Alternative Patient Consent

Patient Consent: As outlined by the Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans (TCPS2), Dial-Mag met the following criteria for a waiver of patient consent:

Minimal Risk to Participants

Magnesium concentrations are Health Canada approved and distributed in Canada.

The Trial Cannot be Practically Carried Out Without Alternative Consent

While nephrologists obtain consent from patients to receive dialysis, they do not currently obtain consent for different components of dialysate. In current practice, the medical director orders the dialysate Mg concentration used for all treatments in their centre. Since this is a pragmatic trial, consent reflects routine practices. Requiring individual consent would increase burden on patients and care providers.

The Altered Consent is Unlikely to Adversely Affect Participants

In routine care, nephrologists can alter elements of a patient’s treatment, including concentrations of magnesium, without patient consent. Dial-Mag patient partners felt that utilizing the same altered consent approach in Dial-Mag would not adversely affect patients.

There is a Plan to Inform Patients of the Trial and Intervention

Participating centres posted at least one poster describing the trial in a high-traffic area (i.e. patient waiting area, weight-scale, etc). In addition, centre staff provide information handouts to patients twice a year until trial completion.

If you have any questions or would like to contact us, please email dialmagcanada@lhsc.on.ca

The team derived the information used on this website from our own research and other reliable sources. For a full list of the sources used to create this website, please check out our References Page.