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Impact of COVID-19 Outbreak on Ongoing Research and Protocols Under Advarra IRB Review

Note: This news item was updated March 16, 2020, to include additional information and guidance since the original post, including a new “Ask Advarra” resource to help with unique study-specific COVID-19 questions.

Advarra has policies and processes in place to keep IRB operations functioning as normal during the current coronavirus disease (COVID-19) outbreak. Additionally, Advarra offers complimentary, direct support for sponsors and study teams seeking guidance regarding the research impact of the current public health situation.

Impact on Advarra IRB Operations

The COVID-19 outbreak has raised concerns among sponsors and study teams about how the outbreak may impact Advarra’s operations as well as protocols overseen by Advarra’s IRB that are currently enrolling. Advarra continues to have 15 IRB meetings a week, and the IRB has been prioritizing the review of the numerous COVID-19 protocols received as well as amendments relating to changes in research conduct because of unforeseen circumstances.

IRB meetings and processes are not impacted by any restrictions on travel. As a standard practice, the IRB meets remotely via video conference technology, and Advarra staff have the resources and flexibility to work remotely.

For more information on Advarra’s business continuity efforts, read this press release.

Personalized Answers via “Ask Advarra” Online Form

Sponsors and study teams are encouraged to use the Ask Advarra online form for answers to urgent questions regarding COVID-19 and its impact on human subject protections, biosafety, and other research compliance issues. Advarra experts will respond to inquiries within 1 business day. Click here to submit a question.

General Guidance and Support for Research Professionals

During the current outbreak, researchers may implement changes to the IRB approved research, prior to IRB review and approval of the research changes, when necessary to eliminate apparent immediate hazards to participants (see 45 CFR 46.108[a][3][iii] and 21 CFR 56.109[a] for details).

For sponsors and study teams navigating the public health situation, Advarra offers the following recommendations:

    1. Changes to the protocol necessary to eliminate apparent immediate hazards to participants may include:
      • Changing from in-person visits to virtual visits (e.g., use of digital technology as a substitute for in-person visits).
      • Elimination of study visits/procedures that do not impact the integrity of the study or participant safety.
      • Incorporation of screening questions to identify potential COVID-19 exposure.
    2. When changes are made to eliminate an apparent immediate hazard to participants, those changes still need to be reported promptly to the IRB.
      • Exception: Incorporating screening questions to identify potential exposure to COVID-19 does not require IRB approval.
    3. When changes necessary to eliminate apparent immediate hazards to participants are implemented prior to IRB review, no new consent is required unless the change fundamentally alters what the participants consented to.
      • While the phrase “re-consent” is widely used, it does not exist in the regulations. If someone consents to participate in research, they only need to consent again if something changes that essentially negates their consent to participate.
      • Participants can be informed of changes in the research by way of a notification that is not a new consent document.
    4. Research participants may be asked to complete a short screening for exposure to COVID-19 before in-person interactions. The incorporation of this screening procedure does not require IRB approval. The wording below may be changed to accommodate changes in the current public health situation but should be comparable to the following:
      • Have you traveled to China, Iran, Italy, Japan, or South Korea in the past 14 days?
      • Have you had any of the following symptoms in the past 14 days without confirmation as something other than COVID-19 (such as a positive flu test, chronic medical condition, etc.)?
        • Fever greater than 100.4 degrees Fahrenheit
        • Cough
        • Difficulty breathing
        • Sore throat
      • In the last 14 days, have you lived with, visited, cared for, or been in a room for a prolonged period of time with someone who is under investigation or has been confirmed for COVID-19?
      • If a participant says yes to any of the above questions, it is recommended that study staff identify a resource to direct the participant to.
    5. Review the study to determine if any study procedures that require participants to come to a hospital or a clinic can be eliminated or managed remotely through telemedicine or home visits.
      • This would require an IRB determination stating that changes in these procedures to either eliminate them or manage them remotely would not impact the integrity of the research.
    6. If, at the time of continuing review, some studies appear to not be meeting enrollment goals due to COVID-19 outbreak-related issues, describe the impact of this outbreak on the study in the continuing review report.
      • The IRB will be mindful of the current situation in its continuing review assessment.
    7. If research participants are not able to come to hospitals or clinics because of infection, self-quarantines, or travel restrictions, submit an amendment identifying alternative processes such as:
      • Digital technology to record symptoms.
      • Telemedicine options to provide virtual visits.
      • Visits from visiting nurses or home health aides to conduct study related procedures.
      • Please note that shipping study agents to participants is subject to state and federal laws.
    8. Consider remote work options if there may be shortages of study team staff.
      • Also consider establishing back-up coverage plans even when fully staffed.
    9. Conduct monitoring activities remotely if appropriate.
      • During this time when travel is discouraged, remote monitoring is a viable alternative to sending monitors to a site. Email, video conferencing and secure file transfer can facilitate this process.
    10. Protocol deviations do not need to be reported to Advarra unless they impose an increase in the risk of harm to participants or adversely affect the integrity of the data.
      • A protocol deviation is something that applies to one individual.
      • Example: If one person is not able to travel for an in-person visit because of self-quarantine, that is a minor deviation and does not need to be reported unless it impacts the risk to the participant.
      • This is Advarra’s standard reporting requirement; other IRBs’ policies may vary.
      • For more information, see section 18.3 of the Advarra IRB Handbook for Investigators, Institutions, Sponsors, and Sponsors’ Representatives (available in the Reference Materials section of the Advarra CIRBI Platform [login required]).

As always, all changes to research should have prior review by the IRB. Investigators are permitted to implement study changes to eliminate immediate hazards to participant safety. Amendments should be submitted to Advarra promptly, describing any changes that have already been implemented and, as appropriate, justification for why changes were put into place prior to IRB review.

For more information, clients should contact the Client Services Coordinator listed on their IRB submissions or submit a question via the Ask Advarra online form.

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