Frequently Asked Questions

An ethics application must be submitted for review by the REB on UBC RISe.

To login and access RISe from an existing account, please go to rise.ubc.ca.

To create a new RISe account, please visit rise.ubc.ca/accessing-rise for more information.

The RISe Sandbox allows you to log onto the RISe System, create applications, familiarize yourself with the different roles and practice using RISe functions and features without the worries of making a mistake on a LIVE System.

Please visit the UBC RISe Sandbox here: rise.ubc.ca/content/welcome-rise-sandbox

Under your PI & Staff role, click on the Human Ethics button located under the heading “I would like to create a new application for…” on the left-hand side of your “My Home” page.

Please contact the RISe administrator by emailing the following agency/sponsor information to risesupport@ors.ubc.ca: 

• Full Official Sponsor Name
• Address
• Site URL
   

Provisos are questions or requests from the REB to the PI regarding the application. The application cannot be approved until all the provisos have been addressed.

You can submit a “Completion of Study” by clicking the “New Post-Approval Activity” button on the Study Homepage (under the heading, I would like to create …). After clicking on it a window will pop up with a list of PAA options. Choose “Completion of Clinical Study” or “Completion of Behavioural Study” and complete the coversheet. Once the REB has reviewed your Completion of Study they will terminate your ethics approval and your application will be filed under your “Inactive” tab.

Please use the following tool to determine if your project requires ethics oversight: arecci.albertainnovates.ca

If your project falls under QI/QA, it does not need to be reviewed by the REB. Please reach out to the PHC Information Access and Privacy Office for assistance with QA/QI projects.

For further assistance, please forward ARECCI results and a one-page summary of your project protocol to the PHC REBA.

If you are a UBC student, put your Faculty Advisor as the Principal Investigator. If you are a student from another university doing your research at UBC or one of the affiliated teaching hospitals, your research supervisor on site should be entered on the form as the Principal Investigator.

The Principal Investigator (PI) for a study is responsible for adhering to the TCPS and other relevant guidelines, and indicates this by clicking “OK” in the Submit Activity view on the application homepage. Based on security in the RISe system, only the PI listed in Question 1.1 on the application has access to this Submit Activity on the application homepage. The PI’s signature attests to the following:

By signing below, I certify that I have read this application together with its attachments and that all information provided herein is accurate and complete.

UBC Faculty: The Principal Investigator must have a Faculty Appointment (e.g. Assistant Professor, Associate Professor, Professor, or Emeritus Professor). This includes Clinical Faculty appointments in the Faculty of Medicine.

Hospital Employees: The UBC Research Ethics Boards also review research carried out at affiliated teaching hospitals by employees who do not have Faculty appointments and who are not UBC students. In this case, if the employee holds a supervisor status or higher they should be listed as the Principal Investigator and the employee’s Hospital Department Head should sign the application. If the Hospital employee does not have PI status but holds the appropriate appointment from the Hospital please contact the PHCRI Ethics Office for access.

Course Instructors: Course instructors who are applying for research ethics approval for course-based assignments in subjects they are teaching (e.g., research methods courses) can be listed as a PI on their application, even if they do not hold a regular faculty appointment. Please contact the PHCRI Ethics Office if you are submitting a class project and require the capacity to list yourself as a PI on the application.

Behavioural studies:

• Behavioural and social sciences projects study the relationship between people and their surroundings, including how people interact with each other, their communities, and institutional systems.
• These include research involving interviews, observations, and the administration of questionnaires or tests.
• Behavioural and social sciences studies can be about health and include health care providers and patients, where the goal is not to modify direct patient clinical care (i.e., do not involve diagnosis, medication, or treatment).

Clinical studies:

• Clinical research evaluates the effects of one or more health-related interventions on health outcomes.
• These include research involving surgery, the administration of drugs, medical imaging or other diagnostic techniques, biopsies, the taking of blood or other specimens, the review of clinical medical records, and any invasive procedure.

Reach out to the REB in advance of submission if you have any questions about which study type should be selected in Box 4.1. The application questions are populated based on the response in Box 4.1 and, if answered incorrectly, you may need to start a new application.

A research protocol must be submitted for all research applications regardless of the type of study. These must be submitted as separate documents attached to box 9.1 of the RISe application form.

Protocols must include the following components:

1. A background literature review (with accompanying references) that includes an explanation of the need/justification for the study.
2. The study purpose
3. Hypotheses
4. Objectives
5. Specification of endpoints/outcomes (if applicable)
6. Research design including statistical analysis plan (if applicable) and
7. Detailed research procedures

The requirement for a research protocol is a UBC-wide REB policy. Your application will be sent back, and approval delayed, if a protocol is not submitted with your application.

Minimal risk is defined in the TCPS 2 as follows: if potential participants can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the participants in those aspects of their everyday life that relate to the research.

Examples include:

• Studies using previously collected data from existing documents, records or charts (generally "retrospective chart reviews").
• Studies that involve only questionnaires or surveys.
• Observational research on standard treatments where the treatments are determined clinically and not assigned by research methodology (e.g. randomization).

Please note that if your study is funded or supported by the US Federal government or is subject to the US FDA regulations, additional requirements apply.

For more information, please see UBC CREB Guidance Note 5.

In clinical research, peer review is required when a protocol:

1. Is above minimal risk; AND
2. Has not undergone prior peer review (e.g., by a funding agency or other peer review mechanism).
   *Most industry-sponsored clinical trials will not require a separate independent peer review.

The peer review template can be found here.

Data Transfer Agreements (DTAs) and Material Transfer Agreements are used to transfer data/samples between UBC/PHC and a party outside of the institution.

Please access the DTA template here.

Note that if your study also requires a contract or funding agreement, this would supersede the need for a DTA/MTA (in most cases).

Full board applications:

• Studies that are above minimal risk require full board review.
• The application is submitted first to your department head for approval. We highly recommend that applications are submitted at least 3 business days before the submission deadlines.
• Applications received after noon on the submission deadline will be rescheduled for the next available meeting.
• Please see the meeting dates here

Minimal risk applications:

• There are no submission deadlines for projects qualifying for minimal risk review criteria. Applications enter a queue and are reviewed based on: a) order of receipt and, b) quality* of the application.
• Note that the RISe system sends an automated message to the research project principal investigator and primary contact indicating a "virtual" meeting date for the review. It does not necessarily mean that the application will be reviewed on that specific date.
• Typically, the REB reviews minimal risk applications within two weeks of the virtual meeting date but this can vary.

*In terms of quality: Applications that do not meet minimum standards for ethics review (i.e., missing or contradictory information, containing too many errors, not utilizing the local consent templates, etc.) will be returned to you “changes required” prior to review.

UBC and PHC have standard consent templates. Please see below and keep the following in mind when writing consent forms:

• ICFs should be written in lay language
• Required/standard wording should be included verbatim
• Do not try to write from scratch

Please access the clinical consent form template here

The TCPS2, Article 3.7A, states the REB may approve research without requiring the participant's consent if all of the following apply:

1. the research involves no more than minimal risk to the participants;
2. the lack of the participant's consent is unlikely to adversely affect the welfare of the participant;
3. it is impossible or impracticable to carry out the research and to answer the research question properly, given the research design, if the prior consent of the participant is required;
4. whenever possible and appropriate, after participation, or at a later time during the study, participants will be debriefed and provided with additional pertinent information in accordance with the TCPS 2, Articles 3.2 and 3.4, at which point they will have the opportunity to refuse consent in accordance with the TCPS 2, Article 3.1; and
5. the research does not involve a therapeutic intervention, or other clinical or diagnostic interventions. (TCPS2, Article 3.7.)

Please note – if your chart review involves prospective data collection, consent must be obtained.

More information regarding alterations to consent requirements can be found in Guidance Note 14.

ClinicalTrials.gov is one of the clinical trial registries of federally and privately supported clinical trials conducted in the United States and around the world that is accepted by the International Medical Committee of Journal Editors. A list of additional acceptable registries is located at ICJME.

• clinicaltrials.gov
• icmje.org

Clinical trials must be registered if your study results are to be published and this must be done before the research starts. The registration number is entered directly into your application (Box 7.11.B).

Please follow these steps to register your clinical trial and contacts for the relevant administrator for UBC.

For studies regulated by Health Canada:
As of 2022, Health Canada has reduced the period for keeping clinical trial records from 25 years to 15 years.

For studies not regulated by Health Canada:
As per UBC’s policy #SC6, original data for any given study must be retained in the unit of origin for at least five years after the work is published or otherwise presented.

A Certificate of Research Ethics Approval will be valid for no longer than a one-year term. This means that, at a minimum, approved studies must be re-reviewed on or before the one-year anniversary date of the previous REB review.

Ideally, the REB office should receive the submission at least six weeks before the expiry date of the most recent Certificate of Approval. If an annual renewal requires full board approval (if the study is US-regulated, for example), the Investigator is responsible for ensuring that the application is submitted by the appropriate REB meeting deadline.

Requests for annual renewal must be submitted via the PAA – Annual Renewal form in RISe. UBC Guidance Notes for Annual Renewals can be found here.

Researchers are required to submit proposed changes to previously approved research projects to the REB for approval. ALL changes must be submitted prior to the changes being implemented. Some exceptions apply, for example to eliminate an immediate hazard to subjects.

These must be submitted via the PAA – Amendments to Study form in RISe. UBC Guidance Notes for Amendments can be found here.

The Request for Acknowledgement Form should be submitted in any instance where the Investigator or the Sponsor requires an acknowledgement that the REB has received specific information.

These situations include, but are not limited to:

• Protocol Deviations
• Safety letters (provided that they do not meet the criteria for an SAE)
• DSMB reports
• Summary Reports
• Unanticipated Issues
• Unanticipated problems
• New Information
• Studies on hold, off hold
• Studies closed to accrual/enrollment

Please note: Requests for Acknowledgement do not allow access to edit the application. An Acknowledgement Letter will be issued for this. UBC Guidance Notes for Requests for Acknowledgments can be found here.

It is the responsibility of the Principal Investigator to notify the REB of all protocol deviations that:

1. Expose subjects to potential increased risk;
2. Compromise the integrity of the entire study;
3. Are repetitive in nature
4. Alter subject eligibility, or
5. Affect the privacy of the subject.

These must be submitted via the PAA – Request for Acknowledgment form in RISe. UBC Guidance Notes for Protocol Deviations can be found here.

Changes in REB approved documents must be submitted to the REB for review as a study amendment.

Please follow the steps below when updated Section 9:

1. Track all changes made to documents (in Microsoft Word, this can be done by selecting “Review” then “Track Changes”).
2. Delete outdated versions.
3. Upload the updated version of each document with the changes track (clean versions are not required).

Please ensure that version numbers and version dates are consistent.

Amendments can be submitted for ethics review prior to Health Canada NOL receipt.

However, please note that approval will not be granted until the NOL is attached to Box 9.1.B and Box 7.9 is updated with the new control number.

Please see our list here.

Note: If you cannot find a contact for a specific department/clinic, please contact the department directly or email REBA. Approvals should be signed by the patient care managers.

There is a list of hospital approval forms on our website here.

If you cannot see a form for the specific department or clinic, please use our PHC Program Utilization Form.

Yes, as per the PHC IAPO, permission to access medical records for research purposes is required from the relevant department/ clinic.

This is a requirement for all PHC, VCH and UBC team members listed on page 1 of your application. It is simply a one page read with a checkbox.

REBA does not need copies of completed forms.

No. This needs to be received/ finalized BEFORE we can issue approval.

You can find this under your study’s homepage on the UBC RISe under correspondence and it will also be emailed to you when issued.

Please send them to Paula Piper.

Do not attach them to your application in RISe.

No, at PHC, we do not require renewal of Institutional Approval (Ethics Only).

Please submit an amendment and add PHC as a site to your RISe application (Ensure Sections 4, 5 (if recruiting) and 11 are completed).

Once your PAA has been approved, REBA will be notified and contact you on what is required for Institutional Approval.