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Guidance on Conduct of Human Research during COVID-19

March 14, 2020
by Nancy J. Brown and Brian Smith

To the Yale Research Community:

We write to inform you of current policy and guidelines for modifications to our procedures for conducting human subject research at the School of Medicine due to the COVID-19 pandemic. These include modifications as well as information on what needs to be reported to the IRB.

Please note that research conducted in clinical facilities follows all the precautions and procedures articulated in other documents from YM and YNHH. For research that is conducted in sites that are not simultaneously standard clinical care sites, it is necessary to institute the same procedures and cautions that we are using in our ambulatory clinical sites. YM and YCCI are prepared to assist the investigative teams to get to that state.

It is not possible to stop all human subject research protocols in YSM since many of these are interventional and hence of potential direct benefit to patients. However, wherever possible, without compromising these interventional protocols, investigative teams should use telehealth mechanisms, reduction of visits, and other mitigating interventions to reduce the risk for subjects and for staff. It is also highly recommended to pause all non-interventional protocols that require face-to-face contact and convert these, as possible, to telehealth and other non-contact options. The IRB is poised to assist with all of these issues. Some issues can be addressed by “blanket” procedures by the IRB–investigators will be guided in all these matters by HRPP.

As always, thanks to all for the work that you do to provide our patients and our community with the best state-of-the-art investigational options.

Brian R. Smith, MD
Deputy Dean for Scientific Affairs (Clinical Departments)
Professor & Chair, Department of Laboratory Medicine
Co-Director, Yale Center for Clinical Investigation

Nancy J. Brown, MD
Jean and David W. Wallace Dean of Medicine
C.N.H. Long Professor of Internal Medicine

Submitted by Liz Pantani on March 20, 2020