What happens once the application is selected for funding and non-exempt human subjects research activities are planned?
The grantee (and any other institution performing research) will need to provide an assurance in which the grantee agrees to follow ED regulations for the protection of human subjects. In addition, the proposed research will also have to be reviewed and approved by an IRB. ED can offer guidance to grantees with regard to any assurance needed and on finding an IRB.
Related Questions
- Activities must meet the definition of research and involve human subjects as defined in DHHS regulations, or be research and involve human subjects as defined in FDA regulations to be subject to the IRBs jurisdiction. How do I know if my project meets the definition of human research?
- What happens once the application is selected for funding and non-exempt human subjects research activities are planned?
- Are there any examples of activities that aren’t considered Human Subjects Research?
