11 No. 3
December 2008/January 2009
Unraveling healthcare's knottiest problems
Researcher’s alleged transgressions lead to more ethics oversight
“Is it reasonable for [a patient] to be able to demand everything be done regardless of what that does to the healthcare system financially, or to its ability to serve a wider population?”
“I don’t think the main role of the ethicist is to tell people what’s right and wrong. One who does that in my opinion abdicates one’s responsibility.”
Medicine and Compassion
Reaching across the silos to teach the "art" of healing
Things I've learned while I couldn't do my research
Egypt and Emory
Small collection, large footprint
Doing what’s right isn’t the problem. It is knowing what’s right.
—Lyndon Baines Johnson
Emory’s vision statement declares that Emory is an ethically engaged university. This bold assertion is in keeping with higher education’s lofty ideals, and it also reads well. But does Emory walk the walk? Certainly well enough to have attracted a nationally recognized bioethicist to head up the Center for Ethics, whose spacious new digs in the new Candler School of Theology building opened in September.
“I had to be convinced that it wasn’t lip service,” says Paul Root Wolpe, the center’s new director. “It’s very easy to create a vision statement and put the word ‘ethics’ in there. It’s much harder to express that through a university’s actions. I was convinced before I came, and it has been validated in the month and a half I’ve been here that in fact Emory takes the question very seriously.”
The center’s highly visible and geographically central location on campus bespeaks the centrality of ethics in Emory’s culture, as do the very broad, public programs such as the Office of University-Community Partnerships, Volunteer Emory, and the Ethics and Servant Leadership program. But perhaps nowhere does ethical engagement have a more urgent, pragmatic, and personal impact than in the corridors of Emory’s hospital system. Hospital ethics committees have become commonplace and convene to sort out knotty problems. Much more unusual, though, is the on-call, pager-carrying hospital ethics consultant.
“If a family member, patient, physician, or nurse feels awkward about the ethics of a biomedical situation, they will call me for a consult, and I will help them look at it from an ethics viewpoint and guide them to a decision,” says Elwood Spackman, Jr., the clinical ethicist for Emory and Wesley Woods hospitals and executive director of Emory’s Center for Pastoral Services. “The most common dilemma we encounter is the appropriateness of withholding or stopping treatment and moving from curative toward palliative care when attempts at a cure become futile.” Often patients cannot speak for themselves, leaving Spackman to mediate between family members and the healthcare team to reach an ethically supportable decision. That might mean helping a family understand why it is ethically permissible to withdraw life support.
“On one side you’ll have the family saying, ‘do something,’ and on the other the medical team saying there’s nothing more to be done that can save the patient’s life,” says William Sexson, Spackman’s counterpart at Grady Hospital. “Sometimes it’s a matter of making sure that family members understand what clinicians are telling them, so that a decision can be made based on clear information.” Sexson, a practicing neonatologist, estimates that 180 to 200 formal ethics consults occur at Grady every year. This is ethics in the trenches, where the types of cases debated in a lecture hall play out for real, and where the goal is not just to find the right solution, but to identify the best right solution.
Ministry or medicine?
As ethicists, Spackman, a Methodist minister, and Sexson, a physician, face the same issues, but they approach them from decidedly different backgrounds. Does that matter?
“Dr. Sexson and I often look at things out of the same set of values, but the lens I look through has more of a theological bent,” says Spackman. “I have to rely on the physicians who are caring for the patient to get a clear medical picture and learn about issues of futility, for instance. I bring to the table the values of life, hope, and reality—that death is not the ultimate defeat—which is very helpful to families, who tend to trust clergy and appreciate a framing out of the emotional dilemma they find themselves in.” At times another chaplain accompanies him to an ethics consult to assume the role of nurturer, allowing Spackman to maintain a more detached,
professional distance—to “be more in my head” and operate from objective clarity.
Sexson, who underwent ethics training well after he began practicing medicine, recognizes that his training as a scientist may influence the weight he ascribes to the various factors in a particular case. “Physicians,” he says, “naturally predicate their decisions on statistics and empirical evidence: what’s going to have the greatest probability of working. When patients or loved ones make difficult decisions, those decisions are frequently based on emotion and are often faith-based. Many people don’t want or need statistics and evidence in making tough decisions.” Medical ethicists, he adds, must understand a decision-making process that may not rely on rational or logical processes. But neither Spackman nor Sexson believe one foundation—
science versus faith—is stronger than another for an ethicist, as long as fundamental principles are applied judiciously and equitably (those being autonomy, beneficence, nonmaleficence, and justice).
“The goal is always to bring people to some agreement and realization of what their ethical values are, not to impose [the ethicist’s] own ethical values,” comments Wolpe. “An ethicist is not there to tell people what’s right and what’s wrong,” and an ethicist wedded to the doctrine of a particular faith conceivably runs the risk of doing just that. “In a pluralistic society, where people have very different kinds of moral perspectives they make decisions from, it is in fact immoral to impose one’s perspective on other people unless they are violating fundamental moral principles.”
Safeguarding informed consent
Even rarer than the staff clinical ethicist is the staff research ethicist. “I’m asked to do research that ultimately improves research, and there may be only ten of us in the country,” says Rebecca Pentz, professor of research ethics at the Winship Cancer Institute. “It’s a very odd position.” Research involving cancer patients is fraught with ethical knots requiring great circumspection, because the stakes are so high. For instance, Phase I drug trials are designed to assess only an experimental drug’s safety, not its efficacy, and in a Phase I cancer drug trial, all of the subjects must have no curative treatment options; they will not benefit from the new drug at all.
“We can’t test cancer drugs for safety in healthy volunteers because the drugs are hugely toxic, so we have to use cancer patients, who are very vulnerable,” says Pentz. And it would be unethical to test them on cancer patients whose disease might be cured with available treatments. “Yet these often terminally ill patients still choose to enroll in a research study rather than receive palliative care that could make them more comfortable.”
In one aspect of her work, Pentz wants to determine whether such subjects fully understood that some of the procedures in a particular clinical trial are for research purposes and will not benefit the patient. “My hunch is that they really don’t all the time and assume that if their doctor asked them to do it, it’s in order to help their care, even though it’s not,” she explains. “The patients we want on these studies are those that do understand and just want to go out fighting.”
In her experience as both a research and clinical ethicist, Pentz has found that many patients harbor therapeutic misconceptions (particularly about non-therapeutic procedures such as a biopsy), believing mistakenly that any intervention being conducted is meant to help them directly, even after they’ve been told otherwise and subsequently provided their informed consent.
Informed consent is a bedrock ethical principle in human subject research. It provides that a person with adequate reasoning understands and voluntarily agrees to participate in a medical trial (or to receive medical treatment, for that matter). Safeguarding informed consent falls to an organization’s institutional review board (IRB), whose raison d’être is to protect human research subjects.
But by acting as a de facto judge of ethics, the IRB inadvertently removes the impetus for researchers to look intensely at the ethical aspects of their study design and relegates ethics to a bureaucratic hurdle, says Karama Neal, adjunct associate professor of biology. She tries to dispel the “all I need to do is get IRB approval” thinking in the two-day seminar on research ethics she teaches to post-doctoral and graduate students in the sciences. “They conflate ethics with regulations, and they often have the attitude that as long as they comply with the rules, whatever they’re doing is ethical,” says Neal. “It can be a challenge to get [students] to move from ‘tell me what I need to do so I don’t get in trouble’ to really thinking about the best way for them to behave.”
Regina Pyke, senior lecturer in psychology, agrees, noting that an unintended consequence of universal institutional review is that researchers may shift ethical responsibility to the IRB and feel comfortable that their research is ethically benign because they’ve met the regulatory criteria. Thus, an IRB provides essential vigilance and oversight, but it may also absolve researchers from anything beyond a cursory deliberation of how well their research methods protect the autonomy and dignity of vulnerable subjects, whether the stresses to which they are subjected are excessive, or whether the risks are ethically justified and balanced.
The role of ethical engagement in psychotherapy is also undergoing a re-evaluation, says Pyke. One earlier social construction of psychotherapy was that of a judgment-free exchange in which patients could expect to avoid moral verdicts or concerns. But in the 1980s and ’90s, critics, some from within psychology, questioned whether psychotherapy had become a way that patients could relieve themselves of ethical responsibility for their actions and choices, such as such as being unfaithful in a relationship or neglecting obligations in other ways. “An ethical discussion doesn’t have to be off-limits in therapy,” says Pyke. “We don’t have to get anxious or change the language if a patient brings up questions that are ethical in nature.”
Ultimately, choices of ethical conduct rest with the individual researcher or clinician. “We depend enormously on these people’s integrity and goodwill and that they will know to do the right things for the right reasons and make hard choices,” says John Banja, professor of rehabilitation medicine a medical ethicist at the Center for Ethics. “Ethics is a discipline about working at those points where it is not clear what to do; where informed—and uninformed—opinions may differ, and where the stakes are high.”
Healthcare has become so technologically and medically complex, adds Wolpe, “that it’s very difficult to make the kinds of decisions one needs to make without looking at the underlying values that inform those decisions.” —S.F.