Opportunities and Resources
- New Year, New Opportunity for Collaboration
- FOA Focus: U01 Application for Collaborative Research at the NIH Clinical Center
- Propose to Develop Candidate Radiation Medical Countermeasures
- Form a Collaborative Team to Study Organ Fibrosis
In The News
- Don’t Be Alarmed by New Human Subjects Involvement Code
- Use the Correct Application Guides for Late Applications and Continuous Submission for FOAs With January 7 Due Date
- News Briefs
- Where Will Your Application Be Reviewed?
- Reader Questions
New Funding Opportunities
As we do every year, we'd like to thank all the volunteers who served on NIAID peer review committees, our advisory Council, or other such groups in FY 2015.
- For NIH Center for Scientific Review reviewers, see CSR Study Section Roster Index.
- For Council, go to Biographical Sketches of NIAID Council Members.
If you are an experienced investigator, consider serving on an NIAID peer review committee. You would help us fund the best science, and your service could give you invaluable insights into the review process for your future applications. Learn more about Serving on a Peer Review Committee, including How to Become a Peer Reviewer.
If you're unsure about volunteering, try getting a firsthand report from colleagues who already volunteered.
If you are on our Thank You list and spot any issues with your entry, email corrections to email@example.com.
Opportunities and Resources
Are you searching for a collaborative opportunity to kick-start your new year of research? If so, NIH has an R01 funding opportunity announcement (FOA) that may be a perfect fit.
The U.S.-China Program for Biomedical Collaborative Research FOA will support collaborative basic, translational, and clinical research between U.S. and Chinese researchers in the following areas: allergy, immunology, and infectious diseases, including HIV/AIDS and its comorbidities, co-infections, mental health, and selected neurological disorders.
Be aware that this FOA will not support research and activities that involve select agents or include clinical trials (see the NIH Definition of Clinical Trial). Using samples from independently supported clinical trials is encouraged. Both U.S. applicants and Chinese collaborating partners are expected to comply with NIH regulations for conducting research involving human subjects and vertebrate animals.
Unlike a standard R01 application, preliminary data are not required under this FOA; however, supporting evidence for past productivity, proposed approach, and techniques should be included.
Areas of Specific Interest
Applications should support studying host immune response, regulation, and immunopathogenesis of the inflammatory effector response to microbial or viral infection.
Example topics of interest relevant to non-HIV/AIDS immunology include:
- Differentiation and activation of innate and adaptive immune cells and signaling pathways
- Positive and negative regulation of inflammation
- Responses of tissue-resident lymphocytes to microbial and/or viral infections
- Definition of biomarkers of protective immune responses
Infectious Diseases (non-HIV/AIDS)
Submissions for this topic should support research on infectious diseases (non-HIV/AIDS), and focus on malaria, tuberculosis, dengue fever, enterovirus 71, rabies, schistosomiasis, measles, hepatitis, or influenza.
Topics of interest relevant to non-HIV/AIDS infectious diseases consist of:
- Antimicrobial resistance, including mechanisms of resistance
- Resistance in disease vectors
- Immune responses to infectious diseases or vaccines, including the role of immune responses in pathogenesis
- Molecular characteristics of innate immunity in acute or chronic infections and strategies for modulating the immune responses
HIV/AIDS and Comorbidities
Proposed studies should be in priority HIV/AIDS focus areas, such as:
- Improved treatment outcomes
- Reducing incidence of HIV/AIDS
- Improved prevention or treatment of HIV-associated comorbidities, co-infections, and complications
- Other crosscutting topics that include basic research in support of developing strategies for the areas listed above
Collaborative Application Submission
U.S. applicants applying to this FOA must be from a U.S. institution and must name an eligible investigator from the National Natural Science Foundation of China (NSFC) as a collaborating partner. Additionally, U.S. and Chinese collaborating investigators will work together to submit corresponding applications to NIH and NSFC, respectively. By submitting an application to NIH, the U.S. applicant agrees to also provide a complete copy of the application to his or her Chinese counterpart.
Application Deadline and Restrictions
Applications are due March 17, 2016. Proposed budgets are limited to $200,000 in total costs each year, with a maximum project period of five years. Be sure to apply early to allow time to correct any errors found in your application during the submission process.
For complete details, read the December 11, 2015 Guide announcement. Applicants should direct their questions to the NIAID scientific/research contacts listed in the FOA under Section VII. Agency Contacts.
In August, we wrote about two companion funding opportunity announcements (FOAs)—an X02 (pre-application) and a U01 (cooperative agreement)—for Opportunities for Collaborative Research at the NIH Clinical Center.
The first deadline for X02 applications has passed, but you can still submit a U01 application even if you did not submit a X02 pre-application. The deadline for the U01 FOA is in just a few months on April 11. If you're planning on applying for the U01, here are a few key points to keep in mind.
The budget requests for this FOA are complex; therefore, you should begin discussions about logistics and budget issues with your intramural collaborators and NIH program staff in the early phases of preparing your application.
You must submit a detailed budget that distinguishes extramural costs, NIH intramural investigator costs, and NIH Clinical Center costs. Note: Your application must include a complete budget for Clinical Center costs or it may be returned as being incomplete and not proceed to initial peer review.
Budgets are limited to $500,000 in direct costs each year and must encompass all budgets (i.e., extramural, NIH intramural, and NIH Clinical Center). If an award is made, NIAID will support the intramural collaborator’s costs through existing intramural funds; no new intramural funds will be added.
That said, the extramural investigator can support certain intramural costs, exclusive of the Clinical Center costs, which are budgeted and awarded separately.
Other Required Components
Your application must include several components, such as:
- Letters of support from the NIH Clinical Center director and the respective institute or center (e.g., NIAID)
- Request letters as early as possible. Don't wait to finish writing your application before making requests.
- Collaboration Plan that describes how you will maintain the proposed collaboration with your intramural investigator throughout the award duration.
- Applications proposing multiple project directors/principal investigators should also include a Multiple PI Leadership Plan.
- Intramural scientists who are one of multiple PIs must have an active eRA Commons account. To create one, contact Dr. Ken Santora in NIAID's Office of Extramural Research Policy and Operations.
- Applications proposing multiple project directors/principal investigators should also include a Multiple PI Leadership Plan.
- Clinical Protocol Synopsis (if the collaboration involves a clinical trial)
- Statistical Analysis Plan
- Data and Safety Monitoring Plan
- Milestone Plan and Complete Clinical Protocol for Projects Involving Clinical Trials
For More Information
You may also want to check the following resources:
- Opportunities for Collaborative Research at the NIH Clinical Center (U01) website, which includes:
- August 5, 2015 NIAID Funding News article "Opportunities for Collaborative Research at the NIH Clinical Center"
NIAID is soliciting proposals to advance the development toward FDA approval or licensure of one lead candidate medical countermeasure (MCM) or biodosimetry biomarker/device capable of assessing, mitigating, or treating radiation-induced injuries.
NIAID expects that candidate MCMs will enter the evaluation and development pathway at various stages—from early research to post marketing (e.g., drugs already licensed for other indications)—so the offeror’s Statement of Work should be based on the development stage and the work needed to advance the specific MCM orbiodosimetry biomarker/device.
Evaluation of the offeror’s proposal will be based on:
- The extant, underlying data supporting the mitigation or assessment of radiation-induced tissue damage and reduction of major morbidities and mortality.
- The comprehensiveness, soundness, adequacy, and suitability of the proposed scientific approach and methodology used to support the advancement of the candidate MCM, biodosimetry biomarker/device to FDA licensure or approval.
- The adequacy of the scientific and technical personnel, facilities, equipment, project management, and compliance with good laboratory practice and current good manufacturing practice.
NIAID anticipates awarding up to four cost reimbursement, completion type contracts. The contracts will average an annual total cost of $1 to $2 million, although the award sizes will vary depending on the scope of the project and technical objectives of the award.
The maximum period of performance that an offeror can propose is three years. NIAID expects the performance period to begin approximately December 1, 2016.
The deadline to apply is March 22, 2016, at 3 p.m. Eastern time.
NIAID’s Radiological and Nuclear Countermeasures Program is now participating in “Collaborative Projects to Accelerate Research in Organ Fibrosis,” an R01 funding opportunity announcement (FOA) that invites crosscutting molecular, cellular, animal, and/or human studies to better understand, detect, and resolve pathological organ fibrosis.
To reflect the interrelated nature of aberrant fibrogenesis spanning multiple organ systems, this FOA emphasizes collaborative research projects to characterize mechanisms of aberrant fibrogenesis and fibrosis resolution in different organ systems, develop novel therapeutic strategies aimed at mitigating organ fibrosis, or develop novel technologies that can be used to study fibrosis in more than one organ system. To be deemed responsive, applications must include an in-depth study of more than one organ system with at least one organ system being the heart, lung, bone marrow, or vascular system.
To be considered eligible for NIAID funding, your application must be centered on the Institute's specific focus area: ionizing radiation-induced fibrosis.
Multiple program director/principal investigator (PD/PI) applications are strongly encouraged. See Tips for Writing a Strong Multiple PI Leadership Plan for application advice.
Your application budget cannot exceed $350,000 in annual direct costs. The maximum project period is four years.
Applications are due on October 21, 2016. Send optional letters of intent by September 21, 2016.
For more information, refer to the July 17, 2015 Guide announcement.
NIH is using a new human subjects involvement code—Code 35—for institutional training grant applications that include vertebrate animal or human subjects research.
As announced in the October 13, 2015 Guide notice, applicants are no longer required to submit lists of grants that trainees may work on with their associated institutional review board (IRB) or institutional animal care and use committee (IACUC) approvals. Instead your application should describe how the institution will ensure trainees will participate only in human subjects or vertebrate animal research with prior IRB or IACUC approval, respectively.
Applicants who score within or near NIAID's published paylines or those who receive a just-in-time email request from a grants management specialist must submit certain information and documentation before NIAID will issue an award. For those whose summary statement has a Code 35 designation, we require the relevant IRB and IACUC assurances before we will issue an award. See Prepare Your Just-in-Time Information.
From there, your annual progress reports will need to include IRB and IACUC documentation for any research projects that trainees work on with human subjects or vertebrate animal involvement. Also, note that NIH does not require inclusion monitoring for Code 35 institutional training awards.
NIH will continue to use Code 10 to designate training grants under which trainees will not work on research projects involving human subjects or vertebrate animals.
- NIAID Human Subjects Resources
- Know What a Summary Statement Means
- Understand the Annual Progress Report
- Training Grants (T)
Use the Correct Application Guides for Late Applications and Continuous Submission for FOAs With January 7 Due Date
Did you miss the January 7, 2016 AIDS/AIDS-related application due date? Are you eligible to submit a late application or under continuous submission? What’s the new due date? And which application guides should you use?
Those questions have come up a lot lately. We’ll answer them here with specific examples.
|Program Description||Standard Due Date||Council Date||Late Application Window of Consideration*||Last Date for Continuous Submission (for R01, R21, and R34 with standard due date only)||SF424 (R&R) Application Guides|
|AIDS and AIDS-related applications (All activity codes except SBIR/STTR)||January 7, 2016||June 6, 2016||Within two weeks after January 7||February 8, 2016||November 25, 2014|
|Non-AIDS New R01 applications||February 5, 2016||September 12, 2016||Within two weeks after February 5||April 18, 2016||November 25, 2015|
*Note: Some active FOAs (those posted on or before December 17, 2014) still follow the January 13, 2011 Guide notice late policy and may not have the two-week window of consideration. Read the FOA carefully to determine which policy applies.
Only in rare circumstances does NIH accept late submissions. See our January 15, 2015 article “New Policy on Late Applications” for a list of valid reasons for being late. Regardless of the circumstance, NIH will not accept your application beyond a two-week window of consideration following the application due date. Read the Late Applications SOP for additional information.
Eligibility for continuous submission is based on participation in NIH review meetings as described in Frequently Asked Questions—Continuous Submission. Follow the instructions at How to Check Your Continuous Submission Eligibility to determine if you are eligible. The December 4, 2013 Guide notice lists application receipt periods by Council round. Thus, R01, R21, and R34 applicants targeting the January 7, 2016 AIDS receipt date may apply as late as February 7, 2016, if they are eligible for continuous submission. However in this case, since February 7 is a Sunday, the actual deadline is Monday, February 8.
The FOA’s receipt date determines which form set and SF 424 (R&R) Application Guides you should use, not your personal deadline when adjusting for late applications or continuous submission. If you are applying on February 8, 2016 under continuous submission for an AIDS application, you would still use the forms (FORMS-C) and application guides (those posted November 25, 2014) that were in effect on January 7, 2016, even though NIH will have transitioned to new application guides on January 25, 2016 (those posted on November 25, 2015). If you are applying for the February 5, 2016 standard due date for a new non-AIDS R01 application, use the new application guides (those posted on November 25, 2015).
For more information, read our November 4, 2015 article "Timeline for NIH Transition to New Application Forms."
The maximum direct salary that someone may receive under an NIH grant or contract is $185,100 effective January 10, 2016. Previously the limit was $183,300. The December 24, 2015 Guide notice includes additional background information and questions and answers that address related issues like rebudgeting and payments made to consultants.
While NIH originally planned to implement the new rigor and transparency policy for fellowship and training grants beginning May 25, 2016, delays will push back the policy changes until FY 2017. Read the December 17, 2015 Guide notice for additional information.
NIH has completed its Target Timeline for Single-Project ASSIST Support. You can now use ASSIST for all single and multiproject, competing grant applications; single-project administrative supplements; single-project, post-award successor-in-interest (Type 6) requests; and single-project, post-award change of institution (Type 7) requests. Using ASSIST is optional; you can also use Grants.gov downloadable forms and institutional system-to-system solutions.
Small business grantees interested in commercialization strategy should register for I-Corps From the Trenches: Conversation With Pilot Participants, an interactive Webinar scheduled for February 4, 2016, from 1 to 2 p.m. Eastern time. The deadline to apply for the I-Corps program is March 21, 2016. Find application instructions in the October 29, 2015 Guide announcement.
The next NIH Regional Seminar will take place in Baltimore, Maryland, from May 11 to 13, 2016. The two-day seminar and optional preseminar workshops will focus on topics like compliance, peer review, grant writing for success, pre-award and post-award issues, and animal and human subjects research. See the November 23, 2015 Guidenotice for more details.
It's worth knowing in advance whether your application will have its initial peer review through NIH's Center for Scientific Review (CSR) or through one of NIH's institutes or centers.
The reason? If you find that your application will go to a CSR study section, you can request assignment to the most appropriate study section. Knowing the most likely reviewers also lets you write your application with that audience in mind. Learn more at Requesting an Institute and Study Section.
To learn the locus of review, check your chosen funding opportunity announcement. See "Section V. Application Review Information" and then scroll down to the section "2. Review and Selection Process."
Here are general rules of thumb about who will be reviewing your application, based on application type:
CSR review—For applications in response to most program announcements (PA), including Parent Announcements, the most appropriate study section in CSR will conduct the initial peer review. Potentially, many review committees could review applications responding to a single program announcement.
For NIAID, there is an exception to the rule above for career (K) and training (T) PAs. For K and T applications, NIAID oversees the initial peer review instead of CSR.
Institute review—Instead of CSR, institutes like NIAID oversee initial peer review of applications submitted for the following:
- Most requests for applications (RFA)*
- Most program announcements with set-aside funds (PAS)
- Some investigator-initiated applications (for example, program projects)
* For applications responding to RFAs, the lead sponsoring institution usually conducts the review.
If you apply to a program announcement with special receipt, referral, and/or review considerations (PAR), your application might go to CSR or an institute. In either case, a special emphasis panel is likely to review your application. That means instead of requesting assignment to an integrated review group, we suggest that you focus on describing the scientific expertise necessary to review your application.
Note that we used the word "most" a few times above, so there are exceptions. Get confirmation in the opportunity's Guideannouncement.
Feel free to send us a question at firstname.lastname@example.org. 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.
Yes, NIH requires that all personnel involved in the design or conduct of human subjects research receive training in the protection of human subjects. Your business office must provide a certification letter before NIAID will issue an award, either with your grant application or your just-in-time information. See Sample Letter to Document Training in the Protection of Human Subjects.
While NIH does not endorse any specific courses, you may use the Office of Extramural Research's Protecting Human Research Participants tutorial to fulfill the requirement.
“Once a grant application is submitted, how will I receive notice that my summary statement is ready?”—anonymous reader
You’ll need to regularly check the eRA Commons for this information.
You can get a sense of when it will appear as you watch the Commons, though. Here’s how this works for investigator-initiated applications.
- Within 7 to 10 days after you apply, you’ll find your application’s initial assignments in the Commons.
- The Center for Scientific Review posts the roster in the Commons 30 days before the review.
- Then after the review meeting:
- NIH releases scores to you in the Commons within three business days.
- NIH uploads your summary statement within 30 days. New investigators who submitted R01 applications should be able to access their summary statements within 10 days after the review meeting.
- RFP-NIAID-DAIDS-NIHAI2015045, NIAID Clinical Site Monitoring
- PAR-16-081, International Research Ethics Education and Curriculum Development Award
- NOT-TW-16-001, Notice of Information: Parallel Funding Initiative for Collaborative Research Between Investigators in the United States and the State of São Paulo, Brazil
- PA-16-077, NIH Pathway to Independence Award (Parent K99/R00)
- PA-16-066, Administrative Supplements for Research on Sex/Gender Differences
- BAA-NIAID-DAIT-NIHAI2015042, Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Devices
See other announcements at NIAID Funding Opportunities List.