TAG ARCHIVES FOR human subjects research

22
Mar2022

Ensuring that women are represented in research studies and in science fields is an important part of advancing science and ensuring that women justly benefit from research. Research done using only male animals during preclinical trials and predominantly male subjects in human clinical trials leads to knowledge gaps that negatively impact women’s treatment and health outcomes. In recognition of women’s history month, we're highlighting some PRIM&R resources that explore the importance of considering sex as a biological variable and shifting to appropriate sex balance in research studies. Read more

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