Modifications to research protocols in order to adapt to the constraints and risks associated with COVID-19
The situation caused by the COVID-19 pandemic resulted in the suspension of human research activities conducted by research personnel on site and / or involving one or more visits by research participants to the Institute. Only research projects whose suspension could jeopardize patient care were allowed to continue their activities with additional safety measures.
As part of the deconfinement process, the MSSS announced that research activities could gradually resume following: 1) authorization by the Research Ethics Board (REB) who provided the initial approval, 2) authorization from the Institute (CIUSSS). The authorization by the REB will be granted through an amendment in which the researcher states that his/her protocol has been adapted to the public health measures currently in effect.
The Douglas Research Centre plans to resume face to face human research activities on June 29. The announcement was made to researchers, many of whom will then submit a request to resume activities (amendment) to the REB. Several dozen amendments are expected in a short period of time. To speed up the authorization process, the REB has drafted several sentences below that can be inserted in a revised protocol. These sentences are meant to represent the different modifications required for a human research project to resume. The sentences are as follows:
- In the project description
"Research activities were suspended during the containment period imposed by the government in response to the spread of COVID-19. They will only resume at times allowed by the Ministry of Health and Social Services, by the Research Centre, as well as by the West Island of Montreal CIUSSS. For research projects that involve sites outside of the jurisdiction of the CIUSSS-ODIM (e.g. multicenter studies), research will only resume at those sites at times allowed by their respective CIUSSS/CISSS. All directives related to safety and prevention (e.g., face covering, distancing, hand washing, etc.), restricted building access, and disinfecting protocol of physical environment will be applied to both participants and research personnel, including researchers. The guidelines elaborated by the Research Centre will be applied. "
- In the recruitment section
"During the first telephone contact with a potential participant, Health Canada's self-assessment test for COVID-19 (https://ca.thrive.health/covid19/en) will be administered. If the participant is considered to be at low risk of being contaminated, the appendix "Risks related to the participation to a research project during the COVID-19 pandemic" will be administered. "
- In the section concerning the reception of the participant
"The participant will be asked to complete again the Health Canada self-assessment test for COVID-19 (https://ca.thrive.health/covid19/en). The result needs to confirm the low risk of having been contaminated. The information and consent form, as well as the appendix "Risks related to the participation to a research project during the COVID-19 pandemic", will then be presented to the participant so that s/he can acknowledges understanding of the content and sign. "