Consent Document Revisions
Study 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.