TAG ARCHIVES FOR human subject research

27
Sep2022

Research participants who discuss their research participation online may unintentionally disclose information that increases the risks of the research to themselves or others. These risks include unblinding study participants or the research team, communicating incorrect information, or inadvertently licensing participant behaviors that conflict with study requirements, each of which may potentially threaten study integrity and/or participant safety. Read more

23
Jun2022

In recognition of Pride Month, we'd like to highlight some resources—both from PRIM&R and from other organizations—that explore the importance of recognizing and including LGBTQIA+ people in research, strategies for reviewing LGBTQIA-specific research, and the unique ethical considerations for research with LGBTQIA+ populations (particularly children and youth). 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

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