In cancer research findings that could have implications for other diseases and human subjects, investigators found that patients with annual household income below $50,000 were 32% less likely to participate in a clinical trial.
When in doubt, document. That may be the best default position for IRBs based on draft federal guidelines created in part because some boards were being cited or warned about having inadequate meeting minutes.
Students at Columbia University in New York City have expressed curiosity and concern about an ongoing ethnographic study wherein researchers observe their behavior in public settings that have included bars and parties in campus housing. One student termed it “pretty weird and uncomfortable,” while others said the researchers were friendly and forthcoming.
Among the anticipated changes with the Common Rule’s recent Notice of Proposed Rulemaking (NPRM) is a shift from having IRBs make exempt determinations to researchers using an exempt status tool to make their own determination.
When researchers told the Cornell University IRB in a survey how difficult it was to determine whether a study should be submitted for IRB review, the IRB office created a tool that would make it easier for researchers to make the correct choice.