Document is current

Article History

Received: 23 November 2020

Accepted: 9 December 2020

First Online: 6 January 2021

Ethics approval and consent to participate

: Informed consent was obtained at each site, under each site’s Institutional Review Board (IRB)-approved protocols [CitationRef removed]. Informed consent was obtained for all participants as either written or electronic. Some informed consents were carried out over the phone at Vanderbilt, as part of their collection of a prospective cohort, and this was approved by their IRB. Phone and verbal consents were approved at Geisinger in order to increase study participation, and this was approved by their IRB. The two sequencing centers had IRB-approved protocols that deferred consent to the participating sites. Protocol numbers are as follows: Partners Healthcare (2015P000929), Baylor College of Medicine (#H-40455). The federal-wide assurance number is FWA00002344. Ethics committees and reference numbers for each site are as follows: CHOP, The Committees for the Protection of Human Subjects, Federal Wide Assurance number FWA00000459, IRB Registration number IRB00000316; Cincinnati, Institution Review Board, Cincinnati Children’s Hospital Medical Center; Columbia, Human Research Protection Office and IRBs, AAAP7926, AAAQ9205; Geisinger, Geisinger Institutional Review Board, IRB Registration number IRB00008345; Harvard, Partners Human Research Committee, Protocol number 2015P000983/BWH; Mayo, Mayo Clinic Institutional Review Board – IRB-C, DHHS registration numbers: IRB00000020, IRB00003294, IRB00003295, and IRB00005256. Mayo Clinic holds Federal wide Assurance (FWA) number 00005001 covering Mayo Clinic in Rochester, Minnesota, Mayo Clinic in Arizona, Mayo Clinic in Florida, and Mayo Clinic Health Systems; Northwestern, Northwestern University's Institutional Review Board, IRN number STU00201971; UWKP, Kaiser Permanente Washington Research and Humans Subjects Review Office, IRB Registration number IRB00010902; Vanderbilt, Vanderbilt University Institutional Review Board, IRB number 151299. The network data does not include HIPAA identifiers. Only adult participants are included in this study. All data is shared under a consortia-wide data use agreement. No administrative permissions and/or licenses were acquired in order to access the clinical/personal patient data used in this research.

: Not applicable.

: The authors declare that they have no competing interest.