Yen, Tina W. F.
Garacci, Zhuping
Laud, Purushottam W.
Pezzin, Liliana E.
Nattinger, Ann B.
Article History
Received: 29 July 2020
Accepted: 17 December 2020
First Online: 4 January 2021
Compliance with ethical standards
:
: All authors (Yen, Garacci, Laud, Pezzin, Nattinger) declare no conflicts of interest.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this retrospective study, formal informed consent is not required. This de-identified database study (PRO00030472) was determined that it does not meet criteria for human subject research at 45 CFR 46.102 by the Medical College of Wisconsin/Froedtert Hospital Institutional Review Board #5.
: A waiver of the informed consent process was granted by the institutional IRB as this is a retrospective, de-identified database study that contains no Protected Health Information (PHI) and does not involve interactions or interventions with living human beings. The waiver of informed consent does not adversely affect the rights and welfare of the subjects and it would not be practical to conduct the research without a waiver.