Simulated Patient Studies: An Ethical Analysis

• Published in: The Milbank quarterly Vol. 90; no. 4; pp. 706 - 724
• Main Authors: RHODES, KARIN V., MILLER, FRANKLIN G.
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01.12.2012; Wiley Subscription Services, Inc; Wiley; Blackwell Publishing Ltd
• Subjects: access to care; audit methodology; Autonomy; Confidentiality; Consent; Data analysis; deceptive design; Ethics; Ethics, Medical; exceptions to consent; Experimental design; Federal regulation; Health care; Health insurance; Health services; Health Services Accessibility - ethics; Health Services Research - methods; Human Experimentation - ethics; Human subjects; Humans; Informed consent; Institutional review boards; Knowledge; Medical practice; Medical research; Medical service; Original; Patient care; Patient Simulation; Patients; Physician-Patient Relations - ethics; Physicians; Primary health care; public health; Quality Assurance, Health Care - ethics; Regulation; Research ethics; Research Subjects; Risk; simulated patient studies; Simulation; Simulation training; Social problems and social policy. Social work; Sociology; Sociology of health and medicine; Soliciting; Standardized patients; U.S.A; United States; United States Dept. of Health and Human Services; United States Of America; United States; United States > US; Ethics; Health Care; Health; Hazard
• ISSN: 0887-378X; 1468-0009; 1468-0009
• DOI: 10.1111/j.1468-0009.2012.00680.x

Context: In connection with health care reform, the U.S. Department of Health and Human Services commissioned a "mystery shopper," or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over "government spying" on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. Methods: We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. Findings: Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy-relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. Conclusions: As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy-relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge.