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Neonatal research ethics after SUPPORT
1Children's Mercy Hospital, Kansas City, MO, USA.
Insights
The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) trial for premature infants sparked controversy due to differing views on clinical investigator roles. It suggests balancing research risks with practice variation risks in oversight.
Area of Science:
- Neonatal research
- Clinical trial ethics
- Medical controversy
Background:
- The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) investigated oxygen saturation targets in extremely premature infants.
- The study generated significant public, intense, and polarizing national controversy.
Purpose of the Study:
- To describe the SUPPORT study's design, outcomes, and the core issues fueling the controversy.
- To analyze the differing perspectives on the role and ethical obligations of clinical investigators.
Main Methods:
- The article reviews the SUPPORT study's design and reported outcomes.
- It examines the ethical viewpoints surrounding clinical investigators' dual roles in patient care and research.
Main Results:
- The controversy stemmed from conflicting views of clinical investigators: as patient advocates versus individuals with divided loyalties.
- The study highlighted a debate on whether investigators prioritize research over patient care.
Conclusions:
- Current oversight systems may overemphasize research risks while underestimating risks from inconsistent clinical practice.
- A revised oversight approach should consider the risks of research and practice variation as comparable.
Abstract:
The SUPPORT study (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments), sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development to evaluate different oxygen saturation targets for extremely premature babies, led to a national controversy that was surprisingly public, intense, and polarizing. This article describes the study design, the study outcomes, and the key issues. I conclude that the controversy was based on two different views of the clinical investigator. One, held by investigators themselves, is that investigators are primarily committed to the patient's well-being. The other sees the investigator as unable to disentangle his conflicting loyalties and as inevitably prioritizing the goals of research over the goals of patient care. I suggest that our current oversight systems overstate the risks of research and understate the risks of idiosyncratic practice variation. A better system would treat the relative risks of these two phenomena as comparable.
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