) awards. To see the interim paylines, go to NIAID Paylines.

Two New RFIs Will Inform NIH Data Strategies. NIH is developing strategies to facilitate the use of new standards for community-based data and metadata. You can weigh in by following the instructions in the November 5, 2014, Guide notice. NIH is also soliciting feedback about learning resources devoted to biomedical big data management and science. Read theNovember 4, 2014, Guide notice to learn more.

Send T32 and T35 Payback Forms to New Address. When you send your T32 or T35 payback agreements, make sure you are using the correct address and listing John Villella as the recipient. The full mailing address is:

John Villella 
Grants Management Program
NIH/NIAID
5601 Fishers Lane, Room 4E54, MSC 9824
Bethesda, MD 20852-9824

Extension of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome FOAs. The expiration date for the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Etiology, Diagnosis, Pathophysiology, and Treatment R01 and R21 has been extended to February 25, 2015.

Header: Advice Corner.

New to RPPR? Tips for Your December 1 Progress Report

You probably know that as of October 17, 2014, all Type 5 progress reports (including non-SNAP such as P01, U01, U19) must use a Research Performance Progress Report (RPPR). If your next RPPR will be your first, then take heed of lessons learned by others who have already made the switch.

Give Yourself Sufficient Time

You may have grown accustomed to a particular timeline for completing a progress report. Most likely, the same approach will not suffice the first time you submit an RPPR. Avoid a delay in funding due to a late or incomplete RPPR by starting early.

We’ve found that the first RPPR submission is time consuming. For example, many non-SNAP grantees used to collect required information from subawardees in PDF form, combining numerous PDFs into one at the time of submission. The same information may now need to be entered into specific data fields in the RPPR by the parent institution instead. Adjust your timelines for receiving information from subawardees to allow time for RPPR data entry.

You will be prompted to resolve errors when filling out an RPPR, whereas in the past NIAID would contact you after you submitted your progress report to address any issues. This means that the time needed to resolve problems will come ahead of the reporting deadline, not after.

The bright side to all of this is that in future years many of the data fields will populate automatically, which will make progress reporting quicker.

Items to Consider

For training and advice on preparing an RPPR, read the NIH and Other PHS Agency Research Performance Progress Report (RPPR) Instruction Guide. Pay particular attention to instructions on how you will report:

  • Publications (called products in the RPPR) in Chapter 6.3
  • Participants (personnel who have worked on the project) in Chapter 6.4
  • Budget in Chapter 6.8
  • Special reporting requirements in Chapter 6.7
  • Multiproject RPPRs and single-project RPPRs with complicated structures in Chapter 7.6

Even if this is not your first time submitting an RPPR, you should still read the Instruction Guide, which was updated October 17, 2014. For example, reporting sex/gender, race, and ethnicity information in the new Inclusions Management System will be different from the last time you submitted a progress report, as announced in the October 2, 2014, Guide notice.

You should also check out the Research Performance Progress Report FAQs, which can answer questions not directly addressed in the Instruction Guide. For example, grantees have had difficulty filling out some data fields because there is not enough space. While NIH is capturing some information in a defined format across all progress reports, your award might have additional requirements. The FAQs point out that the "Special Notice of Award and Funding Opportunity Announcement Reporting Requirements" section of your application is the appropriate place to provide additional information. Under Reporting Publications, the FAQs also give a thorough explanation of Public Access Policy compliance as it applies to RPPRs.

If you have any questions, contact the eRA Commons Help Desk or Grants Policy Help.

Related Links

Header: Reader Questions.

Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

"If a K99 recipient committed 75 percent effort in his or her proposal, with the remaining 25 percent effort reserved for other activities, can he or she participate in an R01 or R21 and charge his or her salary to the R award?"—Jennifer Cory, Stanford University

While the K99 recipient can participate in an R01 or R21 with the remaining 25 percent effort, he or she cannot charge salary to the R award.

If the recipient has additional questions about the K99 award, he or she should contact the assigned grants management specialist. Read Pathway to Independence Awards (K99/R00) SOP to learn more.

"Is there a time limit to apply for a renewal?"—anonymous reader

No, but we recommend that you apply for a renewal (Type 2) well before your first award ends to avoid a break in funding.

If you do not immediately apply for a renewal, reviewers will probably be concerned that the science has changed in the time between your projects. Take this into account when writing a renewal application, and prepare a new application if the research is dated.

Also, make sure that no other time limit affects your application’s eligibility, such as the expiration of the funding opportunity announcement or the 37-month time limit for resubmissions (A1s).

Header: New Funding Opportunities.

See other announcements at NIAID Funding Opportunities List.

Content last reviewed on November 20, 2014