P-339 Identifying essential information for a valid informed consent (IC) of egg donors: An international Delphi study
Authors: Jacxsens L , Pennings G , Lentacker L , Stoop D , Provoost V 
Published: July 2024

Abstract

Study question
What information does an international group of professionals and egg donors consider relevant and morally necessary for prospective egg donors to provide valid IC?

Summary answer
In the first round, participants considered 56% of the information items relevant (e.g. all legal aspects) and 50% of the items as morally necessary information.

What is known already
Disclosure of relevant and adequate information is essential for IC in medical procedures like egg donation (ED). However, studies reveal inadequate risk awareness among donors. This raises questions about the adequacy of the provided information. The “Egg Donor Informed Consent Tool” aims to assess donors’ understanding of the ED process and its risks. However, Skillner et al. developed the tool exclusively with American endocrinologists and donors and do not touch upon all legal aspects or alternative hormone stimulation. No international study to date has determined what information professionals and egg donors consider relevant and morally necessary for prospective donors.

Study design, size, duration
This modified Delphi study used a survey in an iterative process of three rounds to reach a consensus on what information items are relevant and morally necessary for a valid informed consent of candidate egg donors. Invitations to participate were sent out in November 2023 and the first round lasted six weeks. Reminders and additional invitations were sent out every two weeks. Currently (January 2024), we are preparing the second round with 35 professional participants

Participants/materials, setting, methods
The 35 participants were experts in ED across diverse fields (social and medical sciences, bioethics, psychology, fertility medicine and law) from 14 countries. The egg donor part of round one is ongoing.
The survey consisted of 13 categories and 118 information items, which participants score for relevance via a 4-point Likert scale and moral necessity on a dichotomous scale (yes/no). Content Validity Index (CVI) will be calculated for measuring relevance. A comment section was available.

Main results and the role of chance
Research shows that high content validity (“consensus”) is reached when there is an I-CVI (CVI per item) of .78 or higher. The same cut-off was selected to reach consensus for Moral Necessity. The following results are based on the first round, results from all three rounds will be presented at the congress. For 58 out of 131 information items, the I-CVI was lower than 0.78. The percentage of moral necessity was below 0.78 for 65 items. The relevancy for the total survey (S-CVI/Ave) for the first round was 0.80. Four information items reached a CVI of 1: all experts thought it was relevant for a candidate donor to know that 1) the need to undergo ovarian stimulation and 2) a pick-up procedure, as well as 3) her legal rights over the donated eggs after the pick-up procedure and 4) her legal right to withdraw consent. The latter is the only information item that scored a 100% of Moral Necessity. All 16 information items in the categories “issues concerning multiple donations”, “legal aspects” and “financial aspects” reached a consensus in relevance, but two of these items’ did not reach the cut-off of 0.78 for moral necessity.

Limitations, reasons for caution
There was a relatively low response rate of 24 percent, which can be attributed to the demographics of our population. These professionals typically have limited availability for participation and for some professionals the email addresses we found were outdated.

Wider implications of the findings
The final results can give professionals a standard of essential information to provide to make sure the women are adequately informed and know what to expect when they decide to donate. It also gives researchers a potential standard to evaluate the quality of the informed consent in fertility clinics.

Trial registration number
Not applicable