What is the PHS Assignment Request Form and why should I include it in my NIH grant application?

The PHS Assignment Request Form is an optional form that can be submitted with your proposal. It is not a separate attachment, but rather an embedded form in the application package. The form is used to list expertise needed to review your application, exclude reviewers, request an institute assignment, and, in particular for investigator-initiated applications such as parent R01s, to request assignment to a specific study section.

The PHS Assignment Request Form can be used to:

1. Provide up to five areas of expertise that will be required to understand and accurately review your application. 
• This can include specific disciplines or an understanding of certain methodologies; however there is no guarantee that all of the requested expertise will be represented in the reviewer panel. Write your proposal with this in mind.
2. List individuals who should be excluded from reviewing your application. 
• This section is limited to no more than 1,000 characters. Only a few reasons for exclusion will be considered. Valid reasons that could prevent you from receiving a fair review include if the potential reviewer is a direct competitor, if there is a long-standing scientific disagreement with the individual, or if a conflict of interest exists. 
• Unfortunately, you can't request exclusion of that guy who looked like Russell Brand who spilled his espresso martini all over your shirt when he was tipsy at last year's conference.
3. Request assignment to a particular study section and/or institute. 
• This request should only be made if you are submitting an investigator-initiated R01, R21, or R03 application. 
• Review the Center for Scientific Review's (CSR) study sections here.

More advice about completing the PHS Assignment Request form is available from the National Institute of Allergy and Infectious Diseases (NIAID).

Should critiques from humans be replaced by artificial intelligence for grant proposal reviews?

Today, NIH released Notice number NOT-OD-23-149, "The Use of Generative Artificial Intelligence Technologies is Prohibited for the NIH Peer Review Process". The Notice is linked to NOT-OD-22-044, released in December of 2021, "Maintaining Security and Confidentiality in NIH Peer Review: Rules, Responsibilities and Possible Consequences".

The latest notice was released to clarify that NIH reviewers are prohibited from using any natural language processing (NLP), large language model, or other Artificial Intelligence (AI) based technology to aid in their review and written critique of proposals. In other words, those harsh comments about your Approach from the dreaded Reviewer #2 should be written by an actual human scientific peer reviewer and not by a ChatGPT bot. (Although I do wonder how many times terms like "fishing expedition" and "overly ambitious" would be used by a model that is trained using summary statements from prior grant reviews.)

If you currently serve or will be serving on an NIH study section as a peer reviewer, you will be expected to adhere to revised Security, Confidentiality, and Non-disclosure Agreements for Peer Reviewers that are updated to incorporate the new restrictions regarding AI-based grant reviews. Any reviewer that uploads or pastes content from a grant application into a generative AI tool will be deemed in violation of NIH peer review confidentiality and integrity requirements. 

This new requirement is designed to ensure fairness during the proposal review process. As recent controversial examples in banking and sports have shown, it is relatively easy to introduce bias into an AI based model. Although peer reviewers bring their own biases to the review process, the scoring and outcome are more transparent when written critiques and summary statements are prepared by human beings who are putting forth their best effort to review proposals based on their untainted scientific opinions.

My grant application was "Not Discussed" - what does that mean?

It can be disheartening to wait months for your NIH grant proposal to be reviewed, only to find out that it has been designated as Not Discussed. This designation has also historically been referred to as "unscored" or "bottom-halved". A more detailed description is provided on the NIH Peer Review site.

What does it mean when my grant proposal is not discussed?

There can be many reasons why a proposal is not discussed. In many cases, there are significant weaknesses in the proposal which may or may not be easy to address. 

What should I do with a proposal that has not been discussed? 

It is a good idea to contact the assigned NIH program officer, who may have additional insights and guidance. In some cases, it can be advantageous for proposals that are not scored to be significantly revamped and submitted as new, rather than as resubmission proposals. The rationale for this is that you will be able to make significant changes and address reviewer concerns without having to show the reviewers that you were not scored the first time. However, there may be circumstances in which a resubmission is strategically beneficial, even for a proposal that was Not Discussed. The NIH program staff will likely be able to provide insights that will help you to make this decision.

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 NIH Proposal Videos

Are you still confused by the NIH grant peer review process?  As explained in a recent notice, NIH has released new videos to help you better understand what happens during peer review.
The video that I believe will be most helpful is "Top 10 NIH Peer Review Q&A".  The video includes 10 commonly asked questions and answers from 10 Center for Scientific Review experts. Watch it and share any other tips or questions below in the comments.

Do I need to write a cover letter for my grant application?

In 2016, NIH added a new PHS Assignment Request Form.  Previously, applicants would add a cover letter to request assignment to a particular study section or institute, ask to exclude a reviewer, or request reviewers with particular expertise.  The form streamlines this process and eliminates the need to write a cover letter.  A sample version of the form is located here.  You can also visit this link for more information and instructions.

There are times when a cover letter is required.  This includes:

• Applications that require prior approval to submit, such as grants requesting $500,000 or more in direct costs for any year, conference grants (e.g. R13), and investigator-initiated clinical trial planning and implementation awards
• Applications that will generate large-scale genomic data or that plan to access data in the NIH genome-wide association study (GWAS) data repository
• Corrected applications submitted after the deadline.  This will also require an explanation of why your application is late.
• Indicating you are an NIH study section member who is eligible for continuous submission
• Explaining that you will send video files  

This helpful site provides more details and instructions.

Upcoming changes to review criteria at NIH

In a recently published notice, NIH announced that changes will be made to grant reviewer instructions beginning with applications received January 25, 2019.  Notably, the term "scientific premise" is being replaced with additional instructions surrounding rigor and reproducibility.  (From my perspective, this is an excellent change, since many a scientist has struggled with how to address the scientific premise given the limited guidance provided by NIH.)   Other changes are to inclusion reporting and protection of human subjects. One significant change is the removal of language about children.  Instead of "Inclusion of Children", there will now be a requirement to address "Inclusion Across the Lifespan", which includes children and older adults. 
Unlike the Common Rule, Forms E, and other recent NIH proposal changes, there hasn't been much buzz about these modifications.  Prepare now so you won't be caught by surprise for your winter or spring submission.

Just in Time for the party?

Hooray!  It's time to celebrate!  My grant was reviewed and the JIT link popped up in the era commons.  This must mean my proposal is within funding range, right? 

WRONG. 

In previous years, the JIT link only became active in the commons if scores fell within certain percentiles.  However, this has been changed, and JIT will appear in the commons after every proposal is reviewed.  The only way to know if it is really needed is if the PI receives an email request for information from NIH. 

Can't say it in 6 pages? Don't load up the Appendix!

The new NIH page limits that took effect in 2010 significant cut the length allowance for R01, R03, and R21 applications. This modification has proved difficult for some researchers to adapt to. For parent R01 proposals, what was previously a 25 page research plan is now cut down to 12 pages plus a 1 page aims section. There is much less space to get your point across and convince reviewers that your idea is the best, most innovative, and most worthy of their praise and ultimately NIH funding. This new page limit was created mainly to decrease the burden on reviewers, who devote hours of their time to reading and critiquing applications. The result, unfortunately, is that some researchers have decided to look for a way around the shorter page limits. Instead of following the rules, they prefer to try to sneak one past NIH and put extra information into other sections of the proposal. This is a terrible idea, and one that is sure to backfire and annoy reviewers. Perhaps the first place investigators seek to add extra information is in the Appendix section. Many years ago, placing materials in the Appendix was routinely done to avoid page limit requirements. NIH grew wise to this, however, and over the years began to more tightly regulate what can be included in the Appendix section. Now the instructions are very clear. Ignoring the instructions and trying to pull a fast one may be viewed as being unresponsive to the directions. In an agency that may refuse to score your application because you haven't followed proper font or margin requirements, do you really want to take a chance on including erroneous information in the Appendix?

Here are some excerpts from the SF424 instructions on the Appendix section:

• Only one copy of appendix material is necessary. Use the Add Attachments button to the right of this field to complete this entry.
• A maximum of 10 PDF attachments is allowed in the Appendix. If more than 10 appendix attachments are needed, combine the remaining information into attachment #10. Note that this is the total number of appendix items, not the total number of publications. When allowed there is a limit of 3 publications that are not publicly available (see below for further details and check the FOA for any specific instructions), though not all grant activity codes allow publications to be included in the appendix.
• Do not use the appendix to circumvent the page limits of the Research Strategy. For additional information regarding Appendix material and page limits, please refer to the NIH Guide Notice NOT-OD-10-077.

Items that must not be included in the appendix:

• Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the Research Strategy PDF. However, images embedded in publications are allowed.
• Publications that are publicly accessible. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References cited section, the Progress Report Publication List section, and/or the Biographical Sketch section.

I have seen researchers actually add entire sections to the Appendix to conform to the old sections A-D requirements.  If you write an extra section and include it in the Appendix, at best it will be ignored and not reviewed.  At worst, your application will be labeled nonresponsive to the requirements, and the entire application will be rejected.  This is not worth the risk.  Shorten your research plan and follow the rules like everyone else.

3 Things to do While Waiting for Your Grant to Get Reviewed

You worked hard, followed all of this blog's advice, and submitted your best work for the proposal deadline.  Now it is time to...wait....and wait some more....for months.  Given the gap of 10 months or more that can occur between proposal submission and funded project, it is important that you resist the urge to rest on your laurels and coast through the next year of teaching, working on other projects, or staring out the window fantasizing about your plans for the grant.  Likewise, this is not the time to take an extended vacation, as tempting as this might be: 

Consider this: Your chances of receiving funding on any proposal, especially during the first submission, are extremely low.  Don't believe me?  Look at the NIH grant success rates.  Given these dim statistics, what's a scientist to do?  Here are some suggestions.

1. Get to work!  Instead of waiting around and potentially waiting a year to find out you have been rejected and will need to start the process all over again with an A1 submission, be proactive and start working on the next grant proposal. 
2. Analyze and Publish Data.  If you have previously completed studies or datasets waiting to be analyzed, make the time to complete your analysis and get some papers written and submitted.  If your grant is not funded, you will have more publications to use to enhance your biosketch, especially if the publications are relevant to your proposed project. 
3. Stay Current.  Read new publications in your field and network with other scientists.  Keeping tabs on your particular niche will help you to find out what others are doing and planning.  If your grant proposal is not funded, you may be able to approach some of these people and ask them to serve as collaborators or consultants.  Or perhaps you may learn that some of the methods and techniques you have been using are outdated.  Any of this will be helpful knowledge if you must work on a resubmission. 

How can I get a copy of my submitted proposal?

Are you looking for a copy of the proposal that you just submitted for the June deadlines?  If you would like one big, easily printable PDF that is easier to navigate than cumbersome SF424 application packages, try logging into the NIH era commons.  If you are the PI, you can view your submitted proposal in a large, indexed PDF that includes all pages of the budget and all ancillary documents.  Keeping tabs on your proposal in the era commons will also allow you to view the assignment information for your proposal.  This is your chance to find out if your proposal was assigned to the section that you requested, as well as the date when it will be reviewed.  From this point on, the commons will be the best source of information about your proposal and its progress through the review process.

Do I really need to include a cover letter with my grant application?

As I explained in another post, it can be quite beneficial to include a cover letter with your application when applying for a parent announcement.  When you have a general plan for your research strategy, look over the NIH institutes and centers to determine which may be the best fit for your particular project.  If necessary, talk to a program officer to obtain feedback and make sure that your project fits with the interests of the institute or center to which you plan to apply.  Then, look over the lists of reviewers available on the website of the institute or center.  (Yes, you can see a public listing of all of the people who may be selected to review your proposal.)  After you have done this homework, sit down and write a cover letter to include with your application.  The cover letter should include an explanation of the expertise needed to review your particular project.  You should list the institute or center that you feel would be the most appropriate assignment.  You can also request a particular review group, or request that a particular reviewer not be assigned to your application.  This is sometimes necessary in the case of competition or personality conflict. 

For more information and advice on the cover letter, visit the Center for Scientific Review. 

The letter should be attached in the "Cover Letter" (optional) section of the SF 424 application package.  Since it is an optional component, fail to include one will not generate any Grants.gov errors.  However, you will be missing out on an opportunity to ensure that your proposal has the best odds of receiving a favorable review.

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?

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.

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.

Can I request assignment of my application to a certain NIH institute or center?

Yes, you can make this request, though NIH does not guarantee that your proposal will be assigned based on your request. To request assignment to a particular center or institute, complete a cover letter. This can be uploaded directly into the optional cover letter section of the application package. In the letter, request the center you feel is most appropriate and provide a brief justification for this request. NIH will consider your request when assigning your application to a study section. However, there are no guarantees. If you believe your research would be best suited by a review from NICHD, for example, look at the NICHD website for information regarding the types of research supported by the insititute. Be sure that your proposal is written in a way that falls into one or more of this institute's program areas. If not, look at ways you may be able to revise your aims to be more suited to the insitute. Or, look at other institute's where reviewers may have expertise in your research area as well.

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?