NIH and IES require a document that includes information about how human subjects will be treated whether or not the research is considered “exempt.”
Institute of Education Sciences (IES)
If the research is considered exempt the narrative must contain sufficient information about the involvement of human subjects in the proposed research to allow a determination by the funder that the designated exemption(s) are appropriate. One or more of the six categories of research that qualify for exemption from coverage are selected as part of the proposal submission. The narrative is attached to the proposal as a separate PDF document.
The nonexempt narrative should include the following sections: 1) the characteristics of the subject population; 2) the data to be collected from human subjects; 3) recruitment and consent procedures; 4) any potential risks; 5) planned procedures for protecting against or minimizing potential risks; 6) the importance of the knowledge to be gained relative to potential risks; and 7) any other sites where human subjects are involved. Just like the exempt narrative, the non-exempt narrative is attached to the proposal as a separate PDF document.
The Research on Human Subjects Narrative is a required section for all IES submissions.
Example – Research on Human Subjects Narrative IES 081617
National Institutes of Health (NIH)
You must include a “Protection of Human Subjects” attachment if you answer “Yes” to the question “Are human subjects involved?” on G.220 – R&R Other Project Information Form.
If you answered “No” to the “Are human subjects involved” question but your proposed research involves human specimens and/or data from subjects, you must provide a justification as an attachment for your claim that no human subjects are involved.
Refer to Supplemental Instructions, Part II(PDF) for instructions on this section. Additionally, be sure to follow any specific instructions in your FOA.
