Frequently Asked Questions

Why does Western require faculty, students and staff to obtain Research Ethics Board (REB) approval?

The three federal funding agencies for research – Social Sciences and Humanities Research Council (SSHRC), Natural Science and Engineering Research Council (NSERC), and the Canadian Institutes of Health Research (CIHR) – jointly created the Tri-Council Policy Statement on the Ethical Conduct of Research Involving Humans (TCPS). The TCPS mandates that any institution which receives funds from any of the Tri Agencies must adhere to the TCPS in order to remain compliant and eligible for ongoing access to research funds. Note: Western adopts the TCPS for all research involving humans conducted by its students, faculty and staff. That is, TCPS requirements do not just apply to funded research.

What is the current version of the TCPS?

The TCPS has undergone several revisions since its creation in 1998. The latest version is the TCPS2 (2018).

What system are we using at Western?

The new system was purchased from Infonetica Ltd., which specializes in research management, ethics management, ethics approval and compliance training solutions. The system we are calling Western Research Ethics Manager (WesternREM or WREM) is a web-based electronic platform for conducting research ethics reviews and is built using modern infrastructure that exhibits a vast set of features, while maintaining an easy-to-use interface. The Health Sciences REB has used this system since 2015 for multi-centre clinical trial studies submitted through Clinical Trials Ontario (CTO), for which Western's HSREB acts as the REB of record. This continued relationship ensures CTO Stream and WREM will be continuously monitored and maintained to meet the needs of researchers and REBs.

What browsers support WREM?

WREM currently supports the latest versions of the following browsers: • Google Chrome • Mozilla Firefox • Safari *Please also make sure that you are clearing your browser history and cache regularly and have allowed pop-ups within the WREM system.

When do I need to obtain Research Ethics Board approval?

Research ethics board approval is required for all research activities involving human participants (including biological materials, chart data, opinions (e.g. survey) etc. There are some exceptions to this, please reference TCPS 2 (2018) and, relevant institutional guidance documents.

When is research exempt from REB review?

TCPS2 describes five exemption categories: publicly available information (see TCPS2 Article 2.2), naturalistic observation (see TCPS2 Article 2.3), secondary use of anonymous information (see TCPS2 Article 2.4), quality assurance/quality improvement/program evaluation (see TCPS2 Article 2.5), and creative practice (see TCPS2 Article 2.6). These types of projects *may* be exempt from REB review. Please see the REB’s guidance documents for further information.

How do I verify if my research is exempt from REB review?

Consult the applicable article in the TCPS2. If you are still unsure, consult the Office of Human Research Ethics.

I’m a student, faculty, or staff at Western conducting research in partnership with another institution that already has REB approval. Do I need REB approval at Western?

Western University is responsible for all research carried out by Western’s faculty, students or staff. Western’s REB oversight is dependent primarily on the specific role of the researcher in the project. For more information, please refer to the Multi-Jurisdictional Research Guidance Document under Applicable to both Boards on our Guidelines and Templates Page. https://www.uwo.ca/research/ethics/human/board_guidelines.html

What is a PI?

‘PI’ is short form for ‘Principal Investigator’. The PI is the person who holds ultimate responsibility for the conduct of the project, and this role in limited to individuals who have been deemed ‘research eligible’ by the institution. For more information on research eligibility at Western, please visit Western Research policies and review Research Eligibility: Research-Eligible Faculty Appointments (Password Protected). https://www.uwo.ca/research/ethics/policies.html Notes: • An REB application at Western can only have one PI. Other investigators on a study team would be considered ‘co-investigators’. • Students cannot be PIs. Typically, the students’ faculty supervisor would be the PI on the students’ research projects.

What are the responsibilities of the PI?

A PI oversees the entire conduct of the project and are responsible for ethical conduct from conceptualization through to dissemination and long-term data storage. A PI must sign off on the REB application, explicitly attesting to the Confirmation of Responsibility page (the final section of each REB application – which outlines specifically what is expected). A PI is also responsible for complying with all institutional policies, ensuring each study team member is appropriately selected and trained to carry out their roles, and for ensuring compliance with REB requirements (incl. conducting the research in accordance with the approved application/study documents, submitting and changes for approval, reporting any adverse events, submitting annual updates, etc.).

I am not the PI; can I fill out REB applications?

Yes, anyone with a WREM account can initiate a New Project, and this person will become the Project Owner. Study team members other than the PI also have the ability to create and complete sub-forms *provided that they have been given appropriate permissions* within the WREM file. These permissions are managed within the WREM file by the Project Owner, who must ensure the applicable study team members have been given a ROLE, and that any necessary permissions are verified in the Collaborators tab. Note: The PI must review and sign off on all initial submissions (this includes amendments, reportable events, CERs etc.) of an application to submit for review. Projects signed off and submitted by anyone other than the PI will be returned incomplete unless formal recommendations have been received by the REB.

Can I print a copy of the form to fill it out prior to inputting it into WREM?

There is a PDF copy of the form available in the WREM system by clicking the Help button in the top navigation bar and then selecting templates from the dropdown options. This PDF will show all possible questions that the WREM form can ask. Please keep in mind that the WREM system is a smart form so a question appearing is dependent on your earlier responses.

Do I require any specific training in order to conduct research at Western University /London Hospitals or affiliated institutions?

Yes, researchers at Western, London Hospitals and affiliated institutions must conduct research in accordance with the TCPS2. In, order to ensure this, study team members must be properly trained on the ethical conduct of research. The Government of Canada provides an online training module for research ethics available online (https://tcps2core.ca/welcome). Other training modules may also be acceptable, such as CITI (https://about.citiprogram.org/en/homepage/). For more information on training requirements, contact Grace Kelly, Manager, Research Compliance Programs and Education at grace.kelly@uwo.ca for Western researchers or lawsonapproval@lawsonresearch.com for Hospital and their affiliated institutions researchers. Note: Researcher’s training obligations are managed institutionally, outside of the REB.

How do I login to the WREM system?

A WREM account was generated for all researchers and research support staff with a pre-existing Romeo account. For any new researchers looking to gain access to WREM, you will be required to set up an account. To do so, please click on New User at applywesternrem.uwo.ca.

Where do I find help to navigate the WREM System?

Please see the HELP tab in the WREM system (across the top, there is a navigation bar with a ‘Help’ dropdown menu). Select ’Help’ from the dropdown menu for access to videos, user guides, etc. designed to facilitate researchers’ navigation of the online system. You can also access this information on our WesternREM (WREM) page under Training Materials (https://www.uwo.ca/research/ethics/human/WesternREM.html). You can also look at our Workshops and Seminars page for other materials (https://www.uwo.ca/research/ethics/human/workshops/index.html).

Is ROMEO still accessible?

No, the ROMEO system is no longer available to our research community. Study teams should have downloaded all documents from the ROMEO system prior to it closing as per our Memo sent out on July 4, 2019.

What happened to my studies that were in ROMEO?

Approved studies were migrated from the ROMEO system into WREM. The Migration included: full study title, REB number, PI name, all Research Support Staff name(s), start date, end date, if Lawson-affiliated, and FDA status. A notation of the post-approval events, including amendments, Continuing Ethics Reviews (CER), Reportable Events (e.g., SAE, PD, DSMC, FYI) were brought over but may not contain all information included in the ROMEO form. Important Note: No study documents were migrated with the files.

What if my study is a Quality Assurance/Quality Improvement/Program Evaluation (QA/QI/PE)?

With respect to QA/QI/PE, there is a short application form within Western University’s online REB application system that researchers can submit to verify if their projects are exempt. This application form is accompanied by a guidance document and checklist available here to support researchers in distinguishing between QA/QI/PE and research. Our Guidance Document is available under Applicable to both Boards on our Guidelines and Templates Page (https://www.uwo.ca/research/ethics/human/board_guidelines.html). Note: If a project may have dual purposes (i.e., QA/QI/PE and research), then the highest (i.e., research) standards apply.

Once my application has been submitted, approximately how long should I expect wait to receive feedback?

Please see our review timelines listed on our Deadlines and Timelines page (https://www.uwo.ca/research/ethics/human/deadlines.html).

What are the average timelines for initial review/ approval?

The following timelines reflect the average time between the submission of an application for review and the approval of that study (based on work days): 2019 Metrics: • Health Science Full Board – 81 days • Health Science Delegated – 54 days • Non-Medical – 40 days

What type of feedback might I get?

Upon review, the REB or delegate will either: approve as is, request modifications, or defer review until more information has been obtained. When requesting modifications, specific recommendations will be offered so that the project/application can be revised in accordance with TPCS2 and/or to provide the REB with clarity on the proposed project. More information on the REBs’ approval decisions can be found in our Continuing Ethics Review (CER) Guidance Document under Applicable to both Boards on our Guidelines and Templates Page (https://www.uwo.ca/research/ethics/human/board_guidelines.html).

How long will my project be approved for?

Most often, projects are approved for one year. There may be instances when the REB requests more frequent updates (e.g., for high risk protocols). The expiry date will always be listed on the approval letter and in the Centre’s tab of your application within the WREM system.

What if my project lasts more than one year?

Each year, researchers are expected, in accordance with the TCPS2, to submit an update on the status of the study. At Western, this is called a Continuing Ethics Review (CER), which, upon approval, will provide approval for an additional year. CERs are submitted as ‘sub-forms’ in WREM and will be reviewed by our office within 30 days of the expiry date. It is highly recommended that your CER is submitted at least 2 weeks prior to your Expiry date to ensure enough time to process within the WREM system and there is less risk of your study expiring.

What if I do not submit a CER or Study Closure form prior to the expiry date?

Researchers are provided Three courtesy notifications prior to the expiry date requesting submission of the CER or Study Closure form. If a project expires before this information has been submitted or reviewed, all study activities must stop (and in the event of any potential study-related harms associated with stopping, the research team must contact the REB immediately). The Office of Human Research Ethics will notify the PI’s Chair/Department Head of the expiry and if no communication or sub-form is received, the project will be presented to the Full Board for file closure. For more information, see our CER guidance document.

What if my project is completed prior to the expiry date?

Upon project completion, the researcher(s) must submit a Study Closure Form, summarizing the project outcomes. Study Closure Forms are submitted as ‘sub-forms’ in WREM.

Can I make any changes to my project after my REB application has been approved?

If any changes are needed to the approved project or accompanying study documents, then the PI can submit an Amendment via WREM (i.e., ‘create sub-form') to obtain approval of the required modifications, including the justification for the changes and all new/revised corresponding materials. Approval of the Amendment is required before any changes can be put into action, however you can continue with your currently approved study activities/documents. More information on Amendments can be found on our Post-Approval Events page (https://www.uwo.ca/research/ethics/human/Resources/Post-Approval%20Events.html).

What is a Reportable Event, and when do I need to submit one?

A Reportable Event is any unforeseen and problematic occurrence during the course of a research project. Reportable Events include privacy breaches, participant complaints, protocol deviations or violations, and serious adverse events (i.e., when a participant experiences a study-related harm). Further information on protocol deviations and adverse events can be found here: Reportable Events are submitted to the REB for review in order to determine what, if any, corrective actions are needed. More information on Reportable Events can be found on our Post-Approval Events page (https://www.uwo.ca/research/ethics/human/Resources/Post-Approval%20Events.html).

How do I create a Sub-Form (CER, Amendment, Reportable event or Closure) in WREM?

To create a Sub-Form you will need to go into the application in WREM and click on the “Create Sub-form” button on the left side of your study screen when in the Initial Application is selected in the project tree. If you would like to watch our Creating a Sub-form training video please go to our WesternREM (WREM) page for our training videos and quick guides. https://www.uwo.ca/research/ethics/human/WesternREM.html

Where can I find Educational Materials?

Ongoing training sessions will be available on our Workshops and Seminars page as well as some materials from previous educational sessions (https://www.uwo.ca/research/ethics/human/workshops/index.html). Training manuals and videos for how to use our WREM system are available on our WesternREM page under Training Materials (https://www.uwo.ca/research/ethics/human/WesternREM.html). Our guidance documents and templates are located on our Guidelines and templates page (https://www.uwo.ca/research/ethics/human/board_guidelines.html).

What happens if a team member who is Project Owner leaves without transferring ownership?

The human research ethics team will be able to go into the file to assist you with this at the request of the Principle Investigator of the study. Please contact our office for assistance at wrem@uwo.ca.

How do I remove a study team member from the WREM application?

Due to the system set-up study team members cannot be removed from Q1.4 (initial application) or Q1.7 (amendment form). The REB recommends doing either of the following: 1. If a new study team member will be joining the team in place of one that is leaving …. search for new person in place of old. 2. If a study team member is leaving without a new ...remove the old team member’s access re: roles and collaborators. To remove them from your team list you will need to take the individual who is listed at the bottom of your team list and search for them over the individual who has left the team. Then you can remove the duplicate individual at the bottom of your team list by clicking that there are no other team members above them.

How do I change my account information in the WREM system?

If you are updating your personal information in the WREM system you can click on your name in the top navigation bar and select Personal Details from the dropdown options. From here you will be able to update your profile (name and contact information). If you need to change your email address you will need to contact our office at wrem@uwo.ca. An email address can only be entered into the system once and cannot be changed back once updated. Do not submit a new account request to update your email address as we cannot link the 2 accounts together.

I have questions about ReDA or LORA, who do I contact?

If you have any questions about the ReDA or LORA systems please contact Lawson at lawsonapproval@LawsonResearch.Com. You will also need to contact Lawson to gain access to their systems.