TAG ARCHIVES FOR human subject research

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

14
Jul2021

We are part of a research group at Columbia University Irving Medical Center that is participating in the NIH-sponsored Electronic Medical Records and Genomics (eMERGE) Network study. As part of our site’s exploration of the ethical, legal, and social issues involved in research using polygenic risk scores (PRS), we are conducting a series of focus groups with stakeholders to explore views on these issues. We are interested in IRB members’ perspectives on the ethical and regulatory challenges that can arise from a study like this. Read more