The Delegation of a Controlled Act and Medical Directive Form may be required if the research protocol includes a controlled act as defined under the Regulated Health Professionals Act of Ontario, 1991. A regulated health professional must conduct the controlled act or delegate the act to a qualified person. For more information on this process refer to the Waterloo guidelines on controlled acts and the delegation of controlled acts (PDF) .
As of June 2022, the delegation of a controlled act process has been updated so that a controlled act can be delegated to an individual for a defined period and submitted for multiple research studies over the period of the delegation.
For time-based delegations, the Delegation of a Controlled Act and Medical Directive Form most cover the period from ethics clearance to study renewal. If this period is not covered, researchers will be asked to submit a new delegation form. During annual progress reports, researchers must indicate if all controlled acts have been completed, or if they will continue to be carried out for the study. If controlled acts will be continuing as part of the study, renewal of the study is contingent on the existence of a Delegation of a Controlled Act and Medical Directive Form that spans the renewal period. The onus is on the researcher to ensure that delegations do not lapse.
An option to delegate the act for a single study remains if that is preferred by the delegator and delegate.
It is the responsibility of the delegate and delegator to work out a process for continued communication and oversight over the delegation period.
If your study involves an act that will be outsourced to a regulated clinic or laboratory and/or performed by a person authorized to conduct the act under the regulated health professional act, a delegation form is not required. Details of this process can be added directly in the ethics application.
Delegation forms are not required for acts that will be carried out under the auspice of another institution by a researcher that is not from the University of Waterloo.
Please follow the instructions on the Delegation of a Controlled Act and Medical Directive Form Delegation of a Controlled Act and Medical Directive Form and ensure that a separate delegation is completed for each delegate and for each act.
Research Ethics Board approved standard SOPs for controlled acts