Document is current

Article History

Received: 10 December 2018

Accepted: 15 October 2019

First Online: 30 October 2019

Ethics approval and consent to participate

: The North Texas Regional IRB uses the definitions set forth in Federal Policy for the Protection of Human Subjects (i.e., the U.S. Department of Health and Human Services (DHHS) regulations 45 CFR 46, also known as “the Common Rule”). It says:<i>“Human subject</i> means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e) (1)].Living individual – The specimen(s)/data/information collected must pertain to live subjects.· “About whom” – a human subject research project requires the data received to be about the living individual.· Intervention includes physical procedures, manipulations of the subject, or manipulations of the subject’s environment for research purposes. Interaction includes any kind of communication between the investigator and the subject. This includes face-to-face, online, mail, and phone interaction as well as other modes of communication.”As this project utilized cadaveric material and generated no identifiable or private information, it does not fall under the need for committee or IRB approval.The State Anatomical Board of Texas regulates the use of donated cadaveric material (see Additional file InternalRef removed). They oversee the full disclosure waivers each donor signs. This document states that the donors may be used for teaching or research purposes. The disclosures for the donors used in this study are on file, but are not included in this document to maintain the privacy of the donors.

: Not applicable.

: The authors declare that they have no conflict of interest.