Approvals to Conduct In-Person On-Campus Research with Human Participants
- In-person human participant research requires approval from your Vice/Associate Dean Research (V/ADR). To seek approval, your Research Activity Plan (including COVID-19 precautions) should be submitted through this portal.
- After receiving V/ADR approval, obtain research ethics clearance through the appropriate REB. For projects with previous REB clearance, adding in-person participant research or resuming in-person research (that was halted due to COVID-19) may require submission of an amendment request to the appropriate REB. For more information see HiREB or MREB details on COVID-19 and REB review.
- Researchers and participants are expected to follow the COVID-19 precautions for their study (e.g., self-assessment screening, physical distancing, masking, etc.) approved by their V/ADR through the Phase 2 return to research process and outlined in their approved MREB or HiREB ethics application.
- Researchers are expected to use the on-campus COVID-19 LOI for research with human participants. This should be submitted as part of the Research Activity Plan to your V/ADR. For studies reviewed by MREB, the COVID LOI should be included in the MREB submission. For studies reviewed by HiREB, the COVID LOI does not need to be included in the HiREB submission – see HiREB’s website for more information.
Vaccination Mandate and COVID-19 Safety Protocols
- Research participants will be expected to adhere to the McMaster vaccination mandate, as it covers all persons attending a McMaster campus or facility. Exemptions can be requested for protected grounds under the Ontario Human Rights Code, which includes confirmed medical reasons. If you have any questions about the McMaster vaccination policies, please email firstname.lastname@example.org.
- McMaster student, staff, and faculty research participants will follow the vaccination policy for employees and students. They will need to have University approval to attend a McMaster campus or facility in order to participate in a research study. Approval, via proof of vaccination or an exemption (with testing), will be managed via the MacCheck digital tool (see vaccination FAQs for details). Approval to attend on the day of the study also requires passing the COVID-19 screening via the Daily Check in MacCheck.
- Research participants from outside the McMaster community will follow the vaccination policy for visitors and are considered in the “volunteer” category for the purposes of the policy. They will need to have University approval to attend a McMaster campus or facility in order to participate in a research study. Approval, via proof of vaccination or an exemption (with testing), can be obtained through the McMaster Safety App or through the web-based MacCheck Tool (see vaccination FAQs for details). Proof of vaccination should be submitted at least 24 hours before the individual’s first time attending campus, and a request for an exemption should be submitted as soon as possible and no less than 72 hours prior to the visit.
- Research participants from outside the McMaster community who are visiting the campus or an affiliated off-campus site are expected to use the Provincial Screening Tool the day of the study and follow all of McMaster’s health and safety guidelines in order to be cleared to come to campus. The self-assessment should be done not more than an hour before coming to campus and participants should confirm the result was “you do not need to self-isolate or get tested.”
- If the research is being conducted at an off-campus site, including our host hospitals or MIP, research participants must adhere to site-specific protocols in addition to McMaster’s requirements.
- Research participants do not have to report their vaccination status to researchers. Research participants from the McMaster community will confirm University approval by showing the researcher their green MacCheck clearance check mark. Research participants from outside the McMaster community will confirm University approval by showing the researcher their approval message obtained through the McMaster Safety App or the web-based MacCheck Tool. Researchers will only know that participants have approval to be on campus, and not whether it is due to an exemption or being fully vaccinated.
- A research participant under the age of 12 is ineligible for vaccination (as of September 7, 2021) and is exempt from providing proof of vaccination to attend a McMaster campus or facility to participate in research. However, they must meet all other COVID-19 precautions and university protocols, including masking and physical distancing.
- According to the vaccination policy for visitors, for studies where the results may be impacted by the participant’s COVID-19 vaccination, research participants can attend a McMaster campus or facility even if they are not fully vaccinated. Participants who are part of health studies taking place at an affiliated hospital site who are not vaccinated should follow protocols in place at the data collection site.
- Clinical faculty who are based at hospital sites are required to follow the COVID-19 procedures and policies for both McMaster and their host hospital site.