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 APPROVAL PRIOR 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.

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