Research Ethics Board Frequently Asked Questions

All initial REB applications can be submitted using the eREB system. Please be sure all required documentation is included in your application.

The PI must have a staff appointment at Osler. This does not include volunteers, residents and students. A PI can also support a student or resident in their research with the appropriate approval from their department or division head.

A student or resident can conduct a study at Osler if they have identified someone with an Osler staff appointment who can act as PI. The student/resident can act as a co-investigator on the study.

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.

All individuals (e.g. investigators, coordinators, students, trainees, fellows, etc.) involved in conducting research at Osler are required to complete mandatory research training. Additional training will depend on the type of research you are conducting:

• all individuals require Tri-Council Policy Statement (TCPS2) training
• if you are conducting research with human participants, Good Clinical Practices E6 R2 (GCP) training is required
• if you are involved in research activities for Health Canada-regulated clinical drug trials at Osler, you are required to undergo training in Part C, Health Canada Division 5 of the Food and Drug Regulations (HCD5)

All personnel taking part in the research study are required to submit documentation of their training.

The new study submission required documents are listed below. 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 for the appropriate application form for your submission.

Delegated reviews:

• are conducted for minimal-risk, non-invasive studies (e.g. retrospective chart reviews, questionnaires or surveys, non-invasive assessments, use of tissue)
• are conducted on an ongoing basis

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.

Studies are to be renewed annually. The study expiry date is indicated on the initial study approval letter issued by the REB or the previous annual renewal approval letter.

Please submit the annual renewal form 30 days prior to the expiration of the study. Once reviewed and approved by the REB, an official annual renewal letter will be issued with a new expiration date.

Regulated trials that are actively recruiting patients and applying for renewal will be submitted to the full board for review and approval.

Studies can be closed when all of the following are completed:

• all participant involvement
• data collection
• data verification
• transfer of data
• access to health records
• notification from the sponsor
• clinicaltrials.gov registration is updated with a summary of results

If your study was approved via the eREB, you must submit your amendment through the system through an amendment submission form.

If you have a “legacy application” (paper), you can submit your amendment via email.

To add personnel (e.g. co-investigator, research coordinator, research assistant, research volunteer/student, etc.), you need to complete and submit a change in personnel form to the REB. You will also need to submit copies of the individual's research training.

Please also submit tracked and clean copies of any documents that require administrative change (e.g. the addition of study personnel names to a consent form). If forms require changes that are not administrative (e.g. adding a section to the consent form), please submit an amendment form for these changes.

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.

REB review fees apply to all industry sponsor research conducted at Osler. Please contact the REB office by email for information on our REB review fees.

Access to shared clinical systems for research purposes is not permitted in any instance. Access to shared clinical systems relating to a patient involved in an interventional clinical trial may be permissible, only when the access is related to provision of direct patient care. For more information, please see our related Guideline on our forms and guidelines page.