On May 25, “D” is for “Different”

By now you are most certainly aware that Forms D will be required for all NIH applications on or after May 25. If you are using ASSIST, you will automatically be directed to the Forms D cloud set (in the past few weeks, you were given a choice on the initiation screen, but now we’re very close to the no-option date).  If you are still using the SF424 (why aren’t you using ASSIST?) be sure that any work you are doing is in the correct form set.  The Forms D application guides are revamped and available on NIH’s website.

 

We first warned you of this back in October, so now is a great time to re-familiarize yourselves with the required changes: Brace Yourselves, Forms D Are Coming.  For an exhaustive list of changes, NIH has provided a high-level list of FORMS-D pre-award form changes, as well as a landing page for all things Forms D.  And, as always, drop us a note if anything looks murky; we’re always happy to help find clarification!

 

Brace Yourselves: Forms D Are Coming

It’s that time again: the form sets for federal submissions are a-changin’.  Be on the look out: Forms D take effect for all submissions on May 25, 2016 and after.  There are, however, many changes that take effect before Forms D are released; these go into effect on and after January 25, 2016.  A version of the following table was handed out at today’s Tips and Tools meeting (PDF here).  Here it is, if you missed it:

 

ATTACHMENT   CHANGE
Biosketch Clarifications

NOT-OD-16-004

  • A URL leading to a publication list is optional, but must lead to a .gov website
  • Publications (peer-reviewed or not) and research products may be cited in both the personal statements and contributions to science.
  • Graphics, figures and tables are not allowed.
 

Effective for January 25, 2016 Submissions

Research Strategy

NOT-OD-16-011 and NOT-OD-16-012

 

New rigor and transparency guidelines will be given to reviewers.  This will affect the way the research strategy is reviewed.
Authentication of Key Biological and/or Chemical Resources

NOT-OD-16-004

 

This is an ENTIRELY NEW ATTACHMENT.
Vertebrate Animals

NOT-OD-16-006

 

  • Veterinary care description no longer required.
  • New guidance on necessary criteria (procedures, justifications, pain/distress minimization; euthanasia).

–    Euthanasia descriptions/justifications only required if not consistent with AVMA.

 

Inclusion of Children

NOT-OD-16-010

 

Age definition of “child” is now lowered from 21 to 18.
TRAINING: Recruitment and Retention Plan to Enhance Diversity

NOT-OD-16-004

 

The focus must be on recruitment.
TRAINING: Human Subjects

NOT-OD-16-004

 

 

  • Language must exist stating explicitly how Wayne State will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval.
  • List of potential trainees and associated IRB information no longer required.
TRAINING: Vertebrate Animals

NOT-OD-16-004

 

 

  • Language must exist stating explicitly how Wayne State will ensure that trainees only participate in IACUC-approved vertebrate animal research.
  • List of potential trainees and associated IACUC information no longer required.
TRAINING: Progress Report

NOT-OD-16-004

 

No longer required to report on publications arising from work conducted by the trainee; this will now be requested for Just-in-Time.
 

Effective for May 25, 2016 Submissions – when FORMS D go into effect

TRAINING/FELLOWSHIP: Authentication of Key Biological and/or Chemical Resources

NOT-OD-16-004

 

THIS IS A NEW ATTACHMENT.  It will be required for all Research Plan, Career Development Supplemental, and Fellowship Supplemental sections.
TRAINING/FELLOWSHIP: Plan for the Instruction in Methods for Enhancing Reproducibility

NOT-OD-16-004

 

THIS IS A NEW ATTACHMENT.
Vertebrate Animals

NOT-OD-16-007

 

New questions regarding euthanasia added.
Planned Enrollment/Cumulative Inclusion

NOT-OD-16-004

 

More study descriptors will be added. Additional details will be available prior to the release of the new forms.
Data Safety Monitoring Plan

NOT-OD-16-004

 

THIS IS A NEW ATTACHMENT. This will be included with all clinical trials.
TRAINING: Tables

NOT-OD-16-007

 

 

 

  • Only 8 tables will be required (instead of 12) to minimize individual-level reporting.
  • Tracking of trainee outcomes will be extended from 10 to 15 years.
  • A new NIH system (xTRACT) is now available in eRACommons to help with table preparation.
Assignment Request

NOT-OD-16-008

 

 

This is a new OPTIONAL form.  It is utilized to uniformly request preference in institute, study section, potential conflicts, and necessary expertise.  This replaces the need for some information commonly written in an introduction.
Font Guidelines

NOT-OD-16-004

 

  • Size: 11 points or larger; smaller is acceptable in figures as long as it is legible at 100%
  • Density: no more than 15 characters per linear inch, including characters and spaces
  • Spacing: no more than six lines per vertical inch
  • Color: must be black. Color text in figures is acceptable as long as it is legible.
  • Recommended fonts: Arial, Garamond, Georgia, Helvetica, Palatino Linotype, Times New Roman, Verdana

SciENcv: The Gift That Keeps on Giving

The new NIH biosketch format will be in effect come May 25, but many PIs and administrators* are choosing to make the switch now to avoid crunch-time headaches.  We’ve mentioned SciENcv before, and don’t panic if new systems set your heart a-flutter: it’s not required.  We do, however, think you should consider the many benefits of using the SciENcv tool:

 

  1. Eliminates the need to repeatedly enter biosketch information.  The first time you enter your information into the system will likely be the most time you will have to have to spend with SciENcv. That said, did you know that you can automatically import your information from your eRACommons profile (or ORCID, if you have one) directly into SciENcv?  It’s true!  And it is editable! This will likely save a lot of time, and may even be faster than cutting and pasting text from your old .doc versions of your biosketch into a new template (see below).
  2. Reduces the administrative burden associated with federal grant submission and reporting requirements. Your biosketch information will always be right where you left it: in the cloud, in your MyNCBI account.  Because SciENcv generates and maintains multiple biosketches from your information (including those for NSF and other federal science agencies), you’ll be able to simply tweak any sections you have saved to align more closely with new applications, click a button, and voila! Your biosketch is generated in proper format, tailored to your specifications.  You can even keep multiple profile versions to correspond with different projects or research interests, and generate different biosketches from each one at a later time.  Additionally, SciENcv allows you to pull your publications directly from your MyNCBI.  Your pubs list is generated for you, and you can decide which ones you want to appear in your list.
  3. Provides access to a researcher-claimed data repository with information on expertise, employment, education, and professional accomplishments. Collaborations, anyone?  You can choose whether or which profiles/biosketches are made public to the research community. You will also be provided a unique link to use to direct people to your profile, for your use.
  4. Allows researchers to describe their scientific contributions in their own language. The new biosketch format includes a description of up to five of your most significant contributions to science; in other words, this is where you get to show off a little.  You don’t have to leave your impact open to reviewer interpretation anymore; tell ’em what you’ve done!  You also get to use publications in this section to support your affirmations of grandeur; just keep each description to half of a page.

 

Interested in the power of SciENcv but not sure where to start?  Read all about it, check out the YouTube tutorial provided by NIH, or sign yourself up for a free account (either through your eRACommons account or at the SciENcv portal page) and test it out.  For a little more one-on-one assistance, Dr. Katherine Akers in the Shiffman Medical Library is happy to come to your department for a presentation or individual assistance.  Already started and hit a snag?  RAS is always happy to help get you moving again!  If you would prefer not to use SciENcv, you can access an editable Word copy of the May25-required biosketch format, provided by the NIH HERE.

 

*Note: PIs can designate administrators, research assistants, etc. to have access to their biosketches (and publications) through SciENcv, if said PI does not normally assume responsibility for currency his/herself.

Ch-Ch-Changes

Welcome back, SOM!  As we begin 2015, many of the federal administrative changes that you’ve been reading about are now officially in effect.  You’ve heard and seen (ad nauseam) that the OMB Uniform Guidance is officially official as of December 26, 2014; but there other impending changes that you should note as well:

 

  • December 4, 2014: Modification to identification of marked changes in resubmissions in effect [NOT-OD-15-030]
  • January 11, 2015: The NIH salary cap is increased to $183,300 [Salary Cap Summary]
  • January 25, 2015: New late submission policy is in effect [NOT-OD-15-039]
  • January 25. 2015: Implementation of the new genomic data sharing policy begins [NOT-OD-15-027]
  • End of January 2015 target: ASSIST will be an option for R03s and R21s [NOT-OD-15-044]
  • On or after May 25, 2015: New biosketch formats will be required (though they are encouraged now; this was changed from the original January 25 deadline) [NOT-OD-15-032]

 

For a more comprehensive look at the changes you can expect, take a look at the administration timeline created by the NIH here.  Feel free to reach out if you have any questions!

It’s a bird! It’s a plane! It’s…! The new NIH Biosketch format.

Mark your calendars, the new format is expected to go into effect in early FY2015 (for projects expected to start in FY2016).  Here are some of the changes that you will see:

  • Length: A five page length will apply to the entire biosketch.  
  • Publications: Instead of listing publications, researchers will include a link to complete list of publications in SciENcv or My NCBI.
  • Significance: Description of up to five significant contributions to science, the associated influence of  each, and any subsequent effects on health or technology.
  • Role: Researchers are allowed to describe their specific role in listed significant discoveries, annotated their description with up to four publications.

Several entities (including Sally Rockey) suggest that you begin to familiarize yourself with SciENcv now, so you will be familiar with format by the time the new biosketches are required in approximately six months’ time. The first round of tests is already complete (NIH implemented this requirement on two RFAs already), and the second “fine-tuning” phase – involving more applications – will begin this month.  For more information, see the notice from NIH (NOT-OD-14-09) and/or the latest peer review notes from the Center for Scientific Review.  If you would like some assistance in setting up your SciENcv profile, or you have any questions about the new format, feel free to contact RAS anytime!