DOE Human Subjects Resources

Quality Assurance and Quality Improvement Is it Human Subjects Research?

OHRP has characterized in detail quality assurance (QA) and quality improvement (QI) for human subjects protection programs and offers methods to implement such programs ( However, recently there has arisen a controversy as to whether quality improvement activities and QI-related research should be interpreted as human subjects research and thus be subjected to IRB review. This interpretation potentially could apply to all institutions that adhere to the introduction of a specific QI program. This issue was initiated by a news article in the Baltimore Sun and an editorial in the New York Times, December 30, 2007.

The OHRP presented a position statement in response to this editorial to help clarify the controversy ( pointing out that: "…, the regulations do not apply when institutions are only implementing practices to improve the quality of care. At the same time, if institutions are planning research activities examining the effectiveness of interventions to improve the quality of care, then the regulatory protections are important to protect the rights and welfare of human research subjects. OHRP continues to work to develop guidance to assist institutions in determining when the regulatory protections are required and appropriate and when they are not. OHRP will not stand in the way of practitioners who are only carrying out the important task of providing the highest quality of care."

AAHRPP also has provided a position statement meant to describe the issue further and states: "What AAHRPP looks for, then, is for organizations to consider each quality improvement activity on its own, in light of the federal regulatory definition of research as "a systematic investigation … designed to develop or contribute to generalizable knowledge."

In response to this issue the Secretary's Advisory Committee on Human Research Protections (SACHRPP) convened a Quality Assurance, Quality Improvement and Health Services Activities Panel ( to further review and discuss the matter. All the panel participants generally agreed that much, if not most, of QI activities should be exempt from Common Rule and IRB oversight, notwithstanding the response by OHRP to the New York Times article on this subject. DOE suggests that the presentations and slides by Donald Berwick, M.D., M.P.P., Institute for Healthcare Improvement (IHI) (SACHRP_-_Berwick_-_032708.ppt), Christine Grady, M.S.N., Ph.D., National Institutes of Health Clinical Center (QA_QI_and_Health_Services_Activities_for_SACHRP.ppt), and Nancy Dubler, LL.B., Montefiore Medical Center and Albert Einstein College of Medicine (Dubler_Sachrp--March_27_2008--FINAL.ppt) were the most salient and were the easiest to follow.

Content reviewed: November 12, 2013