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  • COVID-19 Story From an IRB Member and Administrator
  • T. Howard Stone

Introduction

Declaration of the COVID-19 national emergency has had and continues to have a profound effect upon what human research studies are permitted, how permitted studies are conducted, review of these studies, and the guidance that is provided to the research community at the university where I am an IRB member and administrator. From the almost instantaneous cessation in all human research activities to more recent discussions about phasing in permitted human research, human subject safety and well-being has been the touchstone. Ensuring that every corner of the University's research enterprise is provided current, relevant, accurate and useful information and resources about COVID-19 and human research, is a priority but resource intensive in the review and oversight of human research. Until the COVID-19 emergency is lifted however, COVID-19-related limitations on human research will remain in effect.

Cessation of Human Research

Prior to and very soon after the March 13, 2020 issuance of the Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, University leadership issued a series of announcements about imposing a wide range of scaled-up steps to prevent the spread of COVID-19, including new disinfection procedures, quarantine and isolation requirements, remote teaching, cancellation of events and activities, and remote work. These steps were often tailored to the context and environment in which human activities and interaction took place, including, for example, local, national, or international locations; office, classroom, laboratory, off-campus or clinics; teaching, service or research settings; and student, staff, faculty and visitor populations. Considering the precautions that were imposed, the Vice President for Research, Office of Research, and I discussed the implications of the national emergency and University actions upon research involving human subjects. The discussion centered on plans for the University's research leadership to announce a halt to all on-going and planned human research with reference to some possible, limited exceptions to be later explained. The halt impacted OHSP and IRB's operations and reviews, staff and member safety, initial and on-going messaging, and other avenues of communications that the OHSP and IRB provide to the research community. Thereafter, on March 23, research leadership announced as a policy matter, the cessation of research activities that involve in-person interactions or interventions with human research participants ("cessation"). The announcement provided general information about the cessation, specific exceptions, links to additional information and contacts for further questions or concerns. The objective of the cessation was to immediately stop any in-person face-to-face human research activities except for COVID-19 research that involved substantial likelihood of direct and meaningful biomedical or behavioral health-related benefit or outcome. Certain clinical trial activities taking place in licensed health care facilities or offices within the context of a necessary clinical care visit for which activities could not be performed remotely were also allowed to continue. Particulars of the cessation were subsequently provided to the state university system's Board of Governors for their own deliberation of COVID-19-related precautions.

Early Actions

To help ensure the broadest possible dissemination to the University community of the cessation policy, the announcement of the policy was published on the main public-facing web pages of the University, Office of Research and Office for Human Subjects Protection (OHSP)/IRB. The University and Office of Research pages included links to the OHSP/ IRB home page. Additional information and links to a special COVID-19 and Human Research Studies page were provided. Prominently arranged on this special page is first stated the underlying policy for the cessation and their links. The list of research activity exceptions and their criteria [End Page E16] (e.g., no persons deemed at higher risk for severe illness from COVID-19, including persons aged 65 or more years may be included at subjects in any in-person research activity) followed. Requirements for excepted studies (e.g., remote activities where possible; COVID-19 screening; maximizing social distancing; use of protective equipment such as masks) were next. Then, specific instructions for halting non-excepted study activities, such as notices to enrolled study subjects and...

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