NIH eSubmission Items of Interest – November 16, 2015

New Year, New Forms, New Policies

It is hard to believe 2016 is just around the corner. With the new year comes new forms and new grant policies (NOT-OD-16-004, NOT-OD-16-005).

Our updated application forms (we'll be calling FORMS-D) must be used for applications for due dates on or after (but not before) May 25, 2016 and you'll start seeing the updated forms and instructions showing up in funding opportunity announcements by March 25, 2016. You'll be hearing a lot from me about FORMS-D between now and then.

Some of our policy changes couldn't wait (or didn't need to wait) for our FORMS-D forms and will take effect for applications for due dates on or after January 25, 2016. We have new instructions for research and career development applications that specify what we want to see in terms of rigor to enhance the reproducibility of NIH funded research. We redefined the age of a child for the purposes of NIH's inclusion policy to individuals under 18 years old instead of under 21 years old. We also updated guidance for the vertebrate animal and training program plan sections of applications – including a reduction in data collection. Wow – reduction in data collection – that's a rare and wonderful concept!

We strive to have revised guidance available to you at least 60 days prior to the first due dates for which the changes apply. For January changes, that means by November 25, 2015 we'll post an updated FORMS-C application guide. By that date, you will also see a link to revised review language in our active research and career development funding opportunity announcements.

There are certainly a lot of changes ahead, but it was the same last year and the year before that. We are constantly in a state of change and somehow it always seems to work out just fine.

Eyeballs Catch Stuff Systems Don't

People have eyeballs. Systems typically don't have eyeballs. People interpret situations and circumstances to make decisions. Systems take actions based on clearly defined rules. Why is this important? When checking application compliance against documented business rules, some checks can be easily automated and others are best left to actual people with eyeballs and cognition.

We talk a lot about showstopper errors identified by eRA systems that can prevent your application from moving on to our division of receipt and referral for NIH processing. We don't often talk about the manual checks done by our staff once your application gets to them.

Here is some of the stuff our staff look for…

• Does the topic of the application fit NIH's mission?

• Is the applicant eligible to apply?

  For example, if applying to the AREA (R15) program do the applicant organization and PI meet the eligibility requirements specific to that program?

• Does the application include all critical sections?

  Our systems can tell if you attached a pdf document in a certain spot in the application, but can't assess the content of that attachment. We've received all sorts of "unintended" attachments over the years from our own application guide instructions to a great recipe for cranberry margaritas (true story). To be fair, the recipe makes excellent margaritas (I'll be making them again this holiday season), but it was a poor substitute for a research strategy.

• Does the application include information in inappropriate places to get around page limits?

  We refer to the use of appendices and other non-page limited application sections to augment information in page limited sections as "overstuffing" your application (NOT-OD-11-080, NOT-OD-07-018). Your specific aims, research strategy, abstract, biosketches and other application attachments have page limits for a reason – to provide a fair and level playing field to convey information. We take that "fairness" thing pretty seriously around here.

• Was the application submitted on-time?

  Unlike many agencies, NIH does not shut down the ability to submit to a funding opportunity announcement at 5:01 pm on a due date. We keep the submission door open and assess the circumstances of "late" submissions on a case-by-case basis. Staff check your cover letter submitted with your application for documented circumstances allowed under our late policy. They check to see if the application falls under our continuous submission policy. They also check to see if you ran into any system issues along the way and appropriately notified the eRA service desk to document them.

• Do you already have an application with essentially the same content under review?

  Even under our latest submission rules which allow you to submit the same application again, you can't have overlapping applications under review at the same time (NOT-OD-14-074).

• Does your application adhere to FOA-specific instructions in Section IV – Application and Submission Information?

  Instructions in this section are often not systematically enforced, since they are exceptions from our general guidance. So, don't rely on system checks to catch page limits and missing attachments documented in this section.

• If reference letters apply, were the correct number of reference letters received by the due date?
• Did you follow font and margin guidelines documented in the application guide when preparing all your attachments?
• If requesting over $500K in direct costs in any budget period, did you have institute permission to submit?
• If human embryonic stem cells are indicated, were all restrictions for their use met?

Although you may not have seen this particular list of checks before, I doubt there are a lot of surprises. The real takeaway here is that system checks are great (begin shameless plug – The Validate Application feature in ASSIST is awesome!  – end shameless plug), but they are not the whole story when it comes to assessing whether an application meets all the conditions to be accepted for review and funding consideration.

When submitting your application, don't just think about getting through our systems. Stop to think how your application will hold up to the scrutiny of someone with eyeballs.

Mistakes Are Meant for Learning, Not Repeating – Biosketch Compliance

On November 5, NIH started sending email notifications to applicants indicating reviewers found one or more biosketches that did not comply with our current biosketch format (NOT-OD-15-032). Hundreds of letters have already gone out. If you've received one of these notifications, don't panic. These letters are currently just warnings and require no action on your part. However, they do demonstrate NIH's commitment to enforcing compliance with our biosketch policy.

What does it mean to have a compliant biosketch?

eRA systems ensure some biosketch rules are met by flagging errors upon submission. Applications that violate these rules won't even move forward to NIH for consideration.

• A biosketch is attached for each and every Sr/Key person listed in the application
• Each biosketch is less than or equal to 5 pages
• Each biosketch attachment is in PDF format

But, there are additional rules you must follow to be compliant that aren't systematically caught by eRA systems.

Did you catch the part where I said "reviewers found" the non-compliant biosketches? We have provided instructions to our reviewers to flag any applications with biosketches that don't follow current guidelines. Don't make extra work for your reviewer – give them a clean application without the distraction of non-compliant formatting they have to write up.

Having trouble keeping up with NIH's biosketch rules and getting your key personnel to follow them? Encourage people participating on your application to use SciENcv. Not only does SciENcv help manage biosketch information, it also creates perfectly compliant biosketches.

If you've received a warning letter, learn from your mistakes and don't repeat them. Eventually, these warning letters will be replaced with notifications that applications have been removed from consideration. You've been warned (queue foreboding music in your head).

Thought for the Day

Gratitude can transform common days into thanksgiving,
turn routine jobs into joy,
and change ordinary opportunities into blessings.

–William Arthur Ward, writer

Wishing you and your families a very Happy Thanksgiving,
Sheri 

• Include each section (A - Personal Statement; B – Positions and Honors; C – Contributions to Science; D – Research Support or Scholastic Performance)
• Include no more than 5 contributions to science with no more than 4 citations per contribution
• Ensure that if you include the optional link to a full list of your published work in a site like My Bibliography that the URL is public, accessible without providing any login or personal information, and doesn't link to websites that may violate page limit rules
  • Note: We will restrict this link to federal (.gov) sites beginning with applications to due dates on/after May 25, 2016 (NOT-OD-16-004)
• Refrain from including information, such as preliminary data, that belongs elsewhere in the application
• Follow NIH guidance on font type, font size, paper size, and margins (See section 2.6 of application guide)