Opportunities and Resources
- Wanted: Applications for Pilot Clinical Trials Targeting HIV-1 Reservoirs in Children
- Seize an Opportunity To Join Kidney Transplantation Network
- A Chance To Get Supplemental Funds for U.S.-South Africa Program Opportunities
In The News
- NIAID Will Consider an Eligibility Exemption for Some K Applicants
- Implementation Date for Single IRB Policy Pushed Back to September
- News Briefs
- Managing a Grant With Vertebrate Animals Research
- Reader Questions
New Funding Opportunities
In general, we advise applicants to consider themselves fundable when their application receives an overall impact/priority score that falls within NIAID paylines. However, context matters—specifically, the type of funding opportunity announcement (FOA) to which you applied.
Just as there are multiple types of applications, there are multiple types of FOAs. Here are the four types:
- Program announcement (PA)
- Program announcement with special receipt, referral, and/or review considerations (PAR)
- Program announcement with set aside funds (PAS)
- Request for applications (RFA)
There are technical and procedural differences among the FOA types, but generally speaking, a PA defines a broad area of scientific interest, a PAR or PAS defines a narrow area of scientific interest, and an RFA sets specific research requirements within a defined scientific topic.
Each of these FOA types will list the “Funds Available and Anticipated Number of Awards” in Section II. Award Information.
Our PAs then use the following standard language: “The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.” For an example, see PA-16-445, Trophoblast Differentiation and Function (R01).
In other words, applications to PAs are usually funded following our paylines. These types of applications will get a percentile along with their merit score. Our “Parent” FOAs are all issued as PAs, use this language, and follow the paylines. See NIAID Paylines for information on which mechanisms and what payline percentages are currently being used.
Conversely, the other three FOA types state the anticipated number of awards in the following format: “NIAID intends to commit $11 million in fiscal year 2018 to fund up to 5 awards.” That example is taken from RFA-AI-16-080, Systems Biology: The Next Generation for Infectious Diseases (U19).
Because NIAID sets maximum dollar commitments on these initiatives, applications are typically funded in score order until the initiative’s funding limit is reached. This approach precludes the use of paylines.
For example, a given PAR, PAS, or RFA may garner 12 applications for two awards, 25 applications for eight awards, 12 applications for eight awards, or 25 applications for two awards. With such small application and award counts, the percentage of applications funded can vary greatly.
This creates the possibility of situations in which an application may get an excellent score, but because the initiative reached its budget limit funding better scoring applications, the application is not funded.
If this happens to you, contact your program officer to discuss the possibility of resubmitting the application or reworking and submitting it as new to a different FOA. For RFAs, which have only one receipt date, you have the option of reworking the application and submitting it as a new application in response to a parent announcement.
Opportunities and Resources
A new funding opportunity announcement (FOA) might be for you if you are interested in studying the dynamics behind the establishment and maintenance of the HIV-1 reservoir in children.
Your proposed clinical trial must meet the FOA’s objective: to evaluate therapeutic modalities to limit or reduce HIV-1 reservoirs in children (birth to 18 years of age at the time of enrollment). Specific populations of interest include:
- Early anti-retroviral therapy (ART)-treated children who are virally suppressed
- Children who are about to start or recently started ART for acute infection and may not yet be virally suppressed
- Children who started ART later in their disease course
As for the therapeutic modalities, they should have an established safety profile with preclinical and/or clinical data to support a potential effect on HIV-1 reservoirs and may include interventions such as therapeutic vaccines or broadly neutralizing antibodies or a safe latency-reactivating agent.
Your clinical trial may take one of several approaches, for example, testing an immunotherapeutic intervention in children who received early ART due to perinatal infection. For other examples, read the FOA by clicking on the Guide link below.
We encourage you to collaborate with laboratory experts or networks with laboratory capacity as well as with experts in other disciplines, such as oncology or immunology.
Additional FOA Facts
The FOA uses the U01 activity code. Learn more about cooperative agreements in our May 4, 2016 article "Just for 'U': A Closer Look at Cooperative Agreements.” NIAID intends to commit $3,150,000 in fiscal year 2018 to fund one or two awards. Application budgets are not limited but need to reflect the actual needs of the proposed project, the scope of which should determine the project period, which in turn may not exceed five years.
Deadlines, Details, Contact
Optional letters of intent are due February 14, 2017. The deadline for applications is a month later on March 14. Find complete details in the December 5, 2016 Guide announcement.
Reach out to the FOA’s scientific/research contact Judi Miller if you have questions.
NIAID is participating in a new initiative from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to establish as many as 15 clinical centers that will together form the APOL1 Long-Term Kidney Transplantation Outcomes Network (APOLLO).
Recent evidence suggests two alleles of the APOL1 gene, G1 and G2, are associated with a much higher risk of chronic kidney disease and graft loss after kidney transplantation. These variants may explain 70 percent of the excess focal segmental glomerulosclerosis, HIV-associated nephropathy, and hypertensive kidney disease in African Americans.
Thus, APOLLO’s overarching mission is to design and conduct longitudinal studies to determine the impact of APOL1 genetic variants as susceptibility factors in kidney transplant recipients who received kidneys from African-American donors. The Network will also track short- and long-term health outcomes for the African-American kidney donors.
APOLLO’s Clinical Centers will collect data on the rate of change of kidney function in transplant recipients, and rates of acute rejection of the kidney transplant, graft failure, return to maintenance dialysis, and kidney re-transplantation. They will do so by obtaining biological samples as well as genetic and clinical information from African-American kidney donors and the recipients of those kidneys, across the United States, at baseline and longitudinally. The Clinical Centers will transmit those data and samples to APOLLO’s Scientific Data Research Center (SDRC) for repository and biostatistical analyses.
The APOLLO Clinical Centers and SDRC will work collaboratively on the planning, design, execution, and analysis of APOLLO studies. A Steering Committee composed of key members of SDRC, Clinical Centers, and NIH will ensure the designs of the studies are scientifically sound, comprehensive, and have sufficient statistical power to study the primary outcomes.
A successful applicant for a Clinical Center will have access to large populations of African-American living and deceased kidney transplant donors and recipients of those kidneys. The applicant should also have established relationships with a large number of smaller feeding clinical centers that perform relatively small numbers of donor kidney procurements and renal transplants in African Americans, to support the goal of capturing all African-American donor kidney allografts nationally.
This initiative uses the cooperative agreement research project (U01) activity code, which allows for substantial programmatic involvement on the part of NIH, in this case NIDDK, NIAID, and the National Institute on Minority Health and Health Disparities. Read the November 16, 2016 Guide announcement for complete details.
Application budgets are limited to $200,000 annual direct costs, with a maximum project period of five years.
Send an optional letter of intent by January 24, 2017, and apply before the February 24, 2017 deadline. If you have questions, contact Dr. Paul Kimmel.
As you may know, NIH recently published R01 and U01 funding opportunity announcements titled Revision Applications for the U.S.-South Africa Program for Collaborative Biomedical Research.
Both FOAs will provide supplementary funds to current awardees to add or expand activities focused on establishing or enhancing substantive research engagement for underrepresented scientists within South Africa, particularly those previously lacking this expertise.
Both revision FOAs seek to increase the number of underrepresented scientists in South Africa engaged in collaborative research that supports emerging public health needs in the areas of tuberculosis, HIV/AIDS biomedical and behavioral science, and HIV-related co-morbidities, including malignancies.
For these FOAs, underrepresented scientists in South Africa are defined as South African Black, Coloured, and Indian population groups and scientists at South African historically disadvantaged institutions (HDIs) and other Universities of Technology. For a list of these universities and HDIs, see the FOAs.
You may apply for a revision if you 1) were funded in response to either RFA-AI-14-009 or RFA-AI-14-018 or 2) are a South African scientist with active, direct NIH R01 or U01 funding. The parent grant must be active when you submit your application.
South African project directors/principal investigators and collaborators must be either permanently employed at an eligible South Africa research institution or be in a long-term contract (at least for the minimum of the duration of the project).
The funding period for the R01 and the U01 revisions is up to two years. Participating NIH institutes intend to commit approximately $3 million each year and fund a total of 10 to 15 awards in fiscal year 2017.
Our intent is that the supplementary funds will support collaborative research and other activities, e.g., scientist exchanges or specific scientific skill-building activities, which are designed to increase and enhance the research skills of underrepresented scientists participating in South African research.
In The News
It takes time for postdoctoral researchers conducting maximum containment research to gain select agent approval, complete biosafety level 4 (BSL-4) training, and obtain independence in BSL-4 environments. And time is of the essence since several NIAID career development (K) awards include an individual eligibility requirement that caps postdoctoral time dedicated to research activities for prospective applicants.
To help level the playing field, NIAID will now consider those initial maximum containment activities to be non-research training activities, exempt from the four- and five-year research training eligibility limits listed in the NIH Pathway to Independence Award (Parent K99/R00) and NIAID Career Transition Award (K22) funding opportunity announcements, respectively.
We’ll need to consider the amount of time devoted to maximum containment training activities on a case-by-case basis, so contact Dr. Shawn Gaillard, NIAID’s research training officer, to discuss your individual situation and eligibility for an exemption. NIAID will then follow our existing procedures for granting eligibility exemption to determine how much time beyond the four- and five-year limits to allow you.
Back in July, we covered a new NIH requirement for grantees to Use a Single Institutional Review Board for Multisite Protocols Beginning With May 2017 Applications. Our guidance from that article hasn’t changed; however, NIH moved the policy’s effective date to September 25, 2017.
Investigators must take the policy into account for grant applications due on or after September 25, 2017. NIH does not require ongoing grants to convert to a single IRB, but any renewal applications submitted after the effective date must do so. For contracts, the policy applies to all solicitations issued on or after the effective date (rather than the response date).
For the original policy announcement, read the June 21, 2016 Guide notice.
In addition, NIH published a new set of questions and answers about the single IRB policy. Find them at NIH Single IRB Policy FAQs for Extramural Community. If you need additional help or clarification, contact the NIH Office of Clinical Research and Bioethics Policy at SingleIRB@mail.nih.gov.
The next standard due date for applications to the parent Small Business Innovation Research (R43, R44) and Small Business Technology Transfer (R41, R42) funding opportunities is January 5, 2017. In addition, the Direct Phase II and Commercialization Readiness Pilot programs will stop accepting applications after January 5, 2017, and April 5, 2017, respectively, as our Congressional authorization to offer these pilots expires.
Apply early to ensure you have sufficient time to correct any electronic submission errors before the application due date. If your small business has never applied for a grant before, know that you’ll need to complete five registrations as part of the Electronic Submission Process for Grants.
If you missed the live presentation on December 7, 2016, check out “Ethics Rounds: Consent for Online Research: When Is It Needed? How Does It Work?” to learn how federal regulations governing informed consent for human subjects research apply to research conducted online.
For grants involving vertebrate animals, here's a timely reminder about your annual report and a quick review of other requirements.
Annual Report Due January 31, 2017
Your institutional official should email the annual report as a PDF attachment to firstname.lastname@example.org. NIH's Office of Laboratory Animal Welfare (OLAW) wants the report no sooner than December 31, 2016, and no later than January 31, 2017. Learn more about the report in the December 1, 2016 Guide notice and see OLAW's Sample Annual Report.
Requirements for Animal Grants
With each paragraph below, we include a link to the relevant section of NIAID's Research Using Vertebrate Animals tutorial. Our guidance is based on federal requirements and NIH's typical terms of award. You should also read your grant's terms of award and check with your institution for any animal policies that go beyond what we describe here.
Your Institutional Animal Care and Use Committee (IACUC) plays a continuing role during your grant. It ensures that your institution will comply with all terms and conditions of award and stipulates that your project will follow all institutional policies and procedures. The IACUC also monitors your research progress, conducts semiannual evaluations of your animal program, and more. Get details on how IACUCs Monitor Your Progress.
The IACUC can suspend your project due to noncompliance or deviations from your approved animal protocol. Problems at a subaward institution can also result in suspension. Learn more at Avoid Suspension of Animal Activities.
In addition to the annual report we mentioned above, there is another reporting requirement. Your institutional official for animal welfare must notify OLAW promptly of serious or ongoing noncompliance, serious departures from the Guide for the Care and Use of Laboratory Animals, and IACUC suspensions. Find more information at Know Your Reporting Requirements.
Keep your project's data and fiscal information for three years after the end of the grant. Get a list of what to retain at Keep Your Records Accessible.
NIAID also offers guidance on managing other aspects of your grant at Manage Your Award.
You can ask us a question at email@example.com. After responding, we may ask your permission to include your question in the newsletter.
Good planning is critical. Some people wait until the last possible receipt date to send in their renewal applications without a break in funding, though often it's best to apply earlier.
If you have sufficient data, you may consider submitting your application one or more review cycles early. Applying early gives you time to revise and resubmit if you do not get a fundable score.
Unless your Notice of Award explicitly says otherwise, you don't need NIH approval to copyright publications developed under an NIH grant, including training and fellowship awards. Copyright ownership is an arrangement between you and your institution. As the grantee, your institution may exercise its right of ownership over any work created during your official duties.
- PA-17-078, Administrative Supplement for Research on Sex/Gender Influences (Admin Supp)
- PA-17-084, Eradication of HIV-1 From Central Nervous System Reservoirs (R01)
- RFA-AI-16-083, Revision Applications for U.S.-South Africa Program for Collaborative Biomedical Research (U01)
- RFA-AI-16-082, Revision Applications for U.S.-South Africa Program for Collaborative Biomedical Research (R01)
- RFA-AI-16-085, Development of Multipurpose Prevention Technologies: A Strategy for the Prevention of Sexually Transmitted Infections (STIs) (R61/R33)
See other announcements at Opportunities & Announcements.