Chapter 16 : Institutional Review Boards at MD Anderson

Chapter 16 : Institutional Review Boards at MD Anderson

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Description

Dr. Elting sketching her role in MD Anderson’s Institutional Review Boards, including establishing a new IRB when the board overseeing clinical research didn’t serve the needs of non-clinical researchers. She talks about the role of the research review committee (PBHSRC) that also looks at protocols.



Next, she sketches a history of IRBs at MD Anderson, first established in 1966, before the federal requirement to establish such review processes. She explains how attempts were made to create effective processes that would not slow research.



Next, Dr. Elting explains the value of IRBs and traces how their role has changed as more resources have been provided to support monitoring.

Dr. Elting explains that the computer system that enables efficient entry and management of data has lagged behind the development of IRB processes and causes problems with the system. She also notes that when HIPPA requirements

Identifier

EltingL_03_20150326_C16

Publication Date

3-26-2015

City

Houston, Texas

Topics Covered

The University of Texas MD Anderson Cancer Center - An Institutional Unit; Institutional Processes; MD Anderson History; Building/Transforming the Institution; The Administrator; Controversies

Transcript

Tacey A. Rosolowski, PhD:

Now explain to me this role on the Institutional Review Board. Now, did you just serve that role within the department, or was that a go-to place for individuals throughout the institution who needed this--

Linda S. Elting, DrPh:

Oh, it's for the whole institution.

Tacey A. Rosolowski, PhD:

That's what I thought, okay. So, explain to me what that role entailed.

Linda S. Elting, DrPh:

Well I joined as a vice-chairwell let's see. I joined as a member years before that when it was recognized that the research that was not clinical trials, that was going to the IRB, and for scientific review, was not getting the kind of review it needed from the clinicians who populated the IRB and the Clinical Research Committee. And so they started what they called a Psychosocial, Behavioral, and Health Services Review Committee [PBHSRC] that was paralleled to the Clinical Research Review Committee, and it was staffed with people who were psychologists and health services researchers and epidemiologists, to do the scientific review. And then it getsonce passed, the scientific review goes to the IRB for human subjects review, and final approval. And so, I was asked to chair that committee when it started, the PBHSRC. And, so as Chair of that, I was reported as a member to the IRB where all of our protocols would be going. And I presented our protocols there to the group, and you know, that sort of thing. So, my role was to chair the scientific review, and once the scientific review had been approved, then to present the protocol to the Institutional Review Board, and at that point, there was only one IRB. And then it would be voted on, and approved, and then monitored in the future by the IRB.

Tacey A. Rosolowski, PhD:

Now, was there a senseI guess I'm interested in kind of the history of the IRB at MD Anderson. You know, were there changes during the time that you were here, and how that was looked at? I mean, the complexity of the review process, what was looked at, what the benchmarks were, how did that evolve? I mean, because research was changing so much. So that's what I'm trying to get a sense of.

Linda S. Elting, DrPh:

Yeah. Well the IRB started in MD Anderson in 1966, I think? It was atit actually began before it was a requirement of the federal government. It was a group of six or eight physicians to start with, and it only reviewed research that was funded by the NCI originally. And I think at their first meeting, they only reviewed three protocols. And over time, it had morphed to a large committee. WeMD Anderson had signed a federal-wide assurance agreement, which is a contract with the federal government that says all research conducted at MD Anderson will comply with the federal regulations; not just the federally-funded research. And when we did that, that meant everything had to go through the IRB. And so, when I joined the IRB, Aman Buzdar was the chair, andour meetings were just interminable. You know, we would go through twenty or thirty protocols a month, and there was this huge backlog. And so, as I began to be in the IRB group, there was a huge push to make the review and oversight process more effective, more efficient, and not to slow research down. So, while I was still on the IRB, it split into two. And wethat meant there were two meetings a month, and we hoped that would clear the backlog. And when that happened, I was appointed as a vice-chair. As Vice-chair of the IRB at that point, that was the othere were only two IRBs, and they were the same. They reviewed the same research; research was randomly assigned to the two. They were always chaired by physicians, male physicians. [laughs] Andbut there were a lot of duties of the IRB that could be performed outside the actual meeting, and approvals that could be done by a chairman administratively, but only if you had enough vice-chairmen to do the work, because no IRB chair could get all that done. So--

Tacey A. Rosolowski, PhD:

Tell me a little bit, because I actually don't know anything about how the IRB works. So what would you do, what is the work that you're referring to, in reviewing these protocols?

Linda S. Elting, DrPh:

The researchers protocols, written protocols are submitted to the IRB for review. We have to review, first of all, that the language and the informed consent is appropriate; that it accurately reflects the risks and benefits of the study. We had to review the whole protocol design for risks and ensure that there is no way that we could further reduce risks, and make a decision about whether there are risks that have not been appreciated by the principal investigator. We are required once a protocol was approved to monitor the conduct of the study, to monitor all adverse events, to check their reporting status to ensure that the status is going adequately, and then toat the close of the study, to look at the results, and ensure that everything was conducted according to the federal regulations. Our other job to train researchers what the regulations are.

Tacey A. Rosolowski, PhD:

I'm justthis may be a "tip of the iceberg"kind of question, but I'm wondering how do you define, for example, an "adverse event"? I mean, I'm wondering is there discussion about how to interpret risk, how do interpret (inaudible)--

Linda S. Elting, DrPh:

[coughs] Oh yeah. There's a lot of back-and-forth. An "adverse event"is something that happens that's bad during the conduct of the study. And it could be, the patient threw the medicine up. It could be they get an infection; it could also be there was a breach of confidentiality and their data was lost, or distributed. It could be that, you know, they shocked themselves with the little device they're using.

Tacey A. Rosolowski, PhD:

I see, okay.

Linda S. Elting, DrPh:

All kinds of things can be adverse events, and they are all reviewed. So there's one vice-chair who spends full time reviewing adverse events. There's another vice-chair who spends a lot of time looking at changes to protocols, because every change that's made has to be approved by the IRB. There's a vice-chair that spends full time, one or more, reviewing protocols that don't have to go to full review, that are, for example, chart reviews, or things like that, a study to establish a database. That doesn't need to go to full review at the committee. A vice-chair can sign off on it.

Tacey A. Rosolowski, PhD:

Now, I mean, very candidly, I've had so many conversations with people in the process of doing these interviews, and a great many of them, particularly older generation folks, you know, are not shy in saying that the IRB process has become extremely top-heavy and stands in the way of research, and you know, that's clearly their perspective. I mean, as someone who's been very, very involved in this for over a decade now, what is your view of the IRB process and its value to research, to the institution, et cetera?

Linda S. Elting, DrPh:

I guess I would say two things. The first is that when I first came to this institution, the IRB did not have sufficient resources to provide hardly any oversight. And as a result, there were never any situations where the IRB came to you and said, "Your study is deficient in this area. You have to stop until you fix it." So, there's no one who randomly chooses a protocol, and then verifwas no one who would verify that everyone had signed an informed consent. After some inspections from the Food and Drug Administration in the early eighties where we were unable to produce informed consents for clinical trials and such, we began to have a lot more interestthe administration had a lot more interest in ensuring that we were truly complying with the regulations. So the regulations governing research have not changed, but our attention to them has changed dramatically. So that's the first thing. So anyone who was here in the seventies was here in the cowboy research days, where you just sort of decided you wanted to do something, and you did it, and there was no oversight. So, after this started, there was more and more interest in this oversight job, because the oversight piece is what was lacking, and that's what could end up having MD Anderson's right to do research stopped, as has happened in other big institutions in the nation. Which would cost MD Anderson an arm and a leg. So, there was this suddenrecognition that oversight needed to be happening. And so they said, "Okay, now we're going to do it." Unfortunately, there was no trained infrastructure to make it happen efficiently and correctly. And so, over time, the infrastructure has increased. The processes have gotten morein some cases, more efficient, but the computer systems lagged behind, and they were almost entirely paper systems, which is not a good way to manage the number of studies at MD Anderson. So they're still in the process of trying to come up with an electronic system that will, you know, make theautomate the IRB functions, reporting and everything. So that's one of the reasons that someone who has been here a long time would perceive this to be very egregious, because it's so much more specifically-directed at oversight than it was initially. So the other thing I would say is that when HIIPA, the Health Insurance Information and Portability Act, was passed, the intention of which was to ensure that information could move between entities, that act crippled us by putting so many regulations and rules in place that affected research that we have to jump through ten times more hoops than we used to. Now, that is not specifically governing research, but at this institution, as in most others, the IRB is also the privacy board, and manages the HIIPA regulations. And that has been just nightmarish for all of usyou know, for me too as a researcher, to deal with the requirements. And the requirements were put into place without ever really considering researchers. So it's a federal law, and unlike the research regulations, which are also federal laws, instead of just being subject to civil penalties, under HIIPA, all of us as researchers are subject to criminal penalties for violation of HIIPA regulations. So, the stakes have changed considerably as well.

Tacey A. Rosolowski, PhD:

We're almost at our hour time. Can I ask you one more question--

Linda S. Elting, DrPh:

Sure.

Tacey A. Rosolowski, PhD:

--because you've been working with the IRBs, you know, for all of this time. Why have youwhat is the commitment that you felt to dealing with this important part of the institution?

Linda S. Elting, DrPh:

Initially, I did it because it was an opportunity to raise my profile professionally. Getting put in that chairmanship position of the PBHSRC when I was a junior associate professor, was the kind of opportunity that almost no one ever gets, particularly for someone who's not a physician. So, that was an opportunity I needed to capitalize on. I was interested in the whole issue because it was something I didn't understand or know, so as I learned about it, I realized how big a problem it was, and how simple it would be to fix if people had ever read the regulations themselves. But you know, none of us read the instructions when we should. And then, it became really clear as weas I worked there that the whole IRB process, as it was done at MD Anderson for clinical research, didn't fit for research that wasn't clinical research. And just the whole thing didn't work. And we needed a completely different process. And that became more and more and more evident, andthen a decision was made, I think, by Aman Buzdar, andwho Icould have been Maurie Markman, who was Vice President for Research then, that they needed to add another IRB, and it needed to focus on the issues that dealt with social science kind of research, and non-clinical research, and they asked me to be chair, which was a once-in-a-career kind of opportunity to take a leadership position in the institution. So, I felt like I could do the job, and I liked the idea of starting from scratch, and building it, and fixing the issues that I knew were there. And it was a great job. Hard, time-consuming, stressful, but it was a really good job.

Tacey A. Rosolowski, PhD:

Would you like to leave it there for today? I mean, I don't want to abuse your time.

Linda S. Elting, DrPh:

Sure.

Tacey A. Rosolowski, PhD:

Okay. And then we canI hope I can impose on you for another session, because I know we have more things to ask.

Linda S. Elting, DrPh:

Sure. Sure.

Tacey A. Rosolowski, PhD:

All right, great. Well thank you so much. I mean, this is just a really interesting look at a part of the institution that nobody's really talked about from an insider's perspective before, so very, very interesting. Thank you, Dr. Elting for your time today.

Linda S. Elting, DrPh:

Sure. My pleasure.

Tacey A. Rosolowski, PhD:

Thanks.

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Chapter 16 : Institutional Review Boards at MD Anderson

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