Conjoint Health Research Ethics Board (CHREB) (2024)

Q: How do I know if my project requires human ethics review?

A: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 contactchreb@ucalgary.ca

Q: What are the deadlines for submissions to the CHREB?

A:You may submit your application to the CHREB at any time via IRISS. All applications undergo an administrative check prior to going in the queue to be sent out for review. Once your file has been received, feedback regarding any ethical issues of your application will be logged and sent to you via IRISS.

Q: How long does it take for an application to be reviewed and receive approval?

A:The level of review (delegated or full board) depends on the context of the study and the risk of the proposed research. 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 Board and the researcher. Please contactchreb@ucalgary.cafor assistance with your application.

Q: Colleagues have suggested I needed CHREB review/approval for work I've already done. What now?

A: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

Q: When is ethics approval required for the use of cell lines?

A: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 reviewisrequired. 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 reviewisrequired. Only the cell lines that have been generated from an anonymous donor areexemptfrom REB review.

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

A: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.

Q: Is research ethics review required for writing up a case report or case series?

A: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.

Q: I do not deal with patients. I work in labs on human biologic samples. Do I need ethics approval?

A: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)

Q: I am a care provider for patients. Can I go through their charts whenever it might be useful?

A:The Health Information Act outlines conditions under which personal health information can be accessed. You can go through a patient’s chart without consent only if:

1. it is to provide that patient with health care OR
2. to undertake quality assurance work outside the context of research OR
3. both the CHREB has granted a waiver of consent for actual or potential research and the custodian of the records gives you access.

In advance of a study application, researchers may need to review charts to see if their site would be eligible/if they have sufficient subject numbers. In these situations, please contact Alberta Health Services (AHS) Research Facilitation for more information.

Q: On what grounds does the CHREB grant a waiver of consent to access personal health information?

A:The CHREB can grant waivers of consent on the grounds specified under theHealth Information Act(section 50) that it isunreasonable, impractical or not feasible to obtain consent. Given the study will involve accessing/collecting health information from patients, the study team must provide a justification for the waiver of consent within the context of the proposed research.

Someexamples include (but are not exhaustive):

• large sample size or geographic range wouldmake obtaining consent impractical
• mortality/morbidity in the target population is likely which makes obtaining consent not feasible (please provide examples/rates of mortality)
• contact details are no longer valid given passage of time makingconsent not feasible (please provide dates)

Q: CHREB granted a waiver of consent to review health information, but the custodian won't give access.

A:REB approval and Researcher/Custodian Agreements are distinct.While an REB might grant ethics approval for access of health records custodians are under no obligation to disclose those records Health Information Act, Section 53(1).

Q: What is the difference between delegated and full board review?

A: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 and Delegated Review:

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.

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 riskresearch 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 consideredgreater than minimal riskwhen 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.

Q: Does my funding need to be approved before I apply for ethics approval?

A: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)

Q: I will be collecting data by electronic questionnaires and surveys. Do I need written consent?

A: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.”

Q: The participant had signed the consent form without a witness being present.

A:The CHREB adheres to ICH-GCP guidelines, which state the following:

4.8.8 Prior to a subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject’s legally acceptable representative, and by the person who conducted the informed consent discussion.

4.8.9 If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject’s legally acceptable representative, and after the subject or the subject’s legally acceptable representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject’s legally acceptable representative, and that informed consent was freely given by the subject or the subject’s legally acceptable representative.

Q: Who can act as an interpreter for a potential participant?

A:Besides the obvious requirements about language/sign language/communication capacity, any competent adult may act as interpreter. Most teaching hospitals have access to a wide range of qualified interpreter services and you may be able to access these if you have any concerns about whether the potential subject will be given full information.

Q: A participant was enrolled as a minor with paediatric consent. They are about to turn 18.

A:Consent is an ongoing, proactive, voluntary engagement (Article 3.3, TCPS2). So when the young person reaches the age of majority you do need their personal consent. All information gained under the paediatric consent will remain in the study, but gathering further information or continuing to store identifiable biosamples for future research does require the new adult’s consent.

Q. Do I "re-consent" participants if a sponsor changes protocol due to newly identified risks?

A.The participants do need to be told of new information about risks, even ifthey have finished the active intervention phase. It may be more appropriate to prepare an information update (consent addendum) rather than a full “re-consent”.

Q. What if a participant refuses to "re-consent" when asked to do so by the sponsor?

A.A sponsor mayaskto “re-consent” participants in the study because of editorial and administrative changes in the consent form.If a local participant refuses to do so and wants to stay in the study, referencing their prior givenconsent, you cangive the participant a copy of the revised consent form, confirm orally that they do understand and do wish to remain in the study, make a written note in your records and keep them in the study.

Q. Is my project Quality Assurance/Quality Improvement/Program Evaluation or research?

A.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

Q. When can my study be closed?

A.A study can only be closed when ALL data collection procedureshave 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.

Q: Where can I find resources or get help with IRISS?

A.You can visit the IRISS webpage for resources and additional links:IRISS webpage

If you have an ethics-related question, please contact chreb@ucalgary.ca.