FDA 483 OBSERVATION · #978 OF 1,932 MOST-CITED
Circumstances of obtaining consent
FDA cited this observation 18 times across 17 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
How FDA worded it — real examples
The general requirements for informed consent were not met in that you did not seek consent under circumstances that minimized the possibility of coercion or undue influence.
The general requirements for informed consent were not met in that you did not seek consent under circumstances that provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate and minimized the possibility of coercion or undue influence.
The general requirements for informed consent were not met in that you did not seek consent under circumstances that minimized the possibility of coercion or undue influence.
The general requirements for informed consent were not met in that you and the investigator did not seek consent under circumstances that minimized the possibility of coercion or undue influence.
The general requirements for informed consent were not met in that you did not seek consent under circumstances that provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate and minimized the possibility of coercion or undue influence.
The general requirements for informed consent were not met in that you did not seek consent under circumstances that provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →