I was wondering if there has been any talk of
using
AI somehow in IRBs especially
to maybe expedite things, or I don't.
I don't know if there's anything I could do, but they're there.
So the short answer is yes.
There's a lot of chatter, for lack of a better word of use
ING
AI to do a variety of things.
I actually heard the tail end of a talk the other day.
So you will learn next week
that there is a new requirement
as it relates to the informed consent
form, that at the very top of the form,
there is key information that is the most important
information
that the potential participant should know.
And so a group at the University of Michigan has basically
created a way
with queries to chat GPT four or 5
or 6 to say, here's the consent form,
please pull out the key information
and put it in a readable, you know, eighth grade language.
And, they sort of attested that for a while.
They haven't adopted it as a service
for all investigators.
But, that's one way that investigators
are using it to comply with regulations.
There has also been
some chatter about, could you use AI to do that
administrative review, for example,
here is the protocol.
Make sure that it has all these seven components
and that there's something that makes sense
below.
So there are a lot of ideas.
There isn't yet any chatter
about replacing the IRB with AI, but who knows?
Hey, Daniel. Hey,
this is super interesting.
My question is about, you mentioned that
IRBs, vary in terms of practice and policy,
historically beholden to federal regulations.
But I'm curious,
how much do they vary from institution to institution?
Do they look like, vastly different
or is it generally pretty similar?
Great question.
And the the short answer, it's a bit of a bell curve, right.
So a really good example is
when you're doing pediatric research,
the IRB must categorize research
as no more than minimal risk,
more than minimal risk with,
a, prospect of direct benefit
and more than minimal risk and potential benefit
to the group of children represented by the population.
You're enrolling.
So that definition of minimal risk
is really important
as it relates to what category of research
it is.
If there's a lot
if there's a lot of risk, right, there has to be some direct
benefit.
And in the third category, you know,
you have to be able to say, well,
what how much risk is too much to expose,
etc..
So, Sima Sha, who was a fellow
here at the Department of Bioethics
many years ago, did a study
where she asked IRBs for pediatric research.
How do you define minimal risk?
And here's a list of potential things.
Which would you call minimal risk
and not so blood draw?
You know, up to like, a lumbar puncture or,
take an amount of blood, right.
She sort of said so.
Bottom line is there was a lot of variation,
but it was about a it was a bell curve, right?
Some IRBs would say none of that is minimal risk,
even a simple blood draw where at the other end, lumbar
puncture?
No, not more than.
Again, that's a little extreme, but
you get the idea.
So it's within a bell curve.
And we as ethics types might worry about either end.
Right.
So we might worry about exposing kids
to too much risk,
or we might worry about valuable research
that isn't happening
because they're so strict.
And that's generally true when you look
at the literature about it's not very wide,
but there is some literature about how IRBs have, you know,
did
some said that is it's exempt, others said it was expedited,
etc..
So it's almost always a bell curve,
and very little on either end
and or one.
Go ahead. Hi.
I just have a question about quality control.
So, I imagine that, like, look, there are a number of local
libraries
and they all have a bunch of different people.
Who sit on these committees.
So is there a procedure for these arabes
to sit like,
step back and look at all the cases that they've, you
know.
Presided over and looked at in the past, you.
Know, a number of months and then, make some sort.
Of determination about whether their.
Decisions have been generally consistent.
Yeah.
So this is a topic that is very close to my heart.
I spend a lot of my time these days thinking about
how can we evaluate the quality of IRB
review and oversight.
The short answer is there are some tools that are
inadequate.
I would say that an IAB could step back
and review.
They could look at how did we,
you know,
decide let's look at all our pediatric research and see
how
we decided whether or not we always said
a blood draw was a minimal risk.
So one could do that.
But IRBs are really busy, don't have
enough staff, don't have enough funding.
So it for some, it's a bit of a luxury
to be able to take that step back.
But there are
there are a couple of ways in which institutions improve
the likelihood that the people around
the table are well situated.
So they're all trained in a particular way.
They have in-service training.
I'm sure that if a chair had a concern,
like you were on the IRB
and you fell asleep and you were never
bringing your reviews in,
they'd probably have a chat with you and
ask you like the at the extremes, right?
There's ways that the sort of local
quality can be maintained.
And but there are ways that you could step
back.
Some institutions do ad hoc audits.
Not for cause.
Right.
We're not worried about a particular person's
protocol.
You can't review everything.
So you say, I'm going to randomly select
ten projects and take a deep dive.
And so those audits can then inform
wow, everybody's forgetting to do X.
So we've got to reorient the investigators
and the IRB to make sure
this is present.
Go ahead.
Hi, Holly. Sally Fowler. Hi there.
I kind of more practical question
on something
you just put up, and it's about irb
used in a responsible parties.
And you wrote that, IRBs have to do the continuing
review.
Yes. On studies that receive full committee
review. Yep.
So expedited reviews which, you know, are minimal
risk.
Yeah.
Are you saying because this would be kind of
good
if you are that they don't need continuing
review.
And I know your your caveats going to be
go to your local.
Yeah I heard that.
So it's a great question.
So one thing none of us mentioned today
is that the common rule was revised
in 2018 after a very long, protracted
process.
One of the things that's different
from before 2018 is that only full
committee reviewed protocols are required
to provide an annual review.
So if it's expedited, you don't have to.
Now, some IRBs could say
we want to do more than what the regulations require,
and we want to review all expedited research,
but they're no longer required by federal regulations to do
that.
So when they approve whichever IRB
you're in, when they approve your study,
they will tell.
You exactly they.
Want a continuing review every year.
We're going to want to know exactly.
Exactly. And it's not required.
And some IRBs will, do an even shorter period.
So here at the Clinical Center,
I think I'm going to mention this
in another, in another, lecture.
The vast majority of research that happens here is phase
one research very early, first in human
trials.
And when that type of trial is going on,
the IRB might say, you know what,
we're a little worried about that
or we really want to have close,
we want to be very careful about the risks
that people are exposed to
and want to make sure that everything is moving
forward.
We want to review you in six months.
So the IRB always has the option to ask
for something earlier if they want to.