Chapter 19: Researchers in Relationship to Institutional Review Boards: A Perspective from an IRB Chair
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Description
In this chapter, Dr. Elting responds to the observation that many researchers have an adversarial view of IRBs. She underscores the importance of training in IRB issues and then explains that she was responsible for formalizing MD Anderson’s IRB training program for new faculty members and research nurses.
She explains her strategy of addressing IBR mistakes while she served as Chair (Institutional Review Board IV, 2003-2005). She gives examples of the kinds of issues that would arise and explains why they appear, particularly in the social sciences departments.
Dr. Elting notes that the IRB she chaired was formed to handle issues arising from research projects, such as hers, conducted in the community with non-MD Anderson patients. She explains the issues that would arise and gives examples of creative solutions to these unexpected situations.
Identifier
EltingL_04_20150423_C19
Publication Date
4-23-2015
City
Houston, Texas
Interview Session
Linda S. Elting, DrPh, Oral History Interview, April 23, 2015
Topics Covered
The University of Texas MD Anderson Cancer Center - An Institutional Unit; Building/Transforming the Institution; Institutional Processes; Understanding the Institution; The Professional at Work; The Researcher; Ethics; Contributions; Leadership
Transcript
Tacey A. Rosolowski, PhD:
This is explaining something else I noticed from my background research, which is that you do a lot of training and explaining about IRBs. I can see why that would be the case now.
Linda S. Elting, DrPh:
Yes. Yeah, everybody and their brother in this institution wants the chair of the IRB to come and give a talk to their department about the current problem or issue. And everybody who trains fellows, and everybody who trains budding scientists, they just all want to know. Can we have a question and answer period? Well, with the number of departments and the number of researchers, pretty soon the answer has to become no. There are only so many IRB chairs. We do always have day jobs that we have to get done.
Tacey A. Rosolowski, PhD:
So how have the IRBs addressed that need in the institution for education?
Linda S. Elting, DrPh:
Well, to begin with, a training program was developed, which is required for all new faculty members. Subsequent to that it was required additionally for all research nurses in the hospital. And IRB had a big part in those training programs. It's all about research methods. That's one way to get it out there. We as individuals did a lot of lecturing, particularly to fellows and trainees, since they were often the people who were implementing research that was being run by faculty members. So we did a fair amount of that. And we've attempted to formalize the training a lot. We've identified online resources that people can use and go back to where they can also get certifications. We've done some materials of our own. There have been many situations where there was some new requirement we were made aware of and it required that people do things where I just sat down and wrote direct instructions, and they went out on the Web. Here's this new form that we're required to fill out by HIPAA. Here's the questions. Here's the things that must be found in your answers. That kind of thing, to expedite stuff. So that's generally how it was handled. Personally, I did a lot of calling PIs who were making mistakes over and over again and talking to them to point out, look, this is a problem, it's showing up in the work you're doing. It would be much faster for everyone involved if you would just change it to this. For people who just couldn't get it, I have occasionally appointed them as a member of the IRB (laughter) where you get to see how it works and see what questions people are asking and all that. So that I think has been helpful. Often when I had a department that always seemed to have a problem with protocols and with doing things, I would just push and push and push until they would give me a member of their research team who would be a member of the IRB. And after about six months on the IRB the problems would start to go away.
Tacey A. Rosolowski, PhD:
Oh. Interesting.
Linda S. Elting, DrPh:
Because researchers don't naturally think in terms of regulations. And more importantly, it's hard for them to think of solutions for the challenges. So once you've been on the IRB a while, you see what the solutions are, or the ways to avoid problems. So that was an effective way for me to work. Now that's partly because there are a limited number of departments that send tons of protocols to my IRB. Whereas with the clinical IRBs, they get them from all over the hospital. So that was more difficult for the clinical IRBs to implement. But for my IRB the majority of the full review protocols and the protocols with problems came from maybe five or six departments. So being sure that there was adequate representation from the different research teams was not hard to do.
Tacey A. Rosolowski, PhD:
And was the concentration of the difficulties in those departments a question of just individuals and accident? Or was it something about the style of thinking in that department that was really out of sync with thinking about regulations?
Linda S. Elting, DrPh:
I think it was two things. It was first of all because when those departments first startedand those are all newer departmentswhen they first started
Tacey A. Rosolowski, PhD:
Do you feel comfortable naming the departments?
Linda S. Elting, DrPh:
Oh yeah. It's the ones in cancer prevention. Things like behavioral science, epidemiology, the whole cancer prevention program, all of those things. Those were newer departments that came to the institution say in the "˜90s. And they brought social science research to this institution. But they then began submitting their research to a clinical IRB, to a bunch of people who had never seen any social science research before. And so it was reviewed as if it was clinical research. That was very awkward. So that's why my IRB was eventually started, because the goal was to have excellent social science research, not social science that had been fit into a clinical science mold. But the initial problems were that, that they were people talking two different languages. And the other part of that is that they came from a different environment of training. They came from colleges and universities, not from clinical practice. And so a lot of the things that they would submit didn't have the clinical piece, much appreciation for that. So you would have somebody who was a basic science researcher who wanted to draw fifty ccs of blood from a cancer patient. And we don't have any patients that can spare that amount of blood. And there wasn't much of aor people who wanted to do exercise interventions in folks who had had a bone marrow transplant who could hardly get up out of the bed because of lack of energy. And so it was that melding of the clinical and social science piece that took some finesse. And it was something that every new researcher who came to the institution had to learn.
Tacey A. Rosolowski, PhD:
Yeah. Well, it's interesting, because it sounds as though the IRB provided another way for a researcher to perfect his or her craft, if you want to put it that way. To learn new
Linda S. Elting, DrPh:
Well, I would love to put it that way. They wouldn't. They would say they had been doing research successfully for years the other way. And we put in unnecessary barriers. And they may be right, some of the time. A lot of it had to do with expanding our knowledge of how to do this kind of research and what truly is low risk.
Tacey A. Rosolowski, PhD:
Yeah, but it sounds to me like the examples that you gave, for example trying to do an exercise program in a population that couldn't. I mean that's necessary information for a researcher. They're learning more about the population at that point.
Linda S. Elting, DrPh:
That's true. And so those were the kinds of things that were issues that we had to deal with. The other thing that was really different about my IRB was that so much of our work was done in the community. It was not done inside these walls. And that caused all kinds of issues. It was research that was done on people who were not our patients. So they don't have a medical record number. So they can't go into the whole big database of all the people whoso things like that that seem so basic and simple were huge problems to fix, because of the systems in the institution. Protecting the research staff was something that we worried about in the institution as it was worried about by different groups of people. There's the employee health and safety people. And they work on things like needle sticks and those sorts of things inside the institution. But when you're drawing blood from families in the Valley to do epidemiologic studies and one of your staff gets a needle stick, what do you do? Those are the kinds of issues that I had to write new policies for. We had to develop new kinds of procedures for those studies. What do you do for a sociologist who's going to be traveling with seasonal farmworkers around the state of Texas, entering information in a database on a computer about how they're doing? And how do you protect them and the subjects when the people who hire them don't necessarily want people to know about their occupational exposures to pesticides? What do you do when you get the answer that this bunch of people were exposed to these pesticides? How do you ensure you can find them again if they've been exposed to something bad? All of those kinds of issues were new to the institution. They were things that had been dealt with by other institutions, primarily universities, but not by hospitals like MD Anderson. So that was the cool part about the job, because it was so new. It's creating a whole new thing and a way to do things. That was the really exciting part.
Tacey A. Rosolowski, PhD:
I can see where it's also complementing too the work that you were doing at the same time in the effect of policy decisions. There's just a real nice intellectual environment that you were creating at that time for yourself.
Linda S. Elting, DrPh:
Yeah. But because it was new, and because I didn't necessarily think I had the expertise to do it all, I think I did a good job of engaging the researchers themselves and in just saying, "œWe've never done this before at MD Anderson. We need to write some policies about how to do it well. I know what the regulations say. You know what you need to do to do the research. Let's sit down and figure out how we can make this work with the minimum amount of problems." And so I tried very hard to keep good working relationships and good partnerships with the investigators who routinely sent their work through the IRB so that we could handle these problems when they came up quickly and efficiently. Because usually it was like that. I would get a call. It's always on Friday afternoon. So-and-so has a research assistant who's in Brownsville and they're doing the protocol and they're drawing blood and it's an anonymous study, they're just doing fifty people in this area. And they've got a needle stick. Which means from our perspective as a health care provider, as a hospital, we need to have that subject tested for HIV. But they never agreed to that before the study. And then if it's positive, what do you do with them? Because they need help immediately if they're positive. So that's why it was such a good job. It was very cool. Because there was always something weird happening. Somebody figured out a new way to have a problem doing really straightforward research.
Tacey A. Rosolowski, PhD:
Now you mentioned at the end of our time together last time, and it was actually off record, you said that unlike a lot of people at the institution, social sciences people like IRBs. Or maybe I misunderstood your implication.
Linda S. Elting, DrPh:
I think they liked our IRB, because they were part of it.
Tacey A. Rosolowski, PhD:
And so this is the close working relationship.
Linda S. Elting, DrPh:
Yeah. Because most of what they did and sent through the IRB would be considered low risk. So all of this rigmarole about protecting the subjects, while absolutely still true, was less a problem. And so the goal often for low risk research was to minimize the burden to the researchers for really good research that put people at very low risk. And that's completely different than the clinical IRBs where they're irradiating people and giving them poisons. So the subject is number one, and to heck with the researchers, we're sorry it's hard, just do it. And that's appropriate. But in low risk research where you're doing surveys or you're drawing a small amount of blood and it's going to be anonymous, that's very very low risk. And so we worked hard to create new ways to reduce the barriers. And we created new policies to allow people to do things with verbal consent. Verbal consent was never used before I was the chair. No one ever used verbal consent. But we used verbal consent routinely in a lot of these studies. It actually lowers the risk to the subjects because you don't have to take their name. And that was interesting too, because here are your regulations, you know you have to follow them, we all do. But here's the requirements of the research. Now how can we do this? Reduce the barriers but still be compliant with the spirit of the law. And so that was another good thing about the job, because we did a lot of that. We did a lot of creating good solutions that reduced time and effort.
Recommended Citation
Elting, Linda E. DPh and Rosolowski, Tacey A. PhD, "Chapter 19: Researchers in Relationship to Institutional Review Boards: A Perspective from an IRB Chair" (2015). Interview Chapters. 723.
https://openworks.mdanderson.org/mchv_interviewchapters/723
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