11 Research Ethics Board

11.1 Meet the Team

Una Glisic

Una Glisic oversees the research ethics compliance and research information system portfolios within the Office of Research Services. She is a graduate of Laurier’s MA program in Psychology.

Contact Information

E: uglisic@wlu.ca
T: +1 548-889-4131
LinkedIn: Una Glisic

Jennifer Frayne

The Research Compliance Officer coordinates Laurier’s Research Ethics Board and the Animal Care Committee.

Jennifer Frayne joins Laurier from the University of Guelph where she most recently served as a Research Animal Technician – Quality Assurance. Prior to this role, she was employed as a Compliance Coordinator within University of Guelph’s Animal Care Services.

Contact Information

E: jfrayne@wlu.ca
T: +1 548-889-4143
LinkedIn: Jennifer Frayne

Allison McManus

The Strategic Research Initiatives Officer reviews all internally and externally funded projects to determine whether the funded projects require compliance certifications from the Research Ethics Board, Animal Care Committee, and/or Biosafety Committee prior to releasing the funds. She also oversees the review and approval of applications for internal Administrative Research projects. She is a graduate of Laurier’s BSc Grography and MSc Integrative Biology programs.

Contact information

E: amcmanus@wlu.ca

Samantha Moeller

The Research Ethics Coordinator coordinates Laurier’s Research Ethics Board. She is a graduate of Laurier’s BSc Psychology Research Specialist program and Brock’s MA program in Psychology - Lifespan Development.

Contact Information

E: smoeller@wlu.ca
T: +1 548-889-4128
LinkedIn: Samantha Moeller

11.2 Service statement of the Research Compliance Unit?

All research conducted within Laurier’s jurisdiction or under Laurier’s auspices involving human participants must be reviewed and approved by the Research Ethics Board accordance with Laurier policies and procedures relating to research ethics and compliance.

The Research Ethics Compliance unit manages the ethics review process for research involving human participants, research with animals and internal administrative research projects. The team supports the work of the University Research Ethics Board (REB) and Animal Care Committee (ACC), to ensure compliance with applicable research ethics guidelines including the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), the Canadian Council on Animal Care (CCAC), and Ontario’s Animals for Research Act.

The Research Ethics compliance unit provides the following services:

Developing and implementing policies, procedures, and guidelines pertaining to compliance standards in the review and conduct of ethical conduct of research involving humans;
Providing administrative support to the REB including coordinating all aspects of the submission, review, revision and approval processes for REB applications;
Promoting a culture of ethical responsibility through education and training for Laurier’s research community;
Providing guidance on research compliance review requirements and processes;
Reviewing research grants and contracts to determine research ethics compliance requirements and facilitating requests for limited release of funds

11.3 What is the REB and what is its approach to research review?

The mandate of the University Research Ethics Board (REB) is to review the ethical acceptability of research on behalf of the institution, including approving, rejecting, proposing modifications to, suspending or terminating any proposed or ongoing research involving humans. This mandate applies to research conducted under the auspices or within the jurisdiction of Laurier, using the considerations set forth in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2022).

The REB reports to Senate through the Senate Committee on Research and Publications (SCRAP) and must adhere to University Policy 11.13: Ethics Review of Research Involving Humans.

11.3.1 Who is on the REB?

The REB at Laurier consists of approximately 20 members including faculty, staff, student, and community representatives. The expertise of members spans the relevant research disciplines, fields, and methodologies covered by the REB.

In the event the REB lacks the specific expertise or knowledge among the membership to review the ethical acceptability of a research proposal competently, the REB will identify and consult with expert ad hoc advisors.

11.3.2 What is the REB’s Approach to Review?

Following TCPS 2 (2022) guidance, the REB takes a proportionate approach to REB review and tailors the level of scrutiny to the level of risk presented by the research. The ethical acceptability of research is assessed through a consideration of the foreseeable risks and the potential benefits. The research may positively affect the welfare of participants themselves or other individuals or it may simply benefit society and the advancement of knowledge. Risks include any negative effect on the welfare of participants and they may be social, behavioural, psychological, physical, or economic in nature. The REB assesses whether the potential research outcomes and benefits merit the risks that have been identified, and whether there are ways to sufficiently minimize those risks.

11.3.2.1 Level of Risk in Research

As per the TCPS 2, ‘minimal risk’ research is defined as “research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research.” These projects are generally reviewed via a delegated review process. In assessing the threshold of minimal risk, the REB has an ethical obligation to individuals or groups whose circumstances make them vulnerable in the context of a research project, and to those who live with relatively high levels of risk on a daily basis. Their inclusion in research should not exacerbate their vulnerability.

11.3.2.2 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. Projects deemed as higher-than-minimal risk must also undergo a higher level of scrutiny and are required to be reviewed by the full-board. 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.

11.4 How does the REB define research?

Research is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation (TCPS 2, 2022). Researchers are required to seek REB review and clearance prior to obtaining and/or using data for research purposes. 
Human participants are those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question (TCPS 2, 2022).
Human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids (TCPS 2, 2022). Please note that research involving human biological materials may require clearance from the Institutional Biosafety Committee (IBC) if it includes biohazardous materials (e.g., human tissues, cells, blood, and body fluids). For further information, refer to Research Involving Biohazardous Materials.

Research with human participants and human biological materials includes both primary data collection and the secondary use of data: 

Primary data collection includes the of use surveys, questionnaires, interviews, focus groups, observation, and experimental methods to gather data from human participants. 
Secondary use of data refers to the use in research of information originally collected for a purpose other than the current research purpose. Examples include:
- Datasets that are collected for specific research or statistical purposes, but then re-used to answer other research questions; and
- The use of 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.

Note: Various university policies, agreements and privacy legislation further regulate the use of data collected and maintained by Laurier. Researchers seeking access to such data should ensure compliance with these items. Please see Legal Services and Privacy Office for more information.

11.5 What are the responsibilities of researchers related to the ethical conduct of human-participant research?

Researchers are responsible for the ethical conduct of the research and following REB approved procedures and protocols throughout the lifecycles of their projects. They must also follow the TCPS2 guidelines for multi-jurisdicitonal research.

Additional responsibilities include:

Obtain clearance from the Laurier REB along with any other approvals, permits, and/or permissions that may be necessary for your research prior to the commencement of research activities.
Ensure proposed research activities are in compliance with all applicable University policies.
Ensure that your research team is able to meet any time sensitive deadlines (e.g., conducting research at an event that is scheduled in advance), that projects are feasible to complete within restricted timeframes (e.g., course-based research projects) and to plan for the timely submission of REB applications accordingly.
Be knowledgeable on the TCPS 2 (2022) guidance relevant to their research and demonstrate compliance with relevant guidelines to the REB in the proposed research design and methods.
Demonstrate expertise working with the research participant populations particularly if the population could be considered to be in vulnerable circumstances in the context of the research project.
Complete TCPS 2: Course on Research Ethics (CORE) Tutorial and provide copies of completion certificates for all Laurier project team members.
Provide sufficient details in applications submitted for REB review to enable the informed review of the ethical acceptability of the research.
Ensure applications/protocols submitted for review as well as associated research materials are clearly written, with limited technical language and jargon as appropriate, and are free from grammatical and spelling errors, and include accurate and consistent descriptions of research activities.
Use correct forms and follow required formatting for the submission and resubmission of applications/protocols.
Be aware of ethics codes (e.g., professional codes of conduct) or laws (e.g., those requiring the reporting of children in need of protection or the presence of reportable communicable diseases) that may require disclosure of information obtained in a research context or limit expectations of privacy and confidentiality in any way.
Supervise all research project team members in the application of the research procedures, and ensure that they are properly qualified and versed in the conduct of ethical research
Submit requests for any changes to approved research projects for review by the REB prior to implementation of changes via submission of a modification request form. The only exception to this requirement is when a change is necessary to eliminate an immediate risk in which case this should be reported immediately follow its occurrence.
Report all unanticipated or adverse events (e.g., undesirable experience or response by a participant) associated with their research to the appropriate REB immediately following the occurrence.
Submit required annual/final reports by the due date. Failure to do so will result in the file being marked as expired and if tied to funding, Research Finance will be notified to freeze the funding until the required reports are submitted.

11.6 What are the requirements for multi-jurisdictional research?

Chapter 8 of the TCPS 2 outlines guidelines for multi-jurisdictional research. Researchers should be aware that additional clearances may need to be obtained if they are planning to access participants located within schools, hospitals, correctional institutions, private sector companies, Indigenous communities or in foreign countries. Researchers are responsible for obtaining any further clearances that might be required to complete their project. For any research that involves off-campus activities researchers should refer to the Off-Campus Activities Program.

11.6.1 Off Site Research

If you are a Laurier researcher who will be conducting research off site (e.g., at another institution, province, country), note that REB review by another institution does not satisfy Laurier’s requirements for ethics review.

All research conducted by members or associated members of the university must also receive clearance from Laurier’s REB. Please refer to [Applications Approved at Another Institution] section.

11.6.2 Research Outside of Canada

When 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 the TCPS 2.

11.6.3 Waterloo Region District School Board

The Human Research Ethics Coordinator, Psychology and Manager, Research Compliance coordinate any necessary clearances with the Waterloo Region District School Board (WRDSB). 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 research ethics application and review process from the school board’s Research Ethics Committee).

Contact Doreen Weise (Psychology Applicants) or Samantha Moeller (Non-Psychology Applicants) for additional details.

Please check the WRDSB Research and Evidence-Based Practice Department webpage for updates.

11.7 What happens if I do not follow the TCPS2 and the university’s policies and guidelines on research with human participants?

Failing to follow TCPS2 and university policies or guidelines, applicable laws or regulations on research with human participants can be considered as research misconduct and a breach of the Tri-Agency Framework: Responsible Conduct of Research. This applies to all research projects involving human participants regardless of funding status. Researchers must ensure that all of their projects that require REB review and approval, receive the REB review and approval prior to commencement of the project, and that the research is conducted as approved by the REB (either via original approval or a modification request). If you are unsure about whether your project requires REB review and approval you should consult directly with the REB.

11.8 Who must apply for REB review and what are the exemptions?

All research (both funded and non-funded) involving human participants and human biological materials that is considered to be under Laurier’s jurisdiction/auspices must obtain REB clearance prior to commencement. This includes research conducted by members or associated members of the University (e.g., Laurier faculty, emeritus faculty, staff, sessional instructors, administrators, students, visiting or adjunct scholars, postdoctoral fellows, paid or unpaid associates or assistants) acting in their University capacity, and research that utilizes Laurier resources (e.g., equipment, e-mail, meeting rooms) regardless of where the research takes place.

Contract Teaching Faculty (CTF) members may only seek REB review and have REB clearance while on an active teaching contract at Laurier.

11.8.1 Is my research exempt from REB review?

Some research may be exempt from REB review. Researchers are required to consult with the REB on the applicability of these exemptions to their research prior to commencing any projects. Examples of activities exempt from review include.:

Research that relies exclusively on publicly accessible and appropriately protected by law information or publicly accessible data when there is no reasonable expectation of privacy (e.g., Statistics Canada public use files); 
Research involving the observation of people in public places (e.g., stadium, planetarium, beach, museums, parks, or library) where there is no intervention staged by the research or direct interaction with the individuals or groups, those under observation have no reasonable expectation of privacy, and any dissemination of research results does not allow identification of specific individuals;
Research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, as long as the process of data linkage or recording or dissemination of results does not generate identifiable information. Note: anonymous is distinct from anonymized or coded data that was initially collected with identifiers. Secondary use of anonymized and coded data is required to undergo REB review. Please see Secondary Use of Data for details; 
Quality assurance and quality improvement studies, and program evaluation activities. These administrative research activities are required to undergo administrative review prior to implementation. Please see Administrative Research for Internal Purposes for details;
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 exempt from REB review when the project is used exclusively by the employer (i.e., it will not be used for academic purposes at Laurier) and there is no reference or association linking the project to Laurier;
Creative practice activities, in and of themselves, do not require REB review (e.g., an artist makes or interprets a work of art). However, a creative practice that seeks input from participants whose responses will be analyzed to answer a research question is subject to REB review; and
The REB at Laurier recognizes that the university must from time to time gather personal data under the authority of the Wilfrid Laurier University Act and that it will store, analyze and use this data to fulfill various reporting requirements lawfully imposed upon the university or for activities deemed necessary for the proper administration of the university. Such activities are exempt from REB (and Administrative) review.

If it is unclear whether your project meets the above criteria or you have any questions, contact the REB directly with a description of your research project to determine requirements for review. The REB makes the final decision on exemption from research ethics review.

11.8.2 Do pilot studies require REB review?

Pilot studies fall within the TCPS 2 (2022) definition of research and require REB review and clearance prior to commencement. The purpose of pilot studies should be clearly identified in the application for REB review.

11.8.3 Do I need REB approval to engage with community members or partners?

As per Article 10.1, REB review is not required for the initial exploratory phase of research which may involve contact with individuals or communities and is intended to determine the feasibility of the research, establish research partnerships, and/or design a research proposal.

11.9 How long are the REB clearance periods?

The Research Ethics Board (REB) has a four-year maximum clearance period for projects involving human participants and requires the submission of annual reports to maintain clearance.

Once this four-year maximum renewal period has passed, you must submit your final progress report and a new application to the REB. 

Projects that have been archived or expired for less than six months may be reactivated following the submission of a modification request for a new end date provided that this does not extend the end date beyond four years from the original date of REB clearance. If a project has been marked as archived or expired for six months or more, it cannot be reactivated and a new REB application must be submitted for review and clearance.

11.10 What are the requirements for annual and final reports?

All REB projects require the completion of a final report, and projects lasting longer than a year also require the completion of annual report(s). You will receive e-mail reminders that a report is due within 60 and 30 days of its due date and you can also monitor projects that have reports due within Romeo.

Projects with overdue annual/final reports are automatically marked as expired.  The REB will notify Research Finance when an REB project, tied to a research account, has been marked expired. In such cases, Research Finance will freeze the funds associated with this project.

Once you indicate that the project is inactive (i.e. contact with participants is complete) in an annual/final report, the project will be archived in the Romeo system.

11.11 What do I do if I modify my projects?

The REB must review and provide clearance for any changes or modifications to projects that relate to the researcher’s dealings with participants before changes are implemented.

Examples include adding a new survey, recruiting additional participants, or adding a project team member. Such modifications will be submitted through Romeo.

Modification requests must include a clear and detailed summary of all requested changes. If these changes require revisions to previously approved research materials (e.g., consent form, recruitment ad) then revised copies of these documents must also be submitted for review. Any revisions to previously approved documents should be made using track changes (or highlighting or underlining the changes in the document) to facilitate the review process.

Modification requests will not be processed until any overdue annual reports have been submitted. Please see the Romeo User Guidelines for instructions  on how to submit a modification request.

11.12 What do I do if there is an adverse event?

Researchers are required to report all unanticipated occurrences associated with their research to the REB immediately following their occurrence with an adverse event report.

This includes but is not limited to any undesirable experience or response by a study participant (emotional, psychological, or physiological in nature) related to study participation or as a result of the research procedures.

Please see the Romeo User Guide for instructions on how to submit an adverse event report.

11.13 Does my project need a scholarly review for scientific merit?

According to the TCPS 2 (2022), Article 2.7, the REB shall review the ethical implications of the methods and design of the research which where appropriate, includes evaluating relevant disciplinary scholarly standards. Following this guidance:

All research protocols involving human participants that are clinical trial research and/or research considered to be higher than minimal risk must undergo a scholarly review for scientific merit.
The extent of the scholarly review that is required for biomedical research that does not involve more than minimal risk will be determined on a case-by-case basis according to the research being carried out.
Research in the humanities and the social sciences that is considered minimal risk will not normally be required by the REB to be peer reviewed.

In determining review requirements, the REB will consider what scholarly review has been applied and will avoid duplicating previous professional peer-review assessments unless there is a good and defined reason to do so. Researchers are responsible for demonstrating to the REB whether, when, and how appropriate scholarly review has been and will be undertaken for their research and may be requested to provide the REB with full documentation of scholarly reviews already completed.

For research funded by a major granting agency with an established peer review system (e.g. NSERC, CIHR, NIH), the awarding of funds will constitute scholarly review for scientific merit. For protocols with funding sources that do not have established peer review systems or in other cases where scientific review has not been completed, the Research Ethics Coordinator will work with the Research Facilitator(s) from the Office of Research Services to determine whether the funding was peer reviewed for scientific merit.

If a scholarly scientific merit review of a research protocol is required and has not yet been completed, the REB will coordinate the review. In order to facilitate the review, the researcher must submit a proposal that explains the objectives, hypotheses, potential contributions, and methodological approach of the study.

The proposal must present the proposed research in the context of a systematic review of the literature on that topic. The systematic review should be carried out according to professional standards of the relevant disciplines(s) or field(s) of research.
Researchers are responsible for making this information available to the REB as REB applications do not typically include all the necessary scientific information and are not structured to provide this information.

In cases where the REB has the necessary scholarly expertise, the REB may assume responsibility for the scholarly review. The REB may also consult with external expert reviewers and/or establish an ad hoc independent review committee to complete the review as deemed necessary.

11.14 How long does it take to get REB clearance and what is the process for review?

Research Ethics Board review is a multi-step and ongoing process. Review turnaround times may vary due to a variety of factors. Review turnaround times (for initial submissions, resubmissions, and modification requests) may vary due to a variety of factors such as the availability of reviewers, the volume of applications submitted to the REB, the level of risk associated with the research project, and the complexity of the application.

It is the Principal Investigator’s responsibility to ensure that the research team is able to meet any time sensitive deadlines and that projects are feasible to complete within restricted time frames. Average REB Review timelines

Type of Review	Average Review Time*
Initial review (minimal risk projects)	15 business days
Initial review (higher than minimal risk projects or projects requiring expert review)	20-30 business days
Initial review of modification requests	5-10 business days
Review of resubmissions	5-10 business days

*Note: Although these are general guidelines, they may be exceeded during busy periods.

The REB recommends submitting minimal risk projects at least 1 - 1.5 months before any anticipated start dates. For example:

For courses beginning in September, submit no later than August 1
For courses beginning in January, submit no later than December 1
For courses beginning in May/June, submit no later than April 1
If you are planning on conducting research with WRDSB, please note that all projects must first be approved by Laurier’s REB prior to submission to the WRDSB Research Review Committee (which meets 4 times per year). Please see the WRDSB deadlines for more information.

Due to the high volume of projects submitted to the REB, it is not possible to guarantee review turnaround times or accommodate requests for expedited reviews except in exceptional circumstances. Exceptional circumstances do not include research deadlines or timelines known well in advance (e.g., course timelines). If you are requesting an expedited review, you will need to clearly define the exceptional circumstance to the REB.

Projects that have been submitted for review will be automatically withdrawn from the review process if there has been no activity after a period of 6 months.

Please note that alternative review processes (e.g., psychology review process, full board review, expert review) may also impact review timelines. If you have any questions or concerns, please contact REB@wlu.ca.

11.14.1 Process for review

11.14.1.1 Delegated (minimal risk) non-psychology applications

Step 1: Application Submission

Applications are submitted through the Romeo system. Upon submission you and all project team members will receive an e-mail confirmation. If you do not receive this e-mail confirmation, please contact REB@wlu.ca to ensure that the application has been submitted.

Please note, applications are processed 8:30 a.m. – 4:30 p.m. Monday to Friday and not on holidays or weekends.

Step 2: Administrative Review

The majority of applications submitted to the REB are delegated (minimal risk) review.

During Administrative Review the application will be reviewed by the Research Ethics Coordinator to ensure completeness. Administrative review is generally completed within five working days of application submission. Incomplete applications will be returned to the applicant.

Step 3: REB Review Process

Following Administrative Review, minimal risk applications will be delegated to the Chair and one other reviewer (selected based on expertise and availability to complete review). The average processing time to receive the initial review from the REB is 15 business days.

The Chair of the REB will send comments and suggestions for changes to the projects in the form of a review memo. All research team members whose Romeo profiles have been added to the application will receive the review memo e-mail.  If there are no comments and suggestions, you will instead receive the clearance notification at this stage.

Step 4: Resubmission Process

The review memo e-mail contains instructions on the correct resubmission format and how to re-submit the file on Romeo. Applications that do not follow the required format (i.e., point-by-point revisions summary attached, use of track changes or highlighting to denote changes, CAPITAL LETTERS for Romeo application revisions) will be returned.

Once the REB has received your resubmission, the average processing time for review of resubmitted documents is 5-10 business days. Similar to the initial review process, this timeline may vary due to the availability of reviewers, volume of resubmissions received, and the complexity of the resubmission.

If there is additional information required or items from the initial memo that have not been adequately addressed, another reviewer memo will be issued to the research team and the resubmission process will repeat.

This ongoing review will take place until all REB concerns have been addressed at which point the clearance notification will be issued.

Deadline to resubmit: Projects that have been submitted for review will be automatically withdrawn if there has been no activity after a period of 6 months. In such cases the principal investigator (PI) will be notified via email and the project will be marked as withdrawn.

11.14.1.2 Delegated (minimal risk) psychology applications

Step 1: Application Submission

Applications are submitted through the Romeo system. Upon submission you and all project team members will receive an e-mail confirmation. If you do not receive this e-mail confirmation, please contact REB@wlu.ca to ensure that the application has been submitted.

Please note, applications are processed 8:30 a.m. – 4:30 p.m. Monday to Friday and not on holidays or weekends.

Step 2: Administrative Review

During Administrative Review the application will be reviewed by the Human Research Ethics Coordinator, Psychology to ensure completeness. Incomplete applications will be returned to the applicant. Administrative review is generally completed within five working days of application submission.

Step 3: Psychology Research Ethics Review Process

Following Administrative Review, minimal risk applications will be reviewed by the Human Research Ethics Coordinator, Psychology within 15 business days.

The Human Research Ethics Coordinator, Psychology will send comments and suggestions for changes to the projects in the form of a review memo. All research team members whose Romeo profiles have been added to the application will receive the review memo e-mail.

Step 4: Resubmission Process

The review memo e-mail contains instructions on the correct resubmission format and how to re-submit the file on Romeo. If there is additional information required or items from the initial memo that have not been adequately addressed, another reviewer memo will be issued to the research team and the resubmission process will repeat. Once your resubmission is received, the average processing time for review of resubmitted documents is 5-10 business days.

Once there are no further comments and suggestions from the Human Research Ethics Coordinator, Psychology, you will receive a notification of your project being forwarded to the REB Chair for review.

Step 5: REB Review Process

The REB Chair may send comments and suggestions for changes to the projects in the form of a review memo with the resubmission process repeating or you may instead receive the clearance notification at this stage. The average processing time to receive the review from the REB Chair is 5-10 business days.

11.14.1.3 Joint review process with the University of Waterloo

This process is under review. Updates will be posted once finalized. In the meantime, contact REB@wlu.ca with any questions. 

11.14.1.4 Approved elsewhere applications (psychology and non-psychology)

Step 1: Application Submission

A copy of the application approved at the other institution and all supporting should be submitted via email to reb@wlu.ca. The application will be uploaded into the ROMEO system by the Research Ethics Coordinator.

Step 2: REB Review Process

Applications that have already been approved by another institution are only reviewed by the REB Chair. The average processing time to receive the initial review from the REB Chair is 15 business days.

The Chair of the REB will send comments and suggestions for changes to the projects in the form of a review memo. All research team members whose Romeo profiles have been added to the application will receive the review memo e-mail.  If there are no comments and suggestions, you will instead receive the clearance notification at this stage.

Step 4: Resubmission Process

The review memo e-mail contains instructions on the correct resubmission format and how to re-submit the file on Romeo. Applications that do not follow the required format (i.e., point-by-point revisions summary attached, use of track changes or highlighting to denote changes, CAPITAL LETTERS for Romeo application revisions) will be returned.

Once the REB has received your resubmission, the average processing time for review of resubmitted documents is 5-10 business days. Similar to the initial review process, this timeline may vary due to the availability of reviewers, volume of resubmissions received, and the complexity of the resubmission.

If there is additional information required or items from the initial memo that have not been adequately addressed, another reviewer memo will be issued to the research team and the resubmission process will repeat.

This ongoing review will take place until all REB concerns have been addressed at which point the clearance notification will be issued.

Deadline to resubmit: Projects that have been submitted for review will be automatically withdrawn if there has been no activity after a period of 6 months. In such cases the principal investigator (PI) will be notified via email and the project will be marked as withdrawn.

11.14.1.5 Full Board review (greater than minimal risk psychology and non-psychology)

You will be notified of the decision to move the project to a full board review once this decision is made along with the expected time frames once available. In some cases, this determination may be made during the initial review or following resubmission and subsequent review of additional requested information.

Step 1: Application Submission

Applications are submitted through the Romeo system. Upon submission you and all project team members will receive an e-mail confirmation. If you do not receive this e-mail confirmation, please contact REB@wlu.ca to ensure that the application has been submitted.

Please note, applications are processed 8:30 a.m. – 4:30 p.m. Monday to Friday and not on holidays or weekends.

Step 2: Administrative Review

During Adminsitrative Review the application will be reviewed by the Research Ethics Coordinator to ensure completeness. Administrative review is generally completed within five working days of application submission. Incomplete applications will be returned to the applicant.

Step 3: Full Board Review Process

Projects that are deemed to be higher than minimal risk require review by the full REB and will often require a face-to-face meeting of the entire REB to discuss the project. A full board review will take at least 20-30 business days, depending upon scheduling of REB meetings and the complexity of the project.

The Chair of the REB will send comments and suggestions for changes to the projects in the form of a review memo. All research team members whose Romeo profiles have been added to the application will receive the review memo e-mail.  If there are no comments and suggestions, you will instead receive the clearance notification at this stage.

Step 4: Resubmission Process

The review memo e-mail contains instructions on the correct resubmission format and how to re-submit the file on Romeo. Applications that do not follow the required format (i.e., point-by-point revisions summary attached, use of track changes or highlighting to denote changes, CAPITAL LETTERS for Romeo application revisions) will be returned.

Once the REB has received your resubmission, the average processing time for review of resubmitted documents is 5-10 business days. Similar to the initial review process, this timeline may vary due to the availability of reviewers, volume of resubmissions received, and the complexity of the resubmission.

If there is additional information required or items from the initial memo that have not been adequately addressed, another reviewer memo will be issued to the research team and the resubmission process will repeat.

This ongoing review will take place until all REB concerns have been addressed at which point the clearance notification will be issued.

Deadline to resubmit: Projects that have been submitted for review will be automatically withdrawn if there has been no activity after a period of 6 months. In such cases the principal investigator (PI) will be notified via email and the project will be marked as withdrawn.

11.14.1.6 Applications requiring expert review (psychology and non-psychology)

Step 1: Application Submission

Applications are submitted through the Romeo system. Upon submission you and all project team members will receive an e-mail confirmation. If you do not receive this e-mail confirmation, please contact REB@wlu.ca to ensure that the application has been submitted.

Please note, applications are processed 8:30 a.m. – 4:30 p.m. Monday to Friday and not on holidays or weekends.

Step 2: Administrative Review

The majority of applications submitted to the REB are delegated (minimal risk) review.

During Administrative Review the application will be reviewed by the Research Ethics Coordinator to ensure completeness. Administrative review is generally completed within five working days of application submission. Incomplete applications will be returned to the applicant.

Step 3: External Review Process

If the REB determines that there is not sufficient expertise on the Board to review an application, the REB may request that an external expert review be conducted prior to the completion of the REB review.  The applicant will be notified of the decision to request an expert review and will be asked to provide the names, contact information, and a written explanation outlining the qualifications of three proposed expert reviewers. All research project team members must have an arms-length relationship with the proposed expert reviewers. An expert review may take 20-30 business days, depending upon the availability of external expert reviewers.

Step 4: REB Review Process

Following the external review applications will be delegated to the Chair and one other reviewer (selected based on expertise and availability to complete review). The average processing time to receive the initial review from the REB is 15 business days.

The Chair of the REB will send comments and suggestions for changes to the projects in the form of a review memo. All research team members whose Romeo profiles have been added to the application will receive the review memo e-mail.  If there are no comments and suggestions, you will instead receive the clearance notification at this stage.

Step 5: Resubmission Process

The review memo e-mail contains instructions on the correct resubmission format and how to re-submit the file on Romeo. Applications that do not follow the required format (i.e., point-by-point revisions summary attached, use of track changes or highlighting to denote changes, CAPITAL LETTERS for Romeo application revisions) will be returned.

Once the REB has received your resubmission, the average processing time for review of resubmitted documents is 5-10 business days. Similar to the initial review process, this timeline may vary due to the availability of reviewers, volume of resubmissions received, and the complexity of the resubmission.

If there is additional information required or items from the initial memo that have not been adequately addressed, another reviewer memo will be issued to the research team and the resubmission process will repeat.

This ongoing review will take place until all REB concerns have been addressed at which point the clearance notification will be issued.

Deadline to resubmit: Projects that have been submitted for review will be automatically withdrawn if there has been no activity after a period of 6 months. In such cases the principal investigator (PI) will be notified via email and the project will be marked as withdrawn.  

11.14.1.7 Modification request (psychology and non-psychology)

Step 1: Modification Request Submission

Modification Requests are submitted through the Romeo system. Upon submission you and all project team members will receive an e-mail confirmation. If you do not receive this e-mail confirmation, please contact REB@wlu.ca to ensure that the application has been submitted.

Please note, modification requests are processed 8:30 a.m. – 4:30 p.m. Monday to Friday and not on holidays or weekends.

Step 2: REB Review Process

Upon submission, the modification request will be reviewed by the Research Compliance Officer and the Research Ethics Coordinator. The Research Compliance Officer and Research Ethics Coordinator will send comments and suggestions for changes to the projects in the form of a review memo. All research team members whose Romeo profiles have been added to the application will receive the review memo. The review process typically takes 5-10 business days.

Step 3: Resubmission Process

The review memo e-mail contains instructions on the correct resubmission format and how to re-submit the file on Romeo. Applications that do not follow the required format (i.e., point-by-point revisions summary attached, use of track changes or highlighting to denote changes, CAPITAL LETTERS for Romeo application revisions) will be returned.

Once the REB has received your resubmission, the average processing time for review of resubmitted documents is 5-10 business days. Similar to the initial review process, this timeline may vary due to the availability of reviewers, volume of resubmissions received, and the complexity of the resubmission.

If there is additional information required or items from the initial memo that have not been adequately addressed, another reviewer memo will be issued to the research team and the resubmission process will repeat.

This ongoing review will take place until all REB concerns have been addressed at which point the clearance notification will be issued.

Deadline to resubmit: Projects that have been submitted for review will be automatically withdrawn if there has been no activity after a period of 6 months. In such cases the principal investigator (PI) will be notified via email and the project will be marked as withdrawn.

11.15 How do I apply to the REB for review?

Review our instructions for below for information on where to submit your application, which applications you’re required to submit, how standard operating procedures are reviewed and which research materials are required for review.

11.15.1 Before You Apply

Plan REB Application Submission Timeline

Research Ethics Board (REB) review is a multi-step and ongoing process involving administrative review, initial REB review, resubmission, and review of resubmissions. It is the Principal Investigator’s responsibility to ensure that the research team is able to meet any time sensitive deadlines and that projects are feasible to complete within restricted timeframes. Please ensure to review REB Timelines and Review Process and plan the submission of your REB application accordingly.

Complete the TCPS 2: CORE Tutorial

The TCPS 2: CORE (Course on Research Ethics) tutorial provides an introduction to and examples of important principles from the TCPS 2. All Laurier individuals listed on an REB project (e.g., principal investigators, co-investigators, research assistants and supervisors) will need to complete the CORE tutorial and submit their certificate(s) of completion with their REB project. 

REB projects will not be reviewed until all those listed on the project have completed the tutorial. Please ensure that the certificates for all those named on the project are uploaded into the Romeo system at the time of submission.

For further details about this requirement, refer to Policy 11.13: Ethics Review of Research Involving Humans. 

Register with Romeo

Romeo is Laurier’s online application system for REB review of research involving human participants. It must be used for review of all research projects by faculty, staff, graduate students or undergraduate students when their supervisors will be using their data.

Romeo provides access to all of your approved projects for future reference. Romeo is used for the submission of new projects, annual/final reports, modification requests, and adverse event reports.

Note: If your department has a Research Ethics Committee (REC) in place and the project is a course-based research activity, then it may be eligible for departmental REC review. This is the only application not administered through the Romeo system. Completed applications are submitted to the appropriate departmental REC and not the University REB. Please see the Which Application Do I Submit for Review? tab below and General Ethics Guidelines for more information including application criteria, a list of departmental REC contacts, and downloadable forms.

11.15.2 Where do I submit my application for review?

University Research Ethics Board (REB)

The Research Ethics Board (REB) must review and provide clearance for all research activities involving the use of human participants or human biological materials prior to research beginning. Unless the activity is an undergraduate course-based research activity as outlined below, it will need to be submitted to the University REB through the ROMEO application system.

Departmental Research Ethics Committees (REC)

As per TCPS 2 (2022), Article 6.12 the REB has delegated the review of undergraduate* course-based research activities to departmental Research Ethics Committees (RECs) when all of the following criteria are met:

You and all members of your group are undergraduate* students.
Your department has a departmental REC.
Your research activity is course-based (i.e. not undergraduate theses or equivalent research projects such as directed studies and major research papers). Such pedagogical activities are normally required of students with the objective of providing them with exposure to research methods in their field of study. Examples of course-based research activities include:
- Structured or semi-structured Interviews with key informants working in a particular area/field (e.g., professors, not-for-profit organizations, employers)
- Surveys with family/friends/other students/members of the general public
- Focus groups/group interviews with employees or members of an organization or group
Your supervisor/instructor will not be using the research data as part of their own research program and data will not be used outside of the course.
Your research activity is considered minimal risk to human participants (see below).
The research does not aim to recruit Indigenous Peoples (including First Nations, Inuit and Métis peoples of Canada), use Indigenous identity or membership in an Indigenous community as a variable for analysis, or meet other criteria that would require Indigenous community engagement in accordance with Chapter 9 of the TCPS 2 (2022).
Your research does not involve individuals, groups, or populations in vulnerable circumstances. This includes individuals who lack decision-making capacity (e.g., children, those living with cognitive impairments, persons who are not able to legally consent to participate in research).

If any of the above criteria is not met, the project must be submitted to the University Research Ethics Board (REB).

* In some cases, graduate classwork may be subject to review by the REC. This can only occur if the instructor has sought previous approval to do so from the REB. Details on this process can be found in the Request for REC Review for Graduate-Level Course-Based Research Projects document.

Research delegated to review by departmental RECs is subject to the same policies and guidelines as research reviewed by the university REB. If your department has a REC in place and the project meets the above criteria, then it can be submitted for REC review rather than REB review. This application is not administered through the Romeo system and is submitted directly to the REC. Instructors/students applying for REC review must submit the following information to their departmental REC Contact:

The REC Review Application form.
TCPS 2: CORE certificates for all individuals listed on the application (students and supervisors).
Research Materials (e.g. recruitment materials, informed consent statements, surveys/questionnaires, interview questions/guide, etc.)
An approval letter from the REB indicating that the graduate research can be reviewed by the REC (if applicable).

11.15.2.1 Departmental REC contacts

Anthropology: Sara Matthews
Criminology: Andrew Welsh
Communications: Nathan Rambukkana
Geography and Environmental Studies: Alison Blay-Palmer
Global Studies: John Boye Ejobowah
History: Susan Neylan
Kinesiology and Physical Education: Paula Fletcher
Lazaridis School of Business and Economics: Scott C. Ensign
Joint Faculty of Liberal Arts and Faculty of Human and Social Sciences: Judy Eaton
Political Science: Kim Rygiel
Psychology: Doreen Weise
Religion and Culture: Jasmin Zine
Social Work: Sonia Meerai
Sociology: Jasmin Zine

11.15.3 Which application do I submit for review?

You can find instructions for submitting all applications processed through Romeo on the Romeo User Guidelines page.

11.15.3.1 Standard REB Application (Primary Data Collection)

If your research involves primary data collection and you are looking to submit the standard form for REB review, you will need to complete and submit an Ethics Application on Romeo. If you are a researcher in the Psychology Department, then you will need to submit the version labelled Psychology Ethics Application. All other researchers should submit the form labelled Non-Psychology Ethics Application.

11.15.3.2 Secondary Use of Data

If your research exclusively involves secondary use of data, you will need to complete and submit the Secondary Use of Data Ethics Application on Romeo.

11.15.3.3 Research Database

If you are looking to establish an ongoing database of participant data to support current or future research projects, you will need to complete and submit the Research Database – Request for Human Ethics Review event form on Romeo.

11.15.3.4 Modification Request

If you are looking to submit changes to your post-clearance REB application, you will need to complete the Request for Ethics Clearance of a Revision or Modification event form through Romeo.

11.15.3.5 Adverse Event

If you are looking to submit an unanticipated or adverse event to your post-clearance REB application, you will need to complete the Adverse Event Report event form through Romeo.

11.15.4 Annual/Final Report

If you are looking to submit an annual or final report for your post-clearance REB application, you will need to complete the Annual (or Final) Report for Approved Human Research Projects event form through Romeo.

11.15.4.1 Laurier and Waterloo Joint Review Process

If you are conducting a multi-jurisdictional research project with researchers at the University of Waterloo (UW), you can apply for a joint research ethics review. If the Principal Investigator (PI) is at Laurier, then the Laurier REB will lead the coordinated review. If the PI is at UW, then the UW Office of Research Ethics will lead the coordinated review. Please contact the REB for details and to initiate this review process.

11.15.4.2 Applications Approved at Another Institution

11.15.4.2.1 Internal Researchers

If your research project has received REB clearance from another institution, Laurier’s REB will review the application submitted to the other institution (including all associated materials and clearance letter) if it meets the following criteria:

The application clearly outlines the aspects of the project that are specific to Laurier, i.e. any research activities taking place at Laurier or utilizing Laurier resources.
Laurier researchers (and their role in the project) are identified on the application.

Please note that a full-time Laurier faculty or staff member on an active employment contract will need to serve as the local Principal Investigator for the purposes of the Laurier REB review.

If the above criteria are met, please email the full application package that was approved by the other instituion to the Laurier  REB. The Research Ethics Coordinator will upload the material to the ROMEO system. The full application package should include the following documents. All documents should be clearly labelled.

REB clearance letter (and clearance for any related modification requests, if applicable)
Final approved application (and any related modification requests, if applicable)
- Please ensure that the aspects of the project that are specific to Laurier are clearly outlined in the application and that Laurier researchers and their role in the project are identified.
Final approved research materials (e.g., recruitment materials, consent, surveys, interview questions)
TCPS 2 certificates for Laurier investigators
The full name, affiliation, and e-mail address of anyone that should have access to the online Romeo file. If they do not already have an account, they will need to self-register for a Romeo account to be added to the file. This access is required for the local Laurier PI as well as the external PI listed on the application under review and any other research project team member that requires access to the application and to receive e-mail correspondence related to the application.

11.15.4.2.2 External Researchers

An external researcher is a researcher not employed by 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. Please contact the REB for further guidance on this process.

11.15.5 Can standard operating procedures be approved?

If you plan on using the same procedure across a number of different projects you 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.

To request to have a standard operating procedure reviewed and approved by the REB please contact the REB. 

11.15.6 What research materials do I include for review?

11.15.6.2 Surveys/Questionnaires/Interviews/Focus Groups

If you have surveys or questionnaires or interview guides, they need to be attached to your application. If you are using an unstructured interview or focus group, attach a list of topics or questions that will be covered during the interview or focus group.

11.15.6.3 Recruitment Posters/Ads/Emails/Scripts

If you are recruiting participants with a poster, letter, or email, or telephone call, attach a copy of the materials used in the recruitment process. Researchers must list their REB tracking number on their recruitment materials.

11.15.6.4 Debriefing Statement/Script

A debriefing statement/script must be submitted when researchers are using deception or concealment.

Deception is the act of deliberately misleading participants.
Concealment is the act of keeping information from participants without deceiving them.

This statement/script must be prepared in order to remove any misconceptions about the project that participants may have and to re-establish trust which might have been lost; be sure to explain why the deception or concealment was necessary. The participant must be assured that the deception or concealment was neither arbitrary nor capricious. In the interest of the right to withdraw at any time, participants would be allowed to remove their information from the research once the deception or concealment has been explained to them.

11.15.6.5 TCPS 2 Certificates

All investigators listed on the application are required to attach their TCPS 2 CORE certificates to the application. 

11.16 Tips for an Efficient REB Review

Use correct form / application format (see Which Application Do I Submit?)
If you have a complicated research design, consider attaching a chart or table to facilitate review
Review application for the following prior to submission:
- Clarity – write using language that a reviewer outside of your research area would understand, avoid jargon and define any unknown terms.
- Write concise responses to each section of the application (e.g. answer only the questions posed in each section rather than simply cutting and pasting your grant or thesis proposal).
- All documents that are read by the public (e.g. consent forms, recruitment material, debriefing statements) should use language that will be understood by the intended layperson recipients and should be free of typographical and grammatical errors.
- Completeness – complete all sections of the application and attach all required documents)
- Adherence to TCPS2and university policies.
- If the REB application is completed by a student, then the faculty supervisor should perform the above review. 
Clearly label all documents. When documents are referenced throughout the applicaiton, refer to the title of the document. 
For resubmissions:
- Follow the format requested in the reviewer memo and submit a point-by-point summary and highlight changes in all attached document using track changes or with highlights.
- Clearly label all revised documents as revised and include the revision date.

11.17 Romeo User Guidelines

Romeo is an online database for digital management and the reporting of internal and external research funding and ethics certifications. Below, you will find answers to common questions people have about using Romeo.

Refer to the Process for review for more information about the REB review process and procedures.

11.17.1 How do I register for ROMEO?

Proceed to the Romeo login page.
Select the “Register” button.
Select the “Click here for guide” at the top left corner of the registration page for registration guidelines.
Fill in your Laurier e-mail, first and last name, and select your institution, affiliation(s) (please ensure to check off “Primary Affiliation”), and rank. All other fields are optional and we request that you do not provide your personal address(es) or phone number(s). Please leave these fields blank. 
Click “Register” once complete. 
- If you see “Error: User with same Email-ID already exists” you already have an account. Please proceed back to the Romeo login page and follow instructions for resetting your password if needed. 
Follow the instructions in the email sent to you to complete your first-time registration process. This includes opening the provided link, entering your confirmation code, selecting and confirming a password and selecting “Confirm”.

Please note that passwords must meet the following minimum requirements:

8-16 characters in length
1 uppercase letter (A-Z)
1 lowercase letter (a-z)
1 numeric base 10 digit (0-9)

11.17.2 How do I reset my password?

If you have previously accessed your online account and have forgotten your password:

Proceed to the Romeo login page.
Enter your username (which will be an email address, most likely your Laurier email address).
Click the “Reset Password” button.
Follow the instructions in the email sent to you to complete your first-time registration process. This includes opening the provided link, entering your confirmation code, selecting and confirming a password and selecting “Confirm”.

Please note: Passwords must meet the following minimum requirements:

8-16 characters in length
1 uppercase letter (A-Z)
1 lowercase letter (a-z)
1 numeric base 10 digit (0-9)

Once your password has been successfully reset you should be re-directed and receive the following message “Your password has been reset successfully. Please click Login button to proceed further.” If you do not receive an email or experience any issues resetting your password, contact the REB for assistance.

11.17.3 How do I add team members to a project?

11.17.3.1 Pre-Submission

Go to “Application: Drafts”, find the application you want to add project team members to, and select “Edit”;
Select the “Project Team Info” tab and under “Other Project Member Info” select “Add New”;
Type the first and last name of the individual you want to add to the application and select “Search Profiles”. Do not hand type data for this section;
Click “select” beside the correct individual that you want to add to the project then use the drop-down menu to select their “Role in Project” i.e., Co-Investigator, Student, or Supervisor then select “Save”.
All project team members added to the project will be able to view/edit the application under “Role: Project Team Member” on their Romeo homepage.

A video explanation of how to add a team member to a project is available on YouTube.

Note: The individual(s) must be registered for a Romeo account to show up in the search results. If they do not have a Romeo account, they can self-register following the instructions under “How Do I Register for Romeo?” Alternatively, if they do not require Romeo access or e-mail correspondence related to the file, you can list the project team member(s) name(s), role in project(s), and institution(s) in the Comments field of Principal Investigator section (e.g., Dr. John Doe | Co-Investigator | McGill University)

11.17.3.2 Post-Clearance

If your project has already undergone review and received REB clearance and you would like to add a new project team member you will need to submit a modification request.

The modification request should indicate the project team members’ name, role in the project (e.g., R.A., co-investigator), affiliation (e.g., MA student at Wilfrid Laurier University), and indicate whether they require Romeo access. You will also need to attach a copy of their TCPS 2 CORE certificate.

11.17.4 How do I submit a project for a REB review?

From your home screen select “Apply New.” Please select the appropriate type of application for your purposes. Please see Which Application Do I Submit? 
The online application form you selected will open up and you will see a series of tabs (described below). Provide the information requested under each tab. Be sure to continually hit “save” as you work on your application.
Project Info: Captures information on project title, start and end dates, and keywords
Project Team Info:
- Principal Investigator: Use this to identify yourself as the principal investigator on the project
- Other Project Members: Use the Add/Edit button to search for the name(s) of co-investigators or faculty supervisors you wish to add to the project. Please see How Do I Add Project Team Members to a Project?
Request for ethics review: This contains several different sections that deal with specific aspects of the REB review process.
Attachments: Use this tab to attach additional documents related to your project (e.g., TCPS 2 certificates, consent letters, questionnaires, surveys, recruitment posters, etc.). Please see How Do I Upload An Attachment? 
You may save your project and return later to complete it. When you have completed the application form, press “submit” to forward it to the REB. If you have not filled in all of the required fields marked with a red asterisk (*), you will not be able to submit the project until the required fields are filled in. Check the “Errors” tab for further information. 
You can track the status of the project(s) you have submitted as the principal investigator by looking at your home page under “Role: Principal Investigator” or “Role: Project Team Member” depending on your role in the project.
Updates and requests for additional information from the REB will be sent to your email account as your project moves through the review process. Check your email account regularly.

11.17.5 How do I submit a modification request post-clearance?

Find the approved REB project that you wish to modify. All approved projects are on your ROMEO home screen either under “Role: Principal Investigator” (if you are the principal investigator) or “Role: Project Team Member” (if you are a co-investigator or supervisor). Regardless of which screen, go to the link “Applications (Submitted – Post Review)” for a listing of all your current and approved projects; and 
Press the “Events” button next to the title of the REB project you wish to modify; and
Under the “New Event Forms” listing, select “Request for Ethics Clearance of a Revision or Modification” form. Fill in all applicable tabs. You can save this form (to work on it later) or hit submit to forward it to the REB for review and clearance.
Modification requests must include a clear and detailed summary of all requested changes. If these changes require revisions to previously approved research materials (e.g., consent form, recruitment ad) then revised copies of these documents must be submitted for review. Any revisions to previously approved documents should be made using track changes (or highlighting or underlining the changes in the document) to facilitate the review process.

A video explanation of how to submit a modification request is available on YouTube.

11.17.6 How do I submit an annual/final report post-clearance?

All REB projects require the completion of a final report, and projects longer than a year also require the completion of an annual report; 
The form can be found on your home screen under “Role: Principal Investigator” (if you are the principal investigator) or “Role: Project Team Member” (if you are a co-investigator or supervisor); 
For a listing of all your projects that need an annual/final report, go to the link “Reminders.” Note: The “Reminders” link only appears if you have a pending annual or final reports due within 30 days.  If you are submitting a report 30 + days in advance (e.g., project is ending and you are submitting a final report in advance of the current end date) go to “Applications Post-Review”; 
Press the “Events” button next to the title of the REB project that requires an annual report; and 
Under the “New Event Forms” listing, select “Annual (or Final) Report for Approved Human Research Projects.” This form will open up; fill in the tabs. You can save this form (to work on it later) or hit submit to forward it to the REB for review and clearance.

A video explanation of how to submit an annual/final report is available on YouTube.

11.17.7 How do I submit an adverse report post-clearance?

Find the approved REB project that you wish to modify. All approved projects are on your ROMEO home screen either under “Role: Principal Investigator” (if you are the principal investigator) or “Role: Project Team Member” (if you are a co-investigator or supervisor). Regardless of which screen, go to the link “Applications (Submitted – Post Review)” for a listing of all your current and approved projects.
Press the “Events” button next to the title of the REB project that requires an adverse event report.
Under the “New Event Forms” listing, select “Adverse Event Report.” Fill in all applicable tabs. You can save this form (to work on it later) or hit submit to forward it to the REB for review.

A video explanation of how to submit an adverse event report is available on YouTube.

11.17.8 How do I upload an attachment?

The maximum individual attachment size is 5MB. All attachments larger than 5MB will stall the system, and your data may be lost. However, you may upload multiple attachments, provided that each is no larger than 5MB;  
Go to the “Attachments” tab and select “Add Attachment”; and
- If you have trouble uploading an attachment: 
  - Check that your file is not larger than 5MB.
  - Save and close the application.
  - Log out of your current Romeo session.
  - Exit your current web browser session and re-open a new web browser session and or a new web browser.
  - If you are still experiencing issues attaching a file contact the REB.
If an attachment is larger than 5MB you could take the following steps to reduce attachment size:
- saving the file as a reduced file size pdf
- consider another format for uploading the content (e.g., word document)
- separate documents included in one attachment into multiple separate files

A video explanation of how to upload an attachment is available on YouTube.

11.17.9 Can I change the principal investigator on an REB project?

The principal investigator on a REB project can only be changed before REB clearance is granted. Please take this into consideration prior to submitting a project for REB review.

A video explanation of how to change the PI before REB approval is available on YouTube.

11.17.10 How do I unlock my project?

Although multiple users can view one REB project simultaneously, only one user can edit a Romeo project at any given time. While the project is being edited, Romeo locks the project to other users. Once the user saves and closes the project, the project unlocks and is accessible to other users for additional edits
If a project is appearing as locked by another user please ensure that all other project team members are not currently working on the project and have saved and closed the project; and 
If the project still appears locked after logging out and logging back in, please contact the REB.

11.17.11 How do I access copies of REB emails?

Locate the file by either using the search function or going to “Applications: Post Review.”
Select “View” then go to the “Logs” tab .
Select “Shared Communications”. This is where copies of all REB e-mails including memos and clearance notifications are available. 
Locate the e-mail (e.g., REB #XXXX Clearance Notification), select Preview (magnifying glass and plus sign).
Select “Print” then save as pdf. 
Note: This is a more recent feature available on Romeo. If you have an older REB file, older e-mails may not be visible. If this is the case and you require a copy of an e-mail that is not visible please contact the REB.

A video explanation of how to copies of REB emails is available on YouTube.

11.18 Recruitment Guidelines

As outlined in TCPS 2 (2022) Chapter 3, consent begins with the initial contact with research participants (e.g., recruitment) and carries through to the end of participants’ involvement in the research project. How, when, and where participants are approached and who recruits them are important elements in assuring (or undermining) voluntariness. When developing recruitment procedures, you should be cognizant of situations where undue influence, coercion or the offer of incentives may undermine the voluntariness of the informed consent process.

As outlined in TCPS 2 (2022) Chapter 4, particular individuals, groups or communities should neither bear an unfair share of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of research participation.

11.18.1 Recruitment templates

The REB has developed templates for various modes of recruitment.

11.18.2 Determining inclusion and exclusion criteria

When determining inclusion and exclusion criteria for your research study, you should ensure the criteria are informed by the focus, objective, nature of research, and context in which the research is conducted. As per TCPS 2 (2022) Article 4.1, you shall not exclude individuals from the opportunity to participate in research on the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.

11.18.3 Undue influence and coercion

TCPS 2 defines undue influence as the impact of an unequal power relationship on the voluntariness of consent. This may occur when prospective participants are recruited by individuals in a position of authority over them (e.g., doctor/patient, teacher/student, employer/employee). You should consider whether prospective participants may feel constrained to follow the wishes of those who have some form of control over them whether that control is physical, psychological, financial, or professional. Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or not to participate in or withdraw from a research project. For example, you should ensure:

Continued enrollment in a program or service is not linked to research participation.
Students who do not want to participate in a research project for course credit should be offered a comparable alternative.

TCPS 2 defines coercion as an extreme form of undue influence, involving a threat of harm or punishment for failure to participate in research. Coercion negates the voluntariness of a decision to participate or remain in a research project.

You should ensure that there is no undue influence or coercion throughout the recruitment or consent process.

11.18.4 What information should be included in recruitment materials?

Copies of all recruitment materials must be submitted for REB review even if another person or agency is doing the recruitment on your behalf. Recruitment materials should generally include the following information:

Invitation to participate in a research study
Brief description of the research study including time commitment for participants
Statement indicating that the project has received REB review (REB four-digit approval number optional on recruitment materials)
Name, contact information for the researcher and the faculty supervisor (for student research projects) as well as their affiliation to Laurier (e.g., MA student at Wilfrid Laurier University)
Other pertinent details as applicable (e.g., compensation, location, etc.)

11.18.5 Crowdsourcing

If you plan to utilize crowdsourcing services in your research studies, you 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 the Amazon Mechanical Turk Acceptable Use Policy and Participation Agreement for a full description of permitted and prohibited uses of MTurk. You are responsible for reviewing and adhering to the policies of the crowdsourcing service you will be using. 

The REB has been made aware of researchers experiencing issues with bots while utilizing MTurk. If you are utilizing MTurk, or other crowdsourcing platforms, please ensure you take steps to check data quality.

11.18.6 In-class recruitment

If you are proposing to use students in your class as research participants you must demonstrate to the satisfaction of the REB that:

There is no undue influence or manipulation on your part as the instructor that would likely result in students feeling pressure or coercion to participate.
Consent will be given voluntarily and not as a result of your position of power/authority over the students you instruct.
Data provided by those who volunteer to participate will remain confidential and anonymous so that other students in the class and yourself 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 as research participants 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 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.

11.19 Informed Consent Guidelines

11.19.1 Free, informed and ongoing consent

As outlined in TCPS 2 (2022) consent in research involving humans must be “free, informed and ongoing”. An informed consent statement/information letter has two main purposes: 

To enable potential research participants to make an informed choice as to their whether they wish to participate in a study.
To document their decision to participate.

The voluntariness of consent is important to ensure individuals have chosen to participate in research according to their own values, preferences, and wishes. You must be cognizant of situations where undue influence or coercion may undermine the voluntariness of a participant’s consent to participate in research. Please see Recruitment Guidelines for further information.

In order to make an informed choice, potential participants must understand the study, how they are involved in the study, and what sort of risks it poses to them. The words and language used to describe these factors must be understandable to potential participants.

Consent begins with the initial contact (e.g., recruitment) and continues throughout the entirety of the participants’ involvement in the project. You have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research such as any changes to the risks or potential benefits.

11.19.6 Decision making capacity

As per TCPS 2, Chapter 3, decision-making capacity refers to the ability of an individual to understand relevant information presented about a research project and to appreciate the potential consequences of their decision to participate or not participate. A participant’s decision-making capacity is not static and may change overtime and may vary depending on the complexity of the decision or circumstances surrounding the decision.

As per Article 3.9, for research involving individuals who lack the capacity to decide for themselves whether to participate, the REB shall ensure that, as a minimum, the following conditions are met:

You must involves participants who lack the capacity to decide on their own behalf to the greatest extent possible in the decision-making process.
You must seek and maintain consent from authorized third parties in accordance with the best interests of the persons concerned.
The authorized third party can not be any member of the research team.
You must demonstrates that the research is being carried out for the participant’s direct benefit, or for the benefit of other persons in the same category. If the research does not have the potential for direct benefit to the participant but only for the benefit of the other persons in the same category, you must demonstrate that the research will expose the participant to only a minimal risk and minimal burden, and demonstrate how the participant’s welfare will be protected throughout the participation in research.
When authorization for participation was granted by an authorized third party, and a participant acquires or regains decision-making capacity during the course of the research, you must promptly seek the participant’s consent as a condition of continuing participation.

11.19.9 Debriefing Statement Template Standards

As per TCPS 2 (2022) Article 3.7B:

Debriefing must be a part of all research involving an alteration to consent requirements (Article 3.7A) whenever it is possible, practicable and appropriate.
Participants in such research must have the opportunity to refuse consent and request the withdrawal of their data and/or human biological materials whenever possible, practicable and appropriate (Article 3.1).

When drafting your debriefing statement, please ensure to follow the below guidelines as they apply to your research study. It’s recommended that you follow the format of the Debriefing Statement Template.

Follow the same heading and title template standards as outlined for the Informed Consent Statement.
Thank participants for their participation in the research study and explain why participants were temporarily led to believe that the research, or some aspect of it, had a different purpose, or why participants received less than full disclosure.
Give details about the importance of the research and the necessity of having to use alterations to consent requirements, and address any concerns raised by participants.
In order to address any misconceptions that may have arisen, researchers must explain why these research procedures were necessary to obtain scientifically valid findings.
Participants in such research must have the opportunity to refuse consent and request the withdrawal of their data and/or human biological materials whenever possible, practicable and appropriate.

11.20 Privacy, Confidentiality and Data Management Guidelines

As outlined in TCPS 2 (2022) Chapter 5, privacy and confidentiality risks are related to the identifiability of participants and the potential harms they may experience at all stages of the research life cycle including data collection, storage and retention, analyses, dissemination of findings, and disposal of records or devices on which data is stored.

In addition to research ethics guidance, researchers are responsible for compliance with all applicable legal and regulatory requirements with respect to protection of privacy, and consent for the collection, use or disclosure of information about participants (e.g., obligations under the Constitution including the Canadian Charter of Rights and Freedoms and federal or provincial privacy legislation).

11.20.1 Privacy

TCPS 2 defines privacy as an individual’s right to be free from intrusion or interference by others. An individual’s various domains of privacy (e.g., bodies, personal information, thoughts and opinions) may be affected by research in different ways depending on the research project. Informed consent is related to the right to privacy and respecting an individual’s opportunity to exercise control over access to and use of their personal information.

11.20.2 Confidentiality

TCPS 2 defines confidentiality as an ethical and/or legal responsibility of individuals or organizations to safeguard information entrusted to them from unauthorized access, use, disclosure, modification, loss or theft.

11.20.3 Security

TCPS 2 defines security as the measures used to protect information including physical (e.g., locked filing cabinets), administrative (e.g., organizational rules about who has access to personal information about participants), and technical safeguards (e.g., computer passwords, encryption, firewalls).

11.20.4 Identifiability of information

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).

11.20.5 Safeguarding participant data

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 and hard-copy data should be stored in a secure manner.

11.20.6 Data management

You are 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 and hard-copy data should be stored in a secure manner.

When selecting software solutions for research activities it is strongly recommended that you utilize properly vetted solutions to ensure the privacy and confidentiality of research participants. The REB may not approve the use of solutions that have not been properly vetted. You can find full details on relevant policies and guidelines below. To summarize, ICT has vetted the following solutions for use in research:

Data Sharing and/or Storage: OneDrive for Business
Online Survey Systems: Qualtrics
Videoconferencing Tools: Microsoft Teams has been approved for use with all data types and is the preferred videoconferencing platform. Zoom for Education has been approved for Type 1 (open) or Type 2 (internal) data. Zoom for Healthcare has been approved for Type 3 (restricted) data.

Note: REB guidelines pertaining to software solutions are based on expertise provided by ICT. These guidelines will continue to be updated based on ICT recommendations. Any questions pertaining to software access or use should be directed to the ICT service desk.  

11.20.7 Collecting participant data via email and text (SMS)

If recommended solutions for research data collection (e.g., Qualtrics, OneDrive, MS Teams, telephone) are not a viable option for your research project and you are considering using your university e-mail or text messaging for data collection, please ensure that data collection procedures using these methods are in line with the following guidelines:

It is not recommended that you use your personal phones for research purposes for privacy and security reasons (for both you and the participant). The recommendation is to communicate with research participants via your Laurier e-mail.
Data collected via these methods should not include sensitive information (e.g., questions related to mental health and/or medical or health information).
Any online data transfers should be done using encrypted protocols (e.g., https, sftp, etc.) For example, using Laurier OneDrive to share files. Please see the ICT OneDrive Connect page for instructions on how to securely share files using OneDrive. Note: Google Drive and Dropbox are not university approved solutions for collecting or storing research data.
At a minimum, all data on electronic devices should be password protected.
When online data transmission (e.g., e-mail) takes place you must make the participants aware of this in the informed consent statement, e.g., While in transmission on the internet, the confidentiality of data cannot be guaranteed.
Any personal information (e.g., contact information) and research data or correspondence should be permanently deleted from the e-mail account or phone as soon as the research project is completed and moved to a secure storage method (e.g., OneDrive).
Messaging apps (e.g., WhatsApp) are not be permitted as they have not been properly vetted for compliance with Laurier privacy and security policies.

11.20.8 Collecting participant data via online survey systems

For the collection of research data, you are required to use online survey systems that have been reviewed and approved through a Privacy and Security Impact Assessment (e.g., Qualtrics). Online survey systems that are not university-approved (e.g., Survey Monkey, Google Forms) may not be approved for use by the REB.

11.20.10 Video conferencing tools

If you are using video conferencing tools to conduct research projects involving interviews and focus groups or other methodologies you should be aware of the privacy and security limitations of these tools.

11.20.10.1 Microsoft Teams

Microsoft Teams is a solution that has been approved at Laurier for use with all data types, including Type 3 data (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 data types. Faculty and staff can find more information on Microsoft Teams on the Teams Connect page. Students do not currently have access to the Laurier managed Microsoft Teams instance. In order for students to use the Laurier managed Teams, faculty or staff can set up a meeting in Teams and invite students to participate in the meeting. In highly specific use cases where students require direct access, faculty or staff can request a sponsored account for a student to allow them to access the Laurier managed Microsoft Teams directly. Please use the Network and Email Account Request Form to request a sponsored account for a student.

11.20.10.2 Zoom for Education

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 Type 3 data (e.g., sensitive or health-related information). Please see Zoom (Web Conferencing) for more information.

11.20.10.3 Zoom for Healthcare

Zoom for Healthcare has been approved for Type 3 (restricted) data. 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 visit ICT’s Zoom for Healthcare page on Connect.

For further information about the different data classes and the protections associated with them, please review University policies 9.4 Information Security Policy Statement, 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 x 4357.

11.20.11 Data retention timelines

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 after the activity was completed.

You should also refer to any professional guidelines (e.g., American Psychological Association) when determining data retention schedules.

If you are 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. You should inform participants of their obligations to self-report all income in the informed consent statement.

11.20.12 Online transmission of participant data

If you are using the internet to transmit or receive participant data you 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. It is recommended that any online data transfers are done using encrypted protocols (e.g., https, sftp, etc.)

When such data transmission takes place you need to make the participants aware of this in the informed consent statement.

11.20.13 Privacy and confidentiality in the dissemination of research results

While the default approach is to maintain confidentiality of research data, there are some research contexts where you may plan to disclose the identity of participants. As per TCPS 2 Article 10.4, participants may waive anonymity (e.g., they want to be identified for their contributions to the research) and you may accept the waiver of anonymity as long as the waiver does not compromise the welfare of other participants (see Articles 3.2[f] and Application of Article 5.1).

11.21 Research Involving Indigenous Peoples of Canada Guidelines

If you are 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 other distinct communities as they highlight the need to respect a community’s cultural traditions, customs and codes of practice.

11.21.1 Key concepts and definitions

Key concepts as defined in TCPS 2 (2022) Chapter 9 include:

Community: A community is defined as a group of people with a shared identity or interest that has the capacity to act or express itself as a collective. A community may include members from multiple cultural groups and may be territorial, organizational, or a community of interest.

Territorial communities have governing bodies exercising local or regional jurisdiction (e.g., members of First Nations who reside on reserve land)
Organizational communities have explicit mandates and formal leadership (e.g., regional Inuit association or a friendship centre serving an urban Indigenous community)
Communities of interest may be formed by individuals or organizations who come together for a common purpose or undertaking, such as a commitment to conserving a First Nations language. Communities of interest are informal communities whose boundaries and leadership may be fluid and less well- defined. They may exist temporarily or over the long term, within or outside of territorial or organizational communities.

Individuals may belong to multiple communities or may not identify with any particular community. How individuals define which of their community relationships are most relevant will likely depend on the nature of the proposed research project.

Community Engagement: Community engagement is defined as a process that establishes an interaction between a researcher (or a research team) and the Indigenous community relevant to the research project. It signifies the intent of forming a collaborative relationship between researchers and communities, the nature and extent of engagement may vary depending on the research project.

11.21.2 Requirement to advise REB on plan for community engagement

As outlined in Article 9.1, community engagement is required where research is likely to affect the welfare of an Indigenous community, or communities, to which prospective participants belong. The conditions under which engagement is required include, but are not limited to:

research conducted on First Nations, Inuit or Métis lands;
recruitment criteria that include Indigenous identity as a factor for the entire study or for a subgroup in the study;
research that seeks input from participants regarding a community’s cultural heritage, artefacts, traditional knowledge or unique characteristics;
research in which Indigenous identity or membership in an Indigenous community is used as a variable for the purpose of analysis of the research data; and
interpretation of research results that will refer to Indigenous communities, peoples, language, history or culture.

The nature and extent of community engagement should be determined jointly by the research and the relevant community and should be appropriate to community characteristics and the nature of the research. Article 9.2 provides examples that illustrate the forms of community engagement that may be appropriate for various types of research. It is the responsibility of the researchers to advise the REB how they have engaged or intend to engage the relevant community or provide a rationale if they are seeking an exception to the requirement for community engagement.

As per Article 9.10, when proposing research expected to involve First Nations, Inuit or Métis participants, researchers must advise the REB how they have engaged or intend to engage the relevant community. Alternatively, researchers may seek REB approval for an exception to the requirement for community engagement, on the basis of an acceptable rationale such as the nature of the research and the community context (see Articles 9.1 and 9.2).

11.21.3 First Nations, Inuit, and Métis governing authorities

As outlined in Article 9.3, when the proposed research project is to be conducted on lands under the jurisdiction of a First Nations, Inuit or Métis authority, researchers shall seek the engagement of leaders of the community, except as provided under Articles 9.5, 9.6 and 9.7.

11.21.4 Respect for community customs and codes of practice

As outlined in Article 9.8, researchers should be informed of and respect the relevant customs and codes of research practice that apply in the particular community or communities affected by their research. Researchers should consult their institutions to ensure that the application of community-based ethics codes is consistent with institutional policies and the TCPS 2 (2022). Where divergences or inconsistencies exist, they should be addressed and resolved prior to the commencement of the research if possible or as they arise.

11.21.5 Ownership, control, access and possession (OCAP®)

The First Nations principles of ownership, control, access, and possession (OCAP®) outline how First Nations data and information will be collected, protected, used, and shared. If you are considering conducting research with First Nations, you should familiarize yourself with OCAP® prior to commencing research. OCAP® is a registered trademark of the First Nations Information Governance Centre (FNIGC). Full details can be found here.

11.22 Clinical Trial Research and Invasive Methods Guidelines

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.

terventions 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.

11.22.0.1 Registration of clinical trials

As per TCPS 2 (2022) Article 11.10, all clinical trials must be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the World Health Organization or the International Committee of Medical Journal Editors (ICMJE) (e.g., www.clinicaltrials.gov). Researchers should provide the REB with evidence of registration (e.g., registration number).

11.22.0.2 Phlebotomy standard operating procedures

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 technician employed by a laboratory licensed under the Laboratory and Specimen Collection Centre Licensing Act;
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);
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:
- 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.
- Additional supervised practical experience (e.g., practicing on a dummy arm)
- 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.  
- 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 for blood draws is conditional on permit approval from the Institutional Biosafety Committee. If you have any questions about these requirements, please consult with the REB.

11.22.0.3 Secondary Use of Data Guidelines

Secondary use of data refers to the use of information originally collected for a purpose other than the current research purpose. Examples include:

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.

11.22.0.4 Secondary use of identifiable information

Article 5.5 A, TCPS 2 states that if you have not obtained consent from participants for secondary use of identifiable information you shall only use such information for research purposes if you have satisfied to 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.
You will take appropriate measures to protect the privacy of individuals, and to safeguard the identifiable information.
You 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.
You have obtained any other necessary permission for secondary use of information for research purposes.

If you satisfy all the conditions in Article 5.5A (a) to (f), TCPS 2 the REB may approve the research without requiring consent from the individuals to whom the information relates.

Article 5.6, TCPS 2 states 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.

11.22.0.5 Secondary use of non-identifiable information

Article 5.5 B, TCPS 2 states 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 you 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 you have 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 you do not have access to the key. Consent would not be required in this situation.

11.22.0.6 Data linkage

If you are seeking to engage in data linkage you must obtain REB clearance prior to carrying out the data linkage.

The application for review and clearance should describe the data that will be linked and the likelihood that identifiable information will be created through the data linkage.

As per Article 5.7, TCPS 2 where data linkage involves or is likely to produce identifiable information, you must satisfy to the REB that:

The data linkage is essential to the research.
Appropriate security measures will be implemented to safeguard information.

11.22.0.7 Exemptions from REB review

As per TCPS 2, Article 2.2, research that relies exclusively on publicly available information does not require REB review when:

the information is legally accessible to the public and appropriately protected by law (e.g., Freedom of Information requests); or
the information is publicly accessible and there is no reasonable expectation of privacy (e.g., StatCan data).

However, there are situations where REB review is required.

There are publicly accessible digital sites where there is a reasonable expectation of privacy. When accessing identifiable information in publicly accessible digital sites, such as Internet chat rooms, and self-help groups with restricted membership, the privacy expectation of contributors of these sites is much higher and researchers must submit their proposal for REB review (see Article 10.3, TCPS 2).

Where data linkage of different sources of publicly available information is involved, it could give rise to new forms of identifiable information that would raise issues of privacy and confidentiality when used in research and would therefore require REB review (see Article 5.7, TCPS 2).

Please note that in order to determine the applicability of TCPS 2 articles the REB may request that you complete the a REB application for review at its discretion.

11.23 Can I use incentives in my research?

TCPS 2 (2022) neither recommends nor discourages the use of incentives. The onus is on the researcher to justify to the REB the use of a particular model and the level of incentives. When describing and justifying the model and level of incentives to the REB, researchers should consider and ensure compliance with the following guidelines:

Consider the possibility of undue influence.
Be sensitive to issues such as economic circumstances of prospective participants, age and decision-making capacity of participants, the customs and practices of the community, and the magnitude and probability of harms.
The participant should not suffer any disadvantage or reprisal for withdrawing, nor should any payment due prior to the point of withdrawal be withheld. If the research project used a lump-sum incentive for participation, the participant is entitled to the entire amount. If a payment schedule is used, participants shall be paid in proportion to their participation.
Guardians and authorized third parties should not receive incentives for arranging the involvement in research of the individual they represent. However, they may accept reasonable incentives or compensation on behalf of that individual.
The consent process should set out any circumstances that do not allow withdrawal of data or human biological materials once collected.

11.24 What is the new REB application?

The Research Ethics Board (REB) has initiated a project to update the Romeo ethics application form in late summer 2023.

In an effort to streamline the ethics review process for researchers and reviewers, the REB has designed this new ethics application to include questions that represent our current understanding of human research ethics and to align with the recently updated TCPS 2: 2022. The questions in the newly designed form are intended to be more specific with the option to provide additional information as necessary, which will lead to a more accelerated review process.

11.24.1 New REB Application Drop-In Sessions and Support

To provide support for researchers post-launch, the REB is hosting application-specific drop-in hours on August 2^nd, 4^th, 9^th, and 11^th from 10am-11am. You can join the drop-in sessions using the link below. Join our New Application Drop-In Sessions! (Note: you must be signed into Zoom to attend.)
Regular REB weekly drop-in sessions will begin August 31, from 3-4pm.
A Companion Document is available to guide researchers on how to complete the new application.
Instructional videos on how to complete tasks in Romeo are available on YouTube and our Romeo Guidelines Student and Connect webpages.

11.24.2 Process Changes

The new application form will look similar in design to the previous application form, but many questions, forms and tabs have been updated. As the previous application form was launched in 2013, the updated questions are more consistent with the TCPS 2: 2022 version and will allow for a more efficient review process. You will not be able to directly clone an old application to use after the launch of the new application form as many questions have changed. However, you can still view your old application forms and can manually copy over applicable answers if needed.

11.24.2.1 During the Shutdown

The shut-down will allow the REB to review existing applications within the system. Researchers will not be able to submit new applications during this time. Researchers will still be able to submit modifications, annual/final reports, and adverse event reports during this time.

11.24.3 Student Processes

11.24.3.1 Principal Investigator (PI)

Once the new application is launched, only full-time faculty, contract teaching faculty who are on an active teaching contract, or staff will be able to act as Principal Investigator on ethics applications. This change will ensure that we are compliant with the TCPS 2 Definition of Principal Investigator, and will remove the requirement for students to attach proof of their supervisor’s sign off with every application.

Students will be listed as Lead Student Investigators.

If a Romeo application is submitted with a student listed as the PI, the application will be returned for revisions.

11.24.3.2 Preparing and Editing Ethics Application

Students can still prepare an ethics application as all individuals added to a Romeo application can edit the application. While you can start and edit all sections of an application, you will not be able to be listed as a PI when it comes to the final submission to the REB.

If a you generate a new Romeo application, you will be defaulted to the PI. You can draft the application but will need to change the PI to your supervisor for their review and approval before submitting to the REB. To change the PI to your supervisor:

Navigate to the Project Team Info tab of your application.
Click Change PI in the top left corner of the tab.
Search for a full time or contract teaching faculty member or staff member.
Click Select next to their name.

Alternatively, a supervisor can generate the application in ROMEO and add the student as a student co-investigator or principal student investigator so that the student can fill out the remainder of the application. The final approved version must be reviewed, approved, and submitted by the PI (supervisor) in order to be reviewed by the REB. This new process will also remove the requirement of students having to submit a screenshot of their supervisor’s approval with every new application.

11.24.4 Access to Previous Applications

All previously approved applications will be available for viewing as well as submitting modifications and progress reports/adverse events. Any application drafts that are not submitted by July 14, 2023 will be deleted from the system.

11.1 Meet the Team

11.2 Service statement of the Research Compliance Unit?

11.3 What is the REB and what is its approach to research review?

11.3.1 Who is on the REB?

11.3.2 ​What is the REB’s Approach to Review?

11.3.2.1 Level of Risk in Research

11.3.2.2 Higher Risk Procedures

11.4 How does the REB define research?

11.5 ​What are the responsibilities of researchers related to the ethical conduct of human-participant research?

11.6 What are the requirements for multi-jurisdictional research?

11.6.1 ​Off Site Research

11.6.2 ​Research Outside of Canada

11.6.3 ​​Waterloo Region District School Board

11.7 ​What happens if I do not follow the TCPS2 and the university’s policies and guidelines on research with human participants?

11.8 Who must apply for REB review and what are the exemptions?

11.8.1 Is my research exempt from REB review?

11.8.2 Do pilot studies require REB review?

11.8.3 ​Do I need REB approval to engage with community members or partners?

11.9 How long are the REB clearance periods?

11.10 What are the requirements for annual and final reports?

11.11 What do I do if I modify my projects?

11.12 What do I do if there is an adverse event?

11.13 Does my project need a scholarly review for scientific merit?

11.14 How long does it take to get REB clearance and what is the process for review?

11.14.1 Process for review

11.14.1.1 Delegated (minimal risk) non-psychology applications

11.14.1.2 Delegated (minimal risk) psychology applications

11.14.1.3 Joint review process with the University of Waterloo

11.14.1.4 Approved elsewhere applications (psychology and non-psychology)

11.14.1.5 ​Full Board review (greater than minimal risk psychology and non-psychology)

11.14.1.6 ​Applications requiring expert review (psychology and non-psychology)

11.14.1.7 Modification request (psychology and non-psychology)

11.15 How do I apply to the REB for review?

11.15.1 Before You Apply

11.15.2 Where do I submit my application for review?

11.15.2.1 Departmental REC contacts

11.15.3 Which application do I submit for review?

11.15.3.1 Standard REB Application (Primary Data Collection)

11.15.3.2 Secondary Use of Data

11.15.3.3 Research Database

11.15.3.4 Modification Request

11.15.3.5 Adverse Event

11.15.4 Annual/Final Report

11.15.4.1 Laurier and Waterloo Joint Review Process

11.15.4.2 Applications Approved at Another Institution

11.15.4.2.1 Internal Researchers

11.15.4.2.2 External Researchers

11.15.5 Can standard operating procedures be approved?

11.15.6 What research materials do I include for review?

11.15.6.1 Information/Consent Letters

11.15.6.2 Surveys/Questionnaires/Interviews/Focus Groups

11.15.6.3 Recruitment Posters/Ads/Emails/Scripts

11.15.6.4 Debriefing Statement/Script

11.15.6.5 TCPS 2 Certificates

11.16 ​Tips for an Efficient REB Review

11.17 Romeo User Guidelines

11.17.1 How do I register for ROMEO?

11.17.2 How do I reset my password?

11.17.3 How do I add team members to a project?

11.17.3.1 Pre-Submission

11.17.3.2 Post-Clearance

11.17.4 How do I submit a project for a REB review?

11.17.5 How do I submit a modification request post-clearance?

11.17.6 How do I submit an annual/final report post-clearance?

11.17.7 How do I submit an adverse report post-clearance?

11.17.8 How do I upload an attachment?

11.17.9 Can I change the principal investigator on an REB project?

11.17.10 How do I unlock my project?

11.17.11 How do I access copies of REB emails?

11.18 Recruitment Guidelines

11.18.1 Recruitment templates

11.18.2 Determining inclusion and exclusion criteria

11.18.3 Undue influence and coercion

11.18.4 What information should be included in recruitment materials?

11.18.5 Crowdsourcing

11.18.6 In-class recruitment

11.19 Informed Consent Guidelines

11.19.1 Free, informed and ongoing consent

11.19.2 Documentation of consent

11.3.2 What is the REB’s Approach to Review?

11.5 What are the responsibilities of researchers related to the ethical conduct of human-participant research?

11.6.1 Off Site Research

11.6.2 Research Outside of Canada

11.6.3 Waterloo Region District School Board

11.7 What happens if I do not follow the TCPS2 and the university’s policies and guidelines on research with human participants?

11.8.3 Do I need REB approval to engage with community members or partners?

11.14.1.5 Full Board review (greater than minimal risk psychology and non-psychology)

11.14.1.6 Applications requiring expert review (psychology and non-psychology)

11.16 Tips for an Efficient REB Review

11.20.3 Security

11.20.10.1 Microsoft Teams

11.20.10.2 Zoom for Education

11.20.10.3 Zoom for Healthcare