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

28
May2020

Researchers in the Department of Bioethics at the National Institutes of Health invite IRB members to participate in a short study related to pediatric research ethics. The purpose of the study is to explore and compare the views of members of the general public and the views of members of IRBs on various types of medical research with children. The information collected is intended to inform how IRBs evaluate the ethical acceptability of proposed medical research in the future. Read more

19
May2020

The proposed Supplement subverts the aims of scientific transparency in a manner that potentially harms public health, increases time and resource burdens on scientists, and threatens to reduce the ability of researchers to recruit study subjects. PRIM&R joins stakeholders in urging the EPA to reconsider the rule, so that vital, potentially life-saving research may continue. Read more