Duke Medical Ethics
Understanding the Complexities of Health Interventions with Dr. Robert Malkin
Q. Could you introduce yourself and what you do as a faculty member at Duke?
A. I am a professor of the practice of Biomedical Engineering and Global Health. I teach classes in both biomedical engineering and global health, and my research is primarily focused medical equipment in resource-poor settings.
Q. In your experience in BME research as well as in the field, are there any unique ethical challenges that a biomedical engineer faces in their line of work?
A. Absolutely. The two that I think are the most prominent are that most medical equipment is attained through donations and the problem of field repairs. But let me talk about donations first. Donations bring up two problems. One is that the majority of donations do not work. This brings up a long list of ethical issues. But primary amongst them is what is your ethical responsibility when you’re donating something. Among the questions would be are you obligated to distribute information. How about manuals, manuals in language they can read and whatnot. How about supplies? There are three major players in all donations: the donor, the middleman, and the recipient hospital. And it is unclear where those responsibilities lie between those three players. And regarding field repairs. It is generally impossible to execute a eld repair of technologies to the same standards as a U.S. repair. Let’s say a piece of technology breaks in Kenya. Even in the capital city of Nairobi, it can be impossible to execute a field repair due to a lot of factors such as a lack of materials or diagnostic tools. This brings up a lot of ethical questions, primarily, is this acceptable? Is it acceptable to have a second standard of repairs in a remote site compared to the United States?
Q. Usually, with many of the innovations in health- care technology, you see that the richer patients are the only ones that can afford them. How can we guarantee that these innovations are accessible to people of all socioeconomic levels?
A. You cannot. That’s absolutely impossible. All medical technology enters the market in narrow slices. You can potentially change the slice that is first served to the neediest, to the poorest, or to the richest. But there is no way for medical innovations to enter the market accessible to all people all at once. There has been no desire to do that. Medical technology is introduced in niches and narrow categories intentionally. It protects the wider public from exposure to technologies that are defective. So that is not going to change. Technology is always going to be introduced into narrow slices and eventually into wider slices.
Q. On a daily basis, how much of a role does medical ethics and patient autonomy play in your line of work?
A. Well every rollout of technology is subject to ethical review. We can’t introduce anything without ethical review. It’s huge. Everybody in a lab, every student, any person that is remotely touching a new piece of equipment has to go through ethical training. Ethics is a major chunk of what biomedical engineers have to address.
Q. So on that note, in the process of product roll- out, what is the typical ethics criteria that an ethics board goes through?
A. The first one that we encounter the most is consent, informed consent. That could be super tricky because you are going across language barriers and cultural barriers. Getting informed consent is the first priority usually. How are we going to inform and how are we going to get consent. After that, there’s the usual criteria such as bene t-risk ratios. But overall, informed consent provides the most challenge.
Q. In terms of medical technology, with the rise of systems such as electronic registration systems, do you see any concerns with the dehumanization of healthcare especially as doctors seem to be seeing their patients less and less?
A. No and yes. First off, most of what I do is in rural parts of the world. For instance, in the U.S. we have a program in West Virginia and also in other parts of the world such as Belize and Guatemala. In the rural parts where we work, most of our patients never see a doctor, so they already have zero contact. So what’s happening is that patient care is being pushed into lower cadres. Nursing assistants, traditional healers, etc. These lower healers, in terms of years of formal training, are what people are actually seeing. It isn’t particularly obvious to me that the number of contact hours for healthcare workers has changed recently. In fact, it may have gone up in some countries. the type of worker that the patient sees has changed, but the amount of time patients are being seen is actually go- ing up. And to address medical registration systems, I cannot see any influence. If anything the time patients are being seen has increased in developing countries as there is less paperwork.
Q. As a conclusion, what is the most important part about your eld of work that you’d like to emphasize.
A. All engineering, including BME, is done to help people. That’s why someone becomes an engineer, they want to make the world a better place. That’s why most of us get into engineering. For biomedical engineering that is done through healthcare equipment. From my perspective, it is the most exciting eld of engineering. I’ve been in engineering for a while, and in my time, BME has constantly been changing. It isa great eld, and I think we have succeeded largely in making the world a better place whether it be in treating polio or eradicating diseases like smallpox. Biomedical engineering has made a significant contribution to society.
Q. In light of all the achievements BME has helped accomplish such as the eradication of smallpox, what is the next step?
A. Well, there’s a couple of things. We’re seeing now a lot of developments in tissue engineering. There is going to be engineering of tissues such as cartilage, and there will even be more complex developments such as retinal replacements. Tissue engineering is going to be huge. Next, there is also engineering at the molecular level. We’re starting to see that in examples like CRISPR. But there is a lot more exciting engineering going on at the molecular level in instances like very targeted cancer treatments. The basis of pharmaceuticals for thousands of years has been finding molecules in the wild and refining them for drugs. But now, specific molecules are being developed artificially.
This interview was conducted and compiled by Paul Kim of Duke University