TAG ARCHIVES FOR human subjects research

8
Sep2021

IRBs come in many types, focusing on dramatically different categories of research from Phase I drug research to studies focused solely on education and social science. It may seem at first that the latter entails simpler ethical problems than, say, multisyllabic first-in-human drug trials for cancer, but very low-risk nonmedical research presents its own challenges for the IRB. Read more

25
Aug2021

As hospitals have become essential treatment centers for COVID-19 patients, clinical trial participants have become increasingly averse to attending check-ups and monitoring visits at these sites. Telemedicine is now being recognized not only as an option for those who do not have convenient access to healthcare, but also as a means by which clinical trials can be accomplished. Read more

18
Aug2021

The digitization of everyday life has led to an interesting phenomenon for research administrators; the ethical concerns that arise from secondary uses of large and open data now pose a greater challenge for the ethical management of research data than do the conventional challenges of primary data acquisition. As debates over consent forms give way to discussions of differential privacy, it is hard to ignore the new reality that the highest levels of risk and benefit to human participants in research may now arise from secondary data uses. What should research administrators and IRB members do to understand and manage the risks and benefits? Read more

14
Apr2021

The new PRIM&R Knowledge Center houses a wide range of resources to keep you inspired and informed for your work in research ethics and oversight! As you familiarize yourself with the Knowledge Center, we want to direct you to some of our top resources. First up in this blog series, our Discussion Guides, which now available individually in the Knowledge Center to help you deepen your understanding of journal articles and other resources by providing a guide for individual review or fostering group discussion. Read more

19
Jan2021

Last year, Heather H. Pierce, JD, MPH and I shared some thoughts about the Belmont Report at 40, and about the evolution and flexibility of the Belmont principles of respect for persons, beneficence, and justice in the face of changing circumstances. As we leave behind the extraordinary year of 2020, I have been thinking about how the pandemic, together with the Black Lives Matter social justice movement, has shone new, and I would say welcome, light on the principle of justice in research. Read more