The Royal Victoria Regional Health Centre Research Ethics Board (RVH REB) acknowledges the impact that the COVID-19 pandemic has had on the clinical research environment, and the potential impact on the daily conduct and oversight of clinical trials. The safety of participants is of primary importance, and the potential harms of initiating or continuing a trial should be weighed against anticipated benefits in such a setting. Investigators should work with their study sponsors to consider whether the start of a new study should be delayed, or if an existing study should be modified in light of the impact of COVID-19 related constraints on the clinical services, and to assess the impact of any changes on participant safety and data integrity.

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The RVH REB Activities during the Pandemic

 

The RVH REB has policies and processes in place to continue with its reviews and ethics oversight during the current coronavirus (COVID-19) outbreak.

• The REB oversight activities are continuing remotely, as per SOP 501

• The REB will prioritize the review of amendments that are necessary as a result of COVID-19.

• We may schedule ad hoc REB sub-committee meetings as needed, as per SOP 501.

• An e-mail authorizing approval from the PI will be accepted in lieu of a wet-ink signature on all application forms.

• We are waiving the requirement of triplicate paper submissions until regular activities resume.

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Reporting Expectations of the Investigator/Study Sites

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Sponsors and investigators should inform the REB as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID19. In this way, the REB can evaluate the proposed changes and ensure that the context and the anticipated outcomes have been assessed appropriately. The implementation of alternative processes should be consistent with the protocol to the extent possible, and sponsors and investigators should document the reason for any contingency measures implemented. Examples of this include, but are not limited to, the impact on the informed consent process, study visits and procedures, data collection, study monitoring, adverse event reporting, and changes in investigator(s), site staff, and/or monitor(s). Policy and procedures should be compliant with applicable policies for the management and control of COVID-19. Efforts to ensure the safety and welfare of participants and to minimize impacts on trial integrity, and to document the reasons for protocol deviations, will be significant.

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1. Changes in approved research should not be initiated without the REB’s review and approval except where necessary to eliminate an apparent immediate risk to research participants. Changes to the study necessary to eliminate apparent immediate hazards/risks to participants may include:​​

   • Changing from in-person visits to virtual;

   • Change or elimination in study visits/procedures that do not impact the integrity of the study or participant safety – e.g., change to dispensing of study medications; suspended sample collection; delayed submission of data to sponsor; revised consenting procedures; suspension of follow-up visits;

   • Incorporation of screening questions to identify potential COVID-19 exposure. The incorporation of this screening procedure does not require REB approval given that they are being utilized across RVH.

2. If a study sponsor needs to make a change to a study in order to eliminate apparent immediate risks to participants, these changes can be made and then reported to the REB within 10 business days. The notification to the REB may be a full protocol, however, it also may be a memo, letter, or other document that explains the changes being made, as long as it provides sufficient information for the REB to assess the relative risks resulting from the changes.

3. When changes necessary to eliminate apparent immediate hazards to participants are implemented prior to REB review, consent is not required unless the change fundamentally alters what the participants previously consented to, which requires documented ongoing (oral)  consent. However, if required, participants also would be informed of any relevant changes through a revised consent form, which would be submitted to the REB with an amendment form.

4. The impact of any changes in the conduct of the study should be documented to enable appropriate evaluation and reporting and to ensure that ongoing consent is maintained.

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Considerations for Initiation or Continuation of a Study

 

• The initiation of a study or the ongoing conduct of a study should be aligned with RVH’s requirements during the pandemic.

• The impact of COVID-19 on recruitment and retention of participants should be carefully considered before initiating a new study. The ability to confirm eligibility and to conduct key safety assessments and study evaluations within the specified time window is (are) of particular importance.

• The investigator and sponsor should assess each study to determine if recruitment should be temporarily suspended, or participants discontinued. Such decisions should be proportionate and based on benefit-risk considerations and impact on the health and safety of the participant.

• Contingency arrangements must be made if an investigator is unable to carry on with the PI role – e.g., coverage by a co-investigator; assignment to a new PI. If the study will be assigned to another PI, submit an amendment form to the REB with the change in Centre PI.

• Alternative mechanisms - e.g., remote monitoring, must be put in place for ongoing sponsor monitoring of the study, as applicable.

• If a participant is unable to attend an on-site appointment, other measures, such as home nursing, home delivery of study medications, or contact via phone may be required to identify adverse events and ensure ongoing medical and study oversight. However, the limitations of such methods should be taken into account. Changes to existing practice should be proportionate and based on benefit-risk principles.

• Participants must be kept informed of the new information, such as privacy considerations if communications are changed from in-person to phone and/or require the disclosure of personal health information (PHI) such as for home delivery of medications.

 

The RVH Research Ethics Board is committed to the safety of study participants, and to supporting research as much as we can through these challenging times. Please do not hesitate to contact us with any questions at  ethics@rvh.on.ca

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Relevant Related Materials:

March 23, 2020: Health Canada Notice to clinical trial sponsors published on their website.  

FDA Clinical Trial Guidance during COVID-19 Pandemic

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Archived Webinar: Clinical Trials in the Era of COVID-19: The Changes You Need to Make Now

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