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

Capsule:
We describe the development of a new valid reliable tool (Egg Donor Informed Consent Tool [EDICT]) for assessing oocyte donors’ understanding of the process and risks associated with oocyte donation.

Authors:
Amanda Skillern, M.D., Marcelle Cedars, M.D., Heather Huddleston, M.D.

Volume 99, Issue 6, Pages 1733-1738.e4, May 2013

Abstract:

Objective:
To develop and validate a novel tool to assess the objective and subjective understanding oocyte donors have of the process and potential risks of oocyte donation.

Design:
Prospective cohort study.

Setting:
University based, tertiary reproductive health practice.

Patients:
Prospective oocyte donors.

Interventions:
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 Measures:
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, legal, and psychological issues. We demonstrated good content validity, a readability level of the EDIC T consistent with goal readability of informed consent documents, and good reliability upon pilot testing.

Conclusions:
For the first time, we describe development of a valid, reliable, novel tool for assessing oocyte donors’ understanding of the process and risks associated with oocyte donation.

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