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As a reminder,

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write consent is a process, not
a form.

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I'm going to talk a lot about
the form

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as I move forward,

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but I just want to reiterate
that,

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you know, informed consent
process

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is the only one way to,

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convey respect to the person,
potential participants.

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You need to,
you know, make sure that you

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respect them

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and in all sorts of ways, even
after

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you've gotten their informed
consent.

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So I'm going to talk a little
about best practices,

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about the form
and then promoting

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understanding.

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So style and again
I'm not going to read all of

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these to you.

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And some of these should be I
would

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imagine pretty straightforward
right.

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If you imagine, you know,
the last time I read a book by

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Faulkner,

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it was really hard to read
because it was

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basically one long sentence.

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Very complicated words, very
complicated

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text.

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Right.

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You're looking for something
that has short sentences, short

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words,

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and importantly, like states

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one main idea clearly in each
paragraph.

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And you know, you'll be
maybe not surprised to learn

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that putting space
between paragraphs is really

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helpful.

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When someone is given a form
that is 25 pages long.

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Yes, adding
some space may make it longer,

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but

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it's a it's a message to the
individual

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that it's.

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Here is one idea.

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So, you
know, present a clear sequence

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of events.

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I was reviewing a protocol.

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We had a consult, the other day
where,

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individual clinician is
concerned

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about the ability

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of the participant
to read consent to a protocol.

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There was a change in the
protocol.

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That means that the consent form
changed

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in this case,

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and everybody has to be re re
consented.

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The one of the ways that they
organize

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their data was
they had this really lovely

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table

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and there was a little icon or
an emoji,

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I guess.

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And these days.

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And that was like a blood draw.

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So they had a picture of a
needle

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and talked about the blood draw.

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And then they had a picture of
there was a

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in some cases
they may take a biopsy of the

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liver.

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So there was a little picture of
a liver,

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only to say, like you don't,
you can use things other than

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words.

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Images, photographs, all sorts
of things

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under the heading
of making it as clear as

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possible,

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what the person is getting
themselves

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into avoiding legal jargon.

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Write it in a conversational
style

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and after voice.

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Be consistent.

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This is often something that, I
encounter

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when folks are just starting
to write a consent form.

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When you learned how to write an
essay

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in English class in high school
or in college,

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you might have heard your
teacher

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say something like,

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use different words
to convey the same point, right?

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It gets kind of boring
if you use the same word over

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and over.

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In this case, you really want to
make sure

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you're using the same words

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to describe the same thing on
page

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one as you're using to describe
it

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on page two, because describing
it

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differently, the person be like,
wait,

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is this what they just told me
about?

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Or is this a new thing?

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No. Your

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audience, I this is really
important.

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I don't think we spend enough
time

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as investigators thinking about
this,

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that when your planning your
protocol,

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you likely have in mind
your sample population.

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And who's the average person
in that sample population?

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If the average person in your
sample

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population is not literate,

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that's very different
than the average person in

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your sample is a clinical
investigator

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at the NIH,

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you're going to have
a very different approach

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to thinking about how best to
write

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and convey that information.

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Now, the default of doing
something

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that's readable is always good,

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regardless of whether they're
not literate

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or an NIH investigator.

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But knowing
your audience is really

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important.

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Another thing is that,

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you know, no offense to all the
MD

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PhD is here at the clinical
center

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and out in the audience, but

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you never took a class called
How to Write a Consent form.

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You took classes to prepare you
to write grant proposals,

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articles

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published in Njm, you know,
presentations

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to a world wide audience.

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You know, you may not have

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the ability
and be humble about not having

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the ability

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to have someone help you out
in writing your form.

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You know, sometimes you can have
it reviewed by a patient or,

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you know, I often say,
well, I'd have my grandmother

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review it,

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or someone in your life who is
perhaps

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more average than you
because you're an MD, PhD.

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Review the form and circle the
words

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they don't understand.

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In terms of format.

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Again, to me, really obvious,
but readable, like no Comic Sans

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in the consent form.

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Use large point, uppercase and
lowercase,

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double spaced,
have a blend of white space and

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text.

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Again, I appreciate that
this might make things longer,

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but it's also going to make it
more readable.

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And I should say it's not the
case

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that consent forms in the recent
past

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have gone from ten pages to 20
pages,

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because they are double spacing
them.

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They are still single spaced ten
pages

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now single spaced 20 plus pages.

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Now, I just want to go to
understanding.

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And so I, I have,

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goal of making all of you

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believers in what I'm about
to share with you because I

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think it's the

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a really good, thoughtful way to
assess

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understanding and a
understanding.

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We know from the literature
that understanding is improved

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when patients are subjects,
verbalize information.

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So if you ask them an open ended
question

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and ask them

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to verbalize what they
understand,

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because you can
then intervene and talk further,

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it actually improves
understanding

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and understanding

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is improved by administering
quizzes

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and correcting incorrect
responses.

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But frankly, I think that's
a bit of teaching to the test,

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right?

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So let's say I give Alex the
quiz.

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There's ten questions.

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The first time he takes it
he gets five. Right.

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My cut is seven.

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So I could say,
sorry Alex, you can't be in my

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study.

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But what a lot of studies do is
they say,

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okay Alex, let's review
the ones you got wrong.

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You said true on these
and they were false.

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Let's give you the quiz again.
Now,

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if Alex doesn't get the quiz
right

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that time, then we're concerned.

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But it's highly likely
that Alex is going to pass it.

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I don't think that's a robust
way

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of assessing, understanding.

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So here's what I want you all to
do.

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So you've written your consent
form

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and you're ready to open your
study

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and bring folks in.

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You've recruited them.

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You're now scheduling them.

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I want you to think about what,
for your study

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are the most important things
that you want this person to

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know.

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And I'm going to posit
that these things that I've

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listed up here

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are likely at least some of the
things

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you're going to want to know.

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And I also want you to prepare
answers

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to those questions.

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If you are answering the
question

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or having reviewed the form,

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how do you think
you would answer those

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questions?

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So you have in your mind
this is the, maybe not the right

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answer,

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but this is an adequate response
to my question.

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And now you're ready
to ask the participant

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after you've gone through the
consent

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form, a series of questions like
this.

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They're open ended.

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So, for example,
if you're going to go home

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and tell a friend about this
study what

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the study's about, what would
you say?

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Right.

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That's that's not saying
tell me the purpose of the

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study.

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I want, in their words,

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for them to tell me what they
think

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they're getting themselves into.

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Now, if they say, oh, gosh,

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this study is going to cure my
cancer,

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that may not be true.

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That creates an opportunity
for you to say, oh,

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that's interesting that you
heard that,

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let me tell you a little more.

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It's actually not going to cure
your cancer.

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It's going to do X, Y, or Z.
Right.

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And we'll set aside for

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a moment the folks who insist
that it's

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going to cure their cancer.

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Let's assume that at least
having a conversation with them,

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or that highlights
something that they may not

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understand.

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And then what's going to happen
to you?

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Right.

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Are you going to get some MRI,
some Pet scans, a blood draw,

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etc.?

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And if there are particular
things

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about your study

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that you're really it's really
important

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for you to know them to know.

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So, for example,

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let's say I'm doing a
longitudinal study

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and I need people to come in.

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And this was a study we also got
to consult about the other day.

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I'm going to take your blood
today.

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I'm going to have
you come back every week,

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and I'm going to measure a
substance

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in your blood every week,

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and you're going to have to come

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back every week
until I can't see that substance

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anymore.

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The average person, it's ten
weeks.

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But I've had someone for whom
it's taken 20 weeks.

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Are you ready?

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And do you like,
is this going to work for you?

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Do you think you could come back
20 times once a week?

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That might be really important,
right?

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Because if someone says, oh
gosh, no,

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I'm going on vacation for three
weeks or

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oh gosh, no,
in a month, I'm switching jobs

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and they're not going to be,
as you know, flexible.

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So that might be something
really important for your study.

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What are the risk?

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What are the potential bad
things

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that might happen?

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What are the good things
that might happen?

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And then voluntariness

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randomization as we've described
is always

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a really challenging thing for
folks

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to understand and appreciate.

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But if there is randomization

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that might be something you
really want

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to make sure they understand.

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So I want you to all go out
and use this approach

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and tell all your friends about
it so that

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we just diffuse this across the
globe.

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That's my plan.