Category: Law

March 19th, 2020
Given the evolving circumstances with COVID19 Western’s Research Ethics Boards (REB) encourage all researchers with active protocols to evaluate the necessity of ongoing study activities at this time, and if needed, to make appropriate (and applicable) revisions to their study in response to Public Health Ontario recommendations until further notice – maintaining compliance to all institutional, provincial and federal guidelines.

The Principal Investigator (PI) on the application is responsible for exercising sound judgment in determining when ongoing study activities are appropriate, taking into consideration: (a) the objective of the research; (b) the mandate to protect all participants, research staff and the community at large; and (c) the resources available (e.g., access to study sites, personnel, technologies, etc.) to carry out ongoing activities.

1. Are ongoing study activities essential at this time?
2. If ‘yes’, what study activities must continue?
3. Are any modifications to approved study procedures needed to responsibly carry out these activities?
4. If ‘yes’, will these modifications increase any risk to participants, researchers, the community at large or the institution?
5. If ‘yes’, what steps will be implemented to minimize risk to all involved?

Western’s Research Ethics Boards (REBs) recognize the with a wide range of research across campus will necessitate diverse modifications to facilitate research activities during this time.

Below are some technologies Western makes available which may help facilitate social distancing and minimize travel to campus and face-to-face interactions, while still allowing research teams to communicate with each other and with participants as needed.

• Consent modifications: verbal consent via telephone (required: verbal script and evidence of documented consent such as via audio-recording); written consent received via email attachment; online consent via Qualtrics (mysurveys.uwo.ca).
• Videoconferencing options: Western Zoom and hospital options
• Office 365 Suite: deemed secure for collection, transfer, storage of sensitive information (e.g., de-identified research data)

As per the Memo sent on March 13, 2020, researchers must report these modifications to the REB within 5 days of implementing the change if not possible to do so before. These reports must be submitted as a Reportable Event in WREM (see Actions: “Create Sub-Form”), selecting “For Your
Information (FYI)” in Q1.8 of the application form.

You must go into WREM and use the correspondence feature to message the specific Ethics Officer (EO) assigned to your file to efficiently communicate with the REB about your own individual studies. It will be much faster and the most efficient way to ensure your message gets to the most appropriate person. The messages go right to the email for the EO assigned to the file.

Office of Human Research Ethics Phone: 519.661.3036, Email: ethics@uwo.ca

photo credit: Prachatai Covid-19 via photopin (license)

March 13, 2020. Memo from Erika Basile, Director, Research Ethics and Compliance Office, Western University

Impact of COVID-19 on Western University Research Ethics Board (REB) approved Studies

Given rapidly evolving circumstances presented by COVID-19, Western’s Health Sciences and Non-Medical Research Ethics Boards (HSREB/NMREB) are monitoring the situation carefully in conjunction with hospital and university programs and units. Our primary concern is the health and well-being of our patients, staff, faculty and students. This is particularly important for ongoing research taking place within our hospitals/university and affiliated sites. This is a fluid situation we are monitoring closely.

The Office of Human Research Ethics does not have the resources necessary to provide their usual levels of ethical oversight. As such, investigators will temporarily need to bear an increased burden for oversight of their projects to ensure research participant/patient safety. This is particularly critical for research participants/patients whose care involves investigational drug or medical device interventions and whose safety depends on regular evaluations.

Effective immediately, enrollment of new research participants into Lawson-affiliated studies not providing a potentially essential treatment option with a time limited enrollment window should be suspended until April 30, 2020. Please note this date may be extended as the situation evolves. In contrast, enrollment of new research participants for non-Lawson affiliated studies is NOT suspended at this time.

We are advising investigators to consider whether their active research protocols could be modified or delayed to limit personal contact, laboratory visits or trips to clinics and hospitals. These modifications must be completed in collaboration with the study sponsor where applicable.

Specifically, in-person interactions should be reduced and/or replaced with telephone or online communication wherever it is possible to maintain the protocol’s scientific validity. Considerations include the nature of the protocol, the type of participants engaged in the research and any additional risks that may arise by switching from in-person to virtual communication (e.g., Cisco Webex at the hospitals, Zoom at Western).

Revised participant consent or consent addendums may be required (e.g., to update privacy considerations with use of different communication channels), but these communication changes do not need to be approved by the HSREB/NMREB prior to implementation. Please note this is not a blanket approval for protocol changes. This correspondence applies only to changes made in response to COVID-19 precautions.

Where research staff are feeling unwell, care should be taken to stay home to prevent transmission of any illness. Institutional protocols must be followed, as determined by Western/LHSC/SJHC/Lawson, if COVID-19 is known or suspected.

While regulations (e.g., TCPS2, FDA) typically require review and approval of research protocol modifications prior to implementation, an exception can be made where the change is necessary to eliminate an immediate risk to participant(s) (TCPS2 Article 6.15 and 21 CFR 56.108(a)(4)). Such changes may be implemented immediately; however, where possible, the notification to the REB should be performed prior to implementing the changes, and when notification to the REB is not possible before implementation, they must be reported to the HSREB/NMREB within five business days (via WREM-Reportable Event-FYI). Please specifically
reference “COVID-19”.

Ethical oversight is the responsibility of PIs if they are introducing additional risks and making urgent changes prior to formal HSREB/NMREB approval. Investigators must also submit a document that describes the changes and explains how participants will be protected. Copies of
any new or revised participant-facing materials must also be submitted. Sign-off on the submission by WREM must be provided by the PI or a PI-delegated person.

This change to the REB process will be in place until further communicated.

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

photo credit: Prachatai Covid-19 via photopin (license)