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- Funding for Integrated Preclinical/Clinical AIDS Vaccine Development
- Big Data Opportunity for Small Business Innovation Research
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New Funding Opportunities
Application Missteps—Misfiring on Innovation
In our August 19, 2015 article “Application Missteps—Weak Project,” we pointed out a common application pitfall and how to sidestep it, with advice from those in the know: program and scientific review officers who have years of experience overseeing the grant process.
Next on our list of frequent stumbling blocks: innovation. Here we show you how to clear this hurdle.
As one of the standard NIH initial peer review criteria, innovation is used to assess how much a project can 1) shift the current research paradigm or 2) refine, improve, or propose a new application of an existing concept, method, instrumentation, or clinical intervention.
In deciding which part of the definition to satisfy, take note that you don't need to make one giant leap for science.
Taking incremental steps is fine as long as you clearly show how your project will move the ball down the field, adding significantly to knowledge and pushing its frontier forward, as illustrated by the graphic on the right.
In short, you should be on the cutting edge without going over the edge.
With this in mind, be aware that paradigm-shifting research can be an uphill climb, especially for new investigators or people entering a new field. You'll have to convince reviewers that it's feasible and that your preliminary data are strongly supportive of a possible paradigm shift, while being aware that some reviewers might think that challenging the status quo means challenging their world view or research.
Depending on your circumstances, a better plan may be to take the second approach. Most investigators, whether new or experienced, choose this route by showing how their proposed research is new and unique, e.g., explores new scientific avenues, has a novel hypothesis, or will create new knowledge.
Along those lines, a program officer in our Division of AIDS (DAIDS) expands on how applicants can demonstrate innovation: "Innovation can take many forms. It can include using a new technology. It might involve developing new animal models or combining disciplines to tackle a problem."
To learn more, go to Be Innovative, But Be Wary in Part 2 and Innovation in Part 3 of the Strategy for NIH Funding, linked below.
Reviewers and Innovation
Of course, how you fare with innovation depends on your reviewers, who will likely fall into two categories: those who readily grasp and appreciate the cutting edge elements of your project (and will thus give you a good innovation score), and those who may not be as receptive to these same elements (and will thereby give you a poorer score).
Make Sure Each Reviewer "Gets It"
To help get as many people on your side as possible, it's essential to clearly convey what is innovative about your proposed work so that all your reviewers—experts and non-experts alike—"get it."
Our DAIDS program officer seconds this notion:
"Applicants must set the stage so that all reviewers, no matter what their background, can appreciate the project's innovative aspects. For example, if an investigator proposes applying tried-and-true 'Technology X' to develop a rapid diagnostic test for an organism that clinicians have a dire need to identify, he or she should address 1) reviewers who are familiar with the technology but not with the organism and thus may not see the innovation in using a well-established technology to address this diagnostic need and 2) reviewers who understand the organism and why a rapid diagnostic test is necessary but who are not familiar with the technology and the feasibility of its use for the new test."
For more on addressing your reviewers, go to Know Your Audience, linked below.
Address How Your Project Does and Doesn't Fit the Innovation Shoe
Highlighting your project's innovative aspects is important but so is pointing out where innovation is not essential. Two of our program officers explain why covering both bases is crucial.
"Many reviewers interpret this criterion as a requirement to develop or use novel technologies or techniques, so they often criticize or penalize applicants who use 'standard and established techniques' even if they're the most appropriate. Given this, applicants should explicitly describe at what level their project is innovative, i.e., at a technological or scientific level (innovative hypothesis or model system), or both! If they're not developing new technologies, techniques, or protocols, they shouldn't hesitate to point that out themselves and explain why."—Wolfgang Leitner, program officer, Division of Allergy, Immunology, and Transplantation (DAIT)
"Since innovation is a standard review criterion, reviewers have to evaluate this factor, even for later stage product development applications that are frequently devoid of innovative approaches. I encourage applicants with projects that rely on straightforward methodologies to highlight any other novel aspect of the project, such as how the technology or product will be applied or integrated in a new way. In the absence of any identifiable innovation, applicants should acknowledge or briefly explain why their project lacks the innovation reviewers are charged with looking for."—Alec Ritchie, program officer, Division of Microbiology and Infectious Diseases (DMID)
Persuade Reviewers of Your "Risk"y Business
Introducing anything new or unique has its risks. Think of gadgets, like smart phones and e-readers, that have come out over the last few years. The creators had to convince people, whether business partners or shareholders, that their innovative product was worth the risk and destined for success.
Here are some tips on how to do that.
Frank De Silva, a scientific review officer in our Scientific Review Program, advises:
"Depending on the proposed research, reviewers may view innovative ideas and technologies as risky. Consequently, applicants should thoroughly describe why the innovation being described (be it an idea or technology) is important in moving the scientific field of interest forward. For innovative ideas, it should be rational and supported by the literature and, if possible, preliminary data. With innovative technologies, the application should indicate experience with the proposed methodology, provide some preliminary evidence that it is feasible and appropriate, and consider possible alternative approaches to address potential problems and limitations, i.e., mitigate the potential risk."
Our DAIDS program officer adds:
"Innovation often involves an element of risk. That said, the more you can demonstrate the feasibility of your project, the better. For example, has the proposed technology been used before? Do you or your team members have experience with the technology? If you've used it but not for this organism, have you demonstrated that you appreciate the challenges that a different organism poses? If you propose something that is really outside the box, consider an initiative, e.g., a request for applications, that is seeking this."
As an example, see Innovative Technologies and Assays in Support of HIV Cure Research (ITAS-Cure) (R41, R42) and (R43, R44) on our NIAID Funding Opportunities List. Read more about applying for initiatives that call for innovation in Getting a Grant for Innovative Research. For a list of other innovation-seeking initiatives, go to The NIH Common Fund's High-Risk Research page. Both resources are linked below.
Give Yourself Time, Ask Yourself Questions
Now that you know some of what to expect when it comes to reviewers, you probably see that it's wise to give the innovation aspect of your application time and consideration. Don't leave it as an afterthought; you should be thinking about innovation early on, as one of our program officers advises:
"The innovation criterion should be in mind as applicants develop their research question and Research Plan. They certainly shouldn't wait until they get to the Innovation section of the Research Strategy to start thinking about how to address the innovative aspect of their research."—Annette Rothermel, program officer, DAIT
As you ponder innovation from the get-go, you might find it useful to ask yourself some key questions to gauge whether reviewers will think your project fits the bill.
Wolfgang Leitner suggests these:
"I would recommend that applicants ask the following: Is my approach unique and my experimental design creative, unconventional, or multidisciplinary? Will I generate novel, meaningful insights? Answering 'yes' will likely garner high marks for innovation.
However, a low innovation score is guaranteed if applicants play it very 'safe,' e.g., their scientific approach is very conservative, the scope of the research is narrow, and the proposed study is more of the 'same old, same old.'
Playing it safe also includes the uncritical embrace of dogmas and established models in the field instead of following up on findings that are or appear to be inconsistent with the models and do not support the commonly held beliefs.
While it is not necessary to propose a radical overturn of imperfect models, refining and correcting them will benefit the research community, thus move the field forward and likely be rewarded with a good innovation score."
Related Links
- Strategy for NIH Funding
- Review Criteria SOP
- NIAID Funding Opportunities List
- NIH Common Fund
- High-Risk Research
- Webinar on high-risk, high-reward research
Funding for Integrated Preclinical/Clinical AIDS Vaccine Development
NIAID continues its longstanding Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Program to facilitate the translation of sufficiently advanced, innovative, and promising vaccine candidates into early clinical testing. Through a reissued funding opportunity announcement (FOA), we seek applications that can help advance vaccine concepts into clinical studies.
The IPCAVD Program provides the critical resources necessary to support:
- All stages of vaccine platform research and development through facilitation of nonhuman primate (NHP) proof-of-concept studies, and subsequent down-selection to identify the final lead candidate
- All product development stages including processes development, Current Good Manufacturing Practice (CGMP) manufacturing, and formulation
- All investigational new drug-enabling studies and regulatory submissions
Research programs funded under this FOA will be composed of multiple components, including:
- Administrative core—program resources providing overall management, coordination, and supervision of the program
- Projects—applications must propose a minimum of two projects, and one of the projects must perform product manufacture.
- Scientific core(s)—one or more scientific cores may be proposed as a resource to the multiproject grant. Each of the proposed cores must support at least two research projects.
- External Advisory Committee—a committee of independent experts in the areas of research that the project addresses, to be identified soon after award
Note that this FOA uses the U19 activity code, which entails substantial federal programmatic staff involvement to assist, guide, coordinate, or participate in project activities.
This award will not support clinical trials, and a preclinical research application alone is not sufficient for this announcement. Applications consisting of preclinical research without a direct pathway to clinical testing are ineligible for consideration.
Application Submission
Application budgets are not limited but need to reflect the actual needs of the proposed project. As a guideline the approximate range of funding in direct costs is $1.5 million to $2.5 million each year, and the maximum project period is five years.
The FOA has three due dates, the first of which is March 9, 2016. For that deadline, send optional letters of intent by February 8, 2016. Apply early to allow adequate time to correct any application errors found during the submission process.
For complete details, read the August 14, 2015 Guide announcement. Also, read Guidance for Preparing a Multiproject Research Application for more advice.
Contact Dr. Jeffrey Pullen if you have any questions.
Big Data Opportunity for Small Business Innovation Research
As part of its Big Data to Knowledge (BD2K) program, NIH issued a funding opportunity announcement (FOA) that may interest investigators at small business concerns (SBCs). Specifically, this may interest those who want to submit a Phase II Small Business Innovation Research (SBIR) application that proposes software hardening as well as developing and disseminating existing technologies in biomedical computing, informatics, and big data science.
Consider applying if you have met the objectives of a Phase I SBIR grant through non-SBIR funds and seek to initiate the Phase II SBIR stage of development, without needing to perform more early-stage, Phase I SBIR-type research.
Note: This FOA will not accept "regular" Phase II submissions from SBCs for projects that have completed the proof-of-concept Phase I type of research through an SBIR or Small Business Technology Transfer (STTR) award from NIH or any other agency that participates in the SBIR/STTR programs.
Four Topic Themes
Investigators should target one or more of the following four themes of biomedical computing, informatics, and big data science that will advance biomedical research.
For examples of each theme, read the June 30, 2015 FOA, linked to below.
- Collaborative environments and technologies: Address the issues of releasing big data and tools and gaining access to and using big data and tools.
- Data integration: Propose efficient and effective ways to create connections across data types (i.e., unimodal or multimodal data integration).
- Analysis and modeling methodologies: Propose to develop approaches for modeling, simulation, or analysis to produce useful biomedical information in ways that current methods cannot provide.
- Computer science and statistical approaches: Propose to develop enabling technologies in basic computer science.
Deadlines and Contact
NIH's Standard Due Dates apply. The next deadline is January 5, 2016. Note that SBIR and STTR grant applications now follow the new due dates outlined in the December 17, 2014 Guide notice and in our January 8, 2015 article "Plan to Shorten SBIR/STTR Grant Cycle Takes Effect."
For complete details, including information to provide in your application, read the June 30, 2015 Guide announcement. If you have questions, direct them to NIAID's scientific/research contact Dr. Mary Chelsea Lane.
News Briefs
Continue to Use Grant Forms That Expired Last Month. A number of grant application and management forms expired on August 31, 2015. Continue to use those forms, despite the expiration date. Once new forms are approved and ready, NIH will announce implementation plans. For full details, read the August 28, 2015 Guide notice.
Reminder of Legal Requirements for Acquisition, Use of Human Fetal Tissue. Last month NIH posted a list of laws, regulations, and policies relevant to the research involving human fetal tissue. Learn more by reading the August 14, 2015 Guidenotice.
Still Time to Register for October NIH Conferences. The 2015 NIH Regional Seminar: Program Funding and Grants Administration will be held October 14 to 16, 2015, in San Diego, California. Conference workshop and session topics range from budget basics to human research protections to grant writing to eRA Commons account administration. And don't forget, the 17th Annual NIH SBIR/STTR Conference will be held in Seattle, Washington, from October 27 to 29, 2015. Find each conference's agenda and registration information on the respective websites.
Loan Repayment Program Launches New Website, Deadline Approaches. The NIH Division of Loan Repayment has a new website to walk you through the Loan Repayment Program (LRP), whether you're an applicant, awardee, research supervisor, referee, or business official. The LRP application cycle is open now and closes November 16, 2015.
Director's Remarks to Council: Watch Online. NIAID's Advisory Council will meet on Monday, September 21. Go online to watch NIAID Director Dr. Anthony Fauci's remarks, scheduled for 10:30 a.m., at NIAID Advisory Council Meeting-September 2015.
Delayed Onset Awards Explained
Suppose you are applying for an R01 grant and intend to conduct human subjects research but need the results from the preclinical research before you can finalize your plans. What do you do?
For single project awards like this, NIH uses delayed onset awards to create a checkpoint—after award but before the involvement of human subjects—for you to submit updated, detailed human subjects documentation for our approval.
We also use delayed onset awards for cooperative agreement and multiproject awards that are likely to add new protocols over the course of the award, e.g., clinical research networks and pilot project programs. This article focuses on single project awards since the approval process for those other types can vary by both IC and award.
Before You Apply
Talk to a program officer. Do not assume we will view your research proposal as a potential delayed onset award. That determination is uncommon, so you should proceed only with the encouragement of a program officer. More often, when preclinical research results could prompt research with human subjects involvement, the grantee will write a new grant application.
You should also check with your institution to verify whether your proposed research is considered delayed onset.
When You Apply
In your grant application, include as much information about prospective human subjects involvement as possible.
Designate Yes in response to “Are Human Subjects Involved?” on the SF 424 (R&R) Other Project Information Form. Enter your Federalwide Assurance number if you have one.
Follow the instructions for Scenario D. Delayed-Onset Human Subjects Research in the SF 424 Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan.
In the Research Plan section Protection of Human Subjects, explain anticipated protections for human subjects or else explain why protections cannot be described. Be explicit about the information needed to develop definite plans for the involvement of human subjects, factors affecting the availability of the information, why that information is not currently available, and when the information is expected to become available during the course of the project.
Remember, your justifications will weigh into your overall impact/priority score. If you don’t justify why the study is delayed onset and do not provide a Protection of Human Subjects section, your application will receive an HS Code 44 for human subjects concerns.
Finally, prepare a blank “placeholder” inclusion data record in the Inclusion Management System accessible through the eRA Commons. Enter a comment on the Planned Enrollment Report(s) indicating that this is a delayed-onset study. For the study title, use the project title along with the words “Delayed Onset Study.” You can indicate in the comments section of the Planned Enrollment Report whether more than one study is anticipated.
After Award
When you are ready to begin the human subjects portion of your research, you must submit a written prior approval request to your grants management specialist. Include your authorized organizational representative's signature. We must receive the request at least 30 days before any human subjects involvement. Be sure to write the complete grant number in the subject line of your email.
Your prior approval request must include (as an attachment) the scientific protocol or revised research timeline and a new or revised human subjects section that clearly describes risk, protections, benefits, and importance of the activities. In essence, you are completing the NIH Supplemental Grant Application Instructions.
As applicable, you will attach new or revised inclusion plans for women, minorities, and children and a new or revised data and safety monitoring plan and board. Provide a new or revised Inclusion Enrollment report in the Inclusion Management System.
Finally, if not provided previously, you’ll attach certification that key personnel have appropriate education in the protection of human subjects and certification of Federalwide Assurance and institutional review board approval of the IC-approved plans. See our Human Subjects Federalwide Assurances SOP to learn more.
To learn more about delayed onset awards, including details for large research consortia and pilot project programs, read the July 30, 2015 Guide notice.
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.
“Can an institution apply an inflation rate to its budget on competing grant applications?”—Rose Cornet, Charles Stark Draper Laboratory
No, NIAID does not allow unjustified direct cost escalations. Here, “unjustified” is used in the sense that the cost escalation is not explained in the budget justification based on research aims. This goes for cost of living increases for all budget categories, to include personnel. You must spell out increases in the budget justification.
Here's an example of a justified out-year increase for a direct cost item: a grantee requested cost for 200 mice in year one of the grant, but the next year (year two), the grantee’s plan will need 600 mice. Because the increased number of mice is based on the research aims/plan, the direct cost increase to pay for the additional mice in year two is justified.
Conversely, listing different requested costs in the application budget for the same amount of mice in year one and year two would be an unjustified direct cost escalation.
We do allow grantees to rebudget in out-years to account for pay escalation, but we will not increase committed funding.
“For investigators with R01 funding, are there limits on the salaries of postdoctoral assistants and technicians?”—anonymous reader
There is no specific cap on R01 postdocs or technicians as long as the salary is consistently applied based on the grantee institution’s organizational policy for those employee types. Many institutions try to align their R01-supported postdoctoral salaries with the salary rates paid by NIH fellowship awards, depending on the post-graduate year status of the postdoc. Keep in mind, the overall salary cap applies as well. See Salary Cap and Stipends.
For more information, see Salaries and Wages and related entries in Section 7.9.1 Selected Items of Cost in the NIH Grants Policy Statement.
See announcements at NIAID Funding Opportunities List.