Skip to main content
Close

Application & Review

The REB explains how to submit a new application and manage a submission after it has been approved. It also sets out its meeting schedule (and submission deadlines) and fees. 


New applications

The Researcher Information Services system (RISe) is used for both the submission and approval process of all research ethics applications submitted to the REB (see RISe ). 

The guiding principle governing human research ethics review in Canada is the Tri-Council Policy Statement (TCPS-2).  TCPS-2 Chapter 2: Scope of Research Ethics Review defines the general categories of research that require REB review.


http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter2-chapitre2/#toc02-1a

To determine whether your study requires ethics approval Please see section 4 – Types of Research that Require Review at:

https://ethics.research.ubc.ca/ore/ubc-clinical-research-ethics-general-guidance-notes

 

TCPS2 Articles 2.2 to 2.6 describe projects that are exempt and do not require REB review such as quality assurance and quality improvement studies.

 

Please refer to section 4.4 – Activities Not Requiring Review at:

https://ethics.research.ubc.ca/ore/ubc-clinical-research-ethics-general-guidance-notes

 

Expedited (Delegated) or Full Board Review?
Expedited (Delegated) Review means a review by the Chair only and applies only to "minimal risk" projects, otherwise, full board review is required. There is no submission deadline for expedited projects. Please be sure to check the criteria for minimal risk projects and the submission deadlines and meeting dates if full board review is required. 


Min. Risk Criteria for Clinical projects:
http://research.ubc.ca/ore/ubc-clinical-research-ethics-general-guidance-notes#GN5


Min. Risk Criteria for Behavioural projects: https://ethics.research.ubc.ca/behavioural-research-ethics/breb-guidance-notes/guidance-notes-behavioural-application


 
 

‎Please see the Guidance Document for Industry and Practitioners - Special Access Programme for Drugs at:

http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/sapg3_pasg3-eng.php#a11

PI's submitting an ethics application to the BC Cancer REB must have a BC Cancer appointment and the application must be approved by a BC Cancer Department Head. 


Examples of acceptable BC Cancer appointments include but are not limited to full or part time research scientist, physician, nursing, pharmacy, patient and family services, radiation therapy, dental or nutritional consulting staff; full time residents, fellows, graduate students or other trainees enrolled in programs supervised by BC Cancer staff.

The principle is that the PI must have a sufficiently clear connection to BC Cancer that there is a reasonable assumption that the PI will feel bound by requirements placed on her or his performance of the research by BC Cancer. 

Non-BC Cancer researchers conducting research on humans, or material or information derived from identifiable humans, to be carried out ONLY at a BC Cancer facility, must designate a Principal Investigator who has a BC Cancer staff appointment (see above) and obtain ethics approval from the BC Cancer REB.

 

If the research is carried out at a BC Cancer facility and a non-BC Cancer facility, the researcher must do one of the following:

1)     Designate a Principal Investigator who has a BC Cancer staff appointment (see above) and obtain ethics approval from the BC Cancer REB.

Or

2)     Obtain ethics approval from one of the other UBC REB's (see the One Board of Record agreement below) and ensure that the BC Cancer participating sites are listed in the ethics application and that there is at least one BC Cancer co-investigator on the study.

 

One UBC Research Ethics Board of Record 

Effective March 21, 2007, the UBC Research Ethics Boards agreed that each new research study reviewed by a UBC REB should have a single REB of Record. This now includes all 6 UBC REBs.

UBC REBs

  • UBC BC Cancer Agency REB (BCCA REB)
  • UBC Children's & Women's (C&W REB)
  • UBC Providence (PHC REB),
  • UBC Clinical REB (CREB),
  • UBC Behavioural REBs (BREB)
  • UBC Okanagan BREB (BREB-O)


 

All projects require BC Cancer Department Head approval prior to the REB receiving the application.


This applies to "new projects" only (not required for post-approval activities). All new projects must be approved by a BC Cancer Department Head in the RISe system before the system will route it to the REB (the REB is not aware of an application until it receives Dept. approval in RISe). Only the PI can "submit" an application and the action will display a list of departments to select one for Dept. approval. If a UBC Department is selected, the application will be routed back to the PI as 'incorrect department approval" as this must be a BC Cancer Department. If their BC Cancer department is not listed, the PI can add it by updating their profile (by clicking on their name on the top right of their RISe homepage).


If the BC Cancer PI is also the Dept. Head then the PI should select "BCCA Administration" (the PI may need to add this Department to their profile in order to select it when they submit the application). 

 

If a BC Cancer Dept. Head or alternate reviewer is also a co-investigator, then one of the alternates who are not listed on the application should provide Dept. approval. The Dept. Head or their assistant are responsible for notifying an alternate.


 
 

All research personnel who are associated with a research project are required to complete the TCPS2 online tutorial (CORE) before the application is submitted to the REB. This includes (but is not limited to) undergraduate and graduate students, medical residents, research assistants, research coordinators and faculty, whether they are the Principal Investigator or not.

The TCPS CORE Tutorial is free and can be completed in about two hours. CORE Certificates do not need to be attached. Copies should be retained and available on request.

Click here for the TCPS2 2014 Document.
Click here for the TCPS2 'CORE' Tutorial.

This tutorial provides an essential orientation to Canadian human research ethics guidelines.


Equivalency

The CITI courses on behavioural and clinical ethics are considered equivalent to the TCPS2 tutorial:

https://www.citiprogram.org/index.cfm?pageID=14

BC Cancer does not have a centralized insitutitional approval process, and the ethics approval applies to research ethics issues only. The ethics approval does not obligate an institution or any of its departments to proceed with activation of the studyAnyone conducting research, behavioural or otherwise, at BC Cancer, must make sure they obtain approval from any BC Cancer Department whose resources are affected by the conduct of the study and to identify and ensure that institutional policies such as those related to conflict of interest and privacy protection are followed and that resource impacts from the study are properly negotiated. The Principal Investigator is responsible for identifying and meeting those requirements. 

 

Investigators conducting clinical trials involving either investigational drug(s), device(s), or natural health products formulated for therapeutic purposes OR involving a drug/device/natural health product used for an indication outside those specified in the Health Canada Drug Identification Number, Notice of Compliance or Medical Device License, must submit the appropriate application for regulatory approval to Health Canada before research can begin.

 

Although it is not necessary for the copy of the evaluation by Health Canada to be available when a research project is submitted to the BC Cancer REB, a copy of the Health Canada Approval (i.e., NOL "no objection letter") must be received by the REB before the certificate of approval is issued.

 

The above applies to subsequent amendments that require Health Canada approval and such amendments should be submitted to the REB for review by the full board.

 
 

The International Committee of Medical Journal Editors (ICMJE) now require registration for all clinical trials as defined by "Any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes".  Health related interventions include any intervention used to modify a biomedical or health-related outcome; for example, drugs, surgical procedures, devices, behavioural treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health related measures obtained in patients or participants, including pharmocokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) do not require registration".  Please also see:

https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered

The REB refers to the legal contract as a CTA. This refers to the legal contract between the Sponsor, Principal Investigator and Institution. A certificate of approval will be issued only upon receipt a completed copy of the CTA for review/approval. 

 

The BC Cancer REB will only issue the certificate of approval upon approval of the project and completion of applicable administrative requirements.
See Certificates of Approval policy 

 
 

If the study is conducted or funded by the US Department of Health and Human Services (DHHS) or is required to comply with either the US FDA or any other US regulations, this must be indicated on the application. See the right hand side of the application and the list below for further information.

 

Office of Human Research Protections(US Department of Health & Human Services)

Food and Drug Administration (FDA)

US National Cancer Institute (NCI)

National Institutes of Health (NIH)

On-Line Surveys to be conducted at a PHSA facility - please email surveys@phsa.ca prior to initiating a new survey. 

 

Submissions to the BC Cancer REB must use the BC Cancer Informed Consent Templates. The main consent should contain only the information about what is required in order for  participants to understand their involvement. 


Optional components should not be included in the main consent; instead, use the Optional Consent template.


Contact Letters, Handouts, Advertisements should be submitted as individual documents (separate from the protocol) with a version date and page numbering in the footer (page x of y). If these are BC Cancer generated, submit on BC Cancer letterhead. These will be listed on the approval certificate.

  • For all study data records that leave BC Cancer, unique independent identifying numbers such as social insurance number, telephone number, hospital or BC Cancer number must not be included. 
  • Participant's initials and full date of birth should not be used on data records that leave BC Cancer. Coded initials and partial date of birth (month/year) are acceptable.  

Post-approval

Please see  section IV– Study Amendments at:

 

https://ethics.research.ubc.ca/clinical-research-ethics/creb-guidance-notes/post-approval-guidance-notes

 

Please note that Amendments requiring REB full board review/approval must be submitted by the deadline for a full board meeting (see Meetings & Fees tab for meetings/deadlines).


Questions? email reb@bccancer.bc.ca 

Please see section III – Annual Renewals at:

 

https://ethics.research.ubc.ca/clinical-research-ethics/creb-guidance-notes/post-approval-guidance-notes

 

The pdf document below is to help determine whether full board review or expedited review of an annual renewal submission is required. This also indicates when a study no longer requires annual renewal and reporting of Serious Adverse Events (SAEs), and when a study can be considered complete (at which time a completion of study notice must be submitted to the REB in RISe).

Quick Reference Table for Annual Renewal & SAE Reporting & Completion of Study  (Oct 18, 2012)


Please note that Annual renewals requiring full board review/approval must be submitted by the deadline for a full board meeting (see Meetings & Fees tab for meetings/deadlines).

 

http://www.bccancer.bc.ca/our-research/ethics-oversight/research-ethics-board/application-review


Questions? email reb@bccancer.bc.ca 

Please see section VII – Submitting Unanticipated Problems at:

 

https://ethics.research.ubc.ca/clinical-research-ethics/creb-guidance-notes/post-approval-guidance-notes


Questions? email reb@bccancer.bc.ca  

Meetings & Fees

2018 Submission/Fee Deadlines and Meeting Dates


Month
Submission/fee Deadlines
Meeting Dates
JanuaryJan 2
Jan 23
FebruaryFeb 6
Feb 27
MarchMar 6
Mar 27
AprilApr 3
Apr 24
MayMay 1
May 22
JuneJun 5
Jun 26
JulyJul 3
Jul 24
AugustAug 7
Aug 28
SeptemberSep 4
Sep 25
OctoberOct 2
Oct 23
NovemberNov 6
Nov 27
DecemberNov 23
Dec 11

Jan 2019                  Jan 3                         Jan 22


2017 Submission Deadlines and Meeting Dates


Month
Submission Deadlines
Meeting Dates
JanuaryJan 3Jan 24
FebruaryFeb 7Feb 28
MarchMar 7Mar 28
AprilApr 4Apr 25
MayMay 2May 23
JuneJun 6Jun 27
JulyJul 4Jul 25
AugustAug 1Aug 22
SeptemberSep 5Sep 26
OctoberOct 3Oct 24
NovemberNov 7Nov 28
DecemberNov 24Dec 12

Jan 2018                  Jan 2                         Jan 23


Please note: We strictly adhere to deadlines.  


New applications 

Applications requiring full board review (e.g., new applications, deferral responses, PAAs, etc.) must be received in the REB inbox (i.e., already approved by the Department Head) prior to midnight on the deadline date to be considered for that month’s meeting. 


If applicable, the initial review fee must be submitted prior to or along with the application (see below for information on fees). Applications received after the midnight deadline or without fees will be deferred until the next month's meeting or until payment is received in full.


Please submit new applications at least 3 days prior to the deadline to allow for department head approval.

Submit minimal risk projects for delegated review  at any time (no deadline or meeting dates).


Annual Renewals

Annual Renewals requiring full board review should be submitted by the deadline date for the applicable full board meeting for review prior to the expiry date. 


Annual Renewals requiring expedited review should be submitted 2 weeks prior to expiry. 


Questions? email reb@bccancer.bc.ca 


REB Fees apply only to research that receives its funding from a for-profit entity (i.e., pharmaceutical/medical device company) or other for-profit organization.


The BC Cancer REB has two fees:  initial review fee and annual renewal fee. 

Initial Review Fee

Criteria

Effective 1 September 2015, the initial ethical review fee is $4,000 CAD (Canadian Dollars) for each new application funded by a for-profit entity, and covers the cost of the initial review of the new application (regardless of the outcome of the review).


Fees for annual renewals are separate from this initial fee (see Annual Renewal fees below).


Fee Waiver Criteria

Studies that are funded by the following are excluded from REB fees:

  1. Cooperative groups (i.e; NSABP);
    ii. National Cancer Institute of Canada Clinical Trials Group
    iii. Grant from a non-profit organization, for example, CIHR, NIH or a cancer-specific foundation
    iv. BC Cancer internal

The fee may be waived in other circumstances if requested in writing with an explanation.


Payment

As at 1 July 2015, the UBC BC Cancer REB requires payment of the initial review fee to accompany the initial application (please note that services provided by the REB commence immediately upon submission of the application).  If payment is not received, the application will not be placed on the Agenda for review at the REB meeting.  The change is implemented in order to reduce significant outstanding revenue, as well as the administrative burden associated with pursuing outstanding fees.   The PI is responsible for communicating REB fee requirements to their sponsor.


Refunds: Once the REB has commenced review processes, a refund is not available. If an application is withdrawn prior to review, a refund is only available upon request. A refund under these circumstances is not automatically issued - the Principal Investigator must notify the REB by email to request a refund and include an explanation for the withdrawal. The email must include the REB #, project title, and the details for the refund such as the BC Cancer account into which the refund should be transferred or identification of the designate to whom the cheque is to be made payable.

Annual Renewal Fee

Effective 1 September 2015, the annual renewal fee is $750 CAD (Canadian Dollars) per renewal that meets the criteria below.  NOTE:  the increase to annual renewal fees will not apply to contracts existing prior to 1 September 2015 given budgetary agreements (these will remain at $500), but will be phased in to apply to projects after 1 September 2015.


Criteria

The annual renewal fee applies to only to projects that are funded by a for-profit entity (i.e., pharmaceutical/medical devices company) or other for-profit organization that were submitted for initial ethics review on or after April 1, 2011 and are ongoing.


This fee covers the cost of the annual renewal and other ongoing oversight, including amendments and unanticipated events.


Criteria for Discontinuing the Renewal Fee


The REB will discontinue renewal fees once a study is completed and a "Completion of Study" notice is submitted in RISe and acknowledged by the REB. Until that time, an ongoing project must maintain a valid ethics approval and submit a request for renewal annually.

There are certain conditions under which the REB may waive the renewal fee for an ongoing project, therefore, when submitting a request for annual renewal it is important to clearly explain the status of the study and the status of subjects locally; and, if applicable, state what the study-specific long term follow up involves.


The REB will discontinue the renewal fee for an ongoing study where it is either clear or requested in the renewal application that the following apply:


  • study is closed to accrual, and 
  • all research related interventions are complete for all subjects except for long term follow up (as defined below), or 
  • study is limited to the analysis of data

"Long term follow-up" activities may include:

  • the collection of follow-up data to monitor for disease progression or recurrence.
  • quality of life surveys.
  • a blood draw for a small amount of blood (e.g., 30ml or two tablespoons) once or twice a year.
  • chest x-rays, abdominal ultrasounds, etc to be done, if that is the usual practice for that patient population.

The REB will consider discontinuing the fee due to other circumstances if a request with an explanation is included in the renewal application.


Questions regarding REB fees:


Please email: reb@bccancer.bc.ca 


Tab Heading
SOURCE: Application & Review ( )
Page printed: . Unofficial document if printed. Please refer to SOURCE for latest information.

Copyright © BC Cancer Agency. All Rights Reserved.

    Copyright © 2017 Provincial Health Services Authority