Multimedia Recordings

⏴back to Guidance Series document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_1487’);});Edit Multimedia Recordings Version: April 25, 2025 ⇓ Download PDF Version Guidance Using multimedia tools to record the image and/or voice of an individual creates a record that requires careful handling and storage, particularly if the content of media or the purpose of the research may be considered sensitive. These guidelines […]

Read More

Deception & Debriefing

⏴back to Guidance Series document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_1483’);});Edit Deception & Debriefing Version: April 20, 2025 ⇓ Download PDF Version Guidance Deception is the intentional misleading of participants or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, the role of the researcher, […]

Read More

Basic Physiological Research

⏴back to Guidance Series document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_1486’);});Edit Basic Physiological Research Version: April 14, 2025 ⇓ Download PDF Version Guidance The Food and Drug Administration (FDA) is responsible for regulating devices for human use including Investigational Device Exemptions (IDE). An IDE allows an investigational device (i.e., a device that is the subject of a clinical study) to be […]

Read More

Expedited Category 8(A) Decision Chart

⏴back to Guidance Series document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_1485’);});Edit Expedited Category 8(A) Decision Chart Version: April 3, 2025 ⇓ Download PDF Version Guidance Allowing the research to be reviewed using expedited review procedures under category 8(a)1 requires a clear understanding of the status of the study. If in doubt, ask for more details about the status of the participants […]

Read More