Life after ARRA funding

This article on Bloomberg.com underscores the importance of planning for your research beyond ARRA funding. If you were lucky enough to obtain funding through the stimulus act, you know that it was designed to jump-start the economy, and that the grants could not be renewed. With many ARRA-funded projects coming close to ending, it is important to consider where your future funding will come from.

We all should have seen this coming. The Recovery Act/Stimulus Act/ARRA/Whatever you want to call it was only supposed to be a temporary fix, to keep research and innovation going until the economy rose out of its depression. Unfortunately, almost 2 years into the Recovery Act, the economic outlook, while improving, is still quite gloomy. Who will be there to step in and replace the money when the ARRA funding runs out? NIH will not have its permanent budget increased. Many of those temporary ARRA-funded jobs created by the stimulus will disappear, and more Americans will be out of work.

Rather than pray for a second wave of ARRA funding, it is time to be proactive. If you have already been working on an idea, consider devoting more time to a proposal and submitting for the October deadline. Or begin to work on your writing and gather preliminary data so that you can submit in February. My hunch is that next year's June and October deadlines will be full of people who are nearing the end of their ARRA funding who are trying to get their projects funded via other mechanisms, so there may be some advantage to being ahead of the curve.

Incidentally, I am happy to see that Matt State at Yale has had such tremendous success in obtaining funding for his laboratory. He is a brilliant researcher who has contributed extensively to the field of neurogenetics and, specifically, to research on genetics and autism. It is nice to see that the stimulus money has helped this type of important work.

NIH, are you my mother?

I have been asked several times what the term "Parent Announcement" means. The term is now used in place of the previous terms "Unsolicited Application" and "Investigator-Initiated Application". Essentially, the parent announcements are open PAs that include most institutes and centers and have standing deadlines. Typically these deadlines are in February, June, and October of each year for new applications. The parent announcement is useful because it allows you to select the appropriate grant mechanism for your project and apply when you are ready, rather than waiting for a targeted PAR to be released that is more specific to your research. When applying to parent announcements, don't forget to include the optional Cover Page attachment in the application package. This letter can be very useful if you want to make the case that your proposal should be assigned to a particular institute or center or even a particular study section.

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.

Hate the new NIH page limits? Don't try to cram things into the Appendix!

Many veteran researchers are frustrated with the new NIH page limits that took effect in 2010. This is understandable. 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 new 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.

The National Institutes of Health - 1965

This is a very interesting video from NIH. It looks like a PR video of some kind from 1965. It is very interesting to see some of the history of NIH.

How do I decide which funding mechanism to apply for?

Determining the differences between mechanism, such as between an R03 and an R21, can be confusing. NIH has provided a helpful information sheet that breaks down the different available mechanisms with a brief description of each.

An R03, for example, is designed to support a smaller-scale research project, with a smaller budget and time period than an R01. An R21, meanwhile, is designed for completing exploratory research, often to gather data to support a future R01 application.

Read the proposal guidelines and directions- and pay attention to the fine print!

Recently I had a very interesting exchange with the president of a small foundation. I was helping her with grant proposal writing, and one day she sent me an excited email telling me about a grant opportunity she had found that she thought would be perfect for the organization.

Her: "We should apply to this right away! This is perfect for the kind of work that we do- I think we have a great chance!"

Me: "Have you taken any vows recently that I don't know about?"

Her: "What are you talking about?"

Me: "To be eligible for this grant, you need to have a Roman Catholic nun on staff."

Obviously NIH will not have this same restriction, but it does illustrate my point. You need to read the entire RFA and pay attention to the details, including eligibility requirements. Otherwise you may do a lot of work for nothing.

I saw this done by one investigator who did not realize that something she was working on did not qualify for a particular type of supplement. She went through the entire process of writing the proposal and trying to submit it in the era commons- only to have it rejected. Please, save yourself some time and do the reading.

What should I write first?

After you review the lengthy proposal instructions (yes, you need to do this), your head will likely be spinning. "How am I going to get all of this done?", you may think, "And where do I begin?" A common mistake made by newer applicants is to begin by drafting the budget. This is actually one of the last pieces you should be worrying about.

To get started on your proposal outline, sit down and write out the specific aims that you hope to accomplish with this project. Use this process to jot down all of your ideas for the project, without regard to budget or other factors. Limit yourself to no more than 2 pages.

Then read the NIH instructions for the Specific Aims section:

• State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.
• List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.
• Specific Aims are limited to one page.

Now look at your page again. How many aims have you proposed? Ideally, they should be narrowed down to no more than a handful, depending on the type and duration of project. There is a reason that NIH does not want to see more than a page worth of aims- one major complaint of reviewers is that some proposals attempt to do too much! Look at the ideas you have written down and determine which few are reasonable to expect to complete in your project's time period. Remember to focus on aims that are innovative but achievable.

Once you have completed a draft of your aims, be sure to discuss it with your collaborators and any experienced individuals in your field who may be willing to help. When you have something narrowed down that you are relatively happy with, I highly recommend talking to an NIH program officer. Typically an RFA has a contact person listed, and that may be a good place to start. If you know which institute or center your proposal will be likely to be assigned to, it can be very helpful to talk to someone there. All of the institutes and centers have websites that include contact information.

NIH Tips for Applicants

Here is a great video directly from the source- NIH has made this video that provides some tips and things to consider for applicants.

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.

Joe Biden is on your side...

In an article published today by CNS News, Joe Biden lashes out at individuals who complain about the merits of some NIH-funded projects. The article mentions several funded grants including a $60,000 grant to study hookah smoking in college students in Jordan. The vice president clearly supports NIH, stating in the CNS News article that those who complain about NIH-funded projects "know nothing about science". While I applaud the VP's effort to support NIH and the important work of NIH scientists, in some ways I do agree with the critics. While many projects may seem insignificant to the lay person, within their respective fields they may be contributing to ground-breaking research. Unfortunately the only easy public access to learn about funded NIH grants is through the NIH RePORTER database. This is the revised version of CRISP, and includes information about past and current projects including award amounts and abstracts. However, the database does not include full proposals or progress reports. While I understand that these may contain some confidential information such as unpublished research data, I believe it is important for the public to view entire proposals and be able to examine the progress of funded projects. An abstract does not convey the significance of a project to its field, or fully explain the path that a particular project may pave for other projects. Without this information, it is understandable that many members of the public may label some NIH-funded projects as wasteful.

Update: This post also illustrates the public outcry that can result when complete and accurate information is not made public. Though it is focused on a USAID-funded project, the same principle still applies.

Advice from NINDS on writing your research plan

One great resource that I recommend reading is "How to Write a Research Project Grant Application", written by the National Institute of Neurological Disorders and Stroke. While some of the content in NINDS-specific, the page contains quite a bit of informaiton that can be generalized to all research proposals. For example, it provides suggestions on developing your hypothesis, including emphasizing that your hypothesis should be stated in both your abstract and your specific aims.

A word of caution- the site has not yet been updated to reflect the revised research plan guidelines. It still contains sections A through E, which are holdovers from previous requirements. However, some of the advice on getting started is still relevant and very useful.

Creating Your Biographical Sketch Personal Statement

Under the new NIH Biosketch requirements, all investigators (not just the PI) must now include Section A: Personal Statement on every application. This new section is designed to provide an overview of each individual's experience and qualifications directly related to the proposal being submitted. In other words, this section must be modified and tailored for every proposal that you submit!

Many investigators, including proposal veterans, are finding it hard to write this section. The NIH instructions state: Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor) in the project that is the subject of the application. Unfortunately, there are no suggested length or other requirements included. This has caused some confusion and led to many different interpretations of the requirement. For one, some individuals have been writing in the first person, while others write the section in the third person. Based on my personal experience, it appears that at this time both options are acceptable. There is also a major variation in length. Some investigators are including no more than a very vague sentence describing their general experience. This is probably being done intentionally, in the hopes that they can continue to use the same biosketch for multiple proposals, but it does not fully meet the requirements.

How should you write your personal statement? First, remember that the statement is going to be used to help reviewers as they look at the Investigator portion of the review criteria. This states: 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? Look at the criteria and make sure that your personal statement will provide the reviewers with the information they need to make an evaluation based on this criteria. As you may guess, a brief, general sentence will not suffice.

Conversely, it is also probably not a good idea to write an entire page of information. Several paragraphs should be all you need to describe your accomplishments and expertise without overloading the reviewer. See the NIH biosketch example located here.

Consultant or Co-Investigator? How do I choose?

It can sometimes be difficult to determine whether an individual should be budgeted as a Consultant or Co-Investigator on a project. There are several factors to consider when making this decision.

1. Will this person be essential to carrying out the scientific duties of the project? Will he/she bear some responsibility for it's progress? Or will he/she simply be advising on one aspect of the project?
2. What type of time commitment is the individual willing to devote to the project?
3. Is the individual employed by another institution, or your own? If located at another institution, will your budget allow room for a subcontract, including any indirect costs?
4. If the person is located at your institution, will they be willing to devote measurable effort to the project? (NOTE: In most cases consultants are not able to be hired from one's own institution. Many universities, etc., do not allow this. In this case, if you want to budget someone from your own institution, he/she must be included in your personnel list, not budgeted as a consultant. )

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?

Curious about what happens during NIH peer review?

NIH has created a great video that provides a behind-the-scenes look at the peer review process. I have watched this video with several experienced reviewers, who all indicated that this provides a very realistic depiction of review sessions. I highly recommend that you view this video before preparing your application. It will help you to understand your audience, how the process is conducted, and how to best tailor your application to make your major points clear to reviewers. To view this video, visit this link.

What do all these #*&(#*$% abbreviations mean?

Don't know a PI from a DUNS? Unsure what NICHD stands for? Visit the NIH Glossary and Acronym List, located here. It provides information on policies, definitions of common terms and explanations of acronyms. If you are new to NIH proposals, I recommend bookmarking the page or printing it out.

NIH Error Submission Window to Disappear

Have you ever had to rely on the NIH Error Submission Window to fix a mistake in your proposal? If so, you should read this new announcement. NIH, AHRQ and NIOSH will be eliminating this window beginning with the January 25, 2011 due date. This means that, when your proposal is submitted on the deadline, it is final. Be sure to do all of your error checking before it is submitted to NIH.

Note that, if you submit your proposal prior to the deadline, you will still have a 2-day window in which to review and change your application. This new policy will only affect those individuals who submit on the actual proposal due date.

I personally believe this is a great change. Under the current error submission window policy, you are given up until 2 business days after a proposal deadline to make changes, so if you submit on the deadline, you still have 2 days to correct any errors. This policy is easy to take advantage of, and I am sure some investigators have (though I hope not many). Theoretically, you could submit on the deadline and manipulate your way into having 2 extra days to finish your research plan. This is not fair to all of those PIs who meet the deadline, of course. I think this is a great decision on the part of NIH, as it will help to ensure a fair and equitable process for everyone.

Complying With New NIH Biographical Sketch Requirements

In the August issue of its Extramural Nexus, NIH provides great advice regarding the preparation of biosketches under the new guidelines. In this brief article, OER suggests that you start early when requesting biosketches from key personnel. This is quite important now that the guidelines have changed. Though the biosketch requirements were modified earlier this year, many individuals including veteran researchers are unaware of the changes. The biosketches are the last thing that should be holding up your proposal!

Under the previous guidelines, investigators needed to include education and work experience, publications, and current and completed (within 3 years) research support. Though it was suggested that publications included on biosketches be tailored to particular proposals, in reality most investigators used the same biosketch for many different types of proposals. The revised guidelines require a new Section A : Personal Statement. This statement must include information about the individual's expertise and how he or she will contribute to the proposed project. Now, investigators who previously did not put much time into their biosketches are being required to write this section for each and every proposal. This takes some time, so you should plan early and be sure that your collaborators are aware of this change in requirements.

For a sample biosketch under the new guidelines, visit this link and scroll down to the biosketch sample.

ARRA Grants Can Get No-Cost Extensions Too

Did you know that your American Recovery and Reinvestment Act (ARRA) grant may be eligible for a no-cost extension? When the original application announcements were released, some contained wording that caused many to believe that ARRA grant money had to be spent within the awarded time frame, and that no-cost extensions would not be permitted. However, this is not the case for all ARRA-funded projects. Check your notice of award to see if it is permitted for your particular project. Read more about NIH's statement here.

Advice on Proposal Timing from NIH

As part of its New Investigator Series, NIAID has released an overview of the ideal planning process for a grant application. It provides an excellent timeline for new investigators to use in planning and preparing an application. Though the information provided is geared toward NIAID proposals, its message is important for all new investigators. In this article, NIAID suggests that you allow 12-21 months to complete your first grant proposal. It may seem like a very long time, and some new investigators can put together excellent applications in a much shorter amount of time. However, this timeline takes into account the planning process and time for review and comments by individuals who are more experienced in your particular field. This type of "pre-review" can be quite useful. Consider using the NIAID timeline in planning your proposal. You may find that it pays off!

My NIH Proposal Blog

Welcome to my NIH proposal blog. I hope this will be a great resource for you in your pursuit of NIH funding. Feel free to post questions and comments, and I will do my best to find answers and resources that will help you.