Frequently Asked Questions

How do I access training for the eREB system?

To access training for the eREB system, please contact the REB office. We can provide you with guides and training videos, or help you schedule one-on-one training sessions.

Warning: The Project owner must update your project in order to submit this form?

If you see this error message, please complete the following: 1. Please have the Project Owner (The individual who started the initial eREB application) login to the eREB. 2. After selecting the project, please press UPDATE

Applying for Research Ethics Board approval

If you are planning to conduct research activities at Osler you will need to apply for Research Ethics Board (REB) review and approval prior to conducting your research study. All initial REB applications can be submitted using the eREB system. To apply for REB review, you must obtain all of the following: 1. Identify a principal investigator (PI). A PI is someone is who taking overall responsibility for the research study at Osler. You must have a staff appointment at Osler in order to act as a PI (residents, volunteers and students at Osler cannot act as a PI). 2. Ensure all individuals conducting research activities have completed the necessary training (TCPS2, GCP, Health Canada Division 5) based on the study type. 3. Obtain approval from the head/lead of the department the research study will impact. 4. Provide an REB approval letter from the lead REB site, if the research study is initiated elsewhere. 5. Complete research contract prior to conducting any research activities if the study requires one. For example, non-disclosure agreements/confidentiality agreements; clinical trial agreements; site agreements; material transfer agreements; data transfer agreements. Osler’s Research administration office facilitates the review and negotiations of all research contracts and will also ensure the contract undergoes legal review to ensure that the interests of the Institution are protected. The final agreement must be signed by an authorized signatory from Osler. A fully executed copy of the contract will be maintained by Osler. If you have any questions or require a research contract, please contact the ORIHI Research Office Research@williamoslerhs.ca 6. Submit your study in the eREB system

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

Yes, anyone with a eREB 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 (they must be provided permissions in the eREB file). These permissions are managed within the eREB 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 eREB submissions (this includes the initial main application, amendments, reportable events, annual renewal and study closure) in order for the application to be submitted to submit for review. Projects signed off and submitted by anyone other than the PI will be returned incomplete.

How do I add someone to my study team?

1. Forms can be shared with collaborators to grant them full permission to the application (ie. to read, write, share, submit, etc). These roles match the roles that are in the eREB application. Applicant Roles should be used for PIs and research team members who require full access to the application. 2. *IMPORTANT* Do not add additional individuals via ROLES until the amendment form for personnel changes has been submitted and approved. 3. After the amendment has been approved, select the ROLES button, enter the individual’s email into the “Collaborator’s email” field in the pop-up window and select either the “Principal Investigator” “Co-Investigator” or “Study Contact Person” “Study Team Member” role from the drop down menu. Then select “Share Role” to share the application. Important Note: If you are unable to locate a team member's name (i.e. PI, Co-Investigators, Study Team Members, Study Contact Person etc.) using the search function below, they do NOT have an eREB account. Please ensure that they create an account before you proceed further or you will encounter issues during the approval process.

I am not from Osler. Can I conduct research at your hospital?

You will need to have an Osler PI who has a staff appointment. This person will be solely responsible for the scientific and ethical conduct of the study at Osler.

What documents should be included with my initial eREB application submission?

All documents uploaded into the eREB will require a version number and date: Study protocol (mandatory) Research team training certificates - TCPS2, GCP, Health Canada Division 5 (mandatory) Please email WOHSREB@williamoslerhs.ca for access to training information Master linking log (if applicable) Data collection form/data abstraction form, case report forms (if applicable) Study budget (if applicable) Consent forms (if applicable) Questionnaire/survey (if applicable) Interview guide (if applicable) Recruitment material - recruitment email, scripts, posters, etc. (if applicable) Certificates of translation for translated documents (if applicable) Investigator’s brochure/product monograph/device manual (if applicable) Other REB approval letters (if applicable) Health Canada authorization - NOL, ITA, NOA, etc. (if applicable – must post-date protocol) Please refer to our forms and guidelines page for templates.https://www.williamoslerhs.ca/en/research-and-outreach/forms-and-guidelines.aspx

What is delegated review versus a full board review?

Delegated Reviews: Delegated reviews are conducted for minimal-risk, non-invasive studies (e.g. retrospective chart reviews, questionnaires or surveys, non-invasive assessments, use of tissue) and are conducted on an ongoing basis Full Board Reviews: Full board reviews are conducted for research studies that are above minimal risk (e.g. phase I-IV studies, medical devices, studies with high-risk populations, etc.). If you plan to submit a research study for full-board review, please see our REB meeting dates for submission deadlines. https://www.williamoslerhs.ca/en/research-and-outreach/research-ethics-board.aspx

Do I need Department Head sign off?

Yes, you must obtain approval from the head/lead of the department the research study will impact for your initial application. You can request for their signature in the eREB system. If you are unable to locate their name using the search function in the system, they do NOT have an eREB account. Please ensure that they create an account before you proceed further or you will encounter issues during the approval process.

Our REB application was approved via paper (legacy file). Can we now migrate to the eREB system?

Yes, teams whose REB applications were approved via the paper (legacy) system can now migrate their applications to the eREB system. This migration will streamline the process, allowing you to manage future submissions and updates through the new eREB platform. To begin migrating your legacy study, please complete a legacy study application form. Once you legacy study has been acknowledged, you can then begin to submit post-approval submissions (annual renewals, amendments etc.) through the eREB. If you require further assistance, please email WOHSREB@williamoslerhs.ca for a copy of the training guide.

How do I know if my study needs a contract?

A contract is required if: - any services or funds are incoming or outgoing to/from Osler - any information, data (e.g. video and audio or personal health information) or biological materials (e.g., blood, other bodily fluids, and/or tissues) will be sent to an external party - any research materials (e.g. animals and/or animal samples, viruses, or equipment) will be sent or received by Osler - any researcher or external party wishes to conduct a clinical study at Osler If you have any questions about research contracts, including new or existing contracts, please contact the research contracts specialist WOHSResearchContracts@williamoslerhs.ca

What training do I need to conduct research at Osler?

All individuals involved in conducting research at Osler (e.g., investigators, coordinators, students, trainees, fellows, etc.) are required to complete mandatory research training. The specific training you need will depend on the type of research you are conducting: 1. Tri-Council Policy Statement (TCPS2) – All individuals conducting research at Osler must complete this foundational training. 2. Good Clinical Practices (GCP) E6 R2 – If your research involves human participants, GCP training is required. 3. Health Canada Division 5 (HCD5) – If you are involved in Health Canada-regulated clinical drug trials at Osler, you must complete training on Part C, Division 5 of the Food and Drug Regulations. Documentation: All personnel involved in research activities must upload documentation of completed training into the eREB system. If you're unsure which training applies to your role or you require access to the trainings, please contact the Osler REB.

My study is complete. How do I close a study?

The REB considers a study to be complete (i.e., ready to be closed) when the following criteria have all been met for all Osler sites: All participant involvement is complete. All data collection is complete. All data clarification is complete. All data transfer is complete. All access to participants’ health records is complete. If your study meets all these criteria, please submit a study closure form in the eREB.

How can I withdraw a study?

If your study has not yet received REB approval, you can contact the REB directly to withdraw your study. If your study has received REB approval, you will need to submit a Study Closure Application to formally withdraw your study.

Common errors in retrospective study applications

The following are common errors to be aware of when submitting a retrospective study application: End date of data collection exceeds the date of submission to the REB (i.e. prospective data collection involved). If consent is not being obtained for secondary use of identifiable information, TCPS2 Article 5.5A criteria (a)-(f) must be satisfied. If consent is not being obtained for secondary use of identifiable human biological materials, TCPS2 Article 12.3 criteria (a)-(f) must be satisfied. The confidentiality surrounding the data is unclear or inconsistent across the application: 1. If the study data is de-identified, it means that identifiers are being collected and stored separately in a master linking log. 2. If the study data is anonymized, it means that the master linking log that was being used to link the identifiers to the rest of the study data has been destroyed. 3. If the study data is anonymous, it means that no identifiers were ever collected with the study data. 4. The protocol is lacking information: The protocol should include background and study rationale, the study purpose and hypothesis, primary and secondary outcomes, the study methods (e.g.; data collection process, data sources to be used, sample size, date range of collection, etc.), data analysis plan, data management plan (e.g.; confidentiality surrounding the data, timepoint for data anonymization, timepoint for data destruction, etc.).