What if my research does not involve human subjects and I will not be collecting any data identifiable to a private person?
You must still complete the Privacy Certificate and Form titled “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption” and include them with your grant application. On the Privacy Certificate , in the section “Brief Description of Project,” indicate “No data identifiable to a private person will be collected.” In subsequent boxes, insert “Not applicable since this study is not collecting any individually identifiable data.” Do not leave sections blank and do not insert “N/A” or “Not Applicable” without providing a reason. On the Form titled “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption ,” in box 8, indicate “This project will not involve human subjects.” Both forms must have the appropriate signatures and date affixed.
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 if my research does not involve human subjects and I will not be collecting any data identifiable to a private person?
- When does research with human specimens, cells, cell lines, or data involve human subjects?
