NIH_Applications_2016

Summary of Changes to NIH Applications in 2016

Phase

1

2

For applications due

01/25/2016 – 05/24/2016

05/25/2016 and beyond

Form set

Existing (FORMS-C)

New (FORMS-D)

ScienceRigor and transparency

All applications EXCEPT Fs and Ts

All applications INCLUDING Fs and Ts

Significance

  • Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data

Approach

  • Describe the experimental design and methods proposed and how they will achieve robust and unbiased results
  • Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans

Authentication of Key Biological and/or Chemical Resources

  • Briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used

ScienceVertebrate animals

All applications EXCEPT Fs and Ts

All applications INCLUDING Fs and Ts

Description

  • Provide a concise description of the proposed procedures to be used that involve vertebrate animals
  • Identify the species, strains, ages, sex, and total number of animals by species to be used
  • If dogs or cats are proposed, provide the source of the animals

Justification

  • Justify 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)

Pain

  • Describe the interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints to minimize discomfort, distress, pain, and injury

Euthanasia

  • State whether the method of euthanasia is consistent with American Veterinary Medical Association guidelines
  • If not, describe the method and provide a scientific justification

ScienceDefinition of child

Individual under 18 years old

Science:  Research training

Recruitment and Retention Plan to Enhance Diversity

  • Focus on recruitment

Human Subjects

  • Describe how the institution will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval

Vertebrate Animals

  • Describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval

Formatting:  Rigor and transparency

Existing Other Attachments upload for Authentication of Key Biological and/or Chemical Resources information

New Authentication of Key Biological and/or Chemical Resources upload

FormattingResearch training

N/A

New Research Training Data Tables form

FormattingAssignment requests

Existing Cover Letter upload

New PHS Assignment Request form

FormattingFont

 

N/A

Recommended (either serif or sans serif)

  • Arial
  • Garamond
  • Georgia
  • Helvetica
  • Palatino Linotype
  • Times New Roman
  • Verdana

Formatting:  Other

 

N/A

  • PHS Inclusion Enrollment Report form
  • Data Safety Monitoring Plan upload