Human research ethics FAQ

Applications must be complete before submitting. Submitting an incomplete application will cause delays.

Incomplete refers to:

• missing appendices or uncompleted sections
• poorly written applications that don’t provide enough information on the study for review

Only course-based applications have deadlines.

Application deadlines

You can find sample forms here.

RAIS support and help

Only Human Research Ethics administrators can change the Principal Investigator (PI).

If the PI is still at UVic and available to submit the request:

1. The PI will complete the notification of change of PI form, with signatures, and submit it with the amendment request form through RAIS. 
2. Ensure that any study documents (e.g. recruitment documents, consent/assent forms) get revised to reflect the change.

If the PI is no longer at UVic and unable to submit the request: 

1. The new PI will complete the notification of change of PI form, with signatures, and email it to the HRE office.
2. Once reviewed, the HRE office will change the PI and request that the new PI submits an amendment request form through RAIS.
3. Ensure that any study documents (e.g. recruitment documents, consent/assent forms) get revised to reflect the change.

How to submit an amendment in RAIS

Once the amendment is approved, the Human Research Ethics Board (HREB) will issue a new Certificate of Approval to the new PI (faculty or faculty supervisor).

If this happens, submit an unanticipated event report through RAIS.

For BC harmonized studies, submit a request for acknowledgement on the Provincial Research Ethics Platform (PREP).

An unanticipated event:

• includes any incidents, experiences or outcomes that are not previously accounted for in the approved protocol
• places participants or others at greater risk (i.e., physical, psychological, economic, etc.) than previously anticipated

As an unanticipated event may have implications for the conduct of the study or the integrity of the research data, you should report the event to the HREB immediately.

If the incident or issue has immediate implications for participant safety, the HREB may:

• halt the research until the matter gets addressed and/or the project gets amended
• revoke ethics approval if necessary

In all cases, the HREB will work with the research team on required actions.

If you've received a grant to fund a study that needs ethics approval, you will need the approval before funds are released. If you have an existing ethics approval, we will check whether the study needs an ethics amendment or a new ethics application before the funds are released.

If you need access to funding for preparatory activities before the involvement of human participants (e.g. research design, hiring staff, consultation, travel), you can submit a request for funding release prior to human research ethics review.

Email the research finance if you have any questions.

Apply for UVic ethics approval with our bridging process when:

• you are a UVic-affiliated researcher (faculty, student or staff), coming to UVic with ethics approval from a Canadian institution* (e.g., a university, college, hospital, health region, etc.)
• you are a UVic-affiliated researcher working on a multi-jurisdictional project with ethics approval from a Canadian institution*

The bridging process is available to you when:

• data collection is ongoing and will remain the same as the approved research ethics application
• data collection is ongoing and you will be making some changes to the approved research ethics application
• data collection is complete and as a UVic researcher, you plan to analyze data and report on findings, add UVic personnel to the study team (faculty, students or staff)
• research funding will be transferred to UVic from your previous institution

Note: bridging applications are prioritized in the review queue.

*If you have a research ethics approval from a BC university or health authority, and affiliation with that institution is ongoing – i.e., you will retain adjunct or affiliate status and/or your research team member(s) remain there – then you need to submit your study through PREP (via UBC RISe), instead of through UVic-RAIS.

1. In the case of bridging applications, you can proceed with initiating a standard research ethics application via the UVic-RAIS online portal.
2. Please complete sections A: research team, B: project information and C: project funding of the application.
3. In section J: description of research project, please clarify:
   • what research activities have occurred in relation to this study
   • what research activities are ongoing (i.e., data collection)
   • what ongoing research activities are undertaken by UVic researchers
   • where data collection is taking place
4. Attach all your approved research ethics documents from the other institution, such as:
   • approved research ethics application
   • protocols
   • recruitment materials
   • consent forms
   • data collection documents
5. If you are making some changes to the approved research ethics application, use the relevant sections of the Research Ethics Application to clarify the changes.
   • include a lot of detail and refer to the relevant sections of the approved Research Ethics Application for clarity
   • attach any new/revised recruitment materials and/or consent materials for these new participants
   • for example, “The approved University of Lethbridge research ethics application (attached) includes recruiting participants in Alberta only. I will be adding to this and recruiting participants in BC.” [Describe your recruitment procedure for your new BC participants in the recruitment section]
6. The Research Ethics Application will require that you answer some questions before you submit the application.
   • please put N/A in the relevant sections or some brief information as you see fit
   • for example, “Please see attached the REB-approved documents from UofX”

Once we receive your application along with your approved documents, we will conduct a research ethics review. Bridging applications are prioritized in the review queue.

• at this time, we may have questions for you and/or points of clarification/revisions
• these are sent to you through the UVic-RAIS system as a notice of ethical review
• once all questions have been satisfactorily addressed, the HREB will approve the study and you will receive a UVic Certificate of Approval

Note: if your approval is on the UBC-RISe system, then this process can move forward without having to submit additional research ethics information. If your research ethics approval is not on UBC-RISe, then you may be able to bridge your approved research ethics application to PREP, as outlined above.

Visit Research Ethics BC for more information.

Refer to the conducting research virtually with participants guide.

1. Guidelines for Research Using Social Networking Sites from UBC's Behavioural Research Ethics Board
2. Social Media Research: A Guide to Ethics from the University of Aberdeen 

• you’ll receive an email notification if your application requires revisions prior to approval
• we will notify you via your preferred email address (set via Online tools) upon application approval

Online survey instruments based out of the US (e.g., Surveymonkey instances which are not hosted at UVic or other Canadian institutions – universities, health authorities, organizations) are subject to the US Freedom Act.

As such, there is a possibility that information collected via these surveys may be accessed, without the survey participant’s knowledge or consent, by the US government in compliance with the US Freedom Act.

For this reason, we require this information to be disclosed to research participants who will be using a US-based survey instrument during the consent process. (Preferably, this will be stated at the beginning of the questionnaire so that it is not overlooked by the participant.). Alternatively, you may choose to use a Canadian-based survey tool.

Ethical approval is not required for the initial exploratory phase(s) of a project, which may:

• involve contact with individuals or communities intended to establish research partnerships
• inform the design of a research proposal (refer to Article 6.11 in the Tri-Council Policy Statement)
• assess the feasibility of a project, identify budgets and priorities and/or plan a project grant through discussions and consultations

However, if researchers intend to (also) study project management processes that serve the purposes of project preparations and research with humans, these would require human research ethics approval before starting any activity.

For example:

• observations of stakeholders
• using notes and information gathered from planning meetings
• analyzing stakeholder conversations 

Yes, once the recruitment and data collection phase of your study is complete, you must submit the project completion form through UVic-RAIS for studies approved through UVic-RAIS. 

Do not close your research ethics protocol when:

• students (undergraduate, graduate and post-docs) have not completed their program.
  • students need to maintain research ethics approval until after successful completion of the program in the unlikely event that their committee/supervisor requires them to collect further data
• data will be shared with others, i.e., future students and collaborators (within or outside of UVic) who were not listed in the research ethics application.

When your approval is permanently closed, you must submit a new application and have it approved for further data collection and/or data sharing with future students and collaborators.

It’s not the size of the change that dictates the ethics review process. It's rather the ethical implications and risks associated with the proposed change.

Changes that substantially alter the nature of the approved research may be assessed as a new research project and require a new REB review.

Researchers should report proposed changes to approved research that affect participants at any stage of the process, including, but not limited to:

• changes to the consent form
• changes to the tasks or interventions involved in the research
• changes to measures to protect privacy and confidentiality

You should not implement any substantive change to the research without documented approval by the REB, except when necessary to eliminate an immediate risk(s) to the participants.

Email the research ethics office or call 250-572-4545 if you're unsure if an amendment is acceptable or requires a new application.

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) is the joint research ethics policy statement of the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC).

The TCPS 2:

• was published in August 1998 to promote the ethical conduct of research involving humans
• outlines standards and procedures for research involving humans
• applies to those conducting, participating in or reviewing human research in institutions funded by CIHR, NSERC or SSHRC
• requires that researchers and more than 80 affiliated institutions follow the TCPS 2 as a condition of funding