When the virus that causes COVID-19, SARS-CoV-2, enters the epithelial cells of a person’s nasal or throat passage, it binds to an enzyme called ACE2 (angiotensin-converting enzyme 2). The interactions between these cells and SARS-CoV-2 have fueled a lot of speculation in the scientific community about the impact popular blood pressure prescription drugs have on COVID-19 patients. Dr. J. Brian Byrd, assistant professor of internal medicine at the U-M Medical School, studies several of these popular prescription medications.
Dr. Byrd is part of a multi-site study that is evaluating whether continuing medication versus discontinuing common blood pressure medications (ACE inhibitors or angiotensin receptor blockers) at time of hospitalization for COVID-19 makes a difference in how people recover and respond to treatment, focusing on two of the most common blood pressure treatments in the U.S. “One of the main medications we’re evaluating is the most prescribed and another is the ninth-most prescribed drug in the United States,” Dr. Byrd explained.
To learn more, Dr. Byrd and his team joined a multi-site clinical study of these drugs and their interactions with COVID-19, initiated by the University of Pennsylvania. The study is being conducted through the University of Pennsylvania in partnership with U-M, the University of Ottawa, Duke University, and others.
Having worked with MICHR’s Clinical Research Management (CRM), IND/IDE Investigator Assistance Program (MIAP), and Biostatistics teams on several other projects, it was natural for Dr. Byrd to seek input from MICHR when the opportunity to join this multi-site study came along. Dr. Byrd said MICHR was instrumental in getting Michigan Medicine’s site ready for the study.
Dr. Byrd contacted the CRM team to discuss e-consent and the REDCap data collection practices that were being proposed by the lead site. Consent is the process by which potential study participants must be given the information they need to understand the nature of the research, its possible risks, and inconveniences, as well as the benefits that may arise from joining in the research. Electronic or e-consent was a new approach for Dr. Byrd, and critical for working with COVID-19 patients so that participants could consent without worrying about contaminated paperwork.
A conference call was scheduled with the Principal Investigator at the University of Pennsylvania to review the database set up and e-consent process that had been devised. An expert MICHR database developer was able to facilitate the discussion so that both the technical and operational aspects of the project were clarified. A MICHR study management mentor also provided guidance on the use of SignNow, another e-consent tool available at the U-M. These conversations helped Dr. Byrd consider what options were available to him for e-consent and data collection prior to joining the study.
Utilizing an electronic system where participants are able to consent with e-signature authorization through a HIPAA-compliant software such as SignNow, the tool Dr. Byrd ultimately selected, allows researchers and participants to implement the study with the utmost safety and care.
“I would not be able to do this work without the support of common resources accumulated at MICHR,” Dr. Byrd explained. “I value the work I am able to do at U-M and so much of it is enabled by the MICHR team. They are fundamental to getting good clinical research done at Michigan.”