Öznur Özkurt, Mathilde Leblond, Rebecca Middleton and Sandra Igwe: How has design research shaped the Generation Study?

The Generation Study is a research initiative aiming to explore
the use of whole genome sequencing in newborns, to screen for
more than 200 rare genetic conditions. This study will recruit
100,000 babies across England, and you can learn more about the
Generation Study via the study's official website.


Design research has played a vital role in shaping the Generation
Study. Parents, NHS staff, and the public have been involved from
the start, providing input through public dialogues and usability
testing to guide the development of the study.


In this episode, our guests discuss the use of design research in
the Generation Study, and the importance of designing a robust
and inclusive consent process, focusing on building trust and
engaging diverse communities. They also discuss how the design of
study materials such as posters, videos, and written content was
shaped by community feedback.


Our host, Öznur Özkurt, Director of design and research at
Genomics England is joined by Mathilde Leblond, Senior
Design Researcher at Genomics England, Rebecca Middleton, a
rare condition patient, and Chair of the recruitment working
group of the Generation Study and Sandra Igwe,
CEO/founder of The Motherhood Group.


 


"It’s not enough to just ask people afterwards. It’s also not
enough to engage just at the beginning and then stop listening
once we’re live, once it gets hairy and a bit difficult. So, we
are very excited to find out all the things that we hadn’t
considered before we launched, and just continue to learn."


 


You can hear more information about Generation Study in our
previous podcast episodes too:


Genomics 101 with David Bick - What is the Generation Study?

Which conditions will we look for initially in the Generation
Study? With Vivienne Parry and David Bick



You can download the transcript or read it below.


Öznur: Welcome to Behind the Genes. 


Sandra: Every community’s different and every patient is
different as well, and so that may require different focuses or
different formats, or different messages for different groups.
And so we like to have people with lived experience from the
community representing that, and also driving the uptake of
consent as well. But failing to engage diverse voices can lead to
perpetuating inequalities in access and uptake, so it’s really
important to have representation because the lack of it in
research can overlook communities’ specific concerns and
needs. 


Öznur: My name’s Öznur Özkurt and I’m the director of design and
research at Genomics England. On today’s episode, I’m joined by
Mathilde Leblonde, senior design researcher at Genomics England,
Rebecca Middleton, and Sandra Igwe, CEO and founder of the
Motherhood Group. Today we’ll be discussing how design research
was used in the Generation Study by involving participant and
users’ voices to address ethical considerations, implementation
and consent. If you enjoy today’s episode, we’d love your
support. Please like, share and rate us on wherever you listen to
your podcasts. 


So, before we dive into our questions, would our guests like to
briefly introduce yourselves to our listeners? Sandra, let’s
start with you. 


Sandra: Hi everyone, I’m Sandra Igwe and I’m the founder and
chief exec at the Motherhood Group. The Motherhood Group is a
social enterprise that supports black mothers, birthing people in
their pregnancy and beyond. 


Öznur: Great to have you on the podcast, Sandra. Rebecca? 


Rebecca: Hi everyone, I’m Rebecca, I’m a rare condition patient,
and I also have the pleasure of chairing the recruitment working
group of the Generation Study. 


Öznur: Fantastic, thank you, Rebecca. And over to you,
Mathilde. 


Mathilde: Hi, I’m Mathilde. I’m leading design research on the
Generation Study, and I have had the pleasure of working with
Sandra and Rebecca and many others, trying to shape the processes
and materials of recruitment and consent in the Generation
Study. 


Öznur: Fantastic, thank you. Mathilde, let’s start with our first
question. What is the Generation Study? 


Mathilde: Sure. So, whole genome sequencing is a technology
that’s improving. We’re finding new ways of using that, and
there’s interest globally to explore the use of this technology
to screen for rare genetic conditions in babies, so that we can
treat them earlier on, so they’re not having two different
departments trying to figure out what’s wrong with them. And
because we can look for hundreds of conditions with whole genome
sequencing, it’s really much more efficient, and we’re able to
look at these rare conditions, so it’s really exciting. There’s
still a lot of questions about implementing this operationally
within the NHS, and so the Generation Study is aiming to explore
this. We’re going to be aiming to recruit 100,000 babies across
England to take part in this, and they will be staying on the
Generation Study for 16 years, or until they withdraw, so that we
can see how their health develops, and really understand how
genes affect their health. 


Öznur: Thanks Mathilde. And if you’d like to learn more about the
Generation Study, you can listen to our previous Genomics 101
podcast called What is the Generation Study, and Which Conditions
Will We Look for Initially in the Generation Study. 


Mathilde, can you briefly outline for us what we mean by design
research? 


Mathilde: So, design research is a design and research
methodology, which involves users from scoping through iteration.
So, even back when we didn’t know this would be called the
Generation Study and we weren’t even sure of the boundaries of
that, we were involving parents, NHS staff and other users of the
service to try and understand what it might be. And later down
the line it went all the way through to iterations once we
started having materials and a better idea of what it could be
like (inaudible 0:04:18) with users outside of the company to
understand what their needs are, what would work well for them,
and how we can shape the whole service to do things better. 


Öznur: And how have we implemented design research in the
Generation Study? 


Mathilde: Yep, so we’ve also done a lot of engagement, which was
bringing public views in the form of public dialogues, so
understanding which conditions should be looked for, what
principles should be guiding that work, but also we’ve been
involving users in regular rounds of codesign and usability
testing to understand what works and what doesn’t work. It’s been
around 105 people now that have taken part, and it’s only going
to be growing. Involving users has been shown to improve the
implementation of interventions in the healthcare context, so we
really hope that this will help the Generation Study when it
launches. And regular rounds of codesign have had to be balanced
with ethics, operations, feasibility, but I’m proud to say that
user perspectives have been central to the decisions of the
programme throughout.  


Öznur: That’s fantastic to hear. I’m going to come to Rebecca and
ask, why is it important for us to be guided by the patients and
the participants? 


Rebecca: It’s absolutely central, and the public dialogue that
really underpinned this, which started in 2020, the messages from
that have really come through to the whole codesign process of
the project. The public consultation really told us that people
were genuinely keen about the project, but wanted to ensure that
they were part of the process, and that coproduction really began
from day one. This is a new world leading project. This has not
been done before, so we needed a whole new approach to how we
produced and how we designed this with patients and with parents,
and that’s exactly what we’ve done. And why we have done it is
because we know ultimately it leads to trust within the project,
within the research study, which is essential, as I say, ‘cos
this is a world first. But it also leads to better consent, a
better pathway through the study, a better results pathway as
well, and all the way through, ensuring that expectations are
managed, that there is transparency, and people are fully
informed and can make the right decision for themselves and for
their baby.


Öznur: Thank you. And would you like to add something,
Sandra? 


Sandra: Yeah, so I know from my community that we represent black
mothers and black ethnic minority patients and participants, and
we have very unique lived experiences that many research may not
be privy to or just do not understand. And so engaging with
patients from the community ensures that research is grounded in
real authentic community needs and priorities. And also involving
women like myself and those from my community, it can really help
to identify and overcome barriers to inclusion or getting mums
involved. I know I always hear, you know, “Sandra, black mothers
are so hard to reach, they don’t really get involved in
research.” Well, if you include those from the community to lead
in the research or support in engagement, you will have a lot
more uptake, and it leads to more accessible inclusive research,
which of course everyone really, really desires to have more
of.  


And then also participants from the community can flag issues and
suggest solutions that researchers may miss, because it’s not
knowledge, it’s experience. It’s, you know, having someone go
through the experiences without necessarily studying it, but
again lived experience to me, it’s more crucial than any other
experience that you could possibly have. 


Öznur: 100 percent, lived experience is really, really crucial
for us to make the services that we’re making really speak to the
actual context of our users. Thank you for that. And Rebecca, how
has this process been different to the 100,000 Genomes Project?
What was your experience?


Rebecca: I was consented onto the 100,000 Genomes Project back in
2015, and I can remember that experience very vividly, on a cold,
wet December afternoon, going off to meet my genetic counsellor,
and receiving the consent form for the 100,000 Genomes Project,
which was very much like War & Peace. Scratching my head at
the time, going, “Gosh, I’m going to have to (inaudible 0:08:54)
to go through this.” And then going home that evening and sitting
on the sofa, and, you know, considering myself an educated woman,
just realising I had so many questions. I really didn’t
understand it, and I needed somebody to help me unpack this, and
translate it. And I’m pleased to say that our consent process and
our recruitment process is very different to this, which is a
fantastic thing.


And what’s really key about the lessons that we have learnt from
the 100,000 Genomes Project is that, to really build trust in a
research programme and a new research programme, you need to
manage expectations, and that’s wrapped up in building trust
around the programme as well. And with the 100,000 Genomes
Programme, there have been challenges and issues around that
expectation management, and some expectations weren’t managed.
And even now nearly ten years on, we are still feeling the
effects of that, and patients and families are still feeling hurt
because of that. So, we have learnt from that and therefore we
have designed a process with patients and with parents. We know
that no two experiences are the same, that we have to ensure that
we remain flexible, and we have to ensure that we are addressing
any misconceptions, any misunderstandings.


Perception and reality have to be treated the same. We have to
understand how people are understanding genomics, because outside
of pockets, genomics is not a standard NHS piece of healthcare.
So, people come to this study with different assumptions, and we
have to learn to go beyond them. We have to understand what their
health literacy needs are, and how we can help manage that, how
we can help translate, so that nobody is stuck at home on a cold,
wet December evening, scratching their head, going, “Well, I
don’t know what this actually means.” We are ensuring that the
NHS professionals and everybody involved in the pathway is fully
aware of how to explain the project, explain the risks, explain
the benefits, and be fully transparent. And we know what the
risks and the benefits are that need to be addressed because
we’ve asked parents and patients as well.


So, we know the challenges and we’re trying to address them head
on, and that’s essential. It’s essential in building trust, and
that’s one of the key learnings from the 100,000 Genomes Project.
And it has been brilliant to be involved in this project and
really kind of learn from that past experience, but move forward
in such a unique and fresh way that really will have benefit to
those new parents.


Öznur: Thank you, Rebecca.


And we have been talking about the consent process in the context
of newborns, and we know that, while consent given for newborn
screening is really high in the UK, parents often leave this
conversation relatively uninformed. Sandra, can you tell us a
little bit about what you think the risks of not designing this
consent moment appropriately might be?


Sandra: I guess not designing appropriately can break down trust.
So, I think engaging in a variety of parents in this research and
design is crucial for trust. And that’s a topic that’s come up
many times in our community is that they believe that there is a
lack of trust between research practitioners and this wider
system as a whole, and the community of marginalised patients,
parents, mothers. So, I think it’s really important that
communities have this. But also researchers must make the effort
to meet parents where they are at, not just physically but also
conceptually, as well as emotionally. So, hosting conversations
in familiar, comfortable community spaces is essential. We had
our session in our hub, our community hub, and mothers were
really familiar with the space and with each other as well. And
so partnering with local grassroots organisations and leaders to
create inroads is so beneficial, and I can hand on say that when
you connect with the community, you’ve already done the first
step in building trust.


And consent conversations should be guided by what matters most
to each parent within each community, ‘cos every community’s
different and every patient is different as well, and so that may
require different focuses or different formats, or different
messengers for different groups. And so we like to have people
with lived experience from the community representing that, and
also driving the uptake of consent as well. But failing to engage
diverse voices can lead to perpetuating inequalities in access
and uptake, so it’s really important to have representation
because the lack of it in research can overlook communities’
specific concerns and needs.


Öznur: Absolutely, and that inclusion is really important for the
study. Is there anything you’d like to add, Mathilde?


Mathilde: Yes. When we talk about consent, oftentimes we think
about that one moment, the moment of conversation with a
clinician, and signing on the dotted line, and I think what we
have done here in the Generation Study is to consider recruitment
from the very first time that they hear about the Generation
Study all the way down to that moment. And it’s been really
important because, yes, the moment of consent - you know, during
pregnancy, you’ve got a lot of information coming in, a lot of
different priorities, so you may be a little bit all over the
place and not understand specific things, or not have the time to
really spend thinking and understanding jargon, etc. And that
presents a big risk because, when you may receive results, there
may be confusion. There may be a loss of trust if there’s media
coverage that talks about the Generation Study in a way different
from what you had understood it. So, these are some of the risks
that we’re trying to avoid. 


But the big risk is also, as Sandra has said, the risk of not
engaging a wide variety of parents, not just in the moment of
consent but the whole process. So, if we’re thinking about where
we’re using the word genomic and how are we using that, this is a
word that’s actually really scary for a lot of people. And we
might be very proud of the cutting edge technology that we’re
using, but actually it can sound very science-y and almost sci-fi
to people. So to us, the moment of consent is really from the
first time that you hear about the Generation Study, you start
creating a mental model about what that means, all the way down
to the consent moment, when the samples are taken, the results
and beyond. It’s really been looking at this whole journey
holistically.


Öznur: And that language point is a really interesting one. I
know that the study is obviously being communicated to the public
through posters, leaflets, websites, which speak to how the study
works, you know, the conditions we test for, and the benefits and
risks of joining. There’s a lot of language. There’s written
words in there, there’s audiovisual content, videos, images. How
did we inform what type of content is needed to communicate the
depth of the study?


Mathilde: I think the example of the introduction video is a
really good one, and I want to discuss this a bit with Sandra,
because actually it was quite a crucial turning point. We tested
the video several times in user research before and after the
Motherhood Group workshop, but the thoughts that her community
gave us really helped change the tone of this video from
something very professional to a conversation between parents
raising questions. I wonder, Sandra, if you remember what your
community’s feedback had been, and if you can talk a little bit
about that.


Sandra: Yes. So, the mothers from our community at the Motherhood
Group definitely gave lots and lots of feedback that the initial
posters didn’t really resonate with mothers from our community.
They said that the visuals and the language felt a little bit
generic and also too clinical, and it didn’t speak directly to
our community. They also expressed that seeing more black parents
and more black families represented signals for us too as well –
so, seeing people like look like us in the posters and the media
would have allowed a lot more uptake. So, narratives and videos
featuring real people that looked like members of our community,
they expressed that would go a lot further. And also it made them
feel a lot more relevant, and again it goes back to the notion of
having more trust and feeling less abstract, but more like an
authentic way of engaging or directly communicating with our
community.


They also appreciated the effort to be more upfront, but the risk
and also the downside, not just selling only the positives. You
know, members from our community were saying they wanted to know
the real deal. And also our community have been misled in the
past. You have to understand that. The history kind of shows that
there has been a breakdown in trust, and so transparency, they
shared, was really, really key to rebuilding that trust, as well
as materials that are culturally tailored and designed for
different formats for our community.


Mathilde: It’s really exciting how much this feedback has pushed
all of us in the team and the designers – pushed us to think
about how to talk about the Generation Study, what narratives to
use, what tone of voice, but also you’ll see on the posters
there’s space there to have photos of several different family
types and people of different backgrounds. It’s not just one
photo. And there’s also some very small tweaks, it seems like,
but it actually has a very big impact, about what it is that
you’re trying to say and what people understand in a split second
when they’re seeing that.


Öznur: Absolutely, and that open dialogue is definitely key to
keeping on bringing those perspectives in, and keeping updating
and moving the language of the study as well. Obviously, the
study will keep being shaped. I’m curious about how will design
research continue to shape the Generation Study going forward.


Mathilde: Yep, so we will have an iterative process, where we’re
still listening to the sides as they’re launching to hear what
are the questions that are being raised, what are some of the
challenges that they’re facing. At the same time, we have a
survey that parents will be able to fill in, and we have an
evaluation partner, UCL, who is doing an independent review of
how well all of this is landing, and evaluating the work that
we’ve been doing to see is it really hitting all of these points,
and what we may need to be iterating or changing as we learn.


Rebecca: I should also point out that the recruitment working
group is very much in the background, but we are still very much
alive, and we will come back to look at those first pieces of
feedback and to look at what the experiences have been, and how
we can learn and how we can help kind of shape what comes next.
Because it’s critically important that we have this always
learning philosophy. It’s critically important that now, you
know, the rocket has launched, how will it land, and we don’t
know until we’ve actually had that feedback. So, we can plan and
absolutely plan to the nth degree, but actually how it exists out
there in the real world, we won’t know until the project goes
live and that feedback comes through. And that’s what we’re also
really excited about is to actually learn those first lessons and
see how we can support going forward, and see what needs a tweak
here, a change there. And again, it’s that dialogue that started
with the public dialogue back in 2020, and here we are in 2024
and that dialogue will still continue, and we are still listening
and we are still learning.


Öznur: Thanks Rebecca. I’d like us to reflect on the importance
of continuous learning. What’s the importance of continuous
learning in this project? I’ll start with Sandra.


Sandra: Continuous learning to me and my community really means
listening to the voices that are often seldom heard. It means
trusting and placing trust in the community to be a part of or
lead or be involved in research, changes that affect our
community. It also means actively and proactively working to
rebuild that trust, because there’s been a lack of trust from the
community, and that means transparency. It also means honesty,
and it also means continuous involvement as well. There’s no
point in involving us at the end of a study for our feedback, but
at the very start to show that you are trying to be
authentic. 


Rebecca: Ultimately, genomics is the science of people. Genomics
is people, so we have to keep talking to the very people that we
are looking to try and support, help, care for, and ultimately
impact them and their families as well. So, I completely agree
with Sandra, continuous learning, it’s a continuous dialogue, and
understanding how our opinions differ, how our opinions may shape
and grow as the general conversation about genomics continues as
well in the public discourse. So, we have to understand and we
have to stay sort of on our feet, that this is a dynamic
conversation, therefore we need to change and we need to remain
flexible as well. And if we keep our ears open and if we keep our
minds open, then we will continue to build that trust, and we
will continue to ensure that we have a robust study that will
ultimately fulfil its research aims.


Öznur: Thank you. And Mathilde? 


Mathilde: I think there’s only so much that we could really cover
in theory before we launched, and now, you know, it’s going to go
out into the world, and there’s many things that we couldn’t have
predicted that will happen. We have that humility to understand
that. And what’s super important going forward is that we have a
team there to keep kind of staying on our toes, listening to
what’s happening, to make sure that we respond to that, so that,
as Sandra said, it’s not enough to just ask people afterwards.
It’s also not enough to engage just at the beginning and then
stop listening once we’re live, once it gets hairy and a bit
difficult. So, we are very excited to find out all the things
that we hadn’t considered before we launched, and just continue
to learn.


Oznur: We will wrap up there. Thank you to our guests, Rebecca
Middleton, Sandra Igwe and Mathilde Leblonde for joining me today
as we discussed the use of design research in the Generation
Study. If you’d like to hear more episodes like this, please
subscribe to Behind the Genes on your favourite podcast app. I’ve
been your host, Öznur Özkurt. This podcast was edited by Bill
Griffin at Ventoux Digital, and produced by Naimah Callachand.