Office of Research Ethics
The University of Windsor’s Office of Research Ethics strives to be a welcoming and approachable office that carries out its primary mission of protecting research participants by working collaboratively with researchers under the auspices of the University of Windsor and our community partners. The Office of Research Ethics supports the work of two Full Boards—a biomedical board and a socio-behavioral board, four delegated review committees, departmental level research ethics committees and speciality review committees. Each Board and Committee is comprised of faculty colleagues, students and community representatives who review research projects for their ethical acceptability. The Office of Research Ethics also recruits expert advisors who provide consultation in speciality areas to ensure that relevant protocols are appropriately reviewed. The list of current Research Ethics Board (REB) members and expert advisors can be found on the REB website.
In addition to conducting ethics reviews of research applications, the Office of Research Ethics provides information, education, and resources to our faculty, staff, students, and community partners for conducting research involving human participants. The Office of Research Ethics and its review Boards and Committees operate in accordance with the ethical guidelines contained in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018) and the University of Windsor’s Guidelines for Research with Humans. The University of Windsor’s REB also serves as the ethics review board for Hotel-Dieu Grace Health Care, Erie Shores Health Care, the Windsor-Essex County Health Unit as well as several organizations in the Windsor-Essex community.
Commonly asked questions and brief answers
The Tri Council Policy Statement on the Ethical Conduct for Research Involving Humans (TCPS2) indicates that all research with human participants requires Research Ethics Board (REB) review, regardless of whether the research is funded or where the research takes place. (TCPS2, 2018, Article 6.1). Per the University of Windsor Guidelines for Research with Human Participants, any research that takes place at the University of Windsor, under the auspices of the University of Windsor or uses University of Windsor resources to conduct research, is subject to REB ethics review.
Research is defined by the TCPS2 as “an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation” (TCPS2, 2018, Article 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 biological materials, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question(s). For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids. Materials related to human reproduction include embryos, fetuses, fetal tissues and human reproductive materials. Research involving human remains, cadavers, tissues, biological fluids, embryos or fetuses is subject to review by the REB (TCPS2, 2018, Article 2.1).
The TCPS2 outlines three research activities that are exempt from REB ethics 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, 2018, Article 2.2).
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“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, 2018, Article 2.3).
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“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, 2018, Article 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 that will be analyzed to answer a research question is subject to REB review” (TCPS2, 2018, Article 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, 2018, Article 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 should consult with the Office of Research Ethics 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, Article 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 ethics 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 ethics 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 Institutional Quality Assurance Process (IQAP).
Yes, REB ethics 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 ethics 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 organization or community agency for QI, QA or program evaluation, as described above, and will not be used by the researcher or any other purposes, then the REB may consider the activities to be exempt under TCPS2, Article 2.5 and will issue an exemption letter. The researcher should consult with the Office of Research Ethics for the determination of exemption.
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 ethics review.
Please have the researcher call the REB office immediately. We will work with the researcher to examine the activities and determine alternatives for 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 ethics review. Please see the Pre-Release of Funds form via the REB Forms page. The form must first be submitted to the Office of Research Ethics for signature and then to the Office of Research and Innovation Services (ORIS) for approval for pre-release of funds.
All applications submitted to the Office of Research Ethics activate an assessment that determines a “proportionate approach” for the level of review (TCPS2, 2018, Introduction: Chapter 2) which follows assigning an appropriate Board or Committee and ethics review date. The University of Windsor REB has three levels of review: Full Board review, Delegated review, and Executive review.
The Full Board and Biomedical Board review research application that are more than minimal risk, clinical trials, biomedical protocols and hospital or clinic-based research with patients, and other protocols as determined by the Chair that may benefit from Full Board or Biomedical Board review. The Full Board and Biomedical Board meet monthly, so depending upon when protocols are submitted to the REB and the volume of protocols submitted to the Full Board or Biomedical Board, the turnaround for ethics review and comments to the researcher can be up to 6 weeks.
The Delegated Committee reviews research that is minimal risk. The main Delegated Review Committee meets weekly. Speciality Committees, such as the Scholarship of Teaching, Learning and Education or the Humanities Committee meet as needed to review appropriate applications assigned to them. Depending upon the number of protocols submitted during a week, most protocols for delegated ethics review are scheduled within 2-3 weeks. Most delegated review comments are returned to the researcher within 2 weeks after the ethics review, for a total review turnaround of 4 weeks. Some delays may occur during high volume times*.
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 ethics review decisions are made within 2 weeks.
Researchers should call the Office of Research Ethics 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 ethics review schedules. The Office of Research Ethics is currently undergoing a benchmark study to determine volume and review trends. The results from this benchmark study and volume trends will be posted on the REB website to assist researchers in planning their REB application submissions.
Researchers who have questions about the comments received from the REB are encouraged to contact the Office of Research Ethics or the REB Chair. Feedback from researchers is one mechanism that the Office of Research Ethics uses to assess the quality of our communications and make the necessary modifications or ethics review adjustments, so we appreciate receiving both positive and negative feedback from our researchers.
The Office of Research Ethics 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 issues relevant to the University of Windsor. 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 to receive the new University of Windsor REB clearance letter as confirmation of the transferred ethics oversight. For further information on transferring research files to the University of Windsor, please contact the Office of Research Ethics.
Yes, the University of Windsor is the REB of record for research conducted by their faculty, staff, or students or others affiliated 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/approval 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 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, Article 2.5 if used only for QI/QA purposes. However, if the instructor wishes to conduct a research study on 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 ethics 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 REB reviews for courses that include a research component conducted by the instructor of the course, 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/or contact the Office of Research Ethics with any questions about the ethics review process and meeting schedules, forms, policies, ethics resources, or other research inquiries. You can also schedule a meeting with the REB Chair through the REB website. We encourage researchers to meet with a member of the REB prior to the submission of an application which 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. Our phone number extension is 3948 and our e-mail address is ETHICS@uwindsor.ca.