Simulated patient studies: An ethical analysis.

Simulated customers—commonly called secret or mystery shoppers—have long been used for quality control purposes by retail establishments and other companies that serve the public. These mystery shoppers seek or use a company's own services and then report back to the quality control staff. Research using a similar technique was proposed in 2011 in anticipation of the large expansions in coverage by Medicaid and private insurance as a result of the Patient Protection and Affordable Care Act. The U.S. Department of Health and Human Services (DHHS) commissioned a study in which researchers posing as prospective patients would use a script to call doctors' offices and attempt to obtain appointments for primary or specialty medical care. The purpose was to better understand the extent to which new patients with Medicaid or private insurance could expect to gain access to medical care. Announcement of the proposed study in the Federal Register (Federal Register, April 28, 2011), followed by an article describing the study in the New York Times, triggered strong public criticism by some doctors and members of Congress (Pear 2011). One doctor remarked, “I don't like the idea of the government snooping. It's a pernicious practice—Big Brother tactics, which should be opposed.” Another stated, “If federal officials are worried about access to care, they could help us. They don't have to spy on us.” Echoing these sentiments, Senator Orrin Hatch (R-UT) declared that the Obama administration was “wasting taxpayer dollars to snoop into the care physicians are providing patients.” In response to the public criticism, the plans for the research were dropped. Although this controversy certainly had a political element, the question we address in this article is how such methods should be viewed from the perspective of research ethics, particularly with regard to the use of deception with human subjects without soliciting their informed consent. Mystery shopper methods are not new in research, having been used to generate powerful evidence of negligent business practices that impact public health (Sorenson and Vittes 2003) and to document racial discrimination in fields such as real estate and mortgage lending (Fix and Struyk 1993; Ross et al. 2002; Turner et al. 2002; Turner and Ross 2005). Such methods have been used, as well, in health services research to measure access to and the timeliness of needed outpatient medical appointments (Asplin, Rhodes, and Levy 2005; Bisgaier and Rhodes 2011; Medicaid Access Study Group 1994; Rhodes et al. 2009), to study the consultation practices of pharmacists (Weiss et al. 2010), and to examine the prescribing practices of primary care physicians (Kravitz et al. 2005). But previous use does not answer the question of how such methods comport with ethical principles and the regulatory framework that applies to research involving human subjects. Addressing this issue is now of particular concern, as we have relatively few reliable methods for measuring access to care. Gathering knowledge regarding access to care is relevant to current public policy, as both Medicaid and private insurance coverage will undergo major expansions under the Patient Protection and Affordable Care Act (2010, Pub. L. No. 111–148) (Rosenbaum 2011). While mystery shopper research using simulated patients adopts a naturalistic and scientifically sound study design, this mode of research raises ethical concerns relating primarily to the use of deception with human subjects without soliciting their informed consent. This article provides an ethical analysis of simulated patient techniques used for health services research, with a particular focus on research measuring access to care. To describe this ethical analysis, we present next a brief case study of one completed simulated patient study of access to health care.