Controlled acts and the delegation of controlled acts

Concern for welfare and respect for persons are two of the three core guiding principles outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2022). This means that researchers and Research Ethics Boards (REB) need to “protect the welfare of participants and in some circumstances promote that welfare in view of any foreseeable risks associated with the research” (Chapter 1, Section B). It also means that researchers and REBs need to ensure “individuals who participate in research do so voluntarily, understanding the purpose of the research, and its risks and potential benefits, as fully as reasonably possible” (Chapter 1, Section B). “Because research is a step into the unknown, its undertaking can involve harms to participants” (Chapter 1, Section A) and “while researchers should attempt to estimate the occurrence of the relevant harms, this may be more difficult, or not possible, for new or emerging areas of research where no prior experience, comparable research or publications exist” (Chapter 2, Section B).

As noted in TCPS 2, “risk is a function of the magnitude or seriousness of the harm, and the probability that it will occur” (Chapter 2, Section B). Therefore, it is the responsibility of researchers and REBs to conduct a risk-benefit assessment concerning the proposed research and, through this process, “minimize the risks associated with answering any given research question” and “attempt to achieve the most favourable balance of risks and potential benefits in a research proposal” (Chapter 1, Section B). “A proper ethical analysis of research should consider both the foreseeable risk and the available methods of eliminating or mitigating the risk” (Chapter 2, Section B) and it is the responsibility of both researchers and the REB to ensure prospective participants are provided “full disclosure of all information necessary for making an informed decision to participate in a research project” (Chapter 3, Introduction).

When conducting studies that could pose a risk to participants, researchers are also responsible for complying with any professional or governmental legal and regulatory requirements. There are instances when “the law affects and regulates the standards and conduct of research involving humans in a variety of areas ...” (Chapter 1, Section C). This means that researchers need to be aware of the applicable laws that may exist in the conduct of their research and be able to identify the legal issues that exist. Moreover, researchers and REBs also need to keep abreast of the “legal and regulatory requirements as they may vary depending on the jurisdiction in Canada in which the research is being conducted” (Chapter 1, Section C).

The Regulated Health Professions Act of Ontario (RHPA, 1991) governs the various medical professions referred to in the RHPA and identifies a number of acts as being “controlled”. This means that controlled acts may only be performed by specifically designated regulated health professionals legally authorized to perform designated controlled acts associated with their defined “scope of practice” when providing health care services to others. When an individual pricks his/her own finger for blood glucose monitoring or self-administers insulin or epinephrine by injection, for example, these would not be considered to be controlled acts. Researchers who want to use a controlled act as a procedure in their research are seen as engaging in acts which can create risks for participants which are similar to those created when providing health care services using the same controlled acts.

The purpose of this guideline is to detail how the RHPA might apply to controlled acts conducted in a research environment at the University of Waterloo. The intent is to ensure that the risk undertaken by participants is not increased simply because the controlled act is conducted in a research environment rather than in the course of providing health care services. Nevertheless, a controlled act may be delegated by a regulated health professional to others who may or may not be members of a regulated health profession, so long as these guidelines and provisions of the RHPA are observed.

These guidelines have been created to assist Waterloo researchers when planning studies using a “controlled act.” These guidelines outline:

• What is a controlled act, the Regulated Health Professions Act, and the implications of using controlled acts in research?
• The process for delegating a controlled act and the responsibilities of the person delegating a controlled act.
• The forms of delegation that may be used and the factors that need to be considered in a supervisory plan for a delegate, such as the suitability of the training, the training required by a delegate, and/or a description of their experience.
• What is required when submitting a research ethics application when the proposed research involves a controlled act?

The appendices list each of the controlled acts and the controlled acts that may be performed by the various regulated health professionals. These guidelines are meant to be a living document. Changes may be required if there are revisions to the RHPA or as the research conducted using controlled acts at Waterloo grows and evolves.