By Susan Ipaktchian
Illustration by GÉrard Dubois
The resident is seated at the conference table giving her colleagues an overview of a patient in one of Stanford Hospital’s ICUs. The unconscious man with no ID had been brought in the previous day after being found in a pool of blood. He had vomited an additional 5 liters of blood and his condition remained unstable. If he begins to bleed again, the resident says, the medical team feels there’s little more that can be done.
Next to her at the table is David Magnus, director of Stanford’s Center for Biomedical Ethics and a regular participant in the weekly ICU interdisciplinary rounds, along with physicians, social workers, nurses, respiratory therapists, dietitians and clergy. At these sessions, the participants review the status of all the patients currently in the medical ICU. “Who is making the decision to discontinue medical care?” Magnus asks the resident.
“Well,” she replies, “we are.”
“You can’t do that,” Magnus points out, explaining that for an unresponsive patient with no designated representative to make a decision, an ethics consult is required. The ethics team would assess the situation and make a recommendation to the hospital’s chief of staff, who would then make the decision. “So, are you requesting an ethics consult?” Magnus asks with a gentle smile. The resident assents, and Magnus writes himself a note to follow up on this case.
A clinical ethics consult — which addresses situations such as how to protect a patient from the harmful acts of a family member or whether a psychiatric patient can refuse treatment — allows a small, multidisciplinary team to gather relevant facts from all of the involved parties, elucidate values and make recommendations in which those values are prioritized. In emotionally wrought circumstances when there may be conflicts between the desires of the patient, the patient’s family and the doctors and nurses providing care, the ethics team works to provide thoughtful, respectful and evidence-based guidance. The team approach is a stark contrast to the early days of medicine when doctors alone made the decisions, often without consulting the patient.
No longer relegated to the background, bioethics has become a strong team player in the medical establishment as society wrestles with such high-profile issues as the role of stem cell research and how to handle end-of-life care. And in these situations, bioethicists wear many hats. They give scientists and clinicians practical tools and advice for dealing with the ethical, legal and social ramifications of their work. They also play roles in educating the public, protecting the rights of patients and giving a voice to vulnerable populations.
“The world of medicine has been washed up in this tsunami of commercial health care, and it makes it very difficult to see each patient as a person,” says Albert Jonsen, PhD, one of the early bioethicists and author of The Birth of Bioethics, among other books. “That’s what bioethics is supposed to do.”
Bioethics’ reach extends far beyond the bedside and the practice of clinical ethics. Its primary purpose is to inquire, reflect and debate the ethical issues associated with medicine, bioscience and health. Somewhere between 2,000 and 6,000 people in the United States focus on bioethics as their primary area of research, teaching or clinical practice, says Magnus. Their debates play out in a variety of venues, from the courts, to the halls of government, to the media.
And yet, despite the field’s growth since the 1970s, bioethics is still maturing. Its practitioners face skepticism from those who believe bioethicists have built-in biases and an overly “American” approach that lacks a true understanding of other cultures’ values. The field also has internal struggles: Should its training programs share a common curriculum? And — a biggie — should clinical bioethicists be certified?
“Bioethics is a field that is always evolving because it exists in relation to newly emerging moral questions in society,” says bioethicist Laura Roberts, MD, professor and chair of psychiatry and behavioral sciences at Stanford. “The field itself struggles — we are always trying to make sense of things and to understand and resolve complex issues in ways that rely on more than mere intuition.”
And though the struggles may take time to resolve, bioethicists are doing what they do best — rolling up their sleeves, gathering as much information as possible and going where the evidence leads them.
Two days after Magnus steered the ICU resident toward an ethics consult for the unconscious patient, a hospital social worker learns the man’s identity and tracks down his brother. With a family member involved, the ethics consult is no longer necessary. Examinations show the patient, in his 40s, suffered significant brain damage and among other problems is in liver failure. While the hospital will continue to treat him, the man’s family signs a do-not-resuscitate order which means that there will be no attempts to revive him if his heart or breathing stop.
‘We are always trying to make sense of things and to understand and resolve complex issues in ways that rely on more than mere intuition.’
Just 40 years ago, a request for an ethics consultation, now routine, was rarely an option. Few hospitals or academic medical centers had bioethicists on staff. Jonsen notes that when he accepted a position at the University of California-San Francisco in 1972, he was only the second bioethicist on the faculty at any U.S. medical school. The 1976 case in which Karen Ann Quinlan’s parents went to court to remove her feeding tube was among the first to stir public debate about the ethics of withholding life-prolonging treatment. The field’s reach soon broadened to the research world with the 1978 publication of the Belmont Report, establishing principles for protecting patients enrolled in clinical trials. Jonsen, one of the report’s authors, says that by the 1980s most medical schools saw the need for bioethicists. However, many of the programs that emerged in subsequent years operated primarily as think tanks and had little involvement with the clinical and research cases arising on their own campuses.
As the field reaches middle age, though, the think-tank approach is changing. An increasing number of U.S. bioethics centers have begun emulating Stanford and other pioneering programs by providing both clinical and research consulting services in addition to conducting their own research. The growing need for research guidance is due in part to a National Institutes of Health initiative to streamline the process of turning lab findings into therapies. This program, the Clinical and Translational Sciences Awards, requires medical schools that receive CTSA funding to offer bioethics consultations to its researchers. Stanford’s bioethics center had been offering benchside consults since 2004, and the center is now providing those services through Spectrum, the program that administers Stanford’s CTSA grant.
Sociologist Renee Fox, PhD, of the University of Pennsylvania is in the unusual position of being both a participant in and observer of bioethics since its inception. Fox has spent her career conducting first-hand studies of the sociology of medicine as well as medical education, research and ethics. Because of her expertise, she was named to the founding board of the Hastings Center, the first U.S. bioethics center.
One of Fox’s main criticisms of bioethics is that its U.S. practitioners don’t always seem aware of just how “American” the field’s foundational values are. For instance, bioethics places heavy emphasis on individual rights, including the ability of informed individuals to freely make decisions for themselves. That focus, says Fox, doesn’t always give enough weight to other crucial values, such as the connection between individuals and others, kinship, community and the common good. It also doesn’t adequately reflect the values of other cultures, which have largely imported the bioethics model developed in the United States. “Bioethics has become global without becoming international,” she says.
It’s important, Fox and others say, for bioethicists to continually challenge their own assumptions about the values underlying their approach as well as the issues they study.
Stanford’s Roberts, a longtime practitioner of evidence-based ethics in support of her work with vulnerable populations, says relying on evidence is critical for bioethicists to understand the impact of their decisions. “Reality is so much more complicated and rich than what we can imagine ourselves,” Roberts says. “Evidence can help resolve certain kinds of questions that good, well-intentioned people might naturally disagree upon. When ethicists have opinions and beliefs that are not grounded in the real experiences of the people whom they are advising, they can do harm despite their desire to help others.”
This point was driven home early in her career when psychiatry researchers questioned the ethics of enrolling people with schizophrenia in clinical trials aimed at finding treatments for the disease. The prevailing wisdom was that people with severe mental illness were incapable of providing informed consent for trial participation, but when Roberts interviewed patients she found this was not uniformly the case. While some clearly fell into that category, she saw others who, though ill and experiencing symptoms such as hallucinations and delusional beliefs, were also “rational, intelligent, wonderfully altruistic, thoughtful and aware.”
“So if there are arm-chair philosophers who are not attuned to the strengths of people with serious illnesses, whether it be cancer or schizophrenia, there is the potential to underestimate, stigmatize and discriminate against them.”
Like many bioethicists of her generation, Mildred Cho didn’t even know what the field was about until she unintentionally wandered in. She began moving toward it when she enrolled as an undergraduate in biology at MIT in 1980 and learned that just a few years earlier the Cambridge, Mass., city council had imposed a three-month moratorium on recombinant DNA research. City leaders were concerned about what the “people in white coats” would do with this frightening new capability to combine DNA from two or more sources.
‘At its best, bioethics can help researchers do better research and it can help translate that research into practical applications.’
“That got me interested in science policy,” says Cho, PhD, associate director of Stanford’s bioethics center. That interest persisted through Cho’s doctoral work in developmental biology at Stanford, and led to a fellowship at UCSF’s Institute for Health Policy Studies.
A big part of her work since joining Stanford’s faculty has been getting researchers to welcome bioethicists into the lab setting, in the same way that clinicians had come to value clinical ethics input over the years. Stanford’s bioethics center was one of the first to offer a benchside consulting service, and has one of the most active such services in the country. Cho, who oversees the lab consults, believes that “at its best, bioethics can help researchers do better research and it can help translate that research into practical applications.”
As an example, Cho says one of the big problems in research involving human subjects today is how to handle “incidental” findings, such as when the analysis of a person’s genome for a clinical trial turns up unexpected results. How should the study participant be told about this? While the trial’s principal investigator may not have considered such a situation, bioethicists have. As a result, Stanford’s bioethicists have helped develop language now included in the informed-consent documents signed by clinical trial subjects addressing how such incidental findings will be handled.
One of the inspirations behind Stanford’s benchside consulting service was a request for advice from Irving Weissman, MD, director of Stanford’s Institute for Cell Biology and Regenerative Medicine. In 2001, he asked for recommendations about creating animal models to study human brain diseases, such as Alzheimer’s and Parkinson’s, that do not normally occur in animals. To do that, he posed the possibility of inserting human neural stem cells derived from patients with a brain disorder into the brains of fetal mice, thereby creating a cellular chimera — an organism made up of two genetically distinct types of cells. Mindful of possible concerns from the public about creating this kind of mouse, Weissman wanted some guidance.
A team of bioethicists researched the case and advised him on how they thought such work could proceed. For instance, they suggested that Weissman conduct the least controversial work first and move slowly to ensure that the brains in the mice didn’t take on human characteristics. So far, Weissman has done some preliminary work by creating mice in which about 1 percent of the brain cells were human.
“Ethics isn’t just about things like informed consent; it’s also about doing research that’s of value to the research participants and to the populations that are supposed to be served by the research,” Cho says. “We can help identify those values and communicate them to the researchers.”
Although many medical schools offer training programs and classes in bioethics, the field is still developing a core curriculum. “In engineering, you can’t have different ideas of how to build a bridge,” Jonsen points out. “Right now, there’s no common curriculum for training bioethicists.”
The lack of consensus about the prerequisites for qualifying as a bioethicist also troubles Fox, who notes that there isn’t agreement on how much philosophy, religion, sociology, anthropology, law and other training students should receive in master’s and doctoral programs. “I really don’t know what they’re learning at Stanford compared with what they’re learning at Penn, for example,” she says, adding that she believes students also need in-depth training in research methods before conducting field interviews and observations, and clinical and psychological training before offering counsel at a patient’s bedside.
And should the curriculum be focused solely on the theories and social-science research methods that underlie the discipline, or should it include training in clinical ethics as well? And should there be a formal accreditation process for bioethics programs?
At Stanford, for instance, students and postdoctoral trainees have the option of participating in the clinical ethics rounds at the two hospitals. The training was particularly useful to former postdoctoral trainee Holly Tabor, PhD, who was hired in 2008 as an assistant professor of pediatrics in bioethics at the University of Washington and a scholar at the Trueman Katz Center for Pediatric Bioethics at Seattle Children’s Hospital. Tabor says that during her time at Stanford, she began shadowing Magnus on the clinical rounds and enjoyed it so much that she trained to become a full-time, on-call ethics consultant at the hospitals. She now does clinical and research consultations as well as studying issues surrounding whole-genome sequencing, such as how the genetic test results are interpreted and delivered to patients. “The clinical work will always be an important part of what I do,” Tabor says.
For years bioethicists have debated how far to go in professionalizing the field — particularly clinical ethics. Currently, there is nocertification process, but Magnus and others think the field is moving toward some kind of credentialing for those who practice clinical ethics. The debate over credentialing has come up repeatedly, says Magnus, and the lack of resolution has prompted a few outside, for-profit groups to express interest in setting up a clinical ethics certification process.
That outside interest, in part, has spurred the American Society for Bioethics and Humanities to update the core competencies for clinical bioethics that were established in 1998, setting forth the skill set required for hospitals that offer clinical ethics consultations. For instance, the skills would include the ability to distinguish the ethical dimension of a particular problem from the legal and medical dimensions, as well as being able to research peer-reviewed ethics publications for precedents. “In some hospitals, there may not be an individual who possesses the full skill set, but there should be a committee or group that collectively has all of the skills,” Magnus says.
The revised core competencies will be published in the coming months, he says, although the requirements would not initially be binding. But he holds out hope that hospitals and other health-care organizations will play a stronger role in requiring that their clinical ethicists meet the core-competency requirements. “It’s embarrassing, in some ways, how poor the quality of clinical ethics is at many institutions,” Magnus says.
One organization that could influence the certification debate is staying on the sidelines for now. The Joint Commission, which accredits all hospitals, currently requires that hospitals have the ability to provide clinical ethics consultations, but hasn’t stipulated the level of expertise needed for those providing the services. Paul Schyve, MD, senior vice president of the Joint Commission, says it “is not contemplating requiring certification of clinical ethicists” at this time, adding that it is up to each health-care organization to determine the competence of the people providing clinic ethics services.
Fox believes some sort of license or certificate would help assure that those practicing clinical ethics have the requisite knowledge for effectively interacting with patients and health-care professionals.
But Jonsen and others, while noting that a certification process would be helpful, wonder if the field is big enough to support the needed infrastructure. “Certification in medicine itself is a very complex and expensive business,” Jonsen says. “I think the world of bioethics may be too small to support that at the present time. And given the diversity of theoretical and practical approaches, it’s hard to figure out how to give a standard examination.”
For two weeks, the unconscious man remains at Stanford Hospital. It’s clear that he has end-stage liver disease and, given his host of other complications, he is not a candidate for a liver transplant. After consulting with the physicians and social workers, his family agrees to shift his treatment to comfort care only. He dies a few days later.
Being part of the decision to withdraw life-sustaining measures from a patient is one that bioethicists don’t take lightly.
While the field debates accreditation and data-driven decisions, bioethicists know that the heart of their profession is aiding people as they confront the most difficult of dilemmas — both in the hospital room and in the lab.
When Lauren Milner arrived at Stanford this past September to begin her postdoctoral fellowship in biomedical ethics, she knew she’d be sitting in on discussions involving the ethical implications of research projects. She was pleasantly surprised to find out that she’d also have the opportunity to participate in ethics discussions in Stanford’s hospitals, listening as doctors and other health-care providers wrestled with decisions involving their patients.