Respect for ethics in research is essential to the development of knowledge, to scientific innovation and to research excellence. The FRQ would like to see the entire scientific community embrace a culture of research ethics. The expected mobilization requires the integration of ethical thought at all stages of the research process.
Funding holders must comply with the ethical standards adopted by each of the Funds. In addition, the FRQ expect funding holders to adhere to best practices in research ethics by respecting the different applicable norms and standards, depending on the context.
- Conditions d’exercice des comités d’éthique de la recherche désignés ou institués par le ministre de la Santé et des Services sociaux en vertu de l’article 21 du Code civil – Avis (Gazette officielle, 1998)
- Civil code of Québec
- Act respecting access to documents held by public bodies and the protection of personal information
- Act respecting the protection of personal information in the private sector
- Tri-Council policy statement: Ethical conduct for research involving humans – TCPS 2 (2018)
- How to address material incidental findings (Panel on Research Ethics, 2018)
- Ethical issues in health research in children (Canadian Paediatric Society, 2018)
- CIHR best practices for protecting privacy in health research (2005)
- Nuremberg Code (1947)
- Belmont report : Ethical principles and guidelines for the protection of human subjects of research (National commission for the protection of human subjects of biomedical and behavioral research, 1979)
- WMA declaration of Helsinki – Ethical principles for medical research involving human subjects (World medical association, 2013)
- Universal declaration on bioethics and human rights (UNESCO, 2003)
- WMA declaration of Tapei on ethical considerations regarding health databases and biobanks (World medical association 2016)
- International ethical guidelines for health-related research involving humans (CIOMS and WHO, 2016)
- Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicine (Council of Europe, 1997)
- Additional protocol to the Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine, on the prohibition of cloning human beings (Council of Europe, 1998)
- Additional protocol to the Convention on human rights and biomedicine, concerning biomedical research (Council of Europe, 2005)
- Cadre de référence ministériel pour la recherche avec des participants humains (Ministry of Health and Social services, 2020)
- Cadre de référence des établissements publics du RSSS pour l’autorisation d’une recherche menée dans plus d’un établissement (Ministry of Health and Social services, 2016)
- Act respecting health services and social services
- Guidance E6(R2): Good clinical practice (International council for harmonisation, 2016)
- Food and drug regulations
- Natural health products regulations
- Clinical trials for medical devices and drugs relating to COVID-19 regulations
Statement of the MSSS:
Standard legal clauses:
In February 2021, a revised version of the Standard legal clauses for information and consent forms for clinical trials was published. The FRQS requires that these Standard legal clauses be used in clinical trials funded by the FRQS or conducted at FRQS-funded research centers. They have been updated, under the coordination of CATALIS Québec, by a working group including experts (ethics, research and law), as well as representatives from the ministère de la Santé et des Services sociaux (MSSS), the FRQS and pharmaceutical companies.
This document essentially deals with the text of the consent form. However, the use of appropriate wording is only one part of the broader process of seeking informed consent. Research teams should communicate the information in the consent form in a way that facilitates its understanding. The use of information tools that are appropriate for the individuals who are being solicited, as well as the quality and continuity of the information exchange with the research team, are critical to the consent solicitation process.
- Standard legal clauses (MSSS, 2021)
- Word format of the Standard legal clauses (in French, MSSS, 2021)
- Table of changes since 2016 (in French, MSSS, 2021)
- Website of the ministère de la Santé et des Services sociaux (in French)
The FRQS continues to be involved in the updating of these tools for the scientific community. You can send us any comments on their content at the following address: firstname.lastname@example.org.
- International declaration on human genetic data (UNESCO, 2003)
- Universal declaration on the human genome and human rights (UNESCO in 1997 and UN in 1998)
- Recommendation on human biobanks and genetic research databases (OECD, 2009)
- Statement of principles: human genome research (Network of applied medical genetics, 2000)
- Statement of principles on the ethical conduct of human genetic research involving populations (Network of applied medical genetics, 2003)
- Statement of principles for genetic research involving children (Network of applied medical genetics, 2007)
- Énoncé de principes sur l’utilisation secondaire de données et de matériel biologique recueillis dans un contexte de soins ou de recherche (Network of applied medical genetics, 2010)
- Statement of principles on the return of research results and incidental findings (Network of applied medical genetics, 2013)
- Position paper on genetic discrimination (Network of applied medical genetics, 2016)
- Consolidated statement of principles from the Quebec network of applied genetic medicine (Network of applied medical genetics, 2016)
- La santé et le bien-être à l’ère de l’information génétique : enjeux individuels et sociaux à gérer (Conseil de la santé et du bien-être, 2001)
- Encadrement des banques de données et des banques de matériel biologique à des fins de recherche en santé – Brochure (Groupe-conseil du FRSQ, 2006)
- Encadrement des banques de données et des banques de matériel biologique à des fins de recherche en santé – Rapport final du groupe-conseil (Groupe-conseil du FRSQ, 2006)
- Encadrement des banques de données et des banques de matériel biologique à des fins de recherche en santé – Sommaire (Groupe-conseil du FRSQ, 2006)
All projects involving animals require the approval of the animal care committee of the principal applicant’s institution (section 5.5, Common General Rules). The decisions of this committee must be in accordance with the policies and guidelines of the Canadian Council on Animal Care (CCAC) and the institution where the research is being conducted must be accredited by the CCAC.
The Board of Directors of each fund appoints the members of its Committee on ethics and scientific integrity. Each of these committees is mandated to propose to the Board of Directors orientations regarding the fund’s action in the area of research ethics and the promotion of good practices adapted to research.
The Central ethics committee (Comité d’éthique central) falls under the jurisdiction of the Minister of Health and Social Services. It evaluates the ethical acceptability of research projects involving children or adults incapable of giving consent that take place in establishments that do not have a research ethics committee designated by the Minister of Health and Social Services (in accordance with article 21 of the Québec civil code). Its mandate also covers other situations, including the evaluation of projects where the institution does not have a research ethics committee.
For more information:
Research projects that are likely to affect the integrity of a person under 18 years of age or an adult who is incapable of giving consent must be approved and monitored by a research ethics committee established or designated by the Minister of Health and Social Services (in accordance with section 21 of the Civil code of Québec).
The FRQS, the Institut national d’excellence en santé et services sociaux and the Ministry of Health and Social Services have created a committee to help prioritize research projects and highlight methodological elements of particular interest in the context of COVID-19. The purpose of the committee is to support health care institutions in evaluating clinical studies on COVID-19 and to assist them in selecting those that are most promising and adapted to the context of the pandemic, while taking into account the limitation of resources.
Resources on ethics
- Tutorial in research ethics (Ministry of Health and Social services)
- Directory of resources in the health and social services network in ethics and research authorization (in French, Ministry of Health and Social services)
- Web page on ethics in health and social services (in French, Ministry of Health and Social services)
- Ethics certification recognition agreement (in French, Fédération des cégeps, 2019)
- Science & Technology Ethics Commission
If you have any questions, please contact Emmanuelle Lévesque, Research Ethics Advisor:
514 873-2114 ext. 4280 or email@example.com.