Except in very specific circumstances, approved on a case-by-case basis by the reviewing Committee or subcommittee, consent forms should not be pre-signed.
Who should sign as the investigator on the consent form?
Consent forms should be signed by the person actually administering consent, at the time consent is administered. The person who administers consent, if that person not the principal investigator, is acting as the agent of the principal investigator and must be able to represent the study with full knowledge and authority to prospective subjects; this person should be listed as an investigator in the Investigators' Information section of the consent form. The principal investigator is ultimately responsible for any defects in the consent process, and the chain of responsibility must be clear.
Who should be listed as an investigator on the consent form?
In addition to the principal investigator, the consent form should list the members of the study team who have been delegated the responsibility of administering informed consent, and those who will have on-going contact with study subjects.