Julie Ozier, MHL, CIP, CHRC

Measuring IRB quality is often an effort to determine whether an IRB’s actions improve research participant protections.

sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.

FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.

Both sites and sponsors must consider how DCT funding and legal structures can impact sites and the study itself.

Each incidental finding has an impact on how research professionals handle the result and whether it should be shared with participants.

Read this blog to learn IRB review considerations for artificial intelligence and machine learning studies.

Local IRBs and central IRBs are not really that different, although sIRB mandates have complicated things for local IRBs.