The Consent Form

The primary informed consent tool that involves both the researcher and the IRB is the consent form. This document is used in all research for which there is no approved waiver of consent. Thus, most research will involve use of an IRB approved consent form.

An approved consent form must comply with several regulatory requirements:

• The document must be accurate and complete.
• The required elements (as defined by the regulations) must be appropriately included.
• The content of the consent form must be understandable to a non-scientist.
• No waiver of rights or other exculpatory wording may be present or appear to be present in the consent form.
• The investigator must give the participant or LAR adequate opportunity to read it before it is signed and dated.
• The document must be signed and dated by the participant or LAR.
• The document must be signed and dated by the person obtaining consent.
• For clinical research: If the participant cannot read, an Impartial Witness must witness the consent process and sign and date the form.
• A signed and dated copy must be given to the person signing the form