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Wilfrid Laurier University Office of Research Services
September 23, 2014
 
 
Canadian Excellence

Research Ethics Board Requirements and Procedures (Listed Alphabetically)



The following list of topics is presented alphabetically and outlines various requirements and procedures  related to the Research Ethics Board (REB) review process at Laurier.


Academic Qualification

In describing a researcher’s academic qualifications please ensure that only those degrees or qualifications that have been fully completed and awarded are listed after their name.

Researchers may indicate that they are presently enrolled in a specific academic program (e.g., I am a doctoral student in the sociology department at Laurier.)

In some cases the use of ‘Dr.’ may not be appropriate, particularly in the case of clinical research as it may lead some participants to conclude incorrectly that the researcher is a medical doctor. In such cases the use of ‘Professor’ or adding ‘Ph.D.’ to the end of the researcher’s name is encouraged.

 
Approval Period

REB approval can be granted for a maximum of two years on each new protocol. The end date that the REB will choose for the project will be the ‘end date’ that that is requested by the researcher in his or her ROMEO application (up to a maximum of two years from the date of REB approval). If a researcher wishes to have a two-year approval period for his or her project, this should be reflected in the ‘end date’ they choose on his or her application.

 
Changing the Principal Investigator

The principal investigator on an REB protocol cannot be changed after REB approval is granted.

 
Clinical Trial Research

Some research projects undertaken at Laurier will meet the requirements of a clinical trial as defined in TCPS2. Standard Operating Procedure (SOP) 1: Review of Clinical Trial Research has been adopted by the REB to guide the review and approval process for such projects. Please refer to SOP 1 for additional details.

 
Co-oP and Workplace Projects

Laurier students on Co-oP placements or similar work terms may be asked by their employer to undertake a variety of projects and assignments involving human participants. Such projects will be except from REB review when the project is used exclusively by the employer (i.e., it will not be submitted for academic purposes at Laurier) and there is no reference / association between the project and Laurier.

 
Course Projects for Students

When individual members (or groups of students) within a class will each be undertaking the same research project, the instructor will submit one REB application (as the principal investigator) on behalf of the entire class:

  • - Each student (or group of students) must be assigned essentially the same research question or problem to answer.
  • - The instructor must provide copies of the consent letter to be used as well as any questionnaires that will be distributed by the students in order to provide the REC / REB with an overall sense of the project and the type of data being collected from the participants.
  • - Minor variances to the consent letter and questionnaire submitted to the REB are allowed in order to accommodate for differences between individual (or group) projects. Such changes should be reviewed by the instructor.
  • - Only the class instructor can submit requests for modifications.
  • - If the instructor is NOT using the data and the project is considered to be minimal risk and it is for an undergraduate class, the REB application will be reviewed by the department level REC (use the MS WORD based REB application.)
  • - If the instructor WILL use the data from the project (or the project is of higher risk or is part of a graduate level class), the application must be submitted for review using the ROMEO system.

When individual members (or groups of students) within a class will each be undertaking different research projects, each student (or group of students) will need to submit their own REB application. The student (or one member within a group of students) will be listed as the principal investigator on the application; the class instructor shall be listed as the supervisor.

  • - If the instructor is NOT using the data and the project is considered to be minimal risk and it is for an undergraduate class, the REB application will be reviewed by the department level REC (use the MS WORD based REB application.)
  • - If the instructor WILL use the data from the project (or the project is of higher risk or is part of a graduate level class) the application must be submitted for review using the ROMEO system.

 
External Researchers at Laurier

An external researcher is a researcher not affiliated with Laurier who wishes to access Laurier resources to conduct research. Such projects will need to be reviewed and approved by the Laurier REB. External researchers will first need to obtain REB approval from their home institution before the REB at Laurier will review their research. Further external researchers will need to identify a full time Laurier faculty member (adjunct or Contract Academic Staff (CAS) appointments do not qualify) as the principal investigator on their REB application to Laurier; external researchers can only be listed as co-investigators, not as the principal investigators on Laurier applications . Please contact REB@wlu.ca for further guidance on this process.

 
Human Biological Materials

Research projects that make use of human biological materials (e.g., tissue, blood, DNA, cells, skin, hair, body fluids) require REB approval as noted in TCPS2 (and approval from the Laurier Biohazardous Safety committee). For further information, please refer to Chapter 12 of the Tri-Council Policy Statement 2nd Edition.

 
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. When such procedure(s) have been identified by the REB, Standard Operating Procedure (SOP) 2: Review of Higher Risk Procedures will be used to guide the review process. Please refer to SOP 2 for additional details.

 
Joint REB Review Process with the University of Waterloo

Laurier and the University of Waterloo have entered into a joint review process that allows for the simultaneous review of research projects (minimal risk only) that require REB approval from both institutions. The simultaneous review process provides the researcher with a combined set of comments from both REBs, resulting in a faster review and approval process. If your project requires REB approval from Laurier and uWaterloo and you would like to use the joint review process, please contact REB@wlu.ca for further guidance.

 
Minimal Risk Research

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.

 
Negative Option or Passive Consent

Research projects that require participants to contact the PI to indicate that they do NOT want to be a participant have been deemed to be an invalid use of the consent process by the REB at Laurier. Use of this consent process is not allowed.

 
Online Survey Systems

Researchers using online survey systems to gather participant data (e.g., Qualtrix, Survey Monkey etc.) should be aware that many of these systems also allow the researcher to capture and access additional information about each respondent over and above what they provide in the online survey.

When a researcher is using one of these online systems the following statement shall be added to the participant information / consent letter:

“The researcher(s) acknowledge that the host of the online survey (e.g., Qualtrix, Survey Monkey etc.) may automatically collect participant data without their knowledge (i.e., IP addresses.) Although this information may be provided or made accessible to the researchers, it will not be used or saved without participant’s consent on the researchers system.”

 
Overdue Annual Reports

Modification requests submitted for an REB protocol will not be processed until all overdue annual reports have been submitted.

 
Participant Databases

Researchers may wish to establish an ongoing data base of participant data to support current or future research projects. Approval to set up such a data base is required from the REB. Please submit the “Research Data Base – Request for Human Ethics Review” form via the ROMEO system.

 
Participants under the Age of 16

The REB has affirmed that when using participants under the age of 16 the consent of the parent or guardian will be required (in addition to that of the participant), except when the participant is no longer living under the care or control of their parent or guardian. Additional exceptions to this requirement maybe considered by the REB on a case by case basis.

Please note that when using participants under the age of 16 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.

NOTE: Researchers planning to access participants within local school boards should be aware that school boards often have different age requirement (e.g., 18 years) for obtaining parental / guardian consent. Research in schools also requires consent from the school principal and the school board REB before research commences. If you will require the use of participants from the Waterloo Region District School Board (WRDSB), please click here for more information.

 
Post-Doc Students Submitting REB Applications

When a post-doc is receiving research funding they will need to list a full-time faculty member  as their supervisor on their REB application. A post-doc who is not receiving research funding is not required to have a faculty supervisor on their REB application.

 
Projects Approved by another REB

If a research project has been reviewed and approved by another REB, in most cases the REB here at Laurier can complete its review based on the documentation that was reviewed and approved by the other board. Please contact REB@wlu.ca for further guidance on this process.

 
Quality Assurance/Improvement Projects

Studies that are conducted solely in order to gain information for assessment, management or improvement purposes (e.g., quality assurance, program evaluation or quality improvement studies), and that will only be used within Laurier for administrative/quality assurance purposes are subject to Administrative Review. If the intent of such projects is to be presented outside of Laurier (i.e., at a conference presentation or in a journal article), then REB review is required.

 
Recruitment Posters / Ads /Emails

Researchers must list their REB tracking number on their recruitment posters / advertising and email invitations to potential participants.

 
Requirement for Additional Approvals

Researchers should be aware that additional approvals and clearances may need to be obtained if they are planning to access participants located within schools, hospitals, correctional institutions, private sector companies, and aboriginal communities or in foreign countries. Researchers are responsible for obtaining any further approvals that might be required to complete their project.

Please note that the Human Ethics and Statistics Lab Coordinator (Psychology) coordinates any necessary approvals with the Waterloo Region District School Board. Local school boards have additional requirements that may not be part of the ethics review process at Laurier (e.g., consent is needed from principals, valid police checks for all researchers, and a separate REB application and review process from the school board’s own REB.) Please contact dweise@wlu.ca for additional details.

In the specific case of working with participants in foreign countries, researchers are advised to take appropriate steps to ensure that their project respects local regulations and customs for research involving human participants. REB clearance provided by Laurier is based solely on complying with Canadian requirements and standards as outlined in TCPS2.

 
Safeguarding Participant Data

The researcher listed as the principal investigator on an REB protocol 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; hardcopy data should be stored in a secure manner.

 
Standard Operating Procedures (SOPs)

Researchers that 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 protocol. When approved by the REB this will eliminate the need to have the procedure repeatedly reviewed when included as part of future applications to the REB.

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 approval.

Requests to have an SOP reviewed and approved by the REB are submitted using the standard REB application form in the ROMEO system.

 
TCPS2 Tutorial on Research Ethics (CORE) Requirement

Beginning March 2013 all Laurier individuals listed on an REB application (e.g., principal investigators, co-investigators, research assistants and supervisors) will need to complete the TCPS 2 online ethics tutorial and submit the certificate(s) of completion with their REB application. The online tutorial can be found at: http://tcps2core.ca/welcome. For further details about this requirement, refer to Policy 11.13, "Ethics Review of Research Involving Humans.”

Please note: REB applications will not be reviewed by the REB until all those listed on the application have completed the tutorial. Please ensure that the certificates for all those named are uploaded into the ROMEO system at the time of application

 
Online Transmission of Participant Data

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 by adding the following statement to their consent / information letters:

“Because this project employs e-based collection techniques, the confidentiality and privacy of data cannot be guaranteed during we- based transmission.”