How you submit a research project through NAGANO depends on the type of project, and how many sites will participate in research.
- A research project evaluated at the WCMH REC, for which the research activities will be executed only at the WCMH installation(s) (e.g. Jewish General Hospital, Maimonides, CLSC de la Montagne, Constance-Lethbridge Rehabilitation Center, etc)
- A Research project evaluated at the CRIR REC for which the research activities will be executed at the WCMH installation(s).
- A research project evaluated at the WCMH REC, for which the research activities will be executed at the WCMH installation(s) and at other institutions
- A research project evaluated at another REC (other than the CCOMTL REC) for which the activities will be executed at local sites , in this case, at the WCMH 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 WCMH REC holds two sub-committes. The selection of sub-committee can be done through the NAGANO on line submission:
- Medical-Biomedical (MBM) Sub-committee
- medical research
- clinical trials
- First-line Psychosocial (PLP)Sub-committee
- psychosocial research
- geriatric research
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 WCMH, 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 WCMH, the feasibility review is initiated directly by answering the questions in the initial NAGANO submission form.
4. INSTITUTIONAL AUTHORISATION
Une autorisation émise par le Bureau de la personne mandatée au CCOMTL pour autoriser la recherche qui englobe les trois évaluatons précédentes. sans ce document final, l'équipe de recherche n'a pas l'autorisation de débuter les activités de recherche dans l'institution. AU CCOMTL l'autorisation institutionnelle sera émis via NAGANO.
At the RRO, Submissions are processed one of three ways:
- Full Board Review: Studies that involve risk to participants for the advancement of scientific knowledge.
- 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 by the Director of Professional Services according to article 19.2 de la Loi sur les services de santé et des services sociaux. When data collected for research purposed can be linked back to the participant, the authorization from the Research Ethics Office is also required. If they study warrants approval an approval letter signed by both the Director of Professional Services and the Chief of the Research Ethics Office will be issued.
Amendments to the protocol
After a protocol is approved and activated, any modifications or amendments must be submitted promptly to the Research Review Office (RRO) 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.
The Consent Form will have to be modified to reflect the changes, and the participant must give his or her consent. The latter amendments may be approved by the chairman in an expedited fashion. A protocol modification form must be completed.
At times, it may not be clear as to whether an amendment requires expedited or Committee approval. A discussion with the Research Review Office (RRO) will clarify the necessary route to take. A Full Board Protocol Modification Form must be completed through NAGANO for all amendments taken to the Committee.
For the most part, however, minor changes such as the requirement for one more visit to the research center by the participant, or the drawing of one extra vial of blood at a given sitting, do not require a full committee review.
For any questions please contact us.