COVID-19 has been an exceptional epidemic for its scale and impact on societies’ “life as usual” approach. Particularly in the research space, COVID-19 outbreak has raised concerns among sponsors and research teams about how the outbreak has impacted research study operations, and how to address a similar situation better in future. At the onset of the pandemic, IRB meetings and processes were greatly impacted by the restrictions on travel; however, as a standard practice, the IRB meetings were made virtual via video conference technology (e.g., Zoom and Google Meet). New digital technologies and resources like Slack, Dropbox and Google Drive have provided the flexibility to work remotely. Studies that were able to enrol subjects virtually and continue studies remotely found this seamless. However, for the studies that still need the physical presence of the subjects, this digital transition has faced hardships. It impacted the timelines, milestones, delivery, and funding.

With the experience of spearheading digital transformation initiatives of our esteemed clients before and during this unprecedented public health situation, conducting non-COVID related research on human subjects, we offer the following recommendations and best practices:
1. Investigators should include provisions in the protocols for subject enrolment that there can be flexibility of switching to virtual visits without a protocol modification, if needed. Clinical follow-up visits should be shifted to virtual visits whenever to manage them remotely and that these changes will not impact the integrity and quality of the research. Apart from reducing the costs and addressing the logistical challenges, this also provides lot more flexibility.
2. 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.
3. Flexibility to be provided in the protocol to not have new consent requirements, when changes are implemented to eliminate the apparent immediate hazards to participants prior to IRB review unless the changes fundamentally alter what the participants consented to. Approvals to new changes made to the procedure can be facilitated via notifications.
4. Successful collaboration between research teams even in remote work-from-home options can be made possible with digital technologies. In these scenarios, cloud systems, data storage and network security become extremely important.

At Key Solutions, our research compliance i.e., IRB (Human Subjects) e-Protocol module and research administration products help teams navigate these changes with ease. Our product features include centralized access across teams and protocol version tracking including development, submission, tracking, review, approval, audit, and so on. An entire history of forms, comments, attachments, notes, agenda, and meeting minutes is maintained for each protocol application through our software. This helps with data collection, change management and timely approvals for your research. Contact us today for more information.