In reflecting on the SBER19/AER19 opening remarks by PRIM&R's Executive Director, Elisa A. Hurley, PhD on the relevance of the Belmont Report today, I feel that the Belmont Report continues to be relevant and maybe more applicable than we think dat-to-day, especially for communities intertwined with their members. Though the Belmont Report is an old document, it can always be seen with new eyes and new perspectives. 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
Attending the 2018 Advancing Ethical Research (AER) Conference was a fantastic opportunity to connect with colleagues, hear renowned speakers address regulatory hot topics, and share ideas and best practices. Science and technology are expanding exponentially; as a result, our research community is becoming increasingly diverse and multi-center research is booming. While historically the regulations have remained relatively unchanged, in recent years the regulatory community has worked together to provide feedback on suggested major updates and new guidance which are greatly shifting the regulatory world. This year's AER Conference takes place November 18-20, 2019 in Boston, MA Read more
I am a researcher working in an inner-city neighborhood serving a disadvantaged population. As such, I found the session “Navigating uncertainty: Research with Undocumented Immigrants” at the 2018 Advancing Ethical Research Conference quite relevant to my practice. This presentation helped me to understand the vulnerability of undocumented individuals involved in research. A person's documentation status may be a risk factor for health disparities; however, undocumented individuals should not be automatically excluded from research. Read more
Past disregard for human rights in studies such as the Tuskegee experiment, has left some individuals (rightly so) with an inherit distrust of the clinical research process. Over time, increased regulatory oversight of the clinical research environment was put into effect to protect those who participate in research, particularly those who might be more vulnerable. But sometimes the regulations don’t keep up with developments in the modern research enterprise. Read more
