New NIH Post-submission Materials Guidelines

A glacier cave located on the Perito Moreno Glacier in Argentina. (Photo credit: Martin St-Amant – Wikipedia – CC-BY-SA-3.0)

While the focus of my job is the time period before the application deadline, I do spend a considerable amount of time managing clients’ expectations and anxieties in that time between application submission and review. The timescale of grants can seem glacial to those who are new to the grant funding process, and so much can happen in the career of a researcher or to a research project between the time a grant application is submitted and the time it is reviewed. This applies equally to academic researchers and private sector researchers, because, although the SBIR/STTR timeline is shorter than the R01 timeline, for example, small businesses tend to have less of a financial cushion and a tighter timeline than academic research programs. When something good (promotion! publication!) or bad (loss of an animal colony due to natural disaster) happens, what can you do? Most people do presume that they can (and should!) contact the agency in the case of a natural disaster, but are at a loss over the ability to communicate less dramatic happenings, like publication. What many applicants don’t realize is that there is a mechanism by which they may update their applications post-submission. This is the topic of today’s blog, so take a deep cleansing breath, release that anxiety, and read on.

In August, the NIH published NOT-OD-16-130 detailing new guidelines for materials that can be submitted post-submission effective for all applications due on or after 25 January 2017. (This is the same implementation date as the new guidelines for appendices, and as you continue to read this entry, you will see how these guidelines dovetail.) These guidelines apply to submissions to the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), and National Institute for Occupational Safety and Health (NIOSH).

The new guidelines for all submissions include (verbatim from the announcement):

  • Revised budget page(s) (e.g., due to new funding or institutional acquisition of equipment)
  • Biographical sketches (e.g., due to the hiring, replacement, or loss of an investigator)
  • Letters of support or collaboration due to the hiring, replacement or loss of an investigator
  • Adjustments resulting from natural disasters (e.g., loss of an animal colony)
  • Adjustments resulting from change of institution [e.g., Program Director/Principal Investigator (PD/PI) moves to another university]
  • News of professional promotion or positive tenure decision for any PD/PI or Senior/Key Personnel
  • Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of the application (see NOT-OD-12-111)
  • Videos, within defined limits, that demonstrate devices and experimental data with a temporal element, which refers to the need to show how something functions or occurs over time, or demonstrates movement or change.  Applicants must follow the directions in NOT-OD-12-141 for submitting videos to accompany grant applications
  • Other post-submission materials specified in the FOA for which the application was submitted or in a special Guide Notice.
  • News of an article accepted for publication since submission of the application, which must include only:
    • List of authors and institutional affiliations
    • Title of the article
    • Journal or citation (if available)

Please refer to NOT-OD-16-130 for any additional guidelines specific to the type of application you are submitting (there are a few). And, as always, I add my usual warning to always carefully read and follow the funding opportunity announcement (FOA) to which you are applying for specific instructions.

Also note that, while you can submit basic information about an article accepted for publication since submission of your application, you should also be sure to update your online bibliographic database, which is linked to your Biosketch. While it won’t put your new publication front-and-center with your other select publications included in the body of the Biosketch, including the new publication in your online bibliography will automatically “update” your Biosketch in a fashion by making your updated bibliography available to reviewers.

I hope this entry has helped assuage any anxieties about the post-submission period. If you have any questions or comments, please feel free to leave a comment!


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