Confidentiality Challenges and Good Clinical Practices in Human Subjects Research: Striking a Balance

Marianne ShaughnessyDepartment of Veterans Affairs and Veterans Affairs Medical CenterBaltimore Geriatric Research, Education and Clinical Center (GRECC);University of Maryland Baltimore, School of Nursing, Baltimore, Maryland.

Susan M. BeidlerChristine E. Lynn College of Nursing, Florida Atlantic Florida Atlantic, Florida.

Karen GibbsDepartment of Veterans Affairs and Veterans Affairs Medical CenterBaltimore Geriatric Research, Education and Clinical Center (GRECC), Baltimore, Maryland.

Kathleen MichaelUniversity of Maryland Baltimore, School of Nursing, Baltimore, Maryland.

Abstract

The Health Insurance Portability and Accountability Act (HIPPA) has been fully implemented in clinical practice and research settings. Although subject confidentiality has always been a concern, clinical researchers must now take extra care to attend to the mandates of privacy while also minding good clinical practice guidelines. Unanticipated conflicts may arise as a result of these dual priorities. This article presents two examples of potential challenges to confidentiality with comment from the bioethical perspective.

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Confidentiality Challenges and Good Clinical Practices in Human Subjects Research: Striking a Balance

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