Panel II: Weeding Out Useless Research: What’s an IRB to Do?

Questions not answered from the live session, along with responses, can be accessed by clicking on the Session Handouts button below next to Alex London's name.

There is ample evidence that many clinical research studies fail to yield scientific value. Such “uninformative” research is a source of waste and it raises important participant protections issues, given the risks of research are typically justified by an assumption that studies will yield scientific value. Despite the broader recognition that uninformative research studies can cause potential harms to participants and to the research enterprise, this issue remains largely unaddressed in practice by research stakeholders, including IRBs. As a result, uninformative trials continue to be initiated in large numbers. This panel will review the underlying ethical concerns, as well as provide data regarding the main causes of uninformative studies in both biomedical and social science research. Speakers will discuss potential practical approaches IRBs or other oversight bodies can take to ensure that any proposed trial is not unnecessarily redundant with, and is informed by, existing/past trials. A proposal of operational standards for assessing scientific value will be presented.