Madabhushi, Praneeth http://orcid.org/0000-0002-8297-6781
Kinthala, Sudhakar
Ankam, Abistanand
Chopra, Nitin
Porter, Burdett R.
Article History
Received: 7 August 2020
Accepted: 7 September 2020
First Online: 14 September 2020
Ethics approval and consent to participate
: This study was approved by Institutional Review Board of The Guthrie Clinic, IRB00000918<b>. (</b>IRB# 2004–38). The study was retrospectively registered at clinicaltrials.gov ExternalRef removed on May 27, 2020. Our study first patient recruitment was done on May 07,2020 and the last patient recruitment was done on May 19, 2020. The IRB approved the waiver of consent documentation for the research in accordance with the regulatory requirement of 45CFR46.117.The IRB waived written consent as our research presents no more than minimal risk of harm to subjects and the research involves no procedure for which written consent is normally required outside of the research context. Supporting document from IRB for waiver of written consent is provided in supplementary material . Informed verbal consent was obtained for all patients, and the patients received a letter of invitation. The registered nurse caring the patient witnessed the verbal consent and documentation of verbal consent was done in the electronic medical record.
: The authors consent for use of identifying images for publication.
: The authors declare no competing interest.