C19

In a recent webinar on the impact of COVID-19 on research, experts from Advarra and Johns Hopkins University School of Medicine provided practical guidance on conducting research during the COVID-19 pandemic. Over 2,000 clinical research professionals joined us for the webinar to learn about the specific issues faced by the research community during the public health emergency. While we didn’t have time during the webinar broadcast to respond to all of the 500+ questions submitted by attendees, we’ve addressed some of the most popular topics here. Additional information is available on our Coronavirus Guidance page.

Note: Some questions were outside of our presenters’ area of IRB expertise, but we’ve provided external links to relevant information where possible. Additionally, it was challenging to answer some questions because we needed more specific information to understand the situation. If you don’t see your question answered below or on our Coronavirus Guidance page, please follow up with us at Ask Advarra.

Q. How should we make sure our staff and participants are safe when we return to the clinic? We are looking for information about personal protective equipment (PPE), enforcing social distancing, guidelines for in-clinic visits, etc.
A. We suggest reviewing the Centers for Disease Control and Prevention (CDC) website Information for Healthcare Professionals About Coronavirus (COVID-19), which covers many of these topics.

Q. We are planning to move from in-clinic consenting to remote consent, what do we need to do?
A. For the latest information, please review the sections Remote Consenting and Informed Consent: Inability to Obtain a Digital Image of the Informed Consent of our Coronavirus Guidance page.

Q. How do I obtain eConsent and what platforms are Part 11 compliant?
A. At Advarra, we use the term electronic consent (eConsent or eIC) to refer to the use of electronic systems and processes that may employ multiple electronic media (including text, graphics, audio, video, podcasts, passive and interactive websites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent. For more information on eConsent, reference FDA/OHRP Guidance on Use of Electronic Informed Consent – Questions and Answers.

For the latest information on eConsent during the current pandemic, please review the section Part 11 Compliant Electronic Signature Capture of our Coronavirus Guidance.

Q. How do we obtain consent from a COVID-19 patient in an isolation unit?
A. For the latest information, please review the section Consent From COVID-19 Patients in a Containment Unit or Quarantined Space or From a Physically Unavailable LAR of our Coronavirus Guidance. The step-by-step guidance provided in that section meets Advarra’s IRB requirements for obtaining consent from COVID-19 patients in a containment unit or quarantined space, or from a physically unavailable legally authorized representative (LAR). Please check with your IRB of record for their specific requirements.

Q. Do we need to report protocol deviations (like out-of-window visits) caused by the pandemic to the IRB?
A. Please check with your IRB of record to determine whether reporting is required. At Advarra, we provide current guidelines for reporting protocol deviations in the section General Guidance for Advarra Studies of our Coronavirus Guidance.

Q. What changes in research can we make before IRB approval to address the pandemic? What changes need to be reported to the IRB?
A. Check with your IRB of record to determine what changes need to be reported to the IRB. At Advarra, we provide current guidance in the section Changes to the IRB Approved Protocol of our Coronavirus Guidance.

We suggest that participants be notified by letter or other communication of all study changes. All changes should be documented in the study records.

Q. The most challenging aspect of this pandemic has been determining which hierarchy to follow and figuring out what changes are needed and whether they need to be reported. Whose rule takes precedence: The institution because they are following state law? FDA guidance? The IRB (local vs central)? The sponsor?
A. In addressing changes to research needed because of the COVID-19 pandemic, researchers should keep abreast of federal regulatory guidance, sponsor directives, and local organizational policies and requirements. Particularly important is adhering to local requirements at the site where the research will be performed; these requirements will consider the availability of local resources, state law restrictions, and the risk of local exposures. In cases where the requirements of a central IRB or sponsor are not as restrictive as local requirements, investigators should be sure to adhere to local standards at their own sites.

Q. Are IRB submission timelines and review times impacted by the pandemic? What about study startup and site activation?
A. Check with your IRB of record for information on changes in IRB submission timelines and review times. At Advarra, our IRB timelines have not been impacted by COVID-19, and we have made an additional pledge to review COVID-19 drug and device research within 24 hours of a complete submission.

For many studies, the expected startup and site activation timelines have been impacted by COVID-19 due to site restrictions, which will vary depending on the study and the site. Check with the site for details.

Q. How do other sites address additional expenses caused by COVID-19 that couldn’t have been part of the CTA/budget (e.g., higher recruitment efforts, sanitizing measurements taken, PPE, spacing out participants and personnel, etc.)?
A. While we don’t have specific information on how sites are addressing this, we suggest referring to the following NIH guidance which discusses unexpected expenses and what to do about them:
Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19

Q. How do you monitor studies effectively during the COVID-19 pandemic?
A. For the latest information, please review the section Remote Monitoring Visits of our Coronavirus Guidance.

Q. What do we need to know about moving to telehealth visits since we don’t want participants to be exposed in the clinic?
A. For the latest information, please review the section HIPAA Compliance and Telemedicine Application Vendors of our Coronavirus Guidance.

Thank you again to everyone who attended our webinar and shared your questions. We hope you find this information helpful. As a reminder, we are available to assist with any ongoing questions via Ask Advarra. We will respond to your questions within one business day.

While the COVID-19 pandemic has challenged us in unprecedented ways, we have been gratified to see the collaboration, innovation, and diligence brought to bear on solving this problem. We are humbled to be part of this effort, and we are grateful to all those on the front lines of COVID-19 research.

For more information on the research impact of COVID-19, watch our webinar Ask Advarra Live: The Real-World Impact of COVID-19 on Research or review our Coronavirus Guidance.

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