Clinical Trials at MUSC: Institutional Review Board
Transcript:
Guest: Dr.
Suzanne Thomas – Psychiatry
& Behavioral Sciences
Host: Dr.
Linda Austin – Psychiatry
Dr. Linda Austin:
I’m Dr. Linda Austin. I’m
interviewing Dr. Suzanne Thomas who is Associate Professor of Psychiatry here
at the Medical University of South Carolina.
She has a PhD in experimental psychology. Dr. Thomas, one of your interests is in
research in general, and I know you sit on the IRB, the Institutional Review
Board. I wanted to use this chance to
talk some to folks who may be thinking about participating in a clinical trial
in general here at the medical university, or even more specifically, in a
clinical trial in your area, which is substance abuse. Let’s start by talking about what the IRB is
and what it does and why it is so important for those who are interested in
participating?
Dr. Suzanne Thomas:
Thank you, Dr. Austin, for having me.
When you are considering participating in a research study, either in
psychiatry or in substance abuse, or in any other area on the campus, there is
no research study that is being conducted at our institution, or any other
institution in the nation, that has not first gone through a vetting
process. The vetting process can either
be through a federally funded mechanism, such as the NIH, the National
Institutes of Health, giving money to a researcher to study a particular
question, or from private industry, or pharmaceutical companies providing money
to study that. But that’s not the only
vetting process.
So that’s one way that you can get through the
first area, to say, okay, this is a valuable question that needs to be
studied. That’s the first step. Before a study can be implemented though, at
a school or an institution, it has to go through a special committee comprised
of people who are involved in research, who know about studies, physicians as
well as members from the community, all who sit on a board, the Institutional
Review Board, and look at every study that is proposed to be conducted at an
institution and determine whether it’s going to be something where participants
are protected when they engage in that study.
For example, the IRB will review a protocol. They will review the document that all
researchers have to give potential research subjects. It’s very explicit. No one is included in a study who hasn’t
first gone through what we call the informed consent procedure.
The IRB essentially makes sure that all of that is
crystal clear to the participant before they enroll in a study.
Dr. Linda Austin:
I was thinking as you were describing that. It’s almost like having a group that
functions as if they were your attorney looking over all the documentation primarily
on behalf of the patient or the person who might participate. Of course, in so doing, they’re also
protecting the institution from running into problems that they may not
recognize upfront.
Dr. Suzanne Thomas:
That’s absolutely right. And I
think all the members of the IRB are interested in thinking, okay, if this
was my husband or son, or mother, or father, you know, if they were going to
participate in this study, what would I want them to know, and how explicit do
I want the researchers to be in showing, okay, here’s exactly what is going to
occur.
Dr. Linda Austin:
So, when a research study is proposed and hits a snag with the IRB, what
are some of the typical kinds of problems that you have seen an investigator
run into, with the IRB?
Dr. Suzanne Thomas:
The most common problem is not that the study is dangerous; it’s not
that. It’s that the informed consent
form, the document that the researcher and the potential participant sit down
together and look at where the researcher explains what’s going to happen in
the study. That document has to be
written in language that a regular person can understand. You don’t have to have a PhD or an MD to
understand. We don’t want to use big
words or jargon to describe the study.
We want to make it crystal clear so that anybody who has a sixth grade
reading level, for example, could understand.
That’s the biggest problem, that sometimes you’ll read a document that
you think, okay, this is a little bit too hoity- toity, you need to have a
better word here to describe this. So, we’ll ask the researchers, okay, please
explain this in lay terms.
Dr. Linda Austin:
What are some other common problems that you’ve seen?
Dr. Suzanne Thomas:
I think another issue that we like to make sure that research subjects
know is how long each visit is going to take.
You know, if they come and enroll in the study and they come to MUSC or
wherever it is that the study is being conducted, they should be able to plan
their day. We should say, okay, when
you come for visit five, it’s going to take about 45 minutes, and then visit
ten is going to take an hour and a half.
So, you know, it’s sort of just common courtesy to make sure if somebody
is participating in your study, you’ve been very clear about what you’re going
to do and what sorts of medicine they’ll be taking and what the side effects
might be of that medicine. Those are all
explained in the informed consent. But
also the common courtesy of saying how many times you’re going to be expected
to come into our office and how long you should expect those visits to take.
Dr. Linda Austin:
So the IRB really does advocate for the patient’s needs?
Dr. Suzanne Thomas:
We really do. That’s our number
one goal. And when we meet, that’s the
purpose, thinking, how can we best protect individuals who would like to
participate in a research study?
Dr. Linda Austin:
Now, you’re involved in substance abuse research. Are there any particular ethical issues or
even procedural issues that the IRB has to take a look at in substance abuse
research?
Dr. Suzanne Thomas:
Particularly regarding substance abuse research, our standards of
confidentiality are very high. They’re
higher than in other areas of research; we take confidentiality seriously. Unfortunately, there is still a stigma with
addiction. You know, people who have
heart disease or cardiovascular disease, or even Alzheimer’s disease don’t have
the same stigma attached to them as people who have cocaine addiction or
alcoholism. We’re trying to remedy
that. But, in the meantime, if anybody
participates in a study involving substance abuse research, we take extra
precautions to protect their confidentiality, not linking their name, for
example, to any of their data, and all of that.
Dr. Linda Austin:
Dr. Thomas, thank you so much for talking with us today.
Dr. Suzanne Thomas:
Thank you, Dr. Austin.
If you have any questions about the services
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Carolina or if you would like to schedule an
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