Consent Document Revisions
participants need to be informed of any new and important
information that might affect their willingness to participate. If new
information, knowledge, or an adverse event has been discovered, it should
be communicated to the subjects. This may require a revised consent
document. New information will require that the investigator evaluate the
facts to decide on a revised consent document for future participants as
well as what information should be given to former or current subjects.
Unexpected complications, adverse events, or breaches in confidentiality
all signify developments that may require a revised consent form. Consult
the IRB to establish if a revised document is required.