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 (HREBA). Please complete this online form to request a review.
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.
Activities exempt from ethics review include quality improvement/assurance or program evaluation initiatives, which are understood to be those things relating to the assessment, management or improvement of a local program. There is no prohibition against publishing work that has been defined as QI. Please refer to this guidance document and this decision tree to help determine whether a project is best categorized as research or as Quality Assurance-Quality Improvement-Program Evaluation. A useful tool to help you determine whether a project requires ethics approval is the ARECCI screening tool.
Yes, 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).
Creating an IRISS account is very easy! Simply go to the IRISS website and click on the ‘Not Registered Yet’ button. You will fill out a short registration survey and within 24 hours you should receive e-mail confirmation that your account has been set up.
The Tri-Council Policy Statement 2 2018 (TCPS2 2018) 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 TCPS 2 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 TCPS 2 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. Good Clinical Practice 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 University 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, you want to collect data about cancers) then you must apply to the Health Research Ethics Board of Alberta (HREBA) – Cancer Committee for ethics approval.
While you will still apply via the IRISS application system, you will need to register for an IRISS account on the HREBA website. As well, you must use the HREBA-specific consent and department approval templates (instead of the CHREB templates).
Quality can make a difference. 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 Faculty signature, and then between the ethics board and the researcher once the application is submitted to CHREB or HREBA. Overall, please allow at least 4-6 weeks to complete the entire ethics approval process (NRO + CHREB/HREBA). If AHS operational approval is required as well, please allow for a few additional weeks.
Yes, all ethics applications must include CHREB’s budget summary document. If your project is self-funded, you will need to indicate this in Section 1A; also note that the project expenses you plan to incur will be provided ‘in-kind’ using your own funds (e.g. computer, gift cards, recorder.). Please delete all line items in Section 2 that do not pertain to your study.
You will need support letters to demonstrate that you have access to the participants and/or data that you want to included in your study. Support letters should be uploaded to the IRISS ethics application.
For example, if you are recruiting patients from a hospital you should have a support letter from the manager of the unit that you wish to recruit from. Another example, if you are conducting research interviews with healthcare providers at a hospital in a designated space, then you would need a support letter indicating you have permission to use the space for interviews and that the healthcare providers are allowed to participate on their work time.
If your study requires operational approval from Alberta Health Services, AHS will also require copies of these letters (the Nursing Research Office will assist you with this).
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 standard consent forms to be written at a grade 6-8 reading level. There are several free resources that you can use to check the reading level of your consent form. CHREB recommends the Hemingway App.
If you are using the Qualtrics platform in your research project to collect survey data, you may use the following information in your application and informed consent forms 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.
The security statement for this web-survey company is included in the following link:
The University of Calgary's Policies and Regulations to be considered with the use of this web-survey company is included in the following link:
Modifications, Renewals & Closures
Requests for changes to approved research need to be submitted to CHREB or HREBA prior to implementation. Changes that substantially alter the nature of an approved project may be assessed as a new research project and require a new ethics application be submitted.
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.
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.
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 the initial application. You do not need the Nursing Research Office to review any modifications, renewals, or closures. However, you are more than welcome to contact us if you need help with any of these things. We do provide support in completing these processes.
- To create a modification or closure in IRISS, simply go into your approved ethics application and click “Create a Modification” or “Request Closure”.
- To create a renewal, you will receive an e-mail directly from IRISS 30 days before your ethics certification expires. Once you receive this e-mail, you can then login to your ethics application and press the “Create a Renewal” button.
- Please note that if you have a modification created, you will NOT be able to initiate a renewal until the modification is sent and approved and vice-versa.
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.
Once you have received ethics certification from CHREB or HREBA, you may contact AHS to request operational approval for your study. Click on the button below to access the online questionnaire and a tip sheet to help you complete it correctly.
It typically takes 10 business days for AHS to process and approve 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 approval has been granted.