“Mystery patient” research: Ethically justified or not?

When the Department of Health and Human Services announced plans in 2011 for a “mystery shopper” study of access to primary care, some physicians raised ethical concerns about the use of deception with human subjects without soliciting their informed consent.1

“Just two days after The New York Times reported the administration’s plans, it reported that the study had been shelved,” says Michelle N. Meyer, JD, PhD, an academic fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School.2

Mystery patients can be used to assure and improve the quality of all aspects of the health care system, and health care providers should be supportive of that goal, argues Meyer. “In fact, in some cases, the sponsor of this kind of research might have an ethical obligation to conduct it,” she says, adding that it is the only effective way of producing evidence of discrimination. “One can imagine mystery patients used to help investigate some forms of health disparities that might result from either explicit or implicit bias against certain kinds of patients.”

Context matters

In 2012, researchers from the University of Pennsylvania’s Perelman School of Medicine used a case study to explore ethical principles relating to deceptive research without informed consent.3 They concluded that minimally intrusive simulated patient research that gathers policy-relevant data on the health system without the consent of individuals working in that system can, in some cases, be ethically justified.

“It might seem surprising to take the position that research that involves a deceptive interaction and without any process of consent might be ethically justified. But the context matters,” says Franklin G. Miller, PhD, one of the study’s authors and senior faculty in the Department of Bioethics at the National Institutes of Health in Bethesda, MD.

Simulated patient studies facilitate socially valuable and scientifically valid research to obtain accurate data about access to health care with virtually no risk of harm to subjects, explains Miller. “We offer a set of guidelines for when this type of research is ethical, and discuss the applicable federal regulations,” he says. “I see the role of bioethicists as analyzing the ethical issues at stake in this sort of study design.”

Ethical justification

If approved by an Institutional Review Board (IRB), mystery shopping can be justified by the inability to obtain accurate observations when people know they are being observed, according to Mark A. Hall, JD, professor of law and public health at Wake Forest University in Winston-Salem, NC.

When patients are involved in research, they are almost always being asked to do something to benefit future patients or society that would not be required for their own course of treatment, says Meyer, such as consenting to having an extra vial of blood drawn.

“The potential conflict between the interests of society and researchers pursuing generalizable knowledge, on one hand, and patient subjects on the other hand, is the chief reason we have the IRB system,” says Meyer. Health care professionals, by contrast, are trained and paid to serve the interests of their patients and of the health care system more broadly, rather than primarily to serve their own interests, she adds.

“A mystery patient study thoughtfully designed to determine the extent to which providers are in fact meeting their professional obligations and goals, likewise serves patients and the health care system,” adds Meyer.

Mystery shoppers might be viewed as more ethically troubling, however, when extended beyond a physician’s front office to the actual examination room. “Doing that could compromise the trust-based fiduciary relationship that is at the core of medical ethics, and so, would require extra justification,” Hall says. “But simply contacting a physician’s office to make an appointment or inquire about prices does not step into this special protected realm.”

Here are some ethical concerns involving mystery patients:

• Mystery patients might interfere with the care of actual patients or waste scarce resources.

“This concern can largely be addressed by limiting these kinds of studies to non-emergency medical settings,” says Meyer.

• If health care providers know or suspect that they will be approached by mystery patients, they might view every patient with distrust, which could undermine the patient-provider relationship.

Rather than viewing mystery patients as out to deceive providers, however, providers might choose to keep in mind that mystery patient studies are intended to assure and improve the quality of the health care system. “Every stakeholder in that system, including providers whose livelihoods depend on it, has an interest in its health and longevity,” says Meyer.

• The privacy of providers whose behavior is studied is potentially being violated.

“It’s not immediately obvious that a health professional’s behavior on the job should be treated as private information. In some cases, the public may have an interest in this information,” says Meyer. “But to the extent that it is a legitimate issue, researchers can focus on aggregate or de-identified data.”

• The practice necessarily involves deception.

“As is the case with much psychology research, concealing the true purpose of the patient-provider interaction is very useful — and with respect to some research questions, necessary — in order to prevent ‘priming’ the research subject — here, the provider, and obtain meaningful data,” says Meyer. “It’s important to see that the deception is not gratuitous.”

References

1. Rhodes K. Taking the mystery out of “mystery shopper” studies. N Engl J Med 2011;365:484-486.

2. Pear R. Administration halts survey of making doctors visits. The New York Times June 28, 2011. http://www.nytimes.com/2011/06/29/health/policy/29docs.html?_r=0

3. Rhodes KV, Miller FG. Simulated patient studies: An ethical analysis. Milbank Q 2012;90(4):706–724.

Sources

• Mark A. Hall, JD, Professor of Law and Public Health, Wake Forest University, Winston-Salem, NC. Phone: (336) 716-9807. E-mail: mhall@wakehealth.edu.

• Michelle N. Meyer, JD, PhD, Academic Fellow, Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School, Cambridge, MA. Phone: (617) 571-3795. E-mail: mmeyer@law.harvard.edu.

• Franklin G. Miller, PhD, Department of Bioethics, National Institutes of Health, Bethesda, MD. Phone: (301) 435-8719. E-mail: fmiller@nih.gov.