COVID-19 presents enormous challenges to research ethics oversight. Here, we’ve begun a collection of oversight-related resources in order to best prepare our community for the operational and review concerns brought on by the viral outbreak. Read more
The IRB at the University of Wisconsin-Stevens Point is quite small, and I was curious, in attending AER19 and connecting with other HRPP professionals, how we compared with other small institutions. As a young professional in a single-staff IRB office, I was also looking for tricks of the trade to improve my limited capabilities and address challenges that arise. Clear communication with campus stakeholders and planning small improvement objectives are effective measures when working against challenges like budget, capacity, and misconceptions. Read more
Researchers at the University of Toledo invite researchers, IRB members, and research compliance staff to participate in a short survey on procedural changes implemented by HRPPs and IRBs throughout the United States in response to the COVID-19 pandemic. Read more
A team comprising Holly Taylor of the NIH Clinical Center’s Department of Bioethics; Susan Kornetsky of Boston Children’s Hospital; and Megan Kasimatis Singleton of the Johns Hopkins University School of Medicine, and myself recently completed a project examining how, in the absence of federal guidance, institutions are interpreting and applying the key information requirement and, specifically, whether and to what extent they are developing policies, guidance, templates, or other tools to help researchers and IRBs apply this provision of the Common Rule. We undertook this project as part of the Consortium to Advance Effective Research Oversight (AEREO)—a group of leaders in human research oversight, research ethics, and empirical methods dedicated to evaluating and improving the effectiveness of IRBs and HRPPs through empirical research. PRIM&R is pleased to share with the human research protections community the materials collected during this project as a public resource. Read more
COVID-19 has taken the lives of more than 120,000 people in the United States and debilitated millions more since arriving on our shores. While anyone can contract the virus, there is a pattern to who gets sick and dies from it here. Yet very few of the Tech Sector’s responses to the disease seem to acknowledge — let alone respond to — this fact. Read more
Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted. Read more
For COVID-19 clinical trials, we advise researchers to give careful thought to trials’ inclusion and exclusion criteria, make sure people are aware of and invited to participate in trials when eligible, ensure that those eligible to participate have access to studies where they live or get their care, and minimize participation burden. This piece first appeared in Health Affairs and has been cross-posted with permission. Read more
