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Article History

Received: 13 May 2022

Accepted: 29 July 2022

First Online: 13 August 2022

Declarations

:

: This study fully adheres to the Regulations for the Protection of Human Subjects of Research codified in 45 CFR Part 46. The protocol, informed consent forms, recruitment materials, and all participant materials have been reviewed and approved by the Xavier University of Louisiana’s and Tulane University’s Institutional Review Boards (IRBs), and the Research Review Committee (RRC) at the University Medical Center at New Orleans. All members of the research team (principal investigators, medical residents, research assistants, and project coordinator) have completed the required training to conduct research with human participants and are authorized by the respective IRB of each clinical site to carry-on study activities. Any amendment to the protocol requires review and approval by the respective authorities before the changes are implemented to the study. Any change to the consent forms requires IRB approval including the determination regarding whether previously consented participants need to be re-consented.Informed consent and HIPAA authorization forms—describing in detail the study intervention, study procedures, and risks—are given by members of the research team to those participants willing to join the study. Signature documentation of both forms is required prior to starting patient activities. All participants receive an explanation in terms suited to their comprehension of the purposes, procedures, and potential risks of the study and of their rights as research participants. Enough time is given to prospective participants to carefully review the written informed consent and HIPAA authorization forms, discuss the study with their surrogates or think about it, and ask questions prior to signing. The participants sign the full informed consent and HIPAA authorization prior to any procedures being done specifically for the study. Participants considering the interventions offensive, risky, embarrassing, or not appropriate to their cultural beliefs may stop participating at any time. No additional information about these participants is collected when they stop participating.

: Not applicable.

: The authors declare that they have no competing interests.