Upcoming NIH Proposal Preparation Changes Upcoming NIH Proposal Preparation Changes NOT-OD-16-004 (Summary of All Changes) Revised SF 424 RR Application Guide

PHASE I: Changes Effective for Proposals with a Due Date on or after January 25, 2016

Rigors and Transparency NOT-OD-16-011 and NOT-OD-16-012 Purpose: Enhance reproducibility of research findings through increased scientific rigor and transparency. See notices for which grant mechanisms this applies to. Changes include: Use of a new “Authentication of Key Biological and/or Chemical Resources” attachment. Changes to instructions for Research Strategy including Significance and Approach sections.

Rigors and Transparency NOT-OD-16-011 and NOT-OD-16-012 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 in the proposed studies. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics. Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Provide this section to your fund manager as a separate PDF upload. Jan. 25 – May 24 – Uploaded under Other Attachments section. On or after May 25 – New attachment section under Research Plan with release of FORMS-D.

Rigors and Transparency NOT-OD-16-011 and NOT-OD-16-012 Resources: Rigors & Transparency NIH Page FAQ Training Module

Vertebrate Animals NOT-16-16-006 Purpose: To remove redundancy with IACUC review while meeting the requirements of PHS policy. Effective for all proposals except Ts and Fs as of Jan. 25th. Ts and Fs will be effective May 25th. Changes include: Updated guidance on criteria to be addressed Description of veterinary care is no longer required Justification for the number of animals has been eliminated Description and justification of method of euthanasia is required only if the method is not consistent with AVMA Guidelines

Definition of Child NOT-OD-16-010 Purpose: To align the NIH definition for the age of a child with the typical age of consent and the common perception of the age of adulthood. Change: For the purposes of inclusion policy, the age of a child will be defined as individuals under 18 year old instead of under 21 years old.

PHASE II: Changes Effective for Proposals with a Due Date on or after May 25, 2016

Summary of Upcoming Changes NIH will be releasing a new set of proposal preparation forms (FORMS-D), along with an updated set of instructions (NIH SF424 RR Application Guide). Expected Release Date: March 2016 Changes include: New PHS Inclusion Enrollment Report Form will replace the Planned Enrollment Report and Cumulative Inclusion Enrollment Report Forms found in FORMS-C. New Data Safety Monitoring Plan as a new separate attachment from the Resource Sharing Plan. Appendix Policy is currently being reevaluated.

Summary of Upcoming Changes Changes Continued: New PHS Assignment Request Form will be added. NOT-OD-16-008 Applicants will no longer include the following requests in the Cover Letter. Institute Requests, Study Section Request, List of Potential Reviewer Conflicts, List of Scientific Expertise Needed to Review New Font Guidelines NOT-OD-16-009 BioSketch Clarifications URL for a publication list is optional, and if provided, must be to a government website like My Bibliography. Explicitly stating that graphics, figures and tables are not allowed