The Ethics of Translational Research

Lorell LaBoube

It's called Frontiers, the Heartland Institute for Clinical and Translational Research. Based at the University of Kansas Medical Center, its aim is to transform laboratory discoveries into treatments and cures. We'll talk about Frontiers and the ethical component of that program in this edition of the Bioethics Channel, a production of the Center for Practical Bioethics. For more information about the Center and its programs, visit practicalbioethics.org. Practicalbioethics.org. Lauren Aronson is a principal investigator and deputy director with Frontiers and a professor at the KU School of Nursing and Department of Health Policy and Management. Dr. John Lantos is also with us from the Children's Mercy Bioethics Center, along with Glenn McGee, the John B. Francis Chair at the Center for Practical Bioethics. Lauren, let's start with you. Give us the basics of Frontiers, the Heartland Institute for Clinical and Translational Research.

Lauren Aaronson

Frontiers is a new program that we have launched here in the Kansas City region. It is part of a national effort that is supported by the National Institutes of Health. There are 60 institutions across the country that have these awards and that operate as a national consortium. We were thrilled to become a member of this select group to work and support clinical and translational research, to move discoveries that we have in laboratories more rapidly into first trials in humans, and then to move further with all of the clinical research findings and discoveries that emerge into actual practice in healthcare to benefit the public, which is our ultimate goal.

Lorell LaBoube

Now, this isn't just the University of Kansas, but you have partners that include two other academic institutions and eight health delivery systems. So it's more of a regional effort, I suppose.

Lauren Aaronson

Absolutely. This is really critical to the effort that we are doing. We have partners across the Kansas City region and across the state of Kansas. So we really are reaching out to a number of partners here. and health care delivery systems to make this a larger regional effort to facilitate and help all of our scientists and investigators work together, collaborate on important health research.

Lorell LaBoube

This was funded by a grant from the federal government from the National Institutes of Health.

Lauren Aaronson

Correct. And that program is called the Clinical and Translational Science Award Program. The acronym for that is CTSA. We find a lot of acronyms in the federal government.

Lorell LaBoube

Amazing how that works. Well, ethics is incorporated into this endeavor as well, and Dr. Lantos, talk about how important it is to have ethical considerations at the forefront of an effort like this.

Dr. John Lantos

Sure. The CTSA program was established. developed in order to promote quicker transition of scientific discoveries from the laboratory bench to the patient's bedside. It's a bench to bedside program. And what happens when you try to take a new discovery and introduce it into clinical medicine is you have to test it on people. You have to enroll people in research projects, and by their very nature, research projects sometimes have unexpected side effects, unexpected risks, unexpected problems, and that's where the ethical controversies lie. Which patients are going to be the first to try a new discovery, and what do we do when we find out that some bad things have happened that weren't predicted?

Lorell LaBoube

And this starts, Glenn McGee, at the very beginning at the foundation with studies, design and implementation of these studies. It's important to get that right, isn't it?

Glenn McGee

One of the reasons that I'm so excited about working with and for Dr. Lantis on this is that John really gets something that is important, in my mind, about how fast science has advanced to the bedside from the bench. It's been very hard over the years. for us to learn how to train both physicians and researchers, not only about how to get along, they get along fine most of the time, I think, but also, as John put it, about how to deal with the confusing reality of research. On the one hand, researchers have to struggle with translating the language of their scientific grant into real, meaningful information about risks and benefits, and on the other hand, medical students, doctors, and others have to often play dual roles as research becomes part of both their clinical activity and their research activity. So here's Kansas City, a booming area for bioscience, where translational medicine, or translational research, depending on who's talking,

Glenn McGee

is going to explode, and it's also a place where there's an enormous amount of clinical research going on. We have to capture, I think, in a better way, and the CTSA is the brass ring for an institution or a group of institutions to capture it,

Dr. John Lantos

how

Glenn McGee

to best educate scientists and doctors and nurses and others and also how to educate the public and patients so that that effort from bench to bedside doesn't feel so much like the express train, and also so that we don't fall into the almost inevitable pitfalls that come with the introduction of, for example, a radically new area of research.

Lorell LaBoube

So, Dr. Lanto, it sounds like we have a couple of different mindsets that are trying to play well together.

Dr. John Lantos

Would it be fair to say that? Well, there's a tension between science and clinical care. The scientist is working to advance knowledge. The physician is working to care for the patient. There's overlap as well because patients want the best treatments, and the best treatments are often the newest treatments. So the scientist and the clinician working with institutional oversight committees try to design studies that advance the science while not putting the patient at any increased risk. Here's the way it works. Anybody who has a scientific study they want to do

Glenn McGee

has to present that study to the Institutional

Dr. John Lantos

Review Board. The Institutional Review Board is a group of peers and public representatives who look at the study and make sure that it's scientifically sound. but also make sure it's ethically sound, that it doesn't deny the patient any known benefits, make sure that the informed consent process is adequate, and make sure that data are reviewed as they accumulate and decisions are made about when to stop the study or whether there are unexpected adverse events that should be considered.

Glenn McGee

Glenn? Another piece of this that has changed a great deal in recent years is awareness of the importance of community. So the community's involvement isn't just the partnerships between institutions, but if you take, for example, emergency research and research, as John knows very well, involving children and others who aren't able to give consent, we've just generally become aware that our traditional methods of getting consent and so on for individual studies aren't enough. If you're going to engage in research where people cannot consent, for example, someone who's in an accident, and you want to advance emergency medicine, sometimes you have to have, and in fact there are federal exceptions made for this sort of research, sometimes you have to have a conversation with the community to make them aware, for legal reasons as well as moral reasons, that there are such programs going on. You don't want to ever say a federal program is a panacea, but the CTSA programs have probably done more than anything else to focus attention on consulting with communities, developing mechanisms for getting buy-in from community leaders to make that happen, and helping the community's involvement with research to be one that engages their trust. rather than their suspicions and fears about that scary word, experiment.

Lorell LaBoube

And, John, an important component of this, too, is the underserved, perhaps minorities, getting inequitable treatments, and that's an important piece of this as well, isn't it? Or, Lauren, can you address that?

Lauren Aaronson

Yes. We actually, in two components of the program, there is a whole community engagement program as well as the ethics program, and they will be working – closely together to address some of those concerns about disadvantaged populations and the special needs of different populations that may need additional attention to ensure both their clear understanding of studies to help our investigators learn from them as well what kinds of health issues are of most concern to them that they would like to see research be conducted on. The program, the ethics component, and we are just excited about the team that we have been able to put together for this program with John and Glenn and the involvement of the Center for Practical Bioethics and Children Mercy's bioethics program as well. has just been a very exciting opportunity for all of us to be working together for the entire breadth of issues and concerns that come up when you're interested in conducting clinical and translational research. Glenn mentioned earlier the issues of education.

Lauren Aaronson

Much of what we've talked about so far has been more the infrastructure end of things of supporting investigators to do research or working with communities. There's another very important large component to the entire national CTSA program, and that is the educational arm to train the next generation of clinical and translational investigators and to excite more physicians, nurses. dentists, pharmacists, and others who would be interested in moving their careers in the area of clinical and translational research.

Lorell LaBoube

So, John, how do you see this unfolding as we move forward with this? How will things work as all of these things start coming together and from the ethical perspective, how that will inform how we move forward on something like this?

Dr. John Lantos

Well, one of the first things that... We will try to do, because this is a regional program, is to bring together the people who are responsible for the ethical oversight of research at all the partner institutions, Children's Mercy, KU, St. Luke's, UMKC, and the other clinical centers to figure out whether there's a better way to educate researchers and to identify the ethical problems that arise in the projects that they're doing and so that we can analyze them, write about them, and really ensure that KU and the Kansas City region are at the forefront both of clinical and translational research, but also the ethical analysis of problems that arise in research.

Lorell LaBoube

Is there a unique infrastructure in Kansas City that allows this project to be able to do that?

Dr. John Lantos

Oh, Kansas City is the best place in the world to do this kind of research. Partner institutions have been meeting regularly. The hospitals and research centers are phenomenal. The people involved in the program have been remarkably cooperative and receptive to incorporating ethics into the very foundation of this project. So I think great things are going to happen.

Lorell LaBoube

Now, Glenn, with projects like this, there's always a surprise. There's always the unexpected. Putting on your crystal ball a little bit, what do you think might be a surprise or unexpected from this endeavor? Well, in bioethics,

Glenn McGee

you usually get

Lorell LaBoube

hit with the crystal

Glenn McGee

ball. And, you know, in research ethics training, one of the things that's so difficult that has been over the years is, you know, you have a large group of physician scientists in training in front of you, and you tell them stories about how people paint white mice black to accomplish their results or how they've invented an embryonic stem cell technique. clone that didn't really exist. It's astonishing some of the really egregious behavior that's happened in science. It is harder to get across, it has been anyway, the positive effect of doing ethics and science together, the leadership component that that can bring to a research project that might otherwise not receive attention, even on its scientific merits, by pushing the ethics piece. This is a pretty boring suggestion, but it's a paradoxical question. If I knew the surprise, of course I'd be a magician. I think it would be really amazing and maybe even it's predictable that if this city, which has done so much work, for example at KCUMB in a program that's I think unique nationwide in using model research subjects, I think this city could develop a model for helping those who are medical students and others, as Lauren mentioned, across the variety of health-related spectrums, understand, believe in, write about, think about, and build into their training. The idea that ethics isn't something where a guy with a gun and an ethics badge comes in. Ethics is something that... actually advances the world. I mean, literally five, ten years ago, people tried to do this informally. We'd go to scientific investigators and say, hey, write in 10% of your budget for ethics.

Lorell LaBoube

And they would.

Glenn McGee

And then money would come back from the NIH and there would be a 10% cut. And guess what? It went out the

Lorell LaBoube

window. Ethics.

Glenn McGee

So I think here, and perhaps as John said, uniquely here, the development of relationships and of KU's capacity, its unique new school of public health, of all of the things that go on in history in philosophy of medicine, and all of the partner institutions, one of the nation's only centers for pediatric bioethics, center for practical bioethics, outreach, or community, if all those things were to come together in the right way, a model that actually taught scientists that the morality they bring to the lab is more than what they learned in the sandbox, could be advanced. And that would be the biggest change, in my mind anyway, in the practice of science in 100 years.

Lorell LaBoube

Now, Lauren Aronson, we've been waxing eloquent about the capabilities of Kansas City, but we should also note that within CTSA, that these groups, other groups across the country also have an ethics component. So it's not just regional here, but it's national through this effort.

Lauren Aaronson

Absolutely. And the national effort, because it functions as a consortium, has committees on each of the what is called key functions of CTSA institutions across the country. And so both John and Glenn are members of the Ethics Key Function Committee. and they regularly meet via webcast conference call meetings and may have an occasional in-person meeting as well so that not only can we share the exciting innovations that we can bring to the national consortium, but we also can benefit from the innovations, new ideas, approaches that come from other institutions across the country.

Lorell LaBoube

Lauren Aronson is Deputy Director of Frontiers, the Heartland Institute for Clinical and Translational Research, and a professor at the KU School of Nursing and Department of Health Policy and Management. Dr. John Lantos is Director of the Childless Mercy Bioethics Center, and Glenn McGee is the John B. Francis Chair at the Center for Practical Bioethics. I'm Laurel LeBue. Thanks for listening to the Bioethics Channel.