Category: COVID-19

With the continued risk of COVID-19 exposure and as Public Health and institutional directives such as physical distancing continue to be mandated, researchers must think about converting studies involving in-person contact into remote methods of data collection. Modified study procedures may be carried out with Research Ethics Board approval when feasible (and only when appropriate).

The Office of Human Research Ethics (OHRE) is aware of the urgency to provide the research community with guidelines to support continued research activities. To that end, they have developed two new guidance documents:

Ethical considerations for remote consent and assent : This guidance document was developed by the OHRE in collaboration with six other institutions, including local hospitals, Western’s privacy office and the Lawson Health Research Institute. It provides guidelines for our research community for alternative consent processes, as opposed to the traditional in person consent process. In addition, it also provides a board framework for different consent options and documentation.

Western Qualtrics for electronic documentation of consent: Working closely with Western’s privacy office as well as Western’s Technology Services they have developed a guidance document that addresses specific requirements for the use of Western Qualtrics to document consent (electronic consent).

When conversion isn’t possible: There may be instances when it is not appropriate to make a specific change to your data collection (e.g. conducting in-person interviews about a sensitive topic and with a vulnerable population). In these instances, study activities may have to remain on hold until physical distancing requirements are not required.

Please remember that during these times, the logistics for any prospective research must be carefully considered. For more information, please see the past communication, Considerations for New Initial REB applications and Amendments for ongoing studies.

If you would like to review any previous memoranda or other communications, you can find them on the website under Communications and Memos. To review all guidance and template documents, please visit the Guidance and Templates page, or go to WREM (under HELP > Templates).

If you have any questions or concerns, please contact the office at ethics@uwo.ca or 519-661- 3036.

On behalf of the Panel on Research Ethics, the Secretariat on Responsible Conduct of Research has shared new interpretations to support the community in applying the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, TCPS 2 (2018) during the current COVID-19 publicly declared emergency. The interpretations can be found at this link.

June 2, 2020

Given persisting public health recommendations to maintain social distancing and to adhere to other related safety precautions, Western University’s research ethics boards (REBs) encourage all researchers to exercise sound judgment and to speak to their Deans/Department Chairs or Chair/Chiefs and the REB when considering their research programs and specific ethics protocols.

On May 29, the Vice-President (Research) distributed a COVID-19 Research Recovery Plan that outlines Western’s four-phased plan for returning to campus. If you are considering restarting or initiating any on-campus, community-based or field research, you must first receive approval from your Dean or designated Department Chair or School Director (Western) or your Chair/Chiefs (Lawson).

During the early phases of the pandemic, the Office of Human Research Ethics updated its processes to address immediate and temporary changes needed to eliminate risks to participants using the FYI notification feature in WREM.

Changes no longer considered urgent or temporary to minimize participant risk must now be submitted as amendments for REB approval, including those initially submitted as FYI.

When considering submitting an amendment:

• General modifications due to public safety guidelines do not require an amendment (e.g., standing two metres apart, wearing masks, etc.);
• Changes to study procedures as a result of public safety guidelines will require an amendment (e.g., switching from an in-person focus group to individual interviews or online data collection);
• Any additions of COVID-related inquiries to an existing study (e.g., additional questions/analyses) must be related to the original research questions/objectives; otherwise, please submit as a new REB application;

Modified study procedures may be carried out with REB approval when feasible, and only when appropriate. There may be instances when it is not appropriate to make a specific change (e.g., conducting in-person interviews about a sensitive topic and with a vulnerable population may not be appropriate to switch to online interviews; therefore, study activities may still have to be on hold until social distancing requirements are not required). Different considerations will be needed depending on the type of research and typical procedures for that study team. The logistics for any prospective research must be carefully considered.

For more information and some considerations to evaluate prior to submitting an REB application please see the full memo.

photo credit: Gamaliel E. M. No ez un covid mochiron via photopin (license)