Khan, M. M.
Manduchi, B.
Rodriguez, V.
Fitch, M. I.
Barbon, C. E. A.
McMillan, H.
Hutcheson, K. A.
Martino, R. http://orcid.org/0000-0002-3298-7714
Funding for this research was provided by:
Canada Research Chairs
Article History
Received: 6 February 2022
Accepted: 11 September 2022
First Online: 30 September 2022
Declarations
:
: All versions of the study protocol and informed consent forms were reviewed and approved by the Research Ethics Board (REB/Institutional Review Board (IRB) of each site before the trial was implemented. The Princess Margaret Cancer Centre (PM), part of the University Health Network (UHN) in Toronto, ON is the prime site and was reviewed by Clinical Trials Ontario, as the review of record (CTO Project ID: 1363). In addition, the MD Anderson Cancer Center (MDACC) site also underwent local ethics review (ProjectID: 2018–0019). Across both sites, informed consent forms were harmonized for relevant trial particulars while adhering to local REB/IRB standards. As part of the informed consent process, the study team approached only eligible participants once they have shown interest in the trial to a member from their direct circle of care. The study team explained the research study to the participant and answer any questions that may arise. A verbal explanation was provided in terms suited to the participant’s comprehension of the purposes, procedures, and potential risks of the study and of their rights as research participants. Participants had the opportunity to carefully review the written consent form, ask questions and discuss the study with their family or surrogates prior to agreeing to participate. The participant signed the informed consent document prior to any procedures being done specifically for the study. Participants were informed that participation is voluntary and that they may withdraw from the study at any time, without prejudice. A copy of the informed consent document was given to the participants for their records. The informed consent process was conducted and documented in the source document (including the date), and the form signed, before the participant undergoes any study-specific procedures. The rights and welfare of the participants were protected by emphasizing to them that the quality of their medical care will not be adversely affected if they decline to participate in this study.
: Not applicable.
: The authors declare that they have no competing interests.