April 17, 2013Feature Articles
- Next Step for Ten Steps to a Winning R01 Application
- Sidestep These Application Missteps: Flawed Project Design
- Immunologists: Be Part of a Cooperative Center
- Join the Fight Against Antimicrobial-Resistant Pathogens
- Seeking Applications on Underlying Mechanisms of Stigma
- RFA Bridges NIH Intramural and Extramural Research Communities
- FOA Supports Partnerships Between Life and Physical Scientists
- NIAID Seeks R&D on Platelet Regeneration and Survival After Radiation Exposure
- From the White House: Request for Comments on DURC Rules
- Heads Up: Changes Coming to K99/R00
- News Briefs
- Spending Your ARRA Money: A Six-Month Warning
- Reader Questions
Spring has sprung, so what better time to freshen up our Ten Steps to a Winning R01 Application. We're adding more advice and information, which we'll bring you as feature articles in upcoming issues.
For those unfamiliar, Ten Steps is part of our Strategy for NIH Funding and designed as an iterative training tool to help you identify a topic and create a high-impact application.Look for an updated Step 1 next month.
For previous installments in our series, go to Sidestep These Application Missteps.When flawed, project design can spell trouble for your application, so it's important to think about it carefully during the planning stages. Here's some advice to help you avoid this potentially damaging misstep.
Note: We cover a few basics of project design in this article. To learn more, see Design a Project in our Strategy for NIH Funding, linked below.
Build Your Foundation: Hypothesis and Specific Aims
As the driving forces for your project, the central hypothesis and Specific Aims are essential to its design. For more information on both elements, go to the resources in Related Links below. Our participating program officers touch on a few additional points here.
A central hypothesis is crucial since reviewers will examine it closely, but it can be difficult to develop, especially if you're proposing a brand new project or one that changes direction.
In those cases, you may have to include a fair amount of descriptive preliminary data to define basic parameters. Unfortunately, descriptive data often does not excite reviewers. Keep this in mind as you design your project and write your application.
Wolfgang Leitner, a program officer in our Division of Allergy, Immunology, and Transplantation (DAIT), has these tips for you:
"Make sure to a) keep the descriptive ('model-development/characterization') aspects of the project to a minimum and b) justify them well (ask yourself: do I really need to conduct a comprehensive characterization in order to proceed with the mechanistic aims or would a more targeted and selective characterization provide enough information?)."In designing your project, be mindful to develop Specific Aims that are based on, and test, your hypothesis. Also establish a close link between the two. You'll need to demonstrate this connection clearly to your reviewers, as another DAIT program officer points out:
"Reviewers like to see a central hypothesis and how the Specific Aims address it. It can be helpful to fully lay out the hypothesis in the aims section, then conclude with a clear summary of what the applicant expects to know at the end of the award, how that fits with the hypothesis and thus drives the field forward, and where the project could go in the future."—Annette RothermelAs for the Specific Aims themselves, Annette Rothermel cautions against having them depend on one another:
"Applicants shouldn't have aims build on each other since if one fails, the entire project may fail. Always have contingency plans, and design the project so that the aims work together but that one aim doesn’t require the 'success' of another."A scientific review officer has this advice for investigators responding to a request for applications (RFA), though it applies to investigator-initiated applications too:
"There should be a simple testable hypothesis that is supported by preliminary data. Show preliminary data relevant to each aim and clearly tie the data to the aim (highlight your data when applicable)." —Frank DeSilva, Scientific Review Program (SRP)For additional information, go to Choose a Testable Hypothesis and Draft Specific Aims to Test Your Hypothesis. And to learn about how to avoid a lack of focus in these two areas, see our last installment, "Unfocused Hypothesis or Specific Aims." Find links below.
Consider Other Critical Components
Here are some additional thoughts from SRP's Frank DeSilva on other key elements to ponder when designing your project (though his focus is on RFAs, the advice applies across the board). You'll need to address them all in your application to show that you've considered every angle.
"Demonstrate significance of your proposed work. Justify choice of methods and convince reviewers that you know your methods. If you don't, show that you've enlisted collaborators who can do what you propose. Describe potential pitfalls and alternative approaches, and address future directions."Take Time to Consider Timing
An important part of designing your project is figuring how long it will take to complete. In tackling this step, many investigators tend to underestimate, so plan your research with the understanding that it may take more time than you might think.
To come up with an educated "guesstimate," consider as many actions or circumstances that will play into the amount of time you'll need for your project, start to finish.
Susan Brobst, a program officer in our Division of AIDS (DAIDS), suggests asking yourself questions, such as:
"Have you anticipated potential pitfalls and ways to overcome them? Have you considered the time needed to get samples from an off-site collaborator? If conducting human subjects research, do you have a contingency plan for accruing human subjects if you can’t meet your goals with the initial performance sites? Have you allowed sufficient time from when the last human subject is off the study and when the grant ends so that samples can be tested and data analyzed?"As a planning tool, consider mapping out a timeline to visualize what you hope to accomplish in each year of your grant. Keep in mind that the most you can request for an R01 is five years, so it's crucial to assess whether you can do what you set out to in the limited number of years you ask for (which doesn't necessarily mean you'll get it). Moreover, you will likely be writing your renewal application before the first award period is over, so ask yourself where you will be at the time you need to write the next proposal. Will you have key data in hand by then?
With that in mind, having a timeline can give you a clearer picture of whether you're planning to do too much, as another program officer points out:
"New investigators in particular, are frequently criticized for being unrealistic and overly ambitious by proposing too much. Therefore, it helps greatly to prepare a detailed timeline which takes into account potential delays and the time it takes to repeat experiments. Applicants should also consider including a high-level version of this timeline (space-permitting) in the application."—Wolfgang LeitnerBring In Collaborators
Quite likely, you'll need additional expertise to execute parts of your research. That's why you should carefully contemplate in what areas you'll need help and whom you'll choose to provide that help.
Think about this sooner than later as you design your project since identifying the need for additional expertise early on will give you adequate time to get feedback from those you seek out and to make adjustments.
Our participating program officers agree that if you have a gap in expertise somewhere, fill it with a collaborator. It's better to bring in reinforcements than to leave reviewers wondering why you didn't. That said, be sure a collaborator is truly that by having an active role in the research.
Annette Rothermel states:
"It’s a misstep not having a collaborator for an area of expertise that a PI doesn’t have documented evidence of mastering. However, it's important to have a collaborator who provides a strong letter of support, has assisted in the design of the proposed work, and reviews what is written in the grant application. Reviewers will question whether there’s a real collaboration if they find a disconnect between the stated collaboration and flaws in the project design."If you think that bringing in collaborators will be seen as a weakness, think again. In fact, trying to do everything yourself may be more detrimental than having others take an active part in your project. Wolfgang Leitner offers some insight:
"Investigators, especially those who are new, should not try to do everything 'in house' in an attempt to demonstrate independence. They should not hesitate to recruit collaborators for different aspects of the project, or at least consultants who are willing to assist intellectually with aspects for which applicants do not have well documented (i.e., publications) expertise. In any case, it's crucial that investigators clearly describe the roles and contributions of collaborators and consultants."DAIDS' Sue Brobst provides a warning worth heeding while also stressing the importance of addressing collaborators' roles:
"Avoid name dropping. Don’t include senior-level collaborators thinking their name alone will aid your project. This can backfire on you if their role isn’t apparent to reviewers. Be clear about the level of involvement, expertise, and role played by the people named in your application.For Clinical Research, Consider the Scope
Also, get feedback from the collaborators. If reviewers find flaws in the design, they’ll check to see whether appropriate expertise was involved."
If you're interested in proposing a clinical research project or responding to a clinical research RFA, consider the scope of the project. Sometimes, what you or an institutional review board considers clinical or human subjects research may actually be a clinical trial. Since NIH's definition of a clinical trial is very broad, you should get clarification from a program officer.
Designing a project that involves a clinical trial has many facets, so you should have experienced clinical investigators, physicians, biostatisticians, and project managers on your team. Before getting too deep into your proposed project, we recommend talking to a program officer or others who are knowledgeable about this area.
Note that NIAID supports investigator-initiated clinical trials through planning grants (R34), implementation grants (R01), or implementation cooperative agreements (U01) using a defined policy and process. For more information, see Investigator-Initiated Clinical Trial Resources, below.
- Strategy for NIH Funding
- Investigator-Initiated Clinical Trial Resources
Consider applying if your studies can help define the molecular mechanisms responsible for activating and regulating human immune functions involved in protecting against non-HIV infectious pathogens.
The FOA calls for a minimum of two projects and a maximum of four, at least one of which must be hypothesis-testing while the other(s) may propose new technology development. All must 1) include proposed studies on primary human cells or tissues and 2) focus on human immunology in the context of infection, vaccination against infectious disease, or administration of a vaccine adjuvant that targets an innate immune receptor.
To eliminate overlap with other existing NIAID programs, CCHI will not support hypothesis-generating, systems biology, or immune profiling studies nor studies whose major research activity is the discovery of immune epitopes recognized by T cells or antibodies.
For additional research areas that are excluded as well as complete details on this FOA, see the March 21, 2013, Guide notice. The deadline for optional letters of intent is June 28, 2013, with applications due by July 29, 2013.
Through this FOA, you'll be able to translate basic research findings into the very early stages of antimicrobial therapeutics discovery and development for bacterial pathogens where resistance threatens effective treatment.
Eligible projects include target development for the following:
- Small molecule inhibitors
- Therapeutic antibodies and peptides
- Adjunctive therapeutics targeting resistance mechanisms that may not perpetuate the spread of resistance
Note that if your project does not address assay development and target validation for bacterial pathogens where antimicrobial resistance is currently a clinical concern, your application will be considered nonresponsive and will not be reviewed.
Optional letters of intent are due June 18, 2013, while the deadline for applications is July 18, 2013.
For full details, go to the March 26, 2013, Guide notice. And, to learn more about the activity code this FOA uses, read our R21/R33 Phased Innovation Award SOP.
This FOA will support projects that expand the understanding of underlying mechanisms relevant across health conditions or stigmatized statuses. Projects may focus on stigma processes and mechanisms from the perspective of stigmatized individuals or groups or of individuals or groups holding stigmatizing beliefs.
Collaborations between behavioral and social sciences investigators and applied stigma researchers are particularly encouraged.
Optional letters of intent are due July 2, 2013, with applications due August 2, 2013. For complete details, see the March 20, 2013, Guide notice.
If you’re an early-career clinical researcher, consider applying for NIH’s Lasker Clinical Research Scholars Program.To be eligible, you should have completed your core residency training within the past 10 years.
This unique opportunity offers you a chance to obtain an independent research position either in NIH’s Intramural Research Program (IRP) or at an extramural research institution.
The Program has two phases:
- Phase 1—an appointment within IRP for up to five years, with the possibility of an extension for two additional years, as a tenure-track investigator with an independent research budget.
- Phase 2—after completing the first phase, you will be eligible for one of two options:
- Remain in IRP with continued intramural funding and potential progression to tenured senior investigator status.
- Continue research at an extramural institution by competing for a grant under the Lasker Program.
The deadline for optional letters of intent is May 24, 2013, with applications due June 24, 2013. See the February 8, 2013, Guide notice for complete details.
This funding opportunity is designed to encourage collaboration between engineers, physical scientists, and biomedical researchers to catalyze their developing innovative approaches to biomedical research, clinical investigations, and medical practice.
Projects should clearly serve NIAID’s mission to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.
For complete details, read the March 7, 2013, Guide notice.
Read the April 2, 2013, Broad Agency Announcement for details, application instructions, and more information.Proposals are due July 1, 2013.
The White House published its proposed DURC changes in the Federal Register and opened them to public comments.
For details and instructions on submitting your input, read the February 22, 2013, Federal Register notice.
Deadline for comments is April 23, 2013. For more background, read the White House’s Proposed Policy Targets Dual Use Research of Concern.
- Reissued parent program announcement (PA):
- Will be published later this year and must be used for applications due February 12, 2014, and after.
- Current parent PA will remain active through the October 12, 2013, receipt date for new, non-AIDS applications and January 7, 2014, for all AIDS and AIDS-related applications.
- Revised eligibility criterion:
- You will be limited to having no more than four years—rather than the five years currently allowed—of postdoctoral training at the time you submit your initial or resubmission application.
For complete details, read the March 22, 2013, Guide notice. See our Pathway to Independence Awards (K99/R00) SOP to learn more about the K99/R00, including NIAID-specific information, e.g., on duration of support.
RFI: Share Your Ideas on Prevention Research Priorities. NIH is looking for your perspective on the strategic priorities for the Office of Disease Prevention’s (ODP) Fiscal Year 2013 Strategic Plan. ODP also welcomes your suggestions on how to enhance the prevention research portfolio at NIH. Responses are due April 30, 2013. For details, read the March 22, 2013, Guide notice.
After September 30, 2013, the Federal government will take back all ARRA funds remaining in accounts.
We have already placed terms of award prohibiting extensions of active ARRA grants beyond that date and do not have authority to modify those terms or permit you to transfer or reuse ARRA funds for another grant.
Feel free to send us a question at firstname.lastname@example.org. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.
You should be able to get this from NIH RePORT. Check out the Funded Organizations reports or NIH Awards by Location and Organization.
If neither of those give you the information want, you can select your own parameters using the advanced search view function of NIH’s RePORTER query form.
"If a PI will be on maternity leave when her progress report is due, can she ask for an extension? "—anonymous readerThat depends on the progress report due date, the award budget start date, and the timing of the PI’s absence. Contact your assigned grants management specialist as early as possible to see whether this is possible.
- RFA-OD-13-199, NIH Administrative Supplements to Recover Losses Due to Hurricane Sandy Under the Disaster Relief Appropriations Act–Non-Construction
- RFA-OD-13-005, Limited Competition: Restoration of New Investigator Pilot Projects Adversely Affected by Hurricane Sandy (limited competition)
- RFA-MH-14-170, Eradication of HIV-1 From CNS Reservoirs: Implications for Therapeutics
- PA-13-179, Indo-U.S. Vaccine Action Program (VAP) Small Research Grant Program
See other announcements at NIAID Funding Opportunities List.