As a reminder,
write consent is a process, not a form.
I'm going to talk a lot about the form
as I move forward,
but I just want to reiterate that,
you know, informed consent process
is the only one way to,
convey respect to the person, potential participants.
You need to, you know, make sure that you
respect them
and in all sorts of ways, even after
you've gotten their informed consent.
So I'm going to talk a little about best practices,
about the form and then promoting
understanding.
So style and again I'm not going to read all of
these to you.
And some of these should be I would
imagine pretty straightforward right.
If you imagine, you know, the last time I read a book by
Faulkner,
it was really hard to read because it was
basically one long sentence.
Very complicated words, very complicated
text.
Right.
You're looking for something that has short sentences, short
words,
and importantly, like states
one main idea clearly in each paragraph.
And you know, you'll be maybe not surprised to learn
that putting space between paragraphs is really
helpful.
When someone is given a form that is 25 pages long.
Yes, adding some space may make it longer,
but
it's a it's a message to the individual
that it's.
Here is one idea.
So, you know, present a clear sequence
of events.
I was reviewing a protocol.
We had a consult, the other day where,
individual clinician is concerned
about the ability
of the participant to read consent to a protocol.
There was a change in the protocol.
That means that the consent form changed
in this case,
and everybody has to be re re consented.
The one of the ways that they organize
their data was they had this really lovely
table
and there was a little icon or an emoji,
I guess.
And these days.
And that was like a blood draw.
So they had a picture of a needle
and talked about the blood draw.
And then they had a picture of there was a
in some cases they may take a biopsy of the
liver.
So there was a little picture of a liver,
only to say, like you don't, you can use things other than
words.
Images, photographs, all sorts of things
under the heading of making it as clear as
possible,
what the person is getting themselves
into avoiding legal jargon.
Write it in a conversational style
and after voice.
Be consistent.
This is often something that, I encounter
when folks are just starting to write a consent form.
When you learned how to write an essay
in English class in high school or in college,
you might have heard your teacher
say something like,
use different words to convey the same point, right?
It gets kind of boring if you use the same word over
and over.
In this case, you really want to make sure
you're using the same words
to describe the same thing on page
one as you're using to describe it
on page two, because describing it
differently, the person be like, wait,
is this what they just told me about?
Or is this a new thing?
No. Your
audience, I this is really important.
I don't think we spend enough time
as investigators thinking about this,
that when your planning your protocol,
you likely have in mind your sample population.
And who's the average person in that sample population?
If the average person in your sample
population is not literate,
that's very different than the average person in
your sample is a clinical investigator
at the NIH,
you're going to have a very different approach
to thinking about how best to write
and convey that information.
Now, the default of doing something
that's readable is always good,
regardless of whether they're not literate
or an NIH investigator.
But knowing your audience is really
important.
Another thing is that,
you know, no offense to all the MD
PhD is here at the clinical center
and out in the audience, but
you never took a class called How to Write a Consent form.
You took classes to prepare you to write grant proposals,
articles
published in Njm, you know, presentations
to a world wide audience.
You know, you may not have
the ability and be humble about not having
the ability
to have someone help you out in writing your form.
You know, sometimes you can have it reviewed by a patient or,
you know, I often say, well, I'd have my grandmother
review it,
or someone in your life who is perhaps
more average than you because you're an MD, PhD.
Review the form and circle the words
they don't understand.
In terms of format.
Again, to me, really obvious, but readable, like no Comic Sans
in the consent form.
Use large point, uppercase and lowercase,
double spaced, have a blend of white space and
text.
Again, I appreciate that this might make things longer,
but it's also going to make it more readable.
And I should say it's not the case
that consent forms in the recent past
have gone from ten pages to 20 pages,
because they are double spacing them.
They are still single spaced ten pages
now single spaced 20 plus pages.
Now, I just want to go to understanding.
And so I, I have,
goal of making all of you
believers in what I'm about to share with you because I
think it's the
a really good, thoughtful way to assess
understanding and a understanding.
We know from the literature that understanding is improved
when patients are subjects, verbalize information.
So if you ask them an open ended question
and ask them
to verbalize what they understand,
because you can then intervene and talk further,
it actually improves understanding
and understanding
is improved by administering quizzes
and correcting incorrect responses.
But frankly, I think that's a bit of teaching to the test,
right?
So let's say I give Alex the quiz.
There's ten questions.
The first time he takes it he gets five. Right.
My cut is seven.
So I could say, sorry Alex, you can't be in my
study.
But what a lot of studies do is they say,
okay Alex, let's review the ones you got wrong.
You said true on these and they were false.
Let's give you the quiz again. Now,
if Alex doesn't get the quiz right
that time, then we're concerned.
But it's highly likely that Alex is going to pass it.
I don't think that's a robust way
of assessing, understanding.
So here's what I want you all to do.
So you've written your consent form
and you're ready to open your study
and bring folks in.
You've recruited them.
You're now scheduling them.
I want you to think about what, for your study
are the most important things that you want this person to
know.
And I'm going to posit that these things that I've
listed up here
are likely at least some of the things
you're going to want to know.
And I also want you to prepare answers
to those questions.
If you are answering the question
or having reviewed the form,
how do you think you would answer those
questions?
So you have in your mind this is the, maybe not the right
answer,
but this is an adequate response to my question.
And now you're ready to ask the participant
after you've gone through the consent
form, a series of questions like this.
They're open ended.
So, for example, if you're going to go home
and tell a friend about this study what
the study's about, what would you say?
Right.
That's that's not saying tell me the purpose of the
study.
I want, in their words,
for them to tell me what they think
they're getting themselves into.
Now, if they say, oh, gosh,
this study is going to cure my cancer,
that may not be true.
That creates an opportunity for you to say, oh,
that's interesting that you heard that,
let me tell you a little more.
It's actually not going to cure your cancer.
It's going to do X, Y, or Z. Right.
And we'll set aside for
a moment the folks who insist that it's
going to cure their cancer.
Let's assume that at least having a conversation with them,
or that highlights something that they may not
understand.
And then what's going to happen to you?
Right.
Are you going to get some MRI, some Pet scans, a blood draw,
etc.?
And if there are particular things
about your study
that you're really it's really important
for you to know them to know.
So, for example,
let's say I'm doing a longitudinal study
and I need people to come in.
And this was a study we also got to consult about the other day.
I'm going to take your blood today.
I'm going to have you come back every week,
and I'm going to measure a substance
in your blood every week,
and you're going to have to come
back every week until I can't see that substance
anymore.
The average person, it's ten weeks.
But I've had someone for whom it's taken 20 weeks.
Are you ready?
And do you like, is this going to work for you?
Do you think you could come back 20 times once a week?
That might be really important, right?
Because if someone says, oh gosh, no,
I'm going on vacation for three weeks or
oh gosh, no, in a month, I'm switching jobs
and they're not going to be, as you know, flexible.
So that might be something really important for your study.
What are the risk?
What are the potential bad things
that might happen?
What are the good things that might happen?
And then voluntariness
randomization as we've described is always
a really challenging thing for folks
to understand and appreciate.
But if there is randomization
that might be something you really want
to make sure they understand.
So I want you to all go out and use this approach
and tell all your friends about it so that
we just diffuse this across the globe.
That's my plan.