The Precarious World of Bioethics
Today’s breakthroughs in science and technology are improving and extending life for millions of people throughout the world. New approaches to disease monitoring and management are enhancing the quality of life for individuals suffering from chronic illnesses, while developments in bioengineering promise to improve outcomes for transplant recipients, premature infants and other fragile patients.
But the very research and technology that can improve outcomes and extend life can also raise troubling ethical questions. How do we decide which transplant candidates receive organs and which do not, since the demand exceeds the supply? How should we think about prenatal testing for Down Syndrome, which often leads to selective termination of pregnancy, at a time when people with the condition are living longer, healthier and more productive lives? Are pharmaceutical companies preying on economically disadvantaged populations when they go to developing countries to test vaccines?
“That’s where bioethicists come in,” says Sean Philpott-Jones, associate professor of bioethics and director of the Clarkson-Mt. Sinai Bioethics Program. “Bioethicists look at the broader, sometimes competing, interests that can surround an ethical dilemma. We help people who are struggling with an ethical problem to use their own moral framework to develop a solution. We don’t tell people what to do; our goal is to get people to ask the right questions, consider the bigger picture and, hopefully, find a patient-centered solution.”
Ethical dilemmas in healthcare settings are often related to end-of-life issues, such as when,
or if, to suspend treatment.
“One example is a hospital team dealing with an older patient who has run out of medical options. Everyone wants to do what is best for the patient but they disagree about what that looks like. There are medical personnel weighing in on quality of life issues, while the family is looking at it another way, and religious beliefs and cultural values come into play. In a situation like this, our job is often to be a mediator and to help these individuals find points of commonality.”
A Growing Need
The need for healthcare and medical professionals, as well as social scientists, lawyers and policymakers, who are trained in bioethics is growing.
Moral precepts have guided the medical profession from its beginning. But it was after World War II, with the widespread introduction of technology into medicine and revelations of human rights violations in medical research in the 1960s, that the field of bioethics was born.
Philpott-Jones never planned to be an ethicist. “I wanted to be an ethnobotonist — the guy who goes into the rain forest and interacts with traditional cultures to find the next great drug,” he says. “But that didn’t really turn out to be plausible.”
Instead, after graduating from college, he worked in international aid and development, then left for graduate school. After getting a Ph.D. in infectious disease microbiology in 1996, he moved to Albany for a post-doctoral position with the N.Y. State Department of Health, doing laboratory work in HIV transmission and pathogenesis.
“As a research scientist, I began working with human subjects, HIV-infected or high-risk women — sex workers in Nairobi, HIV-infected people in The Gambia and injection-drug users in Thailand,” he recalls. “And as I worked with these groups, I became concerned about ethical issues. How did we recruit them? What were we promising them? How did the stigma of participating in the research affect them?”
Philpott-Jones saw an article in the newspaper about the bioethics graduate program at Union Graduate College (UGC), now Clarkson University, which, at the time, focused exclusively on clinical ethics. In 2006, he graduated from the program. Three years later, after working for a nonprofit focused on global health, he got a call from Bob Baker, founding director of the bioethics program. Philpott-Jones joined the Department of Bioethics as a full-time faculty member. Two years later he was named interim, and then director, of the program.
His reputation in the field of research ethics is firmly established. He has served on numerous national and international review boards, including as chair of the Environmental Protection Agency’s Human Studies Review Board. He has published widely on issues, ranging from the ethics related to pesticide testing on human subjects and access-to-care issues raised in HIV-prevention trials to the illegal distribution of painkillers and other addictive drugs.
Most recently, Philpott-Jones has raised concern over the serious threats to human health posed by the Zika virus and a probable increase in its global distribution and transmission rates as a result of the Rio de Janeiro Olympics.
A Program Not Limited by Geography
Today, Clarkson's Department of Bioethics offers both a master’s degree and a certificate program. While maintaining a clinical focus, it is the only program in the county that also offers a specific focus in research ethics. In addition, the department administers two NIH-funded Fogarty International Center grants to teach research ethics to physicians, educators and scientists in Central and Eastern Europe and the Caribbean Basin.
For both the students and faculty, one of the strengths of the program is its hybrid format. Designed primarily for online delivery (and the first of its kind to be approved by a state education department), the program requires students to participate in three on-site practicums — two on the Schenectady, N.Y. campus and a clinical practicum at the Icahn School of Medicine at Mount Sinai.
“We are not limited by geography, and that benefits our students,” says Philpott-Jones. “We’ve had students from 27 states and 15 countries. Diversity — geographic and professional — is a strength of our program. A multitude of voices makes the learning experience that much richer. When we bring the students together on campus, they develop closer relationships with each other and with our faculty.”
“With no on-site location requirement, we also attract the best faculty — world-renowned experts working in the field,” he adds.
The program focuses on practical training. “We want students to go on to work as clinical-ethics and research-ethics professionals.” One way students get practical training is by working in clinical scenarios at Mount Sinai, where they interact with "patients" — trained professional actors who mimic symptoms and memorize detailed medical histories.
That emphasis on practical training, along with the opportunity to focus on research ethics, is what attracted Dr. Lindsay McNair ’13 UGC (M.S.) to the program.
McNair, who is trained as a general surgeon and also holds a master’s degree in public health, spent much of her career in the biotechnology and pharmaceutical industries, providing medical guidance and designing protocols for clinical trials. She had also been involved in ethics committees and in work to protect human subjects.
“Getting the master’s degree in bioethics was a way of bringing my medical and research-ethics backgrounds together and advancing professionally,” she says. “It also gave me a level of academic credibility in ethics that people don’t expect from someone who spent many years working in pharmaceuticals.”
Today, McNair is chief medical officer of WIRB-Copernicus Group, the world’s largest provider of regulatory and ethical-review services for clinical research. She started at the company in 2013, two weeks after she completed her bioethics degree.
For medical personnel and researchers, a grounding in bioethics is becoming a necessary component of their training and will aid them in navigating a complex world of medical innovation, legal compliance and the social and moral implications of treatment for their patients.
But the benefits of bioethics extend well beyond the medical community. For Provost Chuck Thorpe, the addition of the Bioethics Program at Clarkson is a natural fit for a University that educates engineers, scientists, business leaders and healthcare professionals. “Ethical considerations come into play in everything that our alumni deal with in graduate school and in their careers — the technology and systems they design, the research they perform, the healthcare they provide and the policy they influence,” he says. “We need leaders who consider the broader implications of what they do and the decisions they make.”
Innovative Surgery or Research without Consent?
For her thesis in the bioethics program, Lindsay McNair ’13 UGC (M.S.), M.D., M.P.H., M.S.B., surveyed the chairs of surgical departments at academic institutions to assess awareness levels of surgical-innovation recommendations and the distinctions among surgical practice, innovation and research.
“In medicine, the introduction of a new drug or medical device is subject to extensive review,” says McNair. “In contrast, when surgeons modify or deviate from standard surgical techniques, they are not subject to formal oversight.”
“A surgeon, who tries something new — once or even twice — to improve a patient’s outcome, is operating within the scope of professional discretion. But, if he or she tries a new procedure multiple times, with the intent of generating data so that information can be shared with others to inform changes in practice, at that point it is no longer surgery; it is research that is being performed on the patient.”
And that, she says, is where ethical issues of informed consent and patient protection come in.
Back in 2008, the Society of University Surgeons (SUS) recommended the creation of institutional surgical innovations committees (SICs) to ensure appropriate oversight and disclosure of innovations. McNair’s research focused on the level of awareness of the SUS recommendation and the existence of SICs or other mechanisms for oversight.
Her conclusion: Only a minority of chairs of surgical departments is aware of the SUS recommendation, and less than 25% of departments had an SIC.
As it stands today, most institutions still rely primarily on the professionalism and ethical standards of their medical faculty to oversee surgical innovations, rather than an internal peer committee or review board.
Her research was published in the Annals of Surgery in 2014.