Food & Drug Administration (FDA) Regulated Research Questions/Answers
Investigators are responsible for ensuring that studies testing FDA-regulated products are conducted under a valid Investigational New Drug (IND), Investigational New Device (IDE), meets Abbreviated IDE requirements or is exempt from IND/IDE requirements.
Investigators are responsible for the control and accountability of FDA-regulated investigational products.
Investigators follow FDA regulations and UK procedures for emergency use of a test article.
Answers
What is the difference between Single Subject Emergency Use and Planned Emergency Research?
The single subject emergency use provision in the FDA regulations [21 CFR 56.104(c)] is an exemption from prior review and approval by the IRB for an investigational drug or device to be used in a human in a life-threatening situation where time is not sufficient to obtain IRB approval. FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval.
FDA regulations for planned emergency research [21 CFR Subpart B 50.24] provide a narrow exception to the requirement that the investigator obtain informed consent from each subject, or the subject's legally authorized representative, prior to enrollment in research conducted in an emergency setting. The regulations also provide additional protections for subjects enrolled in these Exception from Informed Consent (EFIC) studies.
For example, the regulations require advance public disclosure and consultation with representatives of the communities in which the clinical investigation will be conducted. They also require public disclosure of enough information following completion of the clinical investigation to apprise the community and researchers of the study. As well, the regulations require that an independent data monitoring committee exercises oversight of the clinical investigation.
What resources are available for investigators conducting FDA-regulated research?
The ORI FDA Research Question and Answer website [HTML] provides training materials, interactive tools, resources, and information on multiple areas of FDA-regulated research including research testing drugs, devices, software as medical device, and treatments including emergency use, expanded access, and Humanitarian Use Devices.
