My name is
Elena Ghanaim, I'm a policy analyst here at NHGRI
and I'm focused on
issues around and the appropriate ways to do genomic data sharing.
My name is Julie Sapp.
I'm a genetic counselor, also with NHGRI and I am part of lots of different
research protocols, all involving a human volunteer participants.
So, Julie, let's get started with a pretty foundational or basic question.
What is informed consent?
So informed consent is a process where a volunteer participant
and a researcher talk about the goals of a research study
and what being in the study might mean for the prospective volunteer.
It's an opportunity for a research scientist to explain
why they're doing this research
and why it's important and why we need people to be in the study
and to ask the volunteer to make a decision
about whether or not being in a research study is is right for them
and for the prospective volunteer to ask questions to make sure
that they are getting the information they need to to make that decision.
I think part of what's important here is that being in a research
study is different from getting clinical care in the sense that, you know,
the purpose of research is to
come up with or generate
generalizable knowledge that we hope will benefit everyone.
But in clinical care, when you're talking with the doctor
or thinking about undergoing a medical procedure, for example,
you know, the goal is really to make you as an individual better
or to do something that will benefit you.
And that's one key way where research is different than clinical care.
So informed consent is a really important part of that process.
And as I'm sure you're very well aware, Elena,
that's the whole idea of getting informed
consent from prospective research participants
is is kind of new, and it certainly hasn't always been the case that that we've
thought about this,
this carefully and tried to secure that kind of permission, right?
Right.
It might surprise people to know that these regulations
and expectations of researchers are relatively new.
I think as a society, we started to learn about studies
where people didn't know that they weren't patients or people were treated
in ways that today we would deem definitely unethical because there wasn't
sort of an infrastructure around how
we did research in an ethical way where we're obtaining
permission from prospective participants.
And so there are a number of, you know, sort of historical documents
from recent times that have laid a framework for many of the regulations
that exist in the US today and policies for obtaining
informed consent from prospective participants.
Yeah. And again, I totally agree with you.
I think a lot of people might find that really surprising
and it's really
great that I think now that we're in an era and a situation
where we have all of these different supports to ensure that the research
that we conducted is done again in an ethical way, exactly like you said.
Right.
So part of that support for ethical research
is the institutional review board, and they do play a role in
the informed consent process and form.
So can you talk a little bit about what they do, how they're constructed and
what they serve?
Yeah, absolutely.
So the Institutional Review Board, or IRB, is a group of people
that review research proposals before the research starts
and on an ongoing basis to make sure that the research
that includes human volunteer participants is in line with these regulations
and standards that you mentioned earlier, essentially
that the research has been being conducted in an ethical way.
And I think one thing that's really important to note about IRBs,
about these groups of people, is that they include both scientists
and non-scientists.
So there's always representation on these committees,
these groups of people
from people who are not scientists that are members of the community.
And so in addition to
kind of reviewing research before it starts and on an ongoing basis,
one of the things that they pay careful attention to is
both the informed consent document, so what it says about the research,
and also the process by which the researcher plans to obtain
informed consent from their perspective, research participants
to be sure that both of those things are understandable
and that they cover important points like the potential risks
and benefits of being in the study and also ongoing
and future use of participants data and information.
What do you think are some of the ongoing challenges
for obtaining informed consent today?
Yeah, it's a great question, and, you know, I think a lot of people really
think of informed consent as, you know, a document that two people sign
after they read it.
And that's really only part of it, you know, informed consent
I really think of again as this ongoing process where researchers explain
really key elements of the research study
and what it could mean for participants both now and in the future.
And where research participants are engaged and ask questions
and carefully consider if being in the study is the right decision for them.
And so making both that document and the conversation
clear and accessible and convenient for everybody,
for both the research scientist and for the participant is tough.
And I think another ongoing challenge that we're meeting is this idea of
that research studies now maybe involve more than, you know,
just trying a new drug or something like that right in the era of genomics.
We can generate all kinds of data sets and very big data sets.
And how we handle that data, I think, is certainly an ongoing challenge.
And I'm sure you have some thoughts about that.
People can kind of think of data as more so a forever thing, but
many researchers can can utilize in their work.
And so explaining the nuances of that to research participants can be,
I think, a bit of a challenge, especially as genomics
is one part of the study and there are other aspects to it.
So I totally agree that that's a challenge that we're trying to
meet is being more clear about how the data will be
used, who will be used by in the future and those sorts of things.
Absolutely.
As someone who's a bit closer to the practice
of obtaining informed consent, what would you say it looks like
for there to be a successful informed consent dialog with a participant?
I think that's a really, really great question.
You know, on the surface of it, I think that a successful informed
consent session looks like two people having a conversation
in a way that it's clearly understandable
and accessible to both people who are involved in the conversation.
So there's really an exchange of information
rather than the information flowing in just one direction,
like from the researcher to the prospective participant.
So that means doing things like actively inviting people to ask questions about,
you know, different parts of the study, checking in for understanding
to make sure that what you're saying is clear and understandable.
And I think also another thing that I think of
when I'm consenting participants is I'm kind of expecting at least
some people to just decline participation
at some point in the length of a study, right?
Because we know that being in a research study is not for everyone.
And we also know that some people may come into
the idea of being in a research study with a set of understanding
that's actually, you know, different from maybe what they might hear from
a researcher or read in the consent form.
And maybe the answer to one of those questions
that they've asked is something that will make them change their minds.
So I think successful informed consent does include
occasionally people declining participation
because it's just not right for them and they've gotten the information
and ask the questions
that they need to be able to make a decision from the beginning.
In your opinion, what do you think the future looks like for informed
consent?
In what ways do you think it might get better over time?
You know, I think I hope that
in the future, informed consent feels more like an ongoing conversation
than a form to sign, you know, both for participants and scientists.
I think that, you know, we need to continue to think creatively
about how we communicate with prospective research participants.
You know things like electronic portals and other ways that we can use
technology to connect researchers and participants is great.
On the other hand, I also hope that, you know,
communication or improving communication doesn't just mean more technology.
I really think we need to meet prospective research participants where they are
in really as many senses of the word as possible, you know, sharing information
about the research that we do and why we think it's important for people
to consider joining or research
studies in lots of different languages and in lots of different ways.
You know, just generally trying to lower barriers to participation,
I think, is something that I hope we continue to to
to think about in the future.
What do you think, Elena?
Yeah.
Harkening back to the issues or challenges with communicating about
the uses of genomic data, I do hope that
we will get better at being clear
about what people's data will be used for
and that participants feel empowered to
to change their preferences over time, potentially
given that it can be used for a very long time.
So I think that engaging participants on that issue as a group
and then individually would be really a great thing to see in the future.