Who signs a consent form?

Federal regulations (45 CFR 46.117) require written informed consent, one that is approved by the IRB and signed by the participant or the participant's legal representative and the principal investigator (or his/her delegate). The delegated responsibility can fall to members of the investigator's “research team”, provided the team members have been trained by the investigator and had also taken the UMBC Collaborative Institutional Training Initiative (CITI) web-based course.

Consent forms should be signed by the person actually administering consent, at the time consent is administered, attesting to the informed consent conversation. At no time should the consent forms be pre-signed by the members of the research team.

Further details about the consent process may be found at http://www.umbc.edu/research/HARPO/IRB/consentassent.html