Resources

Useful resources

The TCPS does not recommend or discourage incentives. However, justification for incentives must be included in the REB submission form section «15. IDENTIFICATION AND RECRUITMENT OF RESEARCH PARTICIPANTS» and specific information should be added to the consent form (Article 3.1 and 3.2[j]).

Draw or lottery are acceptable method of recruitment provided that the prize, irrespective of the odds of winning, is not significant enough to unduly influence participation in the study. For research involving draws, specific information must be included in the consent form as required by Ontario law, such has information on the prize(s) and its/their value, the odds of winning and the number of participants in the study. This approach must not require subjects to pay money or other valuable consideration in order to participate. In addition, to respect the law, winning the lottery must be based on skill as well as chance. Thus, lotteries require the participants to answer a skill-testing question in order to qualify for a chance to win, thus personal information (name, phone number, email, etc.) must be collected for the draw, the researcher should maintain security of this information throughout the duration of the study.

Draws are not usually appropriate for anonymous research, as they would require identification where otherwise none would be needed, and present an unfair advantage to those willing to identify themselves, versus those who do not.

Use of data bank and Human biological materials

The REB’s role is to ensure the protection of the research participant’s privacy. Note that ethical concerns regarding privacy will decrease the more difficult it will be to identify to whom the information belongs to. The constitution of a data bank for the purpose of future research raises some specific issues, thus the ethical review process will determine the level of risk for participants by evaluating the following elements:

  •  The possibility of identifying (re-identification) the participants by associating data
  • The type of the information which will be saved in the databank (with identified, coded or anonymous data)
  • The potential damage for the participants during the access, the transportation (transfer agreement), the use and the disclosure of the data
  • The authorization for secondary analyses (link with the owner/in charge of the bank) or the coupling of data with other sources (ex. another bank)
  • The retention period of the bank as well as the destruction of data and the bank
  • The procurement of an informed consent.

The REB will refuse all requests of use of these data or the biological material if the objective of the research does not respect the expressed wishes of the participants or if it does not respect the principle of human dignity. When the data of the bank is anonymous (when impossible to make identification) it is not necessary to obtain a consent form because participants can’t be identified. However this would not apply if there is coupling of data.

The REB ensures that the databanks (data and biological material) already existing are complying with the current ethical standards at the time of their constitution and as possible, with the current standards.

Creation and use of data bank and human biological materials

Here are the specific guidelines related to ethics for creating a database:

  • Data bank management framework
  • Consent form requesting permission to use data
  • Data transfer agreements if relevant

Use of data from an existing bank

Voici les lignes directrices particulières reliées à l'éthique pour l'utilisation de données d’une banque existante :

  • Ethics approval certificate of the project
  • Consent form authorizing the use of data
  • Data transfer agreements if relevant

Tools & resource

Le Cadre de gestion et l'EPTC2 chap. 5 et chap. 12. peuvent être utilisés la création d’une banque de données et l'utilisation de données d’une banque existante.

REB's Plenary Meeting Schedule

  • The REB invites researchers to submit their applications as soon as they are completed, according to the level of risk to the participantthey may qualify for delegated review does not require an evaluation at a plenary meeting.
  • The investigator or his representative must be available the morning of the day of the meeting to answer questions from REB members, if applicable.

Meetings Calendar

Submission Deadlines REB Meeting Dates 
(8:30 am – 12:00 pm)
January 8, 2025 January 22, 2025
February 5, 2025 February 26, 2025
March 5, 2024 March 26, 2025
April 2, 2025 April 23, 2025
May 7, 2025 May 28, 2025
June 4, 2025 June 25, 2025

The REO has developed templates to assist researchers in the submission process of their project for ethics review. We also encourage you to regularly visit this section of our Web site in order to use the latest approved version when you submit your project for ethical review.

Initial assessment

Forms / tools   Date de la version
1. Checklist to confirm that submission to the Research Ethics Board (REB) is complete V. June 2022
2. Application form to the Research Ethics Board, duly completed, dated and signed, or initial submission form from another REB  NEW VERSION V. Oct. 2023
3. Consent form used (see templates below)  
4. Research project suitability evaluation V. Aug. 2024
5. Confidentiality agreement V. Sept. 2020
6. Application form for clinical chart review, as applicable V. May 2017
7. Request form to waive ethics review   NEW VERSION V. June 2023

8. Billing form for clinical trials (available in French only at this time

V. Feb. 2020

 

Ongoing assessment

Forms / tools   Date de la version
1. Amendment request form (or your institution’s amendment form) V. Sept. 2020
2. Minor-amendment request form V. Sept. 2020
3. Annual renewal request form to request an annual renewal of the ethics approval V. Nov. 2019
4. Late annual form for an expired ethics certificate V. Sept. 2020
5. Final report or file closure form to submit a final report or to request a file closure V. Sept. 2020
6. Protocol deviation form V. Sept. 2020

7. Notification of an adverse event or serious adverse reaction form

V. Sept. 2020

 

Consent forms

Forms / tools   Date de la version
1. General Consent Form V. Juillet 2021
2. Use of incentives V. Avril 2017
3. Clinical Trials Consent Form V. Juillet 2021
4. Questionnaire Information Sheet V. Juillet 2021
5. Addenda to consent form SDM V. Juin 2018
6. Addenda to consent form – Contact again V. Juin 2017
7. Case Study Consent Form V. Sept. 2020

8. Form to withdraw my dat

V. Juillet 2021

 

Recruitment tools

Forms / tools   Date de la version
1. Recruitment poster with Hôpital Montfort logo V. Avril 2017
2. Recruitment poster with ISM logo V. Juin 2017
3. Recruitment script  V. Jan. 2016
4. Permission to contact template  V. Sept. 2020

5. Support letter

V. Oct. 2016

Ethical services available

Tools and information shared in this section are in compliance with current research ethics standards and practices.  In order to facilitate the ethical application process the REO has developed templates.

Ethics plays an important role in the field of research and in health. To this end, the REO is offering the following services to the researcher:

  • Support in the preparation of the ethics submission request
  • Claim to establish the current status of a project reviewed by REO
  • Consultations and interpretations of ethics research regulations
  • Send out a due date reminder to all project logged on our registry
  • Customized training

It is possible to submit a specific training request to the REO in order to meet a research team needs or your field of research.

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:

  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.” (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).

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:

  1. Article 2.1.b;
  2. Chapter 12 provides additional information concerning research work that uses secondary human identifiable biological materials gathered previously;
  3. 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;
  4. 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).

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:

  1. A psychologist performing research with participants who is also a therapist to the same persons;
  2. A researcher acting as an attending physician to these same research participants;
  3. 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:

  1. Psychologist-researcher and clinical psychologist;
  2. 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:

  1. Delegate recruiting tasks to another member of the research team (for example, a research assistant);
  2. Explain to potential participants that their decision to participate or not will have no impact on their services, care, evaluation, etc.

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 initial 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).

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

Your recruitment poster ( see templates : with Hôpital Montfort logo and with ISM logo) must include the following information:

  1. The Hôpital Montfort logo;
  2. The study title;
  3. Inclusion and exclusion criteria
  4. Name and contact information of the principal investigator;
  5. 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:

  1. Guidance Document for Clinical Trial Sponsors
  2. Overview of the Clinical Trial Application Process

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 Letterbefore 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:

  1. Vitamins and minerals
  2. Herbal remedies
  3. Homeopathic remedies
  4. Traditional medicine (ex., traditional Chinese medicine)
  5. Probiotics
  6. 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.