Guidance Note on Harmonized Studies

The following guidance is provided for the harmonization of studies involving multiple institutions or organizations.

If you wish to search for a specific term in the page, please first expand all of the content.     Open All  

I Background and Purpose

UBC’s Policy 89 “Research Involving Human Participants” Article 5 now permits the University to enter into Ethics Review Agreements with other research institutions or organizations.  Such agreements allow for alternative models for ethics review with the express purpose of facilitating collaborative research projects involving researchers, data or participants from more than one institution, and in order to avoid a duplication of efforts with respect to research ethics reviews.

As of the date of this guidance, UBC has entered into written agreements with: Simon Fraser University, University of Alberta, University of Northern British Columbia, University of Saskatchewan and the University of Victoria. 

UBC has agreed to facilitate the initial review and approval of studies that have already been reviewed and approved by an authorized board of an Institution with which UBC has an Ethics Review Agreement.  It has revised its ethics review forms to allow researchers who apply for approval in these circumstances, to complete a truncated initial application form, and by revising its review processes to provide for a facilitated review of the study that at least initially, relies upon the ethics review information received from the other REB, and that will generally entail no more than a delegated review of the study, even in circumstances where the study is considered to be above minimal risk.  

The harmonized review process for multi-jurisdictional studies assumes that prior to the submission of the First Initial Review Application the Researchers are aware that the study is a multi-jurisdictional study involving institutions with which UBC has an Ethics Review Agreement.  It also assumes that if there is more than one investigator conducting the multi-jurisdictional study at various sites, that the Investigation team has selected one researcher to be the Lead Investigator for the study.

Note: The Ethics Review Agreements anticipate the implementation of a harmonized process for review and approval of post-approval activities and it is hoped that this can be achieved very shortly, but particularly for out-of-province studies there are some legislative restrictions.  Accordingly, implementation of a post-approval process is not covered in this version of this Guidance at this time.

Note:  This Guidance and the harmonized process for ethical review do not apply to studies that are being conducted at more than one UBC site.  In accordance with UBC’s One Board of Record agreement, studies conducted by the same researcher at more than one University site, or the same study conducted by different researchers at more than one University site require only one UBC REB approval and the approving UBC Board is the Board of Record for all post-approval activities related to such studies. 

II Definitions

Ethics Review Agreement: means an agreement between UBC and another research institution or organization that authorizes an alternative model or models for ethics review of human participant research.

Ethics Review Information: means all documentation created in the course of an initial review of an ethics application by an Initial Review REB, including but not limited to the initial application form, the correspondence between the REB and the researcher, all informed consent/ assent forms, surveys, questionnaires, peer review documents and any documentation deemed relevant to the study and required to be reviewed by an Initial Review REB.

First Initial Review Application:  means the first initial application for ethical review and approval of a multi-jurisdictional study submitted by a Lead Investigator to any of the sites where the research is going to be conducted.

Initial Review REB: means an REB authorized by UBC or by an Institution with which UBC has entered into an Ethics Review Agreement to conduct independent review of research conducted under its auspices, that amongst all of the Institutional REBs required to review the multi-jurisdictional study, conducts the first initial ethical review of and issues the first initial certificate of approval for such study.

Lead Investigator:  means the only Investigator conducting the multi-jurisdictional study at various sites (sole Lead Investigator) or the Investigator chosen from amongst numerous Investigators from various sites to lead the multi-jurisdictional study.   For funded studies, the Lead Investigator will generally be the Investigator whose Institution holds the grant funding.

Multi-jurisdictional study: means a research study requiring review by more than one Institutional REB in accordance with the Institution’s institutional policies, and including the requirements of the TCPS2. 

Note:  This Guidance and the harmonized process for ethical review apply only to multi-jurisdictional studies involving institutions with which UBC has an Ethics Review Agreement. 

III Process for Researchers

First Initial Application review process
(i) The Lead Investigator must submit the first initial review application for the multi-jurisdictional study to his or her home institution’s REB (i.e. the REB for the Institution with which the Lead Investigator has his or her primary affiliation).

(ii) If the Lead Investigator is a UBC faculty member, the First Initial Application for Review must be submitted using the UBC ethics on-line application and procedure via RISe. If the Lead Investigator is not a UBC faculty member, he/she should submit the first initial review application to his / her home REB in accordance with that Institution’s REBs process for harmonized review.

(iii) In View 1.8 (project nickname) the Investigator must include “Harmonized Review Project” in the first part of the study nickname.

(vi) In View 4.6  the Investigator should check “yes” to the question of whether or not the study is a multi-jurisdictional study.

(v) The RISe smart form will direct the Investigator to either View E or View F. In View E.1/F.2 the Investigator should check “yes” this is the first initial application for review of the multi-jurisdictional study at any of the sites.

(vi) In View E.2/F.3, the Investigator should check “yes” to the question of whether or not he/she is the Lead Investigator.  At this point, the Investigator will be directed to View 5 and will be required to complete the entire UBC ethics review application in accordance with UBC’s normal process. 

(vii) In View 9.8.A (clinical form)/View 9.7.A (behavioural form), the investigator should append a word document that indicates which other organizations with which UBC has an Ethics Review Agreement are also participating in the multi-jurisdictional study, and if / as applicable, the investigator should provide the names and affiliations of the other investigators at the other sites.

(viii) A UBC Certificate of Approval will be issued when all conditions have been satisfactorily met, and there will be a reference to the fact that this study was reviewed in accordance with the harmonized review process on the Certificate of Approval.

Subsequent Application Review Process
Note: This process applies to multi-jurisdictional studies where review and approval by an Initial Review REB has been completed. 

(i) The sole Lead Investigator, or the UBC “non-lead” Investigator should submit for UBC approval via UBC’s on-line RISe application system.  If the Investigator is the sole Lead Investigator conducting the study at various sites, he/she should contact REB administration to determine which board to submit to, and to obtain a campus-wide log-in which will allow him / her to access RISe.  Contact information for UBC’s REBs can be found here

(ii) In View 1.8 the Investigator should provide a nickname for the study that includes “Harmonized Review Project” in the first part of the nickname.

(iii) In View 4.6, the Investigator should check “yes” to the question of whether or not the study is a multi-jurisdictional study.

(iv) The RISe smart form will direct the Investigator to View E.  In View E.1, the Investigator should check “no” this is not the first initial application for review of the multi-jurisdictional study.

(v) In View E.2/F.3. the Investigator should indicate whether or not he/she is the Lead Investigator for the multi-jurisdictional study.  UBC “non-lead” investigators should check “no”.  Sole Lead Investigators from other Institutions should check “yes”.

(vi)  For UBC “non-lead investigators” The UBC RISe smart form will truncate to View 9 and the Investigator will be  requested to append all Ethics Review Information (see definition) to View 9.8.A (clinical form)/9.7.A (behavioural form).  UBC “non-lead” investigators should also append UBC specific documents, such as UBC informed consent / assent forms, recruitment letters etc., to the other relevant views in 9. 

(vii)  Sole Lead Investigators from other institutions will be directed to View E.3/F.4 and asked to confirm which institution with which UBC has an Ethics Review Agreement is their home institution (i.e. which Institution’s REB provided the First Initial Review and approval.)  The sole Lead Investigator will then be directed to View 9, and requested to append all Ethics Review Information (see definition) to View 9.8.A (clinical form)/9.7.A (behavioural form), and also to append, as applicable, UBC specific documents.
 
Post Approval Activities
As indicated in the Background and Purpose section, efforts are being undertaken to develop and implement a harmonized process for post-approval activities related to multi-jurisdictional studies.  Researchers will be notified as soon as these processes are in place.

IV Submissions to Other Partner Institutions

As indicated in the discussion of the First Initial Application Review process, all Lead Investigators must submit the First Initial Review application to their home institution.  If you are a UBC researcher who is a sole Lead Investigator requesting subsequent review and approval at a partner institution, you should contact the external Institutional REB administration for guidance. 

If you are a UBC Lead Investigator who has been chosen as the Lead Investigator from amongst multiple sites where the study is conducted, once you have received a Certificate of Approval for the  First Initial Review of the multi-jurisdictional study, you should notify all other Investigators at all relevant sites that UBC approval has been obtained, provide them with all REB Review Information (see definition) and request that they submit for “subsequent” ethical review to their respective institutions, in accordance with their harmonized review process. 

A list of the contact information for the partner Institutions follows:

Simon Fraser University 
Dina Shafey, Associate Director, Research Ethics
Phone: 778-782-9631   E-mail: Dina_shafey@sfu.ca

University of Alberta
Kim Kordov, Research Ethics Officer, Research Ethics
Phone:  780-492-2615  E-mail: kim.kordov@ualberta.ca

University of Northern British Columbia
Isobel Hartley, Research Ethics Officer
Phone: 250-960-6735  E-mail: isobel.hartley@unbc.ca
        
University of Saskatchewan
Beryl Radcliffe Ethics Facilitator (Behavioural)
Phone: 306-966-2084  E-Mail: beryl.radcliffe@usask.ca

Bonnie Korthuis, Ethics Facilitator (Biomedical)
Phone: 306-966-4053 E-Mail: bonnie.korthuis@usask.ca

University of Victoria
Eugenie Lam, Human Research Ethics Coordinator
Phone: 250-472-5202   E-mail: hrethics@uvic.ca