Hospital-Based Clinical Research

Published December 23, 2020

Dear School of Medicine Faculty, Staff, and Trainees:

As you know, the ongoing winter surge in COVID-19 cases is imposing substantial additional burdens on hospital personnel. To meet the additional clinical demands, BJC has implemented a contingent staffing model across its facilities in which nurses and other hospital staff are being redeployed to new clinical areas. Under these complex circumstances, it is crucial for hospital staff and unit leaders to be able to devote their focus and resources to delivering outstanding patient care, without additional non-essential responsibilities.

We fully appreciate that many clinical studies are closely integrated with the patient care we deliver, and that all of them are important contributions to our ability to improve our patients’ health. For certain hospitalized patients, therapeutic clinical trials offer essential treatment options; the ability to offer these trials is also closely aligned with an academic medical center’s mission to deliver therapeutic advances to our patients in the future. For these reasons, in August 2020, we moved Washington University guidelines for clinical research to Yellow Level 2 status, which enables most research to proceed under Department/Division-approved research transition plans that outline measures to maintain the safety of participants and personnel.

However, at this time, to support the needs of our patients and hospital staff colleagues, we urge all researchers who are conducting hospital-based clinical studies to: (1) re-evaluate the potential impact of your studies’ conduct on hospital personnel, processes and resources; (2) consider how to alter the conduct of your studies to reduce reliance on clinical personnel (e.g. unit nurses) and to minimize clinical workflow impact; and (3) for studies that require substantial involvement of, or impact on, the clinical staff of specific hospital unit(s), pro-actively coordinate with the applicable units’ Patient Care Services Director and/or Medical Director to develop mutually satisfactory plans to conduct the study. In some instances, it may make sense to avoid initiating new studies or resource-demanding processes, or to avoid enrolling new patients.

We regret the need for these recommendations, but we hope you will recognize them as small but important sacrifices that are necessary to preserve our essential capacity to take care of our patients and partners. Please direct any questions about these recommendations to Suresh Vedantham or Yi Zhang.

Sincerely,