The Faculty of Pharmacy Undergraduate Research Ethics Review Committee (or FERC for short) has been created to review research involving human subjects conducted by undergraduate students in the Faculty of Pharmacy. The FERC has the authority to approve “expeditable” (i.e. low risk) research protocols, and thereby speed up ethics approvals. Protocols that the FERC deems to be non-expeditable will be referred to the University of Toronto Ethics Review Office for adjudication.
Why has the FERC been created?
- To ensure that all research conducted under the auspices of the Faculty of Pharmacy meets federal ethics guidelines
- To speed up ethics review of low risk research
What kind of undergraduate research should be reviewed by the FERC?
Research involving human subjects, either funded or unfunded, initiated by undergraduate (BScPhm & PharmD) students, including:
- research conducted as part of residency training (including hospital, community pharmacy, and industry residencies), or
- research conducted as part of undergraduate course work, or
- other research not otherwise under the auspices of the Graduate Department of Pharmaceutical Sciences.
Research involving human subjects includes:
- obtaining data about a living individual through intervention (e.g. a medical procedure) or interaction (e.g. a survey or interview) with the individual, or the obtaining of private personal information about the individual,
- secondary use of data (i.e. information collected for purposes other than its primary purpose) that contains identifying information about a living individual, or data linkage through which living individuals may become identifiable,
- naturalistic observation, except the observation of individuals in contexts in which it can be expected that participants are seeking public attention (such as a public speech or performance).
What kind of undergraduate research does not need to be reviewed by the FERC?
- Undergraduate participation in faculty-initiated research that has already received ethics approval
- Research involving only the use of published or publicly available information or materials, performances or archival materials
I am the Faculty Liaison of an undergraduate residency trainee who is conducting research involving human subjects. What do I need to do?
First, determine if the FERC needs to review the undergraduate research proposal. The FERC does not need to review the following kinds of research:
- Assessment activities, such as quality assurance studies; activities conducted by residency trainees that would normally be conducted in the training environment (such as survey research conducted by an industrial resident that is routinely conducted by the business); performance reviews or testing within normal educational requirements.
- Research that has received approval from an ethics review board from the University of Toronto, one of its affiliated hospitals, or another ethics review board.
If the FERC does not need to review the research proposal, kindly provide documentation and signatures on an exemption form, which you can download here.
If the FERC does need to review the research proposal, then download and complete the Residency Trainee research ethics review form, which you can download here.
I am the Instructor of an undergraduate course that requires students conduct research involving human subjects. What do I need to do?
- If students in a class are all performing research that falls within tight constraints, then it may be possible to have the activities covered by submitting a “course template” form.
- Otherwise please submit the “student-initiated project” form.
I am supervising student-initiated research involving human subjects. What do I need to do?
- Please submit the ‘student-initiated project’ form.
When do these policies take effect?
Immediately for any research that is currently being planned or initiated. These policies also apply to hospital residents rotations.
In any case, please submit the completed forms and related documentation to Donald Wong via one the following:
E- mail: firstname.lastname@example.org
Mail: Leslie Dan Faculty of Pharmacy, Room 670, 144 College St, Toronto ON M5S 3M2
If the research requires ethics approval by the University of Toronto, the FERC will screen it to determine if the ethics review can be expedited. The FERC can grant approval for “expeditable” protocols for up to one year. The expedition-status of research depends on the level of risk to study participants and the “vulnerability” of the study participants. Expeditable research is research that:
- exposes “low vulnerability” subjects to low levels of research risk, OR
- exposes “medium vulnerability” subjects to low levels of research risk, OR
- exposes “low vulnerability” subjects to medium levels of research risk.
Research that is not expeditable will be referred to the University of Toronto Ethics Review Office for adjudication.