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Journal of the American Psychiatric Nurses Association
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HIPAA's Preconsent: Impact on Study Validity

Michael J. Rice

College of Nursing and Healthcare Innovation, Arizona State University, Phoenix, Arizona, Michael.Rice{at}asu.edu

Kathie Records

College of Nursing and Healthcare Innovation, Arizona State University, Phoenix, Arizona

The Health Insurance Portability and Accountability Act (HIPAA) regulations added potential validity threats to clinical studies. The HIPAA regulations, using the principle of patient autonomy were designed to increase patient's control over the all health related information. The Department of Health and Human Services did not identify rules related to research regulations believing HIPAA regulations facilitate investigations through use of de-identified information. Yet, under HIPAA guidelines, health care agencies can not allow access because of the need to obtain a patient's prior permission to release raw data. The problem of how to conduct investigations in the face of the HIPAA "Privacy Rule" raises concerns for effects on subject recruitment and selection. This paper examines the impact of obtaining a HIPAA preconsent on subject recruitment, selection, and subject characteristics, and offers strategies for addressing the validity threats associated with the HIPAA regulations. J Am Psychiatr Nurses Assoc, 2008; 14(3), 225–230. DOI: 10.1177/1078390308319224

Key Words: HIPAA • privacy • personal health information • confidentiality • preconsent • study validity • common rule • IRB

Journal of the American Psychiatric Nurses Association, Vol. 14, No. 3, 225-230 (2008)
DOI: 10.1177/1078390308319224
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