Harmonized review guidelines
Applications for harmonized review must be submitted through the Provincial Research Ethics Platform (PREP), not UVic-RAIS. PREP is a new 2018 iteration of the well-established UBC online research ethics system called Research Information Systems (RISe). RISe and PREP refer to the same system.
Ethics harmonization in BC
Harmonization removes duplication in the ethics process and reduces researchers’ efforts and time in any of the following cross-institutional scenarios:
- research team members are distributed across institutions
- researcher(s) conducts their activities (participant recruitment, data collection, human materials collection, data storage) at partner institution(s)
- researcher(s) access student records, patient charts, human biological samples/materials etc. at partner institutions
Harmonization is not limited to health and clinical research. It is open to humanities, social science, education and all research involving human participants subject to the national research ethics policy (TCPS 2) are eligible.
The current harmonized system only applies in BC between the following partner institutions:
- BC Institute of Technology
- Camosun College
- Capilano University
- Douglas College
- Emily Carr University
- Kwantlen Polytechnic University
- Langara College
- Royal Roads University
- Simon Fraser University
- Thompson Rivers University
- UBC & UBC-Okanagan
- University of Northern BC
- University of Fraser Valley
- UVic
- Vancouver Community College
- Vancouver Island University
- Fraser Health
- Interior Health
- Island Health
- Northern Health
- First Nations Health Authority
- BC Cancer
- BC Children's & Women’s
- Provincial Health Services Agency
- Vancouver Coastal Health
Note: when researchers identify in their PREP application that a health authority and/or a clinic that is under a health authority is involved in their study, additional instructions and information from the specified health authority/authorities will appear.
FAQs
- yes, as your home academic institution, we are required to be involved
- when a UVic researcher submits a harmonized study, UVic Ethics will be involved in the process with whichever partner ethics board(s) (BC health authority/authorities or universities) you identify in the ethics application form
- this is the foundation of harmonization; a one-stop process for you, the researcher
E.g., for 1 study it might be UVic + Island Health. For another study, it might be UVic + SFU + UBC. For a large province-wide health study, it might be UVic + all the BC Health Authorities.
- remember, UVic is your home academic institution
- we have not “outsourced” ethics reviews to UBC; this would go against our own UVic research policies
- as a harmonized study, there is at least 1 other partner institution involved in your process together with UVic
- we will always be involved in the process
- UBC is providing UVic ethics (and all the partner institutions) with system use
- that use is restricted ONLY to the reviewing and approval of harmonized studies
- as a UVic researcher who is conducting a harmonized study, you are a visiting user of this system
- refer to the How to answer questions section for more information
- work with the UBC guidelines and materials as best as you can
- the contents are very helpful and reflect research ethics best practices regardless of which partner ethics board(s) UVic is involved with
- when in doubt, please try to apply UVic policies and procedures where applicable as best you can
- the UVic ethics staff will work with you to clarify what is required at any point in the process
- the results of the ethics review will outline UVic-specific requirements and directions as needed
- please refer to the How to answer questions section for more information
- regular UVic studies are submitted on UVic-RAIS
- regular means “non-harmonized” when UVic is the only BC Research Ethics Board that’s involved
- if UVic ethics receives a new harmonized ethics application on UVic-RAIS, the researcher will be re-directed to submit the application to PREP
- they will be guided and supported through the PREP process if PREP and harmonization are unfamiliar
- if a UVic-approved study began as “non-harmonized” and the researcher proposes to amend it so the study will require harmonized review, they need to contact the UVic ethics office
- such situations will be addressed on a case-by-case basis with the partner institution and researcher
When a UVic researcher (or your research colleague from a partner institution) completes specific fields in an ethics application in PREP, the study is flagged for harmonization when any of the following occur:
- team member(s) and graduate students are listed as being from partner institutions
- the sites and locations where different research activities will occur are selected from a list of partner institution(s) (e.g., university campuses, clinics, hospitals, affiliated health clinics)
- the application flags that more than one partner BC institution is involved in the study
Even when a researcher does not have knowledge about harmonization, ethics staff from all partner institutions are trained to flag studies that required a harmonized review.
UVic ethics staff are regularly on the PREP system. We also receive automatic notifications from PREP and emails from our ethics colleagues from our partner institutions.
Getting set up as a UVic researcher
To access PREP, UVic researchers with no current appointment at UBC must apply for 2 UBC accounts in the following order:
1. Apply for a UBC campus-wide log-in (CWL) account
- non-UBC affiliated individuals will create a basic CWL account
- Basic Account option must be selected on the Validate Your Identity page
- the CWL account is always created by the user and they choose their own username and password
2. Apply for a RISe account
The UBC RISe support staff will create a researcher RISe account for you. The RISe account is connected to a RISe Profile with your coordinates.
Email the following to UBC RISe support to request a RISe account:
- title (e.g., Dr., Mr., Ms, etc.)*
- full first name/middle initial/last name*
- work email address*
- work telephone number*
- rank*
- dept./UBC affiliation*
- main work location (if at hospital)
- UBC employee number (if available)
- UBC student number (if available)
- your CWL username
*Indicate your rank as a non-UBC faculty or non-UBC employee where appropriate.
Note: only UVic faculty are permitted to hold the principal investigator (PI) designation in new studies submitted to UVic ethics, including PREP. Names of UVic students and staff are to be identified by their university/institution in the Research Team section of the PREP application. See the Special Instructions section for more information.
- when an account gets created, an email with a special code is sent to the user's email
- that code and researcher number are required for the initial login to the system
- after the initial login, only your CWL is needed to login to PREP going forward
Need help when applying for RISe account? Contact UBC’s RISe Support and let them know that you are a UVic researcher for PREP.
In your RISe account work information (appointments and affiliations)
- for UVic individuals, UBC asks that you add the University of Victoria in section 1.b within your RISe profile
- also add this in section 2 under UBC dept name
- indicate your rank as non-UBC faculty or non-UBC employee where appropriate
Log in to RISe
- Go to the RISe homepage
- Log in with your CWL username and password
Helpful resources on the UBC RISe homepage
- explore the RISe sandbox
- you can create a mock application to become familiar with the application process
- review the appropriate tutorial(s) on the RISe website
- tutorials are publicly accessible
- no RISe account is needed
- read and download the extensive guidance notes available for each of the 6 UBC research ethics boards
- make use of the forms & templates available on the homepage
- take advantage of the built-in guidance notes in the PREP ethics applications when it's time to prepare an application
Submitting applications to PREP
The following section highlights some key areas that UVic researchers should be aware of when submitting applications on PREP as the PI and how to proceed/respond.
Electronic sign-off procedures
The procedures and questions in the PREP ethics application forms default to a UBC principal researcher. Electronic sign-off for ethics applications defaults to a UBC department chair, director or dean.
Do NOT choose a UBC department on the departmental approval page if you are not from UBC. UVic signatories are not programmed into the system to provide electronic sign-off. In this case, you must choose Research Ethics Board from the drop-down list.
You will still be able to submit your PREP application without the UBC electronic sign-off.
UVic signatures page for UVic PI
- when the UVic ethics board is involved in your harmonized review and a UVic faculty is the PI, you will upload the UVic signatures page with your department chair and dean’s electronic email signatures or hard copy signatures
- PREP will allow you to print a copy of your ethics application to aid your chair and dean to know about your study when they sign-off
- if you forget about the signatures page, UVic Ethics will provide you with it via email and instructions if it's not uploaded to PREP
Cross-appointments & affiliate appointments with BC partner institutions
If your primary appointment is at UVic, do not choose a UBC department to sign off.
The exception is Island Medical Program (IMP) faculty as they already use the system for UBC signatory sign-off.
How to answer questions
These refer to questions on the ethics application form that have UVic-specific considerations. Answer “N/A” when they do not apply to you at UVic.
Question 1.6 TCPS2 CORE Tutorial (Course on Research Ethics online tutorial)
This applies only to UVic graduate students for their projects, capstone projects, theses and dissertations that require ethical review.
Note: effective September 1, 2020, UVic graduate students are required to complete a national research tutorial as part of their human ethics process.
- you may upload the CORE certificate as an attachment either at the time of submitting the ethics application before review, or with your research ethics revisions/changes as instructed by the ethics board’s review
- the Harmonized Research Ethics Approval Certificate will NOT be issued to you until the CORE certificate has been provided
- as CORE is a new requirement, the UVic ethics office will advise you and your supervisor of what is needed and when
- the Course in Research Ethics (CORE) tutorial is an online course launched by the federal government’s research funding agencies in 2011
Question 2.4 A Source of Funds
Select response “Funds at other institutions” and identify UVic when funding will be held by or transferred to you as a UVic PI or a UVic Co-I.
Question 2.6 & Question 3 Conflict of interest page: if answer to 2.6 is yes
Conflict of Interest (COI) declarations are managed at UVic in faculty members’ department and not within the ethics review application process.
Question 4.1: Choose study type in PREP - behavioural research or clinical research
Choose between 2 study types (behavioural or clinical). When you make a selection, the application will automatically branch off to either the behavioural application form or the clinical application form.
Behavioural projects are those that are behavioural or social scientific in nature or involve humanities research. They may involve the study of patients or healthcare providers; however, they are not clinical and do not involve invasive procedures. They do include research involving interviews, observations and the administration of questionnaires or tests.
Clinical projects are those involving surgery, the administration of drugs, medical imaging or other diagnostic techniques, biopsies, the taking of blood or other specimens, the review of clinical medical records and any invasive procedure. A clinical research project that also includes questionnaires or interviews should be submitted as a clinical study.
You can preview both application forms from the RISe homepage. Contact UVic ethics if you need guidance about the study type.
Informed consent forms
When a UVic researcher is involved in a harmonized study, consent forms normally include the name and contact information of the ethics board that is the lead for the specific study. In some studies, contact information for more than one ethics board may be recommended.
When your study undergoes a harmonized review, you’ll get instructions and feedback from the UVic Ethics Board about ethics contact information on informed consent forms.
Please use the UVic consent form templates:
Special instructions
When a UVic student conducts research involving humans to fulfill a thesis, dissertation, project, capstone project or honors project, only UVic faculty are permitted to hold the PI designation when submitting for ethics clearance to UVic. The PI designation applies to UVic when using PREP and UVic-RAIS.
- UVic faculty supervising a UVic student in a study requiring harmonized review will need to apply for UBC-CWL and RISe access
- the names of UVic students (and UVic staff) will be identified according to their university/institution in Questions 1 to 1.6 of the PREP application: Principal Investigator & Study Team
- UVic student researchers and post-doctoral fellows cannot hold the PI title on an ethics application
- add UVic student researchers and post-doctoral fellows conducting their own project, thesis or dissertation (in Questions 1 to 1.6 3 of the PREP) to the ethics application
- in such cases, the faculty supervisor will be the PI
- the designations are for administrative purposes and do not change anyone's role in the research
Need help?
UVic ethics staff are trained as PREP administrators and have managed harmonized reviews since 2014. We work closely with the research ethics staff and boards of partner institutions.
Email us or call 250-472-4545 for questions or more information.
UVic Research Ethics Manager, Eugenie Lam is on the BC advisory for ethics harmonization. Email Eugenie or call 250-472-5202.