Human Subjection Section in Federal Applications

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Human Subjection Section in Federal Applications

Human Subjects Section in Grants.gov and IES Electronic Submissions

A new feature of proposals submitted through grants.gov and the IES System is a section on the face page that requests detailed information about the involvement of human subjects in the research. PLEASE NOTE THAT THIS IS NOT A REQUIREMENT FOR IRB APPROVALPRIOR TO SUBMISSION. Rather, investigators just need to provide a brief overview for all exempt and non-exempt research that touches upon the following issues:

  • A basic description of the subject population
  • Estimated Sample Size
  • Recruitment sites (can be general types of sites)
  • Anticipated method of recruitment
  • Basic provisions for obtaining informed consent
  • Anticipated confidentiality protections
  • Anticipated means to minimize obvious risks
  • Provisions for obtaining consent of collaborating institutions and/or parents as appropriate.

Please note that all of the above can be extremely general and leaves you free to make changes as warranted once the project is funded.