title: Ethics and Regulatory Challenges and Opportunities in Patient-Centered Comparative Effectiveness Research.
abstract: The Affordable Care Act includes provisions for the conduct of large-scale, patient-centered comparative effectiveness research. Such efforts aim toward the laudable moral goal of having evidence to improve health care decision making. Nevertheless, these pragmatic clinical research efforts that typically pose minimal incremental risk and are enmeshed in routine care settings perhaps surprisingly encounter an array of ethics and regulatory challenges and opportunities for academic health centers. An emphasis on patient-centeredness forces an examination of the appropriateness of traditional methods used to protect the rights, interests, and welfare of participants. At the same time, meaningful collaboration with patients throughout the research process also necessitates ensuring that novel approaches to research (including recruitment and consent) entail necessary protections regarding such issues as privacy. As the scientific and logistical aspects of this research are being developed, substantial attention is being focused on the accompanying ethics and regulatory issues that have emerged, which should help to facilitate ethically appropriate research in a variety of contexts.
authors.affiliation: J. Sugarman is Harvey M. Meyerhoff Professor of Bioethics and Medicine, Berman Institute of Bioethics, professor of medicine, Department of Medicine, School of Medicine, and professor of health policy and management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
mesh_terms: D000046:Academic Medical Centers / Q000941:ethics / Q000331:legislation & jurisprudence; D057186:Comparative Effectiveness Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D003219:Confidentiality / Q000941:ethics / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D033181:Information Dissemination / Q000941:ethics / Q000331:legislation & jurisprudence; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D063868:Patient Outcome Assessment; D058991:Patient Protection and Affordable Care Act / Q000331:legislation & jurisprudence; D018802:Patient-Centered Care; D064792:Pragmatic Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D014481:United States
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