What information must an applicant provide to ED at the application stage regarding research activities involving human subjects?
On the ED Supplemental Information for SF 424 Form in the application package, every applicant must indicate whether research activities involving human subjects are planned at any time during the project period. If human subjects research activities are planned, the applicant must indicate whether these activities are exempt or covered (nonexempt) and provide detailed information about covered research activities. EAGs that involve nonexempt human subjects research will need to obtain a Federal Wide Assurance (FWA) to abide by ED’s regulations for protection of human subjects in research and be reviewed by an Institutional Review Board (IRB) before beginning non-exempt activities. ED will make the final determination regarding whether a grant requires IRB review. Additional information about human research subjects and the need for IRB approval is available on ED’s protection of human subjects website at: http://www.ed.gov/about/offices/list/ocfo/humansub.html. Applicants with questio
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