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Medical Delegation of Controlled Acts

SOP Series: SOP 200 REB Operations
SOP Title: REB SOP 215:  Medical Delegation of Controlled Acts
Version Date: May 27, 2025
Approved: May 21, 2025

1.0 Purpose

These procedures outline controlled acts and medical directives for research studies involving human participants, as defined under Ontario’s Regulated Health Professions Act, 1991, S.O. 1991, c. 18 (RHPA).  Under the RHPA, only regulated health professionals are legally permitted to perform controlled acts unless an exception applies (e.g., through medical delegation).  Regulated health professionals are held to strict standards of practice, ethics, and continuing competence by their respective colleges (e.g., College of Physicians and Surgeons of Ontario) as controlled acts include procedures that expose study participants to higher risk.

When controlled acts are involved in research studies, participants may face higher risks.  The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) emphasizes participant safety, minimizing harm, ensuring informed consent and compliance with applicable legal and regulatory requirements (TCPS 2, Chapter 3).  Concern for welfare is a core principle of the Tri-Council Policy Statement 2.  This principle requires researchers and Research Ethics Boards to prioritize the well-being of participants by considering any foreseeable risks associated with the research (TCPS 2, Chapter 1).  To achieve this, researchers and Research Ethics Boards should avoid exposing participants to unnecessary risks and strive to minimize risks while addressing the research question.  Using regulated health professionals or properly delegated individuals to perform controlled acts helps to ensure that risks are managed by those with the appropriate expertise.  The overall goal is to achieve the most favorable balance between risks and potential benefits in any research study (TCPS 2, Chapter 2).

2.0 Definitions

A “controlled Act” are specified in the RHPA as acts which may only be performed by authorized regulated health professionals.  Refer to Appendix A for examples of controlled acts.

“Delegate” is an individual who has been granted the authority to perform a controlled act through medical delegation by a regulated health professional in Ontario. The delegate is not legally authorized to perform controlled acts independently.

“Delegator” is a regulated health professional in Ontario, who is legally authorized under the RHPA to perform and delegate a specific controlled act. The regulated health professional may only delegate acts they are authorized to perform according to the RHPA. To effectively delegate a controlled act, regulated health professionals must be a member in good standing with their respective regulatory College and must follow any guidelines which their College may have enacted concerning delegation of controlled acts. 

“Energy” In the context of a controlled act, “Energy” refers specifically to the types of energy identified in Appendix A. This Standard Operating Procedure (SOP) is applicable only to those designated forms of energy listed in Appendix A.

“Medical Delegation” is a mechanism that allows a regulated health professional who is authorized to perform a controlled act within their scope of practice and temporarily delegates a controlled act to another person who is not legally authorized to perform the act independently.  The delegation must comply with the regulations of the delegator’s professional college (e.g., College of Physicians and Surgeons of Ontario, College of Nurses of Ontario, College of Psychologists of Ontario).

“Medical Directive Form” is a formal document found on the REB’s website, which is completed when a controlled act is delegated through medical delegation by a regulated health professional. The form outlines the conditions under which the controlled act may be performed, identifies the delegator (the regulated health professional authorizing the act) and the delegate (the individual receiving the delegation), and specifies any training, supervision, or competency requirements. The Medical Directive Form ensures compliance with the RHPA and institutional policies, providing a clear framework for the safe and authorized delegation of controlled acts within a defined period and setting.

“REB” means the Research Ethics Board at Ontario Tech University.   

“REB Administrator” means the Manager Research Ethics, Research Ethics Officer and/or Research Ethics Coordinator.

“Regulated Health Professional” is an individual who is authorized to practice a health profession and perform certain controlled acts under the RHPA and the specific legislation governing their profession in Ontario.  A regulated health professional must be registered and in good standing with one of Ontario’s health regulatory colleges (e.g., the College of Physicians and Surgeons of Ontario, the College of Nurses of Ontario).

“University” refers to the University of Ontario Institute of Technology.

“University Member” means any member of the University community who teaches, conducts research or works at or under the auspices of the University and includes any of the following:

  1. A person who is an employee of the university (core or complementary faculty members, staff, adjunct faculty, research personnel).
  2. Any person who is an appointee (including a volunteer on research related committees and boards) of the University.
  3. Undergraduate or graduate students, post-doctoral fellows, visiting scholars and any other research personnel while they are engaged in research or scholarly activities under supervision of a member.

3.0 Responsibility

The REB Chair, Vice-Chair and REB administrators are responsible for overseeing the implementation, administration and interpretation of these procedures. 

4.0 Procedures

In Ontario, under the RHPA, controlled acts must be performed by a regulated health professional who is legally authorized with their scope of practice and in good standing with their health profession college. Alternatively, a controlled act may be delegated to a qualified individual through a medical delegation for a specified duration.

Research studies that include controlled acts may move forward under any of the following conditions:  

4.1. A regulated health professional performs the controlled act

4.1.1. The regulated health professional is responsible for performing the controlled act specified in the research study, and this act is not delegated to any other member of the project team.
4.1.2. The regulated health professional must be a university member with an active appointment. For adjunct professors, proof of an active appointment must be included in the REB submission. Acceptable proof includes a copy of the appointment letter or an email confirmation from the Dean.
4.1.3. The regulated health professional must be included as a project team member in the REB application and be familiar with the research study involving the controlled act.
4.1.4. They must also provide their health profession college membership and license registration number in the REB application 

4.2. Delegation of a Controlled Act

4.2.1. The controlled act may only be delegated when the research study includes a controlled act as defined by the RHPA. Only a regulated health professional who is authorized to perform the act and delegate the act can grant the authority to another individual who is not legally authorized to perform the act independently, for a defined period, through a medical delegation.  In this context, the regulated health professional is the delegator, and the person receiving the medical delegation is the delegate.
4.2.2.When a controlled act is delegated, the delegator remains responsible for ensuring that the delegate is competent, properly trained, and adheres to established protocols outlined in the research study while performing the delegated act. The delegation is granted for a defined period and must comply with institutional and regulatory requirements.
4.2.3. The delegator must be a university member with an active appointment. For adjunct professors, proof of an active appointment must be included in the REB submission. Acceptable proof includes a copy of the appointment letter or an email confirmation from the Dean.
4.2.4. Both the delegator and the delegate must be named as project team members on the REB application and be familiar with the established protocols outlined in the research study involving the controlled act.
4.2.5. Completion of the REB’s Delegation of a Controlled Act and Medical Directive Form is mandatory. A separate form must be completed for each controlled act and for each designated delegate which must be included in the REB submission.   The delegator must also provide their health profession college membership and/or license registration number on the REB’s Delegation of a Controlled Act and Medical Directive Form.  The form must cover the entire period from the start of ethical clearance until the study's closure.
4.2.6. The REB administrator will provide the University’s Risk Management department with the delegator’s membership number from their professional governing body and their contact information to ensure inclusion in the university’s insurance coverage.
4.2.7. The Principal Investigator of the research study is responsible for ensuring the medical delegation remains active throughout the study.
4.2.8. The Delegate and Delegator must establish a clear process for continued communication and oversight during the delegation period. This structured approach ensures compliance with regulatory requirements and maintains participant safety.

4.3. The controlled acts are outsourced

4.3.1 Controlled acts are outsourced to a regulated clinic or laboratory and/or performed by an individual legally authorized to conduct the controlled act. In such cases, a Medical Directive Form is not required for outsourced controlled acts.
4.3.2 Similarly, if controlled acts are conducted under the auspices of an external institution by another researcher, a Medical Directive Form is not needed.

5.0 Surface techniques

Surface techniques are non-invasive procedures that involve placing electrodes on the skin to record and monitor the electrical activity of the body.  This includes surface electromyography (EMG) to measure muscle activity, electrocardiography (ECG or EKG) to assess cardiac function and/or electroencephalography (EEG) to monitor brain activity.

5.1. Studies that use surface techniques solely for the recording of physiological signals — without applying energy, electrical stimulation and/or using intramuscular electrodes — are not classified as controlled acts under the RHPA. These techniques may be performed by University Members who have appropriate training and demonstrated competency. A regulated health professional is not required in these cases.
5.2. Surface techniques that involve the application of a prescribed energy under the Controlled Acts regulation (Appendix A of this SOP) are classified as controlled acts under the RHPA. The use of intramuscular electrodes on a participant’s body are classified as controlled acts under the RHPA. In these cases, the procedures outlined in Section 4 must be followed.

6.0 Transcranial Magnetic Stimulation for research and non-therapeutic use

6.1. Trans-cranial magnetic stimulation (“TMS”) used solely for research and non-therapeutic purposes is not considered a form of energy under Ontario’s regulated Controlled Acts.  Therefore, it is not subject to the restrictions associated with controlled act under the RHPA. 
6.2. Despite this exemption, the use of TMS for research and non-therapeutic purposes must comply with all applicable legal and ethical requirements. The equipment must be licensed or authorized in accordance with the Medical Devices Regulations under the Food and Drugs Act, and meet established  safety and performance criteria.
6.3. University Members using TMS must have the knowledge, skill and judgement to perform the procedure safely and ethically. They must also be capable of managing any outcomes and be authorized to carry out the procedure.
6.4. Study specific standard operating procedures must be prepared and included in the research ethics application for research involving TMS.


7.0 Monitoring and Review

These Procedures will be reviewed as necessary and at least every three years (unless another timeframe is required for compliance purposes).  The REB Chair, REB Vice-Chair and/or REB Administrators, or successor thereof, is responsible to monitor and review these Procedures.

8.0 Relevant Legislation

  1. Delegation of Controlled Acts, College of Physicians Surgeon Ontario
  2. Food and Drugs Act, R.S.C., 1985, c. F-27.
  3. Medical Devices Regulations, SOR/98-282.
  4. Ontario Regulation 107/96 Controlled Acts
  5. Regulated Health Professions Act, 1991, S.O. 1991, c. 18

9.0 Related Policies, Procedures and Documents

  1. College of Nurses of Ontario, “Performing Laser Therapy”, online: https://www.cno.org/standards-learning/ask-practice/performing-laser-therapy.
  2. College of Occupational Therapists of Ontario, “Guidance: Controlled Acts and Delegation, 2021”, online: https://www.coto.org/resources/controlled-acts-and-delegation/.
  3. Ontario Tech’s Research Ethics Policy
  4. Ontario Tech’s Policy on the Responsible Conduct of Research and Scholarship
  5. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)
  6. Delegation of a Controlled Act and Medical Directive Form
  7. Appendix A – Examples of controlled acts and energy

Appendix A – Controlled acts and  prescribed forms of energy

Controlled acts include any of the following done with respect to an individual: 

  1. Communicating to the individual or his or her personal representative a diagnosis identifying a disease or disorder as the cause of symptoms of the individual in circumstances in which it is reasonably foreseeable that the individual or his or her personal representative will rely on the diagnosis.
  2. Performing a procedure on tissue below the dermis, below the surface of a mucous membrane, in or below the surface of the cornea, or in or below the surfaces of the teeth, including the scaling of teeth.
  3. Setting or casting a fracture of a bone or a dislocation of a joint.
  4. Moving the joints of the spine beyond the individual’s usual physiological range of motion using a fast, low amplitude thrust.
  5. Administering a substance by injection or inhalation.
  6. Putting an instrument, hand or finger,
    1. beyond the external ear canal,
    2. beyond the point in the nasal passages where they normally narrow,
    3. beyond the larynx,
    4. beyond the opening of the urethra,
    5. beyond the labia majora,
    6. beyond the anal verge, or
    7. into an artificial opening into the body.
  7. Applying or ordering the application of a form of energy prescribed by the regulations under Regulated Health Professions Act, 1991.
  8. Prescribing, dispensing, selling or compounding a drug as defined in the Drug and Pharmacies Regulation Act, or supervising the part of a pharmacy where such drugs are kept.
  9. Prescribing or dispensing, for vision or eye problems, subnormal vision devices, contact lenses or eye glasses other than simple magnifiers.
  10. Prescribing a hearing aid for a hearing impaired person.
  11. Fitting or dispensing a dental prosthesis, orthodontic or periodontal appliance or a device used inside the mouth to protect teeth from abnormal functioning.
  12. Managing labour or conducting the delivery of a baby.
  13. Allergy challenge testing of a kind in which a positive result of the test is a significant allergic response.
  14. Treating, by means of psychotherapy technique, delivered through a therapeutic relationship, an individual’s serious disorder of thought, cognition, mood, emotional regulation, perception or memory that may seriously impair the individual’s judgement, insight, behaviour, communication or social functioning.

Energy are forms of energy are prescribed under the RHPA.

  1. Electricity for,
    1. aversive conditioning,
    2. cardiac pacemaker therapy,
    3. cardioversion,
    4. defibrillation,
    5. electrocoagulation,
    6. electroconvulsive shock therapy,
    7. electromyography,
    8. fulguration,
    9. nerve conduction studies, or
    10. transcutaneous cardiac pacing.
  2. Electromagnetism for magnetic resonance imaging.
  3. Electricity for,
    1. diagnostic ultrasound, or
    2. lithotripsy,