All research involving human participants must be reviewed by a Research Ethics Board.
The first step in determining if a feasibility study requires ethics review is to determine whether or not it is considered research involving human participants as defined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
Definition of research (from Article 2.1)
- “an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. The term “disciplined inquiry” refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.”
- “human participants” (referred to as “participants”) are those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.”
The second step is to define what is covered by the term ‘feasibility study’. For the purposes of this discussion, a feasibility study could include the following;
- Mockups – an assemblage of commercially available equipment which will be tested for functionality. Testing equipment that has been developed through a research program and/or by University personnel would be considered a proof-of –concept trial described below.
- Demonstrations or display items – to demonstrate or train individuals on the use of a particular piece of equipment or technique. Examples include, but are not limited to, class demonstrations and demonstrations for community events such as College Royal
These processes are not considered to be research since they are not disciplined inquiries, nor is there usually a research question which responses from the human participants could help to answer.
Proof-of-concept: Note that a proof-of-concept trial would be considered research, since it is a systematic inquiry which attempts to address a research question. An example of a proof-of-concept trial is the testing of a piece of equipment that has been developed on/with humans participants.
Note that involving human beings in feasibility studies can raise both ethical and safety issues. Participation should be voluntary and the participants should be made aware of the associated risks involved. It is the responsibility of the supervisor (primary course instructor, advisor etc.) to ensure appropriate procedures are followed and controls are in place to ensure the safety of the participants. The REB strongly recommends that Environmental Health and Safety is consulted prior to embarking on any process involving humans. If you are involving Teaching Assistants or students in your feasibility study within the structure of a course, it is recommended that you notify your departmental Chair and/or curriculum committee.