Username Post: Medical devices - trials
S. Isbill 
Beginner
Posts: 15

Loc: New Jersey
Registered on 01-09-06
03-03-06 08:47 AM - Post#3302    
    In response to

There is so little information in the initial question that an adequate answer is impossible.

However, re the response: If a sample is taken from a person then permission for it's use must be obtained. This is informed consent.

Maybe not; if your doctor or a clinical testing lab takes a blood sample during a routine visit, no consent is required. Routine medical procedures that do not involve a clinical study do not require consent. If your test is one required by a clinical study protocol, then consent is needed prior to the test. This includes tests that would not be done if there was no clinical study involved.
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