Ethics approval and consent to participate
ARDS
SECONDARY, ARDS
The SAILS clinical trial (ClinicalTrials.gov Identifier: NCT00979121, accepted September 16, 2009) was approved by the Institutional Review Board at each of the 44 enrolling hospitals in the NHLBI ARDS Clinical trial network, and assent for participation was collected from patients and their families as part of SAILS trial enrollment at all centers. The HARP-2 trial (International Standard Registered Clinical Trial Number: 88244364) was approved by a national research ethics committee (approval August 9, 2010, ref: 10/NIR02/36) and by the research governance department at each study site in the United Kingdom and by the institutional research ethics committee at each study site in Ireland. All the patients or their representatives provided written informed consent or assent at all centers of both trials, including consent to use biospecimens for future research for subjects included in this analysis. Ethical approval for this analysis for the HARP-2 trial was granted by Queen’s University Belfast School Research Ethics Committee (ref. 14/06). Both studies were conducted in accordance with institutional ethical standards and as described by the Declaration of Helsinki. The Stanford Institutional Review Board waived monitoring for this secondary analysis.