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COVID-19: FAQs

Guidance for clinical research in the context of COVID-19:

*Updated: June 17, 2022.  All questions below that have been newly added or updated are indicated with "New!", "Revised", "Updated" or "Clarified"

Refer back often- this page will be updated as required

REB review during the pandemic

Sunnybrook research ethics oversight activities are continuing, with modified procedures, where appropriate, as per REB SOP 501.

Monitoring

How do we address requests for alternate monitoring procedures during the pandemic?

Principal Investigators should work with the sponsors of each of their studies to assess an appropriate monitoring plan which may include on-site monitoring and/or central/remote monitoring. The plan may change over time and should be assessed as the situation evolves. This is consistent with guidance provided by Health Canada entitled “Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors” (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html).

(Note: For guidance on protocol and consent revisions please refer to the “Protocol and consent modifications FAQ”.)

Are on-site monitors allowed and are they required to be fully vaccinated?  

Monitors who need to be on-site, must follow the Sunnybrook protocol for vendors and contractors which requires evidence of full vaccination (2 dose minimum) and passing screening upon entry.  

What are the current acceptable document sharing practices for the purpose of remote monitoring?

The Sunnybrook Privacy Office and the Human Research Protections Program (HRPP), have published the following N2 SOP Addendum outlining acceptable document sharing processes for the purpose of remote monitoring:

What is the process for requesting remote access to Sunnycare for our Research Monitors?

Click Here

Is the Adobe Acrobat Pro Redaction function appropriate to use for Clinical Research purposes?

Click Here

(Updated) Adobe Sign

Click here for Adobe Sign FAQs and Instructions

Is it safe to handle human biological specimens in the context of COVID-19?

Biological specimen handling MUST always comply with biosafety standards. 

For other health and safety concerns and general training inquiries, who should I contact?

Home Visits

Any questions about the information below can be directed to the Manager, Research Ethics.

Home visits done by sponsor/contracted third party

  • When Sunnybrook REB is the Board of Record:
    • Submit the plan to the REB for review and approval.
    • The participant must consent to these visits.
    • The Informed Consent Form (ICF) or consent addendum should include the following:
      • Identify the name of the company conducting the home visits
      • State that they are not affiliated with Sunnybrook but have been contracted by the sponsor
      • Specify what activities may be conducted
      • State that the PI and research team will be providing the company with information about the participant in order to conduct the necessary research activities
      • Explain how privacy and confidentiality will be maintained
      • Outline any risks related to these visits
      • Detail the measures the company will be taking to protect the participant e.g. wearing PPE
      • Outline any other applicable details
  • When Sunnybrook REB is NOT the Board of Record, consult with the applicable REB for their requirements.

Home visits done by the research team

Contact SRI Safety and Compliance

Protocol and consent modifications

Changes to documents previously approved by the REB should follow standard procedures for submitting and admendment to the REB. 

Obtaining Informed Consent during a pandemic: What are some alternative methods in order to help prevent possible transmission of SARS-CoV-2?

All informed consent procedure changes should be in compliance with the current version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS(2), and where applicable ICH-GCP and the Canadian Food and Drug Regulations (FDR) for Health Canada regulated clinical trials.

Ultimately, the sponsor is responsible for ensuring the trial is implemented in accordance with these regulations.

*If the process you plan to implement is different than what is described in the approved protocol or REB application, an amendment should be submitted to the REB for review and approval.

Some solutions may include:

  • Electronic consent
    • May be considered if the technology is available
    • The electronic consent system should have been properly validated in accordance with the International Council for Harmonization (ICH) E6 5.5.3
    • All required elements outlined in FDR C.05.010(h) and ICH E6, 4.8.10 should have been present in the electronic informed consent form
  • Consent obtained orally by phone or video conference (Interventional Research)
    • The research team should arrange a three-way call or video conference with the participant or Substitute decision maker (SDM)/representative AND an impartial witness (can be a family member).  If desired and feasible, the participant/SDM may invite others to join (e.g., next of kin)
    • Documentation of this process is important
    • For Health Canada regulated interventional clinical trials, the witness must sign an attestation:
      • It must be clear that the witness was present during the process regardless of the method of communication
      • A scanned copy or picture of the attestation may be forwarded to the investigator by email or text (ensure this meets privacy requirements)
      • The conversation should be recorded if it isn’t possible to have a witness
        • This recording becomes part of the trial records and must be archived for entire retention period
        • Check with the Privacy Office for appropriate recording options
      • Check if the REB of Record has specific requirements for an attestation
  • Consent obtained orally by phone or video conference (Observational Research)
    • The research team should arrange a two-way call or video conference with the participant or Substitute decision maker (SDM)/representative. If desired and feasible, the participant/SDM may invite others to join (e.g., next of kin)
    • Once the consent discussion is complete and the participant/SDM verbally confirms their consent, the person conducting the consent discussion will complete the signature pages of the ICF by writing in the participant/SDM name, the date of the consent discussion, and their own name, signature, and date of signature.
    • Documentation of this process is important
  • Consent obtained by email
    • Consenting documents are sent to participants or SDMs via email for their review.  Consider including in the email an explanation of the consent process, and contact information for participants/SDMs if any questions arise prior to signing documents.
    • Conduct informed consent discussion
    • Participants/SDMs returns a signed copy of the ICF to the research team.  See above section to determine if a witness is required. 
    • The research team signs the consent form and sends participants/SDMs a copy for their records

The process for obtaining informed consent through alternative methods should be clearly outlined and detailed in a procedure or policy.

Research site personnel, those delegated responsible for the consenting process by the qualified investigator, should be trained on the new process and have appropriate documentation regarding the training.

Given the rapidly-changing pandemic environment, participants should be made aware of important new information as it becomes available, as it may affect their willingness to participate. This information should be provided in a timely manner to the participant, SDM, or representative.

For further guidance, see regulatory guidance links below.

How should I document protocol deviations?

Clinical trial site(s) should have a system in place to identify, document, assess and report all protocol deviations to the sponsor and REB in accordance with sponsor and REB requirements. These deviations need to be documented, to facilitate future analysis of the study findings.

To help manage deviation tracking, please find a protocol deviation tracking log on the QA&E webpages.

NOTE: This PD Tracking Log is to be used in conjunction with the Protocol Deviation Reporting Form

Notes for Health Canada regulated trials:

  • Health Canada recognizes that there may be an increase in protocol deviations during the COVID-19 pandemic.
  • It is the sponsor’s responsibility to define and identify the protocol deviations to be reported. Unless the deviations may place participants at risk, sponsors will not be required to report these deviations to Health Canada

Regulatory Guidance:

Health Canada Guidance for the Management of Clinical Trials during COVID19 Pandemic

FDA Guidance Document

The guidance is intended to provide general considerations to assist in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.

All other questions can be directed to: HRPP@sunnybrook.ca

Previous Guidance:

    Is it safe to handle human biological specimens in the context of COVID-19?

    Biological specimen handling MUST always comply with biosafety standards. Sunnybrook is taking an inventory of current practices, specimen types and processing locations to ensure safe practices are in place. estins should be directed to SRI’s Biosafety Officer kkathir@sri.utoronto.ca .

    All other questions can be directed to: