Egg Donor Informed Consent Tool (EDICT): development and validation of a new informed consent tool for oocyte donors

Objective To develop and validate a novel tool to assess the objective and subjective understanding that oocyte donors have of the process and potential risks of oocyte donation. Design Prospective cohort study. Setting University-based tertiary reproductive health practice. Patient(s) Prospective oocyte donors. Intervention(s) We developed an informed consent questionnaire specific to oocyte donors, the Egg Donor Informed Consent Tool (EDICT), using published informed consent guidelines and known egg donation risks. Main Outcome Measure(s) We assessed content validity, readability, and reliability after pilot testing of the EDICT. Result(s) The Subjective EDICT assesses donors' perceived understanding, and the Objective EDICT measures donors' actual knowledge. Questions cover the process of oocyte donation, potential risks, and legal and psychologic issues. We demonstrated good content validity, a readability level consistent with readability goal of informed consent documents, and good reliability on pilot testing. Conclusion(s) For the first time, we describe development of a valid and reliable new tool for assessing oocyte donors' understanding of the process and risks associated with oocyte donation.