How Science Is Building a Global Standard for Informed Consent in Egg Donation
Imagine making a significant medical decision that involves weeks of hormone injections, minor surgery, and potential long-term health implications—but without a clear understanding of what exactly to expect. For many egg donors worldwide, this scenario has been their reality. The process of egg donation is crucial for helping countless individuals and couples overcome infertility, yet studies have consistently shown that donors themselves often feel inadequately informed about the procedure's risks, benefits, and implications 5 .
Did you know? Egg donation involves ovarian stimulation with hormones, egg retrieval under sedation, and carries risks like Ovarian Hyperstimulation Syndrome (OHSS) that donors need to understand.
The issue of informed consent in healthcare isn't just about signing a form—it's about ensuring genuine understanding and voluntary agreement. Now, a groundbreaking international study is tackling this problem head-on, working to establish comprehensive guidelines that protect donors' rights and well-being. Through an innovative research method that harnesses collective wisdom, scientists are answering a critical question: What exactly does a woman need to know before ethically consenting to donate her eggs?
At the heart of this groundbreaking research lies the Delphi technique, a methodological approach designed to transform individual expertise into collective wisdom. Originally developed by the RAND Corporation in the 1950s for military forecasting, the Delphi method has since become a gold standard for tackling complex problems characterized by uncertainty across numerous fields including healthcare, social science, and technology 8 .
Think of the Delphi process as a structured form of crowd wisdom—but instead of quick opinions, it fosters deep reflection and gradual consensus among experts who might never sit in the same room together.
"What makes the Delphi particularly valuable for ethically complex fields like reproductive medicine is its ability to navigate controversial topics without letting dominant personalities override the conversation."
The anonymous nature of responses ensures that each participant—whether a seasoned physician, an ethicist, or an egg donor herself—has an equal voice in shaping the outcome 8 . This levels the playing field and prevents hierarchy or personality from influencing the consensus.
The international Delphi study on egg donor informed consent, scheduled for completion in November 2024, represents a landmark effort to establish global standards for what every potential egg donor should understand before proceeding with donation 1 . Led by researchers from Ghent University, the study asked a fundamental question: "What information does an international group of professionals and egg donors consider relevant and morally necessary for prospective egg donors to provide valid informed consent?" 1
The driving force behind this ambitious project was the consistent evidence that current informed consent practices for egg donors remain inadequate, with donors themselves expressing a desire for more comprehensive information about the process 4 5 . Without clear guidelines on essential information, clinics worldwide provide varying levels of disclosure, potentially leaving donors unprepared for the physical, emotional, and legal dimensions of their decision.
First Delphi round begins
Second and third rounds conducted
Study completion and results
The study employed a modified Delphi design conducted through three iterative rounds of surveys between November 2023 and November 2024 1 . The research team recruited 35 participants from 14 different countries, intentionally creating a multidisciplinary panel that included:
This diverse composition ensured that the resulting guidelines would reflect not just medical perspectives, but the lived experiences of donors and the ethical considerations central to truly informed consent.
Participants evaluated 133 concrete information items (CIIs) organized into 13 categories covering every aspect of egg donation—from medical procedures and physical risks to psychological impacts, legal rights, and practical implications for daily life 1 . For each item, they assessed both relevance (using a 4-point Likert scale) and moral necessity (using a simple yes/no format) 1 .
The consensus threshold was set at a Content Validity Index (CVI) of 0.78 or higher for relevance, with the same percentage applied to moral necessity 1 . This statistical approach ensured that only information items receiving strong agreement across the diverse expert panel would be included in the final essential guidelines.
Concrete Information Items evaluated
| Expert Category | Primary Perspective | Key Contributions |
|---|---|---|
| Egg Donors | Lived experience | First-hand knowledge of physical and emotional impacts |
| Fertility Doctors | Medical procedural | Clinical expertise on risks and procedures |
| Bioethicists | Ethical dimensions | Moral frameworks for consent requirements |
| Lawyers | Legal rights & protections | Understanding of legal implications and rights |
| Social Scientists | Psychosocial impact | Research on psychological and social effects |
The findings revealed remarkable consensus on what potential egg donors need to know, while also uncovering fascinating disciplinary divides in perspectives on moral necessity.
80% of all concrete information items achieved consensus as relevant 1
67% were deemed morally necessary to disclose 1
An impressive 80% of all concrete information items achieved consensus as relevant, while 67% were deemed morally necessary to disclose 1 . This suggests that while experts agree donors need extensive information, they make distinctions between what is helpful versus what is absolutely essential for ethical consent.
Four information items achieved perfect consensus (CVI of 1.0), meaning every expert—regardless of background—agreed on their relevance:
Of these, only the right to withdraw consent also achieved 100% agreement as morally necessary 4 , highlighting the fundamental importance of preserving donor autonomy throughout the process.
Perhaps the most striking finding emerged from comparing different expert groups. In several categories—including physical side-effects, psychological risks, and practical lifestyle impacts—almost all CIIs reached consensus among egg donors, bioethicists, and humanities experts, while far fewer achieved agreement among fertility experts and lawyers 1 4 . This suggests that those with medical training prioritize different information than those who consider the lived experience or ethical dimensions of donation.
"The family type and characteristics of potential recipients"
32% relevance 1
"An egg donor's social circle might give negative feedback/opinions"
36.36% moral necessity 1
The largest discrepancy appeared between what egg donors and medical professionals considered morally necessary to disclose 4 , highlighting a crucial gap between the healthcare provider and patient experience perspectives.
Conducting rigorous research in reproductive medicine requires specialized methodological tools and approaches. The table below outlines key components utilized in the featured Delphi study and their functions in advancing ethical practices in egg donation.
| Research Component | Function & Application | Example from Featured Study |
|---|---|---|
| Modified Delphi Technique | Structured consensus-building among experts | Three iterative survey rounds with controlled feedback 1 |
| Multidisciplinary Expert Panel | Incorporates diverse perspectives | 35 participants from 14 countries including donors, doctors, ethicists, lawyers 1 |
| Content Validity Index (CVI) | Statistical measure of consensus | Threshold set at ≥0.78 for both relevance and moral necessity 1 |
| Concrete Information Items (CIIs) | Break complex topics into evaluable units | 133 specific information elements across 13 categories 1 |
| Moral Necessity Assessment | Distinguishes helpful from essential information | Dichotomous (yes/no) scoring of mandatory disclosure 1 |
14 countries represented in the expert panel, ensuring global relevance of findings
Distinction between relevance and moral necessity creates ethical guidelines for consent
Direct inclusion of egg donors ensures the patient perspective is central to guidelines
The international Delphi study on egg donor informed consent represents a significant step forward in protecting women's health and autonomy in reproductive medicine. By establishing clear, evidence-based guidelines for what information truly matters, the research provides fertility clinics with a practical standard for ethical practice and gives prospective donors the assurance that they will be fully prepared for their donation journey 1 4 .
"Perhaps the most encouraging outcome is the demonstration that global consensus is achievable even in ethically complex fields. By harmonizing the insights of medical professionals, egg donors, and ethical experts, the study creates a more comprehensive understanding of informed consent—one that respects both medical realities and human experiences."
As these guidelines are implemented worldwide, the future of egg donation looks increasingly transparent, ethical, and donor-centered. Every potential donor will better understand what to expect—from the practical details of injections and procedures to her fundamental right to change her mind. In the delicate intersection of medical innovation and human generosity, such clarity isn't just helpful—it's essential.