TAG ARCHIVES FOR IRB

12
May2022

Years ago, I attended a conference and was handed a small button that read "I (heart symbol) Paper." Nothing resonated more deeply with me at that moment! Technology and automation may pose an inherent element of fear and unfamiliarity. The concept of change may be especially challenging to the deep-rooted paper trail practices in the field of research, no matter the phase. Read more

21
Apr2022

In the not-so-distant past, IRBs reviewing artificial intelligence and machine learning protocols were quick to give not-human subject research determinations because the application was presented as a software development project. More recently, many IRBs improperly issue exempt determinations because the application is presented as a secondary-use data project. Read more

6
Apr2022

In April of 2020, the Bioethics Research Center at Washington University School of Medicine announced a survey, aiming to understand the ethical, regulatory, and practical barriers to conducting and overseeing COVID-19 research. Principle investigator and director of the center James DuBois, DSc, PhD, is pleased to report the results of the survey. Read more

29
Mar2022

Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed three AER21 sessions on implementing OHRP and FDA regulations. In each session, the presenters dismantled any fear I had surrounding interaction with regulatory entities by offering rubber-meets-the-road application of regulatory requirements and resources to be properly prepared. Read more

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