- Items of Interest in New FDA Legislation
- News Briefs
- Keep Form Changes From Becoming Your Waterloo
- Reader Questions
Before you can swerve out of the way, however, you need to know what you're trying to avoid. To help you, we’ll be writing a series of articles that cover both bases—common pitfalls applicants run into and how to sidestep them—starting with this one.
To make this information as useful as possible, we're including advice from those in the know: program and scientific review officers who have years of experience helping investigators try to get a grant. Based on what they've seen applicants do wrong, they share how you can do it right.
For this series, our "board of advisers" is composed of the following staff:
- Dr. Susan Brobst—program officer, Division of AIDS (DAIDS)
- Drs. Brandt Burgess and Frank DeSilva—scientific review officers, Scientific Review Program
- Drs. Michael Minnicozzi and Wolfgang Leitner—program officers, Division of Allergy, Immunology, and Transplantation (DAIT)
- Dr. Alec Ritchie—program officer, Division of Microbiology and Infectious Diseases (DMID)
First on our list of traps to dodge: proposing a weak project, which comprises these areas:
- Lack of significance.
- Little potential to produce information that can significantly advance the field.
- Proposed project is a fishing expedition.
- Problem more complex than investigator may realize.
By having a project without significance—one of the standard NIH initial peer review criteria—you likely seal your fate, i.e., not faring well in review and therefore losing out on a chance at funding. That's why it's absolutely critical to avoid this fatal flaw.
Here's advice on how.
Use sounding boards
A good way to gauge whether your project is important is to bounce it off of other people and see what sticks.
Susan Brobst 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."Scientific review officers (SROs) are 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 the drawing board."—Brandt Burgess and Frank DeSilvaSeek 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 our Council-approved concepts. 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 RitchieAsk yourself key questions
"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."—Brandt Burgess and Frank DeSilva
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 aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
- How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
"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 MinnicozziTo learn more, go to Highlight Significance and Innovation in the Strategy for NIH Funding, linked below.
Potentially Problematic: 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.
"[The concept of producing] is also 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 MinnicozziSpeaking 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.
"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." —Susan Brobst
"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
Gone Fishing: Proposed Project Is a Fishing Expedition
To avoid this misstep, show reviewers that you're focused, not floundering.
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.
Brandt Burgess and Frank DeSilva provide 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." —Susan BrobstIt's Complex: Problem More Complex Than Investigator May Realize
"We see this comment not infrequently with product development-related R01 projects. It's very important for an applicant to focus any exploratory aspect of their application and back it up with data as much as possible."—Alec Ritchie
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 "BEST":
- 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.
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."
Susan Brobst 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 article. 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."Related Links
- Strategy for NIH Funding
- Part 2. Pick and Design a Project
- Part 3. Write Your Application
- Part 5. Assignment and Review
- Know What a Summary Statement Means
- Concepts: Potential Opportunities
Division of Allergy, Immunology, and Transplantation.
DAIT is soliciting comments from grantees and others involved in its clinical research. The draft policies cover a range of topics:
- Essential documents at clinical research sites conducting clinical research funded or sponsored by DAIT.
- Pharmacy facilities at DAIT-supported clinical research sites.
- Source documentation in clinical research funded or sponsored by DAIT.
Comments are due August 31, 2012.
Here are some highlights from the bill.
Generating Antibiotic Incentives Now Act. This legislation creates incentives to develop new antibiotics. It authorizes FDA to allow an additional five years of marketing exclusivity for antibiotics that treat infections with the potential to pose a serious threat to public health, including antibiotic-resistant infections such as methicillin-resistant Staphylococcus aureus.
Extension of user fees. For the next five years, FDA can continue to collect user fees to process applications for prescription drugs and devices. The act also creates similar programs for approving generic drugs and generic biologics.
Focus on pediatric clinical research. The Act also reauthorizes sections of the Best Pharmaceuticals for Children Act, which promotes pediatric clinical research.
You can read the full text of the legislation at S.3187—Food and Drug Administration Safety and Innovation Act.
Extra Receipt Date for PA on Improved HIV Assays. You get one more chance to apply for the funding opportunity announcement HIV Incidence Assays With Improved Specificity. NIAID extended the expiration date to January 8, 2015. Read the July 10, 2012, Guide notice.
CCR Is No More. Central Contractor Registration has officially moved to the System for Award Management (SAM). Your institution must use SAM to register and update information. If your institution's registration was set to expire between July 15 and October 15, it has a 90-day extension; for details, read Additional Information About SAM Transition.
Join the August 14 Webinar on Financial Conflicts of Interest. If you're responsible for sending your institution's reports on financial conflicts of interest, register and tune in to an NIH Webinar on the revised reporting requirements and the new eRA Commons reporting module. Read the July 27, 2012, Guide notice for details.
A new SF 424 application package should get your frontal cortex neurons firing away: you may no longer be able to use the forms you are working on.
For example, NIH just published a new program announcement for conference grants, PA-12-212, NIH Support for Conferences and Scientific Meetings (Parent R13/U13), that has new forms and review criteria.
If you’ve already filled out the forms, you’ll need to redo them. Here’s how to proceed:
- Copy the information from the old forms into the new ones.
- Add or revise information if necessary.
- Reattach the form documents.
Even if you haven't heard any news, it's a good idea to make sure you are using the right application package just before you apply.
Check your funding opportunity announcement’s NIH Guide announcement and Notable Changes Made to SF 424 (R&R) Application Guides (for grant types using the SF 424).
You can find a table of all NIH instructions and forms at NIH Forms and Applications. Remember that requests for applications and program announcements also have NIH Guide announcements that supplement these basic instructions.
To see all NIAID-relevant NIH Guide announcements except funding opportunities, go to our list of Special Announcements. Find our funding opportunities on our Funding Opportunities List.
For major form changes, go to Top Policy Changes.
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.
"Does NIAID support predoctoral fellowships? How are these applications reviewed?"—Katie Brouk, Washington University School of Medicine
Yes. We support NRSA Predoctoral Fellowships to Promote Diversity in Health-Related Research (F31) for members of underrepresented groups.
We do not participate in other opportunities for predoctoral fellowships.
NIH's Center for Scientific Review handles peer review. Fellowship applications are assigned to review groups based on scientific content, then clustered for review by fellowship type.
For more information on Fs, go to Fellowships in our Advice on Research Training and Career Awards.
"Do I need NIAID's permission for changes in key personnel on my grant?"—anonymous reader
Yes. Contact your grants management specialist if any of your key personnel want to withdraw, take more than three months off at a time, or reduce the time devoted to your project by 25 percent or more.
Keep in mind this rule extends to project and core leaders on multiproject awards, the investigator serving as contact on a subaward, and any other personnel named on your Notice of Award.
For instructions on requesting permission, read our Prior Approvals for Post-Award Grant Actions SOP. For more information, go to Some Actions Require Our Approval in the Strategy for NIH Funding.
- PAR-12-244, Ethical Issues in Research on HIV/AIDS and Its Co-morbidities (R01)
- PAR-12-243, Ethical Issues in Research on HIV/AIDS and Its Co-morbidities (R21)
- RFA-AI-12-028, Understanding the Functions of Uncharacterized Genes in Infectious Disease Pathogens