Pandemic’s Effects on Clinical Trials Draw Attention to Importance of IRBs and Trial Services Teams

Extraordinary measures taken in the midst of the COVID-19 crisis, from “shelter in place orders” to ramping down non-essential services, have significantly disrupted institutional review board (IRB) and clinical trial research operations, according to BRANY, a national provider of IRB review and trial start-up services.

Information supplied by the organization, which is owned by four academic medical centers (AMCs) in New York, notes that front line healthcare providers are focusing their time and energy on myriad patient care issues. Clinicians who may have served on IRBs have necessarily shifted their focus to patient care. Meanwhile, research professionals, such as clinical research coordinators, are working from home, sometimes without the appropriate set-up or resources.

“Research institutions, hospitals, and [AMCs] across the United States are all deeply impacted by the ongoing COVID-19 pandemic,” says Paddy Mullen, chief executive officer of BRANY.

Current conditions are breeding the potential for staffing to become sparse and for research administrators to be pulled away from study oversight to tend to other organizational priorities, the organization notes. Consequently, it can become more challenging for study teams to remain compliant with regulations and institutional requirements.

“Several institutions are implementing investigator-initiated trials focusing on COVID-19,” adds Mullen. These urgently needed protocols require swift IRB review, she says. Considering the circumstances, some organizations may need to temporarily transfer IRB oversight of some or all of their trials to ensure the protection of human subjects during this crisis, BRANY indicates.

Edited by Gary W. Cramer