Federal regulations require IRBs to include at least one non-affiliated, non-scientist member on the boards, commonly known as the "community member."
Translation of full informed consent forms into other languages can be a costly and time-consuming endeavor for researchers, particularly if there are few non-English speaking participants in a study.
Academic and medical research institutions and their IRBs often have to deal with study proposals that fall between research and quality improvement (QI).
A large health system IRB found that incomplete study submissions were clogging up the IRB review system, resulting in long waits up to three months for approval.