So to start with it as a basic idea.
Consent is something that's very familiar
to all of us.
It's a moral and legal protection
from unauthorized invasions of one's body
or one's property.
And it has a very strong facilitative
moral power.
In other words,
it makes things permissible that otherwise would not be
permissible.
So, for example,
I could borrow your car.
I can agree to have sex with you.
I can have my blood drawn.
If I give consent, all of those things
without my consent
would be robbery, rape,
and bodily assault.
And it's a very well entrenched concept
in our society and in many societies around the
world.
In, in our values, in our jurisprudence
and in health care.
So it's a very common concept.
Now, interestingly, in health care,
in both medical care and in research,
we don't just talk about consent.
We talk about informed consent.
And that just means basically that the
the authorization, the consent
that we give is based on understanding,
what the activity entails.
So you might wish that that was true for all consent.
And maybe it is true for most kinds of consent.
But in the health care we don't talk about consent.
We talk about informed consent.
And so and you probably know it is a legal, regulatory and
ethical
requirement in most health care and in most research with human
subjects.
It's also and you've heard this, I'm sure, before, a process.
It's a process of reasoned decision
making.
It is not a form.
It is not a single episode
in the trajectory of delivery of health care or
research.
And in a very classic textbook that Ruth Fagan and Tom Beecham
wrote,
more than 30 years ago now, they describe it, it is called
The Fear.
The book is called The History and Theory of Informed Consent.
They describe informed consent as autonomous authorization.
So that's an important concept to sort of keep in mind
ethically.
The idea of informed consent is based on a notion of respect
for autonomy, for people's capacity
and right to define their own goals
and make choices consistent with those goals.
And in a lot of the literature, this second quote is from the
Belmont
Report.
This sort of idea is reiterated in one way or another,
but it is tied to informed consent
in the Belmont Report very explicitly.
So respect for persons requires that
subjects, to the degree they're capable,
be given the opportunity to choose
what shall not happen to them.
And this happens through informed consent.
There is also a
sort of special importance to the ethical injunction
against
using people for the benefit of others
without their consent.
So sometimes you can do things with somebody for their consent.
I mean, for their benefit.
Excuse me without consent, but you're asking people to do
things
for the benefit of others, so you really need their consent
to do so.
And as we talked about last week,
informed consent,
although critically important for, for
ethical research, is only one
aspect of conducting ethical research.
And if you remember my eight principles,
it's like,
you know, seven out of eight in order.
It is required.
Excuse me.
By virtually all codes of research
ethics and regulations and laws.
Although there are some exceptions
and there are some limited exceptions,
and that includes the US federal regulations, the
excepted
Helsinki science, and most
national, state and institutional requirements.
Talk about informed consent in research.
It's interesting
to look at the language of the US
federal regulations,
because it helps us understand certain things about what
the expectation and requirements are.
So this basically says you can enroll
somebody's research unless you've obtained
their legally valid or legally effective,
excuse me, informed consent.
And that that has to be prospective
and it has to be documented.
So those are important things.
This is a statement from an FDA guidance
that came out a few years ago, or I guess just last year.
It was revised last year.
That's what it was.
And I like it because it gives you
the sort of full flavor of what's involved in this
process.
So it's providing a prospective subject
or their legally authorized representative
with adequate information so that they can make a
decision,
facilitating their understanding,
giving them an opportunity to ask questions and to consider
whether to participate, obtaining their voluntary
agreement,
and then continuing to provide information
as as indicated there.
As things change one way or the other.
Sorry, I don't know why my voice is
doing that.
So if you take this paragraph,
it it boils down to into the three things
in the middle and that is information
disclosure, comprehension or understanding and voluntary
decision.
Now, I put two other things on this list
because there are critically important
to thinking about how we think about informed
consent.
One is we have to be sure that the persons
that we're talking to have the capacity
to give consent.
And you're going to hear from Scott
right after me.
So I'm not going to talk about that
at all.
And then, as you saw in the regulatory
language, there needs to be documentation.
So there needs to be some authorization of consent.
Usually it's a written signature.
There's a lot of debate about that. And there's a lot of,
other options.
But that's it's it's an important thing that needs to
be.
There needs to be some documentation.
So I'm going to talk about the three
in the middle.
First starting with information disclosure.
There's an interesting challenge.
And that is trying to decide what information should be
disclosed.
What is important what's adequate
for the person to make a decision?
What's understandable, what's relevant
to them, what's accessible to them.
And this is an interestingly difficult
challenge
in the context of research, which is often quite complex.
And then there's the second part of disclosure.
And that is how should that information
be presented?
Oftentimes we see written consent documents as one way of
presenting
information, almost always accompanied
by somebody talking to the participant.
Sometimes other kinds of information or
educational materials, videos, whatever.
It could be one on one.
It could be groups, it could be all kinds of things.
And those all matter in terms of,
how information is disclosed and how a person might receive
it.
The regulatory
language, again goes like go back to that
for for two reasons.
One is it says it should be in language
understandable to the subject or the law.
And how do you figure that out?
Well, you have to figure out
what a reasonable person that's that's like the people
that you're
inviting to participate in research
might want to know and might,
be able to understand and how to present it in that
way.
The regulations also,
revised in 2018,
added an additional requirements for informed consent
that consent forms, for example, have to begin with a concise
and focused presentation of the key
information
organized in a way that people can comprehend or that
facilitates
comprehension, but insufficient detail
so that you know, they get the whole list.
I mean, it's not just a list of facts,
it's a it's a detailed list of facts.
So this is an interesting sort of a little
bit of a conflictual challenge here.
You know, you want concise information,
but you want an insufficient detail.
And there's plenty of recognition
in this came out of a new guidance
that was just published by the World
Health Organization just recently.
That basically
says, and a lot of people, agree with this, it's essential
that potential recruited participants
are appropriately informed.
But presenting exhaustive
or excessive detail can work against a subjective
by overwhelming, confusing, or disconcerting participants.
And so that's the sort of challenge
in terms of disclosure.
So how are we doing?
Well, there's been a lot of research
that's looked into how we do
one research informed consent.
And I just put some references here.
But basically the overall conclusion of the
data
that has been collected about these, about
consent is that, in consent forms,
the reading level is really high and higher
than what people
believe is the average
reading level of the US population,
and higher
than eighth grade, which is what a lot of the guidance
recommends.
We write it at that level.
So the reading level is high, consent
forms are long
and they've actually increased in length over time.
So if you look at, you know, consent forms from 35
years ago,
they might be five, six pages.
Now they're 25 or sometimes higher pages.
So they're quite long and, and take a while to read and sort of
absorb.
And then there've been a few studies
that have looked at okay, given
that they're long and complex,
do they have everything in there that they're supposed to have?
And the answer is no.
They sometimes are missing information
that is believed to be relevant or even required by the
regulations.
So we're not doing so great on the consent
forms.
There's also really interesting and unanswered questions about
the effect
of how information is disclosed
on how people understand it or receive it.
Now, you might imagine the sort of,
you know, ideal is somebody sitting down
one on one with somebody having a conversation, giving
them
information, letting them ask questions
and, discussing it.
And that does happen.
It definitely happens, but it doesn't always happen.
So I love to tell a story that happened
to me years ago, on a consult.
It was a young man who had come,
from far away for a very,
complicated protocol that was going to treat his.
He had a kind of cancer, and the it would require him to be
hospitalized
for several weeks and receive infusions
of this novel, substance.
But the idea was it might spare his arm.
He had a tumor in his arm, and he was an artist.
And he was really, you know, he didn't care about anything
else,
really, except sparing his arm so he could continue to do his
art.
So the scenario was he was sitting in a room.
I was there with him.
There were three investigators who came in.
They all stood. He sat.
They gave him lots of information.
I mean, they bombarded him with information in a certain
way.
And in the middle of this conversation,
they they each had pagers on
the pagers would go off.
One would go out in the other room,
just answer the pager, come back and,
you know, in and out. So it was like
felt like
dumping information on this guy who was sitting down.
And then when they were finished,
they said, do you want to do it?
And, I remember
feeling like, whoa, you know,
too much information, too much aggressive information.
And he needs some time and some space to just kind of
sit
with it, ask questions, think about it, etc..
And that wasn't the plan, at least at that moment.
We did give him that opportunity.
But it also the reality of how
how information is presented is very critical.
And then the other thing is, of course,
we have people,
many people who are participating
in research who are in dire straits.
They're in distress, they're in pain.
They have headaches. They they're confused.
I mean, these are all realities of the clinical situations
in which we're often presenting information to people
and how hoping that they can then use it to make a decision.
So these are really critical.
Questions about who does it,
where, when and how the information is
disclosed.
Of course, in recent years, this was this came out of an
FDA,
guidance, I mean, a sorry Federal Register
guidance about eight years ago
that basically said informed
consent doesn't have to be on a piece of
paper.
It doesn't have to start with a piece of paper that you
then talk to somebody about it can be electronic.
It can be, you know, all kinds of electronic text,
graphics,
audio, video, podcasts, interactive sites, etc..
And so this is another way to disclose information.
And the question is, is this, you know,
how does this help people understand?
Does it help people understand better or not so much better?
So what are some of the challenges with disclosure?
I've already mentioned determining that
what is the relevant
information and context to disclose
in order to facilitate decision
making is is a challenge.
I mean, scientific information, research
information is sometimes
quite complicated.
The other thing is that written consent
forms or written consent documents
serve multiple purposes.
They not only are designed to help
somebody get information that they need,
but they also protect the institution
and protect the investigators.
So that's a really important thing
to keep in mind,
someone said, and it's attributed
to different people if you look it up.
But basically, easy reading is damn hard
writing.
I don't know if any of you have tried
to write something in one paragraph
that you really want to write in four pages.
It's hard, and it's hard to make it
understandable.
And then
ironically, I think, but maybe not
completely.
Unsurprisingly, institutions, sponsors,
investigators, and even IRBs often want more.
They want more information, more detailed information, and
therefore
consent forms actually get longer and more
complex
based on those inputs.
Okay.
The second, all right, information is
disclosed.
The second important part of informed consent is
understanding.
And we all know
that, you know, when you hear information,
even when you're listening,
there's only a sort of, little bit,
I guess is the right word.
And where am I?
Here we go.
That part in the middle.
Where, where are you really understanding?
So understanding is
important, but it can't be expected
that everything you're told
is something you understand.
So the questions that really plague the
sort of process of informed consent is,
what and how much should participants
understand in order to, to really give valid consent?
This is a question that people have
debated in the literature.
Joe Milam, who used to be in our group
with Danielle Brown,
which I've written a number of page papers
on this,
suggesting a fairly minimal understanding
that, is consistent with valid informed consent.
There's also a question about how should we,
how should we and how do we assess
whether people do understand.
So I've seen the full gamut of the example
that I gave you, you know, are you okay?
You want to do it without even.
Do you have any questions?
Sometimes people say, do you have any questions?
Sometimes in some studies, people,
investigators, research teams use quizzes.
They have written quizzes.
And people have to get a certain
percentage right in order to demonstrate understanding.
So there's a wide range of how we do it
is a question about how should we do it.
And then there's a question about what happens or what
should happen
when participants don't understand.
And then the question again goes back to the first one.
If they don't understand what they don't understand
anything,
they understand certain things, but not other things.
And, you know, should they be able to
participate or not?
And it doesn't depend on the study.
These are hard questions to answer.
Again, there's been a fair amount of research on informed
consent,
which is basically concluded overall
that research participants
have variable understanding of the studies
that they have consented to.
So they've consented there in the study,
somebody interviews them or surveys them,
to figure out what they've understood,
and they understand some things
and not other things. And that's basically the
all of the data suggests that that's
the case.
And the range is quite striking.
If you look at some of these down
here, research purpose and nature,
sometimes as low as 27% understand it,
sometimes 100% understand it of risks,
the same kind of range
of randomization and placebo use is often lower.
People understand that less well in general
than they do some of these other things.
But still there's there's quite a range.
There's also been a couple of meta
analyzes of,
informed consent studies to try to show
what people do or do not understand.
This is a busy slide, and I'm going
to show you another busy slide.
Two takeaways from this slide.
Nothing really approaches 100%.
That's one thing to notice.
And you can see that there are several things like
placebo
randomization and alternative treatments
that are, you know, closer to 50%.
So that's that's a little bit
disconcerting.
There's
this was a meta analysis that was published
in 2015, based on data that had been collected to that
to date.
There was a second one published just this year,
which used some of the same methodology.
And this is basically you can see the numbers there.
They're not much different than the other meta analyzes.
And what these authors concluded actually,
is that the results show that most participants
understood the fundamental components
of informed consent,
meaning study, nature, voluntariness,
and freedom to withdraw most.
That's a question mark.
But other things like placebo and the ability to name
at least one risk was much lower.
So what if sex
understanding what makes people understand
more or less.
And there's a lot of things, of course.
There's process related factors.
What they're told with what they're given
information about
has to affect what they understand,
as does how and by whom and how
well they listened or read that impacts how they
understand.
But there's a number of those factors
that have been shown in studies to,
influence
the understanding of research participants,
including some of these won't surprise you
at all age.
Older people understand less education.
Less and less educated people understand
less people in pain.
People who have cognitive impairment,
people who are under stress, those
those those factors are associated
with lower,
lower levels of understanding.
And then there's a really important
and a little bit
still unexplored aspect of
what impacts understanding research
participants.
And that is what I call expectations and familiarity.
So thinking about the motivations,
why do people enroll in research?
What do they think is going to happen
before they get any information?
Why do they do it that influences
what they're willing to listen to
and what they end up understanding?
There's also, of course, cultural views.
There are, therapeutic misconceptions,
which I'll talk about in a second,
and other related understandings.
Importantly, thinking about
both disclosure and understanding is helpful
to think about health literacy,
and health literacy.
This is U.S data,
and this comes from both the National Library of Medicine
and this other organization that I can't think of the name
of.
Anyway, they agreed on the numbers,
so I just put them both down there.
Basically, they say nearly nine out of ten
adults
struggle with health literacy,
and even people with otherwise good literacy skills, people
who can read and write and calculate,
they may have low health literacy.
And I find that really interesting.
And I suspect that you will know people like I do smart
people who are masters in their domain of the world,
who just don't understand much at all about health.
And it's quite interesting.
But this has to influence how people
understand the kinds of information
that we're providing to them in the context of making
decisions about,
research participation.
Dave Wendler, who you're going to hear
from in this course,
published a paper now, gosh, more than ten years
ago,
where he suggested that how much people understand
and how we assess understanding
should vary by the level of risk to the participant.
So I'm not sure
which one of these works better.
Can I I don't know how to use the arrow,
so I'm not going to do it.
That's okay.
I'll just say if you look at the
row that says understanding,
he will he recommended that if it's low risk,
you can just assume that people understand it
and that they're competent to understand it.
If it's moderate, or high risk with potential benefit,
you might do an informal or brief formal assessment of
how
how much they understand.
But the higher the risk.
Or if it's high risk with little or no potential benefit,
then you really need a higher threshold
of knowing that the person
understands the details of the study
that you're presenting to them.
I agree with that.
By the way.
So what happens if there is misunderstanding?
Well, first of all, there's there are
different kinds of misunderstanding.
And that's helpful to sort of think through.
So a lot of people focus on the therapeutic
misconception,
which is basically not recognizing
that research is different than regular clinical care.
And I'm going to give you a definition
of that in a minute.
But there are other kinds of misunderstandings.
So some people actually understand
that research is research,
but they miss estimate either
the level of benefit for the level of risk or both.
And that could be problematic if they think this is, you know,
100%
beneficial or and it's, you know, completely unknown
or the expectation is it'll be 5%
beneficial or, you know, whatever.
So understanding that kind of a misunderstanding is important
too.
And then there's been a whole bunch of
literature on the influence of optimism.
There are people who,
because of their expectations and their hopefulness, they say,
but I remember a guy years ago who said, okay, I get it, I get
it.
This is brand new. First in human.
I don't know if it's going to help me at all.
I don't know if it's going to work
in anybody, but I'm going to be the one.
And so that kind of optimism can be
certainly natural for certain people,
but it also can accompany misunderstanding of the details.
So sort of separating what's hope.
That's that's okay with hope.
That's unrealistic.
It's also in the literature
that has been a really important distinction,
which I think is helpful to know between knowledge of relevant
information,
which could be seen as understanding
and appreciation of how it applies.
So the classic example is a study
that led to the terminology of therapeutic misconception,
a group of people who have schizophrenia
who are joining
a placebo controlled trial of an
intervention, and
the interviews that were done with these individuals
after the consent process was finished,
they actually had a pretty good
understanding of the facts.
You know, this is a randomized trial.
Half the people are going to get,
you know, the experimental drug, half
are going to get placebo.
I forget the other facts, but they basically had
a pretty good understanding of the facts,
and they could recite them back.
And then they said, oh, but my doctor
is going to make sure that I get the drug.
So that's the difference between knowledge of facts or
to recite the facts and appreciation
of how those facts might apply to an
individual
themself.
And Paul Applebaum was the person who
coined the term therapeutic misconception.
And what he said in the early papers
was it's when a research participant fails
to recognize how individualized medical care
that is the physician's obligation
to make medical decisions in the patient's
best interests might be compromised
by research procedures,
because research often has a protocol
which dictates who gets what, how,
what doses they get, etc.
it's not decided by the individual physician
based on the individual person's needs.
And Appelbaum and colleagues go on to make the point in many
papers
that failure to to recognize these differences
and negates the ability to provide
meaningful, informed consent.
So this is a type of misunderstanding
that they claim makes it impossible to get
valid informed consent.
There has
also been a number of studies that have tried to look at
what could we do to improve understanding
in the context of informed consent.
And there were two, two, sort of,
surveys, systematic reviews, sorry,
that categorized the types of studies into these
groups.
And I think they're quite
telling even today, even though most of these are both old
studies.
So we need a new one.
But they compared studies that tested multimedia,
interventions to try to improve understanding with enhanced
consent forms meeting different styles
or shorter or whatever.
Extended discussion, test feedback,
and a bunch of other mixed and misleading
misleads.
What do you think works the best?
And the ideas?
I'm looking at the people in the room
I know you know,
and this extended discussion.
Shocking, right?
The more you talk to somebody about what's happening, the
better
they understand it.
And that although there were only
a few studies in that category,
there was clearly better understanding
from that than anything else.
And, you know, there are ways in which that
makes sense.
There's also resource questions that limit
how much time
we can spend talking to people.
So I mean, it's not a it's not like,
okay, now we know what to do.
Let's do it.
One of the interesting thing is that the,
both of these meta analyzes said
enhanced consent forms might work,
but we need a randomized trial.
So our group did a number of randomized studies
where we took we did three different versions
of it,
with healthy
volunteers in phase one drug studies with healthy
volunteers
and flu vaccine studies, and with
persons who have HIV in a multinational treatment
study.
And all together, you know, the healthy volunteer
studies
were about 100 or 130 people, and each one in the,
HIV study was about 4000 people.
We randomized them to get the standard consent form
or a shorter, simpler,
lower reading level consent form.
And the amazing thing is, it didn't make a difference.
They most people understood
certain things better than other things,
but the shorter forms
didn't help them to understand more,
which is quite interesting.
There's also been some studies that have been done more
recently.
Holly was involved with one of them
where they randomized people
to three different formats, and actually people exposed to
video
understood more and had more satisfaction.
There are other studies that similarly showed that even
though
and in some cases, even though video
kind of presentations and data
doesn't always improve,
understanding
as measured by the tests that measure them.
But it's some but it does improve satisfaction
and it does improve engagement with the information.
So now I think that's interesting to
and then people are looking at this,
you know, web based and interactive
kinds of methods
and how much they might,
increase understanding.
So I'll just say what we don't want to, but.
So the third pillar is voluntary choice.
So disclose information people understand
hopefully enough to be able to make an informed decision.
And then they have to make a voluntary choice.
And interestingly,
this one I think has gotten
the least amount of attention in the literature on informed
consent.
And I think it's really interesting
to think about what a voluntary choice
is, because we make choices every day.
We make choices,
hopefully voluntarily,
but they're based on our experiences,
our expectations, the kinds of things
that our network of supporters
push for.
I mean, there are a lot of things that
influence how we make decisions every day.
And yet I wouldn't call them not voluntary.
Right?
So thinking about how do you think about a
voluntary choice
within the context of research is not,
completely straightforward.
The, regular
regulatory language and the literature
suggests that there are three things
we have to avoid in order for a choice
to be voluntary.
There should be no deception,
there should be no coercion, and there should be no undue
influence.
And so understanding what those terms mean
is helpful to sort of thinking,
okay, well how do we make sure it's
voluntary.
So deception of course is concealing or
distorting the truth in order to in order to mislead.
And I mentioned Joe Milam and Danielle Brown, which they
talk about
in one of their papers, something called fraudulent
disclosure,
which is like withholding information or
sometimes just presenting it in a way that
is not factually incorrect, but is
misleading.
And that's that's deception.
Coercion is compelling.
Somebody to do something against their
will
by threatening them, threatening to make them worse
off.
And there certainly are examples of coercion in in
research.
But I think probably not that many
that we could probably identify
that interestingly.
So I find interesting one is this undue influence
which people define as an offer.
So it's not a threat.
It's not coercive.
It's an offer that distorts somebody's judgment
or entices them to do something that they actually
it's against their interests or they really don't want to do
it.
And this is tricky too, because if you think about,
you know, if you give somebody an incentive to do something
that's not necessarily an undue incentive, right?
If you get paid to come to work, you're not unduly being
influenced.
So there's a line between what an incentive
is
and what's okay as an incentive and what's excessive or
inappropriate or,
makes people do things against their own interests
or distorts their judgment.
What could influence voluntariness in research?
Well, certainly things like dependent position or power
relationship.
So if you're dependent position, meaning,
your boss asks you
to participate in a study or maybe even your doctor,
for somebody you feel subservient
to in some way, in a power relationship,
pressure.
And these are all overlap.
A little bit pressure from somebody can also influence
your voluntariness in terms of making a decision.
And that could be from a number of sources.
It could be from the research team, could also be from your
family.
It could be from your friends, it could be from,
you know, the fact that you have no money.
I mean, there are ways in which pressure
comes from lots of things.
Trust in the health care providers
is one that people worry about there.
But I know lots.
There are several studies that suggest that people
who make decisions about participating in research
make them based on my doctor told me to do it,
and without really paying attention
to what's being asked of them or what
the risks and benefits might entail.
And this is, there's again, a small amount
of literature on the dual role.
So a physician who is also part of a study
inviting their patients to be part of the study,
that sort of is a at least precariously,
influence on voluntariness.
Then there's some other things
that people worry about, but I think they're less
clearly,
direct influences on voluntariness.
So one of the ones that
I've been interested in over many years is restricted
choices.
Now, if you don't have a lot of alternatives for doing
something
and you decide, this is what I want to do,
does that make it
less voluntary than it would be if you had a whole bunch of
choices?
I don't think so.
But some people do that, you know, you
have to sort of put the context in there.
And the same way with illness, you know,
if you're sick, you may have less,
you may feel like you have less choices.
You may have less, interest in, making choices.
You may put more trust in your providers.
There could be lots of things that would influence your
ability to
make a voluntary choice,
in addition to
not confusion, but less clarity on the
concepts.
There's also it's less clear how you measure voluntariness.
So there's a couple of studies that I think are useful
for a couple things to think about that
are useful, that you can find in studies.
One is do people report feeling pressure from others?
And for the most part, people, the number of people who report
pressure
from others, including family members
and and doctors, is pretty low.
But in many studies, people report pressure from
the fact that they have a disease.
You know, they really feel like
they have to do something and that feels like pressure to
them.
There's a question about, do people know they can quit
or that it's a voluntary choice?
And again, the range is all over the place.
And then you could look at numbers
of who actually declines, who's offered
study, who's offered participation
and doesn't doesn't participate.
The Coleman
and Doug Watson are, well, again,
a few years back did an interesting,
paper in the Journal of Empirical Research
on Human Research Ethics,
where they talked about how to measure
voluntariness. And,
they basically said there's some indication of how
we can,
measure it, but we really don't have any
consensus
on how we understand whether something is voluntary
or not.
And then we have these data that I've showed you already.
And if you look at, for example, the two inside that circle,
voluntary nature of participation
and freedom to withdraw at any time,
you know, you might say, okay, 75%
more or less know that those are true,
but then these 25% don't.
And so the question is, is that good enough or should we be
doing better on that?
So informed consent is complex.
There's enduring challenges.
And it's affected by a number of different things.
Some of which I've mentioned. And you're going to hear about
more.
I just want to spend five minutes is all I have left
to talk about some of the changes.
So we've had certainly, lots of kinds of research
that have grown in recent years, like biobanks and data
repositories
and research with big data, pragmatic trials and
decentralized trials.
All of these pros,
I don't know if challenges is too strong of a word,
but you have to think carefully about how you get consent
in these contexts, which is different
than the sort of traditional sit down
with somebody in a clinic and to ask them to join a
clinical trial.
And of course, as I've already alluded to,
there are lots of ways to exchange
information and to get verification
and authorization of consent,
including electronic devices, apps, web interfaces, etc.
all of these,
are offer advantages in certain ways,
but also offer some challenges in certain ways.
Despite the way that consent is obtained,
whether it's on the old fashioned paper
sitting down with a participant in a room,
or it's through a decentralized trial
and there's an app and there's a remote interaction or
whatever,
there's still require you still have to think through
what's
the information we're going to be giving,
what's the disclosure elements?
How do we,
first decide how much people have
to understand in order to give consent?
And how do we assess whether they are understanding
and how do we know if it's voluntary
and some of these remote?
Methods of obtaining consent
offer convenience to people and opportunities
that they might not otherwise have,
but it also offers some challenges
in these domains
because you don't see the person,
you can't read their body language.
You have to identify their sorry, verify
their identity even.
I mean, there's different challenges
that come with how do you know that
something is voluntary when you can't even see the
person?
So that's the end
I messed up, I'll let you read this too.
That's.