Opportunities and Resources
- Check Out the Small Business Innovation Research Contract Solicitation
- Diabetes Researchers: A Trio of Opportunities for You
- Enhancing Vaccine Safety to Combat and Prevent Diseases
- Big Data to Knowledge (BD2K) Development Needed for Targeted Areas
In The News
- Have a Multivalent Filovirus Vaccine Candidate? Tell Us About It!
- News Briefs
- Looking Ahead to FY 2016 Budget and Paylines
- Reader Questions
New Funding Opportunities
Over the next few months, we'll explore common application pitfalls and how to sidestep them, with advice from those in the know: program and scientific review officers who have years of experience overseeing the grant process.
Based on what they've seen applicants do wrong, they share tips on how to write a strong research proposal.
First on our list of pitfalls to avoid: proposing a weak project, i.e., a project that reviewers will likely not score well for any one of the following flaws:
- Lack of significance
- Proposed project is a fishing expedition
- Problem more complex than investigator may realize
Lack of Significance
By having a project with little significance—one of the standard NIH initial peer review criteria—you likely seal your fate of not faring well in review. That's why it's absolutely critical to avoid this fatal flaw.
Ask yourself key questions
When thinking about the significance aspect of your application, you may find it helpful to answer for yourself the questions reviewers consider when they assess significance:
- Does the project address an important problem or a critical barrier to progress in the field?
- If the Specific Aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
- How will successfully completing the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Along this line of questioning, Frank DeSilva, scientific review officer (SRO), Scientific Review Program, also suggests:
"To help reviewers better understand the significance of an application, investigators should make an effort to address the following questions: Why is the work important? How will it push the field forward? What is the potential long-term effect that this research will have on science and public health? If an applicant does not clearly articulate these points, reviewers will likely lose enthusiasm for the application. Ultimately, the applicant must present a convincing case that the proposed research is a worthy investment of taxpayer dollars.”
Keeping all these points in mind, your job is to convey and convince in an objective manner. That is, clearly convey the significance of your proposed work so you can convince reviewers your project is worthy of funding.
"Having an ‘impact statement' gives the reviewers an opportunity to understand where things are going in the big picture. Applicants should provide a few sentences in their application that direct reviewers to that as well as future impact."—Michael Minnicozzi, program officer, Division of Allergy, Immunology, and Transplantation (DAIT)
To learn more, go to Highlight Significance and Innovation in the Strategy for NIH Funding, linked below.
Use sounding boards
Significance can sometimes be in the “eye of the beholder.” A good way to gauge whether your project is important is to seek advice from others you trust and see if they agree that your project’s objectives are significant.
A program officer in our Division of AIDS (DAIDS) suggests this:
"If you pitch your idea to people, do they get excited or do they comment 'so what?' If you can then convince them why your question is important, consider using that in your application. This means your project wasn't weak, just your justification. If they still aren't excited, consider another project."
Frank DeSilva is also in favor of using a sounding board to determine whether you must go back to the drawing board:
"If applicants are unsure about the significance of their application, they should approach colleagues at their institution or trusted members in their field of study to help gauge the importance of the proposed research. We also encourage investigators to get advice from NIAID program officers. They know the field and the needs or gaps which are of interest to NIH. If you can't convince these people that your work is significant, it's time to go back to reassess your project."
For requests for applications (RFAs), the narrow scientific scope and unique review criteria make your program officer's insight even more valuable.
"In the case of RFAs, your project needs to be significant in the context of the funding opportunity announcement. An investigator-initiated application may be highly significant when presented to a standing study section but not fully respond to the criteria described in an RFA."—Wolfgang Leitner, program officer, DAIT
Seek out what's high priority or a hot topic, but...
Savvy investigators will find out our high-priority areas by either speaking with a program officer or checking Concepts: Potential Opportunities, linked below. Though a smart move, don't make high priority the basis for describing the significance of your work. That also goes for "hot" topics.
"Investigators often anticipate that addressing a program's high-priority area will automatically establish high significance for their application. While it's important to recognize programmatic high-priorities, applicants must thoroughly convince the review committee of their project's significance, going well beyond a significance statement that simply hinges on what program is interested in."—Alec Ritchie, program officer, Division of Microbiology and Infectious Diseases (DMID)
"While some reviewers may rate the application's overall topic as highly significant (e.g., RSV vaccine development), the proposed methodology or approach may be seen as less significant (e.g., using a common adjuvant with a widely studied antigen). Thus, submitting an application on a hot topic or in a hot field does not necessarily ensure a high significance score. Our reviewers want to see science that will push the field forward, i.e., that the application will have a significant impact on science and/or public health."—Frank DeSilva
Little potential to produce information that can significantly advance the field
At the end of your project period, will you have solid outcomes or little or nothing to show for the time you invested in your work and the money NIH invested in you?
Reviewers will ask the same question. Here's how to help ensure they get the right answer.
"Little potential to produce information that can significantly advance the field is known as ‘incremental benefit to the field.' This is a difficult review hurdle to overcome...The applicant really needs to critically reassess the project's aims and hypothesis, and ask 'is it really cutting edge work?'"—Michael Minnicozzi
"While the question might be important (e.g., study of a new drug proposed to have lower toxicity/higher efficacy than standard of care), poor study design or feasibility issues could render the question unanswerable." —DAIDS program officer
"While a project may be addressing a high-priority area, be innovative, and have a solid approach, the applicant must also convince the review committee that the data or product will have a real impact on human health." —Alec Ritchie
Speaking of data, justify the significance of the data you'll likely generate by describing what you'll do with it (or what will be learned from it).
Remember, the key here is making a case to your reviewers that you'll not only produce data, but that you'll produce something that has an impact on the field or public health—now or in the future.
Proposed Project Is a Fishing Expedition
To avoid this misstep, show reviewers that you're focused, not floundering. Even an Exploratory/Developmental Research Grant (R21) needs direction.
Ensure that your project tackles an important and unique problem, that your hypothesis is well-focused and testable by your Specific Aims, and that your experiments can help meet these aims. If reviewers feel you're fishing for data and not pursuing a logical progression of experiments to answer specific questions, they will not be enthusiastic about your project.
Furthermore, make each aim an achievable objective, not a best effort, with clear endpoints your peer reviewers can easily assess.
Also, support your aims by having key preliminary data when you submit. This is critical—even if it means waiting for another receipt date to obtain the findings you need.
All of these points must come across clearly in your application, lest your reviewers get the wrong impression—and penalize you for it.
It could be in the aim(s)
If the people evaluating your application do get the impression that you've "gone fishing," it may have to do with your Specific Aims.
Frank DeSilva provides some insight:
"When reviewers comment on an application as a 'fishing expedition,' we tend to find that they are really commenting on the lack of focus in the Specific Aims. Applicants occasionally attempt to impress the review panel by proposing to do too much. The reviewers want two to four focused aims that directly relate to the overarching hypothesis or question posed."
Wolfgang Leitner echoes the sentiment about having too many aims:
"New investigators are frequently criticized for writing proposals that are overly ambitious by proposing too much work. Established investigators may have a history of accomplishing a lot of work in a short period of time, but new investigators have to establish a reputation first. They should therefore be realistic about what can be done in two to five years and propose the rest as future research."
And speaking of aims, you don't want to appear aimless, i.e., having no direction. Michael Minnicozzi addresses this point.
"Reviewers may believe that an investigator has no real understanding of the proposed work's direction. He or she should start with a specific hypothesis and have targeted aims to answer the question. The application should be like a story that describes the goal (question to answer) and how the applicant is going to meet it (the aims and approaches)."
Or it could be the type of project
You may also receive the "fishing expedition” remark in your summary statement based on the nature of your project, as two of our program officers point out.
"This comment is sometimes made when investigators propose secondary analyses of samples and data from large clinical studies. Ensure the samples and data being analyzed tie into an overall story so as not to appear as a fishing expedition. Also focus your questions. Otherwise, break up what you plan to do into more than one application." —DAIDS program officer
"We see this comment frequently with product development-related R01 projects. It's very important for an applicant to focus any exploratory aspect of his or her application and back it up with data as much as possible."—Alec Ritchie
Or it could be an impression you're giving
You may also get the "fishing expedition” response because you don't have enough preliminary data to establish what direction to go in.
"When PIs conduct surveys or gather data to develop a hypothesis, reviewers may view their projects as descriptive or as a fishing expedition. If possible, it's better to include preliminary data to point in a specific direction, rather than to have the reviewers trust that PIs will follow their leads appropriately.”—Annette Rothermel, program officer, DAIT
Problem More Complex Than Investigator May Realize
Another strike that could take you out of the running: underestimating how complex your project is.
Reviewers will be able to tell you've made this mistake by evaluating your budget, effort, Specific Aims, and time commitment:
- Budget—asking for too little is a sign that you don't understand the scope.
- Effort—setting an insufficient level of effort shows you're not aware of how much work is involved.
- Specific Aims—not having the appropriate number of aims could mean you don't grasp the complexity of your proposed research.
- Time—requesting too few years for your grant indicates you think your research may take less time than your scope requires.
Sometimes less is more, but in this case, not having or asking enough could be detrimental. To find out what you should consider when thinking about "BEST," see Your Project's Scope: Plot Your Boundaries linked below.
Here's another take from Michael Minnicozzi:
"Reviewers will often use the expression 'too mechanistic.' If this is true, then having strong statements on significance and future direction may appease them. Alternatively, they may feel that the PI has not truly addressed alternative directions or approaches. It may be that after generating a specific hypothesis, the PI has focused too narrowly with the aims and approaches."
Is it really too complex, or is it something else?
While your project may indeed be more involved or complex than you realize, determine whether that's actually the case; it may not be. Various factors could lead reviewers to assess that you're "in above your head."
Our DAIDS program officer has this for you to consider:
"Sometimes this comment is true, and sometimes it's poor grantsmanship. Did the reviewer say this because the investigator failed to state how labor-intensive or technically challenging an experiment is (so unable to judge whether the applicant is aware of the complexity)? Or did the reviewer conclude this due to unrealistic timelines or lack of investigator experience in the methods?"
And note what Alec Ritchie says:
"This could be a reality or could be the perspective of the reviewer(s). Applicants must thoroughly consider and present the scope, resources available, pitfalls, and alternative approaches. They should also vet their proposed project with all key persons and their peers. They could proactively state how thoroughly they have considered and addressed potential complexity and challenges—a critical concern to address upon revision."
A Last Word to the Wise
When you read your summary statement, you may see some of the points covered in this section. However, keep in mind this important caveat, borrowed from Know What a Summary Statement Means, linked below:
"...although your summary statement gives you critical feedback, it is not an exhaustive critique or a teaching tool containing every point reviewers found to be problematic."
Along these lines, here's a final piece of advice, courtesy of Michael Minnicozzi:
"Often reviewers will write these items in the summary statement but have ‘larger or other' issues during the meeting. All the more important that applicants read their summary statement, then talk with the program officer assigned to the application. He or she may have additional contextual insight that was not written in the summary statement."
- Strategy for NIH Funding
- Part 2. Pick and Design a Project
- Part 3. Write Your Application
- Part 5. Assignment and Review
- Concepts: Potential Opportunities
You could compete for contract funds through this year's Small Business Innovation Research (SBIR) solicitation. Read the July 24, 2015 Guide notice for an overview and description of the different phases for the SBIR contract program, a list of contacts, and more.
Your proposal must respond to a topic in the SBIR Phase I Contract Solicitation PHS 2016-1. If you plan to submit a contract proposal in response to one of NIAID’s SBIR topics, provide a written notice of intent to the contracting officer, Charles Jackson. He can notify you if topics are modified or cancelled before the solicitation closing date.
Be sure to follow the new electronic submission process. You must use the electronic Contract Proposal Submission (eCPS) to complete your proposal.
Go to the July 24, 2015 solicitation for more information, including proposal instructions and presentation materials from the August 13 Webinar. These materials will be posted on the NIH SBIR/STTR Listserv. The proposal deadline is 5:00 p.m. Eastern time on October 16, 2015.
Type 1 diabetes (T1D) is the focus of three recent funding opportunity announcements (FOAs) in which NIAID is participating with theNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The specific FOA topics are diverse and may be appropriate for you if you 1) study the pathogenesis and etiology of T1D, 2) can characterize the genetic variations in human genomic region putatively associated with T1D, or 3) are an early-stage investigator proposing highly innovative new research approaches that can potentially have a major impact on T1D-related biomedical and behavioral research.
Before we get to information on the FOAs, here are descriptions of the activity codes they use in case you're not familiar with them.
The DP3-Type 1 Diabetes Targeted Research Award supports research tackling major challenges in type 1 diabetes and promoting new approaches to these challenges by scientific teams.
The DP2-NIH Director's New Innovator Awards supports highly innovative research projects by new investigators in all areas of biomedical and behavioral research.
We provide a brief summary of the FOAs below. Be sure to carefully read the announcements, and direct questions about any of the three opportunities to NIAID's scientific/research contact Dr. Kasia Bourcier.
Understanding the Pathogenesis and Etiology of Type 1 Diabetes Using Biosamples and Subjects From Clinical Studies (DP3)
- Deadlines: October 12, 2015, for optional letters of intent; November 12, 2015, for applications
- Informational webinars: September 17 and September 21, 2015 at noon EDT. Go to Webinar on Funding Opportunities for Type 1 Diabetes Biomarkers Research.
- Award budget: Limited to $1.6 million in direct costs for the duration of the award, with a maximum project period of three years
- Complete details: August 4, 2015 Guide announcement
This FOA supports collaborative projects using human subjects (and/or their samples) who have been phenotypically and genetically characterized for risk of developing type 1 diabetes. To apply for funding, investigators must have documented access to subjects and/or samples from the relevant consortia, or an availability report from the NIDDK Central Repository.
The participating institutes encourage the following:
- Small exploratory pilot studies to gather information relevant to type 1 diabetes prediction and prevention when samples are plentiful and for subject-access studies
- Mechanistic studies in at-risk populations
- Large, collaborative and coordinated projects that make use of multiple program directors/principal investigators, and that make efficient use of limited samples
For examples of possible projects and the kinds of studies allowed (and not allowed), read the Guide announcement.
Mechanisms Underlying the Contribution of Type 1 Diabetes Risk-Associated Variants (DP3)
- Deadlines: January 17, 2016, for optional letters of intent; February 17, 2016, for applications
- Award budget: Limited to $600,000 in direct costs annually excluding facilities and administrative (F&A) costs for subcontracts
- Complete details: July 7, 2015 Guide announcement
Integrative teams and individual investigators should propose projects that can accelerate the discovery of causal genes and variants that influence the risk for T1D. Applicants should also be able to conduct follow-up studies of particular genetic variants to gain novel insights into the functions of these variants and the mechanisms by which they may contribute to disease.
Potential research areas include human studies, comparing wild-type and gene variant functions, identifying causal genes/genetic variants, non-coding RNAs and regulatory elements, epigenetics and epigenomics, and systems-level approaches.
Find additional information in the FOA.
Type 1 Diabetes Pathfinder Award (DP2)
- Deadlines: January 17, 2016, for optional letters of intent; February 17, 2016, for applications
- Award budget: Limited to $300,000 in direct costs (including F&A costs for subcontracts) per year, plus applicable F&A costs to be determined at the time of award
- Complete details: July 29, 2015 Guide announcement
New investigators conducting type 1 diabetes research may want to consider applying for this FOA, the purpose of which is to provide a foundation for investigators to develop an innovative approach to research questions that are major obstacles to curing, preventing, and treating people with T1D.
The research proposed need not be in a conventional biomedical or behavioral discipline but must be relevant to T1D. The FOA encourages investigators who have not previously studied diabetes to apply and establish collaborations with scientists who have a strong background in diabetes research. A helpful resource for finding such collaborations is the Diabetes Research Centers.
Note that NIAID is not contributing money to this initiative. The funds come from the T1D Special Fund allocated to NIH by Congress. NIDDK and NIAID manage funds in areas related to immunology.
See the FOA for additional details, including areas of research that applicants could pursue.
The NIH and CDC are interested in research that will explore potential connections between vaccines and certain diseases. Two funding opportunity announcements (FOAs), using the research project grant (R01) and exploratory/developmental research grant (R21) activity codes, support research that will add to our overall understanding of vaccine safety. The FOAs align with the goals and objectives in the U.S. National Vaccine Plan.
If your project is exploratory or has limited preliminary data, then it is not well-suited for the R01 FOA; instead, apply for the R21, which is designed for two-year projects with limited preliminary data. For both FOAs, your application may include topics involving the development of new vaccines but must not propose clinical trials.
Scientific areas relevant to vaccine safety include: how genetic variations affect immune responses, creating/evaluating statistical approaches for analyzing data on vaccine safety, and genomic/molecular technology methods that evaluate vaccine safety.
Below are some examples of innovative research topics in relation to vaccine safety:
- Evaluating host immune/physiological responses to currently licensed vaccine antigens and/or adjuvant combinations
- Identifying risk factors and biological markers to determine whether there are relationships between certain diseases or disorders and licensed vaccines
- Taking a systems biology approach to investigate the interaction networks of genes, proteins, and other human cellular molecules in response to vaccines
- Comparing the immunologic and physiologic effects of different combinations of vaccines and schedules
Direct questions to NIAID’s scientific/research contact, Dr. Barbara Mulach.
Innovative development of analytical methods and software tools are needed to address the needs of the biomedical research community, especially within fields that use big data. With that in mind, a recent funding opportunity announcement (FOA) seeks applications from investigators with novel approaches for using, managing, and analyzing the larger and more complex data sets inherent to biomedical big data.
Note that the FOA uses the U01 activity code, which entails substantial NIH programmatic involvement. The project director/principal investigator (PD/PI) will have primary responsibility for defining details for projects and performing all scientific activities while NIH staff will facilitate activities. The PD/PI and NIH staff member will also have dual responsibilities.
For more information, see Section VI. Award Administration Information of the FOA.
The FOA focuses on developing approaches in the topic areas of data privacy, data repurposing, and applying metadata. Software and methods developed under this FOA are expected to show innovative approaches to solving difficult problems along with proof-of-concept. Submissions including significant adaptations of existing methods and software are invited.
1. Data Privacy
Data privacy refers to the challenges of collecting, analyzing, and sharing data while ensuring confidentiality of all personally identifiable information. Integrating data generated through avenues such as mobile-health, social networking, and wearable devices, with traditional health data introduces a specific privacy challenge for biomedical research.
2. Data Repurposing
Data repurposing refers to the biomedical research use and application of data not originally created for research purposes. This includes biomedical and health-relevant data collected for purposes of medical care, environmental monitoring data, or quantified-self data. This topic area supports developing methods and software tools that address biomedical researchers’ ease of access to, inclusion of, and challenges of using NIH-relevant “sharable” data not originally captured for research use.
3. Applying Metadata
Software for applying metadata refers to tools and methods that improve the ability of researchers to submit data and materials to databases, journals, and other common community resources by helping them annotate their data and include metadata. Software should help users transform metadata and other information in ways that support and enable data interoperability and exchange of information.
Here are examples of focus areas that would be found in responsive applications:
Applications Should Focus on Developing:
(List is not all-inclusive. Additional focus areas are listed in the Guide announcement.)
|Focus Areas That Will Render Applications Nonresponsive|
||Software tools for:
Note that a single application should have a primary focus on one of the three listed topic areas. You may submit multiple independent applications, each addressing a separate topic area.
Application(s) should not:
- Focus on hardware development
- Encompass tools developed in the normal procession of basic science research not purposefully built specifically to address one of the three topic areas
- Focus primarily on software use or training, data generation, data storage, and database development, or computational modeling and simulation
Application budgets are limited to $300,000 in annual direct costs, and the maximum project period is three years.
Send optional letters of intent by September 6, 2015. Applications are due October 6, 2015. For complete details, read the July 23, 2015 Guide announcement. Contact Dr. David Miller if you have any questions.
A Bit About BD2K
This FOA is a product of the Big Data to Knowledge (BD2K) program, NIH's effort to develop new approaches, standards, methods, tools, software, and competencies to improve scientific use of big data.
Through a new request for information (RFI), NIAID is gathering information about multivalent filovirus vaccine candidates including those that incorporate technological enhancements and may also include a Lassa Fever vaccine component.
Examples of technological enhancements include:
- Rapid onset of protective immunity that will permit a prophylaxis indication in a post-event scenario
- Vaccine presentations or formulations that are stable without the need for cold chain
- Minimal doses to achieve protection
- Addressing issues such as anti-vector immunity and vaccine interference seen with multivalent vaccines
Candidate vaccines should already have shown efficacy in nonhuman primate disease models for at least one of the filovirus components.
To read the full RFI, see the July 29, 2015 Guide notice.
Send your response to Shane Ryan before the September 4, 2015 deadline. Limit your discussion of any multivalent filovirus vaccine product to five pages; ten pages if discussing multiple candidates. In your response, be sure to identify any proprietary information and include your name, institution, and contact information.
New Guidance on Use of Dried Blood Spots From Newborn Screening. In accordance with the Newborn Screening Saves Lives Reauthorization Act of 2014, research using newborn dried blood spots collected on or after March 18, 2015, will be considered non-exempt human subjects research. To learn more about how this policy may impact your research, read the July 23, 2015 Guidenotice.
NIH Seeks Feedback Before Restructuring of Grant Application Instructions. NIH will soon revise the grant application instructions found at SF 424 (R&R) Application and Electronic Submission Information. Help ensure the changes are constructive by responding to Request for Information (RFI): Strategies for Simplifying NIH’s Grant Application Instructions before September 25, 2015.
Stay Informed of eRA Technical Upgrades. NIH's electronic Research Administration (eRA) offers email distribution lists that you can join to receive updates on system downtimes, new features, and technical upgrades. See the July 29, 2015 Guide notice to learn more.
In FY 2016 NIAID will most likely be operating under a continuing resolution (CR). Even though a CR provides funding to sustain NIAID’s extramural and intramural activities, it does not establish the final budget level.
In light of this uncertainty, and consistent with how NIAID has operated under CRs in the past, we will set provisional paylines and priority scores. These will be comparable to provisional paylines set in early FY 2015.
After a final appropriation is passed we will be able to set paylines at a level that supports investigator-initiated awards while providing us with the flexibility to manage resources in the event of reductions to our budget. Consider for example that each additional R01 grant we fund carries with it an obligation to fund three or four out years as well, impacting our future flexibility.
Our budget and planning staff update paylines throughout the year in response to the appropriation process as well as changes in the number of applications received and assigned to NIAID. For more information on how this typically plays out, read Paylines and Budget Pages Change Throughout the Year.
Speaking of paylines, here's a reminder: the numbers you see on our NIAID Paylines page are still for FY 2015 awards. The applications going to Council in September will use our FY 2016 paylines, which we don't have yet.
Later this month, we'll move the FY 2015 paylines to the Archive of Final NIAID Paylines by Fiscal Year as usual.
Feel free to send us a question at email@example.com. 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.
Yes. Postdoctoral trainees can end their NRSA Institutional Research Training Grant (T32) appointment early to start on the NRSA Individual Postdoctoral Fellowship (F32). However, the length of the F32 project period depends on how long trainees were on the T32.
This is because, according to the NIH Grants Policy Statement (GPS), "No individual may receive more than five years of aggregate Kirschstein-NRSA support at the predoctoral level and three years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of Kirschstein-NRSA support from institutional research training grants and individual fellowships."
Read Individual Fellowships in the GPS to learn more.
No. The NRSA Institutional Research Training Grant (T32) is not a research grant and does not necessitate human subjects certification. Instead it supports individual trainees who may work on human subjects research projects.
The projects that trainees work on during the training period should have already been cleared for human subjects research through their research grants.
- PAR-15-330, Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD)
- RFA-AI-15-038, Nonhuman Primate Reagent Resource
- PA-15-329, Administrative Supplements for Research on Sexual and Gender Minority (SGM) Populations
- PAR-15-328, Ethical, Legal, and Policy Issues in HIV Research With Key Populations (R01)
- PAR-15-327, Ethical, Legal, and Policy Issues in HIV Research With Key Populations (R21)
- PA-15-322, Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
- PA-15-321, Research Supplements to Promote Reentry Into Biomedical and Behavioral Research Careers (Admin Supp)
See other announcements at NIAID Funding Opportunities List.