Chandra, Jay http://orcid.org/0000-0002-1674-0180
Armengol de la Hoz, Miguel A.
Lee, Gwendolyn
Lee, Alexandria
Thoral, Patrick
Elbers, Paul
Lee, Hyung-Chul
Munger, John S.
Celi, Leo Anthony
Kaufman, David A.
Article History
Received: 25 December 2021
Accepted: 29 March 2022
First Online: 11 April 2022
Declarations
:
: The eICU study was exempt from institutional review board approval due to the retrospective design, lack of direct patient intervention, and the security schema, for which the re-identification risk was certified as meeting safe harbor standards by an independent privacy expert (Privacert, Cambridge, MA) (Health Insurance Portability and Accountability Act Certification no. 1031219-2). The data in MIMIC-III and MIMIC-CXR have been de-identified, and the institutional review boards of the Massachusetts Institute of Technology (No. 0403000206) and Beth Israel Deaconess Medical Center (2001-P-001699/14) both approved the use of the database for research. The Medical Research Ethics Committee of VU university medical center determined that the AmsterdamUMCdb study was exempt from their review and was not subject to the Dutch Medical Research Involving Human Subjects Act (WMO). The process of developing AmsterdamUMCdb was audited by an external team led by a member of the privacy expert group at the Netherlands Federation of UMCs. The Ethics in Intensive Care Medicine group provided external ethics review and appraisal. The use of AmsterdamUMCdb is exempt from institutional review board approval due to a combination of de-identification, contractual, and governance strategies where re-identification is not reasonably likely and can therefore be considered as anonymous information in the context of the General Data Protection Regulation (GDPR). The data in the SNUH dataset have been de-identified, and the institutional review boards of the Seoul National University Hospital have approved the use of this data for our research (SNUH 2106–118-1228).
: All authors have approved this manuscript for publication.
: Dr. Leo A. Celi was funded by the NIH through NIBIB grant R01 EB017205. Dr. David A. Kaufman is funded by the National Institutes of Health through 1UG3HL141722-01A1 and R01HL140362. Dr. Kaufman is a member of the Medical Advisory Board of Pulsion Medical Systems, has received grant support from Cheetah Medical, and serves as a consultant to FloSonics Medical.