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What is Exception from Informed Consent Research? (EFIC) To conduct a clinical trial to inform best practices in an emergency, researchers use a set of federal regulations, commonly known as EFIC. EFIC regulations allow research to begin BEFORE asking the patient or their family for consent.
Exceptions to Informed Consent Several exceptions to the requirement for informed consent include (1) the patient is incapacitated, (2) life-threatening emergencies with inadequate time to obtain consent, and (3) voluntary waived consent.
If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent
If the FDA determines that an IND is not required in a drug study, then which of the following is true? The investigator should prepare and submit the protocol to the IRB as an approval would be necessary. The materials should include the fact that the FDA has advised the investigator that an IND is not required.
There are two categories for INDs: commercial and research. The main difference is who submits the application to FDA and the intended purpose of their clinical research.
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To be exempt [21 CFR 312.2(b)], 1) the drug must be lawfully marketed in the US, 2) the study cannot be intended to support a new indication or other docHub change in product labelling, 3) the study cannot be intended to support a docHub change in advertising for the drug or be used to promote the drug, and 4
Whether an IND is needed to conduct a clinical investigation of a marketed drug primarily depends on the intent of the investigation and the degree of risk associated with the use of the drug in the investigation.
The IND application must contain information in three broad areas: Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).

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