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
"Protecting human subjects is more than IRB review." The 2019 Advancing Ethical Research Conference session "Use It or Lose It- Recalibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate" began with a statement we HRPP professionals know, but sometimes need to hear as a reminder to advocate for the needs of both the Human Research Protection Program (HRPP) and IRB Office. The lines often blur between the roles of the HRPP and those of the IRB, and for the most part our jobs involve responsibilities that cover both. Read more
When I started my research career back in 2004, I was working in the biggest trauma center in the Atlanta area, Grady Healthcare System. I had arrived in the country under a work visa to help with the Department of Orthopaedics' clinical trials. I remember the nervousness of speaking to potential study participants because I was not only new to clinical research, having only done chart review projects in the past, I was also new in America and America’s history of research with minorities. Now, after all these years working as a research coordinator and IRB professional, and living in the United States for more than 15 years, I know how important it is to rebuild trust and increase minority participation in research to ensure not only that we are doing quality studies, but also that we help in diminishing the social injustices our communities still undergo today. Read more