In response to the recent memo that researchers must obtain proof of vaccination prior to welcoming research participants to campus, the Office of Human Research Ethics (OHRE) has the following guidance:
- Ensure your study team is familiar with Western’s COVID-19 Vaccination Policy (MAPP 3.1.1)
- Amendments to research protocols and documents are not required to address this additional institutional screening requirement. Inclusion/Exclusion criteria, screening scripts and tools, and data collection tools should not be impacted when researchers are solely following institutional policy for on-campus attendance.
- Amendments are required if your study objectives newly require the collection of vaccination information as study data OR if your research as a whole must pivot to new methodology (e.g. remote vs in-person visits).
- The requirements around vaccination should be introduced to participants prior to obtaining informed consent. Ongoing research participants should be notified of the vaccination policy as soon as possible.
- Documentation of a participant’s vaccination status or exemption should not be part of their study record unless it is approved study data.
- Ideally, the collection of vaccination information should be centralized within the faculty, school, or department.
- Do not collect vaccination documents via email, as email is not considered secure (MAPP 1.13). Retain vaccination status information only until Western tells you that it can be destroyed. As per the previous memo, actual vaccination documentation provided by the potential participant should NOT be retained at all.
- As per MAPP 3.1.1, children under 12 are not considered visitors. Therefore, there is currently no requirement for research participants under 12 to be vaccinated or to provide proof of negative COVID tests. However, like all participants they must do Western’s daily symptom screening prior to presenting to campus for research.
- Consider your participant population because not all will have access to certain technology. Obtaining verbal confirmation prior to a research participant coming to campus is sufficient if obtaining it ahead of time is not possible. Proof of vaccination documentation need only be shown in-person.
As the OHRE gathers more information guidance document will be updated. Please consult the Vaccination Confirmation for Research Participants Guidance Document for the most up to date information, scripts and documentation requirements.