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 put in place to ensure that researchers and their teams have the skills required to carry out ethical and quality research in accordance with the highest standards of scientific integrity and responsible conduct. It covers all issues related to conflict of interest and obtaining research privilege.
Researcher status and research privileges
Under Standard 6 of the Departmental Terms of Reference for the research with human participants (2020), anyone wishing to conduct research activities in a health and social services network institution must first obtain from one of these institutions a research status or, in the case of physicians, pharmacists and dentists, research privileges that certify their research skills.
Following the Procedure for Obtaining the Status of Research and Research Privileges of the CIUSSS de l’Ouest-de-l’Île-de-Montréal (ODIM), it is the CRs who are responsible for the evaluation and granting of research status and research privileges on the part of the CIUSSS ODIM and it is the USER that is responsible for recognizing the status and privileges granted by the other institutions. Please refer to the procedure for reviewing the criteria required for research status or research privileges.
Key Rules to remember
The status of researchers and research privileges are managed using the Competence module of the Nagano platform. Each researcher has a record containing the information and documents relating to his or her status or privileges.
It is possible for a researcher to check the validity of their status or privileges directly in this module.
Once granted, the status of researcher or research privileges are valid for a period of 3 years. It is the responsibility of the researcher to renew his status or privileges in accordance with the procedures provided for in the procedure. As the deadline approaches, a reminder will be sent automatically by Nagano.
CMDP member researchers must apply for an assessment with their affiliate RCs. The RC is responsible for the evaluation of their file according to the conditions in force. However, the evaluation must be submitted to the CMDP for approval and then to the Board of Directors for final approval.
As provided for in the procedure, RCs are free to establish their own granting criteria. The supporting documents requested may therefore vary according to the CR.
Training and qualifications
In order to ensure that good practices are respected, it is essential to ensure that all researchers and research staff engaged in research activities within the CIUSSS ODIM are adequately trained and competent. Training and skills include general research-related knowledge that needs to be demonstrated to obtain research status or research privileges but also include additional skills for specific activities such as medical procedures, the use of advanced technologies or psychosocial interventions.
In this sense, any researcher and member of the research team is required to obtain adequate training and/or to document it before performing or supervising any task related to a research project on human participants within the CIUSSS ODIM. Qualifications will be documented within the submission forms of each submitted project and verified by the USER. At the same time, the REB has an obligation to review the curriculum vitae of each member of the research team to determine whether the skills required to conduct the project are satisfactory and do not put participants at risk. These two evaluations are independent of each other.
A Policy on Training and Research Qualifications is under preparation. It will establish the requirements and the process of monitoring and continuous evaluation of the training and qualifications of researchers and their teams. For the time being, the training requirements for the research team are limited to those required for clinical trials and the evaluation conducted by the REB. Please do not hesitate to contact recherche.comtl@ssss.gouv.qc.ca if you have any questions.
ResponsibleDriving
Under Standard 9 of the Ministerial Framework of Reference for Research with Human Participants (2020), the CIUSSS ODIM has an obligation to establish and maintain an environment that encourages and promotes responsible conduct of research. This conduct refers to the expected behaviours of anyone conducting research or research support activities at a few stages of a research project. This conduct also requires knowledge and application of established professional standards and the ethical values and principles that are essential to the performance of all research-related activities. These values include honesty, fairness, trust, responsibility and openness.
The values to which the CIUSSS ODIM adheres to responsible conduct and the arrangements for the processing of allegations of breaches are presented in the Responsible Conduct in Research Policy.
Any allegations of default are dealt with under the Handling of Allegations of Default procedure.
The allegation is transferred to the McGill University Assistant Commissioner for Research Integrity for any McGill University affiliated professor with or without any salary, student or post-decal fellow enrolled at McGill University or an employee or contractor at McGill University. The complaint will then be dealt with in accordance with the provisions of the Regulations Concerning the Investigation of Research Misconduct at McGill University and not in accordance with this policy.
The allegation is transferred to the CIUSSS ODIM PCCR for any research professional, employee or volunteer of the CR Douglas, the CR of St. John’s. Mary, or any other facility of the Institution.
The claim is also transferred to the CIUSSS ODIM PCCR for any physician, dentist or pharmacist employed by the Institution and not having an affiliation with McGill University. The CMDP is informed of the receipt of the allegation of default.
For anyone who does not meet the three previous conditions, the responsibility for assessing the allegation rests with the PCCR.
Conflict of interest
Under Standard 1 of the Ministerial Framework of Reference for Research with Human Participants (2020), the CIUSSS ODIM must establish the rules for the management of conflicts of interest.
The CIUSSS ODIM has such measures within various regulatory documents, namely, the one concerning the conflicts of interest of researchers in relation to a research project, the one concerning the conflicts of interest of the people working within the Institution and the conflict of interest of researchers funded by the U.S. federal agencies. The provisions within these documents are applicable, but the USER works to collect and adapt them to the needs of the research. REB members are also required to declare their conflicts of interest, in particular in relation to the projects submitted to the committee.
Key Rules to Remember
When submitting a research project, researchers disclose within the project filing form any personal, professional or financial conflict of interest, whether real, potential or apparent, and any institutional conflict of interest that may have an impact on their research project.
A researcher must, within 30 days, declare in writing to the management of his VC any direct or indirect interest in a company that is likely to place him in a situation of conflict of interest putting in tension his personal interests or that of one of his relatives and those of the CIUSSS ODIM. This disclosure must be shared with the human resources department of the CIUSSS ODIM.
The PSD maintains a record of all conflicts of interest reported by CMDP members while the RCs keep one for all their affiliated researchers.
Under the departmental terms of reference, researchers must disclose the creation of a business or their incorporation into a business at any time. If a research project is carried out with the competition of such a company, the researcher must comply with the standards in force in order to avoid any conflict of interest.
