Mazza, Genevieve R. http://orcid.org/0000-0002-1661-8118
Komatsu, Emi
Ponzio, Madeline
Bai, Claire
Cortessis, Victoria K.
Sasso, Elizabeth B.
Article History
Received: 12 December 2023
Accepted: 30 March 2024
First Online: 8 April 2024
Declarations
:
: This study received IRB approval on 11/12/2021 (HS-21–00551) from the University of Southern California Institutional Review Board. This is an observational study that did not require participant consent to participate. Furthermore, the stated IRB waived the need for informed consent in the study protocol approval, because the use of such protected health information involves no more than minimal risk to the privacy of individuals and the research could not be practicably conducted without the waiver and without access to the protected health information. The approval statement from the IRB is below:<i>The request for a waiver of HIPAA Authorization is approved. The investigator has provided justification by specifically documenting the following: (1) The use or disclosure of protected health information involves no more than minimal risk to the privacy of individuals, based on, at least, the presence of the following elements: (a) There is an adequate plan to protect the identifiers from improper use and disclosure; (b) There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and (c) There are adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart. (2) The research could not practicably be conducted without the waiver or alteration; and (3) The research could not practicably be conducted without access to and use of the protected health information.</i>
: Not applicable. This is an observational study that did not require participant consent to publish.
: The authors declare no competing interests.