2016 - Changes Regarding NIH Applications

May 3, 2016 - There are a few changes regarding NIH applications to report.

Updated NIH Website

If you have not already been on the web site, please take a few minutes to familiarize yourself with the new set up. I admit, it takes a few minutes to get used to the new format, but it is very user friendly.



New Forms:

With submissions due on or after May 25th the new Forms-D should be used. They look pretty much the same, but there are some differences (a detailed list by NIH is below as well):

  • The PHS398 Research Plan has two more fields:
    • Data Safety Monitoring Plan – note, since MIT does not participate in clinical trials, this field would not be used.
    • Authentication of Key Biological and/or Chemical Resources – this now has its own field.
  • Some fields have changed on the PHS398 Career Development Award Supplement Form – this is for the K99 submissions.
  • There is a new form entitled “PHS Assignment Request Form.” Its purpose is to provide a consistent way to collect application referral information – this information will no longer be captured in a cover letter:
  • Awarding component (NIH institute) assignment preference
  • Study Section preference
  • List of potential reviewers in conflict, and why
  • List of scientific expertise needed to review the application

PHS398 Cover Page now has information regarding Vertebrate Animals (see more information below).

  • If you have Human Subjects, the inclusion table has been reformatted into one form. The PHS Inclusion Enrollment Report replaced the Planned Enrollment Report and Cumulative Inclusion Enrollment Report.

Also note, there a new FOAs for K99 and Parent R01 and R21:

Below is information NIH provided about all the changes to the forms. The following may be helpful as well.

Updated Instructions for Vertebrate Animals:

Please note, the Vertebrate Animals Section has changed, replacing the former 5 point plan with these are the guidelines:

  • Description of Procedures: Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the “Research Strategy” section. Identify the species, strains, ages, sex, and total numbers of animals by species, to be used in the proposed work. If dogs or cats are proposed provide the source of the animals.
  • Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g. computational, human, invertebrate, in vitro).
  • Minimization of Pain and Distress: Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain, and injury.