Varieties of Standard-of-Care Treatment Randomized Trials: Ethical Implications

• Published in: JAMA : the journal of the American Medical Association Vol. 313; no. 9; pp. 895 - 896
• Main Authors: Kim, Scott Y. H, Miller, Franklin G
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 03.03.2015
• Subjects: Clinical outcomes; Comparative Effectiveness Research - ethics; Humans; Informed Consent; Medical ethics; Quality of care; Randomized Controlled Trials as Topic - ethics; Research Design; Standard of Care; Therapeutic Human Experimentation - ethics
• ISSN: 0098-7484; 1538-3598; 1538-3598
• DOI: 10.1001/jama.2014.18528

Comparative effectiveness research has received considerable attention in recent years and has been accompanied by controversy, especially in response to the 2013 Office for Human Research Protections (OHRP) investigation of the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial--a randomized trial of 2 contrasting oxygen saturation settings in mechanical ventilation of premature infants within the established standard of care. The OHRP convened a public meeting in August 2013 on "Matters Related to Protection of Human Subjects and Research Considering Standard of Care Interventions" and recently issued draft guidance on "Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care." This guidance has been sharply criticized. Here, Kim and Miller debate the guidance on ethics for studies that compare interventions within established standards of care.