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always had cystic fibrosis), their trust in
the researchers, and that they wanted to
help make a difference.
Most of them said they had made a
decision to participate based on a baseline
‘yes’. They went in and said, “I want to
help, unless there’s some reason about
the research, or a particular preference
that I have, that makes me not want to
do it.” They said that they didn’t really
come in to assess [the research] based on
the information, but they were ready to
participate and just wanted to hear a bit
more about it.
When I reviewed the article – I was a
blind reviewer – my comment was, “It’s
great that it’s based on interviews with
children, but why would you limit this to
the way children make decisions, because
it suggests we all make decisions this way?”
Does this issue give any credence to the
idea that we should change how we apply
ethics to research?
It suggests that the approach we take to
informed consent, to making sure people
receive information is important, but not
quite enough. When people are making
decisions, they’re often thinking about
things like, “What are the effects of this
on my family? Will I get information from
this that will help me make other kinds of
decisions? Will I get a chance to be seen
more regularly by a health professional
for my condition?” We don’t get them to
talk about that. We’re busy trying to inform
them about the research.
We need to talk to people about, “What
would you hope to accomplish in your life
by participating in this research? Why do
you want to do it? Can we make sure that
you’ve got realistic expectations?”
We have to do more than just tell
them about the research. We have to
try to develop a relationship with them
and understand their reasons for getting
involved.
What are the consequences of not getting
that full sense of their informed consent?
Over the last 40 or 50 years, we keep
focusing institutional resources on
informed consent, and trying to get
it better and do it more. Some of the
forms are ending up in excess of 10 or
20 pages, because they’re busy trying
to give people information. Somehow,
institutions, ethics committees and
researchers seem to take some comfort
in the idea that informed consent is
better all the time. The worry is, that’s
misplaced, and in fact the forms do very
little. They might be important because
of transparency, but we’re failing to get
people to participate in research based
on a relationship and their desire to
participate for personal reasons.
Would it, in any way, potentially skew
research results?
There’s always a worry that people who
agree to participate in research have a
self-selection bias, but this isn’t a way that
would address that. The way we currently
think of informed consent presumes a
trust that people bring into the setting,
rather than the notion that we must earn it.
So, we could find that if we don’t properly
treat them, they’ll lose the trust they had
in the system, and that no amount of
informed consent is going to help us.
For example, in the UK, the National
Health Service sent pamphlets around to
all NHS England patients and households,
and said, “We’re now going to start to use
your data for research, anonymised, and
in aggregate. Researchers can apply to
get access to this in research involving
commercial companies.”
The public and family physicians said,
“No way.”
What the NHS was proposing was
entirely reasonable within law and ethics,
but they did it in a way that excluded
people and failed to explain their potential
concerns. They just said, “This is what we’re
going to do,” and so they lost trust.
What they wanted to do was very
reasonable, but they’re having to work very
hard at regaining public trust, because they
violated it, because they didn’t understand
people’s concerns.
Is there currently a lack of research
participants, or is this just an issue that
could arise in the future?
There certainly are places where we have
difficulty tracking research participants
into the research, but that’s not typically
because of the informed consent.
Actually, people probably anticipate that
informed consent will prevent them from
participating when they otherwise would
have, because they’ll understand the risks.
Also, it’s probably not true that the
consent form discourages participation,
because people come in ready to trust
anyway. This isn’t an issue about attracting
people to research or bias in research. This
is really an issue about how we respectfully
involve people in research.
Is there anything I haven’t asked about that
you think is important?
Often, we’re trying to give people
information and involve them in research,
and we take some comfort that they’ve
understood it, and they’ve agreed to it, but
in many cases they actually haven’t and
they’re trusting us. That trust is based on
some assumptions, and we haven’t actually
earned it. There’s a difference between
being trusted and being trustworthy. Most
of the time, like when we sign online
agreements and licences for downloading
an app, we’re trusting something. We
know we probably shouldn’t trust it. Yet
we somehow think that if it is really bad,
the regulators would have stopped it. We
go ahead and sign, because we want to
get involved.
In some ways, with research,
particularly with more and more consents
going online, we are getting people
to trust us when we haven’t actually
established that there are reasons for
them to find us trustworthy.
One thing we can do is be more
transparent. The informed consent is part
of that, but I also think the movement
to have more patients and participants
involved in how we do research in
research ethics is very important to
encourage people to know that the things
they trust are actually trustworthy.
Finally, is there anything particular to
Australia that you’ll be speaking about?
I start by citing the Australian regulations,
and I put them in the context of the
international movement towards consent
and then focus on individual autonomy
instead of these other issues that I’m
emphasising. I think Australia is faced with
the same challenge: that our institutional
resources are limited, and the focus
tends to be on things that we could easily
bureaucratise, instead of on relationships
with research participants.
For all of this, it falls back to: How
do we get researchers and people who
are involved in research to invest in
understanding what it is to ethically involve
participants, rather than depending on
research ethics committees to do it?
That’s not unique to Australia. That’s a
global problem. ■
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