By Daniel B. Kramer, Elizabeth Roe and Efthimios Parasidis.
Regulators charged with evaluating new medical devices face several unenviable trade-offs. Extensive pre-market evaluation may delay market entry for useful technology, but a rushed assessment may fail to identify important safety concerns. Rigorous post-market studies may help balance these competing concerns, but must also weigh the benefits of large, representative, and granular cohort studies against their costs and complexity.
In the US, the Food and Drug Administration and the Centers for Medicare and Medicaid Services confront these trade-offs and fulfill their overlapping public health mandates in part through targeted use of medical device registries. Many patients receiving new high-risk medical devices are required to enroll in these post-market studies that, to some extent, extend and expand the knowledge base accrued from pivotal clinical trials. Registries can track patients procedural experiences and subsequent clinical outcomes. Data from registries allow regulators and researchers to continually assess “real-world” device safety and effectiveness. Devices such as implantable cardioverter-defibrillators and transcatheter valve implants have been subject to mandates requiring patients to be enrolled in an approved registry, and millions of patients have been studied in this way.
Unlike clinical trials, though, many of these national registries do not require informed consent, or even notification of participation. This is another trade-off: Consent requirements increase administrative burdens, and might dissuade some patients from participating. If patients decline, the registries may become less representative of the overall treated population and lose their analytic heft. On the other hand, informed consent is usually viewed as a bedrock principle for research aside from specific exemptions. Even if registry participation is rightly viewed as “minimal risk” and consent acceptably waived on legal grounds, might something be lost from an ethical perspective in not consent patients – even if, legally, it is not required? What trade-offs arise with or without consent in this case?
The tensions borne of these trade-offs arose organically for us through several parallel experiences: Clinical practice enrolling dozens of patients in the national ICD registry without their consent or knowledge; NIH-funded research leveraging these same national registry data to evaluate patient characteristics, health service utilization, and survival; and analysis of an evolving legal and ethical landscape around big data collection. We then asked whether the compromises around waiving consent requirements for compulsory registries – though apparently legal – holds up to ethical scrutiny.
Our article examines ethical arguments for or against incorporating consent into medical device registries. Ultimately, we argue that many of the apparent trade-offs are illusory. Whatever the added burdens of seeking consent, several primary goals of the registries themselves would be directly advanced by a rigorous, good-faith informed consent process. These goals include building public trust in health data analytics, engaging patients in their own post-market surveillance, facilitating linkages between registry data and external sources, and enhancing accountability for registry investigators and stewards. What remains as “compulsory” about these registries perhaps ought not be the imposition on patients of research using their data without consent. Instead, participation should be presented to patients as the default, with providers compelled to inform patients of the regulatory and clinical reasons for the registry and the rights and responsibilities associated with data use. As medical device registries grow and evolve with new medical device technology, the legal and ethical boundaries around this form of research will need adapt in parallel.
Paper authors: Daniel B. Kramer and Efthimios Parasidis
1 Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston MA; and Assistant Professor of Medicine, Harvard Medical School, Boston MA
2 Professor of Law and Public Health, The Ohio State University
Dr. Kramer is supported in part by the Greenwall Faculty Scholars Program in Bioethics. Dr. Kramer also reports serving as a consultant to the Circulatory Systems Advisory Panel of the Food and Drug Administration, and to Firefly Health.
Social media accounts of post author: @SmithBIDMC