SFU Policy R20.01 “Ethics Review of Research Involving Human Participants”, Article 20, now permits the University to accept reviews undertaken by an external REB. Where there is a formal agreement between Simon Fraser University and the other institution(s) involved, and this agreement includes a commitment to adhere to the requirements of the Tri-Council Policy Statement, 2.
Such arrangements 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, helping to avoid redundant research ethics reviews.
The SFU research community should refer to the two following processes when preparing to submit their application for research ethics review that involves multi-jurisdictional Minimal-Risk research.
1) Research Ethics BC (RE BC) and the Provincial Research Ethics Platform (PREP)
Since 2014, the following BC universities, health authorities and institutions together have created a robust harmonized review system. This enables effective ethical review of multi-jurisdictional studies that involve human research ethics clearance from more than one of the following research ethics boards (REBs):
- UBC, SFU, UNBC, UVIC
- Island Health, Vancouver Coastal, Fraser Health, Northern Health, Interior Health
- BC Cancer, Children and Women’s Hospital, Providence Health
Harmonized and harmonization refer to the process of more than one institution being involved in the ethics review of a research study that involves humans. Multi-jurisdictional research studies require this review by more than one Institutional REB, according to the Institutions’ policies, and the requirements of the TCPS2 (2014).
Benefits of PREP
If you are a researcher (faculty, student, and staff) at one of the above institutions, whose new study requires human research ethics clearance from more than one of the above REBs, benefits of the online provincial system include:
- A single research ethics application for all harmonized reviews, irrespective of which REBs are providing oversight for your study.
- An easy-to-use online interface (presently hosted at UBC).
- An interface that includes separate clinical and behavioural research ethics application forms.
- A web-based system that supports document management and certifications.
Please note: Studies that involve only SFU will continue to be submitted to SFU’s Human Ethics system
- To access PREP you need to obtain a Campus Wide Login or CWL which can be done here: https://www.rise.ubc.ca/accessing-rise
- From the same page create a Basic account for non-UBC affiliated investigators.
- Once you sign up for a Basic account, you will not be able to self-register yourself for a RISe account. You will need to contact firstname.lastname@example.org for access to RISe.
For more information and help with PREP:
- Review the appropriate tutorial(s), which are free and readily available online. These are accessible even without a RISe account.
- Once you have created a RISe account, play around in the Sandbox. This section of RISe behaves exactly like the ‘real’ thing, but allows you to create a fake application in order to become familiar with the process.
- Make use of the Forms & Templates that are readily available online. Note this link takes you to UBC informed documents.
- Take advantage of the built in Guidance Notes when it comes time to fill out an application. A recent reformatting has made the built in guidance even more user-friendly, so that help is always available at the click of a button.
If you have any questions or concerns regarding PREP as a SFU researcher please contact email@example.com
2) Previously Reviewed and Approved Minimal-Risk Research with Non RE BC Partner Organizations
If the research qualifies as Minimal-Risk research according to SFU criteria, is not a partner organization with Research Ethics BC, and it has been reviewed and approved by another Canadian research ethics board complaint with the TCPS 2, a research ethics application must still be submitted via the SFU Research Ethics Database.
1. The SFU principal investigator (PI)* of the study must submit all documents approved by the other institution (protocol, consent forms, data collection tools, other research study materials, etc.) as well as the certificate of approval from that institution.
2. The SFU PI must submit a cover letter stating what their role in the research will be. If his/her role includes recruitment of participants, or conducting any of the study procedures with participants, or, the SFU PI is the grant holder of the study or the nominated PI the following must appear on the consent forms:
- The SFU Logo, if other institutional logos appear on the consent form;
- The contact information for complaints related to the study as follows: If you have any complaints about your rights as a research participant and/or your experiences while participating in this study, you may contact Dr. Jeffrey Toward, Director, Office of Research Ethics at firstname.lastname@example.org or 778-782-6593.
If for some reason the SFU PI cannot comply with the above stipulations, the SFU PI must explain why this information cannot or should not appear on the consent form (e.g. the SFU PI and his/her research assistants, graduate students etc. will not have any direct involvement with participants and s/he is not the nominated PI for the study).
If there are no substantial issues that arise after a review of the documents submitted and point 2 has been addressed satisfactorily, then a SFU letter of approval will be issued to the PI of the study.
* The SFU PI is considered the PI for the purpose of the submission of the study, but may not be the overarching PI of the multi-jurisdictional study (e.g. the SFU PI is a co-investigator for the study, but is considered the PI for the purposes of the ethics application at SFU, because the PI of the multi-jurisdictional study is affiliated with another institution).
If you have any questions about these processes, please contact our office at email@example.com