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).

Addressing Rigor and Reproducibility in NIH Grant Applications

If you are writing your first NIH R01 proposal for the upcoming deadline, chances are that a well-meaning senior faculty member has given you a copy of one of their funded grants to use as a model for developing your application. This is a kind gesture that can be helpful for those who would like to see an example of a well-explained scientific plan, so I do recommend that you accept these types of offers. However, things change quickly in the grants world. If you follow a previously funded grant as a guide without reading the updated application instructions, you might miss key information or include outdated sections.

For example, there was a brief period of time back in the mid-2010s when Scientific Premise was a required component of the application. However, this terminology changed with a 2019 update that changed the requirement from Scientific Premise to Rigor and Reproducibility. Per policy, most research grants and career development awards submitted for January 25, 2016 and beyond as well as training grants and fellowships as of May 25, 2020 and beyond must address specific aspects of rigor and reproducibility in the text of their application.

Addressing rigor and reproducibility in your grant proposal requires addressing four key areas:

1. The rigor of the prior research. 
• Provide a careful assessment of the rigor of the prior research that helps to identify weakness or gaps in a line of research to provide support for the proposed project. Describe general strengths and weaknesses in the rigor of the prior research that lays the groundwork for the proposed project. Critique the rigor of previous experimental designs, incorporation of relevant biological variables, and authentication of key resources. Describe your plans to address any weaknesses or gaps.
2. Rigorous experimental design for robust and unbiased results. 
• NIH defines scientific rigor as "the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results". Clearly state planned experimental details to enable reviewers to assess the proposed research. Enough detail should be provided that other researchers can reproduce and extend the findings.
3. Consideration of relevant biological variables.
• Describe the extent to which biological variables including sex, age, weight, and underlying health conditions will be factored into study design and analyses. In particular, provide strong justification for studies proposing to study only one sex, including animal studies.
4. Authentication of key biological and/or chemical resources.
• Key biological and/or chemical resources such as cell lines, specialty chemicals, antibodies and other biologics should be clearly described. Include the origin of each resource and any steps to ensure quality of the resources that will be used for the project.

As you work to complete your application, be sure to leave time for a final read-through and make sure you address each of these components.

Happy 4th of July - enjoy your barbeque, and then get back to writing!

Happy 4th of July! Today we celebrate Independence Day in the United States with cookouts, parties, fireworks, and a whole lot of red, white and blue. I hope the weather is beautiful for everyone and that you are able to enjoy some time swimming, hiking, partying, and spending time with family and friends.

Enjoy the rest, relaxation, and a hot dog or two while you can. The October 5th NIH R01 deadline is three months from tomorrow - that gives you only 12 weeks to finish writing, obtain input from your collaborators, and seek feedback on your proposal from funded researchers in your field! If you haven't already, you should be working on finalizing your Specific Aims and contacting the relevant NIH program officer to determine whether your project fits with your targeted NIH Institute or Center and funding opportunity announcement (FOA). 

If you have already taken care of these items and your aims are in reasonably good shape, get started on that 12-page Research Strategy. It may seem like you have a lot of time, but pumpkin season will be here before you know it. Enjoy your day off, and prepare to dive into proposal writing tomorrow!

Advice from Nature for Early-Career Investigators applying for their first NIH R01 grant

If you are an Early Stage Investigator seeking advice for your first NIH R01 application submission, you have likely received conflicting advice from multiple sources. Although usually well-intentioned, even experienced scientists often give unhelpful advice for preparing your grant proposal. For example, yes, there are a very small number of researchers who consistently finish gathering their preliminary data, write the grant proposal at the last minute, and manage to be successfully funded. Many of these people are individuals who work best under pressure and who are engaged in fields such as emergency medicine research. In over 20 years of working with hundreds of NIH-funded researchers at multiple high-ranking research institutions, I have come across only a small number of people who are consistently successful with this approach. Thus, taking a last-minute approach is not likely to set you up for the highest likelihood of success.

Trusted grant proposal advice can be hard to come by for new applicants, which is why I was excited to come across a series put out by the esteemed scientific journal Nature last year. There is a collection of articles titled Advice to Early Career Investigators that includes advice on various aspects of proposal preparation aimed at junior investigators. Although I found it grouped within the pediatric research section, the advice is applicable to research in many fields. For example, articles include Unexpected lifeskills for physician-scientists: advice to early career investigators and Essentials of data management: an overview. 

Perhaps the most relevant article listed that will apply to the majority of Early-Career Investigator applicants is Thirty-two steps for getting your R01: advice to early career investigators. This article is packed with direct, honest, and helpful advice. Step 1 is "At least a year ahead of the deadline, decide on the novel, clinically relevant question you would like to answer. Spend a week or two in PubMed, looking at everything that has been published. Decide how you can advance the science beyond what has been published. Look at the data differently: don’t just buy the conventional wisdom. Begin to formulate an overall aim that is novel, relevant and do-able. Dream big. If you don’t have a big vision, or if you are writing an incremental grant primarily to advance your career, stop. Begin again when you are inspired by the question." 

The authors have broken down the R01 proposal development into 32 clear and realistic steps that are likely to lead to a well-scored application. I highly recommend this particular article as well as this resource from Nature, and I hope the journal will continue to add to this collection to provide updated guidance for new NIH grant applicants.

What is an NIH parent announcement? What is a parent grant?

If you’re new to NIH grants, you may be struggling to understand the grant-speak and acronym alphabet soup that are often used by faculty members and research administrators. Given the many, continually changing rules and regulations of the grant proposal and award process, it is not surprising that individuals routinely speak in NIH terms when discussing grants. As with clinical skills, which require regular practice and upkeep, research grant knowledge must be continually applied to stay fresh in the field. Unfortunately, this means that many of us who have been working on NIH grants for many years often become accustomed to speaking in technical terms and forget to ensure that we are providing information in a way that is understandable to a novice. Fortunately, however, many resources exist to help you expand your NIH grant vocabulary, including a grants and funding glossary.

One term that is often a source of confusion is “parent grant”. Sometimes this is also stated as “Parent R01” or “Parent R03”, etc. When you hear this mentioned, your first thought might be of something like this:

Luckily for all parents who have experienced the tantrums of the terrible twos, kids have nothing to do with these grants. The official name for this grant type is “parent announcement.” NIH defines a parent announcement as follows:

Parent announcements are broad funding opportunity allowing applicants to submit investigator-initiated applications for specific activity codes. They are open for up to 3 years and use standard due dates.

It is important to note that not all NIH institutes and centers participate in parent announcements. If you are seeking funding from a particular institute, check the “Components of Participating Organizations” section listed toward the top of of the first page of funding opportunity.

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 you guilty of using active links and hypertext in NIH grant proposals?

So much of our daily lives include links, looking up information, and hopping between websites.  Clicking on active links in documents makes things seamless and fast.  Like other aspects of grant applications (human subjects attachments, anyone?), links have unfortunately been abused by some applicants who are seeking to circumvent the rules. In an effort to level the playing field, NIH created a policy that expressly prohibits hyperlinks in grant applications.  The policy can be found in the Grant Application Guide.  It states, in part:

Hyperlinks and URLs are only allowed when specifically noted in funding opportunities and/or form field instructions. It is highly unusual for a funding opportunity to allow links in Specific Aims, Research Strategy, and other page-limited attachments.

Hyperlinks and URLs may not be used to provide information necessary to application review. Applications must be self-contained and reflect the information available at time of review. 

Reviewers are not obligated to view linked sites and are cautioned that they should not directly access a website (unless the link to the site was specifically requested in application instructions) as it could compromise their anonymity.

When allowed, you must hyperlink the actual URL text so it appears on the page rather than hiding the URL behind a specific word or phrase (hypertext).

Since applicants were either unaware or routinely ignored this policy, NOT-OD-20-174 was released as a reminder. Although this policy has been in existence for years, there are many who continue to attempt to include hyperlinks in the text. The notice "serves to remind the applicant community about existing guidance that restricts use of hypertext (e.g., hyperlinks and URLs) in NIH applications".  It also lists multiple concerns related to the use of hypertext in grant applications, including overstuffing of applications, reviewer confidentiality, and use of malware.

In summary, keep the hyperlinks out of your entire proposal.  Allow enough time to review your complete application and remove any hypertext. Do not take a chance that your proposal will be withdrawn due to noncompliance!

Role Confusion: How to tell the difference between Co-Investigators, Consultants, and others for an NIH proposal

Role confusion comes up often when planning NIH grant proposals.  There are several terms that are sometimes used interchangeably which actually represent different things.  Also, NIH terms differ from those of other funding agencies.  It is important to pay attention to the various role definitions and ensure you are using them correctly in your application.

For example, I have often heard Principal Investigators (PIs) refer to individuals from within their organizations as "Consultants".  At most universities, a Consultant is unable to be listed from within the organization.  Consultants are paid directly from the grant - the money is sent to them in their name - and thus it is typical to include individuals from within the organization as Co-Investigators (with measurable effort) or Other Significant Contributors (with no measurable effort). 

The term "Co-PI" is also used often to describe multiple PIs on a grant application.  However, NIH does not recognize the term "Co-PI"; rather, NIH uses the Multiple PI model and the PIs are referred to as Contact PI or MPI.

Confused yet?

Thankfully, there is a helpful page from NIAID that lists key roles and their definitions.  Keep this handy as you develop your Budget Justification and write about the research team in your Research Strategy.

NIH FORMS-F applications are coming!

Are you working on a proposal that is due May 25, 2020 or later?  It seems like we were all just barely starting to make sense of all the complicated human subjects and clinical trials requirements in FORMS-E, when NIH decided to publish this notice and throw us all another curve ball.  Yes, it's time to start to familiarize yourself with the new application requirements.  There are also updates to the NIH and AHRQ research training grant, career development, and fellowship application requirements, which are outlined here.

Scientific Premise, Rigor, and Reproducibility are still causing confusion

Are you working on an R01 proposal for the upcoming February 5th NIH deadline?  Like many Principal Investigators, you may have spent a lot of time crafting the perfect write-up of your scientific premise.  Unfortunately, that means you missed the recent notice (NOT-OD-18-228) regarding the changes to NIH grant application instructions that take effect this month.  The references to "scientific premise" have been replaced by an explanation of requirements to address scientific rigor and reproducibility.  Still confused?  See this handy website for guidance on rigor and reproducibility from NIH.

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.

NIH forms E Human Subjects and Clinical Trials Information Form- Try this video before you bang your head against the wall

This video will show you all of the required fields on the new Human Subjects and Clinical Trials Information Form that is required of all Forms E applications as of January 25, 2018.  That's right- not only are there an obscene number of new attachments, but there are also required form fields that must be completed.  Some of this is repetitive of information provided elsewhere in the application, but some is not.  For example, be prepared to provide the date of enrollment of your first subject.
Eventually we will all get used to this, but right now it is a steep learning curve and the February R21 deadline is proving to be quite painful for many of us.  Hopefully by the time the next cycle rolls around, NIH will provide us with examples to help decipher what is needed in each section of the application.

Sample successful R01 and R03 grant applications

If you are looking for more sample NIH R01 and R03 applications, there are several located on the NCI website.  The proposals are all focused on cancer epidemiology, but even those in other fields can benefit from seeing the structure and flow of a successful application.  The sample grant proposals are located here.

National Institute for General Medical Sciences (NIGMS) provides grant tips for new applicants

NIGMS has provided a handy page titled Tips for New NIH Grant Applicants.  This list was compiled by soliciting advice from NIGMS staff members.  This is a very introductory list designed for novices who are just learning about the proposal development process.  I highly recommend this list in particular for trainees who are writing career development awards.  The advice may also be helpful to individuals who are writing their first R-series proposals who have had limited training in the area of grant development.

Advice on conducting transdisciplinary research

I recently came across this interesting blog post that provides information on resources that are essential to support the conduct of transdisciplinary research.  We have all been told that cross-disciplinary collaborations are increasingly becoming necessary in order to obtain research grants and make new scientific advances.  However, many disciplines exist in silos and it can be difficult to get started.  The blog post includes mention of the importance of relationships as a resource in transdisciplinary research, emphasizing trust as a key component.  This is an often overlooked area of key importance that crosses into all disciplines.  

Grant application writing help - a technical checklist

The National Institute of Neurological Disorders and Stroke (NINDS) provides a very useful checklist to guide applicants in development of their grant applications.  The list, located here, is relevant to applicants to other NIH institutes as well.

Perhaps my favorite item on this list is in the Specific Aims section.  It states:
"Are they "win-win" - i.e., will an outcome consistent with the null hypothesis still be a contribution to the field?"
This question is something people often lose sight of as they develop grant applications.  I highly recommend using this checklist as a guide to improve the competitiveness of your NIH grant application.

Sample R03 proposal

The June 5th R01 deadline is technically extended to tomorrow because it falls on the weekend.  For those of you preparing for other upcoming June NIH grant proposal deadlines, this sample R03 application may be useful.  Or, you may want to review several examples of successful R21 proposals located here.

Writing an NIH proposal? Time can be your best friend or worst enemy.

Perhaps nobody provides better advice than NIH on how to plan for the writing of a grant application.  In the "Plan Your Application" section of the recently updated NIH website, "Organize Your Time to Complete the Application" stresses the importance of submitting your application days, not hours, before the deadline.  Considering the large number of proposals I have seen submitted minutes before the deadline, under great stress from the PIs and everyone around them, I highly recommend taking NIH's advice on this.

Submit your R01 on Sunday!

Per NIH submission policy, if a grant is due on a weekend, the deadline moves to the next business day.  This would mean the Sunday, October 5th deadline would actually move to the 6th.  However, given the high and increasing volume of proposals submitted for the parent R01 deadlines, Grants.gov may be slow on Monday the 6th.  To ensure that your proposal makes it in on time, and that you will have time to review it in the era commons after submission, I highly recommend submitting on Friday, October 3rd if possible.  If you work at an institution that gives you the ability to submit your own proposal directly, you may be able to wait until Saturday, but if you wait longer than that you will run the risk of not having enough time to review your grant and pull it back for changes if you identify any problems.  In case you missed it, NIH eliminated the 2-day error correction window a few years back, which means that all modifications to the proposal must be made prior to the deadline.