Chapter 18: A Brief History of Institutional Review Boards at MD Anderson

Chapter 18: A Brief History of Institutional Review Boards at MD Anderson

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Description

Dr. Elting begins this chapter by reviewing the proliferation of IRBs at MD Anderson. She discusses the reasons why they were necessary and how they have emerged as pressures on researchers were changing. She explains why the mid-nineties were a key time for rising resources to fund IRB oversight. She explains that when HIPPA went into effect, MD Anderson’s Compliance office became more concerned about adherence to proper policy.

Next Dr. Elting talks about the need for IRB oversight given ethical issues that have arisen with the increase in genetic/genomic research and increases in projects involving ‘big data’ requiring that personal health information moves from institution to institution.

Identifier

EltingL_04_20150423_C18

Publication Date

4-23-2015

City

Houston, Texas

Topics Covered

The University of Texas MD Anderson Cancer Center - An Institutional Unit; Building/Transforming the Institution; Institutional Processes; Understanding the Institution; Understanding Cancer, the History of Science, Cancer Research; The History of Health Care, Patient Care; Ethics

Transcript

Tacey A. Rosolowski, PhD:

Well, if I may, I'll start with some of my questions. And the first one is actually a little detail thing. You had given me a very complex acronym for an IRB that you set up, the one for nonclinical work. Begins with PR or something. And I did not take it down properly. So I wonder if you could review that for me.

Linda S. Elting, DrPh:

Yes. So actually it's not for the IRB. So IRBs are the last committees that research goes to. Prior to that there is scientific review by a separate committee. And the scientific review for clinical IRBs is the CRC, the Clinical Research Committee. And currently there are four of those and two clinical IRBs. And then for the Behavioral and Psychosocial and Health Services IRB, there is the PBHSRC.

Tacey A. Rosolowski, PhD:

PBHSRC. That was the one that I missed.

Linda S. Elting, DrPh:

Which is Psychosocial, Behavioral, and Health Services Research Committee.

Tacey A. Rosolowski, PhD:

OK. So there are the two IRBs associated with clinical. Now there are four IRBs total at the institution, right? What are the other two related to?

Linda S. Elting, DrPh:

Well, there are actually now three clinical IRBs. There were two a while back. But there are three clinical IRBs. There's the Psychosocial and Health Services IRB. And then there's the executive IRB. And the executive IRB deals with policy issues, deals with serious problems that come to the various IRBs.

Tacey A. Rosolowski, PhD:

What kind of a problem? Can you give me an example?

Linda S. Elting, DrPh:

Well, serious mistakes made in research. Failure to obtainserious violation of regulations. And then policy making dealing with problems that are common to all the IRBs in order that they will be consistent. And additionally deals with adverse events. Monitors adverse events. And that's primarily because if you have three clinical IRBs you could have a protocol with a new drug going to all three IRBs but everybody sees only one protocol and doesn't realize that there's a serious problem with adverse events arising. So all the adverse events are reported to the one executive IRB so we can see the whole picture. The executive IRB is comprised of the chairs of all the other IRBs, a couple of vice chairs, and one or two other members who are on there to provide expertise that isn't covered clinically or scientifically by the IRB chairs and vice chairs.

Tacey A. Rosolowski, PhD:

Now when was the executive IRB established and why? I mean why at that time?

Linda S. Elting, DrPh:

It was established primarily because originally we had only one IRB. And pretty soon our meetings were lasting for five and six hours. Just too much work.

Tacey A. Rosolowski, PhD:

Right, I remember you mentioned last time that there was just

Linda S. Elting, DrPh:

And then they went to two IRBs. When we went to three IRBs it became clear that when we had these decisions being made in three different rooms with three different chairs, in order to be relatively consistent and not be giving conflicting answers to problems and dealing with policy issues that affected all three, we needed to meet separately to coordinate those activities. And so my IRB was the third IRB that was started. So when they started the third IRB they also started the fourth IRB, which was the executive IRB. And then we would meet once a month for that IRB as well to discuss those issues. And then later we added a third clinical IRB.

Tacey A. Rosolowski, PhD:

OK. So let's see. I'm trying to look when you went onto the IRB first. In 2003? Is that correct? Or were you involved earlier? Because that's when you were chair?

Linda S. Elting, DrPh:

Yeah, I became theI don't know, I can't remember the years. But I was involved in the IRB as a member on a clinical IRB since the late "˜90s.

Tacey A. Rosolowski, PhD:

And the reason I was just asking about the dates in that way is because I was going to ask you since you also have seen what's going on in the executive IRB. Have you noticed that that IRB has had more issues to deal with? I'm wondering about fluctuations and pressures on researchers basically and if that's showing up either in mistakes or in ethical issues? What's your observation about that?

Linda S. Elting, DrPh:

I think the pressures have changed a lot. Before we had multiple IRBs there was very very little oversight of ongoing research. And I guess in the mid "˜90s maybe, somewhere around that timeframe, mid to late "˜90s, the institution made available to the IRB a lot more resources. And part of those resources were dedicated to monitoring research as it was ongoing to pick up problems before they became major violations. And so an infrastructure grew up around auditing. And it was initially primarily the clinical IRBs that did monitoring of clinical trials. It was a separate mechanism. Audits went on and happened separately. But if there were problems identified they were reported to the IRB. So that was an initiative that got started up, and it resulted in finding a lot of problems, and then the institution putting more money into research infrastructure, particularly in research support at the department level, so that there was sufficient number of support staff to actually do the kinds of things that were required by the regulations and by the Food and Drug Administration. So I think that was a big increase in the amount of nonclinical nonscience requirements for researchers and their staff, because now someone was coming and checking to be sure you had properly documented all this stuff. And documentation was not high on the list of priorities for a lot of investigators. And then I guess the next big push that increased even more the difficulties with documentation and all kinds of things like that and pressure on researchers was HIPAA.

Tacey A. Rosolowski, PhD:

Right. You mentioned that last time.

Linda S. Elting, DrPh:

When the HIPAA regulations were passedwell, when they were written, they really threw a monkey wrench into everything we were doing in terms of research. It made everything more complex to do and more difficult to do if you didn't violate the law. And what was different about HIPAA, I may have said before, I can't remember, was that more than just getting slapped on the wrist by the Food and Drug Administration or having your name on the bad list, there were both civil and criminal penalties associated with violation of that law. So that happened. And then they started auditing for HIPAA purposes some of the big institutions, and they actually shut down research at some big institutions. So that made the people at the top of MD Anderson, particularly in compliance, very interested in having things done properly. So that was a huge increase in documentation and in the complexity of getting informed consent and protecting the privacy of research subjects. And then I guess the most recent thing, two things happened at once. Lots of people started doing genetic testing and genomic research. And that has lots of difficult ethical issues with respect to research subjects and to their families. For example, their children, who carry the subjects' genes. So that happened at about the same time there was a lot more interestwhich is still increasingin use of large databases and data sets and analysis of big data. And big data usually means that it's compiled from a bunch of different places. So data moves from one institution to another. And so if you and I were in the hospital someplace and we had records there, we might have no idea that our records were being shared with somebody across the world. So those changes in science and the political arena caused a lot more work for researchers. And they found out about it through the IRB. So there were external developments and pressures that had to be implemented by the IRB. And so that contributed to an adversarial relationship between researchers and the IRB, which is sometimes bad, and sometimes it's not so bad, depending on the situation and what's going on.

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Chapter 18: A Brief History of Institutional Review Boards at MD Anderson

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