FAQ's
1. How do I know if the Department Head has approved the application?
2. When can I expect my application to be reviewed?
3. How do I get access to RISe?
4. Do I have to submit separate applications for different hospital sites?
5. Whom should I put as the Principal Investigator?
6. Does my Quality Improvement project require review by the REB?
7. How do I register my Clinical Trial?
8. What does the REB require for a research protocol/proposal?
9. How will I find out of my study has been approved?
Application Tips
1. Peer Review
2. United States Regulations
3. Renewals
4. Proviso/Deferral Responses
5. RISe Application Form
6. Documents
7. Version Dates
8. Data Retention
9. Study Completion
*If you have any questions about the status of your application or the process involved please contact us at the PHCRI Ethics office.
FAQ's
1. How do I know if the Department Head has approved the application?
The REB does not track the Department Review. It is the Principal Investigator's responsibility to follow-up with their Department Head to ensure the study is reviewed and approved in time for the REB deadline. In time sensitive situations, it’s best to advise your department head that the study is waiting for sign off.
You can track your submission in RISe by looking at the "Current State" of the application (located at the top left side of the study homepage. When you see the state change from "Department Review" to "REBA Screening" this indicates the REB has received the study.
2. When can I expect my application to be reviewed?
Studies requiring Full Board review:
If the application is submitted before the REB Full Board Meeting deadline then the application will be reviewed at the subsequent meeting date and correspondence from the meeting will be sent via RISe approximately 3-4 days post meeting.
Applications that are incomplete and/or require revision because necessary information has not been provided are handled by the online system in chronological order and therefore each incoming version is placed at the end of the chronological queue. Careful completion of the application is therefore highly recommended.
Minimal Risk Expedited/Delegated applications:
Expedited/Delegated reviews can take approximately 2-3 weeks. They are reviewed on a regular basis and do not have deadlines for submission. Once the application is submitted and approved by the Department Head of the PI it will be reviewed by the Ethics office and Associate Chairs of the REB.
Applicants should thoroughly familiarize themselves with the Guidance Notes for the minimal risk criteria. Studies incorrectly categorized as minimal risk by the applicant will be forwarded to the full board for review, which substantially lengthens the turnaround time.
3. How do I get access to RISe?
To login and access RISe, please click here.
4. Do I have to submit separate applications for different hospital sites?
If you are a UBC or PHC researcher who wishes to conduct research at more than one UBC-affiliated site you may submit your ethical review to any UBC-affiliated REB. We recommended that you submit to the REB most closely associated with the Institution where you hold your primary appointment. The purpose of implementing this one REB of Record is to avoid the requirement for multiple formal ethical reviews of the same research study.
Under this new policy, the UBC REB that initially reviews a research study normally becomes the REB of Record for the study, but occasionally a project is referred to another of the UBC REB’s. Once established as the REB of Record, that REB will deal with all subsequent ethical supervision of that study. This means that the investigator is only required to submit all post approval activity submissions (amendments, annual renewals, etc.) to one REB, regardless of whether or not the research is being conducted at another institution under UBC REB’s’ jurisdiction
Each REB has signed an agreement allowing approvals by one UBC-affiliated REB to be recognized by the others. Research conducted by the same PI at multiple UBC sites needs ethical approval from one UBC sanctioned REB only. For the purpose of allocating resources, most sites will require individual institutional approval.
*NOTE: UBC and Fraser Health REB have now created an affiliation agreement for minimal risk studies - click here for further details.
Affiliated UBC REB’s:
Providence Health Care Research Ethics Board (PHC REB)
Clinical Research Ethics Board (CREB)
Behavioural Research Ethics Board (BREB)
Okanagan REB
BC Cancer REB
Children & Women’s Hospital REB
5. Whom should I put as the Principal Investigator?
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.
6. Does my Quality Improvement project require ethical review?
No, provided that the project is simply quality assurance and not research. If you are uncertain whether your study requires ethical review, or can be designated as Quality Assurance, please complete the. More information is also available at Before You Apply.
7. How do I register my Clinical Trial?
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 in ICJME.
Clinical Trials must be registered if your study results are to be published and this must be done BEFORE the research starts. Protocol records for active trials should be reviewed and modified as needed every 6 months. Please click below for the steps to register your clinical trial and contacts for the relevant administrator for UBC.
8. What does the REB require for a research protocol/plan?
A complete study protocol is required for all research projects (clinical and behavioural). The REB application will not be reviewed without an appropriate protocol attached. The research proposal submitted to granting agencies may be used to meet this requirement; in this case, ensure that the appropriate section of the grant application is referenced. For all other studies, including those that are submitted for expedited review, investigators must submit a protocol that includes at a minimum, the following:
- A background literature review (with accompanying references) that includes an explanation of the need/justification for the study
- The study purpose
- Hypothesis
- Objective
- Specification of end points/outcomes (if applicable)
- Research design including statistical analysis plan (if applicable) and,
- Detailed research procedure
This document is a 'stand-alone' document that describes the study design from which related study documents are created. For example, the consent form describing the research should not contain interventions or procedures that are not described in the protocol/research proposal.
9. How will I find out if my study has been approved?
The Principal Investigator and the primary contact person listed in item 1.2 of the form will be sent an email notification. You can check the status of the study at any time by logging into the RISe system.
Application Tips
1. Peer Review
All studies which are not minimal risk should have some form of peer review attached to Box 9.8 of the RISe application form. This can be internal OR external, from an expert in the field who is at arms’ length from the study. Internal reviews could include colleagues in your Department who are not involved in your study in any way.
For graduate studies, the REB accepts the committee review of the proposal as a form of peer review. Please click here for further information.
2. United States Regulations
Investigators that receive funding for studies conducted by a U.S. government department and/or its agencies (e.g. Department of Health and Human Services (DHHS)/National Institute of Health/National Cancer Institute, Department of Defense, U.S. Army) OR are conducting studies regulated by the Food and Drug Administration are subject to the pertinent U.S. federal regulations. These are part of the Code of Federal Regulations (CFR) mandated by the United States government.
The U.S. regulations that pertain to clinical research are:
45 CFR Part 46 for all U.S. federal government funded research
21CFR Part 50 and 21CFR Part 54 for trials regulated by the FDA
3. Renewals
Please ensure that your renewal requests are submitted 2 weeks prior to your study expiry. RISe will send automatic reminders; however, it is the responsibility of the Principal Investigator to ensure his or her study does not lapse. Please also consider the following:
Studies that must comply with U.S. regulations must be submitted for full board review unless they meet the following criteria for delegated/expedited review:
- The research is (i) permanently closed to the enrollment of new subjects; and (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow up of subjects; OR
- Where no subjects have been enrolled and no additional risks have been identified; OR
- Where the remaining research activities are limited to only the analysis of already collected data.
Please keep this in mind when submitting your renewals for review; PAA’s that must go to the Full Board for approval must be submitted prior to the REB deadline.
Failure to Comply with Requirements for Annual Renewal
4. Proviso/Deferral Response
Please ensure all documents have the requested changes highlighted or tracked. Your response should also include a letter indicating the REB’s provisos and how they have been answered. This can be attached via the “Submit Changes” box when submitting the response.
5. RISe Application Form
Please ensure all boxes of the RISe application form are filled out appropriately. If there is a question that does not apply to your particular study, please fill out the box as “N/A” and clarify why that particular box does not apply.
6. Documents
All relevant study documents must be attached to page 9 of the RISe application form. Please ensure that the attached documents can be opened; if the document is password protected, please indicate the password on the RISe application form.
**PLEASE NOTE: Studies which do not have an appropriate protocol attached will be sent back to investigators.
Please click here for further information:
7. Version Dates
When uploading documents on RISe, you are prompted to enter the proper version number and date on the application form. Please ensure this date matches the date on your document; the Certificate of Approval pulls the information from page 9 of RISe. The REB is unable to issue corrected Certificates of Approval for documents with the wrong version date entered. If this occurs, you will be required to submit a PAA – Amendment to make this change.
8. Data Retention
As per UBC’s Policy #85, 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 (if the form of the data permits this, and if assurances have not been given that data would be destroyed to assure anonymity). Please indicate this will be the case in Box 8.6 of the RISe application form; this must also be stated in Box 1.5 of the PAA – Completion of Clinical Study coversheet when doing a study closure.
9. Study Completion
Annual renewal is not required if the researcher will have no further contact with subjects for the purpose of data collection or research (e.g. for follow-up or verification). Renewal is not required to analyze data or write a paper. Before the Certificate’s Expiry date declare to the REB by completing a PAA “Completion of Study” that the remaining research no longer requires certification because all data collection procedures described in the previously approved project have been completed. Article 6.14 of the TCPS states that “At minimum, continuing ethics review shall consist of an annual status report on the research, followed by an end-of-study report”.
