January 23, 2012, NIAID Funding Newsletter
January 23, 2013
Feature Articles
Sidestep These Application Missteps: Unfocused Hypothesis or Specific Aims
Opportunities and Resources
Submit Your Application for AIDS Vaccine Development Program
RFA Seeks Centers of Excellence for Medical Countermeasures
In The News
NIAID Ups F Interim Paylines
For the First Time: Catch Council Proceedings Online
News Briefs
Application Deadline Extension for Tuberculosis Research RFA
More Tools to Support Compliance with Public Access Rules
Senior-Level Job Opportunity in DEA
Advice Corner
Get Institutional Approval for Pre-Award Spending
Reader Questions
Can you sign me up to receive funding opportunity alerts?
Do I need to submit a final progress report if I request a no-cost extension in my last year of the award?
New Funding Opportunities
See the list
Sidestep These Application Missteps: Unfocused Hypothesis or Specific Aims
For previous installments in our series, go to Sidestep These Application Missteps.
After covering must-avoids like proposing a weak project and misfiring on innovation, we now tackle another pitfall to sidestep: lack of focus in your hypothesis and Specific Aims.
For this article, we use the term "unfocused" rather than "weak" since the two are different.
"Weak" relates to a project's impact and significance. Though an application may be weak, it can still be focused.
"Unfocused" relates to the lack of a strong central hypothesis, which can be too broad (e.g., inflammation is a key etiological component of autoimmune diseases) or too descriptive (e.g., we will observe changes in transcriptional signatures in the involved tissues following infection).
Specific Aims can be unfocused if they lack specific goals and either overly describe or inadequately describe what the aim intends to accomplish.
Why Focus Is Key
To paraphrase a popular saying, your application is only as strong at its weakest link—and you certainly don't want that link to be either your hypothesis or your Specific Aims. One of our program officers explains why:
"An application with an unfocused central hypothesis or Specific Aims that won't rigorously test the underlying concepts will most likely not be discussed at review. These constitute the foundation of a project, so a lack of focus will strongly reduce reviewer enthusiasm for the project."—Alec Ritchie, Division of Microbiology and Infectious Diseases (DMID)
Hypothetically Speaking
Coming up with a solid hypothesis for your application may be more challenging than you might think.
Not only should it be well-focused and testable (through your Specific Aims), but it has to be sound and important enough that reviewers believe your research will be able to make a high impact on its field.
With so much riding on your hypothesis, it's crucial you think carefully about it, considering whether it forms a solid foundation for your Specific Aims.
To gauge the quality of your hypothesis, Susan Brobst, a program officer in our Division of AIDS (DAIDS) gives you a starting point:
"Ask yourself: did I begin with a hypothesis then develop the aims and approach to address it? Or did I build the hypothesis around existing data and samples so it would fit what was available to me? The latter approach sometimes results in an unfocused hypothesis or the appearance of a 'data gathering' exercise."
What makes a good hypothesis
From the perspective of reviewers as well as our program and scientific review staff, the saying "you'll know it when you see it" could apply to a focused (strong) hypothesis. In other words, there's no easy way to explain what makes a hypothesis focused or not. That said, our experts provide some insight.
DMID's Alec Ritchie offers this:
"Alone or together, these major factors contribute to an unfocused hypothesis: 1) insufficient or poorly interpreted preliminary data that the hypothesis is built upon and 2) unlikelihood of fully and objectively testing the hypothesis."
Another program officer, Wolfgang Leitner of our Division of Allergy, Immunology, and Transplantation (DAIT), echoes the sentiment about preliminary data as he describes two categories of suboptimal hypotheses:
"Those that are either based on weak preliminary data or not supported by the preliminary data (i.e., they may be very specific and focused but have no factual basis).
Then there are those that make the reader ask, ‘So what?’ A hypothesis may not be considered strong because the research community doesn’t think the question is interesting. It may have been answered already or it doesn’t add anything to our understanding of the system. Therefore, confirming the hypothesis would have no significant impact on the field."
Jim Turpin, a program officer and branch chief in DAIDS, provides a lengthier description:
"A good central hypothesis is a balance of two components: an addressable scientific gap and the knowledge base needed to support the hypothesis. The knowledge base may come from supporting scientific literature or the investigator's experience and publication record.
Reviewers often judge the strength of a hypothesis by how these two factors synergize to create a compelling rationale for the proposed research. This synergy is often characterized as focus, which is important for how a reviewer perceives the hypothesis and its supporting Specific Aims."
For examples of effective and poorly focused hypotheses, go to Choose a Testable Hypothesis in our Strategy for NIH Funding, linked below.
Presenting your hypothesis
Once you've settled on a hypothesis, you'll want to keep it fresh in reviewers' minds by mentioning it in various parts of your application. According to our experts, your hypothesis should feature prominently in at least two places: the abstract and Specific Aims.
Wolfgang Leitner explains:
"The proposed project makes its first impression through the abstract and the Specific Aims sections, which consequently have a significant impact on how reviewers will score the entire application. Therefore, it is crucial for the central hypothesis, which the project is based on, to have a prominent position in these sections rather than to be introduced in the main body of the application."
Susan Brobst suggests stating the hypothesis in the abstract and using a diagram in the research strategy to focus an application:
"Indicate what your hypothesis is early in the abstract so you don’t lose reviewer interest. To help focus a pathogenesis or mechanistic application, consider including in the research strategy a diagram of the pathways hypothesized and tested.
This diagram could help 1) the reader understand what is currently known and the gaps in knowledge that your project will address and 2) you better understand the analyses needed to test each hypothesis."
Brandt Burgess* and Frank DeSilva, scientific review officers in our Scientific Review Program, address investigators responding to requests for applications (RFAs):
"It is important that the hypothesis is in line with the objective of the RFA and should be stated in the Specific Aims, which is one of the most important parts of an application since it serves as the first impression of an investigator's proposed research."
Getting Specific About Specific Aims
Your Specific Aims are the objectives for your research. To keep yourself from going off in too many directions, determine what two to four aims you could achieve within the proposed project period.
Focus your aims by making each one an achievable objective with clear endpoints your peer reviewers can easily assess.
Also maintain focus by never losing sight of your hypothesis, which goes hand in hand with the objectives of your project. In fact, the link between the hypothesis and aims is crucial, as two of our program officers point out:
"It's critical that the Specific Aims be designed to test the hypothesis as productively and directly as possible within the budget and timeline proposed, while allowing for pitfalls and alternative approaches to be negotiated as need be."—Alec Ritchie
"It must be clear to reviewers that the proposed aims are based on, and closely linked to, the central hypothesis. I would recommend paying close attention to the wording of the Specific Aims. Avoid (as much as possible) terms such as characterize, analyze, evaluate, or screen. They indicate a descriptive study that may not be asking mechanistic questions designed to address the central hypothesis."—Wolfgang Leitner
Focusing the Specific Aims section
As part of your application's Research Plan, your Specific Aims section carries a lot of weight, despite its being limited to just one page (for R01s).
In it, you'll tell reviewers everything they need to know about the central hypothesis, research objectives, and significance of the proposed studies. Since all your reviewers read this part of your application, it's important to pack a punch by getting them excited about your project.
With little room to convey your aims, you'll want to keep them as focused as possible and cover the following bases:
Narrative that includes the "big picture" goal of your project and how the aims address an important scientific question or fill an important gap in understanding the big picture.
Statement of the central hypothesis and general approach you'll use to test it.
Brief description of your aims and how they build on your preliminary studies and previous research.
Brandt Burgess and Frank DeSilva provide some pointers for investigators applying to an RFA:
"The Specific Aims page should briefly describe the question(s) that you are trying to answer in response to the scientific objectives in the RFA, the stated hypothesis to address the question(s), a very brief background, and the significance of the work. Conclude with an impact statement stating how the results, if successful, will advance the scientific field of interest."
For advice on writing the Specific Aims section of your application, go to Explain Your Aims, and to see examples of focused Specific Aims, go to Sample Applications and Summary Statements. Both resources are linked below.
*Since the writing of this article, Brandt Burgess left NIAID.
Related Links
Strategy for NIH Funding
Part 2. Pick and Design a Project
Choose a Testable Hypothesis
Draft Specific Aims to Test Your Hypothesis
Part 3. Write Your Application
Explain Your Aims
Hone Your Abstract and Narrative
Sample Applications and Summary Statements
Submit Your Application for AIDS Vaccine Development Program
Here's your shot at helping NIAID address one of its top priorities: developing a safe and effective prophylactic vaccine against HIV/AIDS.
Consider applying for the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Program, which facilitates moving advanced, innovative, and promising vaccine candidates into early clinical testing.
Through IPCAVD, you can receive seven years' support for all stages of vaccine platform research and development, product development stages, and IND-enabling studies and regulatory submissions.
Your multiproject application must include a minimum of two research projects, one of which has to perform product manufacture. For each project, you should clearly describe goals with measurable milestones and provide a timeline for meeting them.
Though NIAID will not provide funds for conducting clinical trials, we require that you have a clinical development plan outlining how you will initiate a clinical trial during the first five years of the award since we expect you to move your proposed vaccine into clinical testing.
Reduced funding in years six and seven will support ongoing stability studies, updating regulatory submissions, and further optimization of the vaccine product as informed from the clinical studies.
A word of caution: avoid proposing only preclinical research. Your application won't be considered appropriate for this funding opportunity announcement (FOA) and will not be reviewed.
Get complete details on application requirements in the December 14, 2012, Guide notice.
The FOA has three due dates, the first of which is March 15, 2013. For that deadline, optional letters of intent must be submitted by February 15.
For advice on writing your application, go to our Guidance for Preparing a Multiproject Research Application.
RFA Seeks Centers of Excellence for Medical Countermeasures
If your work can translate basic research to medical countermeasures against NIAID's Emerging and Re-Emerging Infectious Diseases, including NIAID Category A, B, and C Priority Pathogens, we have a new funding opportunity for you.
Building on the success of our Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases, this new request for applications (RFA) supports centers of excellence in developing medical countermeasures and technologies.
To qualify, your center must have three to six interdependent research projects organized around a common theme, and you can focus on early-discovery-based efforts, late-stage preclinical development, or any stage in between.
You may propose a single countermeasure, but shy away from a "one-bug, one-drug" concept and instead target flexible, broad-spectrum approaches and technologies.
If your application is funded, you can get up to $4 million in annual direct costs for up to five years.
Because of the translational nature of your research, make sure your application addresses any constraints, challenges, and barriers to product development, licensure, and usage.
Also note: we do not accept clinical trials for this RFA.
Read the November 23, 2012, Guide notice for instructions, program requirements, and examples of research themes. Applications are due March 26, 2013.
NIAID Ups F Interim Paylines
We raised FY 2013 interim paylines for fellowship awards. New interim paylines are:
F31—30 overall impact score
F32—25 overall impact score
Go to NIAID Paylines for more payline information.
For the First Time: Catch Council Proceedings Online
February's meeting of our advisory Council comes with a new perk: you can watch our director's remarks and subcommittee proceedings online.
On February 4, go to NIH VideoCasting and Podcasting to view the following sessions:
National Advisory Allergy and Infectious Diseases Council—remarks from Drs. Anthony Fauci and Gary H. Gibbons, director of the National Heart, Lung, and Blood Institute.
Council subcommittee hearings—scientific, programmatic, and budgetary advice on all aspects of each extramural division’s research, including future research programs, from distinguished subcommittee members.
AIDS Research Advisory Committee (includes the Division of AIDS Subcommittee)
Division of Allergy, Immunology and Transplantation Subcommittee
Division of Microbiology and Infectious Diseases Subcommittee
Previously, you had only two options to catch Council live: attend in person or watch from a computer on NIH's internal network. Now, you can tune in from anywhere you have an internet connection.
If you miss the live sessions, you can view archives at the links above.
Go to NIAID Council Agenda for a full list of February Council events, including subcommittee hearings:
AIDS Research Advisory Committee Agenda
Allergy, Immunology, and Transplantation Subcommittee Agenda
Microbiology and Infectious Diseases Subcommittee Agenda
Visit our Advisory Council portal for information about Council's role, function, and membership.
News Briefs
Application Deadline Extension for Tuberculosis Research RFA. NIAID extended the application deadline for Tuberculosis Research Units (U19) to July 1, 2013. See the January 8, 2013, Guide notice. We wrote about the RFA in the November 28, 2012, article "TB Researchers, Unite!"
More Tools to Support Compliance with Public Access Rules. NIH released a Public Access Compliance Monitor to help institutions track the compliance of publications that fall under NIH's public access policy. Get details in the January 9, 2013, Guide notice. It also created a button on the My Bibliography portal to download the publications report as a PDF formatted for progress reporting—see the January 10, 2013, Guide notice for more information.
Senior-Level Job Opportunity in DEA. NIAID seeks a director of its Office of Knowledge and Educational Resources in the Division of Extramural Activities. Qualified applicants must have NIH program or peer review experience. For details and full job description, read the USAJOBS announcement. This is the position referenced in our November 28, 2012, article “Coming Soon: Supervisory Job Opportunity in NIAID's Division of Extramural Activities.”
Get Institutional Approval for Preaward Spending
Did you know you may be able to use your institution’s money to begin your project up to 90 days before your grant’s official start date?
Contact your institution’s business office for approval on pre-award spending, as your institution takes on the responsibility of your expenses in the event that we reduce your award or cannot issue your grant.
Make sure that charges:
Are necessary to conduct the project.
Are allowable under the grant, if awarded, without NIH prior approval.
Will not impair your ability to accomplish the project objective in the approved time frame or adversely affect the conduct of the project.
Preaward spending does not affect the timing of your award. Your grant still starts on the same date, and your renewal and reporting deadlines also stay the same.
Always exercise caution—we may not make your award by the "Earliest Project Start Date" mentioned on NIH's Standard Due Dates for Competing Applications.
Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.
"Can you sign me up to receive funding opportunity alerts?"—anonymous reader
Good news: you can control your own email subscriptions for information from NIAID.
We offer alerts on a variety of funding opportunities as well as other subjects. Go to NIAID Email Alerts Subscription Center for a summary of topics and what to do.
We also tweet new funding opportunities and other important announcements. Follow @NIAIDFunding on Twitter.
"Do I need to submit a final progress report if I request a no-cost extension in my last year of the award?"—anonymous reader
Yes, but you'll send it within 90 days after the end of your no-cost extension. Read the following pages for more information:
No-Cost Extension SOP
Noncompeting Progress Reports and Program Officer Approval SOP
File Your Final Reports at Award End in the Strategy for NIH Funding
Also note that if you submit a renewal application before the due date of your progress report, you do not need to submit a separate progress report for your grant. Include this information under the progress report header in your Research Strategy.
For more advice on progress reporting, contact your program officer.
RFA-AI-12-060, Autoimmunity Centers of Excellence, Basic Research Program
RFA-AI-12-059, Autoimmunity Centers of Excellence, Clinical Research Program
RFA-AI-13-007, Innovation for HIV Vaccine Discovery
RFA-AI-12-042, Delivering Therapeutics to Residual Active HIV Reservoirs
See other announcements at NIAID Funding Opportunities List.