We looked at several different models.
We published a second Federal Register notice stating we might
cluster or order the presentations and arrange the
schedule.
We looked at half a dozen, four-six models and our eyes
were glazed over and we are like, let's just do the way
folks signed up.
So you're presenting in the order in which you signed up.
That's how that happened.
I think it worked fairly well.
I think there has been a lot of natural flow to the meeting that
we could not have arranged better had we tried to force
into either the questions we put out there or the other models
that we looked at.
So we thank you all very much for your patience with the
process and for your efforts today to make this meeting a
success.
So I just note for the record that we are significantly ahead
but we are going to proceed.
It may effect some of our later afternoon speakers who were
planning to be here, but with logistics today, it may change
everything anyway.
So without further adieu,y see we have our next speak worse us,
Richard Platt and his family -- Shawn Pratt and his family are
here to make a presentation.
>> I'm here with my wife, kerry and my daughter.
We are representing DAGAN today.
I'd like to start off by saying that DAGAN is a child and at the
time of the support study, a vulnerable child.
She is a child.
Not a experiment and not a subject and she deserves the
best possible care regardless of what type of study she may have
been on.
I do have a brief statement I'd like to read as well.
Thank you for inviting us to this forum.
We as parents appreciate your willingness to hear us.
And our very personal comments regarding what we learned and
experienced throughout our daughter's four month residence
in the NICU.
We are here to introduce our daughter and share with you what
we experienced with regards to the study.
The support study.
DAGAN was born six years ago delivered emergency C-section at
a very premature 25 weeks gestation.
From her first breath, she has been fighting and working hard
to achieve every developmental milestone.
In the beginning, when she was a mere one pound, 11-ounces and
she got down to one pound, one ounce, we were approached by the
medical staff with the request to be participants in various
research studies.
As educated professionals we understand the importance of
conducting research and conducting studies and the
importance of the results of those studies on future children
and future of medicine.
Many of the studies we participated in were not
invasive in nature.
To include searches through metadata contained within her
medical records.
Others were relatively studying the characteristics of her core
blood.
My wife, kerry, took part in a study on the mental effects of
having a child in the NICU.
Yes there are mental effects of having a child in the NICU.
As parents we evaluate the details of each research project
before providing consent and subjecting our medically fragile
daughter to testing.
Testing of any kind.
We declined to participate in one study related to acid reflux
due to risks we believe to be troubling.
So we didn't just take part in every study that came our way.
Then there was the DHS sponsored support studies.
After surviving over four months in the NICU, including laser eye
surgery to correct a disease at two months old she was released
in our care with an apnea monitor.
Five.five weeks she was admitted for failure to thrive.
As a result of severe reflux, she had surgery and ghast
astronomy.
She faced a diagnose of cerebral palsy.
She is now a happy child and enjoys life despite her
limitations.
Imagine our surprise as we learned a few months ago about
the risks associate the with the support study.
Based on new information, it appears she was placed into a
random oxygen saturation category instead of a study to
monitor her natural oxygen saturation.
A random category which may have led to ROP plus disease among
other items.
A risk that may have yielded cerebral palsy which she
struggles daily with motor tasks and causes us to travel a
long-distance to physical and occupational therapy and
identity issues now at the age of six.
A risk that caused her pain as she was moved back and forth
from the ventilator to C pap to nasal can la within four months.
She peers to a number of health emergencies to include apnea and
collapsed lungs, multiple times of each.
The support study looked good on paper.
We provided the staff with authorization to record her
oxygen saturation measurements so the results could be
providing medical professionals with information to accurately
study and hopefully reduce the incidents of ROP plus disease
and premature infants.
We were led to believe that we would be helping other babies by
doing the study.
This information would be useful to help catch ROP plus disease
early.
We were guaranteed the study wouldn't hurt her in any way.
And it was just gathering information.
While we appreciated the need to help other babies born with
problems such as hers, our sole motivation was for help.
We assumed her dresser felt the same and shocked to learn the
care she received was based not on what she needed but on some
protocol N our minds it turned her into a subject of an
experiment instead of a participant in a study.
We want to understand why the intend of the study was knots
provided to us as it was invisionized by the designers.
We want to know as information comes in, why the risks and
intent of the study were not clear.
If it were clearer, we wouldn't have taken part in the study.
Why was our child a subject in a medical experiment without our
knowledge or permission what information was eventually
accident trap lated from the experiment?
How did the information help other babies?
Did the study catch ROP plus disease early in other infants?
Tell me what the support study or that support study did not
hurt her any way.
I'd like to know that information.
Finally, I need to ask you, would you place your own
medically fragile premature child into the support study?
Thank you.
>> Thank you.
Questions from the panel?
I'll start with NIH.
>> Thank you very much for taking the time to share with us
your comments your story.
Which has been a challenging one and our hearts go out to you.
I wanted to just reassure you that your comments are really
going to help us as we move towards improving the reach
ethics that we take very seriously, and we really
appreciate your comments and your input today.
Thank you.
>> Thank you for having us here, ma'am.
>> Thank you.
OHR!
>> I'd like to echo Dr. Hudson's comments on behalf of OHRP.
Ultimately it's about giving appropriate information to
subjects, in this case, parents, and the one thing that you
really want to know is what do parents actually understand.
So you're taking time and effort to come here to really get this
exact type of information.
So thank you very much.
>> Thank you, sir.
>> FDA?
>> Just to be sure I understood, you got some kind of consent
form but I take it you're saying that you couldn't tell from
that, that there were actually two things that she was going to
be randomized to?
One the oxygen level and one the nature of the pulmonary support.
But that wasn't clear?
Is that what you're saying?
>> When they told us about the study, they said they are
collecting data, that don't worry.
She will be cared for.
Like, now we are realizing that we didn't understand what he was
going on and we realize that the risks weren't put out.
But with that said, even approaching us at such an
incredibly stressful time, I mean, I think of, there is a
cooling-off period to buy a car.
Like we are talking about our child.
So no, I can't say that from what we heard today and what we
read, that it makes sense to our experience.
>> So they didn't really communicate that it was in fact
an experiment?
It was an experiment.
There were two different -- >> No.
>> It was complicated.
>> So if we would have known that, we would not.
There was an experiment on reflux and we knew she had
reflux.
And there were so many risks on there and we are like, we have
to say no.
And then work -- because she's an individual.
We have to work with her medical team to find out how to fix
this.
And yes, she went home and then we had to go back for the G
tube, but if the risks were written, then we would have felt
informed.
But they weren't.
>> And we wouldn't be here either.
>> Thank you.
>> Thank you, sir.
>> Thank you.
>> Sharissa Cook.
>> Can someone queue these slides?
You're going to have to guide whoever has control now because
they are not -- is there a beginning in the slide deck?
And I'll ask the timer -- thank you.
Can you start the slide deck some of the beginning and then
she'll start her remarks.