NIAID Funding News, February 18, 2015

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February 18, 2015

Feature Articles

Critical Deadlines and Process for Investigator-Initiated Clinical Trials

Opportunities and Resources

In The News

Advice Corner

Remember the Rules for Requesting Big Grant Preapproval
Reader Questions
- Am I required to use My Bibliography or SciENcv to list my published work in the new biosketch format?
- Can my small business establish a subaward with an NIH intramural laboratory using NIH grant money?

New Funding Opportunities

See the list

Critical Deadlines and Process for Investigator-Initiated Clinical Trials

Investigator-initiated clinical trial (IICT) applications need careful planning and have a long lead time, yet many investigators still miss key aspects of the process or start too late.

As a timing example, the next deadline for an IICT application is May 13, 2015. That may seem far away, but that means you should begin your prior consultation process no later than March 4, 2015.

Here's how to get informed and start the prior consultation process.

Confirm That the Proposed Work Is an IICT and Learn What’s Next

Discuss your idea with a program officer well ahead of time, particularly if you’re not sure whether the proposed research would be classified as an IICT. If you do not already have a program officer with whom you’ve been working, reach out to one of the scientific contacts listed in the funding opportunity announcements (FOAs) below.

Refamiliarize yourself with NIH’s Revised Definition of a Clinical Trial; it changed a few months ago. Learn more about the revision in the November 20, 2014, article “Two Noteworthy Items About Clinical Trials.”

Read Is Your Research Covered by NIAID's Policy? for more information on NIAID's process.

Decide which FOA includes the scope of your research. NIAID accepts IICT applications through the following FOAs:

Milestone-driven Clinical Trial Implementation Grant (R01)—for investigators who are ready to begin a clinical trial that is not high-risk*.
Milestone-driven Investigator-Initiated Extended Clinical Trial (R01)—for investigators who propose a clinical trial requiring an extended project period of six or seven years.
Clinical Trial Implementation Cooperative Agreement (U01)—for investigators who are ready to begin a high-risk* clinical trial.

Do not submit clinical trial applications in response to NIH's parent R01 and R21 announcements and request assignment to NIAID. This is not allowed, and your application will be transferred to another IC or withdrawn.

If you need support to get ready for the launch of an IICT, such as planning, designing, and preparing the documentation necessary for implementing an IICT, consider applying first for aClinical Trial Planning Grant (R34).

*The NIAID definition of a high-risk clinical trial is included in the FOAs.

Start the Prior Consultation Process At Least 10 Weeks Before Applying

A prior consultation is vital to your success, so we strongly encourage Requesting Prior Consultation to Discuss Submission of a Clinical Trial Planning (R34) or Implementation (R01 or U01) Application at least 10 weeks before the application due date. Applicants interested in the Clinical Trial Planning Grant for Interventions and Services to Improve Treatment and Prevention of HIV/AIDS (R34) should also complete prior consultation.

Prior consultation enables close interaction with program staff who can help you optimize your application idea, ensure you meet any unique programmatic requirements, explain additional considerations for setting your milestones and budget, and advise you to apply for the right activity code. Recently, we’ve seen applications come in as R01s when they should have been U01 applications.

And remember, if you plan a big grant application ($500,000 or more in direct costs for any year) you’re required to request big grant preapproval, as explained below in "Remember the Rules for Requesting Big Grant Preapproval." We recommend that you complete the big grant preapproval request during the prior consultation process.

For more information, visit our main portal Investigator-Initiated Clinical Trial Resources and check the NIAID Division Clinical Web Sites listed there.

Taking a Systems Biology Approach to Antibacterial Resistance

To combat infectious diseases, it's critical to have an increased understanding of the molecular mechanisms of the host and the pathogen associated with antibacterial resistant (AR) infections.

If your research uses a multidisciplinary systems biology approach to identify, quantify, model, and predict the overall architecture and dynamics of the molecular interactions of AR pathogens and their host during infectious disease initiation and progression or in response to antibacterial treatment, then consider applying to a recent funding opportunity announcement (FOA).

For this FOA, the systems biology approach consists of repeated cycles of generating, analyzing, and integrating experimental data; modeling system-wide molecular networks structure and dynamics; predicting microbial and host systems’ responses to changes, perturbations, or alterations of experimental conditions and experimental validation.

Your application must focus on bacterial pathogens with established antibacterial resistance. Pathogens of highest priority are those identified as urgent and serious threats in CDC's report Antibiotic Resistance Threats in the United States, 2013, with the exception of tuberculosis. Applications focused on tuberculosis are not responsive to this initiative.

Your proposed project should:

Be designed around a primary biological hypothesis to be tested using the systems biology approach.
Use high-throughput “omics” (e.g., transcriptomics, proteomics, metabolomics) technologies and assays of host responses, robust data management processes, data integration, and computational modeling methods.

We strongly encourage studies that use human primary cells or clinical samples (i.e., human tissues, human blood, immune components, bacterial isolates) from human subjects with AR infections. However, using the appropriate animal models of human AR disease is also acceptable.

To adhere to the requirements and timelines described in the NIAID/DMID Data Sharing and Release Guidelines, we also encourage the rapid and efficient release to the broad scientific community of datasets, analysis tools, computational models, reagents, and other resources generated under the grant.

For complete details, including research areas of interest, read the January 27, 2015, Guide notice. The application deadline is July 9, 2015.

Research the Role of Exosomes in HIV Pathogenesis

Consider applying for an R21 exploratory/developmental research grant for new research on the potential role of exosomes in HIV transmission, innate or adaptive immune responses to HIV, or HIV pathogenesis.

NIH particularly encourages studies that focus on the function of exosomes in acute infection, or in chronic infection in individuals on fully suppressive antiretroviral regimens. The opportunity lists potential topics as examples, but you're not limited to those topics. Here are a few:

Does acute HIV infection stimulate the release of exosomes that regulate the innate or adaptive immune response?
Do exosomes regulate events critical for HIV transmission?
What role do exosomes play in HIV neuropathogenesis and neurotherapeutics?

See more suggested topics in the January 30, 2015, Guide notice.

The notice also lists some topics that won't be supported, such as studies that focus on HIV hijacking the exosome release pathway for viral egress.

The opportunity opens May 7, 2015, and follows Standard Due Dates through January 8, 2018.

We strongly encourage you to discuss your application ideas with the scientific/research contacts Dr. Elizabeth Stansell at NIAID orDr. Jeymohan Joseph at NIMH.

Wanted: An Assay to Determine HIV Infection Recency

A missing tool in the fight against HIV/AIDS is a robust test to determine whether an HIV infection occurred within the previous year or is the result of chronic infections. Such an assay would allow public health researchers to better evaluate the efficacy of HIV prevention interventions.

Through a recent funding opportunity announcement, NIAID will fund research that seeks to identify novel biomarkers capable of signaling the recency of infection. For example, the evolution of viral diversity or some aspect of the host response unique to the first year of HIV infection that could be used to determine whether or not the infection is recent.

Identifying promising biomarkers is the first step. The second step is developing accurate, cost-effective HIV-1 incidence assays and algorithms, which NIAID will also support. Unfortunately, many current strategies are too complex or expensive, particularly in resource-limited settings, which prompts the need for cost-effective alternatives.

For complete details, read the January 29, 2015, R01 and R21 Guide notices. Note that the R21 award is limited to a two-year project period with a combined budget of no more than $275,000 in direct costs.

Investigators should follow the Standard AIDS dates when applying. For both opportunities, the first receipt date is May 7, 2015, and the final receipt date is January 8, 2018.

Follow the Rules for New Applications—Or Else

When following an unfunded application with a new one, remember to abide by the rules. New applications must not contain certain content, such as responses to reviewer comments or mention of your previous application's overall impact/priority score. The Center for Scientific Review monitors the rules and if you break them your new application will not be reviewed.

You should still use reviewers’ criticisms of your unfunded application to improve your next attempt. However, if that attempt is in the form of a new application, you must also rewrite the application to appear new, whether your new application follows an unfunded new application, resubmission application, renewal application, or response to a request for applications.

For example, if you included a progress report in your unfunded renewal application and are now submitting a new application, you should present the data from the progress report as preliminary data. You could also transfer information from your Progress Report Publication List to the biosketch section of your new application.

To learn more, read NIH’s January 22, 2015, Guide notice and Resubmissions of NIH Applications FAQs.

Small business applicants should also read How does NIH’s current resubmission policy affect SBIR/STTR Applicants? on NIH'sSmall Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) FAQs.

News Briefs

Register Your Small Business Now for the April Omnibus Deadline. First-time small business applicants must complete five separate registrations before applying for the NIH SBIR/STTR Omnibus funding opportunity announcements. Given that the registration process typically takes six to eight weeks, and the next application deadline is April 6, 2015, new small business concerns should start immediately. To learn more, read Electronic Submission Process and Successfully Submitting a Small Business Grant Application to NIH.

NIH Will Accept Applications Delayed by Winter Storms. If recent winter storms forced your institution to close and thus delayed your submission, you can still apply late by including an explanation in your cover letter. Your application delay should not exceed the time period that your institution was closed. Get more details from the February 10, 2015, Guide notice, NIH Extramural Response to Natural Disasters and Other Emergencies, and Wondering Whether Wintry Weather Delays Due Dates?

Small Bump in R01 Paylines. Thanks in part to careful budgeting, NIAID is raising the FY 2015 R01 paylines to the 11 percentile for non-new PIs and the 15 percentile for new PIs. For more information, see our updated NIAID Paylines.

You Can Use ASSIST to Submit R03 and R21 Applications. Applicants for small research grants (R03) and exploratory/developmental grant (R21) programs now have the option to submit their application using ASSIST rather than the standard downloadable forms. To learn more about the benefits that ASSIST provides, read the January 30, 2015, Guide notice.

NIH Soliciting Feedback on Potential Emeritus Award. NIH is considering an emeritus award that would allow senior investigators to transition away from NIH research grants (to the emeritus award), in order to secure their research legacies by passing on their knowledge and resources to junior colleagues. You can weigh in by responding to NIH's Request for Information: Sustaining the Biomedical Workforce and a Potential Emeritus Award for Senior Researchers. Comments are due March 6, 2015. Also see the Rock Talk blog post Seeking Your Input on Sustaining the Workforce Through an Emeritus Award.

Grants.gov Upgraded to Accept Special Characters. You can now use special characters, including Greek letters, in the free-text form fields on Grants.gov. As explained in the January 27, 2015, Guide notice, applicants should verify that information in their Grants.gov submission matches their eRA Commons profile, e.g., Peña versus Pena.

Remember the Rules for Requesting Big Grant Preapproval

An application that requests $500,000 or more in direct costs in any one year is considered a big grant. If your application’s budget request would qualify it as a big grant, contact the program officer listed in the funding opportunity announcement (FOA) under Scientific/Research Contacts and the division big grant coordinator at least six weeks in advance of the receipt date listed in the FOA to request preapproval to submit your application.

Do not wait until you’ve completed the budget section of your application to reach out to a program officer. Contact one as soon as you realize the potential for your direct costs to approach the big grant threshold.

If you are applying for an NIAID Investigator-Initiated Program Project Application (P01) that exceeds $500,000 in direct costs, you should contact a program officer (Martin Gutierrez for DAIDS, Dr. Cheryl Lapham for DAIT, or Dr. Karen Lacourciere for DMID) at least 10 weeks in advance. This applies even if no project within the program exceeds the $500,000 direct cost threshold on its own. Also, be aware that there are separate Prior Consultation Timeframes for Investigator-Initiated Clinical Trial Applications.

Here’s a chart that shows how you might determine your request date for several upcoming standard receipt dates:

Grant Mechanism	Application Due Date	Planned Submission Date*	Big Grant Request Deadline	Planned Big Grant Request Date*
Standard R01 (new)	June 5	June 3	April 24	April 22
Standard R01 (renewal, resubmission, revision)	July 5	July 3	May 24	May 22
Standard P01	May 25	May 21	March 16	March 12
Standard AIDS R01	May 7	May 5	March 26	March 24
Standard AIDS P01	May 7	May 5	February 26	February 24

*As a reminder, you should apply several days before the application receipt deadline in case you run into technical problems.

Your complete big grant preapproval request will be sent through an internal NIAID approval process. You will then receive a letter signed by an NIAID division director or designee stating whether your request has been accepted or rejected.

Don’t try to circumvent the preapproval requirement for big grants by writing an application that falls just short of the threshold. In fact, any application that approaches $500,000 in direct costs should still make a big grant request, as unanticipated factors, such as out year costs, could push your application up to big grant status. We’ve seen applications reach the big grant threshold when a sponsored office adjusted the budget section to align with institutional policies, unbeknownst to the investigator. The Center for Scientific Review may withdraw your application for not having a preapproval letter.

Remember that you must request preapproval for a big grant application in response to a program announcement reviewed in an institute. For a request for applications, the FOA will state whether you can request a big grant. If you are unsure whether a FOA requires a big grant request, ask the program officer.

Finally, know that resubmission and renewal applications still need big grant preapproval, even if they were approved in a previous submission attempt.

Related Resources:

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.

"Am I required to use My Bibliography or SciENcv to list my published work in the new biosketch format?"—anonymous reader

No, but those databases are great examples of publicly available sources of published work. If you link to a different list, be sure that your peer reviewers will have access and trust its accuracy. Avoid sources that you or your institution manage as well as those that include your name in the URL address.

The new biosketch format, which is required for grant applications with due dates on or after May 25, 2015, is designed to capture your five most significant contributions to science. Within each of those five descriptions, you may list up to four relevant peer-reviewed publications.

Since your biosketch is limited to five pages, including a full list of your publications will take up too much space. Thus, you have the option to link to a full list. We recommend that you use SciENcv because it includes features designed to simplify biosketch preparation, as demonstrated in the YouTube video SciENcv: Science Experts Network Curriculum Vitae

To see the new biosketch instructions and a completed sample, view Biographical Sketch Sample–Forms Version C on SF 424 (R&R) Application and Electronic Submission Information.

“Can my small business establish a subaward with an NIH intramural laboratory using NIH grant money?”—anonymous reader

Yes, but there are restrictions that designate the minimum amount of research effort that your small business must complete.

For Small Business Innovation Research (SBIR) Phase I, your small business must conduct at least two-thirds of the research effort, which limits the amount of effort that an NIH intramural laboratory can undertake. For Phase II, your small business must conduct at least half of the research effort.

For Small Business Technology Transfer (STTR) Phase I and Phase II research, your small business must carry out at least 40 percent of the research effort and your single partnering research institution must perform at least 30 percent, which again limits the amount of research that you could pay an NIH intramural laboratory to conduct.

For technical details, read Section 4.8 Special Instructions for Preparing Applications with a Subaward/Consortium in SBIR/STTR Application Guide SF424 (R&R) Forms Version C on SF 424 (R&R) Application and Electronic Submission Information. Also, learn more about intramural-extramural collaborations at Opportunities and Guidelines to Facilitate Scientific Collaborations.