Ethics & AHS Approval

Yes, the Nursing Research Office reviews all ethics applications from Nursing faculty and students before they are submitted to the Conjoint Health Research Ethics Board (CHREB) or the Health Research Ethics Board of Alberta-Cancer Committee (HREBA.CC). 

The Nursing Research Office has created ethics checklists for faculty and students to help you navigate the ethics application process. 

No. Ethics approval must be sought prior to the initiation of research involving human participants. The University’s ethics board does not and cannot grant approval for work already undertaken. Click here to learn more.

Activities exempt from ethics review include Quality Improvement (QI), Quality Assurance (QA), and Program Evaluation (PE) studies, which are understood to be those things relating to the assessment, management, or improvement of a local program. 

Learn the difference between QI/QA/PE and research studies - and whether or not ethics approval is needed before you begin your study.

Ideally, funding should be in place (when applicable) before a researcher submit their ethics application. If funding is pending, the ethics application will only move forward if the researcher assures the Research Ethics Board 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).

The Tri-Council Policy Statement 2 2022 (TCPS2 2022) contains the rules and guidelines set forth by the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council for the ethical conduct of research involving human participants and/or their data.

The TCPS2 certification is a requirement for all faculty and students who are conducting research involving human participants and/or their data. This certification must be uploaded to your individual “Researcher Profile” in IRISS prior to submitting your ethics application. The certification process involves completing the 2-3 hours TCPS2 Tutorial.

In accordance with Health Canada and FDA regulations and NIH requirements, the University of Calgary has training requirements for researchers and support staff involved in clinical research.  GCP training is required for all researchers and support staff involved in an interventional clinical research study.

(In addition, Health Canada Division 5 Training will be required for all researchers and support staff involved in a clinical research study that uses a drug as an intervention.)

The UCalgary research community is able to access GCP and Health Canada Division 5 online courses free of charge through CITI Canada.

If your project is related to cancer in any way (e.g., you are recruiting oncology patients or nurses who care for them, you want to collect data about cancers) then you must apply to the Health Research Ethics Board of Alberta Cancer Committee (HREBA.CC) for ethics approval.

While you will still submit your ethics application via IRISS, you must:

• register for an IRISS account on the HREBA website, and
• use the HREBA-specific consent and department approval templates (rather than CHREB templates).

An application that is complete, accurate, and concise may take less time because there will be less back and forth between the Nursing Research Office (NRO) and the researcher prior to obtaining the Faculty signature, and then between the ethics board and the researcher once the application is submitted to CHREB or HREBA.CC. 

Overall, please allow at least 4-6 weeks to complete the entire ethics approval process: NRO + CHREB/HREBA. (The NRO typically provides feedback within several business days of receiving the researcher's review request.)

If AHS operational approval is required as well, please allow for a few additional weeks.

Yes, all ethics applications must include a budget document which details the cost breakdown of each item.

• Funded or unfunded studies without a detailed grant or budget -- complete the CHREB budget template found on the CHREB website.
• Funded studies with a detailed grant budget, that was submitted with the grant application -- upload the detailed budget.

Yes, you will need support letters to demonstrate that you have access to the participants and/or data that you want to include in your study. Support letters should be uploaded to the IRISS ethics application (Documentation, Section 12.0).

For example, if you are recruiting patients, clients, and/or staff from a hospital or community organization, you will need a letter from the relevant manager (or other appropriate person) that documents their support for your project, pending ethics approval. 

Letters of support can be either a formal letter or an email exchange between the parties that has been captured via screenshot or as a PDF.

For research involving human participants or their data, please review the University’s data retention rules here. 

Data from human research should be retained for 5 years after study closure.* This includes identifiable information such as recordings and identifiers. Identifiable data should not be automatically removed following data collection, but rather retained as per a master list. The only time it is permissible to remove identifiable information is if a participant withdraws and asks for their data to be removed.

*Data from Health Canada-funded studies must be retained for 25 years.

Several types of consent templates are provided in the Resources (Forms and Templates) section of the CHREB website.

Informed consent forms for cancer-related research can be found on the HREBA.CC website.

Electronic documentation of consent may be used when researchers conduct the consent process with participants in person, as well as when potential participants are not physically present with the researcher during the consent process. Additional guidance can be found here.

CHREB requires consent forms to be written at a grade 8-10 reading level. CHREB recommends the Hemingway App to check the reading level of your consent form.

Yes. For more information:

• read the Chart reviews FAQ on CHREB's website, and
• review CHREB's guidance document on this topic.

If you are using the Qualtrics online platform in your research project to collect survey data, you may use the following information in your ethics application and informed consent form(s) to describe the data security and privacy protections:

The University of Calgary uses an online survey tool called Qualtrics. It is the online-website survey platform from which the ________ survey will be conducted on. As per Qualtrics’ statement and the University of Calgary's policies and regulations regarding the use of this survey tool, the end-user account is only accessed by the research team, and data is not transferred to third parties for any other purposes. This survey does not ask for personal identifiers or any information that may be used to identify participants. All data collected using the software are stored on a Canadian server.

• Qualtrics' privacy policy can be found here. 
• The security statement from Qualtrics is located here.
• UCalgary's policies and regulations related to the use of Qualtrics are found here.

Requests for changes to approved research projects need to be submitted to CHREB or HREBA.CC prior to implementation.

To create a modification in IRISS, simply go into your approved ethics application and click “Create a Modification.”

Changes that substantially alter the nature of an approved project may be assessed as a new research project and require that a new ethics application be submitted.

Ethics approval is valid for one year.  You will receive an e-mail directly from IRISS 30 days before your ethics certification expires. Once you receive this e-mail, you can log in to your ethics application and press the “Create a Renewal” button.

Guidelines regarding renewal applications in IRISS are found here. 

Ethics certifications are valid for a one year period. The onus is on the Principal Investigator (PI) to ensure studies are renewed in a timely manner.

The management of expired ethics certificates is an automated system process via IRISS. Any funding associated with expired certifications will be suspended within 30 days of an expired certificate. Please read this guidance document for more information.

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. If a study is grant funded, a completion notice should not be submitted to the ethics board until there is no active grant that requires ethics approval. 

To create a closure in IRISS, simply go into your approved ethics application and click “Request Closure”.

Updating the study team does not require an ethics modification. Simply log in to IRISS, click on your approved study, and then click on the “Update Study Team” button on the left hand side. A dialogue box will pop up for you to add or remove team members.

Ideally, you should have an ethics certificate active as long as the project is active, including when you are analyzing data or writing manuscripts.

The Nursing Research Office only reviews your initial ethics application. 

If your study will require access to any AHS health information/data, patients, staff, facilities/sites, or other resources you must request operational approval from AHS before you begin.

AHS operational approval is requested within the IRISS ethics application. See this page for full details on how to access the AHS module within IRISS. 

It typically takes 15 business days for AHS to process and approve operational access requests. However, more complex studies (e.g., requiring access to multiple sites or large datasets) may require additional time.

AHS will notify the study PI directly once operational approval has been granted.