The University of Windsor’s Research Ethics Board strives to be a welcoming and approachable office that carries out its primary mission of protecting research participants by working collaboratively with its research colleagues. The REB is a board of researchers’ peers with a membership of faculty colleagues and student and community representatives. The membership of the REB rotates over a three-year period. The REB also recruits expert advisors who provide consultation to the REB in speciality areas to ensure that relevant protocols are appropriately reviewed. The list of current REB members and expert advisors can be found on the REB website.
In addition to conducting reviews of research protocols, the REB provides information, education, and resource support to our faculty, staff, and students in conducting research involving human participants. The University of Windsor REB operates in accordance with the ethical guidelines contained in the Canadian Tri-Council Policy Statement (TCPS2) and the University of Windsor’s Guidelines for Research with Humans. The REB also serves as the ethical review board for Hotel-Dieu Grace Health Care and several community agencies such as the Windsor Essex Community Health Unit and the Cardiac Care Centre. As of April 2017, the REB is in the process of seeking certification as a Clinical Trials Ontario Board to support our researchers who pursue multi-jurisdictional clinical trials research.
Commonly asked questions and brief answers
The TCPS2 guidelines indicate that all research with human participants conducted by faculty, staff, or students requires REB review, regardless of where the research takes place. (TCPS2 , 2014, 6.1). Per the University of Windsor Guidelines for Research with Human Participants, any research that takes place at the University of Windsor, that seeks to recruit persons affiliated with the University of Windsor for research, or that uses University of Windsor resources to conduct research, is subject to REB review.
Research is defined by the TCPS2 as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation (TCPS2 , 2014, 2.1). Whether or not the results will be published is not a determining factor for REB review. The determination of whether an activity is research is based on several criteria including the nature of the information collected, the systematic procedures used to gather information, the intended use of the information, as well as access to and dissemination of the information collected.
The REB is the sole authority to determine if an activity meets the definition of research and/or when review is required for any activity that potentially meets the definition of research.
Human research participant is defined by the TCPS2 as those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question (TCPS2 , 2014, 2.1). Research involving human remains, cadavers, tissues, biological fluids, embryos or fetuses is subject to review by the REB (TCPS2 , 2014, 2.1).
If a Department Head is not sure if an activity meets the definition of research, please check with the REB.
The TCPS2 outlines three research activities that are exempt from REB review:
- Research that relies exclusively on publicly available information when the information is legally accessible to the public and appropriately protected by law; or the information is publicly accessible and there is no reasonable expectation of privacy (TCPS2 , 2014, 2.2).
- Research involving the observation of people in public places where:
- The research does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
- Individuals or groups targeted for observation have no reasonable expectation of privacy; and
- Any dissemination of research results does not allow identification of specific individuals (TCPS2 , 2014, 2.3).
- Research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information (TCPS2 , 2014, 2.4).
Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain information from participants to answer a research question is subject to REB review (TCPS2 , 2014, 2.6).
The TCPS2 indicates that quality improvement (QI), quality assurance (QA), and program evaluation activities that are “normally administered in the ordinary course of the operation of an organization where participation is required, for example as a condition of employment such as staff performance reviews or evaluation in the course of academic or professional training” do not meet the definition of research and are therefore are outside the scope of review (TCPS2 , 2014, 2.5). Activities that are not conducted as part of the ordinary course of an organization may qualify as research under the TCPS2.
Researchers engaging in activities falling under the above description must consult with the REB to determine if they are exempt from review.
If the information is being gathered for the purposes of accreditation or other internal QI/QA evaluation, then the REB may determine that the activities are exempt under TCPS2, 2.5 and issue an exemption letter. If the information is being disseminated to an external accreditation body or other organization external to the University of Windsor, or is not part of the ordinary course of operation of the Department, then REB review may be required depending upon the scope and use of the information. In this case, there are several ways the REB can streamline the review process from conducting an expedited Executive Review, developing a Standard Operating Procedure to cover the accreditation activities, or establishing ethics oversight within a larger governing body in the University such as with the IQAP process.
Yes, REB review is required if the activities are conducted as a component of a research project, or if information that is being gathered will subsequently be used as research data. REB review is also required If the faculty, staff or student is consulting on research activities using their University of Windsor title or association.
However, if the information that is gathered is to be used solely by the community agency or organization for QI, QA or program evaluation, as described above, and will not be used by the faculty member for any other purposes, then the REB may consider the activities to be exempt under TCPS2, 2.5 and will issue an exemption letter.
If the faculty member is acting solely as a private citizen and is not using their University of Windsor association, referring to their faculty or staff position or title, or using any resources provided by the University of Windsor, then they are not acting under the auspices of the University and fall outside of the scope of REB review.
Please have the researcher call the REB office immediately. We will work with the researcher to examine the activities and determine what are the alternatives moving forward. Our approach to working with researchers where an unintended mistake has occurred is to provide education and assistance to the extent we can to rectify the situation.
Researchers can receive a percentage of their grant funds to support the initial start-up of projects that are not yet ready for REB review. Please see the Release of Funds form via the REB Forms page. The form must first be submitted to ORIS for approval for pre-release of funds and then finally by the REB Chair.
All protocols submitted to the REB activate an assessment that determines the “proportionate level of review” (TCPS2, Introduction, Chapter 2) and assigned an appropriate committee and review date. The University of Windsor REB has three levels of review: Full Board review, Delegated review, and Executive review.
The Full Board reviews research that is more than minimal risk, medical protocols, research with First Nations, Métis, and Inuit, and other protocols as determined by the Chair that may benefit from Full Board review. The Full Board meets monthly so depending upon when protocols are submitted to the REB and the volume of protocols submitted to the Full Board, the turnaround for review and comments to the researcher can be up to 6 weeks.
The Delegated Committee reviews research that is minimal risk. The Delegated Review Committee meets weekly. Depending upon the number of protocols submitted during a week, most protocols for delegated review are scheduled within 2 weeks, 3 weeks during high volume times*. Most delegated review comments are returned to the researcher within 2 weeks after the review, for a total review turnaround of 4 weeks.
Research that relies solely on the use of secondary information, administrative research, and determinations of exemptions are assessed through Executive Review by the REB Chair who reviews protocols and such requests weekly. Most executive review decisions are made within 2 weeks.
Researchers should call the REB if they have questions regarding their review date or status of their protocol reviews.
* High volume times for the REB are September, January, and May-August, which can delay the timing of review schedules. The REB is currently undergoing a benchmark study to determine volume and review trends. The results from benchmark study and volume trends will be posted on the REB website in the Fall 2017 to assist researchers in planning their REB reviews.
The REB encourages researchers who have questions about the comments received from the REB to contact the REB Chair or Coordinator. Feedback from researchers is the only way the REB can assess the quality of our communications and make the necessary modifications or review adjustments, so we appreciate receiving both positive and negative feedback from our researchers.
The REB will accept the protocol applications and clearance/approval letters from other Universities on their original forms for new faculty who are transferring their grants from another institution. An Executive Review will be conducted on the transferred research to determine if there are any relevant questions under the TCPS2 or University of Windsor Guidelines. The REB reserves the right to ask applicants to re-submit protocols on the University of Windsor form where the submitted application precludes the REB from conducting an appropriate review. In the absence of any issues, a new clearance letter will be issued from the University of Windsor. Often the prior institution will need to close the researchers’ ethics file at their institution and will need the new clearance letter as confirmation of the transferred ethical oversight. For further information on transferring research files to the University of Windsor, please contact the REB.
Yes, the University of Windsor is the REB of record for research conducted by their faculty, staff, or students or others associated with the University of Windsor. However, the REB will accept the protocol application on the original forms of the PI’s institution together with the clearance letter from the PI’s institution for review at the University of Windsor. In the case where another Institution has cleared the research, the REB will conduct an Executive Review of the protocol and provide a clearance letter for the University of Windsor researcher. As noted in Question 10 above, the REB reserves the right to ask applicants to submit their component of a project on the University of Windsor REB form when the University of Windsor co-PI has scientific and implementation oversight of a specific component of the larger study or acts as the PI of a site within a multi-jurisdictional study or the submitted application precludes the REB from conducting an appropriate review.
Yes, an REB application is needed when using information for a secondary purpose as research data, such as in the use of assignments, papers or information from Blackboard. Pre-post feedback may also be used as secondary research data, if the primary use of the information was to contribute to the development of the course. Activities that are conducted within the classroom, such as new teaching techniques or novel interventions are not inherently research and feedback from students on their experience of these course-based activities may be exempt under TCPS2 2.5, if used only for QI/QA purposes. However, If the instructor wishes to conduct a research study around their course, such as gathering data to evaluate the new teaching methods, assessing the impact on students longitudinally, comparing across sections, or aggregating data over time, this could meet the definition of research and require REB review. An important component of the use of information as secondary data is the need for voluntary and informed consent from the student participants; the REB has a number of different models for ways to obtain consent from student participants in a course-context and will work with faculty to identify the most appropriate for their research study.
The REB is currently working across the University of Windsor with Faculties and Departments to establish review procedures that will facilitate course-based research. Also, the REB is working with individual faculty to develop standard operating procedures that facilitate on-going streamlined reviews for courses that include a research component either by the faculty member of the course itself, or by students within research-based courses. The REB has several models of standard operating procedures and can work with individual faculty members, Departments and Faculties to find ways to promote course-based research and streamline the REB review process.
Please visit the REB website and encourage your faculty, staff, and students to contact the office with any questions about the review process, forms, policies, and/or other ethical research inquiries. Meeting or talking with the REB Chair, Coordinator, or a board member prior to submission of a protocol can often help identify potential REB questions and facilitate a streamlined review process.
The REB is located in Chrysler Hall North, 2nd floor, Suite 2146. Its phone number is Extension 3848 and its e-mail address is ETHICS@uwindsor.ca.
The REB welcomes faculty, staff, and students to drop in its office, call, or make an appointment to meet and talk with the REB Chair or Coordinator.