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Wayne State University

Aim Higher

Oct 21 / RAS

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