Update on the New NIH Biosketch Format

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There are changes pending for the NIH biosketch format, and I think it is good news for NIH grantees. The new NIH biosketch format will allow up to five pages for the entire biosketch, as opposed to the current four-page limit. Even better, rather than simply listing publications, the new format will give researchers the opportunity to highlight the magnitude and significance of the scientific advances associated with their discoveries and the specific role they played in those findings.

Grantees will be permitted to describe up to five of their most significant contributions to science, the influence of their contributions on their scientific field, and any subsequent effects of these contributions on the fields of medicine or technology. This will help reviewers better focus on the applicant’s most important contributions to science. Researchers also will be able to include a link to their complete list of publications in SciENcv or My Bibliography.

NIH recently launched a new round of pilot tests (here and here) to make sure the new format will work well for both applicants and reviewers. The pilot will involve surveys of both reviewers and applicants to help NIH fine tune the application instructions and guidance to reviewers. NIH plans to roll out the modified biosketch for all grant applications received for FY 2016 funding and beyond (which generally refers to applications submitted in early 2015).

To learn more about the NIH’s new Biosketch format click *here*


Design Your Translational Research Project With Patients In Mind

When designing a translational research project, be sure to target the end-user or end-market right from the first basic science experiments. This suggestion seems obvious. Yet time and again I see draft proposals that don’t accomplish this task, or pink sheets that complain a project misses the mark. Here are examples of how to achieve this goal from proposals I have worked on over the past few months:

*Enlist a physician as a consultant. Not a physician-scientist, but an M.D. who regularly treats the patient population you hope will benefit from your work. I recently worked on a polymer science grant that sought to create better cardiac stents—the Program Officer wisely suggested that a physician be added as consultant, given that the PIs were bench scientists. If you already have a physician on the proposal, make sure s/he emphasizes in the personal statement of the biosketch that s/he regularly sees the intended audience for the work being performed. Which leads me to the next point:

*Make sure you know what the patients want and need. According to one of my clients, researchers once thought that what quadriplegics wanted most was the ability to walk, therefore lots of money was devoted to that subject area. But when these patients are surveyed, it turns out that what they miss the most is the use of their hands. Before you design a bench project whose ultimate goal is to ease human suffering, make sure you know from what the patient suffers. If you can’t easily ascertain the main quality of life issues for that patient population, at least determine national healthcare costs that would be alleviated if your research findings informed clinical approaches.

*Keep the cost down. You could design the niftiest gizmo in the world that accomplishes precisely what you (and the patient population) want it to do. But if it is cost-prohibitive to produce, it will never see the light of day. Assure reviewers right from the design phase of your project that cost will be at the forefront of your mind as you proceed through your research. Whenever possible, point out where your device could interface with existing technology (ex- Bluetooth, cell phones, PCs). I work on a lot of NIH proposals where folks are trying to develop some sort of device, anything from activity monitors to robotic surgery gadgets. If you don’t confront the issue of cost from the very first design (yes, even in an R21) then you are almost certain to see that comment on your pink sheets.

*Bring on board a collaborator who has experience with regulatory approval. If you hope to move toward marketing a product, assure reviewers that someone on your team has some clue how to navigate the labyrinthine FDA approval process. If you have no such person, find one.

*Your goal is to help patients, not market a product. Remember that when writing an NIH proposal, you are asking for taxpayer dollars to fund your research, and therefore your work ought to benefit taxpayers. I am working on a diabetes grant for a for-profit company right now, and one suggestion I made was to state that the end goal is to help patients, not market their product. Perhaps it seems like a subtle language shift, but it will play better at review.

I could probably come up with other suggestions but I have finished my coffee and huevos rancheros and need to get back to work. So here’s the take-home message: Assure reviewers that from the very first experiment, your translational research project is aimed directly at the clinical end-users. More-than-the-usual concern prevails on the NIH campus right now that promising bench science is lying fallow, never being developed to the point where it will benefit patients (who, after all, paid for the research through their tax dollars). If you are on the bench side of the bench-to-bedside equation, make sure reviewers know that you are keenly aware of the clinical target and that you are not just a smart person in a white lab coat incapable of thinking beyond your cool idea.

How To Write an NIH Grant in the “New” Format

I put “new” in quotes because the revised NIH grant format went into effect last January, 2010. We are now into our fourth grant cycle with this format. In addition, we have seen pink sheets for two of those cycles, so we know what’s getting funded, what isn’t, what reviewers love and what they hate. I still get asked all the time about the new NIH grant format—it’s the most common question after funding rates (see blog entry from January 10.) So what do you need to know as you embark upon writing an NIH grant in the new format?

It’s all about impact. If you remember nothing else, please remember to emphasize the impact of your work. Remember the NIH mission statement: to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. Make sure the reviewers are abundantly clear how your work will reduce human suffering or improve health. Talk about it in the Summary, in the Specific Aims, and in the Significance section. Highlight it with formatting (bold, italics, underline—but please only one of these, not all three!)

The format aligns with the review criteria. Yea! It seems like a no-brainer that the two ought to be parallel. But the old format was not aligned with the review criteria. What are the review criteria, you ask?

1. Significance . Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach . Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation . Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators . Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment . Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Less real estate. The page length has been halved in the new format: R01s are 12 pages and R03s and R21s are a mere six pages. That means you need to get to the point. This shorter page limit together with the switch to only one resubmission means that you have fewer opportunities to be convincing. But one’s best, most persuasive writing ought to be brief anyway.

Lose the exhaustive literature review. One of the casualties of the shorter format is the lengthy lit review. Save that for your publications.

Ditto the extensive experimental detail. You simply do not have enough space in a 12-page R01 to go on at length about every single solitary detail concerning your methods. Save that for your publications.

Publish in peer-reviewed journals as much as humanly possible. Given the two aforementioned items, one can see that it is now more important than ever to publish in peer-reviewed journals. To a certain extent, you need to demonstrate your grasp of the literature and your experimental expertise in peer-reviewed journals rather than in NIH proposals. For these reasons, I feel the new format favors established investigators over newbies.

Write carefully the narrative overview in the biosketch. That’s right: your NIH biosketch no longer can sit in an obscure file on your computer desktop, ready to be dusted off when you submit a proposal. Now you must write the four-page biosketch anew with each submission. Of particular importance is the brief personal statement in the beginning, where you state how you are uniquely qualified to contribute to this particular project; and the publications, which are limited to 15 and must be chosen to reflect your qualifications for this particular project.

Choose your mentor(s) carefully. If you are a newbie with few publications, it is critically important that you choose a stellar mentor(s). If you are not writing a mentored (K-series) proposal, be sure to bring someone more experienced on as a consultant or key personnel, but not as a multi-PI, or their credentials will eclipse yours and defeat the purpose of writing your own R-series grant. Choose someone with an extensive publication list in solid peer-reviewed journals. Preferably, the person will have a track-record of landing grants at the NIH institute to which you are applying. This mentor’s endorsement of you as a new investigator serves in essence as another type of “peer review” in the eyes of the reviewers.

Still feel overwhelmed and confused? You can always hire yourself an experienced grantwriter!