How you submit a research project through NAGANO depends on the type of project, and how many sites will participate in research.
Research privileges are required to conduct research activities with CIUSSS West-Central Montreal staff or clients (using one of its facilities or integrated sites and including the clientele of its territory who are benefiting from treatment and home care). The request to obtain research privileges is made before the submission of a research study to the Research Review Office. The office can help to determine whether the researcher must submit a request for research privileges and refers them to the person designated for Medical / Biomedical research stream or for First-Line or Psychosocial research stream.
- A research project evaluated at the CIUSSS West-Central Research Ethics Board for which the research activities will be executed only at the CIUSSS West-Central installation(s) (e.g. Jewish General Hospital, Maimonides, CLSC de la Montagne, Constance-Lethbridge Rehabilitation Center, etc).
- A Research project evaluated at the CRIR Research Ethics Board for which the research activities will be executed at the CIUSSS West-Central installation(s).
- A research project evaluated at the CIUSSS West-Central Research Ethics Board, for which the research activities will be executed at the CIUSSS West-Central installation(s) and at other institutions.
- A research project evaluated at another REB (other than the CIUSSS West-Central Research Ethics Board) for which the activities will be executed at local sites , in this case, at the CIUSSS West-Central installation(s).
The 4 steps to begining your research activities:
1. ETHICS REVIEW
Ethics review is an evaluation based on best practices in research ethics in terms of protecting the participant. The CIUSSS West-Central Montreal Research Ethics Board holds two sub-committes:
- Medical-Biomedical (MBM) committee
- medical research, clinical trials, biobanks, etc.
- Psychosocial (PSY)committee
- psychosocial research, gerontology research, education, etc.
2. SCIENTIFIC REVIEW
Science review is an evaluation based on good scientific practices at the methodological level, in relation to research hypotheses, research groups, etc. At CIUSSS West-Central Montreal, we have a scientific evaluation committee available for research protocols that have not already been scientifically evaluated. In the case where a scientific evaluation already exists, it will be possible to download it directly in the NAGANO initial submission form.
3. FEASIBILITY REVIEW & CONTRACT
Feasibility review is an assessment of the material and human resources related to the research project. This evaluation is the responsibility of the department or program where your research will be performed. The contract is a legal document of agreement between the sponsor and the institution A contract is necessary for privately-funded clinical research, and not applicable to projects with public funding. At CIUSSS West-Central Montreal, the feasibility review is initiated directly by answering the questions in the initial NAGANO submission form.
4. INSTITUTIONAL AUTHORISATION
An authorization issued by the Office of the person in charge at CIUSSS West-Central Montreal to authorize research that includes the three previous evaluations. Without this final document, the research team is not authorized to start research activities in the institution. At CIUSSS West-Central Montreal, institutional authorization will be issued via NAGANO.
At the RRO, Submissions are processed one of three ways:
- Full Board Review: Studies that involve risks to participants for the advancement of scientific knowledge are revised at full board meetings.
- Delegated Review: Studies can be reviewed in a delegated fashion if the study does not involve more than minimal risk. The standard of minimal risk is commonly defined as follows: if potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research then the research can be regarded as within the range of minimal risk. Delegated approval is granted by the Chair and the protocol is then presented for corroborative approval at the next Research Ethics Committee Meeting.
- Chart Review: A retrospective Chart Review must be authorized both by the Research Ethics Board and the Director of Professional Services according to article 19.2 de la Loi sur les services de santé et des services sociaux.
Amendments to a protocol
After a protocol is approved and activated, any modifications or amendments must be submitted promptly to the Research Ethics Board (REB) through Nagano for review and approval prior to this modification being implemented. Some may require a full committee review for approval, particularly if the amendment is major, or if the protocol itself has been significantly changed. An example of a major amendment would be substantial changes in inclusion and exclusion criteria.
When an amendment to the protocol involves changes to the consent form, the consent form must be changed to reflect the approved change, and participant consent is often required again.