Morkem, Rachael https://orcid.org/0000-0001-7023-1742
Handelman, Kenneth
Queenan, John A.
Birtwhistle, Richard
Barber, David
Funding for this research was provided by:
Shire Pharma Canada ULC (6020024)
Article History
Received: 9 May 2019
Accepted: 9 July 2020
First Online: 20 July 2020
Ethics approval and consent to participate
: Ethics approval was granted by Health Sciences and Affiliated Teaching Hospitals Research Ethics Board at Queen’s University, Kingston. Ref #6020016.The data available within the CPCSSN database has received research ethics board (REB) approval in all jurisdictions where health data is collected. Permission to extract the clinical data is through provider consent to participate. Patients at each participating site are informed that their provider is participating through a patient information poster/brochure, which explains that they have the right to opt-out by informing their provider or their local practice based research network. A waiver of informed individual consent is utilized by CPCSSN as data transferred to the database contained de-identified information (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, <i>Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans</i>, December 2018<i>., Chapter 5, Section D: Consent and Secondary Use of Information for Research Purposes).</i>
: Not applicable.
: DB and RM received a research grant from Shire Pharma Canada ULC, now part of Takeda, and from Medtronic Canada for an unrelated project. KH receives speaker’s honoraria and is on the advisory board for Janssen, Purdue and Shire. RB has received research support from Merck Canada, Shire Canada and Eli Lily Canada for other unrelated projects. JQ has received research support funds from Shire Canada and Merck Canada for other unrelated projects.