Guidelines for resumption of research involving human subjects

We have recently obtained authorization from the Montreal West Island CIUSSS’ Executive Committee (CODIR) and the Directorate of University, Academic, and Research Affairs (DAUER) to restart suspended research activity involving human subjects. It is also possible to begin new projects involving human subjects. Please see below for the Guidelines developed by the Douglas Research Centre and the Bureau de la recherche to assist you in the process of resuming your research activities.

Guidelines

• The public health measures that are currently in place at the CIUSSS (mandatory use of personal protection equipment) are applicable at all times for research personnel, for students, and for researchers whenever research is being conducted on CIUSSS premises. 
• Any research activities that can be conducted remotely should continue to be conducted remotely. Telephone or virtual contact with participants should be favoured whenever possible.
• When in-person visits are required, their number and duration should be limited as much as possible. As many steps as possible should be conducted by telephone (e.g. obtaining consent, collecting socio-demographic data, etc.) to decrease the amount of time spent in in-person interactions.For research involving users of the Douglas, visits to the Douglas should, as much as possible, be timed with clinically required follow-up visits.
• Research participants should use appropriate preventative measures should be observed during visits to the Douglas. Participants should be contacted by telephone before their appointment to obtain their consent to visit the Douglas. They will also be required to complete a COVID-19 self-evaluation and to confirm that they do not present any COVID-19-related symptoms. For in-person appointments at the Douglas, participants must present themselves at one of the designated entrances monitored by CIUSSS personnel (Perry or Bond) and must be met there by a member of the research team. Participants must wash their hands and wear necessary protective equipment.
• During their participation in research studies, waiting times in common areas should be minimized as much as possible.

Steps to follow to resume a suspended research project

1.    Submit a request for amendment accompanied by a revised ethics proposal in which you have indicated that resumption of research activities will be conducted following public health measures imposed by the CIUSSS and the MSSS. If applicable, the Procedure for consent forms section should also be revised to include, in annex, the addendum described below concerning the risk associated with circulating at the Douglas. The amendment request should be submitted only to recherche.comtl@ssss.gouv.qc.ca.  In order to accelerate the approval of such amendments, REB pre-approved sentences are being made available to researchers for their use, verbatim, in protocols and consent forms. Additionally, an addendum to consent forms has been prepared to explain the risks associated with in-person participation at the Douglas. This addendum must be read over the telephone to potential participants and they must give their verbal consent. 

2.    As described in the directives emitted by the MSSS, it is necessary to obtain REB approval and institutional (CIUSSS) approval before resuming suspended research activities. To facilitate this double approval, the Bureau de la recherche will forward the amendment requests to the REB who, upon approving the request, will transfer the request directly to the person mandated to approve such requests at the CIUSSS (Najia Hachimi-Idrissi) for final authorization. Ethics and institutional approvals, respectively, will be conveyed to researchers by the REB.

3.    Please note that the “Resumption for Research activities – Phase 3” form is no longer required by the Douglas Research Centre. Please refer to information related to Phase 4 of the resumption of research activities.

4.    Once institutional authorization has been obtained the project may restart.