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October 11, 2000

Should Patients in Quality-Improvement Activities Have the Same Protections as Participants in Research Studies?

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorPhil B.FontanarosaMD, Executive Deputy EditorIndividualAuthor

JAMA. 2000;284(14):1786-1788. doi:10.1001/jama.284.14.1783

To the Editor: Here is a real-life example that illustrates some of the ethical concerns raised when QI projects and research overlap, as described by Dr Casarett and colleagues.1 We encountered barriers from our IRB while trying to study how well our emergency department detects and follows up possible elder abuse. Concerns raised included how informed consent could be obtained and how the study should be performed to avoid increasing the occurrence of abuse. In addition, questions were posed as to how the information would be handled, what the threshold would be for reporting, and how this might adversely affect the patients. While we were struggling with these issues, it came to our attention that the state department of public health was conducting a QI project on the detection of domestic violence by surveying all women who presented to our emergency department. Because this was a QI project, there was no informed consent process. In addition, while women who responded positively were offered assistance, there was evidently no process of information sharing with the medical professionals.

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