Background
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS, 2nd edition, 2010) states that a fundamental function of a Research Ethics Board (REB) is to assess the risks posed to participants (and researchers) by a proposed study and to ensure that the foreseeable risks are commensurate with the potential benefits. Requirements in TCPS2 are explicit concerning the use of devices in clinical trials. When equipment and/or devices will be used to collect biometric or physiological data (e.g. blood, skin, temperature, heart rate, blood pressure, muscle movement, eye tracking, electric impulse readings) in research which is not part of a clinical trial, REBs have an obligation to assess the risks created for both participants and researchers in a manner analogous to that applicable in clinical trials. That risk assessment is described as follows:
“Researchers are responsible for providing up–to-date information about the device, for example, any feasibility studies it has been subject to in Canada or in other countries, and its risk classification. If an REB does not have enough safety information about the device to consider in its review of the trial, the researcher should be advised to work with the manufacturer of the device to provide appropriate risk information in the research proposal. In any case, REBs should satisfy themselves (with the assistance of external expertise, if necessary) that the use of the device in the trial is appropriate and that the foreseeable risks to participants are justified by the potential benefits” (p. 153 of TCPS2).
Any anticipated risks must be articulated in writing in the Risks section on the research ethics application. In this section, researchers need to clearly identify all known risks or harms (for both participants and researchers) which could arise in situations where equipment or devices will be used to collect biometric or physiological data. These risks should include any physical discomforts which participants may experience (e.g., sore muscles, rash, swelling, redness, allergic reaction).
After ethics clearance has been granted, researchers are also responsible for monitoring the safety of participants while the equipment or device is being used in the research protocol and promptly advising the REB of any adverse events.
“Researchers shall ... monitor the safety of participants, including ... tabulation, analysis and reporting of safety data and the sharing of other new information in a form that permits REBs to interpret and respond accordingly” (p. 160 of TCPS2).
Review Process
At the University of Waterloo, we have two ethics review routes:
- delegated review, and
- full Research Ethics Board review.
Research that poses minimal risk according to the TCPS2 may be delegated to one of the Office of Research Ethics staff. Research judged to pose greater than minimal risk must be reviewed by either the Human Research Ethics Board (HREB) or the Clinical Research Ethics Board (CREB) as appropriate at a monthly meeting and is not eligible for delegated review.
In certain circumstances, the use of equipment or devices might increase the risk level for participants. Certain devices or equipment may be judged to present greater than minimal risk for participants if either the magnitude or the probability of harm is greater than what one might expect to encounter in his/her everyday life.
|
Magnitude versus |
Low (minimal risk) | Medium (greater than minimal risk) | High (greater than minimal risk |
|---|---|---|---|
| Low (minimal risk) | delegated review | CREB/HREB | CREB/HREB |
| Medium (greater than minimal risk) | CREB/HREB | CREB/HREB | CREB/HREB |
| High (above minimal risk) | CREB/HREB | CREB/HREB | CREB/HREB |
When a device or piece of equipment will be used to collect physiological or biometric data in situations which are judged to be greater than minimal risk, the application must be accompanied by a detailed Standard Operating Procedure (SOP) which clearly outlines how the equipment or device is to be installed in the laboratory and used with study participants. The HREB or CREB will consider the proposed SOP as part of its review of the application to ensure that all factors which could create risk have been addressed. As part of this review, the CREB/HREB may require researchers to demonstrate the use of the equipment for them or to provide additional information (e.g., from the manufacturer of the equipment, safety authorities or other safety and quality control agencies) in order to properly assess both the magnitude and probability of harm for both researchers and participants. Refer to the documentation required.
Increased risk levels
Certain situations may increase the magnitude or probability of harm above minimal levels when using equipment or devices. The following is a non-exhaustive list, given simply by way of example:
- Psychologically invasive data collection (e.g., the use of the equipment or device may induce fear, stress or anxiety);
- Physically invasive or sensitive data collection (e.g., equipment will be used to collect blood or other body fluids);
- The equipment or device will be used as part of a controlled act as defined under the Regulated Health Professionals Act of Ontario, 1991;
- Use of the equipment or device will exacerbate an existing vulnerability participants may have (e.g., the equipment has the potential to make an existing physical infirmity worse; the equipment may induce claustrophobic feelings);
- Situations where a degree of uncertainty exists with the use of the equipment or device because the device is new (i.e. it is not generally available to the public and this is the first time it has been used at the institution);
- The researcher has invented the equipment or device and it has not been subjected to independent safety analysis;
- Equipment or devices in which a participant’s physical body movement is significantly restricted or controlled;
- Equipment or devices which require the use of a dangerous or controlled substance which requires a Material Data Sheet (MSDS);
- Equipment or devices which involve the use of lasers, radiation or biohazards and require review by the University of Waterloo Laboratory Safety Committee;
- Equipment which must comply with specialized safety standards (e.g. medical safety standards, ANSI standards).
Documentation Required
Any research ethics application that includes the use of equipment or devices to collect biometric or physiological data and is judged to be greater than minimal risk as defined above, must include the following supplementary documentation:
- University of Waterloo Safety Office Research Hazards Assessment Form completed within the last three months.
- A standard operating procedure (SOP) which identifies the steps for how the equipment or device(s) will be installed in the laboratory and used to collect biometric or physiological data. This SOP must be completed using the CREB/HREB approved SOP template.
The following is a list of items that need to be considered when developing the SOP for equipment or devices. This list is not an exhaustive list, given simply by way of example.
- If the equipment or device is sold in Canada (or outside of Canada), the name of the equipment, product number as appropriate, and the name of the company who sells it.
- Clear indication of precautions/exclusions when using the equipment (e.g., restrictions for people who have pacemakers, have had a hip replacement, have certain physical limitations).
- Will the equipment be used in the way in which it was originally intended or will this be a new or unusual use?
- How will researchers/student investigators/researcher personnel be trained to use the equipment? Are any special licenses or training required to operate the equipment?
- How will the equipment or device be installed or secured in the laboratory where it will be housed?
- Has the equipment been regularly maintained or serviced in accordance with the manufacturer’s instructions?
- Are any special licenses or approvals necessary to install the equipment? Have these been received by the researcher?
- What processes are in place to clean and sanitize the equipment? Will sterilization be required? How will this occur?
- If the equipment or device is to be used in conjunction with a controlled act as defined under the Regulated Health Professionals Act of Ontario, 1991), a Delegation of a Controlled Act form must be provided with the research ethics application (Form 101).
- Is there evidence provided that the Safety Office has assessed all of the risks associated with the equipment (e.g., a completed safety or biohazard checklist from the Safety Office)?