Follow NIH Application Policies and Requirements

Familiarize yourself with Policy & Compliance topics that are relevant to your application’s area of science, award type, and other characteristics. For example:

• Application Submission Policies cover late applications, weekend and holiday due dates, system issues, resubmission, overlapping applications, disasters, and more.
• Plan to meet NIH Scientific Data Sharing requirements. These include data management and sharing (DMS), genomic data sharing, public access, model organisms, and other sharing policies. Try the interactive tools at Which Sharing Policies Apply to My Research?
• Manage and report Financial Conflict of Interest and potential Foreign Interference.
• Address scientific Reproducibility through Rigor and Transparency in your application, learn what reviewers expect, and find resources to prepare a rigorous application.

Depending on the science you propose, you may have additional requirements. Some major examples:

• Human Subjects Research covers NIH’s definition of human subjects, how assurances and institutional review boards (IRBs) work, certificates of confidentiality, inclusion, and more.
• Clinical Trial Requirements covers NIH’s definition of clinical trials, review criteria, registration and reporting requirements, good clinical practice, forms, informed consent, protocol templates, and more.
• If you plan to use live animals, check the Office of Laboratory Animal Welfare (OLAW) website for resources on animal assurances, reporting, policies, and related guidance.
• Check NIH Stem Cell Information, the Guidelines for Human Stem Cell Research, and NIH Grants Policy Statement 4.1.14 Human Fetal Tissue Research.
• Find Select Agent Information. A select agent is a biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant products.

In certain situations, you must seek NIH’s prior approval before you submit your application:

• If you plan to request $500,000 or more in direct costs for any year of the project:
  • You must request prior approval from NIH institute, center, or office program staff at least six weeks prior to the anticipated due date. Provide approval information in the Cover Letter attachment of your application.
  • Find details in NIH Grants Policy Statement (GPS) 2.3.7.2 Requirements for Submitting Unsolicited Applications Requesting $500,000 or More in Direct Costs.
• If you want to apply for Support for Scientific Conferences:
  • Well before the application due date, request a letter from the appropriate NIH staff contact listed in the funding opportunity to document their advance permission.
  • Your application must include the advance permission letter. 
• Some NIH institutes, centers, and offices (ICOs) request consultation before you apply. Check your funding opportunity for any ICO-specific instructions.

To stay informed about the latest policies and requirements, keep tabs on the following sources:

• NIH Guide for Grants and Contracts notices are posted daily. Check the Other Notices tab and the Notices of Policy Changes.
• NIH Grants Policy Statement (GPS) is updated annually to incorporate policy notices posted in the NIH Guide.
• News & Events shares upcoming events and webinars, blog articles, social media, podcasts, videos, and more updates for applicants and awardees.

Your organization's sponsored programs office is also a good source of news and advice on NIH policies and requirements.