The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight

Danielle Whicher, Nancy Kass, Yashar Saghai, Ruth Faden, Sean Tunis, Peter Pronovost

Research output: Contribution to journalArticlepeer-review


Recently, there have been increasing numbers of activities labeled as either quality improvement (QI) or comparative effectiveness research (CER), both of which are designed to learn what works and what does not in routine clinical care settings. These activities can create confusion for researchers, Institutional Review Board members, and other stakeholders as they try to determine which activities or components of activities constitute clinical practices and which constitute clinical research requiring ethical oversight and informed consent. We conducted a series of semi-structured focus groups with QI and CER professionals to understand their experiences and views of the ethical and regulatory challenges that exist as well as the formal or informal practices and criteria they and their institutions use to address these issues. We found that most participants have experienced challenges related to the ethical oversight of QI and CER activities, and many believe that current regulatory criteria for distinguishing clinical practice from clinical research requiring ethical oversight are confusing. Instead, many participants described other criteria that they believe are more ethically appropriate. Many also described developing formal or informal practices at their institutions to navigate which activities require ethical oversight. However, these local solutions do not completely resolve the issues caused by the blurring of clinical practice and clinical research, raising the question of whether more foundational regulatory changes are needed.

Original languageEnglish (US)
Pages (from-to)132-144
Number of pages13
JournalJournal of Empirical Research on Human Research Ethics
Issue number2
StatePublished - Apr 2015


  • Bioethics
  • Focus groups
  • IRB review
  • Informed consent
  • Qualitative methods
  • Research ethics committee

ASJC Scopus subject areas

  • Social Psychology
  • Education
  • Communication


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