UK regulation is obstructing donation of frozen eggs to research

Thousands of people in the UK freeze their eggs every year, according to figures from the Human Fertilisation and Embryology Authority. Research suggests that most will not return to use them.

People with surplus frozen eggs (SFEs) who no longer want to keep their eggs in storage have several options: discard them, donate them to someone else, or donate them to research. Despite a strong preference among those with SFEs to donate them to research, very few eggs ever make it there.

One reason for this may be the way consent is regulated for egg donation. Notably, the current system limits opportunities to donate SFEs to research. But are these safeguards warranted? Findings from our new research provide important insights into what the public thinks of consent models, and suggest that rethinking the approach to consent could address the issue of low donation rates.

Specific consent as a barrier to donation

Under current UK consent guidelines, people can only donate their eggs to research if they are given detailed information about the exact project the eggs will be used for. This is known as a specific consent model.

Informed consent is a key pillar of medical research and is grounded in several key ethical principles. It supports donor autonomy by allowing individuals to act on their preferences and make decisions that align with their values.

But in practice, requiring donors to be given full and detailed information about research projects limits opportunities to donate. Projects may not exist at the exact time when people want to remove their eggs from storage. Even if there is ongoing research involving eggs, projects often develop over time, and complete information about every stage may not yet be available.

Asking donors to keep their SFEs in storage until a suitable project arises is not a realistic option either. Would-be donors may have any number of personal reasons for no longer wishing to keep their SFEs – not least the ongoing financial costs of storage.

So, a consent process intended to protect donor autonomy may instead be undermining it.

What does the public think of broad consent?

Specific consent is not the only ethically defensible approach to informed consent. In other areas of medicine and research, broad consent is routinely used. Broad consent would allow donors to consent for their eggs to be used in research projects without needing detailed information about each specific study at the time of donation. This means their donation can be used in future studies, even if those studies don't yet exist at the time of consent. In effect, broad consent opens up far more opportunities to donate.

However, broad consent is novel in the context of SFE donation. We do not know what the public may think of such a model, nor has there been a consideration of the ethics of using it for SFE donation. Our research offers the first evidence-based discussion of public attitudes towards consent in this context.

We surveyed 225 members of the UK public. We asked them to consider a scenario involving 'Jane', a woman with SFEs who wanted to donate them to research. We varied the level of information Jane received and whether her preference to donate was fulfilled, to see the impact of these factors on participants' views on consent.

We found that most participants agreed that a broad consent model allowed for meaningful informed consent. On a scale of 1 (strongly disagree) to 7 (strongly agree), participants rated Jane's ability to give valid, informed consent at 5.79.

But what mattered most to our participants was whether Jane could act on her preference to donate her eggs to research.

When Jane was able to donate, our participants agreed she was making an autonomous decision (average agreement score of 5.46 out of 7). When Jane couldn't donate, agreement dropped noticeably to 3.96. In other words, participants only agreed that Jane could make an autonomous consent decision if her preference to donate her eggs to research was fulfilled.

Taken together, our findings suggest that the public sees broad consent as an ethical approach to SFE donation. It preserves meaningful informed consent while enabling more people to act on their preference to donate.

Could broad consent be a workable solution?

Critics of broad consent worry that consenting to unknown future research risks undermining informed decision-making or exposing donors to uses of their biomaterials they may not approve of. There are strategies that mitigate such concerns.

Broad consent does not eliminate ethical research practice. Research using donated eggs would still need approval from ethics committees and would need to meet established ethical and scientific standards.

There are also additional safeguards that could be built into a future broad consent model.
Donors could be given the option to opt out of certain categories of research they find objectionable. Consent could also be managed through an online dynamic consent platform to enable ongoing communication and the accommodation of evolving donor expectations over time.

Conclusion

As egg freezing becomes more common, more people will face decisions about what to do with SFEs.

Consent regulations must evolve to support the populations they have been put in place to support. If people with SFEs want to donate them to research, regulations should, where ethically and legally appropriate, make that possible – not prevent it.

Revising consent regulations to allow for broad consent would not only better support donor preferences but would also overcome barriers to donation, increase the availability of eggs for research, and address rising storage concerns.

Importantly, these challenges are not unique to eggs: people with surplus embryos face similar regulatory constraints, suggesting the need for a broader discussion about how we regulate the donation of reproductive materials to research (see BioNews 1219).

Consent processes are put in place to protect people who are making decisions. But, in this case, in trying to protect donors' choices, we may instead be unnecessarily limiting them.