As per TCPS Article 2.1, the following requires ethics review and approval by an REB before the research commences:

1. Research involving living human participants
2. Research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

Where "research" is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. This includes pilot studies (Article 6.11). The term “disciplined inquiry” refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.

What requires review depends on the exact context of your research. Distinguishing what requires review can sometimes appear difficult or confusing to researchers. When in doubt, please contact either CFREB or CHREB for clarification.

TCPS2 statement
TCPS2 Interpretations
TCPS2 Ethics Framework
TCPS2 - CFREB exemptions

If you are an external researcher wishing to recruit UCalgary faculty, staff, or students for a low-risk survey/questionnaire study, and:

1. you do not have a UCalgary collaborator on your project, and
2. you would like to have UCalgary Staff/Resources distribute a survey invitation, and
3. your institution is the only site conducting the study, and
4. no funding will be held by the University.

Survey Questions for External Researchers

Self-study done for the purpose of research, as defined in the TCPS 2, and involving human participants falls within the scope of TCPS 2, and requires REB review (Application of Article 2.1). 

Self-study typically involves a scholarly reflection on one’s own experiences in a particular context. Self-study may involve narratives, reflections and/or analyses of experiences based on the researcher’s observations of, interactions with, or information about other individuals or communities. In self-study, at least the researcher is a research participant. 

The requirement under TCPS2 is that consent be documented. Deviations from the usual practice of signed consent are acceptable in certain contexts (Article 3.12). You should provide potential participants with an information screen that includes the key headings of the informed consent template (e.g., a description of what you are doing, why and what the survey/questionnaire will cover, and privacy and security provisions in place). 

Submission of the questionnaire by the participant is then construed as “implied consent.”

Even if you don’t work directly with patients, REB review and approval is required for research involving human participants and research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. 

This applies to materials derived from living and deceased individuals (TCPS2 Article 2.1)

Declaration of Helsinki
Nuremberg Code
Belmont Report

Code of Conduct
Conflict of Interest
Policy on Data Retention
File Sharing and Collaboration
Security Classification Standard
Research Integrity

IRISS (Institutional Research Information Services Solution) is an online system that manages all human ethics and animal care protocols for the University of Calgary Researchers.

IRISS Resources
Update the Study Team in a particular study New
Establishing a Proxy for a Principal Investigator 
Manage My Funding 
Expired Ethics Certification

The Indigenous Research Support Team (IRST) assists and strengthens Indigenous-related research capacity at the University of Calgary.

Visit IRST

The REB Exchange (REBX) streamlines the ethics application process for multi-site research.

Researchers conducting multi-site research in Alberta, can now submit using the streamlined REB Exchange (REBX) process within IRISS. Resources and user guides are available on the REBX website.

Visit: REBX
Read: Single Ethics Board Review for Minimal Risk Research TCPS 2 (2022)

The Knowledge to Impact team supports collaborative efforts to maximize and recognize positive impacts of research for the benefit of our local, national and international communities.

Visit: KI webpages

When submitting to the CHREB, all funding must be in place (when applicable), before researchers apply for ethics. 

If funding is pending, the ethics application will only move forward if the researchers assure that the study will take place regardless of whether or not funding is received. If the study is unfunded, but there are costs associated with the study, the PI must indicate how these costs will be covered (e.g. personal funds, department funds).

Proportionate Approach to Research Ethics Review:

“The selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review) (TCPS 2010, Article 6.12).

Full Board 

The default review process is full review where a protocol is brought to a monthly REB meeting and reviewed by the entire board. The committee may decide, based on its deliberations, to approve the research, disallow the research, request further information or clarification from the researcher, or request changes. The researcher’s response to clarifications and revisions may be reviewed either by the Chair, or the committee may request to see the changes at their next meeting.

Delegated Review:

A delegated review only applies to research that is determined minimal risk and involves the REB delegating research ethics review to an individual from the REB membership or a subcommittee of the Board. Determining the level of review (full board or delegated review) involves an evaluation of the risk of the project.

Minimal risk (single ethics review)

Minimal risk research is defined as “research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by the participant in those aspects of her or her everyday life that relate to the research” (TCPS 2010, p 23). Research is considered greater than minimal risk when the risks from the research are greater than participants would experience in their everyday life. The context of everyday life the key consideration but is very context specific.

View: Single Ethics Board Review for Minimal Risk Research 

Research and working with participants can sometimes be an unpredictable process. The type of risks can vary depending on the work proposed but it is recommended that applicants to have some resources identified even if the potential for risks is very low.

In all types of research, mental health and wellness resources can be provided to participants to mitigate harm alongside professional on-site resources as necessary. If you are unsure of what resources to provide participants, below are comprehensive lists of on- and off-campus resources. 

Using these specific resources is not a requirement but are simply suggested starting point. If you know of other local or culturally relevant resources that would better meet the needs of your participants, please be sure to include in your ethics application.

On-campus resources
Off-campus resources

Transcription tools approved for studies involving human participants can be found in the Libraries & Cultural Resources page.

The Biosafety Program applies to all persons directing or involved in the handling or storage of biohazards for research and teaching purposes. Biohazards include, but are not limited to: infectious material (e.g. bacteria, viruses, fungi, cell lines, blood, prions, animal pathogens, aquatic animal pathogens, vector-borne pathogens and plant pests, and microbial toxins (e.g. botulinum toxin, cholera toxin and diphtheria toxin)).

The University of Calgary’s Biosafety Program is designed to promote and monitor compliance with acts, regulations, directives, standards, and guidelines published by the Public Health Agency of Canada (PHAC), the Canadian Food Inspection Agency (CFIA), provincial regulators, and other parties with oversight over biosafety and biosecurity.

Please visit the Environment, Health and Safety website for complete details.

Contact
The Biosafety Program is located within Environmental Health and Safety.

Questions relating to biohazards can be directed to:
Dr. Eoin O'Grady, University Biosafety Officer
biosafety.officer@ucalgary.ca or (403) 220-7509

Go to Environment, Health and Safety

Researchers may find themselves using or being near sources of radiation that are potentially hazardous. Environmental Health and Safety (EHS) is responsible for providing training and information on the unique hazards from the types of sources and each form of radiation. 

There is a registration and inspection process in place to ensure compliance with safety requirements for the radiation emitting devices.

Examples of radiation emitting devices:  

• Diagnostic or therapeutic x-ray equipment
• Computed tomography equipment
• Diffraction and analysis x-ray equipment
• Cabinet x-ray equipment
• Baggage inspection x-ray equipment
• Security x-ray equipment
• Irradiation x-ray equipment
• Class 3b and 4 lasers

There is a list of radioisotope safety training courses available. Please consider reviewing the University's Radiation Safety Manual.

Contact
The Radiation Safety Program is located within Environmental Health and Safety.

For more information or for answers to specific questions, please contact:
EHS at radsafe@ucalgary.ca.

Calgary Board of Education (CBE) Research

Modifications vs. New Application 

CFREB | Preparing a Certification Renewal Request

CHREB | Annual Renewal Guidelines

ALL | Expired Ethics Certification

CFREB

Local SAEs are adverse events experienced by research participants at the site(s) under the jurisdiction of the REB. A local SAE is reportable if the Principal Investigator (PI) believes it is an unanticipated problem related to the research, and places research participants or others at a greater risk of harm.

• Complete the Local SAE Report when the local SAE meets the definition of an unanticipated problem.
• Local SAEs that are fatal or life-threatening must be reported within 7 calendar days of the PI becoming aware of them. All other local SAEs must be reported to the CFREB within 15 calendar days of the PI becoming aware of them.
• Receipt by the CFREB will be acknowledged
• PI will be contacted if more information/action is required

See: Local SAE report

CHREB 

Local SAEs are adverse events experienced by research participants at the site(s) under the jurisdiction of the REB. A local SAE is reportable if the Principal Investigator (PI) believes it is an unanticipated problem in accordance with, Canadian Association of Research Ethics Boards (CAREB) standards, that is, it is unexpected, related or possibly related to the research, and places research participants or others at a greater risk of harm.

• Complete the Local SAE Report when the local SAE meets the definition of an unanticipated problem.
• Local SAEs that are fatal or life-threatening must be reported within 7 calendar days of the PI becoming aware of them. All other local SAEs must be reported to the CHREB within 15 calendar days of the PI becoming aware of them.
• Receipt by the CHREB will be acknowledged
• PI will be contacted if more information/action is required

Non-local SAEs are adverse events experienced by research participants at centres/institutions outside the REB’s jurisdiction. A non-local SAE is reportable if the PI believes it is an unanticipated problem in accordance with Canadian Association of Research Ethics Boards (CAREB) standards, that is, any incidents, experiences, or outcomes that are unexpected, related or possibly related to the research, and places research participants or others at a greater risk of harm.

• The FDA and OHRP advise (under HHS regulations at 45 CFR part 46) that it is neither useful nor necessary for reports of individual adverse events occurring in research participants enrolled in multi-centre studies to be distributed routinely to investigators at all centres conducting the research or to the REB overseeing those centres. Individual adverse events should only be reported to investigators and REBs at all institutions when a determination has been made that the events meet the criteria for an unanticipated problem (i.e. related/possibly related and unexpected) and place research participants at greater risk of harm.
• There is no Health Canada regulation for reporting non-local adverse events to the REB.
• Complete the Non-Local SAE Report when the non-local SAE meets the definition of an unanticipated problem (related/possibly related and unexpected)
• Non-Local SAEs must be reported within 15 calendar days of the sponsor becoming aware of them.
• Receipt by the CHREB will be acknowledged
• PI will be contacted if more information/action is required

CFREB

Protocol Violation/Deviations are departures from the procedures set forth in the CFREB approved application.  These include departures that:

• Compromise the scientific integrity of the study, and/or 
• Constitute or may constitute a potential safety risk to participants enrolled in the protocol or others affected by the research, and/or 
• Are non-compliant with applicable regulations governing human research, and/or 
• Are non-compliant with the requirements or determinations of the CFREB, or an allegation of such non-compliance, and/or 
• Consist of any unauthorized collection, use, or disclosure of participant personal information* 
  • Complete the Protocol Violation/Deviation Report when the protocol violation/deviation meets one or more of the above criteria. 
  • PI will be contacted if more information/action is required Receipt by the CFREB will be acknowledged 
  • Changes to eliminate immediate safety risks to the study participants should be reported within 7 calendar days, all other violations should be reported within 15 calendar days of the PI becoming aware of the deviation/violation

CHREB

Protocol Violation/Deviations are departures from the procedures set forth in the CHREB approved application.  These include departures that:

• Compromise the scientific integrity of the study, and/or
• Constitute or may constitute a potential safety risk to participants enrolled in the protocol or others affected by the research, and/or
• Are non-compliant with applicable regulations governing human research, and/or
• Are non-compliant with the requirements or determinations of the CHREB, or an allegation of such non-compliance, and/or
• Consist of any unauthorized collection, use, or disclosure of participant personal information*
  • Complete the Protocol Violation/Deviation Report when the protocol violation/deviation meets one or more of the above criteria.
  • PI will be contacted if more information/action is required
  • Receipt by the CHREB will be acknowledged
  • Changes to eliminate immediate safety risks to the study participants  should be reported within 7 calendar days, all other violations should be reported within 15 calendar days of the PI becoming aware of the deviation/violation

*The University of Calgary also has specific procedures for responding to a privacy breach. This states that researchers are directed to report the breach to the Access and Privacy Coordinator. 

CFREB

Follow-up reports are requested by the CFREB if/when more information becomes available, and/or if the issue remained unresolved in the initial report.

• Follow up reports may be required after the initial submission of an SAE, Protocol Deviation/Violation, Audit, Suspension or Participant Complaint 
• Upload a new copy of the relevant form (i.e. SAE, Protocol Deviation/Violation, Audit, Suspension or Participant Complaint) containing the follow-up information 
• Receipt by the CFREB will be acknowledged 
• PI will be contacted if more information/action is required.

CHREB

Report submissions may include, but are not limited to, written reports or memorandums from study monitors or sponsors, such as:

• A safety report
• Data Safety Monitoring Board reports (DSMB)
• Data Monitoring Committee (DMC) reports
• SUSARs
• Quarterly Summary Reports (QSR)
• Blind Line Listings (BLL)
• Annual Progress Reports (APRs)
• Safety alert notifications
• Memorandums

Upload a copy of the report; there is no CHREB form to complete. Reports should be submitted within 15 calendar days of the PI receiving the report. Follow-up reports are requested by the CHREB if/when more information becomes available, and/or if the issue remained unresolved in the initial report. 

• Follow up reports may be required after the initial submission of an SAE, Protocol Deviation/Violation, Audit, Suspension or Participant Complaint
• Upload a new copy of the relevant form (i.e. SAE, Protocol Deviation/Violation, Audit, Suspension or Participant Complaint) containing the follow-up information
• Receipt by the CHREB will be acknowledged
• PI will be contacted if more information/action is required.

Suspension of active and ongoing research by the sponsor, PI, REB or institution. This report is to capture suspended studies that have been approved by the REB.

Complete the Suspension Report Receipt by the REB will be acknowledged PI will be contacted if more information/action is required.

Complaints made by participants or others affected by the research concerning their well-being (psychological or physical) and/or respectful and fair treatment from the researchers. Participant complaints should be submitted for review as soon as possible.

• Complete the Participant Complaint Report
• Receipt by the CFREB will be acknowledged
• PI will be contacted if more information/action is required

Participant Complaint Report

CHREB
Audit, inspection, or inquiry by a university, provincial or federal agency. Only reports with information relevant to the CHREB should be submitted.

• Upload a copy of the audit; there is no CHREB form to complete
• Audits should be submitted within 15 calendar days of the PI receiving the audit or inspection report
• Receipt by the CHREB will be acknowledged
• The PI will be contacted if more information/action is required

CFREB

A study can only be closed when ALL data collection procedures have been completed. If there is a possibility that you will need to have any future interaction, further data collection or follow-up with participants you will need an active ethics application. You can close your study once you are sure that all interaction with participants has ended.

Grant Funded Studies: Ethics applications associated with grant-funded studies can be closed if the data collection activities are complete. If you still have an active grant, please email rescompl@ucalgary.ca to remove the ethics certificate from your grant (please include the project number in your email).

CHREB

A study can only be closed when ALL data collection procedures have been completed. Studies that have completed subject recruitment [i.e. closed to accrual] are not considered closed if data related to the subjects are still being collected.

These types of data collection activities can include the following:  

1. post-treatment contact with research subjects; for example, when data is collected via imaging reports, blood analysis reports, etc. and incorporated into the research study database. 
2. indirect collection of data for follow up purposes after the study intervention is completed; for example, quality of life/late side effects/survival data. 

If the study is funded or supported by the US Federal Government (NIH, etc.) it cannot be considered closed until all follow up of subjects is final AND there is no further data analysis involving individually identifiable information.

Grant Funded Studies: Your study can still be closed, even if you still have an active grant. Closing your research study will not close your project account.  

Please note that a study closure should not be submitted to the CHREB until all participant-related expenses in the project have been submitted.

CFREB | Consent Template
CFREB | Confidentiality Form for Transcription Services Template

CFREB | Application Process 
CFREB | New Certification Checklist
CFREB | Tips to Level Up Your Ethics Application
CFREB | Guidance on Research Ethics and Research Agreements  New May 2024
CFREB | Guidance on Preventing Fraudulent Participants  New March 2024
CFREB | Guidelines on Email Security and FAQ
CFREB | SoTL Guidelines for Research, Program Evaluation and Quality Improvement 
CFREB | Guidance for Survey and Questionnaire Research 
CFREB | Guidelines for Modifications vs. New Applications 

REB review is not required if your creative practice activities:

• Do not include interacting with participants to obtain responses that will later be analyzed to an answer a research question, or
• Do not include collecting any materials created by or involving any participants that will be used as research data

As per article 2.6 of the TCPS2, Creative Practice refers to a process through which an artist makes or interprets works of art and can include a study of the work of art generation process. Some common examples include and are not limited to public displays of art work, dance, plays, photography, etc.

What requires review depends on the exact context of your research. Distinguishing what requires review can sometimes appear difficult or confusing to researchers. When in doubt, please contact cfreb@ucalgary.ca

Research, quality assurance (QA), and quality improvement (QI) are all systematic investigations that involve data, use scientific methods, and can be broadly considered science. 

Examples of research can include, but are not limited to, projects funded through the SoTL teaching and learning grants stream or other research streams, and graduate and undergraduate theses. Examples of quality assurance and quality improvement projects include curriculum review, and program and course innovation. Depending on the intentions, scope, data collected, and plans for dissemination, many projects could fall into one or more of these categories. 

Unsure where your project stands? Please see the following assessment tool.

As of May 1, 2020, the Faculty of Arts no longer reviews ethics applications for course-based research. They are now reviewed by the CFREB through IRISS.

If you are the instructor of a course in which students conduct research involving human participants, a course-based application must be submitted in IRISS prior to the commencement of the research. Please note that the CFREB is now placing a submission deadline 3 weeks prior to the start of the semester for Course-based Research applications. Please note that if an application is submitted after this deadline, there is no guarantee that your application will be approved in time for your students to conduct their course-based research.

Instructors that do not yet have IRISS access should visit ucalgary.ca/iriss

For additional information, please review the CFREBs guidance document for course-based instructors or contact cfreb@ucalgary.ca.

View Infographic

Budget Summary - for unfunded studies; studies without detailed Grant or Sponsor budget
Department Approval Form – Faculty of Kinesiology 
Department Approval
Common Rule Consent form Requirements 
Consent to Contact Template
CHREB Standard Consent Template
CHREB Clinical Trial or Interventional Study Consent Template 
CHREB Surrogate Consent and Regained Capacity Consent Template 
CHREB Pediatric (Parental) Consent Template REVISED June 2024
CHREB Assent Template
CHREB Assent form for Younger Children (7-10) Template
CHREB Consent Addendum Template
CHREB Implied Consent Template
CHREB Oral Consent Script Template
CHREB Debriefing Sheet Template
CHREB Telephone Recruitment Script Template
Clinical Trial or Interventional Study Protocol Template

Before You Submit CHREB Submission Checklist
Alberta Health Services Health System Access Resource Page
IT Access Form for AHS network account or connect care training
Cell Line Application Guidance
CIHR Best Practice for Health Research Involving Children and Adolescents
Preventing Fraudulent Participants - NEW March 2024
Modifications vs New Applications
Modification Pro-Tips
Payment of Subjects for Research Participation - REVISED May 2024
Placebo Guideline
Recruitment Guidance

Oral Consent Guidelines and COVID-19 
CHREB Guidelines - Assent, Consent & Decision Making Capacity in Minors
CHREB Guidelines - Obtaining and Documenting Consent Electronically
Health Information Act
Health Information Act guidance
Netcare Access
Consent Form Readability Resource
Consent Amendment Guideline
Common Rule Consent form Requirements
NIH Informed Consent for Secondary Research with Data and Biospecimens

Ethics approval required for the use of cell lines

To be compliant with TCPS 2, research involving cell lines requires REB review (Article 12.1). If the cell line progenitor was at some point known, or is known by the company (i.e. the line is de-identified) REB review is required. If the cell line is anonymized (i.e. irrevocably stripped of direct identifiers and a code is not kept to allow for future re-linkage) REB review is required. Only the cell lines that have been generated from an anonymous donor are exempt from REB review.

Does a cell line study require a full application in IRISS?

Yes - a full IRISS application is required for cell line studies. The application should include a description of the cell line, how it was derived (i.e., was it obtained from a company or otherwise derived?) and a statement regarding the identity of the original donor. Specifically, please state if the cell line is anonymous, or if it has been de-identified. Anonymous means there was NEVER a known identity (some commercial cell line companies retain this information and can confirm upon request), not whether or not the identity is known to the researchers. 

Writing a report of a unique or interesting clinical case would not fall within the definition of research in the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), to the extent that these reports are simply anecdotal accounts of individual cases, and not “an undertaking designed to extend knowledge through a disciplined inquiry or systematic Investigation”. They would therefore not require REB review. As indicated in the application of Article 2.1 of TCPS 2, it is the intent of the undertaking that distinguishes activities that require ethics review by an REB and those that do not.

The publication of individual case reports may however raise ethical issues, e.g. consent, privacy and confidentiality.  Please consult the REB if you have any questions or concerns in this regard.

Where however a physician is seeking to use data collected for non-research purposes (such as a collection of case reports) in order to answer a research question, this would fall within the definition of research and would require REB review. It would be considered secondary use of information not intended for research, and at that time will require REB review. TCPS 2 provides guidance regarding secondary use of identifiable information for research purposes at Articles 5.5 and 5.6.

Ethical Autoethnography: Is it Possible?
Detecting, Preventing, and Responding to “Fraudsters” in Internet Research: Ethics and Tradeoffs

All research involving human participants requires ethics review where research is understood to be an effort to produce new, generalizable knowledge. Activities exempt from ethics review include quality improvement or program evaluation initiatives, which are understood to be those things relating to the assessment, management or improvement of a local program (Article 2.5, TCPS2). Receiving a competitive research grant/award would be an indication that the project is research. Ethics approval cannot be granted for work already undertaken and there is no prohibition against publishing work that has been defined as QI.  

The guidance documents below are intended to help determine whether a project is best categorized as research or quality assurance, quality improvement, or program evaluation (QA/QI/PE). 

Please review the documents and then send an email to chreb@ucalgary.ca with a QA/QI/PE category and your ARECCI project categorization results.  An indication of support from the authorized clinic/department lead is also useful.

QA/QI/PE vs Research
Decision Tree
ARECCI

Ethics approval must be sought prior to the initiation of research involving human participants. The CHREB does not and cannot grant approval for work already undertaken. If you have any questions, please contact chreb@ucalgary.ca