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General Ethics Guidelines

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

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.

1. 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.

2. 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.

3. REB approval is conditional on permit approval from the Institutional Biosafety Committee (IBC).

4. All applications will be considered on a case-by-case basis.

If you have any questions about these requirements, please consult with the REB.

 

Privacy, Confidentiality and Data Guidelines​​​

Research Involving Indigenous Peoples of Canada (First Nations, Inuit and Metis)

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. 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. 

Research Involving Children and Adolescents

 

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.

Please note, in these cases, 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 please consult with the REB.

 

Risk

Minimal Risk Research

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 those aspects of their everyday life that relate to the research.

If you are not sure whether your research qualifies as “minimal risk,” contact the REB for information and advice.

Higher Risk Procedures 

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 please 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.

SOPs that are greater than minimal risk will require full board review and clearance.

To request to have an SOP reviewed and approved by the REB please 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.​