Research Involving Humans

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

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

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

The members of the REB shall by mutual consensus select an acting chair who in the absence of the chair, or when the chair is faced with a conflict of interest, is authorized to perform the duties of the chair.

REB protocols that are past their approved expiry/end date will automatically be marked as expired by the REB and the principal investigator (PI) notified that no further data collection from human participants (or the use of human biological materials) can take place. Such protocols may be reactivated following the submission of a modification request for a new end date provided that this does not extend the new end date beyond two years from the original date of approval.

Applications that have been submitted for review will be automatically withdrawn from the review process if there has been no activity after a period of six months. In such cases the principal investigator (PI) will be notified via email and the file will be marked as withdrawn. The review process may resume when the PI notifies the REB that they wish to restart the review process.

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

Files that have been archived for less than six months may be reactivated following the submission of a modification request for a new end date provided that this does not extend the end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 two years from the original date of approval.

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

A proposal from a faculty member or teaching assistant seeking to use their students as research participants must demonstrate to the satisfaction of REB that:

• There is no undue influence or manipulation on the part of the instructor that would likely result in students feeling pressure or coercion to become a participant in their instructors research.
• Consent will be given voluntarily and has not simply been given to the instructor as a result of their position of power/authority over the students they instruct within the captive audience of a classroom.
• Data provided by those who volunteer to participate will remain confidential and anonymous so that other students in the class and the instructor will not be able to determine who participated.

To demonstrate to the REB that the elements noted above have been fulfilled research projects seeking to use students must:

• Respect that class time is for instructional purposes, not research. Use of class time to conduct research must be kept to a minimal amount of time at the end of each class (i.e., less than 10 minutes). The preferred practice would be to invite students to remain after the end of class to learn more about the research project.
• Consent to participate will need to be provided to (or collected by) an independent third party with no authority or power over the students (i.e., not the class instructor). The instructor must not be aware of who agreed to participate while the instructor-student relationship exists.
• An information/consent letter 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 shall 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 by the instructor. 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.

Some research projects undertaken at Laurier will meet the requirements of a clinical trial as defined in the Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS2). Standard Operating Procedure (SOP) 1: Review of Clinical Trial Research has been adopted by the REB to guide the review and approval process for such projects.

SOP 1: Review of Clinical Trial Research

Purpose: This Standard Operating Procedure (SOP) is designed to guide the Laurier Research Ethics Board (REB) and principal investigator (PI) in obtaining the necessary review and approval for research projects that meet the definition of a clinical trial in TCPS2:

“…any investigation involving participants that evaluates the effects of one or more health-related interventions or health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products, process-of-care changes, preventive care, manual therapies and psychotherapies.” (p.147)

The primary focus of this SOP is to ensure that the REB has obtained the appropriate expertise to review a particular application when it is determined that the REB does not have sufficient expertise to conduct a proper review.

1.0 General

• 1.1: REB applications that meet the definition of clinical trial as defined in TCPS2 may require the REB to obtain expert review.
• 1.2: In the case of REB review of clinical trials, provincial/territorial or federal regulations may outline specific membership requirements in order to conduct the REB review. In such cases the REB shall ensure that these membership requirements have been fulfilled.
• 1.3: The decision on when expert review is required shall be made by the REB Chair after reviewing the REB application. The Chair may consult with the REB to obtain their advice and guidance on how the review should proceed. If the REB Chair determines that the REB does not have the appropriate expertise to conduct a proper review then the services of at least one expert reviewer, external to the REB, shall be obtained. Any member of the REB may also file a request with the REB Chair that an application should be reviewed by an expert reviewer.
• 1.4: The expert reviewer may be identified by the PI, subject to the review and approval of the REB Chair. In such cases the applicant will provide a written explanation to the REB Chair outlining the qualifications of the proposed expert reviewer to conduct the review. In all cases the expert reviewer must have an arms-length relationship to the PI and any co-applicants listed on the REB application.
• 1.5: Subject to the approval of the Vice President: Research, (or designate) expert reviewers maybe eligible for an honorarium (to a maximum of $400) in recognition for completing the review.
• 1.6: REB applications that meet the definition of a clinical trial shall be registered before recruitment of the first trial participant in a recognized and easily web-accessible public registry that is compliant with the criteria set by the World Health Organization or International Committee of Medical Journal Editors. The REB will maintain a list of registries meeting these criteria. The PI shall provide the compliance officer with the number assigned to their trial upon registration.

2.0 Review Process

• 2.1: The Research Compliance Officer will contact the identified expert reviewer to determine if they would be willing to conduct the necessary REB review and outline any terms or conditions attached to the review process.
• 2.2: When the expert reviewer has confirmed that they will do the review they will be provided with a copy of the submitted REB application and any accompanying documentation provided by the PI. This information will be used by the expert reviewer to conduct their review. The Compliance Officer will coordinate this review process.
• 2.3: The expert reviewer will provide a written summary of their review and/or approval of the application to the Compliance Officer.
• 2.4: The REB Chair shall also conduct a review of the REB application and any supporting documents. They may request the PI to make additional changes or modifications to their application.
• 2.5: If the expert review requests any changes or modifications to the project design these shall be communicated to the PI by the Compliance Officer. The PI will be required to change or modify their project to address any concerns or suggestions made by the expert reviewer. Confirmation that these changes have been made will be done by the Compliance Officer in consultation with the REB Chair (or the expert reviewer) when required.
• 2.6: Applications that have been revised as requested by the expert reviewer and/or the REB Chair will be approved.

3.0 Modifications to an Existing Approved Protocol

• 3.1: Modifications and changes to protocols that have been subject to expert review may require review by an expert reviewer, preferably the one who conducted the initial review. The decision on whether or not to consult an expert reviewer shall be made by the REB Chair in consultation with the Compliance Officer.

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

Every project that involves collecting information from human participants needs a consent/information letter. Such documents inform participants about your project, explain what they will be asked to do as participants and set out their rights and responsibilities.

To assist you with this the REB has prepared a sample consent letter. This provides suggestions for dealing with the types of information that generally need to be included in the consent/information letter. You can find this template within the ROMEO online system.

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

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

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

• If the instructor is not using the data and the project is considered to be minimal risk and it is for an undergraduate class, the REB application will be reviewed by the department level REC (use the “Request for Ethics Review” form); do not use the ROMEO system.
• If the instructor will use the data from the project (or the project is of higher risk or is part of a graduate level class) the application must be submitted for review using the ROMEO system.

The university REB reviews and approves research projects of faculty members, graduate students and staff, while the departmental ethics review committees, for the most part, review and approve projects of undergraduate students. However, if the undergraduates’ projects are part of a faculty member’s own research program or if the participants are at greater than ‘minimal risk’ by participating, the university REB needs to review and approve the project.

Once your application has been submitted, either to the REB or to a department research ethics committee (REC), it will be checked over to ensure that all required documentation has been submitted. If the application is complete, the review process will begin (incomplete applications will be returned to the applicant). Normal processing time is 10 working days.

The chair of the REB (or REC) will likely send comments and suggestions for changes to the projects. Once these changes have been made and resubmitted for review, you will receive an approval letter from the chair.

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 Laurier’s 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 (PI) on their REB application to Laurier; external researchers can only be listed as a co-investigator, not as the PI on Laurier applications. Contact reb@wlu.ca for further guidance on this process.

When a PI listed on an active REB protocol leaves Laurier (i.e., a faculty member resigns / retires or a student graduates) they shall be considered an external researcher. All protocols under their name will automatically be marked as expired and the PI notified.

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

Some research projects may involve the use of a procedure(s) that is deemed by the REB to entail a higher degree of risk to the potential participants. When such procedure(s) have been identified by the REB, Standard Operating Procedure (SOP) 2: Review of Higher Risk Procedures will be used to guide the review process.

SOP 2: Review of Higher Risk Procedures

Purpose: This Standard Operating Procedure (SOP) is designed to guide the Laurier Research Ethics Board (REB) and Principal Investigator (PI) in obtaining the necessary review and approval for research projects that involves the use of a procedure(s) that is deemed to entail a higher degree of risk to potential participants.

The primary focus of this SOP is to ensure that the REB has obtained the appropriate expertise to review a particular application when it is determined that the REB does not have sufficient expertise to conduct a proper review.

1.0 General

• 1.1: REB applications that contain procedures that entail a higher degree of risk to the participants may require the REB to obtain expert review.
• 1.2: The decision on when expert review is required shall be made by the REB Chair after reviewing the REB application. The Chair may consult with the REB to obtain their advice and guidance on how the review should proceed. If the REB Chair determines that the REB does not have the appropriate expertise to conduct a proper review then the services of at least one expert reviewer, external to the REB, shall be obtained. Any member of the REB may also file a request with the REB Chair that an application should be reviewed by an expert reviewer.
• 1.3: The expert reviewer may be identified by the PI, subject to the review and approval of the REB Chair. In such cases the applicant will provide a written explanation to the REB Chair outlining the qualifications of the proposed expert reviewer to conduct the review. In all cases the expert reviewer must have an arms-length relationship to the PI and any co-applicants listed on the REB application.
• 1.4: Subject to the approval of the Vice President: Research, (or designate) expert reviewers maybe eligible for an honorarium (to a maximum of $400) in recognition for completing the review.

2.0 Review Process

• 2.1: The Research Compliance Officer will contact the identified expert reviewer to determine if they would be willing to conduct the necessary REB review and outline any terms or conditions attached to the review process.
• 2.2: When the expert reviewer has confirmed that they will do the review they will be provided with a copy of the submitted REB application and any accompanying documentation provided by the PI. This information will be used by the expert reviewer to conduct their review. The Compliance Officer will coordinate this review process.
• 2.3: The expert reviewer will provide a written summary of their review and/or approval of the application to the Compliance Officer.
• 2.4: The REB Chair shall also conduct a review of the REB application and any supporting documents. They may request the PI to make additional changes or modifications to their application in addition to any requested by the expert reviewer.
• 2.5: If the expert review requests any changes or modifications to the project design these shall be communicated to the PI by the Compliance Officer. The PI will be required to change or modify their project to address any concerns or suggestions made by the expert reviewer. Confirmation that these changes have been made will be done by the Compliance Officer in consultation with the REB Chair (or the Expert Reviewer) when required.
• 2.6: Applications that have been revised as requested by the expert reviewer and/or the REB Chair will be approved.

3.0 Modifications to an Existing Approved Protocol

• 3.1: Modifications and changes to protocols that have been subject to expert review may require review by an expert reviewer, preferably the one who conducted the initial review. The decision on whether or not to consult an expert reviewer shall be made by the REB Chair in consultation with the Compliance Officer.

Laurier and the University of Waterloo have entered into a joint review process that allows for the simultaneous review of research projects that require REB approval from both institutions. The simultaneous review process provides the researcher with a combined set of comments from both REBs, resulting in a faster review and approval process. Post-approval, this also includes joint review of any modification requests. If your project requires REB approval from Laurier and University of Waterloo and you would like to use the joint review process, contact reb@wlu.ca for further guidance.

Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.

Please note that the university REB or department REC must review and approve any changes or modifications to the project that relate to the researcher’s dealings with his or her participants before those changes are implemented. Such modifications will be submitted online (if applying to the REB) or sent via email (if applying to an REC).

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

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

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

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

Researchers using the internet to transmit or receive participant data should be aware that while in transmission, data may be subject to access by third parties as a result of various security legislation now in place in many countries.

When such data transmission takes place researchers need to make their participants aware of this by adding the following statement to their consent/information letters:

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

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

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

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

Please note that when using participants under the age of 16, the REB requires the submission of two consent forms for review: one for the parent/guardian and one for the participant. The consent letter for the participant should contain age appropriate language to ensure their understanding of the project and their role within it. In some cases a verbal assent script may be necessary with younger participants.

Note: Researchers planning to access participants within local school boards should be aware that school boards often have different age requirement (e.g., 18 years) for obtaining parental/guardian consent. Research in schools also requires consent from the school principal and the school board REB before research commences. If you will require the use of participants from the Waterloo Region District School Board (WRDSB), please contact Doreen Weise, human ethics and statistics lab coordinator (Psychology) at dweise@wlu.ca for more information.

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

CAS and LTA faculty are requested to contact reb@wlu.ca in advance of their submission to the REB to discuss their research project and time lines for completion.

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

If your project has been approved by another REB, please provide Laurier's REB (reb@wlu.ca) with the documentation (approval letter and application) that was reviewed and approved by the other REB. You do not need to fill out the Laurier application (we will work from the other REB forms in most cases). The project still needs to be reviewed and approved here by Laurier’s REB.

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

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

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

In the specific case of working with participants in foreign countries, researchers are advised to take appropriate steps to ensure that their project respects local regulations and customs for research involving human participants. REB clearance provided by Laurier is based solely on complying with Canadian requirements and standards as outlined in Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS2).

The researcher listed as the principal investigator on an REB protocol is responsible for ensuring that appropriate steps and safeguards have been put into place to protect participant data from loss or unauthorized access. The type of safeguards required will be proportional to the data obtained from the participants, with more sensitive data requiring higher levels of security. At a minimum all data on electronic devices should be password protected; hardcopy data should be stored in a secure manner.

Researchers that use the same procedure across a number of different projects may choose to have the procedure reviewed and approved by the REB as a separate protocol. When approved by the REB this will eliminate the need to have the procedure repeatedly reviewed when included as part of future applications to the REB.

SOPs that are deemed to be of minimal risk can be reviewed and approved via the expedited review process. SOPs that are greater than minimal risk will require full board review and approval.

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

Beginning March 2013 all Laurier individuals listed on an REB application (e.g., principal investigators, co-investigators, research assistants and supervisors) will need to complete the Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS2) online ethics tutorial and submit the certificate(s) of completion with their REB application. For further details about this requirement, refer to Policy 11.13: Ethics Review of Research Involving Humans.

Laurier's REB adheres to the joint research ethics statement of the federal research agencies: CIHR, NSERC and SSHRC. The joint policy statement known as TCPS2 incorporates a number of changes including:

• A consolidation of research core principles;
• Updated guidelines in the areas of: clinical trials, human biological materials, human genetics;
• Updated and expanded information in Chapter 9 on research involving First Nations, Inuit, and Metis People of Canada as well as suggested application re: Indigenous people;
• Expanded qualitative research chapter;
• Responsibilities of researchers and universities related to the security of information;
• Detailed attention to privacy and consent.

TCPS2 is applicable to all research involving human participants regardless of discipline or methodology. The CORE tutorial provides an introduction to and examples of important principles from the TCPS2. The CORE tutorial is used Canada-wide with most if not all university research offices requiring the completion of the Core Tutorial. Laurier faculty and student researchers are requested to complete the tutorial and include the certificate with the REB application.

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

Most activities conducted within Laurier’s jurisdiction or under Laurier’s auspices by students, faculty and staff that meet the definition of ‘research’ and involve ‘human participants’ will be subject to REB review:

“…research is an undertaking intended to extend knowledge through a disciplined inquiry or systemic investigation…" (Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans pg. 15)

“…human participants are those individuals whose data (including human biological materials), responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question…" (Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans pg. 16-17)

The activities listed below, when involving the use of human participants (or human biological material), are provided as examples of activities generally accepted by the REB to need review as they meet the definition of ‘research’:

• Research supported via public funding or the Tri-Councils;
• Research supported via contracts, agreements or industrial funding;
• Graduate research projects;
• Postdoctoral research projects;
• Faculty research projects;
• Staff research projects;
• Projects or assignments that involve the analysis of data resulting in the creation of new knowledge or insights (e.g., term papers, honours level thesis, etc.);
• Projects that use surveys, questionnaires, interviews, focus groups and experimental methods to gather data from human subjects.

In some cases students, faculty and staff may undertake projects which as a result of their intended purpose or outcome may be exempt from human ethics review, as ‘research’ is most likely not the intended purpose of the project. When clarification is needed as to whether or not a project is exempt from REB review, the REB shall make the final decision. Contact reb@wlu.ca for assistance.

Activities that are likely to be exempt from REB take place when:

• The main purpose of the project is solely professional skill development. Such projects are used to demonstrate and allow an instructor to assess specific career skills or professional abilities directly related to future employment. The project is not presented outside the course and any data collected will be destroyed (e.g., a Journalism student is required to set up a series of interviews with small business owners, ask them questions and then write an article so their instructor can assess their interview and writing ability; a graduate student, following professional practices in social work, gathers clinical information from patients in a hospital to prepare admittance reports that will be evaluated by their instructor to see if they meet professional standards).*
• The main purpose of the project is to assess one’s knowledge attainment or understanding of concepts taught in a senior level course with the primary audience being the course instructor. No new knowledge or insights are created (e.g., an Education student enrolled in a curriculum development course writes a report outlining how they modified their lesson plans to better accommodate the learning styles and comprehension levels of the students they were teaching; a Lazaridis School student outlines how they applied effective client management skills while working with a small business owner; a psychology student writes a reflective paper to demonstrate their understanding of cognitive development in children after spending two weeks observing a grade 3 class).*
• Participant data is collected solely for in class training or demonstration purposes and which will be immediately disposed of once the training or demonstration has been completed (e.g., a professor teaching first year statistics has everyone in the class fill in a survey regarding their fast food buying habits in order to create a data set that will be used to run various statistical tests on). Note: If the data collection procedures involve the use of invasive procedures on human participants they will need to be reviewed by the Teaching Safety Committee.*

*Note: If the project is deemed to be exempt from REB review please ensure that appropriate procedures are used to collect any data, secure it and ensure its proper disposal. The confidentiality of data must be maintained at all times. Researchers are not exempt from ethical conduct.

Useful websites on privacy, ethics, professional and/or ethical conduct:

• The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
• Tri-Agency Framework: Responsible Conduct of Research
• The Office of the Privacy Commissioner of Canada
• Laurier’s Privacy Coordinator Office
• The Canadian Association of Journalists (CAJ) Ethics Guidelines
• The Canadian Association of Social Workers (CASW) Code of Ethics
• The Canadian Psychological Association (CPA) Code of Ethics for Psychologists

(Prepared in part using guidelines from the REB at the University of Waterloo.)

A number of activities are exempt from REB review under the Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS2) guidelines. These exemptions have been summarized below. When clarification is needed as to whether or not a project is exempt from REB review, the REB shall make the final decision. Contact reb@wlu.ca for assistance.

Projects that involve the use of humans who themselves are not the focus of the research are exempt from REB review. For example one may collect data from those authorized to release information or data as part of their ordinary course of employment about organizations, policies, procedures, professional practices or statistical reports. In such cases the person is NOT the focus of the research and REB review is not required. (TCPS2 pg. 16)
Research that relies entirely on publicly available information does not require REB review when it is legally accessible to the public and appropriately protected by law OR the information is publicly accessible with no reasonable expectation of privacy. (TCPS2 pg. 17)

REB review is not required for projects that exclusively use the observation of people in public places where A) there is no staged intervention by the PI or direct interaction with the participants B) those under observation have no reasonable expectation of privacy and C) no identification of specific individuals takes place in the research results. (TCPS2 pg. 18)

Research undertaken and used exclusively for Laurier internal assessment, management or improvement purposes (e.g., quality improvement studies, departmental reviews) and testing within normal education requirements does not constitute research under TCPS2 and no REB review is required (TCPS2 pg. 20.) Information obtained under these projects is not to be published or presented outside of the university. Projects meeting these criteria are however subject to Administrative Research Review under University Policy 8.2. For more information on Administrative Research Review, please contact Paul Barnard at pbarnard@wlu.ca.
Research that relies exclusively on secondary use of data that was originally collected anonymously and so long as the process of data linkage or recording of dissemination of results does not generate identifiable information and the data was originally intended to be retained indefinitely for future analysis. Please consult “Secondary Data Analysis: When does it require REB Review?” for further guidance (TCPS2 pg. 19)

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 responses from participants whose responses will be analyzed to answer a research question is subject to REB review (TCPS2 pg. 20).

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.

Note: Please be aware that 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. Visit the privacy coordinator’s webpage for more information.

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• Press “login” to access ROMEO.

• Log in to ROMEO.
• From your home screen select “Apply New.” On this page, you will find three types of Research Ethics Board (REB) applications (described below). Please select the appropriate type of application for your purposes.
  • If you are in Psychology: Use “Psychology Applicants: Request for Human Ethics Review.”
  • If you are not in Psychology: Use “Non-Psychology Applicants: Request for Human Ethics Review.”
  • If you wish to have a participant database approved (regardless of your academic area): Use “Research Data Base: Request for Human Ethics Review.”
• 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 and start and end dates.
  • Project team info:
    • Principal Investigator: Use this to identify yourself as the principal investigator on the application;
    • 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 application. If this search does not find them, they will need to register for the ROMEO system (use the "register" button found on the main Romeo login screen).
  • 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 application (e.g., TCPS2 certificates, consent letters, questionnaires, surveys, recruitment posters, etc.).
• You may save your application 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 asterix (*), you will not be able to submit the application until the required fields are filled in.
• You can track the status of the application(s) you have submitted as the principal investigator by looking at your home page under “Role: Principal Investigator."
• Updates and requests for additional information from the REB will be sent to your email account as your application moves through the review process. Check your email account regularly.

• Log in to ROMEO.
• Find the approved REB file that you wish to modify. All approved files 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 files.
• Press the “Events” button next to the title of the REB file you wish to modify.
• 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 approval.

• Log in to ROMEO.
• All REB files require the completion of a final report, and two-year projects also require the completion of an annual report. The form can be found on your home screen under “Role: Principal Investigator.” For a listing of all your files that need an annual/final report, go to the link “My Reminders.”
• Press the “Events” button next to the title of the REB file that requires an annual report. Note: The "My Reminders" link only appears if you have pending annual/final reports.
• 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 approval.

• Log in to ROMEO.
• Find the approved REB file that requires an adverse event report. All approved files are on your ROMEO home screen under “Role: Principal Investigator.” Go to the link “Applications (Submitted – Post Review)” for a listing of all your current and approved files. Press the “Events” button next to the title of the REB file 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.

The clone function allows you to quickly and easily create another copy of any protocol (submitted after June 7, 2013) that has previously been approved by the REB. For example, when the maximum approval period on an existing protocol is reached (i.e., two years) and you still need active REB approval to cover ongoing research, use the clone function to create a new copy of the expired REB protocol. The cloned protocol can then be updated to reflect any changes and submitted to the REB for review.

• Log in to ROMEO.
• On your home screen, go to the menu “Role: Principal Investigator.” Then go to the quick link “Applications Submitted – Post Review.”
• Find the REB protocol that you wish to copy. Press the "Clone" button next to the protocol that you wish to clone.
• Follow the instructions to select which components of the protocol you wish to clone.
• ROMEO will then create a new file that contains all the aspects and components of the old protocol that you selected to be cloned. You can then go into this “new” protocol, make changes, and attach new documents (if you wish).
• Indicate that this is a cloned file in one of the comments boxes. 
• Hit submit to forward the cloned protocol to the REB for review.

If you have previously accessed your on-line account and have forgotten your password:

• Log in to ROMEO.
• Enter your username (which will be an email address, most likely your Laurier email address).
• Click the "Reset Password" button. You will receive an email explaining how to reset your password. Follow the instructions in the email. If you do not receive an email, contact reb@wlu.ca for assistance.