Research Update: Impact of COVID-19 on Castle IRB Reviews/Protocols

March 16, 2020 (Updated on May 15, 2020)

In order to ensure the safety of human research participants, including new risks due to the Coronavirus pandemic, Castle IRB is issuing the following information and guidelines to our clients:

1. Castle IRB operations are not impacted at this time. Castle IRB operations are in large part virtual and have not and should not sustain any disruptions due to the Coronavirus outbreak. Hours of Operation and modes of communication remain unchanged.
2. Castle IRB is committed to prioritizing any Coronavirus-related trial submissions, protocol amendments/exceptions, and safety reports for accelerated review. Only those events that indicate an increased risk of harm or otherwise fall under Castle IRB’s normal reportable event requirements must be submitted [see Castle Form 018 – Reportable Events Form; Castle Guidance 001 – Investigator Guide].
3. Clinical trials in active treatment phases may continue; however, sponsors, individual research sites and investigators must assess any modifications to study conduct to promote the health and wellbeing of research participants and to reduce the spread of COVID-19. Such measures could include:
   1. Introducing procedures to screen research participants at study visits and/or reminder calls prior to study visits for potential infection risk. The CDC Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Healthcare Situations and screening questions related to travel, verification of symptoms, etc., can be implemented without submission of an amendment to Castle IRB. This also applies to public health surveillance activities and legally required reporting that may impact the study participants.
   2. If some data collection or monitoring can be done remotely (e.g., in a participant’s home, via phone call, or telemedicine (in accordance with local law)), consider making these changes to the protocol. Such changes will require submission of an amendment and approval by Castle IRB. Such submissions are given priority review.
   3. Consider whether to discontinue the administration of an investigational product, eliminate certain procedures that will not adversely impact participant safety or wellbeing, or suspend participation altogether, if the study cannot be conducted safely.
4. Aside from the addition of a COVID-19 screener, public health surveillance, or legally required reporting, all changes to protocols must be submitted for Castle IRB approval prior to implementation unless implemented to eliminate immediate hazards to participants. In case of the latter, an amendment should be submitted as soon as possible (e.g., within 5 days) with an explanation and justification of changes put into place without prior IRB review.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic and OHRP Guidance on COVID-19 have been issued to assist sponsors, investigators and IRBs during this difficult time. Sponsors and Investigators should consult these guidelines, as well as federal, state and local requirements regarding shelter orders and other public health guidelines when making determinations regarding the continued conduct of research.

We will continue to monitor events as they unfold. Please contact our team with any questions or concerns: 888-442-2472 or irbteam@castleirb.com.