Compliance - Research with Human, Animal and Cannabis FAQs

• Research with Human Participants Compliance Specialist
• Research with Animals, Canabis, Biohazards and Dangerous Goods Compliance Specialis

Research Ethics Board (REB) approval is required when conducting research with living people, with information provided by living people or with human biological materials (from living or deceased individuals).

For the purposes of research involving humans, research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. Human participants are defined as individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research questions (TCPS article 2.1). 

Research involving humans includes conducting research, including data analysis, with information provided by human participants, regardless of whether or not that information was collected by you (for instance, it could be provided by a data custodian or shared by a research team member).  

Research Exempt from Research Ethics Board (REB) Review:

• Research does not require REB review when it relies exclusively on information that is:
  1. publicly available through a mechanism set out by legislation or regulation and that is protected by law; or
  2. in the public domain and the individuals to whom the information refers have no reasonable expectation of privacy
• REB review is not required for research involving the observation of people in public places where:
  1. it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups
  2. individuals or groups targeted for observation have no reasonable expectation of privacy; and
  3. any dissemination of research results does not allow identification of specific individuals
• REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information

• Quality assurance and quality improvement studies, program evaluation activities, performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research as defined by the Tri-Council Policy Statement and do not fall within the scope of REB review
• Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review

If you are planning to do a case study, the REB encourages you to send an email to research.ethics@uregina.ca and request a consultation, please note that the REB cannot provide Exemption Letters retroactively, it is best to reach out to us prior to any recruitment.

For more detailed information, University of Regina researchers should contact Research Ethics at  research.ethics@uregina.ca or phone (306)-585-4775. Researchers at other institutions should contact their respective Research Ethics advisors.

Maybe. Pursuant to the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (Chapter 8), the University of Regina is accountable for research conducted under its auspices no matter where the research is taking place. At University of Regina, the review process for multi-jurisdictional research will depend on the situation but in most instances the U of R REB will accept the review of other Canadian REBs. Researchers should submit an “Approved by Another Institution Application” and include all relevant review documentation from their institutional REBs review including the REB application with all relevant Notices of Ethical Review and responses, approvals and all approved documents Information on getting access to the U of R Ethics application system as an external researcher with Research Manuals with step by step instructions can be on the Ethics Forms, Policies and Guidelines page.

In the case that a U of R Faculty member, staff or student is the Principal Investigator and funding is held by the U of R the U of R REB should be the primary REB to review the study, prior to submitting to other jurisdictional REBs. Please contact your institutional REB if you are uncertain which REB you should apply to initially for multi-jurisdictional research.

The University of Regina REB has a reciprocity agreement with the Saskatchewan Health Authority REB and the Biomedical and Behavioural REBs at the University of Saskatchewan, if a study is reviewed and approved at SHA or USask REBs that review will be accepted by the University of Regina REB and vice versa but please note that the REB of Record, the REB that ought to review, is dependent on the primary affiliation of the Principal Investigator and where the funding is held. Please check with your institutional REB to assure you are applying to the appropriate REB.

Research approved by a non TCPS-bound institution - If the research has already received research ethics board approval from another institution that is not bound by the TCPS (e.g. a non-Canadian institution), the research will require U of R REB review and approval regardless of the role of the U of R researcher.

Process – Apply for U of R REB approval. All documents for multi-jurisdictional review must be submitted via our online Converis Standard Appllication process.

Step-by-Step 

• Step 1: Determine if your project requires ethics review
• Step 2: Determine risk level of your research, minimal risk or above minimal risk(TCPS 2, Article 6.12 Above Minimal Risk studies need to be submitted for review 2 weeks prior to full board meetings, only complete submissions will be added to the next REB Full Board meeting. Please see the REB meeting schedule
  
• Step 3: Submit an ethics application using the online converis ethics application system
• Step 4: Make the requested revisions as suggested by the Research Ethics Board (if necessary)
  During the ethics review process the REB will often respond to you with suggested revisions or modifications to the research protocol, consent form, recruitment protocol, etc. These revisions will need to be made and submitted for review prior to ethics approval being granted. Revisions must be submitted electronically.
• Step 5: Receive the certificate of approval and begin the project
• Approval is issued for the protocol and corresponding documents that are described in the application. Changes to any aspect of this protocol (i.e. a change in research method, recruitment of participants, participant population, consenting process, consent form, etc.) require approval from the REB prior to being implemented. An amendment form must be submitted to research.ethics@uregina.ca

It normally takes about 4 to 6 weeks to receive a response from the Research Ethics Board (REB). In most cases, your first response to a new research ethics application will be a review letter in which the REB requests further information or makes recommendations for changes.

When you respond to this initial review letter, it can take another 2 to 3 weeks, depending on REB volume at the time, to provide another REB review of your submission.  You should plan at least 8 weeks from submission to approval, and this estimate is highly variable depending on the nature of the project, the quality of the initial ethics submission and the timeliness of communication between the researcher and the REB.

After you receive REB approval, you may find that you would like to make changes to your project. If this is the case, you will need to submit an amendment request (Word Doc) to the board. Again, you should plan for about 3 weeks to have your amendment request assessed and the review to be communicated with you. Please note that complexity and extent of changes to originally approved studies may determine time to review.

NEEDS REVIEW If your research extends 12 months or more beyond the initial REB approval date, you will need to submit an annual report for continuing review. This should be submitted at least 21 days prior to the current approval’s expiry date (which will be found on your approval letter).

Please see the REB Process Flowchart

Some parts of the review process will be beyond your control. There are an increasing number of submissions, and each must be reviewed by the research ethics staff, board chair and by volunteer board members who give it careful ethical review and prepare written feedback for you. This takes time.

The best way you can contribute to a speedier review process is to submit a carefully prepared application that highlights the ethical considerations relevant to your study. You should read the application and submission instructions carefully and provide the requested information. Please note that TCPS 2 tutorial certification is required for all Principal Investigators and also for research staff that will have any form of participant interaction.

No. There is a whole chapter devoted to the consent process in the TCPS (Chapter 3). You must ensure that consent is documented (TCPS 3.12), but that documentation does not need to be a written consent form, although this format is common and appropriate in many instances.

Researchers should consider the most appropriate means of ensuring potential participants receive all the information necessary to make an informed decision about whether or not to participate in research (TCPS 3.2 details the required elements of informed consent) as well as the most appropriate way to document a participant’s consent, and describe this fully in the research ethics submission.

Sample consent forms are available in the Resources section

Yes. REB review is not required for research that relies exclusively on secondary use of anonymous information (TCPS 2.4). Anonymous information is information that never had identifiers associated with it (TCPS 5A). Although you may be receiving the information in an “anonymous” format, the fact that the data was once identifiable means that the research doesn’t qualify for an exemption from REB review according to the TCPS. Please note that a data sharing agreement may be necessary by some institutions, please check in with the Office of Research Partnerships and Innovation on how to get assistance with any agreements that may be required.

University of Regina does not have a policy on the duration of retention of research information other than to recommend data be retained for greater than 5 years. The Panel on Research Ethics offers more interpretation of this question on its website (Question 5). It is common to keep data for five years, but there is normally no requirement to do so. 

From a research ethics perspective, the most important consideration is protecting the privacy and confidentiality of research participants who have entrusted you with their information.  Sometimes, participants have no expectation of privacy, other times, there are very high expectations.  However long you propose to keep research-related information (consent forms, participant codes, video/audio tapes, survey answers, interview transcripts, datasets, biological materials, etc.), you should carefully consider how long you actually need to keep identifiable information.  Generally, more identifiable the information, the safer it is not to keep it in an identifiable form. However, there is also no requirement to destroy data after a set period of time. The TCPS states that “researchers shall provide details to the REB regarding their proposed measures for safeguarding information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal” (article 5.3). You may choose to retain research data longer term; if so, please describe the rationale, if and how the data will be anonymized or destroyed, and how appropriate security safeguards will be in place for the full life cycle of information (5.3 (e)). Please note that data retention periods should be included in consent forms, if there is potential for future use of the data for similar studies to the one where data was initially collected, researchers may want to request broad consent for the future use of the data set, please see TCPS 2 2022, Chapter 3E on what information needs to be considered in consent forms if broad consent for data or samples is requested.

After. You must have your supervisory committee approval first. Your committee may offer recommendations that will require changes to your research project. This is the project you should present to the Research Ethics Board for ethical review.

The REB recommends the use of Qualtrics or REDCap for web-based survey research. Qualtrics has been approved by Information Security at the U of R and thus recommended by the REB.

REDcap is a secure web application for building and managing online surveys and databases. The data are stored on U of R

If researchers would like to use a different survey tool, they must be mindful of the requirements to protect personally identifiable information (PII) of participants (or information, when combined with other information that could become personally identifiable). Not all surveys collect PII, but those that do must demonstrate to the REB that:

• Any PII is stored on Canadian servers. This is required to comply with the Personal Information International Disclosure Protection Act
• If the PII is not to be stored on Canadian servers, then the risks to participants of having their data stored outside of Canada (and potentially subject to access by foreign governments), must be clearly presented in the consent documents

Researchers should be able to provide the REB with the security precautions in place for web surveys not reviewed and approved by Information Security at the U of R within their REB applications in the internet section, Form Part two, relevant information should also be included in consent forms.

The University of Regina requires all research that is recruiting participants at the U of R for survey studies to submit an application to the University Survey Committee as well as assuring review by the U of R REB. It may be prudent to get U of R REB approval first to assure that the material submitted to the Survey Committee are the final approved documents. It is good to mention within the U of R REB application that once REB approval is received, an application to the University Survey committee will be made.

Yes, this change will require an amendment request (Doc). In your amended submission, the sections that may require updating include:

• 4.1 Informed Consent - Describe any changes to the consent process, such as documenting verbal consent instead of a written signature
• 5.1  Methods and Analysis -  Describe how the interviews/focus groups will be conducted remotely. Include details such as which service/software will be used, what form of recording will occur (audio only or audio and visual), what type of recording device will be used (external or software integrated)
• 6.1 Privacy and Confidentiality – Explain how the recordings will be captured and stored (encryption of audio and video data is required) as well as the plans for retention and/or destruction of the recording. If videoconferencing will be used, address measures that will be taken to ensure privacy/confidentiality. If you choose to use Zoom, refer to the guidelines
• Recruitment and Consent Materials - You may also need to update your recruitment materials if they reference in-person interviews and the consent form(s) (e.g. what you’ll be expected to do)

Sometimes as a researcher you may want to record a research session with participants, such as interviews or focus groups. Recording interviews means that personally identifiable information is being collected about a person—as their face and/or voice is personally identifying—and this enhanced risk to participants should be carefully weighed against convenience for you the researcher. If recording a research session is integral to the success of the research, U of R IT recommends the use of Microsoft Teams for this purpose.

If you do not need to record the video for the research and audio will serve the purposes for the research, it is recommended to only record the audio. Always collect as little personally identifying information as needed for the research purposes and images of a face with a voice are more personally identifying than just a voice. When collecting personally identifying information about a participant, researchers need to be in compliance with Data protection regulations in Canada such LAFOIP, PIPEDA and in Saskatchewan HIPA which regulates the use of personal health data. This means that the personally identifiable information must not be accessible outside of Canada or participants need to give informed consent for their information to be accessible outside of Canada. “Informed” consent means they are informed about the security and privacy risks. It is the researcher’s responsibility to understand those risks and communicate them clearly to the participant. Recordings taken using Microsoft Teams are securely routed and stored in Canada. ZOOM also now has servers in Canada. If you choose to use another videoconferencing tool to record research sessions (such as Skype for Business, Collaborate Ultra, etc.), you will need to learn if any of the participant data is accessible from outside of Canada at any time (e.g., if audio and video content is routed outside of Canada during recording, or when stored afterwards). If personally identifiable information is accessible outside of Canada (either with video or audio), Ensure that consent information is clear about potential security and privacy risks of any technology used.

Another option to recording using the videoconferencing tool is to record on a separate device like a hand-held recorder or smartphone app (use one that does not sync to the cloud). This way the recorded information is more secure as it is not connected to the internet.

Remember, the more sensitive the research, the more diligent you must be in ensuring rigorous privacy protection for your participants.

Note: The information provided here is correct as of September 2024. We will endeavour to keep this FAQ current. However, technology is ever changing and the FAQ will be updated accordingly.

Please send an email to research.ethics@uregina.ca if you require assistance with any aspect of the REB process. Detailed guidance notes, templates and a Converis Researchers Manual and quick sheet with FAQs and screenshots taking you through the application process step by step

University of Regina Research Ethics Boards (REBs) operate in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans - TCPS 2 (2022) and the University of Regina Policies and Procedures for Ethics in Human Research.

The following list represents a broad overview of the range of research projects or situations that would require review and approval by the REB:

• Research that will be published
• Projects where participants are from inside or outside the university
• Research that is funded or unfunded.  Funding may be internal or external
• Research that is conducted by students or faculty
• Research projects that are conducted inside or outside the institution
• Information that is collected directly from participants or from existing records not in the public domain
• Projects that are conducted in person or remotely (e.g., mail, electronic mail, fax, online video conferencing, or telephone)
• Research designs that are observational, experimental, correctional, or descriptive
• Review is still required even if a similar project has been approved elsewhere
• Pilot studies or fully developed projects undergo the same review process
• The primary goal of the research is for teaching or training purposes, or the acquisition of knowledge

All research that involves human participants requires review and approval by a Research Ethics Board (REB) in accordance with the Tri-Council Policy Statement before the research is started.

REB review and approval of the ethical acceptability of research is required prior to the start of recruitment of participants, access to data, or collection of human biological materials.

Questions? Contact the Research Ethics at 306-585-4775 or research.ethics@uregina.ca.

An Amendment Form must be completed for all revisions to your approved study including changes to research personnel (PI, sub-I, student), sponsor and/or funder, location, questionnaires, consent forms, recruitment material.

• Include any revised documents with changes tracked or highlighted, indicating the version number or date
• Changes must be submitted for approval before implementation. Amendment Form (Doc)

Your project is minimal risk if the risk of harm anticipated in the proposed research is not greater, considering probability and magnitude, than that which is ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Risks of daily life mean those risks encountered in the daily lives of the participants of the research, considering their actual life situations, as opposed to the daily life of "all persons" or of "healthy volunteers" as the case may be.

If your study is minimal risk, it will be assessed as either low, medium or high minimal risk, lowest risk studies are reviewed by the Compliance Specialist (Human Research) and the Chair, while studies assessed as medium or higher minimal risk are reviewed by two board members and the Chair.

If your study is above minimal risk, it will be reviewed by the REB at a full board meeting, and will need to be submitted by the appropriate deadlines, please see the following for our REB meeting schedule and submission deadlines

The REB requires that a closure form is submitted when the research study is completed.

A study is completed when there is no further contact between the researcher and participants.  This point might come, for example, at the end of data collection when the researcher has no intent of further contact with participants or after data analysis because some follow-up contact with participants may be needed or possible. In some cases, researchers undertake to report back to individuals, or to the community or group from whom they collected data. In these cases, contact with participants would only end once they have reported their findings in accordance with this undertaking. This would occur after data analysis, interpretation of the findings, and/or drafting of the research report.

• Clinical Trials: Once the study has been completed, the REB must be notified of the study closure. The submission should include:
  • The PI’s affirmation that participant data collection is completed
  • Total number of research participants enrolled at the local site
  • The number of Serious and Unexpected Adverse Events
  • The date of the study monitor’s final visit
  • The final disposition/storage of all research related study documents
  • The final disposition of any electronic data, and
• All Other Studies Enrolling Participants: The PI must notify the REB that the study has been completed. The submission should include:
  • The PI’s affirmation that participant data collection is completed
  • Total number of research participants enrolled
  • The final disposition/storage of all research-related study documents
  • The final disposition of any electronic data, and
  • Any other information relevant to the REB
• Studies Using Secondary Sources of Data Only:
  • The PI must notify the REB that the acquisition of data is complete
• US Federally Funded Research Studies:
  • Studies that are funded or supported by the US federal government may not be closed until analysis of all individually identifiable information is completed

Please find forms, and fill in the appropriate form and submit to research.ethics@uregina.ca. Please note that Adverse Events or Incidences should be reported to the REB as soon as possible but no later than 2 weeks post event.

The Research Ethics Board (REB) makes the final decision on exemption from research ethics review. Even if you believe your research to be exempt from research ethics review, the REB's strongly encourage you to contact the ethics office (research.ethics@uregina.ca) with a short description of your project or, fill out an ethics application, before you begin your research. This will confirm if it meets the criteria for exemption, as retroactive ethics review is not possible. If the research is deemed to be exempt, the REB will issue a letter of exemption for your records.

Please note that if you require a Letter of Exemption from the U of R REB an application will need to be submitted to determine if an exemption is required.

Human Research Ethics Approval is granted for one year, provided there is no change to the approved protocol or consent process. The initial Certificate of Approval includes the approval period the Research Ethics Board (REB) has assigned to your study. If your research is continuing past the expiry date, completed renewal applications should be submitted to the REB a minimum of 10 but not more than 30 business days prior to the study expiry date (unless special permission has been granted).

If a renewal or closure form is not submitted to the ethics office by the expiry date, a warning notice will be issued to you. After the expiry date, the research is out of compliance, and you must cease all research activities. If the REB approval lapses and you want to continue with the research, you must submit a renewal form within one month of the current expiry date.

RED Board Meetings

Please Note: The deadlines are only applicable to above minimal risk studies requiring full-board review. Minimal risk studies are processed in the order received. If you require clarification as to whether your study is above minimal risk, please see FAQ above: How Do I Assess The Risk Level of My Project?

Any University of Regina faculty, staff, or student intending to work with animals in any capacity as part of their research, teaching, program of study both on- and off-campus are required to receive approval from the President’s Committee on Animal Care before any work involving animals can be carried out.  Only those who receive approval may bring animals onto University property, including animals on display for events, involved in fieldwork off-campus and occupying University space.

All non-human, living vertebrates and any living invertebrates of the class cephalopoda, including free-living and reproducing larval forms require approval by the animal care committee.

Yes, but we will explore the best way to expedite the review.

Any University of Regina faculty, staff, or student intending to work with with cannabis must be reviewed and approved by the Cannabis Research Committee prior to obtaining cannabis or its derivatives

Cannabis is defined as "A cannabis plant, or any part of a cannabis plant, including the phytocannabinoids produced by, or found in, such a plant, regardless of whether that part has been processed or not. For clarity, this includes products containing CBD and edibles or oils.  It does not include:

•  a non-viable seed of a cannabis plant
•  a mature stalk, without any leaf, flower, seed or branch, of such a plant
•  fibre derived from a stalk referred to in item 2 (b. above)
•  the root or any part of the root of such a plant