Consent Through the Ages: Crafting Consent Materials that Work for Everyone

By Rhys Vaughan the Genomic Consent Manager at Wales Gene Park

One way or another, I’ve worked in genomic research consent for the better part of a decade. Still, when I was asked to write this piece as a so-called “expert”, imposter syndrome kicked in. Hello, my old friend.

My immediate response was to forget almost everything I knew about the subject and do what I’m sure (at least what I hope) many of us do in secret when asked to explain our area of expertise: Google it.

I searched:

“What is consent?”

The answer wasn’t quite as straightforward as I’d expected.

Consent is one of those concepts that feels universally understood until we try to define it. According to the Oxford English Dictionary (yes, I’m employing that cliché), the earliest recorded use of the word appears in the thirteenth-century Ancrene Wisse, a guide for noble women living in isolation to dedicate themselves to God. The term, written as consence, referred to a deliberate willingness to engage in sin. Over time, however, the meaning expanded and became embedded within law, politics and healthcare.

Screenshot from : Cambridge, Corpus Christi College, MS 402: Ancrene Wisse – Parker Library On the Web – Spotlight Exhibits

In politics, thinkers such as John Locke argued that governments derive legitimacy from the consent of the governed. No King or Government has an innate right to rule – power requires permission. In law, consent became central to contracts, property arrangements and other formal agreements like marriage. Healthcare took longer to embrace the same principle. For much of medical history, patient choice was often secondary to professional judgement. Doctors were expected to act in patients’ best interests, even if that meant withholding information from them. In the early nineteenth century, Thomas Percival’s Medical Ethics argued that a physician’s duty of beneficence could, in some circumstances, justify omission or even deception if it led to better outcomes.

The shift towards modern informed consent was gradual. In 1914, in a famous legal case, Schloendorff v. Society of New York Hospital, a judge penned the following:

“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault…”

One of the most significant developments followed the Second World War with the Nuremberg Code, which declared that the voluntary consent of research participants is “absolutely essential”. Later documents, including the Declaration of Helsinki, reinforced these principles and helped establish informed consent as a cornerstone of ethical research.

Today, consent is understood as an ethical and legal necessity not just a professional courtesy. It is a voluntary, informed and ongoing process. Participants can ask questions, make decisions based on information that is meaningful to them and withdraw consent. Yet as research becomes increasingly complex and data-driven, new questions emerge.

What does it mean to be informed about research that has not yet been designed? How do people consent to future uses of their data? And how do we explain these complexities in ways that people genuinely understand?

These are the questions that sit at the heart of my role as Genomic Consent Manager for a new Welsh genomics databank – The All Wales Genomic Databank.

The challenge is no longer simply obtaining consent. It is creating consent materials that support genuinely informed participation in an increasingly complex research landscape.

Crafting Materials That People Can Actually Use

If consent were merely about providing information, our jobs would be remarkably easy.

We could produce a Tolkien-sized participant information sheet, include every conceivable detail about governance, ethics, data protection and risk, and declare participants fully informed.

Unsurprisingly, this is not the approach recommended by organisations such as the Health Research Authority or Health and Care Research Wales. Participant Information Sheets aren’t, and should not be, designed just to satisfy regulations. They exist to support understanding and perhaps are the most important resource in doing so, given that patients can take them away, reread them, share them with trusted family members.

For that reason, one skill sits at the centre of effective consent practice:

Communicating Complexity … Simply

The HRA encourages the use of clear, accessible language (and in Wales this would include recognising language preferences) and employing a patient-centred approach to design. This means avoiding unnecessary jargon, explaining technical terminology when it can’t be avoided, and presenting information that participants actually want to know. In other words, researchers need to communicate without relying on the language they use every day.

I often use a simple test when reviewing materials:

“Would my mum understand this?”

If the answer is no, the document probably needs more work.

The challenge is particularly evident in genomics. Terms such as whole genome sequencing, data linkage and pseudonymisation may be familiar to researchers but completely new to potential participants. Definitions alone are rarely enough. People want context.

“What does this mean for me?”

“Who will see my data?”

“What are the potential benefits?”

“What are the risks?”

Different participants also want different levels of detail. Some prefer a high-level overview. Others want to understand governance structures, access controls and regulatory oversight in considerable depth.

A good consent process accommodates both.

This is why participant information sheets should form only one component of the process. Layered information, opportunities for discussion with trained staff and accessible supplementary resources can all help people engage at the level that feels right for them.

The Challenge of Broad Consent

Genomic databanks and biobanks introduce an additional challenge.

Participants are often being asked to contribute samples and data that may be used in future research projects years, or even decades, after collection.

Many of those projects may not yet exist when consent is obtained.

This is where broad consent models become important.

Rather than attempting the impossible task of describing every future study, broad consent allows participants to agree to a framework within which future research may take place. That framework includes governance arrangements, data access controls, oversight processes and measures to protect participants’ interests.

Yet broad consent raises a perfectly reasonable question:

If we cannot describe every future research project, what exactly are participants consenting to?

In many respects, it is the framework itself they are consenting to. The systems and processes that will decide whether future research is allowed.

We cannot predict every future research project, but we can explain who will make decisions about future use, what rules they will follow, who can access the data, what safeguards are in place and what choices remain with the participant. Broad consent, therefore, is not only about understanding future possibilities. It is also about trust in the governance framework that will guide future decisions.

The challenge for researchers is not simply explaining today’s study. It is explaining how decisions about participants’ data and samples will continue to be made long after the consent form has been signed.

At this point in my writing, I imagine my Information Governance Lead Liz, raising an interesting (at least she thinks so) point. It’s important to distinguish research consent from data protection consent. Agreeing to participate in research does not automatically mean that consent forms the legal basis for use of a person’s data. For instance, for our databank, patient consent is at the heart of our work and we do not use anyone’s data without it, but the legal basis is public task, not consent. Perhaps I’ll ask her to write a blog post on that idea, it’s not for further exploration here, but I felt remiss not acknowledging that.

Consent in a Digital World

Increasingly, these conversations are supported by digital tools.

For decades, the consent process was largely synonymous with participant information sheets and paper forms. Today, videos, animations, participant portals and electronic consent systems provide additional ways to communicate information and revisit it over time.

This can be particularly valuable in genomic research where it may be easier to explain concepts such as genome sequencing or data linkage visually than through several paragraphs of text. Genomics England did this to great effect with their Data in the 100,000 Genomes Project (available on YouTube).

Having said that, digital does not automatically mean more accessible. A video might help one person but act as a barrier to another. Indeed, the best digital research portal in the world is no good to someone without digital access or confidence.

Some researchers have also explored dynamic consent models, where participants can revisit and adjust aspects of their consent preferences through digital platforms over time. Whether these approaches become widespread remains to be seen, but they illustrate how consent continues to evolve alongside technology.

We are yet to employ digital consent materials in our genomic databank but it’s an ambition for the near future. The objective will not be to replace good communication with technology, but to use technology to support us in better communication.

Across the Ages

Of course, the title of this article can be interpreted in another way.

“Across the ages” refers not only to the history of consent, but also to the people we are inviting to participate in research.

The information that works for a child will not work equally well for someone in their eighties. Language, visual design, reading level, accessibility requirements and communication preferences all influence understanding.

Capacity also varies within age groups. Importantly, a person who cannot provide legal consent should not automatically be excluded from the process. Wherever possible, researchers should still seek to facilitate understanding and involve individuals in decisions about participation through appropriate materials and assent/consultee processes.

Researchers aren’t necessarily best placed to judge what constitutes a clear explanation of their own work. After all, we may have spent years immersed in a topic. What feels obvious to us may be entirely unfamiliar to someone encountering it for the first time. This is one reason Patient and Public Involvement and Engagement is so important. Good consent materials should not simply be written for the public. They should be developed with the public.

In my own work, some of the most valuable feedback has come from members of the Genomics Partnership Wales Sounding Board. They have challenged terminology I thought was obvious, identified questions I had never considered and occasionally demonstrated that something I believed was perfectly clear was anything but. While this can be humbling, it is also precisely the point.

If people struggle to understand our consent materials, the solution is not for them to become researchers.

The solution is for us to become better communicators.

Trust, Not Just Information

Ultimately, consent materials are not merely information resources. They are trust-building resources. For many participants, deciding whether to take part in genomic research depends not only on understanding the science but also on confidence in the people and organisations involved. Good consent materials should explain what researchers hope to do, how decisions will be made and why participants can trust those processes.

As I mentioned earlier, writing this article began with a simple Google search:

“What is consent?”

Somehow that led to me flicking through texts written in Middle English and beginning my writing with some history revision. Odd? Perhaps. Useful? I think so. If the history teaches us any lesson, it’s this: Consent is not a static concept. It evolves. Every new generation refines the process. We assume that how we are doing it now is the right way.

The gold standard. However, if, in the year 3000, your great-great-great-granddaughter is a researcher in genomics, I suspect many of our current practices will seem as antiquated to her as nineteenth-century medical paternalism seems to us. That’s probably a good thing. Consent has never stood still. It has always evolved alongside society, science, and public expectations. Her responsibility, as it is ours, will not be to preserve today’s consent models unchanged, but to ensure that consent reflects the technologies, risks, relationships and expectations of her own time.