This new post by Mildred Solomon appears on the Health Affairs Blog as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.
Increasingly, health systems are studying their own practices in order to improve the quality of care they deliver. But many organizations do not know whether the data they collect at the point of care constitutes research, and if so, whether it requires informed consent. Further, many investigators report that institutional review boards (IRBs) place unreasonable burdens on learning activities, impeding systematic inquiry that is needed to enhance care.
As a result, some commentators have argued that our human research participant protection regulatory framework needs a dramatic overhaul. Yet, it is not the regulations that must change.
Instead, IRBs should educate themselves about quality improvement and comparative effectiveness research, exempt studies that qualify for exemption, and provide waivers to informed consent, when that is appropriate. At the Department of Health and Human Services, the Office for Human Research Protections (OHRP) must clarify the regulations that have an impact on this type of research, create better guidance about how IRBs should regulate such research, including illustrative case studies to guide IRBs.
Read the full post here.