7
Jul2020

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

24
Jun2020

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

18
Jun2020

"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

11
Jun2020

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

8
Jun2020

The current pandemic, like all public health crises, forces us to confront difficult questions about how best to find cures or treatments for a disease that is rapidly taking many lives. Although some may argue that the extreme nature of our current circumstances requires throwing out our prior ethical assumptions, we could not disagree more. Adhering to long-established and widely accepted principles of human research ethics must remain an essential component of our efforts to combat COVID-19. Read more