Questions & Answers
The mission of the REB is to evaluate the ethical acceptability of research involving humans performed under its authority or with its approval, in accordance with the core principles of the Tri-Council Policy Statement (TCPS 2). These core principles are Respect for Persons, Concern for Welfare and Justice. The REB must also monitor the research projects it approves on an ongoing basis, and play an educational role among the researchers and members of the institution it serves (TCPS 2, Chapter 6).
The TCPS 2 states: “The following requires ethics review and approval by an REB before the research commences:
- Research involving living human participants;
- 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.” (TCPS 2, Art. 2.1).
There are two possible research ethics review levels: “In keeping with 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 2, Art. 6.12).
Among other things, the REB relies on the minimal risk research criteria to determine whether a project review can be delegated (TCPS 2, Articles 2.9 and 6.12) based on the following definition: "Minimal risk research – Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects of their everyday life that relate to research." Risk is defined as “The possibility of the occurrence of harm. The level of foreseeable risk posed to participants by their involvement in research is assessed by considering the magnitude or seriousness of the harm and the probability that it will occur, whether to participants or to third parties.” (TCPS 2, Glossary).
The processing time involved in a full REB review is 6 to 8 weeks after receiving the complete proposal. The processing time for a delegated REB review is 2 to 3 weeks following receipt of the complete proposal.
If your proposal entails any risk of creating identifiable information. Bear in mind that secondary use is defined as: “The use in research of information or human biological materials originally collected for a purpose other than the current research purpose.” (TCPS 2, Glossary).
- Le chercheur doit remplir le formulaire au #6 de la section Évaluation initiale « Demande d’accès aux dossiers cliniques ou analyse secondaire de données cliniques pour un projet de recherche » du CÉR de l’Hôpital Montfort.
It all depends on whether your project might generate identifiable information. Article 2.4 of TCPS 2 states that, "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." As a precautionary measure, we suggest that you consult the REB to determine whether or not you need to submit an ethics review application.
Any secondary use of non-anonymous data or non-anonymous human biological material, whether or not they were gathered for research purposes other than those of the original project from persons, must be reviewed by the REB.
For reference, please consult the TCPS 2, specifically:
- Article 2.1.b;
- Chapter 12 provides additional information concerning research work that uses secondary human identifiable biological materials gathered previously;
- Section D, Chapter 5 lists the requirements applicable in cases where researchers intend to use series of data that include identifiable information and combine these series for research-related secondary use;
- Articles 9.20 to 9.22 concerning community engagement and individual consent for the secondary use of identifiable information and identifiable human biological materials for research.
Yes. "For research projects lasting longer than one year, researchers shall submit, at minimum, an annual report with sufficient details to enable the REB to make an informed judgement about the continued ethical acceptability of the research. For research lasting less and one year, an end-of study report may suffice." (TCPS 2, Chapter 6, Application under Article 6.14).
- Depending on your situation, please complete the form Annual report or final and completion report or a renewal research project form or final report from your institution.
A researcher who also plays another role in relation to participants in the research project that he or she is leading fills a dual role that might unduly influence participants collaborating in the research project. Examples:
- A psychologist performing research with participants who is also a therapist to the same persons;
- A researcher acting as an attending physician to these same research participants;
- A professor conducting research involving students that he/she teaches.
In the event of such a dual role, the Hôpital Montfort REB suggests drawing distinctions in the consent form submitted to participants, while describing each role. For example:
- Psychologist-researcher and clinical psychologist;
- Physician-researcher and attending physician.
Furthermore, you will have to explain how you intend to mitigate any undue influence that might result from a dual role affecting participants. For example:
- Delegate recruiting tasks to another member of the research team (for example, a research assistant);
- Explain to potential participants that their decision to participate or not will have no impact on their services, care, evaluation, etc.
► I am a principal investigator at Montfort. I have a team of collaborators, including students and a research coordinator. Do I have to inform the REB of the individuals with access to the research data?
The REB and the researcher must ensure that people with access to the data have the proper authorization. In fact, the "The ethical duty of confidentiality refers to the obligation of an individual or organization to safeguard entrusted information. The ethical duty of confidentiality includes obligations to protect information from unauthorized access, use, disclosure, modification, loss or theft […]"(TCPS 2, Chapter 5). The names of individuals with access to research data must be submitted to the REB and participants in the consent form.
- Please fill out and sign the following document, it is the #5 under ititial assessment: Confidentiality agreement concerning the protection of research data by all individuals with access to the data of a research project.
Security refers to measures used to protect information. It includes physical, administrative and technical safeguards. […]. Physical safeguards include the use of locked filing cabinets, and the location of computers containing research data away from public areas. […]Technical safeguards include use of computer passwords, firewalls, anti-virus software, encryption and other measures that protect data from unauthorized access, loss or modification." (TCPS 2, Chapter 5).
► I have already received approval from the Hôpital Montfort REB and I have started recruiting participants. My research project would be enhanced if I could produce other tests (new measurement tools, blood samples, etc.). Do I have to submit a modification request to the REB?
You need to receive ethics approval for all research project modifications, whether methodological or involving a modification of the documents transmitted to participants (recruitment brochure, consent, addition of a question to a questionnaire, etc.).
You must submit the following document to the Hôpital Montfort REB: "Amendment Request form"
- The Hôpital Montfort logo;
- The study title;
- Inclusion and exclusion criteria
- Name and contact information of the principal investigator;
- Name, contact information and title.
In coordination with the REB, your poster will be reviewed by the Montfort Communications Branch to ensure its compliance with existing policies governing posters. Once you obtain a certificate of unconditional ethics approval, the hospital’s Communications Branch will determine possible locations for your poster and the posting period with you.
No. “Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review” (TCPS 2, art. 2.5).
It can sometimes be difficult to differentiate between what constitutes a quality improvement activity and a research activity. A few questions may help you determine whether an activity concerns quality improvement or research:
Do you hope to contribute to the corpus of knowledge in a given field? Do you intend to publish your findings in a scientific journal that exclusively publishes studies authorized by a research ethics board? Would you like to see your findings generalized to other sectors? Is the activity limited to the institutional (local) level, or do you intend to develop a best practice for a broader level? Who will benefit from the activity: the institution and project participants, or a larger group of individuals? Lastly, do you have a research question or hypothesis? If you answered "yes" to any of these questions, you should probably ask the REB to review your project. In any case, we advise you to check with the Hôpital Montfort REB.
Yes. We advise you to visit the Health Canada site:
You need not wait to receive Health Canada’s No Objection Letter before submitting an ethics review request to the Hôpital Montfort REB. If you have the letter already, please include it with your request. Otherwise, you can simply provide the acknowledgement of receipt of your application to Health Canada. However, you must receive your No Objection Letter before obtaining an unconditional ethics approval certificate from Hôpital Montfort.
“Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.” (Source: ClinicalTrials.gov).
Health Canada defines natural health products in the Natural Health Products Regulations. These products are:
- Vitamins and minerals
- Herbal remedies
- Homeopathic remedies
- Traditional medicine (ex., traditional Chinese medicine)
- Other products, such as amino acids and essential fatty acids.
Natural health products must be safe to be used as over-the-counter products. Products requiring a prescription are governed by the Food and Drug Regulations.
- For more details, visit: Drugs and Health Products by Health Canada