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
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
While the emails I'm getting from various organizations imply that 2022 will be a return to travel and hotel conference centers, many conferences—including the 2022 PRIM&R Annual Conference—will continue to have a virtual conference option. After a full year of attending virtual conferences, I'd like to reflect on what worked for me and what didn't. Read more
The data collected from mobile mental health apps has promising benefit toward the field of mental health. The risks are usually limited to breach of confidentiality and investigators mitigate those risks by implementing processes to protect access to the data. In studies involving algorithms and personalized medicine, the risks increase. So, how do IRBs determine when risks outweigh the benefits? Read more
Amidst the COVID-19 pandemic, it has become clear that rather than combat infectious disease by focusing research on an individual pathogen, efforts need to be shifted to take a One Health approach which focuses on three domains: humans, animals, and the environment, and their intersection during a disease outbreak. Read more
