-. Ensure the form contains all necessary criteria as required by FDA regulations, protocol requirements,
and IRB policies.
-. Ensure the form is properly signed and dated by the subject.
-. Ensure the subject reads and signs the correct version of the form.
-. Ensure a Legally Authorized Representative or witness signs and dates the form when necessary.
-. Ensure the investigative site has a well-defined informed consent procedure.
-. Ensure the consenter is properly trained.
-. Ensure a consent discussion has taken place in which the subject as time to ask questions.
-. Ensure the consent process is completed before study procedures are initiated.
I add interesting English-Spanish glossary to build informed consent in spanish, by
Pablo Mugüerza, Lida Barbetti Vros, and Lorenzo Gallego-Borghini.
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