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Were There "Additional Foreseeable Risks" in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials
The Hastings Center Report
|December 23, 2014
Insights
Infant care interventions in this study differed significantly from standard practices, presenting unique risks. Parents were not adequately informed about these crucial distinctions in care.
Area of Science:
- Neonatal care
- Clinical intervention research
- Patient safety
Background:
- Standard clinical practice provides a benchmark for infant care.
- Interventions adapted from standard practice may introduce variations.
- Understanding deviations in care is crucial for assessing risk.
Purpose of the Study:
- To evaluate the differences between adapted and standard infant care.
- To identify the distinct risk profiles associated with the study's interventions.
- To assess the adequacy of parental informed consent regarding care variations.
Main Methods:
- Comparative analysis of intervention delivery versus standard clinical practice.
- Risk assessment of adapted care protocols.
- Review of informed consent procedures.
Main Results:
- The provided interventions, though adapted, resulted in care significantly different from standard protocols.
- These differences in care were associated with distinct risk profiles for the infants.
- Informed consent processes did not fully apprise parents of these care variations.
Conclusions:
- Care modifications in clinical studies must be clearly communicated to parents.
- Ensuring informed consent requires transparency about deviations from standard practice.
- Failure to disclose differences in risk profiles compromises ethical research standards.
Abstract:
Even though the interventions were adapted from standard clinical practice, the way they were provided meant that the care given infants in the study was distinctly different from standard care, with different risk profiles. Parents should have been informed about those differences.
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