To the Yale Research Community:
We are updating the policy and guidelines recently distributed for modification to our procedures for conducting human subject research at the School of Medicine due to the COVID-19 pandemic. This addendum to the guidelines does not change any underlying policies but updates procedures for the implementation of those policies. It recognizes the existence of several categories of research protocols that require different responses to accomplish our continuing goals. Our primary concern is the safety of our research participants and the research team members who work for YSM and the health system.
Major components of the addendum include: (1) further guidance on the role of the PI and of departments; (2) development of blanket Yale HRPP procedures for COVID-19 related study changes; (3) information on the YNHHS Investigational Drug Service approach to the investigational products plan; (4) further guidance on sponsor monitor visits; and (5) further clarifications from the Yale clinical trials.gov team. As outlined, we will be asking all PIs who need to make protocol modifications to complete a very brief survey. The survey will provide the information necessary to allow us to create blanket IRB approvals to lessen the burden on PIs. In addition, we are providing PIs with an institutional memorandum that can be shared with trial sponsors that documents current University restrictions on visitors: visits scheduled prior to April 1 must be postponed; visits scheduled from April 2 through May 10, must be postponed or converted to one of the following virtual options: 1) email, 2) telephone, or 3) Zoom with video.
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 and 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