Human Research Ethics Applications & Procedures

 

1. Determine which of UBC’s Research Ethics Boards your research falls under

The University of British Columbia REBs include:

  • Behavioural Research Ethics Board (Behavioural Research)
  • BCCA Research Ethics Board (Behavioural and Clinical Cancer Research)
  • Clinical Research Ethics Board (Clinical Research)
  • UBC/Providence Research Ethics Board (Behavioural and Clinical Research at a Providence Health Care site )
  • UBC Okanagan Research Ethics Board (Behavioural Research conducted at the UBC Okanagan campus)
  • UBC Children’s and Women’s Health Centre Research Ethics Board (Behavioural and Clinical Research conducted at the Oak street campus)

2. Complete a REB application and update your COI declaration using the RISe system

Each new research project requires its own REB application and associated protocol. For detailed guidelines on filling out an application, see the REB Guidance Notes, the RISe tutorials, and the Guidance Note regarding the research protocol itself.

PDF reference versions of the application can be found on the RISe website BUT all applications are done online through the RISe system, these PDFs are for reference only.

You will need to have the following information to fill out an application (this is a guideline only, other information may be required):

  • PI, contact person, co-investigators and study team names (all must already have been added to the RISe system to be added to the application)
  • Study name and nickname
  • Start and end date of the study
  • Funding source details
  • Conflict of interest information
  • Peer review details (if applicable)
  • Lay summary of study and research proposal summary
  • Recruitment information (including inclusion and exclusion criteria, recruitment methods for both case and control subjects, and a summary of research procedures)
  • Subject involvement information, including numbers of subjects, risks, benefits, time commitment, and reimbursements
  • Consent form information
  • Details on experimental drugs, devices, or products use (if applicable)
  • Details on subject confidentiality, including subject data
  • Research or Clinical Trial protocol and/or proposal (see guidelines)*
  • Any documents given to the subjects (consent forms, questionnaires, recruitment information, etc)

Note: A fee of $3,000 applies for some industry-funded reviews. This will be assessed during the application process when you declare your source of funding. In a few cases (generally when the study is only partially industry-funded), an exception can be made. Contact the specific REB itself for more information.

If you are performing research at UBC, you should also have a valid Conflict of Interest declaration on file, also through the RISe system. All full-time and part-time members of faculty and staff of the University and any person (including students & visiting professors) who teaches, conducts research or works under the auspices of the University need to have an up-to-date Conflict of Interest/Conflict of Commitment declaration on file.

3. Submit your application for Department approval

When you submit your application, it will go first to the Department for approval. Please be advised that the Department can not guarantee same day approval for applications. If your application is urgent and you are aiming to get it submitted for a specific Council meeting, be sure to submit it on RISe early enough that Departmental approval can be acquired before the meeting deadline.

Departmental deadlines for approval are Thursdays at 4:00 pm. Please consult the following REB and Departmental Deadline table.

4. Modify the application as required by the Department/REB (if required)

Once you have submitted you application, any changes or amendments are submitted the same way. You should receive an email from the Department or REB when any changes, amendments, or provisos to your application are requested. Any changes in the status of your application will be marked in the Inbox section of your RISe homepage.

Note: It is very important to document the changes you make to your submission when you are responding to provisos. Highlight the altered text so that it can be clearly identified. You will also need to respond to the provisos when re-sumbmitting.  The best way to do this is to copy the (usually numbered) requests into a document, and write a short description of what you did to address the request after each one.

Example:

  • Statistical analysis mentioned in research protocol not listed in summary section 5.1.B. Please add.

Statistical analysis has been carried out as requested

  • Specifics about study methodologies not included in protocol. Please add this information

See revised protocol version 2.0 attached.

  • Recruitment poster #3 deemed inappropriate. Please replace or remove this poster.

See revised recruitment poster #3, version 2.0 attached.

This response will be included with your re-submission to detail the areas where the REB will look for changes.

You only have to change the attachments associated with revisions. If there were no comments on a particular attachment, you are able to leave it as is.

5. Once approved, print a copy of your Certificate of Approval

Approval is good for 1 year. Any deviations from the approved protocols or methods must be submitted promptly to the approving REB through the RISe system. Any changes (including annual renewal, amendments to the study, completion of the study, and Request for Acknowledgement notifications to the REB which include accidental protocol deviations, closing of studies to enrollment, new information acquired, and Serious Adverse Event reports) should be filed using the Post Approval Activity process. Each type of PAA has a specific time limit that should be followed (for example, annual renewals must be completed by a given date (usually 2 weeks before the anniversary of the original approval), SAE reports should be filed within 7 days of the event).

Assistance with Ethics Applications

If you are having trouble with your ethics application we encourage you to ask for help. There are a number of local resources which you can access:

  1. The REB staff are very friendly and accommodating and knowledgeable. If you have a specific question you may contact them by phone or by email. Details on how to contact the CREB and PHC REB are listed on their respective websites.
  2. CREB offers hands-on monthly workshops for people who are filling out their first ethics application, or would like to go through the application in detail. Workshops are listed on the Research Office website.
  3. If you are having general issues with your application, you may contact the Research Office and book a time to go over your application with the Research Manager.
  4. VCHRI currently offers ethics facilitation for VCH researchers, through the Clinical Research Unit in the Diamond Health Care Centre. Researchers should contact them directly to schedule an appointment.

Ethics Harmonization

Researchers who are carrying out studies under the jurisdiction of multiple UBC REBs need to only apply to one REB for approval.

In addition UBC REBs have a written agreement with the following:  Simon Fraser University, University of Alberta, University of Northern British Columbia, University of Saskatchewan and the University of Victoria, to reduce duplication of review efforts.

A detailed description of the current harmonization practices, policies and procedures is provided by UBC REB.

REB Contact Information:

If you have questions about your application you may contact the REB.