Centre intégré universitaire de santé et de services sociaux de l’Ouest-de-l’Île-de-Montréal
Direction des affaires académiques et innovation (DAAI)
->Back to Research and Regulatory Affairs Support Unit (RRASU)
Centre intégré universitaire de santé et de services sociaux de l’Ouest-de-l’Île-de-Montréal
Direction des affaires académiques et innovation (DAAI)
->Back to Research and Regulatory Affairs Support Unit (RRASU)
This regulation brings together all the measures of the triple evaluation dictated by the departmental reference framework and developed to ensure that the research that is carried out within the CIUSSS de l'Ouest-de-l'Île-de-Montréal (ODIM) 1 is scientifically valid and relevant, 2) is ethical in all respects and respects the dignity, protection and rights of the participants; and 3) is the subject of evaluations of the operational aspects of the financial and operational aspects. A project can only begin once these three evaluations are completed and positive. The framework continues following the authorisation of projects through the application of other rules ensuring compliance with practices when carrying out research projects.
Rules for submitting research projects
Based on Sections 2.1 to 2.6 of the Three Council Statement of Principles (TPSC) (2022) and the Ministerial Framework of Reference for Research with Human Participants (2020), a project requires approval and follow-up by a REB if it is a research project, but not if:
This is a research based exclusively on: 1) Publicly available information; 2) observation of people in public places, without reasonable expectation of privacy; or 3) Secondary use of anonymous information (except for data linkages or data breaches).
If it is a quality assurance study or a program evaluation without scientific purpose
If the contribution of the CIUSSS ODIM is limited to a service under an agreement with another institution of the health and social services network or a private organization.
Also, under Standard 5 of the Ministerial Framework of Reference for Research with Human Participants (2020), only an REB of the Health and Social Services Network (HSSR), thus excluding those from universities and other institutions, may be responsible for the approval and ongoing monitoring of the implementation of research projects that:
Are carried out in part or in full, under the auspices of an establishment of the RSSS;
Involve the establishment of a database or biobank hosted by an RSSS institution or that is under the responsibility of a researcher affiliated with an RSSS institution;
Recruit users or employees of an SSHR institution;
Conduct the consultation of files held by an institution of the SSHR.
In case of doubt, it is the responsibility of the researcher to consult the REB before submitting a project to determine whether the planned activity is a research activity or not, and whether it should be subject to an ethical evaluation. The project sorting grid () can also be used to determine whether the project is a research or quality.
Only researchers with research status or research privileges granted or recognized by the CIUSSS ODIM may submit a research project as a responsible researcher.
The principal investigator of a research project does not have to be affiliated with one of our research centres or partner with a local researcher except for projects in the Department of Family Medicine at the St. John’s Hospital. Mary. For clinical trials, the responsible researcher must be a local researcher.
Note that graduate students cannot act as a responsible researcher. Also excluded are postdoctoral fellows and medical residents. However, they can register as co-researchers.
Researchers with non-compliance with the framework rules may be subject to conditions for submitting new projects. For example, a researcher who has not submitted the end report of one of these studies may be required to do so and provide explanations before being able to submit a new project. Explanations may also be required in the case of repeated non-renewal of ongoing projects. Finally, no new project can be submitted if one of the responsible researcher’s projects is currently suspended. More specific rules on this subject will eventually be communicated.
Any project approved by a CER other than that of the CIUSSS ODIM must be submitted in our Nagano platform for consideration of convenience and authorization. The registration of the CIUSSS ODIM as a participating site must be approved by the REB either within the letter of declaration of this REB (where the project has been submitted to them) or within a request for amendment to add our Institution to the project. Considering that the project file is not transmitted to us by the REB, it is the responsibility of the researcher to submit it and synchronize it with the file submitted to the REB.
The information and consent forms (ICFs) used in a project at the CIUSSS ODIM must be adapted locally. This essentially means that the CIUSSS ODIM logo must be inserted at the top of the page, that the information to contact the Institution’s Complaints Commissioner must be inserted into the ICF and that all information to contact the responsible investigator is entered. Project proponents may have additional requirements. The guidelines are provided in the Nagano project submission form.
Rules on ethical and scientific assessments
Pursuant to Standard 4 and 5 of the Ministerial Framework of Reference for Research with Human Participants (2020), the CIUSSS de l'Ouest-de-l'Île-de-Montréal (ODIM) ensures the establishment of a REB and ensures their operation in full compliance with the Notice on the Conditions of Practice of Research Ethics Committees designated or established by the Minister of Health and Social Services
The REB first monitors the ethical and scientific evaluations and approvals of research projects. The purpose of ethical assessment is to ensure that research is conducted in accordance with ethical principles and that research respects the dignity of individuals, their autonomy, well-being and their rights as participants. The scientific evaluation focuses on the scientific validity and relevance of research, methodology and recruitment of research participants. It is conducted by the REB, in parallel with the ethical evaluation.
Key rules to remember
The Operating Rules of the CIUSSS ODIM REB subscribe to the standard operating procedures (MONs) of the Catalis Research Ethics Boards based on the N2 standards and created for the benefit of all the institutions of the health and social services network. You can consult these rules in the section Documentation.
A project has to be approved by only one REB of the health and social services network (a CIUSSS, CISSS, CHU). Ethical approvals obtained from committees outside the health and social services network (e.g., university, CR, hospital in another province, etc.) are not recognized.
Evaluations are proportional to the level of risk; projects presenting a risk to participants or including vulnerable participants are assessed in Committee of the Whole, on a fixed date, while projects at minimum risk are assessed by delegate.
The results of scientific evaluations carried out by peer review committees are generally recognized, but do not prevent the REB from conducting its own evaluation.
All decisions of the REB are communicated by an electronic letter and combine the results of both ethical and scientific evaluations.
Rules relating to monitoring,amendment
and the closure of the project
More information to come
Key rules to remember
Coming soon
Rules on examinations of convenience
and authorization of projects
Data collection, recruitment of participants, use of a drug, review of records, management of data and biological material, analysis (primary or secondary) of biological data and material, and writing of documents;
Research is being conducted at one of the facilities of the CIUSSS de l'Ouest-de-l'Île-de-Montréal (ODIM), even if these activities do not involve any CIUSSS ODIM employees, but only members of the research team;
Individuals employed by the CIUSSS ODIM provide assistance in conducting research in or outside CIUSSS ODIM facilities by providing specific services, providing information, helping to approach participants, publicizing research, collecting information, data or samples from participants, etc.;
Participants are approached and/or recruited from among patients/users/clients of the CIUSSS ODIM or among those working there;
Medical or follow-up intervention records maintained by the CIUSSS ODIM are consulted, including, among other things, medical records and records of the Youth Protection Directorate;
The research uses information maintained by the CIUSSS ODIM including clinical-administrative data;
Spaces, equipment or equipment of the CIUSSS ODIM are used, including laboratories, offices of research team members and computers;
Ads or advertisements are displayed within one or more facilities or on electronic platforms of the CIUSSS ODIM;
Flyers are distributed inside the CIUSSS ODIM;
Services of the CIUSSS ODIM (e.g., departments of the medical department of pharmacy) or research platforms (e.g., the brain imaging center) are used.
Under Standard 3 of the Ministerial Framework for Research with Human Participants (2020), the CIUSSS ODIM must be declared and authorized any research activities conducted within the Commission. Authorisation is granted only after the research project has been approved for ethics and science and the clinical directorates concerned by the project give a favourable opinion to the project through what is known as the guess review. The USER shall maintain a record of the searches authorized by the institution to be carried out. Registration in the register shall be kept for a minimum period of three years after the end of the search.
The review of convenience is coordinated by the USER and consists essentially of consulting the clinical and/or RC branches to decide on the relevance of the project and their ability to participate when employees or patients are called upon to participate or when spaces or materials from the CIUSSS ODIM are required. The review of convenience is reserved for RCs for projects in basic research, projects recruiting exclusively outside the CIUSSS ODIM, projects limited to data analysis, and the establishment of banks and biobanks. The CIUSSS ODIM has an institutional convenience review procedure.
Key rules to remember
The review is proportional to the importance of the collaboration required by the CIUSSS ODIM for the project.
The start of a fitness review may be delayed if it is agreed that the project is at risk of being substantially modified following the evaluation of the REB.
A project with a letter of support from the CIUSSS ODIM must be subject to a review of convenience because it is on the basis of the protocol subject to ethics and information about our participation that the final decision to authorize or not a project is based. A review of convenience in such circumstances usually consists of confirmation of support and is usually carried out diligently.
Authorizations, once granted, are applicable for as long as the project is ethically approved, and are therefore automatically renewed when the ethics of the project is renewed by the REB.
A project cannot begin until it has received its authorization from the CIUSSS ODIM, even if it is ethically approved.
A letter of authorization, written according to the size of the MSSS and signed by the mandated person, is sent in Nagano by the USER to the responsible researcher once the results of the evaluations (ethical, scientific and appropriateness) are all favorable. It is at the time of receipt of this letter that research activities can begin. If the CIUSSS ODIM is a site participating in the project, a copy of the authorization letter is sent to the Estable REB.
Rules for maintaining a list of participants
Under Standard 7 of the Ministerial Framework of Reference for Research with Human Participants (2020), the CIUSSS ODIM is required to list all individuals who have participated in research within its facilities to ensure the protection of these participants.
This obligation is set out in the Procedure for the Identification of Research Participants for the Protection Purposes of the CIUSSS ODIM in which the responsibilities of researchers are dictated with respect to the mandatory holding of a list of participants in their research and established the guidelines to be followed in the preparation, retention and transmission of lists.
Key rules to remember
The list must only contain the names or identification codes of the participants, their contact information (if kept), the project number and the start and end dates of participation.
For verification purposes, the list of participants may be requested by the CAAI, by the RCs when renewing the status of researchers or research privileges or by Health Canada and other regulatory authorities.
The information must not be retained more than 12 months after the completion of the search. The researcher must propose quick access to the list of participants in case of sudden absence.
Rules on banks and biobanks
Databases and biobanks (Banks) for research purposes are organized and structured collections of human data and/or biological material kept for future use in research projects. The collection, organization, conservation and distribution of data and/or human biological material of the Banks is governed by the rules described in the Guidelines on Databases and/or Biological Materials for Research Purposes. These guidelines were developed taking into account, among other things, the MSSS’s Guide to the Development of Management Frameworks for Databases and Biological Materials for Research Purposes. These guidelines are intended to guide the researcher in the drafting of a management framework for a Bank.
Key rules to remember
Coming soon
Rules on the management of medicines
The pharmacy department is responsible for the drug circuit of the establishment. The management of drugs and research products is subject to good clinical practices, Canadian federal laws, Quebec provincial laws and the standards of practice of the Ordre des pharmaciens du Québec.
Under Standard 8 of the Ministerial Framework of Reference for Research with Human Participants (2020), the CIUSSS ODIM has an obligation to list all individuals who have participated in research within its facilities to ensure the protection of these participants.
Key rules to remember
The procedures for the management of medicines and department of the Department of Pharmacy are presented within their Standard operating procedures (to come)
Research support activities must be done at zero cost to the clinical departments of the MSSS institutions. To this end, the Department of Pharmacy contacts the researcher responsible for the research projects to establish the service fee during the review of convenience.
Research medicinal products are subject to the same type of control as that provided for prescription drugs;
The primary responsibility for the control of research drugs rests with the head of the Department of Pharmacy, who must ensure that the rules on research drugs are applied and that only this department ensures the preparation, storage and delivery of these drugs.
Pharmacy-related research expenditures are incorporated into the project cost structure prior to approval.
The Department of Pharmacy has sufficient resources for the control of research drugs.
The necessary means are put in place to promote close collaboration between the Department of Pharmacy, the Research Directorate, the research staff, the researcher and the ERC.
Rules on research contracts
More information to come
Key rules to remember
Coming soon
Rules on service charges applicable to industry
Public institutions in the health and social services network have the obligation to charge the private company the costs related to different services provided by the REB, including the various examinations, authorizations, follow-ups and renewals. These fees are updated annually by the MSSS. To review this, please see the MSSS Billing Schedule document in the Documentation section.
The institution shall also ensure that the research budget provides for the payment of indirect costs of the research, calculated on all the direct costs of the research identified in the granting of research from a private company. Individuals who review the contractual and budgetary aspects of a search when reviewing the suitability of the research at the institution will ensure that there is no provision contrary to this standard or the departmental provisions regarding the direct and indirect costs of the research.
