Will NIH accept my late grant application?

If you are hoping to submit your NIH grant proposal late, I may have some bad news for you. Unless your reason for the late grant submission falls into a very small number of approved exceptions, you have likely missed your opportunity to submit the application.

Before attempting a late grant submission, whether it is minutes, hours, or days after the application deadline, be sure to review the NIH late application submission policy. This policy has remained largely unchanged since 2015. The policy clearly states that late applications will only be considered within two weeks of the original application deadline. 

As far as what is considered an acceptable excuse for a late proposal submission, I would liken it to the Reba McEntire song Why Haven’t I Heard From You. The lyrics include: 

There better been a flood, a landslide of mud, 
A fire that burns up the wires, 

And thunder so loud, with a black funnel cloud, 
A natural disaster I know nothin’ about

Along these lines, late NIH grant applications will only be considered for acceptance under the following circumstances:

• Death of an immediate family member of the PD/PI (or MPI)
• Sudden acute severe illness of the PD/PI (MPI) or immediate family member
• Temporary or ad hoc service by a PD/PI on an NIH advisory group during the two months preceding or the two months following the application due date. Examples of qualifying service include: participation in an NIH study section/special emphasis panel, NIH Board of Scientific Counselors, Program Advisory Committee, or an NIH Advisory Board/Council. Qualifying service does not include participation in NIH activities other than those involved in extramural/intramural peer review or NIH Advisory Council/Board service
• Delays due to weather, natural disasters, or other emergency situations, not to exceed the time the applicant organization is closed. 
• For PD/PIs who are eligible for continuous submission (https://grants.nih.gov/grants/peer/continuous_submission.htm), the late application policy applies to activities not covered under the continuous submission policy (i.e., other than R01, R21, and R34 funding opportunities that use standard due dates).

It is important to note that these circumstances must apply to the PI (or one of the MPIs if it is a multi-PI application). The late application policy does not allow exceptions when these factors affect other members of the research team. Additionally, late applications are not approved in advance.

If the reason your application is late does not align with one of the listed options, it is unlikely to be accepted. Exceptions are not made even if you attempted to submit your application 5 minutes after the deadline. Grants.gov provides no flexibility with deadline times. Your next step should be to plan to submit your proposal for a future deadline and modify it accordingly.

For more information about the NIH late application policy, visit the NIAID Late Applications SOP and NINDS list of potentially valid reasons for submission of a late application. 

Are grant reviewers consistent in their proposal scoring?

Many of us have been in the situation where Reviewers 1 and 3 love the proposal, but Reviewer 2's scores are enough to keep the application well out of funding range.  An interesting recent Nature Careers Podcast sheds some light on the issue of low agreement among NIH grant reviewers.

New changes to human subjects mean updated review criteria

NIH has released updated review criteria that will be used to evaluate grant applications proposing clinical trials.  According to NIH, the purpose of the expanded criteria is "to ensure that key pieces of clinical trial-specific information are submitted with each application and that reviewers appropriately consider this clinical trial-related information. Implementing new and more rigorous review criteria for evaluating clinical trial applications will ensure the highest likelihood of translating research results into knowledge that will improve human health."
The full description of the updated clinical trial-specific review criteria and rationale can be accessed here. 

Meeting the new NIH Rigor and Reproducibility Guidelines

NIH has prepared a convenient one-page guide that helps to ensure your application meets the new requirements.  You can download a PDF of this document here.  The NIH Rigor and Reproducibility page located here has more details and guidance on this policy.

Another great image that outlines the new grant outlines was developed by NICHD.  You can find that here.

Appendix Changes are Coming

NIH has gradually been limiting what can be included in the Appendix of your grant proposal over the past several years.  Gone are the days when you could simply move extra text to the Appendix to circumvent page limits.  In a recent notice, NIH announced that Appendix materials will be further limited for upcoming deadlines for NIH, NIOSH, and AHRQ.  Beginning January 25, 2017, most materials will no longer be allowed in the Appendix.  Proposals that fail to comply with the revised instructions will not be reviewed.  For more information, view this NIH Notice.

Innovation should be a simple section to write

When writing the Research Strategy section of your application, you have three major sections to worry about: Significance, Innovation, and Approach.  The Significance section typically takes up approximately 1 page, although in some cases it is longer.  The Innovation section tends to cause unnecessary trips to CVS to buy ibuprofen in the middle of the night.  I am not sure why, but many people make this section much more difficult than it needs to be.  If your proposal is truly innovative, the overall innovative nature of the proposal can be summed up in 1-2 sentences. This should be followed by several bullets highlighting various innovative aspects of your proposal.  Be cautious about seeming too innovative, especially if you are a new investigator.  Proposing to apply an innovative method to solve a problem is one thing - saying you will cure all breast cancers with a 5-year R01 sounds like an exaggeration.  Remember: For the most part, NIH grants are focused on making incremental progress that will advance the field of knowledge - not giant, high-risk leaps.

Matchmaker, matchmaker...

In keeping with the spirit of Valentine's Day, let's talk a little about relationships and needs.  No, I am not turning this blog into a matchmaking site for lonely researchers. (I am sorry to disappoint some of you.)  The relationship I am referring to is the one between research grant proposal authors and grant reviewers.

Like any great partnership, it is important to consider the needs of each person.  The needs of the researcher who submits the proposal should be clear.  This need is fully explained in your research strategy, and should be organized and expressed in a way that makes a clear and compelling argument.  The needs of the grant reviewer should also be considered.  The Center for Scientific Review is responsible for selecting the reviewers based on specific criteria, essentially serving as your matchmaking service.  As you write your research plan and focus on describing your needs, also think about the needs of your reviewers. 

Reviewers are tasked with reading and scoring your proposal based on a set of defined criteria.  For example, an R01, R03, R21, or R34 is scored in the Significance category based on the following questions:
"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?"
If you read your Significance section, how easy is it for you to pick out the answers to these questions?  Does it require searching through the section or putting different ideas together, or is each answer clearly presented?  Can a reviewer easily determine the answers to all of these questions, or will some key elements be missed due to lack of clarity?

Considering the needs of the reviewer will not only help to guide you to create a clearer argument, but will also help to ensure that your score accurately reflects the elements of your proposal.  Unclear explanations leave room for things to become muddled and pieces of information that are critical can be missed if not properly and adequately described.  Help your reviewer to do his/her job, and help yourself to create your best possible proposal in the process. 

SWF Desperately Seeking NIH Reviewer

Slightly inexperienced aspiring researcher seeking older, experienced NIH grant reviewer. Male or female. Similar research interests preferred. Seeking advice and inspiration. Would enjoy hand-holding and long conversations about grant proposal writing.

OK, so maybe you don't need to take out a personal ad to find an experienced grant reviewer who is willing to talk to you. However, you should utilize your professional contacts, friends, relatives, alumni associations, fellow golfers, etc. to help you find someone who is willing to provide sound advice and (hopefully!) review a draft of your proposal. Even if it means waiting until the next deadline for a R01 or R03, for example, it is still to your advantage to have a skilled set of eyes review your proposal before it is sent to an NIH review committee. An individual in your specific field or area or research who has previously served as a grant reviewer will be most qualified to offer advice. Prepare to develop a thick skin - someone who is truly trying to help you will be more critical than supportive. Ultimately, you only have 2 chances to submit the best possible proposal. It is worth a little extra time to find an expert to help you.

Does your race impact your chances of receiving NIH funding?

A recent study revealed a surprising statistic regarding NIH funding. Black researchers were 10% less likely than whites to receive NIH funding between 2000 and 2006. This statistic holds only for black PhD-level researchers - not other minorities - and the disparity is shown even when controlling for similar academic level and institution.

Predictably, NIH has panicked and is working to understand the cause of this disparity and try to find ways to eliminate it. Some critics have suggested that there are inherent flaws in the review system that can be impacted by bias of reviewers. In some cases, I can understand their point. Perhaps some reviewers believe that historically black colleges and universities have poorer resources, or that an education from an HBCU is inferior. However, other than in proposals involving individuals who attended or are employed by HBCUs, I do not understand how race can become a factor for reviewers. True, there are some ethnic names that are more popular among certain races and ethnicities, but I have known just as many black Michaels, Jasons and Ashleys as I have white ones. What else is at play here?

As you may have guessed from reading this blog, I firmly believe that success in obtaining grant funding is often rooted in the quality and quantity of help received in proposal preparation. So perhaps, in exposing the disparity in NIH funding, the researchers actually exposed a disparity in institutional support provided to black researchers.

What do you think?

Clearing up confusion over structuring of Research Strategy related to Specific Aims in NIH grant proposals

One of the most common questions I received from Principal Investigators when NIH released the new Research Strategy section guidelines was regarding Specific Aims. Though NIH has gone to great lengths to clarify the allowed structure of Research Strategy with regard to the aims, the question still seems to pop up.

Here is the official answer, right from the NIH Enhancing Peer Review site:

How I should organize the Research Strategy section to address the Significance, Innovation, and Approach for each Specific Aim, assuming I have more than one?

Applicants should use their discretion in organizing the information to best convey the desired information to the reviewers. For example, if an application had two specific aims, an applicant might choose to organize the Research Strategy in one of the following two ways:

Significance: Specific Aim 1, Specific Aim 2 Innovation: Specific Aim 1, Specific Aim 2 Approach: Specific Aim 1, Specific Aim 2

OR:

Specific Aim 1: Significance, Innovation, Approach Specific Aim 2: Significance Innovation, Approach

If you can't read the directions, don't bother applying

NIH just released a reminder that, in essence, states that PIs should read the directions before applying. You can read this groundbreaking announcement here.

Though in some ways I find it ridiculous that NIH has chosen to spend precious time creating and releasing this document, I can understand why it is needed. When the page limits for research plans were shortened last year, several study section members told me stories of extra information "hidden" in various other parts of the application. "Resources and Environment" sections turned into "Methods and Resources" and dribbled on for pages about methods instead of libraries and office space. One proposal that came across my desk had a "Background and Significance" section brazenly planted in the Appendix.

There is a lesson to learn here, folks: YOU ARE NOT THAT CLEVER. For every trick that you think you have invented to circumvent the page limits, hundreds of others have probably tried (and failed). The people submitting NIH grant applications are scientists- meaning that they, like you, are creative thinkers who are trying desperately to convey the importance of their research in 6 or 12 pages.

For your sake, and to protect the integrity of the review process, spend your time developing new ways to be less verbose in your writing, and stop wasting your time trying to find ways to avoid following the rules.

NIH Grant Proposal Appeal: The Double-Edged Sword

So, you successfully submitted your first grant application and- miraculously!- it wasn't bottom-halved or unscored (look up those old school terms here). Congratulations! What's that, you say? A terrible score? A reviewer who clearly didn't "get" your application? He/She doesn't seem to understand your project? Before you fire off an angry email to the program officer requesting an appeal, stop and take a breath.

NIH recently revised its appeal policies. All principal investigators do have the right to appeal reviewer decisions on certain specific grounds. However, just because you have the right to do it, it is not always the best choice.

Before proceeding with any contact with the program officer, clear your head and pull out the original application. Read it critically, keeping in mind the reviewer's specific criticism of the project. If, after reading the appeal guidelines, you feel that the reviewer made an error that can be the basis for appeal, call your program officer and speak to him/her calmly and rationally. You will get more direct, better advice on the phone than by communicating via email with the PO, and it will help to ensure that your tone is not misconstrued as whiny, angry, or otherwise. If the program officer believes you may have grounds to appeal, discuss the impact of the flawed reviewer on your overall score. Ask for a direct assessment of whether he/she believes that an additional review would result in a fundable score. If this is not likely to happen, an appeal could be a waste of time. In addition, it may create a bias in reviewers' minds that causes them to be more critical in your additional review. I once worked with a PI who appealed successfully and was granted a review at the next round. In the second review, reviewers were critical of things that were not even mentioned in his first review, and the new score was even higher (i.e. worse) than the old one.

If you are in this situation, you may be best served by preparing a resubmission. In your Introduction section, you can address any concerns that were brought up by the "flawed" reviewer and explain your reasons for not addressing them.

NIH Takes a Tough Stance on A2 Elimination

Under the old NIH proposal rules, PIs had three chances to obtain funding for their projects. This was helpful because in many cases a good proposal would need 2 rounds of reviewer comments before becoming a great, and fundable, proposal. In 2009, NIH did away with the A2 (second resubmission) for grant proposals. This means that PIs now have only 2 chances to obtain funding before they must completely rework the entire proposal and start the process over.

In this article, NIH provides a letter that was sent in response to a petition from a large group of scientists that requested a return of the "3-strike" system.

I do find the line "the proportion of funded A1 applications has remained constant while the proportion of funded A0s has risen dramatically" and the accompanying figure very interesting. While the proportion of funded A0s has risen, I wonder how much these numbers are impacted by PIs who rework their proposals and submit variations after not being funded as A0s. It is often difficult to improve from a mediocre score to fundable range from the A0 to A1 submissions. Many PIs that I have worked with in the past 2 years have chosen to not spend the time resubmitting for A1s and instead change their proposals significantly enough to count as new submissions. How widespread is this practice and what has its effect been on this data?

Embedding extra information in your Resources section is not a good idea either

As I mentioned in my previous post, applicants are attempting to be very creative in circumventing the new NIH research plan page limits. Allowable contents of the Appendix are clearly defined by NIH, so for obvious reasons it is not wise to place extra research plan content in your appendix. Another possible target for abuse is the Resources and Environment section. This section is one of the few that does not have any page limits. The section should be tailored to each individual proposal, and provide information on the resources unique to the project and how they will be used by the project. One can argue that it is difficult to discuss the use of resources without at least mentioning the research in some way. However, that is not an excuse for cutting the extra half page of methods you have written and pasting it into the research plan. Reviewers know what belongs in the Resources section and what does not. Attempting to get more information in front of them by placing it in this section will only make you look dishonest. One reviewer I spoke to recently described a proposal with a Resources section that rambled on for several pages and was clearly an extension of the Research Strategy section. Needless to say, that proposal did not fare well. Bottom line: Just follow the page limits. You may think you have found a creative way to get around them, but it has probably already been done and already annoyed reviewers. If you start writing early enough and allow adequate time for editing and review by your peers, you won't have to frantically cut text at midnight the night before the proposal is due.

Which of the new NIH review criteria is most important?

This is an important question, and one that is worth considering when preparing your NIH grant proposal. The five review criteria include significance, investigator, innovation, approach, and environment. Since the new criteria have only been in use for a relatively short period of time, it is still too early to determine the most important of the review criteria. However, as this very interesting post explains, National Institute of General Medical Sciences Director Jeremy Berg is attempting to use science to make this determination. Using NIGMS data, Dr. Berg is examining trends in grant reviews in an attempt to determine which criteria have been most important in determining review outcomes. So far, Dr. Berg's work has focused only on NIGMS proposals, and only on one round of reviews. The current analysis shows that significance and approach appear to be the most important factors in determining impact score. It will be very interesting to see if that changes when another round of reviews are factored in. Stay tuned.

What are the criteria used to score grant proposals?

Quoted From the NIH Site:

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?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?