jueves, 11 de octubre de 2012

October 10, 2012, NIAID Funding Newsletter

October 10, 2012, NIAID Funding Newsletter

October 10, 2012

Feature Articles
Opportunities and Resources
In The News
Advice Corner
New Funding Opportunities
Header: Feature Articles.

Sidestep These Application Missteps: Misfiring on Innovation

Our first installment on application missteps covered how to avoid proposing a weak project. If you missed it, read the August 1, 2012, article “Sidestep These Application Missteps: Weak Project."
We now continue with an eye on innovation, a stumbling block for many investigators. To help you, our contributing program and scientific review officers offer their take on how you can clear this hurdle.
First Things First: What Is Innovation?
Innovation is one of the standard NIH initial peer review criteria 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.
Illustration: starburst graphic showing how your research pushes the borders of your scientific field outward.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.
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, Susan Brobst, 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."
Susan Brobst 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 too 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.
And that's the boat you're in with your research. To score well on innovation, you'll have to engage your power of persuasion to get your reviewers on board.
Here are some tips on how to do that.
Brandt Burgess and Frank DeSilva, scientific review officers (SRO) in our Scientific Review Program, advise:
"Reviewers often view using innovative ideas and technologies as risky. Consequently, applicants should thoroughly describe why the innovation being described (be it an idea or technology) is important to moving the scientific field of interest forward. For innovative ideas, it should be rational and be supported by the literature and if possible, preliminary data. With innovative experimental assays or technologies, the applicant should adequately address possible alternative plans if proposed experiments do not work, i.e., mitigate the potential risk."
Susan Brobst 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., an RFA, that is seeking this."
Read more about applying for initiatives that call for innovation in Getting a Grant for Innovative Research. For a list of 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
Header: Opportunities and Resources.

Seeking Your Insights Into HIV Prevention Research

Here’s an opportunity for you to explore HIV transmission and acquisition from the behavioral-biomedical side.
Take note of a request for applications (RFA) to encourage research exploring comprehensive behavioral-biomedical approaches that can lead to new insights into HIV prevention research.
The RFA seeks research on how behavioral studies in HIV-infected populations, biomedical research in reproductive biology, and female hormones affect HIV acquisition and transmission.
Applications are due on November 29, 2012, with optional letters of intent due on October 29, 2012. For complete details, read the September 11, 2012, Guide notice.
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FOA for Tobacco Regulatory Science: NIAID Now on Board

NIAID has joined other institutes participating in the funding opportunity announcement Tobacco Centers of Regulatory Science for Research Relevant to the Family Smoking Prevention and Tobacco Control Act, a joint NIH-FDA initiative funded wholly by FDA’s Center for Tobacco Products.
This should be welcome news for our researchers interested in helping improve regulation of tobacco products to protect public health.
Note: since we announced our participation just over two weeks ago (see the September 21, 2012, Guide notice), you'll have to act fast if you're interested in applying.
Optional letters of intent are due Monday, October 15, and the application deadline is November 14, 2012.
General Description
The Tobacco Centers of Regulatory Science (TCORS) announcement seeks multidisciplinary research that will further the development and evaluation of tobacco product regulations.
TCORS applications must include the following:
  • At least three synergistic research projects with a central focus.
  • An administrative core and other support cores as needed.
  • Developmental or pilot projects program to explore novel directions.
  • A program for career development and training in the area of tobacco science research.
Investigators should represent a broad range of disciplines working together to increase knowledge across the full spectrum of basic and applied research on tobacco.
For complete details, read the July 10, 2012, Guide notice.
NIAID's Research Areas of Interest
NIAID encourages applications from investigators focused on understanding the impact and health consequences of tobacco* use on 1) immune responses in the respiratory mucosa and systemically, 2) clinical disorders of the upper and lower airways (e.g., sinusitis, rhinitis, asthma), and 3) the ability to respond appropriately to vaccination or an infectious pathogen.
Additionally, we seek research that can lead to identifying biomarkers that predict appropriate immune responses or adverse health consequences in tobacco users.
If you have questions, contact Lynda Chiodetti in our Division of Allergy, Immunology, and Transplantation.
*Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and other tobacco products.
Additional Resources
Header: Other News.

Three Words for the Start of FY 2013: Continuing Resolution, Uncertainty

We begin the new fiscal year as we have in the past: awaiting our appropriation from Congress and operating under a continuing resolution. The current CR funds the federal government to a level of 0.6 percent above FY 2012's through March 27.
As is usual for this time of year, there's no way of knowing what our final appropriation will be. Adding to the uncertainty for FY 2013 is the prospect of sequestration, which was written into the Budget Control Act of 2011.
Unclear Budget Picture
If passed as requested in President Obama's budget, NIH's FY 2013 budget would hold steady at last fiscal year's level of $30.86 billion while NIAID's budget would increase $10 million (0.2 percent) to $4.49 billion.
The requested amounts could be drastically different from what's actually received, however, should a sequester take place. If it does, the Office of Management and Budget (OMB) would have to make across-the-board budget cuts to nearly all of the federal government's discretionary programs, including NIH, starting January 2, 2013.
Those cuts would be sharply felt. According to an OMB report released last month, a sequester would result in an 8.2 percent decrease in the FY 2013 budgets of non-defense agencies. For NIH, that could translate to a loss of approximately $3 billion.
Amidst the Uncertainty, Interim Paylines Are Slowly Coming In
Until we receive our appropriation, we are using interim paylines to fund a limited number of applications. So far, we have provisional paylines for R01s: 6 percentile for non-new investigators, 10 percentile for new ones. We announced these in our September 26 article "Interim R01 Paylines Posted—More Budget News Coming."
As we get more interim paylines, we will publish them in this newsletter and on NIAID Paylines, so stay tuned.
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Stay Tuned for U.S.-Russia Collaboration Opportunity

Be alert: you'll soon have a chance to apply for funding for collaborative research partnerships with Russian investigators.
This new opportunity targets exploratory and developmental HIV/AIDS research that could lead to discoveries to prevent, treat, or ameliorate HIV and HIV-related comorbidities such as malignancies, metabolic complications or opportunistic infections.
We don't know when NIH will release the funding opportunity announcement, but we're telling you now so you can start thinking about topics and partners.
One bit of insider information to help you prepare: clinical trials will not be accepted, though you may propose clinical studies as long as there's no clinical intervention.
For more details about this initiative, read the September 18, 2012, Guide notice.
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News Briefs

NIAID Bows Out of K02, F33. NIAID will stop accepting K02 and F33 applications. See the last due dates for applications at NIAID to Phase Out K02 Participation and NIAID to End Participation in F33 Award on Top Policy Changes.
Coming Soon: Electronic Multiproject Applications. You'll soon be able to apply electronically for multiproject applications. NIH will run a pilot of electronic submission for a few different activity codes before implementing its final policy. Read the September 28, 2012, Guide notice for details.
Header: Advice Corner.

Reminder: Register and Report Results on ClinicalTrials.gov

Are you a principal investigator conducting Phase II, III, or IV clinical trials with interventions involving drugs, biologics, or medical devices? If so, you need to ensure your trial is registered and your study results posted on ClinicalTrials.gov.
Hefty penalty fees may come your way if you don’t comply, as outlined in Public Law 110-85 (Food and Drug Administration Amendments Act of 2007), Title VIII-Section 801. NIAID encourages registration and timely posting of results for all clinical research studies so that we maintain transparency and can share advances in knowledge of disease pathogenesis and therapeutics. 
To navigate the ClinicalTrials.gov site, we suggest familiarizing yourself with key terms that map to responsibilities and submissions requirements, including: Applicable Clinical Trials, Responsible Party, Sponsor, ClinicalTrials.gov Registration, Study Start Date, Results Posting, Primary Completion Date, and Study Completion Date. Start with the ClinicalTrials.gov Glossary of Common Site Terms to get a lay of the land.
If you have a question for ClinicalTrials.gov staff, go to the Contact NLM Help Desk. Have related questions for the NIAID division or center that funds your study?  Contact NIAID programmatic staff, such as your program officer, project officer, medical monitor, or project manager.
To learn more about your responsibilities under Section 801 mentioned above, see What NIH Grantees Need to Know About FDAAA.

Let's Get Specific About Video

If you'd like to send video or nontraditional material to supplement your written application, here's what you need to know. NIH's new rules kick in for applications submitted for the January 25, 2013, deadline and later.
What to Do for Video
You must wait until after you apply to send video, but you'll need to prepare before applying.
First, create the video or videos to meet these requirements:
  • You may submit one or more videos, but your video or videos must total no more than two minutes (or five minutes for multiproject applications.)
  • Include only content that NIH deems acceptable for videos. Some examples:
    • Data that have a temporal component.
    • Unusual interventions or surgical procedures.
    • Prototype model use.
    • Visualization of 3-D structures.
    • Software or database demonstrations.
    • Educational materials.
  • Though not required, it's helpful to include captioning for any narration.
  • Use a cross-platform video format such as mp4, mov, avi, flv, or wmv.
  • Embed videos in separate PDF files.
    • Ensure each PDF's file size does not exceed 25 MB due to the size limit for email attachments to NIH.
    • For technical instructions on how to embed video in a PDF, refer to the documentation for your PDF-making program.
Next, as you write your Research Strategy, include key images from the video and a brief description. Since you can't count on all reviewers being able to see or hear the video, make sure your written summary is descriptive enough to make sense without the video.
Then, before you apply, state in your cover letter that you plan to send your video to your scientific review officer (SRO) later.
After you apply, watch the eRA Commons for assignment information about your application, which could take as long as two weeks to appear. Then check with your SRO to find out his or her preference for how you should send the PDF files described above.
Last, make sure we get your files in time: at least one month before the peer review meeting. Your authorized organizational representative (AOR) may send the files. Or, if you send them yourself instead, you must include a letter of concurrence from your AOR. Merely copying him or her on an email cannot substitute for the letter.
New Limits on Nontraditional Application Material
Now that you have a summary of what to do, here's what not to do (unless specifically allowed by the funding opportunity announcement).
You can no longer send other nontraditional material such as medical devices, prototypes, interactive multimedia, or PowerPoint presentations. Previously these could be allowed at the SRO's discretion.
Also, NIH will not accept video sent using a method other than what your SRO specifies.
This new policy overrides exception 4 of the July 23, 2010, Guide notice about post-submission application materials.
If you have questions about post-submission materials or video, contact your SRO for advice. For more details on the changes we described above, read the September 27, 2012, Guide notice.
Header: Reader Questions.
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.
"Do you offer an F31 for those who are not members of an underrepresented group?"—Christopher Gaulke, UC Davis
The only predoctoral fellowship NIAID supports is the NRSA Predoctoral Fellowship to Promote Diversity in Health-Related Research (F31).
That said, you might be eligible to apply even if you're not part of an underrepresented group since this award is also for people with disabilities or from disadvantaged backgrounds. For more details, read Section III. Eligibility Information in the F31 program announcement.
If you still don't qualify, you could check with institutes that support NIH's NRSA for Individual Predoctoral Fellows (F31) to see if maybe your research might fit. For a list of agency contacts, go to NIH's Parent F31 Contacts, Submission Dates and Special Interests/Instructions.
Do you have any advice for writing a progress report?"—anonymous reader
Though we do not have a comprehensive resource for progress reporting, you may find the following links helpful:
You can also follow this newsletter for more news and advice as NIH gets closer to implementating the Research Performance Progress Report (RPPR). We started covering the topic this year, most recently in our September 26, 2012, article "The Progress of Progress Reports: RPPR."
Header: New Funding Opportunities.
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