General Ethics Guidelines
The following page outlines general ethics guidelines, including:
- clinical trial research
- course-based research projects
- crowdsourcing services
- in-class research recruitment
- phlebotomy
- privacy, confidentiality and data guidelines
- research involving Indigenous Peoples of Canada, and children and adolescents
- research risks
- standard operating procedures
- secondary use of data
- templates
Clinical Trial Research
Some research projects undertaken at Laurier will meet the requirements of a clinical trial. The TCPS 2 defines a clinical trial as any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes.
Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products, process-of-care changes, preventive care, manual therapies and psychotherapies.
Clinical trials may also include questions that are not directly related to therapeutic goals – for example, drug metabolism – in addition to those that directly evaluate the treatment of participants.
For more information please refer to Chapter 11 of the TCPS 2. If your proposed research constitutes a clinical trial please contact the REB to determine any additional information you may need to include with your project.
Course-Based Research Projects
The REB is mandated to review the ethical acceptability of research on behalf of the institution and is the default reviewing body. This includes course-based research activities, the primary purpose of which is pedagogical. Undergraduate course-based research activities may be delegated to a departmental Research Ethics Committee (REC) if the research project meets specific criteria. Please see the Before You Apply section on the Research Involving Humans page for a full list of criteria. Whether you’re applying to the REB or the REC, please consider the following guidelines when preparing your course-based research ethics application.
When Different Students in the Class are Completing Different Research Projects
When individual students (or groups of students) within a class will each undertake different research projects, each student (or group of students) will need to prepare their own application for ethics review. The course instructor would be supervising the research project and should be listed as the Principal Investigator (PI) on these applications. All student(s) should also be listed as members of their own research project team.When Everyone in the Class is Working on the Same Research Project
When individual members (or groups of students) within a class will each be undertaking the same research project, the instructor may submit one application (as the PI) on behalf of the entire class. The research must meet the following criteria:- Each student (or group of students) must be assigned essentially the same research question or problem to answer.
- The instructor must provide copies of materials to be used (including recruitment and consent letters, and any questionnaires or surveys). You may upload one template to be used by all groups or students and you may identify and highlight sections that can be changed by students to include their project-specific details.
- Only the class instructor can submit requests for modifications.
Students are often interested in conducting research on topics that they find interesting and engaging. However, it is very important to carefully consider the topics selected. Higher-than-minimal-risk research, in-person methods (while COVID-19 research resumption requirements are in place), and longitudinal designs are examples of projects that should be carefully considered by the faculty advisor/ course instructor to ensure that the ethics review and approval process and research activities will fit into the proposed timeframe. Examples of research topics that may be considered higher than minimal risk and/or require a higher level of review include:
- ingesting, smelling, tasting, and application of substances that pose health risks
- answering questions relating to sexual or physical abuse, self-harm, and suicidal thoughts and actions
- asking for or providing medical/health information or clinical diagnoses
- reporting of illegal activities
- clinical trials
- projects involving participants deemed vulnerable in the context of research (e.g., people with cognitive impairment, people experiencing homelessness)
- multi-institutional / multi-jurisdictional research
Crowdsourcing Services
Researchers who plan to utilize crowdsourcing services for their research studies are responsible for ensuring compliance with all applicable policies and are advised to contact the service directly with any questions regarding compliance with their policies. For example, Amazon Mechanical Turk (MTurk) prohibits the collection of personally identifiable information (e.g., email address, phone number) and unsolicited contacting of users. If you plan to contact participants for follow-up or future studies via MTurk, you will need to ask for permission to do so and should contact them through the site using their "Worker ID". Please see Amazon Mechanical Turk Acceptable Use Policy for a full description of permitted and prohibited uses of MTurk. As a researcher, you are responsible for reviewing and adhering to the policies of the crowdsourcing service you will be using.
In-Class Research Recruitment
A proposal from a faculty member or teaching assistant seeking to use their students as research participants must demonstrate to the satisfaction of the REB that:
- There is no undue influence or manipulation on the part of the instructor that would likely result in students feeling pressure or coercion to become a participant in their instructor’s research.
- Consent will be given voluntarily and not as a result of instructor’s position of power/authority over the students they instruct.
- Data provided by those who volunteer to participate will remain confidential and anonymous so that other students in the class and the instructor will not be able to determine who participated.
To demonstrate to the REB that the elements noted above have been fulfilled, research projects seeking to use students must:
- Respect that class time is for instructional purposes, not research. Use of class time to conduct research must be kept to a minimal amount of time at the end of each class (i.e., less than 10 minutes). The preferred practice would be to invite students to remain after the end of class to learn more about the research project;
- Consent to participate will need to be provided to (or collected by) an independent third party with no authority or power over the students (i.e., not the class instructor). The instructor must not be aware of who agreed to participate while the instructor-student relationship exists.
- An informed consent statement will need to be created and provided to the potential participants explaining the research project. This document must specifically state that there will be no repercussions to those students choosing not to participate;
- If the project requires the collection of student grades or other identifiable information, this information shall not be provided to the class instructor until the instructor-student relationship has ended. In most cases this will take place only when the instructor has forwarded to the Registrar’s Office all final marks from the class. This process should be clearly outlined in the consent letter.
- Projects specifically seeking to access student academic materials (grades, assignments, essays, journals, etc.) will need to obtain the consent of the student before such material can be used for research purposes. In seeking to obtain such consent, the instructor must clearly explain to the students how their data will be used. Student consent is not needed to report on the average grade for an entire class.
Phlebotomy
The following requirements and qualifications are required in order for an individual to perform a blood draw. These guidelines are in place to streamline our procedures and ensure the safety and welfare of all participants.
- The REB normally expects blood draws to be performed by one of the individuals listed below:
- a. A technician employed by a laboratory licensed under the Laboratory and Specimen Collection Centre Licensing Act;
- b. Licensed Medical Laboratory Technologist (must show proof of successful completion of a medical laboratory technology program offered at an institution accredited by the Canadian Medical Association [CMA] in Canada and certification through Ontario Society of Medical Technologists);
- c. Registered nurses in accordance with their professional regulations.
- On a case-by-case basis the REB may consider certified phlebotomists to perform blood draws if the following requirements and qualifications are met:
- a. Completion of Phlebotomy Certificate Course which includes an in-class component, a practical component (i.e., 10 successful blood draws), and a written examination. Course details must be provided to the REB for review. Online certificates are not considered an acceptable alternative.
- b. Additional supervised practical experience (e.g., practicing on a dummy arm)
- c. Sign-off from an experienced supervisor prior to phlebotomists being approved to draw blood. Please note, the supervisor must have the adequate skills, training, competency and the appropriate amount of experience with drawing blood.
- d. These training requirements are required to be detailed in a Standard Operating Procedure for review and approval by the REB. The experienced supervisor is required to be listed as a project team member on the associated SOP to facilitate ongoing supervision.
- REB approval is conditional on permit approval from the Institutional Biosafety Committee (IBC).
- All applications will be considered on a case-by-case basis.
If you have any questions about these requirements, consult with the REB.
Researchers using video conferencing tools to conduct research projects involving interviews and focus groups should be aware of the privacy and security limitations of these tools.
Microsoft Teams is a solution that has been approved at Laurier for use with all information types, including Type 3 (restricted) information (e.g., research interviews, focus groups, or other research-related discussions that involve sensitive or health-related information) and is the preferred platform to use with all information types. Students have access to the Laurier managed Microsoft Teams instance with the migration of Laurier @mylaurier.ca account to the Microsoft environment. Additional information about students accessing Teams can be found on the Microsoft Teams student website.
Zoom for Education has been approved for research activities that involve Type 1 (open) or Type 2 (internal) information. Zoom for Education should not be used for research that involves collecting Type 3 (restricted) data (e.g., sensitive or health-related information). Please see Getting Started with Zoom for more information.
Zoom for Healthcare has been approved for Type 3 (restricted) information. This includes research interviews, focus groups or other research-related discussions that involve sensitive or health-related information and where Microsoft Teams is not a suitable option. These licenses can be requested from ICT who will review the request and determine whether a Zoom for Healthcare license can be provided for your use case. To learn more about this service and how to request an account please see Getting Started with Zoom .
For further information about the different data classes and the protections associated with them, please review university policies 9.5 External Information Technology and Cloud Services Policy and 10.4 Records Management Policy. Any questions about video conferencing tools can be directed to the ICT Service Desk.
For the collection of research data, researchers are required to use online survey systems that have been reviewed and approved in accordance with Policy 9.5 External Information and Cloud Services Policy (e.g., Qualtrics). Online survey systems that have not undergone an assessment (e.g., Survey Monkey, Google Forms) may not be approved for use by the REB.
The WLUFA collective agreement (see Article 37.2) requires that members retain research and scholarly activity materials that are within their personal control for five years.
If a researcher is compensating participants for their time, University Policy 3.4, Appendix A, addresses the Canada Revenue Agency’s Income Tax Act, which stipulates that all records and supporting documents relating to an individual’s tax obligations and entitlements be maintained for a period of six years from the end of the last tax year to which they relate. Researchers should inform participants of their obligations to self-report all income in the informed consent statement.
As outlined in Chapter 5 of the TCPS 2, the following categories provide guidance for assessing the extent to which information could be used to identify an individual.
Anonymous Information: the information never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low.
Anonymized Information: the information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low.
Coded Information: direct identifiers are removed from the information and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a list that links the participants’ code names with their actual name so data can be re-linked if necessary).
Directly Identifying Information: the information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number).
Indirectly Identifying Information: the information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic).
Researchers using the internet to transmit or receive participant data should be aware that while in transmission, data may be subject to access by third parties as a result of various security legislation now in place in many countries.
When such data transmission takes place researchers need to make their participants aware of this in the informed consent statement.
The researcher listed as the principal investigator on an REB project is responsible for ensuring that appropriate steps and safeguards have been put into place to protect participant data from loss or unauthorized access.
The type of safeguards required will be proportional to the data obtained from the participants, with more sensitive data requiring higher levels of security.
At a minimum, all data on electronic devices should be password protected; hard-copy data should be stored in a secure manner.
Please note that many popular cloud-based tools, such as Google Drive, Dropbox, and Slack for example, have policies around data retention and deletion that do not meet the standards established by Laurier policies relating to certain types of information and information security.
For further information about the different information classes and the protections associated with them, please review the following university policies: 9.4 Information Security Policy Statement, 9.5 External Information Technology and Cloud Services Policy and 10.4 Records Management Policy.
For more information about Cloud Computing at Laurier, your faculty supervisor should review the Finding Software Solutions and Approved Software and Cloud Solutions Connect pages.
As a friendly reminder, Laurier users are encouraged to utilize several cloud-based collaboration tools that have been properly vetted. An example of a Laurier approved cloud solution is Microsoft OneDrive for Business, a storage system with collaboration capabilities. OneDrive for Business data is stored in Canada and backed up by ICT data transfer is completed using encrypted protocols and data is stored at rest with two levels of encryption. In addition, researchers can use this OneDrive for Business as a collaboration tool and share information with other Laurier and non-Laurier researchers and students. Your faculty supervisor can access instructions on sharing files on OneDrive for Business on Connect.
Any questions about this process or how to access Laurier-approved cloud solutions can be directed to the ICT Service Desk.
Researchers planning to conduct research involving Indigenous Peoples, including First Nations, Inuit and Métis peoples of Canada should consult Chapter 9 of the TCPS 2.
The guidelines outlined in this chapter are also considered best practice for any work involving communities.
The consent of the parent or guardian will be required (in addition to that of the participant), for participants under the age of 16, except when the participant is no longer living under the care or control of their parent or guardian. Additional exceptions to this requirement may be considered by the REB on a case-by-case basis.
Consent Forms
The REB requires the submission of two consent forms for review: one for the parent/guardian and one for the participant.
The consent letter for the participant should contain age-appropriate language to ensure their understanding of the project and their role within it. In some cases a verbal assent script may be necessary with younger participants.
If you have questions or concerns about these requirements, consult with the REB.
Minimal risk research is research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects of their everyday life that relate to the research.
Types of risk may include physical, psychological/emotional, and social. Examples of research topics and procedures that may be considered higher than minimal risk include:
- ingestion, tasting, smelling, application of a substance that pose any health risk
- answering questions related to sexual or physical abuse, as well as self harm and suicidal thoughts or actions
- providing medical/health information or clinical diagnoses (e.g., depression, anxiety) particularly if associated with identifiers
- reporting on illegal activities
If you are not sure whether your research qualifies as minimal risk, contact the Research Ethics Board for information and advice.
Some research projects may involve the use of a procedure(s) that is deemed by the REB to entail a higher degree of risk to the potential participants.
If you think your proposed research involves higher-risk procedures, contact the REB to determine any additional information you may need to include with your project.
Standard Operating Procedures
Researchers who plan to use the same procedure across a number of different projects may choose to have the procedure reviewed and approved by the REB as a separate project.
When approved by the REB, this will eliminate the need to have the procedure repeatedly reviewed when included as part of future projects to the REB.
Standard operating procedures (SOPs) that are deemed to be:
- of minimal risk can be reviewed and approved via the expedited review process.
- greater than minimal risk will require full board review and clearance.
To request to have an SOP reviewed and approved by the REB, contact the REB.
Secondary Use of Data
Secondary use of data refers to the use of information originally collected for a purpose other than the current research purpose. Examples include:
- Social science or health survey datasets that are collected for specific research or statistical purposes, but then re-used to answer other research questions.
- Health care records, school records, biological specimens, vital statistics registries or unemployment records, all of which are originally created or collected for therapeutic, educational or administrative purposes, but which may be sought later for use in research.
Article 5.5 A, TCPS 2 says that researchers who have not obtained consent from participants for secondary use of identifiable information shall only use such information for these purposes if they have satisfied the REB that:
- Identifiable information is essential to the research.
- The use of identifiable information without the participants’ consent is unlikely to adversely affect the welfare of individuals to whom the information relates.
- The researchers will take appropriate measures to protect the privacy of individuals, and to safeguard the identifiable information.
- The researchers will comply with any known preferences previously expressed by individuals about any use of their information.
- It is impossible or impracticable to seek consent from individuals to whom the information relates.
- The researchers have obtained any other necessary permission for secondary use of information for research purposes.
If a researcher satisfies all the conditions in Article 5.5A (a) to (f), the REB may approve the research without requiring consent from the individuals to whom the information relates.
Article 5.6, TCPS 2 says that when secondary use of identifiable information without the requirement to seek consent has been approved under Article 5.5A, researchers who propose to contact individuals for additional information shall, prior to contact, seek REB clearance of the plan for making contact.
Article 5.5 B, TCPS 2 says that researchers shall seek REB review, but are not required to seek participant consent, for research that relies exclusively on the secondary use of non-identifiable information.
Application: The onus will be on the researcher to establish to the satisfaction of the REB that, in the context of the proposed research, the information to be used can be considered non-identifiable for all practical purposes.
For example, the secondary use of coded information may identify individuals in research projects where the researcher has access to the key that links the participants’ codes with their names. Consent would be required in this situation.
However, the same coded information may be assessed as non-identifiable in research projects where the researcher does not have access to the key. Consent would not be required in this situation.
Data Linkage
Article 5.7, TCPS 2 says that researchers who propose to engage in data linkage shall obtain REB clearance prior to carrying out the data linkage, unless the research relies exclusively on publicly available information.
The application for review and clearance shall describe the data that will be linked and the likelihood that identifiable information will be created through the data linkage.
Where data linkage involves or is likely to produce identifiable information, researchers shall satisfy the REB that:
- The data linkage is essential to the research.
- Appropriate security measures will be implemented to safeguard information.