The IRB no longer requires the signature of a witness on all informed consent documents. The IRB will review the need to have a witness sign the informed consent document on a case by case basis. If the IRB deems the witness signature is necessary, this will be communicated to the Investigator upon review of the protocol.
If the current IRB approved informed consent document(s) being used includes a witness signature, the witness signature is still required.
If an Investigator wishes to remove the witness signature line, an amendment must be submitted to the IRB requesting its removal from the informed consent document(s).
If the study is being conducted at the VA hospital using the VA informed consent, the witness signature line may NOT be removed. VA regulations require the signature of a witness.