TAG ARCHIVES FOR AER21 Blog Squad

28
Jul2022

Hopefully the pandemic is not here to stay, but even when it's gone, I suspect work from home for research administrators will stay in one form or another for many people. Because in the end, it's not just the HRPPs going virtual: the entire research administrative enterprise is in this virtual world with them. Read more

30
Jun2022

The three largest concerns around the ethics of AI/ML in artificial intelligence human subject research are explainability, identifiability, and algorithmic bias. It is imperative that IRBs understand the AI/ML’s explainability in order to fulfill their responsibility of adequately assessing the risk-benefit ratio in AIHSR. Read more

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

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