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October 23, 2020

IRB Operations in the Time of COVID-19
By Vanessa Smith, MPS, CIP

The Rockefeller University Institutional Review Board (RU IRB) reviews the ethical suitability of all research investigations in the University that involve human participants. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. This includes all proposals for research as well as ongoing or long-term clinical research protocols. The RU IRB meets in person monthly to review and to approve, modify, or disapprove all research projects involving human participants.

When the University began scaling down in-person operations on campus, the IRB Office responded by putting procedures in place to operate remotely under the skilled leadership of Thomas P. Sakmar, MD, Human Research Protection Program (HRPP) Director and Sarah J. Schlesinger, MD, IRB Chair. Working together, the IRB Office, Clinical Research Support Office, and Clinical Research Facilitation Office promptly issued guidance to the research community and IRB members to confirm HRPP operations would remain fully functional via remote procedures during the pandemic. To support the transition to remote procedures, IRB Specialists, Vanessa Smith, MPS, CIP and Dale Miller, BA, CIP reviewed guidance issued by the Office of Human Research Protections and Food and Drug Administration to become informed about recommendations for IRB review of research during the pandemic. Consultations were also had with industry experts to assist the HRPP in responding as flexibily as possible while observing applicable regulations.

The IRB Office continues to operate remotely and will do so for the duration of the pandemic to expeditiously review protocol submissions for current research and assist with any new COVID-19 related clinical protocols. As seen in the above photograph, monthly IRB meetings are being held via Zoom and will continue until guidance is issued that it is safe to resume these activities on campus. IRB Leadership and Staff continue to work in close liaison with the Clinical Research Support Office, Clinical Research Facilitation Office, Hospital Informatics, University IT, and many
other key individuals within the HRPP to maintain open lines of communication. The IRB Office is sincerely grateful for the teamwork and dedication shown by all members of the Rockefeller Research Community to support the ethical conduct of research. We are also very thankful to our IRB members, many of whom have been members for over a decade, who responded kindly to efforts of IRB Staff to hold virtual meetings.
As always our first responsibility is the protection of Human Research Participants, but closely following is our mandate to advance the University’s research. The critical nature of this work is especially important now and it could not be done without the excellent teamwork and dedication of the Rockefeller Research Community