title: Egg Donor Informed Consent Tool (EDICT): development and validation of a new informed consent tool for oocyte donors.
abstract: 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.
  
  
  METHODS
  Prospective cohort study.
  
  
  METHODS
  University-based tertiary reproductive health practice.
  
  
  METHODS
  Prospective oocyte donors.
  
  
  METHODS
  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.
  
  
  METHODS
  We assessed content validity, readability, and reliability after pilot testing of the EDICT.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Center for Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California 94115, USA. skillerna@obgyn.ucsf.edu
authors: Amanda
authors: A
authors: Skillern
authors: Marcelle
authors: M
authors: Cedars
authors: Heather
authors: H
authors: Huddleston
mesh_terms: D015331:Cohort Studies; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards*; D018587:Oocyte Donation / Q000592:standards* / Q000639:trends; D010865:Pilot Projects; D011446:Prospective Studies; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires / Q000592:standards*; D014019:Tissue Donors / Q000941:ethics