NIH Proposal Information

Courtesy of the VP&S Office for Research (OFR), they have available a Grant Toolbox containing a Grant Starter Kit, a Facilities and Resources Bank and NIH proposal checklists:

• Grant Starter Kit - contains templates and primers of the different grant components
  • Resource: NIH Proposal Checklists - each checklist contains links to additional instructions/information to help you complete that section of the grant application
  • Resource: Grant Writing Guides
• Facilities and Resources Bank - contains institutional descriptions to adapt for the facilities and other resources section

• NIH Grants Process - learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting. Includes videos.

• Parent Announcements (For Unsolicited or Investigator-Initiated Applications)

• NIH Guide for Grants and Contracts - NIH's official publication of notices of grant policies, guidelines, and funding opportunities. NIH  publishes daily and issues a Weekly Table of Contents.

• NIH Standard Proposal Due Dates

• Annotated Form Sets - These documents are a great visual resource of the proposal forms, and for understanding many of the business rule checks NIH will run against your submitted application.

• How to Apply – Application Guide - contains the latest application instructions

• NIH Forms Directory - A consolidated listing of forms, format pages, and instructions grouped by their use. Many of the forms found on this page are for reference only and must be completed using the identified online system.

• Budgets: Developing Your Budget for an NIH Proposal

• NIH's Data Management and Sharing Policies - also see Columbia's guidance, resources and FAQs at Columbia's NIH Data Management and Sharing Resources

• NIH ASSIST (Application Submission System & Interface for Submission Tracking) - the online system used to prepare and submit an NIH proposal

• NIH ASSIST Tutorials

• Requesting Administrative Supplements

• Formatting Instructions

• Page Limits

• Rules for Text Fields

• NIH Grants Policy Statement

• Notices of NIH Policy Changes

• See Columbia's NIH Researcher Disclosure Requirements for the latest updates, guidance documents and training materials on the disclosure requirements for NIH Biographical Sketches
   
• See NIH's Biosketch Format Pages, Instructions, and Samples for the latest forms and instructions
   
• See NIH's Biosketches FAQs

See NIH's Single IRB for Multi-Site or Cooperative Research

NIH applicants do not need to submit a Single IRB Plan describing the use of a sIRB at the time of application submission. However, applicants required to use a sIRB must provide the name of the single IRB of record during Just-in-Time submission before an award is issued. Providing the name of the sIRB of record satisfies the sIRB policy requirement for an sIRB plan for NIH grant applicants.

Important:

Regardless of whether an sIRB Plan is required in the proposal, Columbia applicants to the NIH or other federal agencies must complete a Columbia University IRB Reliance Request Form and submit it to the Human Research Protection and IRBs Office (HRPO) early in the process of proposal preparation and prior to proposal submission if their application proposes to:

• Conduct non-exempt human subjects research; AND
• Conduct research at more than one site in the United States.

It is critical to receive confirmation from HRPO on which entity will serve as the Reviewing IRB, which will include the appropriate single IRB costs to include in the proposal budget.

For more information, see HRPOs' Single IRB Information webpage.

Also see:

• Application instructions, FORMS-I, regarding sIRB
• For NIH applicants, the single IRB plan is no longer required. Do not provide an attachment. The applicant must provide a statement naming the sIRB of record in the Just-in-Time submission prior to award
• AHRQ - applicants are required to include a sIRB attachment. See FORMS-I instructions above.

Boilerplate Language:

• Clinical Trial Dissemination Plan (section 4.7 of Study Record (9/25/2018)
  • Word version
  • PDF version

NIH Training Resources:

• Decision Tool: Am I Doing Human Subjects Research?

• Preparing the NIH Protection of Human Subjects Section and an Overview of NIH’s New Policies

• FAQs on the PHS Human Subjects/Clinical Trial Form
• Training Resources on all Clinical Trial Policies
• Clinical Trial Decision Tree
• One Page - Clinical Trial Decision Tree
• Definition of Clinical Trial FAQs
• Case Studies

NIH Blogs/Tips:

• How Do You Define a “Study” for the Purposes of Providing Information on the PHS Human Subject and Clinical Trial Form?

• Tips for Describing Human Subjects Studies in Multi-project Applications

• You Had Clinical Trial K Application Questions, We Have Answers

• Are Studies Ancillary to Clinical Trials Considered to be Clinical Trials As Well?

• Is My Ancillary Study Considered a Clinical Trial?

• Looking for the Latest Definition for Terms Relating to Human Subjects and Clinical Trials?

• What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?

Columbia's ReaDI Program offers many resources for NIH investigators:

• Authentication Plans
• Experimental Design
• Rigor and Reproducibility Resources
• See the ReaDI Program's website for all available resources and consulting services