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

Journal of Empirical Research on Human Research Ethics : JERHRE
Danielle WhicherPeter J Pronovost

Abstract

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 ...Continue Reading

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Citations

Jun 4, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Stephanie Alessi KraftDavid Magnus
Jul 13, 2019·The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics·Joshua A Rolnick
May 9, 2019·International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care·Stuart McLennan
Dec 25, 2019·Trials·Stuart G NichollsUNKNOWN Ethics of Pragmatic Trials project
Jul 25, 2019·Contemporary Clinical Trials Communications·Leonardo TamarizUNKNOWN SPRINT Research Group
Jul 8, 2016·Pediatrics·Joyce P SamuelJon E Tyson

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