Clinical Trials at MUSC: Institutional Review Board

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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 or programs offered at the Medical University of South Carolina or if you would like to schedule an appointment with one of our physicians, please call MUSC Health Connection:  (843) 792-1414.

 


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