Document is current

Article History

Received: 13 January 2023

Accepted: 6 September 2023

First Online: 9 September 2023

Declarations

:

: The authors received no direct compensation related to the development of the manuscript. SS, and CC are employees of BIPI. DS was an employee of BIPI at the time of the study. AS, JJ, and BC are employees of Optum. EJB was a paid consultant for this study. Caroline Jennermann was an employee of Optum at the time of the study.

: This study used only data which, as part of the Optum Research Database (ORD), has been fully de-identified in compliance with United States (US) 45 Code of Federal Regulations (CFR) 164.514(a)-(c) “Requirements Relating to Uses and Disclosures of Protected Health Information.” These data were originally obtained from Covered Entities that permitted de-identification of protected health information (PHI) for use in research studies conducted by Optum. In the US, research involving human subjects is governed by the US Department of Health and Human Services (DHHS) “Common Rule,” as codified at US 45 CFR Part 46, “Protection of Human Subjects.” This legislation explains requirements for IRB review to ensure adequate protections of those human subjects. However, in this case, the research has been conducted with PHI that was fully de-identified, in accordance with the DHHS Privacy Rule’s requirements codified at US 45 CFR § 164.514(b). Therefore, the research conducted for this project was neither subject to the Common Rule requirements, nor was an IRB review mandated or conducted. In addition, neither written nor verbal patient consent was required for this retrospective study. Throughout the process, patient privacy was preserved, and researchers complied strictly with all applicable Health Insurance Portability and Accountability Act (HIPAA, 1996) data management rules and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

: Not applicable.