El Charif, Mohamad Hadi
Hassan, Zeina
Hoballah, Jamal
Khalife, Mohamad
Sbaity, Eman http://orcid.org/0000-0003-2969-4782
Funding for this research was provided by:
American University of Beirut (11.320155.51113.11487.720.9999.0000)
Article History
Received: 10 February 2020
Accepted: 12 June 2020
First Online: 2 July 2020
Ethics approval and consent to participate {24}
: We will submit this protocol, informed consent template, case report forms, and other study-related appendices to the Institutional Review Board (IRB) at the study site to review the scientific soundness of the project, ethical aspects, and its impact on medical practice for our patient population. The PI will submit progress reports to IRB annually from the date of the first IRB approval and within a month of study completion and later upon termination.After the primary surgeon introduces the study to the patient, the research assistant will explain the study and invite the patients to sign the consent form. The research assistant will be trained by the principal investigator on the process of signing the consent. In addition, other members of the study team will be trained and certified to obtain the consent, so they can help in case the research assistant was not available to discuss participation with a potential candidate. The participant will be given an opportunity to ask questions regarding the study and will receive a copy of the IRB-approved and updated consent form (CF) with his/her signature.
: Not applicable
: The authors declare that they have no competing interests.